Title 32 Ill. Adm. Code — Energy

Chapter I Department of Commerce and Community Affairs

Part 100 Administration of the Illinois Coal and Energy Development Bond Act

32 Ill. Adm. Code 100.10 Authority

The Department of Energy and Natural Resources, having been created pursuant to "An Act in relation to natural resources, research, data collection and environmental studies" (Ill. Rev. Stat. 1981, ch. 96 ½, par. 7401(d)), has been designated by the General Assembly to exercise certain powers and perform certain duties in accordance with the Illinois Coal and Energy Development Bond Act (Ill. Rev. Stat. 1981, ch. 96 ½, pars. 4101 et seq.).

32 Ill. Adm. Code 100.20 Definitions

"Act" means "An Act to provide for the financing of a State program for research, development and demonstration in coal and energy; to authorize the issuance and sale of general obligation bonds of the State of Illinois; and to provide for the payment of the principal of and interest on such bonds," which Act is otherwise known as the Illinois Coal and Energy Development Bond Act.

"Agreement" means a signed and written document which defines and describes the rights and obligations of the Contractor and the Department in respect to a Project for the Development of Coal and Other Energy Resources.

"Application" means that written document submitted by an applicant for State Funding which conforms to the form and content of Section 100.30 hereof.

"Bonds" mean the general obligation bonds of the State of Illinois which are authorized to be issued, sold and retired in accordance with the manner set forth in the Act, the aggregate principal amount of which is $70,000,000.

"Coal" or "Coal Resources" means coal, coal products or by-products, including electricity, synthetic fuels, gas and liquefaction.

The "Commission" means the Illinois Energy Resources Commission which is established pursuant to "An Act creating the Illinois Energy Resources Commission and defining its powers and duties" (Ill. Rev. Stat. 1981, ch. 96½, par. 101).

"Contractor" means any business, industrial, university, governmental or other qualified individuals or organizations with whom the Department enters into an Agreement to promote Development of Coal and Other Energy Resources.

"Department" means the Department of Energy and Natural Resources of the State of Illinois.

"Development of Coal and Other Energy Resources" means research, development and demonstration of improved methods of discovery, production, transportation, sale, distribution, conversion, end-use and waste disposal of Coal and Other Energy Resources.

"Director" means the Director of the Department.

"Eligible Project" means that Project for which previous approval of the Commission has been granted and for which funds are authorized to be expended pursuant to the purposes specified in the Act (Ill. Rev. Stat. 1981, ch. 96½, par. 4103), which purposes include, but are not limited to, the following:

"the commercial application of existing technology for development of coal resources,

to initiate or complete development of new technology for development of coal resources, and

for planning, design, acquisition, development, construction, improvement and financing a site or sites and facilities for establishing plants, projects or demonstrations for development of coal resources, and research and development of other forms of energy."

"Other Forms of Energy" means solar energy, geothermal, wind generation, solid waste or any other energy system except that which is generated by nuclear energy.

"Other Funding" is that amount which shall be paid by the Contractor(s) or other Project participants and which, when added to State Funding, shall equal the Total Project Cost.

"Project" means the proposal of work to be done as described in the Application.

"State Funding" is that portion of Total Project Cost which the Department shall pay to the Contractor(s), the amount of which has received prior approval of the Commission.

"Total Project Cost" means all necessary and reasonable costs related to the completion of the Project, but does not include administrative, travel or promotional costs incurred by the Contractor or other Project participants prior to the execution of an Agreement.

32 Ill. Adm. Code 100.30 Application

a) The Application shall be in writing and consist of one (1) original and five (5) copies which shall be submitted to the Director of the Department of Energy and Natural Resources, 325 West Adams Street, Room 300, Springfield, Illinois 62706.

b) Except as provided in subsection (c) hereof, each Application shall contain categories of information which shall include, but are not limited to, the following:

1. Technical Proposal

A) Table of Contents

B) Synopsis of Proposal

C) Project Objectives

D) Project Schedule by Task

E) Site and Facility Location

F) Process Selection and Design

G) Technical Feasibility of Project

H) Engineering, Procurement, Construction and Operation

I) Product Testing

J) Environmental Feasibility

K) Socio-Economic Impact

L) Future Use of Project Results and Facility

M) Other Relevant Information

2. Business Proposal

A) Table of Contents

B) Summary of Total Project Costs

C) Cost-Sharing Formula including Form and Amount of Other Funding

D) Summary of Estimated Costs by Cost Element

E) Basis of Cost Estimate

F) Schedule of Payments for Total Project Costs

G) Economic Feasibility of Project

H) Management Plan and Experience

I) Previous Work in Project Area

J) Key Personnel and Resources

K) Financial Statement(s) of Applicant

L) Justification of State of Illinois Project Involvement

M) Other Relevant Information

c) If the Applicant determines that any of the Application contents, as described in subsection (b), are irrelevant or not applicable to the proposed Project, the Applicant shall fully explain reasons for that conclusion.

d) The Department may, in its discretion, request the Applicant to furnish information in addition to that which is otherwise required in this Section in order to conduct a proper review.

32 Ill. Adm. Code 100.40 Department Review Procedures

a) The Application shall be reviewed by the Department and the Director may, in his discretion, obtain the assistance of other persons and entities either within or outside State government to assist in this review procedure. Such assistance may include professional consultants, such as accountants, architects, attorneys, engineers, planners, etc., applying ordinary professional standards to such review to the extent the Department, pursuant to its administrative abilities, is lacking professional and technical services required to assess feasibility, adequacy, sufficiency and other relevant factors contained in the Application.

b) The time required by the Department to conduct its review of the Application will be determined by some or all of the following factors:

1. the scope and complexity of the proposed Project;

2. the number of other Applications under concurrent review by the Department;

3. the availability of staff and administrative finances of the Department; and

4. the sufficiency and accuracy of the Application.

c) Subsequent to review by the Department, the applicant shall be notified of the conclusion of the Department's evaluation.

32 Ill. Adm. Code 100.50 State Funding

a) The Department allocates State Funding pursuant to statutory language of the Act, which provides that:

"The State of Illinois is authorized to issue, sell and provide for the retirement of general obligation bonds of the State of Illinois in the amount of $70,000,000, hereinafter called "Bonds," $65,000,000 of which shall be for the specific purposes of acquisition, development, construction, reconstruction, improvement, financing, architectural and technical planning and installation of capital facilities consisting of buildings, structures, durable equipment, and land for the purpose of capital development of coal resources, and $5,000,000 of which shall be for research and development of other forms of energy."

b) The Department has the power to recommend an amount of State Funding for a proposed Project to the Commission which amount and which proposed Project must be approved or rejected by the Commission within 45 days of the receipt of the proposal by the Commission.

c) The Department shall exercise its power to recommend an amount of State Funding to the Commission for its approval after

1. making a determination that the Project is a qualifying Project pursuant to Section 100.40 hereof, and

2. consideration of factors which include, but are not limited to, the following:

A) the market potential for the increased use of Illinois Coal, Coal Resources or Other Forms of Energy;

B) the transferability of the proposed Project results to commercial applications capable of utilizing Illinois Coal, Coal Resources or Other Forms of Energy;

C) the potential profit or proprietary benefits which will be derived from the Project by the Contractor and other Project participants, if any;

D) the ability of the Contractor or other Project participants to obtain funding from sources other than the State of Illinois;

E) the amount of State Funding in relation to the amount of Total Project Cost and the amount of other Funding; and

F) the other anticipated direct and indirect benefits of the Project to the State of Illinois.

32 Ill. Adm. Code 100.60 Agreement

Subsequent to Commission determination of an Eligible Project, the Department and the Contractor(s) shall commence to enter into an Agreement, the terms and conditions of which are subject to negotiation between the partners.

Part 110 Administration of the Illinois Industrial Coal Utilization Program

32 Ill. Adm. Code 110.10 Purpose and Scope

a) The purpose of the Illinois Industrial Coal Utilization Program is to increase the environmentally sound use of Illinois Coal by Illinois manufacturers and industries. (Section 9 of the Build Illinois Bond Act as amended by P.A. 84-1070, effective November 27, 1985, hereafter sometimes referred to as "the Act").

b) The Department is authorized to use monies deposited in the Illinois Industrial Coal Utilization Fund, the Build Illinois Purposes Fund or the Build Illinois Bond Fund, subject to appropriation, and to accept guarantees from individuals, partnerships, joint ventures, corporations and governmental agencies for the purpose of implementing a revolving loan program to partially finance new coal burning facilities or conversion of existing facilities to Illinois Coal use.

c) The Department, subject to the approval of the Illinois Coal Development Board, is authorized to make below market rate loans available for Industrial Coal Projects. Any loan or series of loans shall be limited to an amount not to exceed the lesser of $2,500,000 or 25% of the Total Project Cost.

32 Ill. Adm. Code 110.20 Definitions

"Act" means the Build Illinois Bond Act, as may be amended from time to time. (P.A. 84-111, effective July 25, 1985 as amended by P.A. 84-1070 effective November 27, 1985).

"Additional Financing" is the amount of financing needed from other sources which when added to State Financing shall equal the Total Project Cost as stated on the loan application.

"Applicant" means any manufacturer or industry doing business in Illinois who has submitted a written application to the Department for participation in the Illinois Industrial Coal Utilization Program.

"Board" means the Illinois Coal Development Board.

"Borrower" is an Applicant whose application for State Financing has been approved by the Board.

"Department" means the Department of Energy and Natural Resources of the State of Illinois.

"Director" means the Director of the Department of Energy and Natural Resources of the State of Illinois.

"Financial Advisory Committee" is a seven member committee appointed by the Director which shall advise the Department on the financial status of the application. Six members shall be representatives from the Illinois financial community and one member shall be a representative from the Department.

"Illinois Coal" means coal mined in Illinois.

"Industrial Coal Project", hereinafter sometimes referred to as "Project", means any new environmentally sound coal burning facility sited in Illinois or conversion of existing facility located in Illinois to coal use, in an environmentally sound manner.

"Program" means the Illinois Industrial Coal Utilization Program.

"State Financing" is that portion of Total Project Cost which the Department shall loan to the Borrower, the amount and terms of which have received prior approval of the Board.

"Total Project Cost" means only those estimated capital costs that include expenditures for the planning, engineering, acquisition, construction, improvement and conversion of facilities and equipment which will foster the environmentally sound use of Illinois Coal related to the completion of the Industrial Coal Project as shown on the loan application, but does not include corporate administrative, travel, or promotional costs incurred by the Applicant or other Project participants.

32 Ill. Adm. Code 110.30 Solicitation of Industrial Coal Projects

a) The Department will issue solicitation(s) for applications to the Program when moneys are available. Notice of the solicitation for applications shall be published in the official State newspaper and otherwise publicized through press releases, contacting interested parties on the Department's mailing list(s), trade publications, and through other appropriate channels.

b) Applicants shall have forty-five (45) days from the date of announcement of the solicitation to submit their applications to the Department.

c) Notwithstanding Section 110.30(a) of this Part, the Department will accept unsolicited applications for funding under the Program and shall review such applications according to the same guidelines stated in this Part. Consideration of unsolicited applications shall be made on a first-come first-serve basis, subject to the availability of funds to the Department for the Program.

32 Ill. Adm. Code 110.40 Application

a) The application shall be in writing and consist of one (1) original and five(5) copies which shall be submitted to: Manager, Illinois Industrial Coal Utilization Program, Illinois Department of Energy and Natural Resources, 325 W. Adams, Room 300, Springfield, IL 62704.

b) Except as provided in subsection (4) below, each application shall contain categories of information which shall include, but are not limited to, the following:

1. Summary of Proposed Project

A) General description of the Industrial Coal Project.

B) General description of the Applicant including a history of the Applicant's present business, number of employees, days and hours of operation, products, etc., for which the Industrial Coal Project is to be established.

C) Curriculum vitae of the Applicant's project manager, and managers of the Project's engineering, construction and operation.

D) General description of the Project site.

E) Such plans, equipment lists or other documents which contribute to an understanding of the type, structure and general character of the Project.

F) Preliminary engineering and cost estimates for the development, construction or acquisition of new facilities or the modification of existing facilities to be accomplished in the Industrial Coal Project.

G) Estimated Total Project Cost.

H) Project schedule.

I) General description of the expected use of Illinois Coal resulting from the Project, including estimated annual usage and length of commitment to use Illinois Coal.

J) Methods of handling wastes and compliance with existing emission standards.

K) Lists of known permits, licenses and other authorizations as required by governmental agencies or others.

L) Other relevant information which the Applicant wishes the Department to consider in its review of the application.

2. Financial Information

A) Certified financial statements for the previous three years.

B) Projections and forecasts of the next three years' profit and loss statements.

C) Financial statement(s) of Applicant.

D) Curriculum vitae of President, Vice President, Secretary and Treasurer of Applicant.

E) Proposed financing plan.

i) Percentage of Total Project Cost and dollar amount to be provided by State Financing.

ii) Percentage of Total Project Cost to be provided by Additional Financing, identified by source and dollar amount, and percentage contribution to the Project.

iii) Requested length of term of loan.

iv) Certification that the Project would not occur without State Financing.

F) Letter of commitment by Applicant to burn Illinois Coal for a specified period of time. The Applicant must commit to the use of Illinois Coal for at least the duration of the loan.

G) Financial evaluation(s) of the Applicant and Project completed by the provider(s) of Additional Financing, excluding any confidential business information.

H) Letter of commitment from each provider of Additional Financing.

I) Statement of value of any property and improvements thereto provided or to be provided for the Project by other sources, prepared by an independent Certified Public Accountant.

J) Other relevant information.

3. Certification by Applicant that the information provided is accurate.

4. If the Applicant determines that any of the application contents, as described in subsections (1) and (2) are irrelevant or not applicable to the proposed Industrial Coal Project, the Applicant shall fully explain the reasons for that conclusion.

32 Ill. Adm. Code 110.50 Application Review Procedures

a) The Department, with assistance from the Financial Advisory Committee, shall evaluate applications for loans and make such evaluations available to the Board. Evaluation of the loan applications shall be based on, but not limited to, the following criteria: (Section 10 of the Act)

1. The length of time the Applicant will commit to using Illinois Coal in the facility which is modified, acquired or constructed as a result of the Project. The Applicant must agree to use Illinois Coal for at least the life of the loan as a condition of such loan. (Section 10 of the Act)

2. The total amount of Illinois Coal used. (Section 10 of the Act)

3. The financial feasibility of the Project, the percentage of the Total Project Cost for which State Financing is requested, and the extent to which the Project maximizes the use of private funds or funds from other public sources. To be financially feasible the Project must have a positive net present value and an internal rate of return equal to or greater than the cost of capital. (Section 10 of the Act)

4. The technical merits of the Project, including but not limited to the effectiveness of the proposed coal-use system in controlling emissions of sulfur dioxide and other pollutants. The Project's technology must be commercially proven and commercially available. (Section 10 of the Act)

5. The environmental acceptability of the Industrial Coal Project, including the percentage reductions of sulfur dioxide, nitrous oxides and other pollutants. The Industrial Coal Project must comply with all applicable environmental regulations.

6. The type and quantity of fuel displaced by the Industrial Coal Project.

7. The amount of additional loan security provided by the Applicant to the Department, if any.

b) Following its evaluation of the application, the Department shall make a recommendation to the Board regarding the advisability of providing State Financing for the proposed Industrial Coal Project. The Department shall rank the proposals on the above criteria and recommend for funding to the Board the Projects with the lowest cumulative scores.

c) The Department shall use its best efforts to complete the evaluation of applications received and to make its recommendation to the Board in a timely manner.

32 Ill. Adm. Code 110.60 Determination by the Illinois Coal Development Board

a) The Board shall review the recommendations of the Department and shall have final authority for the approval of State Financing for any Industrial Coal Project. In making its determination, the Board shall consider the recommendations of the Department and its Financial Advisory Committee, and shall utilize the evaluation criteria set forth in Section 110.50 of these rules.

b) The Applicant shall be promptly notified in writing of the Board's determination.

32 Ill. Adm. Code 110.70 State Financing

a) The Department allocates State Financing pursuant to the statutory language of the Act, which provides that:

"The Department subject to the approval of the Illinois Coal Development Board shall make below market rate loans available to fund a portion of each qualifying [I]ndustrial [C]oal [P]roject." (Section 9 of the Act)

b) The interest rate for State Financing shall be fixed for the period of the loan and shall not exceed 5% per year. The Department shall annually set the interest rate for all loans that will be issued during the next twelve months based upon the following considerations:

1. current economic conditions;

2. leading interest rate indicators;

3. ability of the State to maximize financial returns to the Illinois Industrial Coal Utilization Fund;

4. potential to sustain the Program through loan repayments;

5. projected availability of other State funds for the Program; and

6. ability of the State to obtain a sufficient number of Applicants for the Program.

c) The period of the loan shall be the term requested by the Applicant, but in any event shall be at least seven years but no longer than ten years.

d) Any loan or series of loans shall be limited to an amount not to exceed the lesser of $2,500,000 or 25% of the Total Project Cost. (Section 9 of the Act)

32 Ill. Adm. Code 110.80 Loan Agreement

After an Industrial Coal Project has been approved by the Board, the Department and the Borrower shall execute a loan agreement. The loan agreement shall, at a minimum, require a letter of certification from the Borrower's fiscal officer or accountant stating that State Financing shall be applied only to the Industrial Coal Project, as described in the application and approved by the Board. The agreement shall include a statement signed by the Borrower certifying that it will comply with the terms and conditions of State Financing provided in connection with the Project and the Program. The loan agreement may specify actions necessary or appropriate to protect the State's interest in the event of default, foreclosure or noncompliance with the terms and conditions of the loan provided under the Program, including the power to sell, dispose, lease or rent, upon terms and conditions deemed to be appropriate by the Department, real or personal property which the Department may receive as a result thereof. (Section 12 of the Act)

32 Ill. Adm. Code 110.90 Repayment of State Financing

a) The Borrower shall repay State Financing with interest in accordance with the terms and conditions of the agreement between the Borrower and the Department.

b) Funds repaid to the State under this Program shall be placed in the Illinois Industrial Coal Utilization Fund to be used for the purposes of the Program, subject to appropriation.

Chapter I Department of Commerce and Economic Opportunity

Part 120 Administration of the Coal Grant Provisions of the Illinois Resource Development and Energy Security Act

32 Ill. Adm. Code 120.10 Purpose

a) The Illinois Resource Development and Energy Security Act [20 ILCS 688] authorizes the State of Illinois, through the Department of Commerce and Economic Opportunity, formerly known as the Department of Commerce and Community Affairs, to promote the development of new, coal-fired electric generation capacity in Illinois. The purpose and scope of the Act is the enhancement of the State's energy security by insuring that:

1. the State's vast and underutilized coal resources are tapped as a fuel source for new electric generating plants;

2. the electric transmission system within the State is upgraded to more efficiently distribute additional amounts of electricity;

3. well-paying jobs are created as new electric plants are built in regions of the State with relatively high unemployment; and

4. substantial grant funds and the full faith and credit of the State of Illinois are made available to facilitate investments in the State's energy infrastructure to achieve economic development within the Illinois coal industry and insure energy security for Illinois citizens.

b) The Department of Commerce and Economic Opportunity Law of the Civil Administrative Code [20 ILCS 605/605-332] authorizes the Department to provide financial assistance to eligible businesses for new electric generating facilities from funds appropriated by the General Assembly. Financial assistance will be provided to eligible applicants in the form of a grant through the Coal Revival Program.

History

• Source: Amended at 29 Ill. Reg. 1195, effective January 5, 2005

32 Ill. Adm. Code 120.20 Definitions

The following definitions are applicable to this Part:

"Act" means the Illinois Resource Development and Energy Security Act [20 ILCS 688].

"Agreement" means a written document executed between the grantee and the Department defining the rights and obligations with respect to the project.

"Applicant" means an entity, as defined in Section 120.30 of this Part, submitting a written request for program funds appropriated under the Act.

"Baseload" means the minimum amount of power delivered or required over a given period of time at a steady state.

"Coal Revival Program" means the Illinois Resource Development and Energy Security Act grant program described in this Part.

"Department" means the Department of Commerce and Economic Opportunity, formerly known as the Department of Commerce and Community Affairs.

"Director" means the Director of the Department of Commerce and Economic Opportunity, formerly known as the Department of Commerce and Community Affairs.

"Eligible business" means an entity that proposes to construct a new electric generating facility and that has applied to the Department to receive financial assistance pursuant to this Part. [20 ILCS 605/605-332(a)]

"Full-time equivalent job" means the number of employees required to equal one full-time employee. For purposes of this definition, employee means a person who works a minimum of 35 hours per week for a minimum of 13 consecutive weeks.

"Grant amount" means an amount that the Department shall pay to a grantee for its use on an eligible project.

"Grantee" means an entity, as defined in Section 120.30 of this Part, eligible to receive program funds appropriated under the Act.

"Illinois coal mining job" means:

a full-time equivalent job in an Illinois coal mine, not including a call back from a layoff, created after July 1, 2001; or

after July 1, 2001, an additional purchase of 9,691 tons of Illinois-mined coal per year (an amount equal to the average annual coal produced per Illinois coal miner, calculated by dividing the total Illinois coal production by the total number of Illinois miners, as reported to the Department of Natural Resources for inclusion in the Office of Mines and Minerals Annual Statistical Report for calendar year 2000).

"New electric generating facility" means a newly-constructed electric generation plant or a newly constructed generation capacity expansion at an existing facility, including the transmission lines and associated equipment that transfers electricity from points of supply to points of delivery, and for which foundation construction commenced not sooner than July 1, 2001, which is designed to provide baseload electric generation operating on a continuous basis throughout the year, and which has an aggregate rated generating capacity of at least 400 megawatts for all new units at one site, uses coal or gases derived from coal as its primary fuel source, and supports the creation of at least 150 new Illinois coal mining jobs. [20 ILCS 605/605-332(a)]

"Project" means the activities described by the applicant in the grant application and approved by the Department.

History

• Source: Amended at 29 Ill. Reg. 1195, effective January 5, 2005

32 Ill. Adm. Code 120.30 Eligible Applicants

Businesses eligible for funding consideration under the Coal Revival Program must meet all of the following criteria:

a) construct a new electric generating facility or a new expansion at an electric generating facility, including transmission lines and associated equipment that transfers electricity from the points of supply to points of delivery;

b) provide baseload electric power operating on a continuous basis throughout the year;

c) construct a new facility or facility expansion that will have an aggregate nameplate generating capacity of 400 megawatts (MW) or more for all units at one site;

d) commence foundation construction on or after July 1, 2001;

e) use Illinois coal or gases derived from coal as its primary fuel source at the proposed facility; and

f) propose a facility or facility expansion that supports the creation of at least 150 new Illinois coal mining jobs.

As an alternative means of determining minimum eligibility under the program, job creation may be indirectly determined from quantities of coal purchased annually, based on the average amount of coal produced per Illinois miner in calendar year 2000, as published in the Annual Statistical Report of the Division of Mines and Minerals, Illinois Department of Natural Resources. The average Illinois miner produced 9,691 tons of coal in calendar year 2000.

History

• Source: Amended at 29 Ill. Reg. 1195, effective January 5, 2005

32 Ill. Adm. Code 120.40 Eligible Uses of Grant Funds

a) The grant amount may be used for capital facilities consisting of buildings, structures, durable equipment and land at the new electric generating facility.

b) Funding for the Coal Revival Program is derived from the sale of general obligation bonds issued by the State of Illinois. This funding source imposes limits on the use of program funds. When authorized, general obligation bonds will be sold in increments and grants awarded to successful applicants upon certification by the Governor's Office of Management and Budget that the State portion of the projected tax receipts will equal or exceed 110% of the maximum annual debt service over the 25-year life of the bonds. State sales taxes from coal used by new plants will be set aside and transferred to the general obligation bond retirement and interest fund to retire these bonds.

History

• Source: Amended at 29 Ill. Reg. 1195, effective January 5, 2005

32 Ill. Adm. Code 120.50 Allocation of Appropriations

Annual appropriations made by the General Assembly to the Department for the purpose of providing grants under Section 605-332 of the Civil Administrative Code of Illinois [20 ILCS 605/605-332] for new electric generating facilities are allocated by the Department.

32 Ill. Adm. Code 120.60 Funding Limitation

In accordance with Section 605-332 of the Civil Administrative Code of Illinois [20 ILCS 605/605-332], the Department may provide financial assistance not to exceed the amount of State general obligation debt as certified by the Governor's Office of Management and Budget, the amount of capital investment in the energy generation facility, or $100,000,000, whichever is less.

History

• Source: Amended at 29 Ill. Reg. 1195, effective January 5, 2005

32 Ill. Adm. Code 120.70 Pre-Qualification Request (repealed)

History

• Source: Repealed at 29 Ill. Reg. 1195, effective January 5, 2005

32 Ill. Adm. Code 120.80 Form of Pre-Qualification Request (repealed)

History

• Source: Repealed at 29 Ill. Reg. 1195, effective January 5, 2005

32 Ill. Adm. Code 120.90 Pre-Qualification Evaluation Procedure (repealed)

History

• Source: Repealed at 29 Ill. Reg. 1195, effective January 5, 2005

32 Ill. Adm. Code 120.100 Application Request

a) Potential applicants are encouraged to advise the Department of their intent to apply to the program prior to submitting a formal application. The Department may request a written or oral description of the proposed project and other information regarding the likely economic and environmental impacts of the project. The Department may, at its discretion, provide potential applicants with a preliminary assessment of their eligibility for the program provided that sufficient project information is presented by the applicant.

b) Grant applications should be submitted in accordance with the following guidelines:

1. Application to the Coal Revival Program can be made only after the Illinois Environmental Protection Agency has issued a draft construction permit for the facility.

2. Applicants may submit brochures and other presentations only as necessary to present a complete and effective application.

3. The Department may require applications to be clarified or supplemented through additional written submissions or oral presentations.

4. One original and 5 copies of each grant application shall be submitted to the Coal Revival Program Coordinator, Office of Coal Development, Illinois Department of Commerce and Economic Opportunity, 620 East Adams Street, Springfield IL 62701-1615.

5. Applicants are discouraged from submitting confidential information since materials submitted in conjunction with an approved Coal Revival Program funding request are subject to disclosure, in response to requests received under provisions of the Freedom of Information Act [5 ILCS 140]. Information that could reasonably be considered to be proprietary, privileged or confidential commercial or financial information should be identified as such in the application. The Department will maintain the confidentiality of that information only to the extent permitted by law.

History

• Source: Amended at 29 Ill. Reg. 1195, effective January 5, 2005

32 Ill. Adm. Code 120.110 Form of Application

a) Applications to the Coal Revival Program for grant funds may be submitted to the Department at any time.

b) The grant application should include, but not be limited to, the following information:

1. Grant Application Cover Page. Form to be obtained from the Department's Office of Coal Development and completed by the applicant;

2. Ownership Disclosure. Identification by name of those businesses or entities with 10% or more ownership of the new electric generating facility, with the percent ownership for each set forth;

3. Performance Disclosure. As asserted against the applicant, or any parent organization or holding company of the applicant, identification of all pending or unresolved violations of State or federal laws or regulations that could result in legal or regulatory impact on the operation of the electric generating facility. All State and federal permits required for the operation of the facility should be identified. If the applicant does not have relevant or necessary operating permits, identification of the status of any permit applications and anticipated date of permit issuance;

4. Executive Summary. A brief and concise overview of the proposed electric generating facility;

5. Facility Description. A description of the proposed electric generating facility, including a description of the scope and nature of the proposed facility; a description of equipment, technologies and processes used; a description of the generation capacity, availability and dispatch; a location map showing project site and connections to existing transportation routes, transmission lines, and water supplies; a description of the facility inputs and outputs; and a description of all permits, rights and agreements necessary for plant construction and operation;

6. Facility Benefits. Economic justification for the facility that includes a summary of the social or economic benefits of the facility to Illinois; identification of those communities, businesses and other entities likely to benefit from the facility; identification of employment impacts such as jobs created or retained by the facility itself and projected payrolls; the existing and/or new coal markets that would be affected by the project; and identification of potential impacts on local and State electric rates and reliability. The discussion on facility employment impacts should include:

A) current employment levels,

B) projections of temporary jobs created (construction, project managers, etc.) that will be created during the project,

C) full-time equivalent jobs to be created at the facility,

D) full-time equivalent jobs retained as a direct result of completing the project, and

E) Illinois coal mining jobs created as a result of new coal purchases for the facility;

7. Facility Capital and O&M Costs. Financial aspects of the facility, including capital cost, operation and maintenance costs, financing, debt service and retirement, and expected return on investment. For purposes of this subsection (b)(7), operation and maintenance costs are defined as those variable costs attendant to the day to day operation and scheduled maintenance of the new electric generating facility; and

8. State Sales Taxes. A certification of the amount of Illinois coal used at the new electric generating facility and the State occupation and use taxes paid on Illinois-mined coal used at the facility for a minimum of four preceding calendar quarters, or the projected amount of Illinois coal to be used at the new electric generating facility and the State occupation and use taxes paid on Illinois-mined coal to be used at the facility. Applicant must provide reasonable documentation of a long-term commitment to Illinois coal use at the facility through binding coal purchase agreements with suppliers, including documentation of coal supply contracts, detailing the terms and duration of each agreement.

History

• Source: Amended at 29 Ill. Reg. 1195, effective January 5, 2005

32 Ill. Adm. Code 120.120 Application Evaluation Procedure

a) All grant applications submitted will undergo a substantive evaluation in terms of the technical, economic, environmental and management components of the new electric generating facility by Department staff. The criteria used in determining whether a grant will be awarded include, but are not limited to, the following:

1. creation of at least 150 new Illinois coal mining jobs;

2. creation of a new electric generating facility that has an aggregate rated generating capacity of at least 400 megawatts for all new units at one site and uses coal or gases derived from coal as its primary fuel source;

3. commitment to provide baseload electric generation operating on a continuous basis throughout the year, including times of significant area load fluctuations and high demand;

4. the total State occupation and use taxes paid on Illinois-mined coal used at the new electric generating facility for a minimum of 4 preceding calendar quarters, or the projected total State occupation and use taxes to be paid annually on Illinois-mined coal used at the new electric generating facility;

5. the beginning and completion construction dates of the electric generating facility; and

6. the amount of capital investment by the eligible business in the new electric generating facility.

b) The Department may obtain the assistance of other persons either within or outside of State government in reviewing part or all of any application. If the Department elects to obtain such assistance, the Department shall select persons that possess a higher degree of environmental, technical or engineering experience and understanding than readily found within the Department and shall use such persons to evaluate only when, in the opinion of the Department, to do so would promote a more thorough and fair understanding of the applicant's statements, plans and processes to be employed.

c) The Department reserves the right to make on-site survey inspections during the review period when, in the opinion of the Department, to do so would promote a more thorough and fair understanding of the applicant's statements, plans and processes to be employed.

d) In addition to compliance with any federal, State or local permitting requirements, funded projects will be subject to review by the following Illinois agencies: Department of Natural Resources, Historic Preservation Agency, Department of Agriculture, and Illinois Environmental Protection Agency. Grantees will be required to comply with requirements established by these agencies relative to their respective reviews. Grantees will be responsible for coordinating directly with the applicable external agencies. Any requirements communicated to the Department shall be incorporated into any grant agreement awarded as of its execution date, or if received from the applicable agency subsequent to execution, as an addendum to the grant agreement. Grantees will be contractually obligated to comply with these requirements. Prior to notification of compliance by the applicable external agency, grantees may request disbursement of funds only for the following purposes: administrative, contractual, legal, engineering or architectural/engineering costs incurred that are necessary to allow for compliance by the grantee with requirements established by the external agency. Funds will not be disbursed for land acquisition or any activity that physically impacts the project site until the Department receives the appropriate sign-off from the applicable agencies.

e) Upon completion of the review, the Department staff shall recommend applications meeting all criteria set forth in subsection (a). Department staff will then forward all applications, together with its recommendations, to the Director for final determination. During the final review process, the Director will determine whether an applicant is awarded a grant. Applicants will be notified in writing as to whether the entity is eligible to receive financial assistance through the Coal Revival Program. If an application is denied, the notification shall state the reasons for that determination.

History

• Source: Amended at 29 Ill. Reg. 1195, effective January 5, 2005

32 Ill. Adm. Code 120.130 Grant Agreement

a) When a grant has been awarded, the grantee and the Department shall execute an Agreement. The Agreement shall be executed between the grantee and the Director or the Director's designee on behalf of the Department.

b) The Agreement shall contain substantive provisions, including, but not limited to, the following:

1. A recitation of legal authority pursuant to which the Agreement is made;

2. An identification of the project scope and schedule, and the work or services to be performed or conducted by the grantee;

3. An identification of the grant amount;

4. The conditions and manner in which the Department shall pay the grant amount subject at all times to annual appropriation by the General Assembly;

5. A promise by the grantee not to assign or transfer any of the rights, duties or obligations of the grantee without the written consent of the Department;

6. A promise by the grantee not to amend the Agreement without the written consent of the Department. Failure to do so will result in a cost disallowance. The project must be completed by the completion date in the Agreement unless a written request for an extension is submitted no later than 30 days prior to the award completion date;

7. A covenant that the grantee shall expend the grant amount and any accrued interest only for the purposes of the project as stated in the Agreement and approved by the Department;

8. A covenant that the grantee shall refrain from entering into any written or oral agreement or understanding with any party that might be construed as an obligation of the State of Illinois or the Department for the payment of any funds under the Act; and

9. A covenant that no grant funds will be disbursed until the eligible business has satisfactorily demonstrated to the Department that the revenue stream will be sufficient to service the debt on General Obligation Bonds issued in support of the project.

History

• Source: Amended at 29 Ill. Reg. 1195, effective January 5, 2005

32 Ill. Adm. Code 120.140 Severability

If any Section, subsection, subdivision, paragraph, sentence, clause or phrase in this Part or any portion thereof is for any reason held to be unconstitutional or invalid or ineffective by any forum of competent jurisdiction, that decision shall not affect the validity or effectiveness of the remaining portions of this Part.

32 Ill. Adm. Code 120.150 Administrative Requirements for Grants

a) Termination of Grant − Grants shall be terminated for the following reasons:

1. Termination Due to Loss of Funding − In the absence of State funding for a fiscal year, all grants for that year will be terminated in full. In the event of a partial loss of State funding, the Department will make proportionate cuts to all grantees. In the event the Department suffers such a loss of funding in full or part, the Department will give the grantee written notice setting forth the effective date of full or partial termination or, if a change in funding is required, setting forth the change in funding and changes in the approved budget.

2. Termination for Cause

A) If the Department determines that the grantee has failed to comply with the terms and conditions of the grant, the Department shall terminate the grant in whole, or in part, at any time before the date of completion. Circumstances that will result in the termination of a grant include, but are not necessarily limited to, the following: consistent failure to submit required reports; failure to maintain required records; evidence of fraud and abuse; and consistent failure to meet performance standards. These circumstances are explained in the Agreement.

B) The Department shall notify the grantee in writing, within 10 working days after the determination to terminate, of the reasons for the termination and the effective date of the termination. Payments made to the grantee or recoveries by the Department shall be made in accordance with legal rights and liabilities in the Agreement.

3. Termination by Agreement − The Department and the grantee shall terminate the grant in whole or in part when the Department and the grantee agree that the continuation of the program objectives would not produce beneficial results commensurate with the future expenditure of funds. The Department and the grantee shall agree upon termination conditions, including the effective date, and, in the case of partial termination, the portion to be terminated. The grantee shall not incur new obligations for the terminated portion after the effective date, and shall cancel as many outstanding obligations as possible. The Department shall allow full credit to the grantee for the Department's share of the noncancelable obligations, properly incurred by the grantee prior to termination.

b) Interest on Grant Funds − In accordance with Section 10 of the Illinois Grant Funds Recovery Act [30 ILCS 705/10], all interest earned on funds held by the grantee under the grant shall become part of the grant when earned, as long as this amount does not exceed the maximum allowable grant award. Any interest earned under the grant, and not expended as grant principal during the term of the grant, shall be returned to the Department.

c) Grant Close-out − In accordance with Section 4 of the Illinois Grant Funds Recovery Act [30 ILCS 705/4], all funds, including any interest, remaining at the end of the grant period or at the expiration of the period of time grant funds are available for expenditure or obligation by the Grantee, shall be returned to the Department within 45 days after the end of the relevant period. The grantee agrees to repay the Department for any funds that are determined by the Department to have been spent in violation of the Agreement.

d) Audits − A grantee shall be responsible for securing a compliance audit for any grant award exceeding $300,000. Additionally, an audit may be required when certain risk conditions exist, including, but not limited to, a negative compliance history and disclosure of previous material audit findings. The audit shall be performed by an independent certified public accountant, licensed by authority of the State of Illinois pursuant to the Illinois Public Accounting Act [225 ILCS 450]. The audit shall be conducted in accordance with generally accepted auditing standards contained in the publication entitled AICPA Professional Standards, American Institute of Certified Public Accountants, Harborside Financial Center, 201 Plaza 3, Jersey City, New Jersey 07311 (June 2001, no later editions are incorporated).

e) Special Audits − The Department reserves the right to conduct special audits, including but not limited to an agency-wide audit, at any time during normal working hours, of the funds expended under Department grants.

f) Monitoring and Evaluation − Grantee shall permit any agent authorized by the Department, upon presentation of credentials, in accordance with the constitutional limitation on administrative searches, to have full access to, and the right to examine, any documents, papers, and records of the grantee involving transactions related to a grant from the Department. Once the Department has concluded its monitoring activities, the grantee will be notified of the Department's findings. If a determination of noncompliance has been made by the Department, the grantee will be allowed an opportunity to cure any and all noncompliance issues. If any noncompliance issues cannot be resolved, the Department will issue a notice requesting that the grantee repay any funds that are determined by the Department to have been spent in violation of the Agreement. If the grantee fails to comply with the Department's notice, the Department shall issue a final notice providing the grantee the opportunity to request an administrative hearing pursuant to the Department's Administrative Hearing Rules found at 56 Ill. Adm. Code 2605.

g) Complaint Process − An administrative hearing is initiated by a party serving a Petition for Hearing on the Department, or by the Department serving a Notice of Charges on the grantee. In either case, the Department and the grantee shall follow the Administrative Hearing Rules as set forth in 56 Ill. Adm. Code 2605.

h) Certifications − The grantee shall certify that it has not been barred from contracting with a unit of State or local government as a result of a violation of 720 ILCS 5/33E-3 and 33E-4.

i) Reports − Grantee shall submit, as required by the Department, reports on the financial status of the project and reports on outcomes and results of the project.

Part 130 Illinois Renewable Fuels Development Program

32 Ill. Adm. Code 130.10 Purpose

The Department of Commerce and Economic Opportunity recognizes that renewable fuels produced from Illinois agricultural products will enhance the economy of Illinois, expand rural economic development, reduce the nation's dependence on foreign oil supplies, and improve the environment by reducing harmful emissions from vehicles. In 2003, factors such as the electric blackout in the northeastern United States, the electricity crisis affecting California and other western states, instability in the Middle East, and extraordinarily high gasoline prices have created a situation in which renewable forms of energy must be utilized in order for both the Illinois economy and national economy to grow.

Reliable supplies of renewable fuels will be integral to the long term energy security of the United States [20 ILCS 689/5]. Illinois is the largest producer of soybeans in the United States and ranks second in annual corn production. Illinois is also the leading producer of ethanol and biodiesel in the nation, with an ethanol production capacity of approximately 800 million gallons per year. Accordingly, the Illinois Department of Commerce and Economic Opportunity administers the Illinois Renewable Fuels Development Program, which will offer grants to new and existing ethanol and biodiesel production facilities in Illinois. Implementation of the Program is intended to reduce costs for ethanol production facilities, stimulate the agricultural sector of Illinois' economy, encourage the use of renewable fuels as alternatives to the nation's reliance on fossil fuels, and reduce global warming emissions. New and expanded renewable fuel production facilities will expand local economies, create permanent jobs, generate revenue for the State of Illinois, and increase revenue for local grain farmers.

When awarding public funds for public works projects, the State of Illinois has a compelling interest in ensuring that the highest standards of quality and efficiency are applied to the project. Project labor agreements provide the State of Illinois with a guarantee that specific public works projects will be completed with highly skilled workers, and also functions as a means to provide for peaceful, orderly and mutually binding procedures for resolving labor issues. Accordingly, recipients of renewable fuel development grants will be required to enter into project labor agreements establishing wages, benefits and other provisions pertaining to labor organization employees. This requirement does not prohibit the construction of renewable fuel production facilities in Illinois that are undertaken without a project labor agreement.

32 Ill. Adm. Code 130.20 Definitions

The following definitions are applicable to this Part:

"Act" means the Illinois Renewable Fuels Development Program Act [20 ILCS 689].

"Award Value Criteria" means the criteria established by the Department in Section 130.90 in order to determine appropriate grant award levels.

"Biodiesel" means a renewable diesel fuel derived from biomass that is intended for use in diesel engines (Section 10 of the Act).

"Biodiesel blend" means a blend of biodiesel with petroleum-based diesel fuel in which the resultant product contains no less than 1% and no more than 99% biodiesel (Section 10 of the Act).

"Biofuels" means either ethanol or biodiesel.

"Biomass" means non-fossil organic materials that have an intrinsic energy content. "Biomass" includes, but is not limited to, soybean oil, vegetable oils, and ethanol. (Section 10 of the Act)

"Cooperative" means a business that is established, financed, operated and owned by individuals for the purpose of providing additional value to their agricultural products.

"Department" means the Illinois Department of Commerce and Economic Opportunity.

"Diesel Fuel" means any product intended for use or offered for sale as a fuel for engines in which the fuel is injected into the combustion chamber and ignited by pressure without electric spark (Section 10 of the Act).

"Director" means the Director of the Department.

"Ethanol" means a product produced from agricultural commodities or by-products used as a fuel or to be blended with other fuels for use in motor vehicles (Section 10 of the Act).

"Fuel" means fuel as defined in Section 1.19 of the Motor Fuel Tax Law [35 ILCS 505/1.19] (Section 10 of the Act).

"Gasohol" means motor fuel that is no more than 90% gasoline and at least 10% denatured ethanol that contains no more than 1.25% water by weight (Section 10 of the Act).

"Gasoline" means all products commonly or commercially known or sold as gasoline (including casing head and absorption or natural gasoline) (Section 10 of the Act).

"Illinois Agricultural Product" means any agricultural commodity grown in Illinois that is used by a production facility to produce renewable fuel in Illinois, including, but not limited to, corn, barley, and soybeans (Section 10 of the Act).

"Labor Organization" means any organization or regional body or group of local unions:

in which building and construction industry trades, crafts, or labor employees, or all or any of these, participate; and

that represents building and construction industry trades, crafts, or labor employees, or any or all of these; and

that exists for the purpose, in whole or in part, of negotiating with the employers of building and construction industry trades, crafts, or labor employees, or any or all of these, terms and conditions of employment, including, but not limited to: wages, hours of work, overtime provisions, fringe benefits, and the settlement of grievances; and

that participate in apprenticeship and training approved and registered with the United States Department of Labor's Bureau of Apprenticeship and Training, in the State of Illinois. (Section 10 of the Act)

"Majority Blended Ethanol Fuel" means motor fuel that contains no less than 70% and no more than 90% denatured ethanol and no less than 10% and no more than 30% gasoline (Section 10 of the Act).

"Motor Vehicles" means motor vehicles as defined in the Illinois Vehicle Code [625 ILCS 5] and watercraft propelled by an internal combustion engine (Section 10 of the Act).

"Owner" means any individual, sole proprietorship, limited partnership, co-partnership, joint venture, corporation, cooperative, or other legal entity that operates or will operate a plant located within the State of Illinois (Section 10 of the Act).

"Permanent Job" means a job in which a new employee works for the owner at the project at a rate of at least 35 hours per week and does not include construction jobs.

"Plant" means a production facility that produces a renewable fuel. "Plant" includes land, any building or other improvement on or to land, and any personal properties deemed necessary or suitable for use, whether or not now in existence, in the processing of fuel from agricultural commodities or by-products. (Section 10 of the Act)

"Plant Construction" means any new construction of a renewable fuels production plant with a minimum annual production capacity of 30 million gallons.

"Plant Expansion" means any modification, alteration or retrofitting of an existing plant, with a minimum annual renewable fuels production capacity of 30 million gallons, that will result in an increased renewable fuels production capacity, yield or efficiency.

"Project" means a plant construction or plant expansion project that is funded under the program. Over a period of time, separated by a reasonable period, multiple "projects" could occur at one facility; for instance, an initial plant construction project followed by a plant expansion project at the same facility.

"Program" means the Renewable Fuels Development Program.

"Renewable fuel" means ethanol, gasohol, majority blended ethanol fuel, biodiesel blend fuel, and biodiesel (Section 10 of the Act).

"Rural County" means a county in the State of Illinois designated as a non-Metropolitan Statistical Area by the United States Office of Management and Budget. A rural county has a population of less than 50,000.

"State" means the State of Illinois.

32 Ill. Adm. Code 130.30 Allocation of Appropriations

Subject to appropriation, the Director is authorized to award grants for projects approved pursuant to this Part. An approved project is eligible for only one grant per fiscal year from the Renewable Fuels Development Program. A project means either the construction of a new facility where such production did not previously exist or an expansion to increase the capacity of an existing production facility, as described in the application approved and funded by the Department through this program. Further, a facility receiving a grant for new construction or a plant expansion in one fiscal year may be eligible for a grant for expansion of the capacity of that facility in another fiscal year.

History

• Source: Amended at 31 Ill. Reg. 2283, effective January 18, 2007

32 Ill. Adm. Code 130.40 Project Eligibility Requirements

In order to be eligible for funding under the program, the proposed project must meet all of the following criteria:

a) the project must be physically located in the State of Illinois;

b) the project must be either a plant construction project or a plant expansion project; new construction must consist of 30 million gallons or more;

c) the owner must commit to entering into a Project Labor Agreement covering the project that is compliant with the provisions of Section 130.60;

d) the owner must commit to securing all financing (debt and equity) necessary to complete the project; and

e) The owner must commit to using Illinois agricultural products as the primary source in the renewable fuels production process.

32 Ill. Adm. Code 130.50 Eligible Uses of Grant Funds

Program grant proceeds may be expended solely for costs incurred, including labor and other bondable expenses, that are directly related to capital facilities consisting of buildings, structures and durable equipment in connection with an approved plant construction or plant expansion project. Grant funding may not be used for administrative expenditures, including labor such as architectural and engineering fees, that are not related to the project.

32 Ill. Adm. Code 130.60 Project Labor Agreements

a) A Project Labor Agreement for the plant construction or plant expansion to be funded through the Renewable Fuels Development Program must include the following:

1. provisions setting forth established standard hourly wages for each class of labor organization employee;

2. provisions setting forth area standard benefits and other compensation for each class of labor organization employee;

3. provisions establishing that no strike, job interruption, or delay will be engaged in by the covered employees;

4. provisions setting forth effective, immediate, and mutually binding procedures for resolving jurisdictional labor disputes and grievances arising before the completion of work;

5. provisions ensuring a reliable source of skilled and experienced labor;

6. provisions to further public policy objectives as to improved employment opportunities for minorities and women in the construction industry to the extent permitted by State and federal law;

7. provisions to permit the selection of the most qualified lowest responsible bidder, without regard to union or non-union status at other construction sites;

8. provisions to bind all contractors and subcontractors on the project through the inclusion of appropriate bid specifications in all relevant bid documents;

9. the names, addresses, and occupations of the owner of the plant and the individuals representing the labor organization employees participating in the Project Labor Agreement.

b) Project Labor Agreements shall include other terms as the parties deem appropriate.

c) The Project Labor Agreement shall be filed with the Director in accordance with the procedures established by the Department (Section 25 of the Act).

32 Ill. Adm. Code 130.70 Form of Application

The grant application package must include all of the following materials/information:

a) Application cover page (Appendix A);

b) Application form (Appendix B);

c) Projected Energy Use by Type form (Appendix C);

d) Narrative description of the proposed project, including:

1. Plant description. A description of the proposed construction or expansion project, including a description of the scope and nature of the plant, a description of equipment, technologies and processes used; a description of the renewable fuels production capacity; a description of the amounts, types and sources of Illinois agricultural products used as feedstock in the project; a location map showing project site and connections to existing transportation routes; and a description of all permits, contracts or other agreements necessary to complete the project. If the applicant does not have all relevant or necessary operating permits, identification of the status of any permit applications and anticipated date of permit issuance should be included in the narrative, in addition to the date that any required contracts or agreements will be executed.

2. Project benefits. Economic justification for the project that includes a summary of the social or economic benefits of the project to Illinois; identification of those communities, businesses, and other entities likely to benefit from the project; identification of employment impacts, such as number and type of permanent jobs created or retained by the project itself (i.e., non-construction jobs) and projected payrolls; and the existing and or new agricultural commodity and renewable fuel markets that would be affected by the project.

3. Project costs and schedule. A project budget and time schedule for completion of the project and for major project components. Direct material and labor costs associated with construction must be defined and itemized in the proposal. For instance, proposals should include specific line item budget amounts for equipment such as fermenters, grain-storage, dryer systems, tanks, and centrifuges, not simply reference to broad categories such as structures, mechanical, electrical, etc.

4. Ownership disclosure. Identification by name of those individuals or entities with 10% or more ownership of the plant that is the subject of the project.

5. Performance disclosure. As asserted against the owner, or any parent organization or holding company, identification of all pending or unresolved violations of state or federal laws or regulations that could result in legal or regulatory impact on the operation of the project;

e) Copy of the Prospectus to Shareholders, if applicable;

f) Copy of the business plan;

g) Organization/management structure information;

h) Copy of the Project Labor Agreement (or draft agreement if the final agreement is still pending at the time of initial application);

i) Certification that owner will obtain all necessary, applicable and required permits;

j) Certification that owner will obtain all financing (debt and equity) necessary to complete the project;

k) Certification identifying the number of permanent jobs to be created/retained and identification of the types of jobs created/retained.

32 Ill. Adm. Code 130.80 Application Submittal

a) Applications to the program for grant funds may be submitted to the Department at any time in accordance with this Part, or pursuant to the time frame specified in a formal Request for Proposals issued by the Department.

b) One original and five copies of each grant application shall be submitted to Illinois Renewable Fuels Development Program, Bureau of Energy and Recycling, Illinois Department of Commerce and Economic Opportunity, 620 East Adams Street, CIPS-5, Springfield IL 62701-1615. Applications submitted by e-mail or facsimile are not acceptable unless the Department specifically requests additional information and/or materials to be submitted by the applicant.

c) The Department may require applications to be clarified or supplemented through additional written submissions or oral presentations.

d) Information submitted that could reasonably be considered to be proprietary, privileged, or confidential commercial or financial information should be identified as such in the application. The Department will maintain the confidentiality of that information to the extent permitted by law.

32 Ill. Adm. Code 130.90 Application Evaluation Procedures

a) The Department will evaluate complete proposals in the following manner: proposals will be evaluated to determine whether the proposed project meets the project eligibility criteria specified in Section 130.40 and to determine whether, based on the information supplied in the application documentation, the proposal demonstrates that:

1. the project is economically viable;

2. the project is technically viable; and

3. the Project will result in economic development benefits to the State.

b) The Department may obtain the assistance of other persons either within or outside of State government in reviewing part or all of any application when, in the opinion of the Department, to do so would promote a more thorough and fair understanding of the proposed project. If the Department elects to obtain such assistance, the Department shall select persons qualified by relevant environmental, technical, or engineering experience.

c) The Department reserves the right to make on-site survey inspections during the

evaluation when, in the opinion of the Department, to do so would promote a more thorough and fair understanding of the proposed project.

d) Upon completion of the evaluation and determination of the grant award, in accordance with Section 130.100, the Department staff shall make a recommendation to the Director. The Director may then approve, reject, or amend the grant award, according to the best interests of the State, at her or his discretion.

e) Rejection of applications. The Department reserves the right to reject any proposal that does not comply with the requirements of this Part.

f) No rights conferred. The submission of a proposal under this Section confers no right upon any applicant. The Department is not obligated to award a grant, to pay any cost incurred by the applicant in the preparation and submission of a proposal, or pay any grant related costs incurred prior to the project start date.

32 Ill. Adm. Code 130.100 Grant Award Evaluation Criteria and Funding Limitations

The Department staff shall utilize the following award evaluation criteria to determine the award amount for any grant to be recommended to the Director:

a) General Award Evaluation Criteria.

1. Cooperative ownership share of the project.

2. The size (total new biofuels production capacity) of the project.

3. The volume of usage of Illinois agricultural products in the production of renewable fuels at the facility.

4. The number of permanent new jobs created.

5. The local or regional economic need for the project.

6. The current local base prices for corn and soybeans in the project area.

7. The use of new process technologies, new energy efficiency or energy production technologies, other new technologies designed to reduce production costs or increase profitability of the facility, or the production of new value-added by-products.

8. In addition to the criteria listed in this subsection (a), the Department may consider one or more of the following factors when evaluating an application, if the Department determines it to be in the best interest of the State of Illinois:

A) the applicant is considering at least one neighboring state for the project and could reasonably and efficiently locate the project outside of Illinois;

B) receipt of the award is a major factor in the applicant's decision to locate the project in Illinois and that, without the award, the applicant likely would not create new jobs in Illinois; or

C) approval of the award would support a business with potential to generate additional growth in the area and create jobs as a result of spin-off businesses.

b) Grant limitations and other grant award considerations.

1. The maximum grant award under the program is $5.5 million for either a plant expansion or a new construction project.

2. Grants for biofuels facilities shall not exceed 10% of the total construction

costs of the facility or expansion, or $0.10 per gallon of additional biofuels production capacity, whichever is greater.

3. The Department reserves the right to determine the final amount of the grant based on its evaluation of the project, amount of funds available, and the number of applications for program funds.

4. Funding awards are not transferable or assignable to another project and may not be assigned to another entity without the Department's prior written permission.

5. The Department will negotiate the structure of the agreement (i.e., advance production payment, conventional grant award, etc.) with the recipient, taking into consideration the organizational status of the recipient, project financing, applicable tax credits and considerations, and applicable Illinois statutory and administrative requirements.

32 Ill. Adm. Code 130.110 General Program Requirements

a) Reporting requirement. Recipients will be required to submit Monthly Progress Reports to the Department during the grant term, including information on the number of jobs created or retained. Recipients shall also be required to provide production data/records for the performance period specified by the Department. The grant term/performance period will be determined on a project specific basis.

b) Disbursement of grant funds. Notwithstanding selection for a grant award pursuant to this Part, disbursement of grant funds is contingent upon the following requirements:

1. Submission of a fully executed grant agreement;

2. Submission of a fully executed Project Labor Agreement for the construction of the project;

3. Submission of evidence of a commitment from a primary lender for all financing necessary to complete the project, or evidence that the grantee has secured other means of financing.

c) Freedom of Information Act/confidential information. Funded proposals are subject to disclosure, in response to requests received under provisions of the Freedom of Information Act [5 ILCS 140]. Information that may reasonably be considered to be proprietary, privileged or confidential commercial or financial information should be identified as such in the proposal. The Department will maintain the confidentiality of that information only to the extent permitted by law.

d) Ownership/use of equipment. Grant recipients may not sell, lease, transfer assignment or encumber any equipment or material purchased with grant funds, without the express written approval of the Department, for the duration of the grant term/performance period.

e) Dissemination of information/technology transfer. Recipients will be contractually required to allow the Department access to the project site and allow the Department to obtain, publish, disseminate or distribute any and all information obtained from the project (except any data or information that has been negotiated as being confidential or proprietary), without restriction and without payment or compensation by the Department.

f) Recapture of grant funds. A recipient must operate the plant to produce renewable fuels for a period of five years. In the event that the plant ceases production during that period, or fails to create and maintain the number of jobs specified in the Grant Agreement, the Department reserves the right to require appropriate proportional repayment of funds up to the entire amount of the grant.

g) The Director may elect to waive enforcement of any provision of this Part or of a contractual provision arising out of a Arant Agreement based on a finding that the waiver is necessary to avert any imminent and demonstrable hardship to the recipient that may result in the recipient's insolvency or discharge of workers.

h) In addition to compliance with any federal, State or local permitting requirements, funded projects will be subject to review by the following Illinois agencies: Departments of Natural Resources, Historic Preservation and Agriculture and the Illinois Environmental Protection Agency. Recipients will be required to comply with requirements established by these agencies relative to their respective reviews. Recipients will be responsible for coordinating directly with the applicable external agencies. Any requirements communicated to the Department shall be incorporated into the agreement awarded as of its execution date, or if received from the applicable agency subsequent to execution, as an addendum to the agreement. Recipients will be contractually obligated to comply with these requirements. Prior to notification of compliance by the applicable agency, recipients may request disbursement of funds only for the following purposes: administrative, contractual, legal, engineering or architectural/engineering costs incurred that are necessary to allow for compliance by the recipient with requirements established by the external agency. Funds will not be disbursed for land acquisition or any activity that physically impacts the project site until the Department receives the appropriate sign-off from the applicable agencies.

32 Ill. Adm. Code 130.120 Grant Agreement

a) When a grant has been awarded, the grantee and the Department shall execute an agreement. The agreement shall be executed between the grantee and the Director or the Director's designee on behalf of the Department.

b) The agreement shall contain substantive provisions, including, but not limited to, the following:

1. A recitation of legal authority pursuant to which the agreement is made;

2. An identification of the project scope and schedule and the work or services to be performed or conducted by the grantee;

3. An identification of the grant amount;

4. The conditions and manner in which the Department shall pay the grant amount, subject at all times to annual appropriation by the General Assembly;

5. A promise by the grantee not to assign or transfer any of the rights, duties or obligations of the grantee without the written consent of the Department;

6. A promise by the grantee not to amend the agreement without the written consent of the Department. Failure to do so will result in a cost disallowance. The project must be completed by the completion date in the agreement unless a written request for an extension is submitted no later than 30 days prior to the award completion date;

7. A covenant that the grantee shall expend the grant amount and any accrued interest only for the purposes of the project as stated in the agreement and approved by the Department; and

8. A covenant that the grantee shall refrain from entering into any written or oral agreement or understanding with any party that might be construed as an obligation of the State of Illinois or the Department for the payment of any funds under the Act.

32 Ill. Adm. Code 130.130 Administrative Requirements for Grants

a) Termination of grant. Grants shall be terminated for the following reasons:

1. Termination due to loss of funding. In the absence of State funding for a fiscal year, all grants for that year will be terminated in full. In the event of a partial loss of State funding, the Department will make proportionate cuts to all grantees. In the event the Department suffers such a loss of funding in full or part, the Department will give the grantee written notice setting forth the effective date of full or partial termination or, if a change in funding is required, setting forth the change in funding and changes in the approved budget.

2. Termination for cause.

A) If the Department determines that the grantee has failed to comply with the terms and conditions of the grant, the Department shall terminate the grant in whole, or in part, at any time before the date of completion. Circumstances that will result in the termination of a grant include, but are not necessarily limited to, the following: consistent failure to submit required reports; failure to maintain required records; evidence of fraud and abuse; and consistent failure to meet performance standards. These circumstances are explained in the agreement.

B) The Department shall notify the grantee in writing, within 10 working days after the determination to terminate, of the reasons for the termination and the effective date of the termination. Payments made to the grantee or recoveries by the Department shall be made in accordance with legal rights and liabilities expressed in the agreement.

3. Termination for convenience. The Department may terminate the grant upon its determination that continuation of the project is not in the best interest of the State such that it would justify further expenditure of public funds. The grantee shall not incur new obligations for the terminated portion after the effective date and shall cancel as many outstanding obligations as possible. The Department shall allow full credit to the grantee for the Department's share of the noncancelable obligations properly incurred by the grantee prior to termination.

b) Interest on grant funds. In accordance with Section 10 of the Illinois Grant Funds Recovery Act [30 ILCS 705/10], all interest earned on funds held by the grantee under the grant shall become part of the grant when earned, as long as this amount does not exceed the maximum allowable grant award. Any interest earned under the grant, and not expended as grant principal during the term of the grant, shall be returned to the Department.

c) Grant close-out. In accordance with Section 4 of the Illinois Grant Funds Recovery Act [30 ILCS 705/4], all funds, including any interest, remaining at the end of the grant period or at the expiration of the period of time grant funds are available for expenditure or obligation by the grantee, shall be returned to the Department within 45 days after the end of the relevant period. The grantee agrees to repay the Department for any funds that are determined by the Department to have been spent in violation of the agreement.

d) Audits. A grantee shall be responsible for securing a compliance audit for any grant award exceeding $300,000. Additionally, an audit may be required when certain risk conditions exist, including, but not limited to, a negative compliance history and disclosure of previous material audit findings. The audit shall be performed by an independent certified public accountant, licensed by authority of the State of Illinois pursuant to the Illinois Public Accounting Act [225 ILCS 450]. The audit shall be conducted in accordance with generally accepted auditing standards contained in the publication entitled AICPA Professional Standards, American Institute of Certified Public Accountants, Harborside Financial Center, 201 Plaza 3, Jersey City, New Jersey 07311 (June 2001, no later editions are incorporated).

e) Special audits. The Department reserves the right to conduct special audits, of the funds expended under Department grants, including but not limited to an agency-wide audit, at any time during normal working hours.

f) Monitoring and evaluation. Grantee shall permit any agent authorized by the Department, upon presentation of credentials, in accordance with the constitutional limitation on administrative searches, to have full access to, and the right to examine, any documents, papers, and records of the grantee involving transactions related to a grant from the Department. Once the Department has concluded its monitoring activities, the grantee will be notified of the Department's findings. If a determination of noncompliance has been made by the Department, the grantee will be allowed an opportunity to cure any and all noncompliance issues. If any noncompliance issues cannot be resolved within 60 days from the date the grantee received notice of the noncompliance, the Department will issue a notice requesting that the grantee repay any funds that are determined by the Department to have been spent in violation of the agreement. If the grantee fails to comply with the Department's notice, the Department shall issue a final notice providing the grantee the opportunity to request an administrative hearing pursuant to the Department's Administrative Hearing Rules (56 Ill. Adm. Code 2605).

g) Complaint process. An administrative hearing is initiated by a party serving a Petition for Hearing on the Department, or by the Department serving a Notice of Charges on the grantee. In either case, the Department and the grantee shall follow the Administrative Hearing Rules set forth in 56 Ill. Adm. Code 2605.

h) Certifications. The grantee shall make all certifications required by statute or

administrative rules or regulations relative to the issuance of a grant.

i) Reports. Grantee shall submit, as required by the Department, reports on the financial status of the project and reports on outcomes and results of the project.

32 Ill. Adm. Code 130.APPENDIX A Renewable Fuels Development Program Application Cover Sheet

Bureau of Energy & Recycling – Alternative Energy Development Section

Applicant Name

FEIN No.

Applicant Address (including 9 digit zip code)

Project Address (if different from above)

County of Project

Project Manager (Please Type)

Phone

Fax

Type of Biofuels Project: New Construction Alteration Modification Retrofit

Owner of Sole Proprietorship

LLC

Partnership

Corporation

Cooperative

Other

Funding:

Total Grant Request:

$

Total Project Cost:

$

Applicant Certifications – The applicant certifies that:

Authorized Official (signature)

Title

Printed Name

Date

32 Ill. Adm. Code 130.APPENDIX B Application Form for Renewable Fuels Development Program

Illinois Department of Commerce & Economic Opportunity

Application Form For Renewable Fuels Development Program

Name and Mailing Address of Organization:

List Type of Organization (Cooperative, LLC, Corporation, etc.)

Type of Renewable Fuels Production Facility: Biodiesel Ethanol

New Construction Expansion Retrofit or Upgrade

Capacity (gallon/year):

New:

Existing:

Total:

Feedstock – Type & Quantity

Facility Location:

Nearest city or town:

Estimated population:

County:

Proposed site location:

Total costs of project:

Total construction jobs:

Total permanent jobs created:

Estimated start date of construction:

Estimated completion date of construction:

Financial Structure:

Cooperative (# of Members):

Cost/share:

Total equity:

List other equity partners & amount of investment:

Debt:

List primary lender:

Design company:

Construction management company:

List other incentives received or applied for:

List of required attachments:

1. Completed Appendix A (Application Cover Sheet)

2. Completed Appendix B (Grant Application Form)

3. Completed Appendix C (Projected Energy Use By Type Information Form)

4. Copy of Prospectus for Shareholders (Either Cooperative or Other)

5. Copy of Business Plan

6. Organizational Structure

7. Copy of budget for construction, including materials, labor hours and total costs, and management/engineering (please indicate if confidential)

8. Copy of Project Labor Agreement

PROJECT NARRATIVE

The Project Narrative should concisely address all topics set forth below:

1. Plant description. A description of the proposed construction or expansion project, including a description of the scope and nature of the plant; a description of equipment, technologies and processes used; a description of the renewable fuels production capacity; a description of the amounts, types and sources of Illinois agricultural products used as feedstock in the project; a location map showing project site and connections to existing transportation routes; and a description of all permits, contracts or other agreements necessary to complete the project. If the applicant does not have all relevant or necessary operating permits, identification of the status of any permit applications and anticipated date of permit issuance should be included in the narrative, in addition to the date that any required contracts or agreements will be executed.

2. Project benefits. Economic justification for the project that includes a summary of the social or economic benefits of the project to Illinois; identification of those communities, businesses, and other entities likely to benefit from the project; identification of employment impacts, such as number and type of permanent jobs created or retained by the project itself (i.e., non-construction jobs) and projected payrolls; and the existing and/or new agricultural commodity and renewable fuel markets that would be affected by the project.

3. Project costs and schedule. A gross project budget and time schedule for completion of the project and for major project components; include cost estimates and anticipated completion dates.

4. Ownership disclosure. Identification by name of those individuals or entities with 10% or more ownership of the plant that is the subject of the project.

5. Performance disclosure. As asserted against the owner, or any parent organization or holding company, identification of all pending or unresolved violations of State or federal laws or regulations that could result in legal or regulatory impact on the operation of the project.

32 Ill. Adm. Code 130.APPENDIX C Projected Energy Use by Type Information Form

Projected Energy Use By Type Information Form

For plant expansions, include both current consumption and

projected consumption per the proposed improvements

Electricity

Monthly Estimated Total Usage:

kWh

a.

Estimated electricity to be purchased:

%

b.

Estimated electricity to be generated on site:

%

c.

Estimated electricity consumption per gallon of biofuels

production:

Natural Gas

Monthly Estimated Total Usage:

Therms

a.

Estimated use for process heat:

Therms

b.

Estimated use for electric power generation:

Therms

c.

Estimated gas consumption per gallon of biofuels production:

Coal

Monthly Estimated Total Usage:

Tons

a.

Estimated use for process heat:

Tons

b.

Estimated use for electric power generation:

Tons

c.

Estimated coal consumption per gallon of biofuels production:

Chapter II Illinois Emergency Management Agency

Subchapter a Administrative Hearing Rules

Part 200 Administrative Hearings

32 Ill. Adm. Code 200.10 Scope and Nature of Rules

a) Authority and Scope

1. Authority. This Part is promulgated pursuant to Section 5-10(a) of the Illinois Administrative Procedure Act (IAPA) [5 ILCS 100/5-10].

2. Scope. This Part shall govern the proceedings of any adjudicatory administrative hearing of the Illinois Emergency Management Agency (Agency), except as otherwise specifically provided by statute or regulation.

b) Communications to the Agency. All communications to the Agency concerning administrative hearings shall be addressed to the Legal Office at Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois 62704, unless otherwise directed.

c) Construction of Rules. This Part shall not be construed to abrogate, modify or limit any rights, privileges or immunities granted or protected by the Constitution or laws of the United States or the State of Illinois. In case of any conflict between this Part and the IAPA or a licensing statute, the procedures of the IAPA or licensing statute shall control.

History

• Source: Amended at 36 Ill. Reg. 16780, effective November 13, 2012

32 Ill. Adm. Code 200.20 Appearance – Right to Counsel

a) The Agency shall allow only attorneys licensed and registered to practice in this State to appear before it in administrative hearings, except that a natural person may appear on his or her own behalf. [420 ILCS 40/18]

b) Each party to a proceeding before the Agency shall inform the Agency in writing of the name and address to which any notice or other document should be served. Attorneys representing a party must enter an appearance prior to the hearing.

c) All persons appearing in proceedings before the Agency shall conform to the standards of conduct of attorneys before the courts of the State of Illinois (RPC Rule 3.3). If a person fails to conform to these standards, and the failure delays or disrupts the proceeding, the Agency or the hearing officer shall have the authority to prohibit that person from appearing in the proceeding.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.30 Parties

a) The parties to administrative hearings before the Agency are the Agency and the Respondent.

b) A Respondent is a person or entity against whom a Preliminary Order and Notice of Opportunity for Hearing or a denial of licensure is issued by the Agency.

c) Misnomer of a party is not a ground for dismissal. The name of any party may be corrected at any time.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.40 Form of Papers

a) Written pleadings, motions or other documents filed in any proceeding shall be typewritten. Copy shall be on one side of the paper and shall be double spaced, except that quotations may be single spaced and indented. Reproductions of any documents to be incorporated into the record may be made by any process that produces legible black on white copies.

b) Written pleadings, motions or other documents filed in any proceeding shall be cut or folded to a width of 8½ inches and a length of 11½ inches and shall have inside margins of no less than one inch width.

c) Written pleadings, motions, or other documents shall be signed in ink with the name and address of the party filing the paper and, if represented by an attorney, the name and address of the attorney.

d) Written pleadings, motions, affidavits, and other documents shall be filed with the Agency and one copy shall be served on each party to the proceeding.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.50 Notice, Service and Proof of Service

a) The hearing officer and all parties to the proceedings shall be served all pleadings, motions, notices and other documents filed by any party. Proof of service on all parties shall be filed with the hearing officer.

b) Any Order or Notice issued by the Agency shall either be served personally or by registered or certified mail on the Respondent.

c) All other pleadings and other documents shall be served personally or by first class United States mail properly addressed, with postage prepaid, to each party to the proceeding.

d) When any party or parties have appeared by attorney, service upon the attorney shall be deemed service upon the party or parties.

e) Proof of service of any paper shall be by certificate of attorney, affidavit or acknowledgement, or certified or registered mail receipt.

f) Wherever notice or notification is indicated or required, it shall be effective upon the date of mailing to the party's last address on file with the Agency. Orders and notices sent by certified or registered mail to the party's last address on file with the Agency that have been returned to the Agency as unclaimed or refused by the addressee shall be considered served.

g) In addition to the methods provided for in this Part, a Respondent may be served in any manner permitted by law.

History

• Source: Amended at 36 Ill. Reg. 16780, effective November 13, 2012

32 Ill. Adm. Code 200.60 Preliminary Order and Notice of Opportunity for Hearing

a) In the event that a person has violated or is alleged to have violated the statutes, regulations or terms of licensure or accreditation, the Agency shall commence administrative proceedings by the service of a Preliminary Order and Notice of Opportunity for Hearing upon the Respondent.

b) The Preliminary Order and Notice of Opportunity for Hearing shall contain:

1. A statement of the legal authority and jurisdiction under which a hearing would be held;

2. A reference to the provisions of the statutes, regulations or terms of licensure or accreditation involved;

3. A short and plain statement of the matters asserted, including dates, location, events, nature, extent, and duration, to advise the Respondent of the extent and nature of the alleged violations;

4. A statement of the right to request a hearing and the date that a request for a hearing is to be submitted to the Agency, which shall be at least 10 days from the date of the Preliminary Order;

5. The time, date and location when the hearing will be held, if one is requested; and

6. A statement of the actions that will be taken by the Agency in the event that a hearing is not requested by the Respondent.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.70 Right to Hearing

a) In the event that the Respondent seeks a hearing pursuant to matters raised in a Preliminary Order issued in accordance with Section 200.60, the Respondent must submit a request for a hearing by the date specified in the Preliminary Order. In the event that a person seeks a hearing pursuant to the denial of an application for licensure or accreditation or the denial of reinstatement of licensure or accreditation by the Agency, the person must submit a request for a hearing within 30 days after the denial.

b) This request must be in writing and must contain a brief statement of the basis upon which the Agency's Preliminary Order or denial of licensure or accreditation is being challenged.

c) If the request is not submitted by the date required in accordance with subsection (a), or if the request is submitted but later withdrawn, the actions proposed by the Agency in the Preliminary Order or denial of licensure or accreditation shall be a final and binding administrative determination subject to the Administrative Review Law.

d) Upon notice from the Agency that a Respondent is required to have an attorney pursuant to 420 ILCS 40/18, the Respondent's attorney shall have 30 days to enter an appearance with the Agency. If no such appearance is filed, the hearing request will be considered withdrawn and the Preliminary Order or denial of licensure shall be a final and binding administrative determination subject to the Administrative Review Law.

e) No final decision shall be made or action taken by the Agency until the Respondent has had an opportunity to request a hearing and, if requested, a hearing has been held, except that, in cases in which there is an immediate threat to public health or safety, the Agency may take action to immediately enjoin the threat pending a hearing. The hearing shall be held within 30 days after the Agency's action [420 ILCS 40/38(a)].

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.80 Motions

A hearing officer may allow oral motions and responses on emergency or purely procedural questions or for good cause shown. Emergency and procedural motions will be ruled upon when made. Other motions, such as motions to dismiss, etc., will not be ruled upon by the hearing officer but will be considered by the hearing officer in preparation of the written report and will be submitted to the Director for a decision.

History

• Source: Former Section 200.80 repealed, new Section 200.80 adopted at 10 Ill. Reg. 17200, effective September 25, 1986

32 Ill. Adm. Code 200.90 Continuances

A party shall be granted one continuance of up to 14 days on request or as agreed to by all parties. Any other requests for a continuance will be granted only for good cause shown. In determining good cause, factors that the hearing officer may consider shall include the inability to produce a material witness or evidence, surprise, required attendance of legal counsel elsewhere, illness or death of a party or witness, and substitution of an attorney.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.100 Hearing Officer

a) When a Preliminary Order and Notice of Opportunity for Hearing is issued and a hearing is requested, the Director of the Agency shall designate a hearing officer to preside at the formal administrative hearing.

b) The appointed hearing officer shall not have direct involvement with the case or have an interest in the decision to be reached. Mere familiarity with the facts shall not disqualify a hearing officer.

c) The hearing officer shall have the duty to conduct a fair hearing, to maintain order, to ensure development of a clear and complete record, and to submit a written report to the Director for the Director's decision.

d) In addition to other authority provided in this Part, the hearing officer shall have the authority to:

1. Direct the parties to meet in an informal conference in accordance with Section 200.120;

2. Administer oaths;

3. Receive evidence and rule upon the admissibility of oral testimony and other evidence;

4. Examine witnesses for the purpose of clarifying the record;

5. Consider and rule upon motions in accordance with Section 200.80.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.110 Ex Parte Consultation

Ex parte communications and consultation between and among parties shall be limited to that which is in accordance with the Illinois Administrative Procedure Act.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.120 Informal Conferences

a) Upon request of any party or on the hearing officer's own motion, the hearing officer shall have the authority to direct the parties to appear at a specified time and place for a conference, prior to or during the course of the hearing, for the purpose of:

1. simplifying the issues;

2. amending the pleadings for clarification, amplification, or limitation;

3. making admissions of fact or stipulating to the admissibility of evidence;

4. limiting the number of witnesses;

5. exchanging witness lists and prepared testimony and exhibits;

6. aiding in the simplification of the evidence and disposition of the proceedings; or

7. stipulation and settlement concerning matters relating to confidential information, e.g. privileged medical records and commercial trade secrets or financial information the disclosure of which could cause competitive harm.

b) The record of the hearing shall reflect any orders or other decisions which are made as a result of such a conference.

History

• Source: Former Section 200.120 repealed, new Section 200.120 renumbered from former Section 200.90 and amended at 10 Ill. Reg. 17200, effective 17200, effective September 25, 1986

32 Ill. Adm. Code 200.130 Conduct of Hearings

a) Unless closing the hearing is necessary to preserve the confidentiality of medical records, or the confidentiality of trade secrets or financial information the disclosure of which could cause competitive harm, hearings shall be open to the public. If matters of confidentiality are involved, the hearing officer shall have the authority to close all or a portion of the hearing to the public.

b) The hearing officer shall direct all parties to enter their appearances on the record. All witnesses shall be sworn.

c) The hearing officer shall inquire fully into the matters at issue and shall receive testimony of witnesses and any other evidence that is relevant and material to the issues presented. The following shall be the usual order of administrative hearings, unless the hearing officer decides otherwise:

1. presentation, argument, and disposition of preliminary motions in accordance with Section 200.80;

2. presentation of opening statements;

3. Agency's case in chief;

4. Respondent's case in chief;

5. Agency's case in rebuttal;

6. Respondent's case in rebuttal;

7. presentation of closing arguments, including legal arguments.

d) Parties may by stipulation agree upon any facts involved in the proceeding. The facts stipulated shall be considered as evidence in the proceeding. Disposition may be made of any case by stipulation, agreed settlement, consent order or default.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.140 Amendments

At any time prior to the hearing or before completion of the hearing, amendments shall be allowed for good cause shown to introduce any party who ought to have been joined, to dismiss any party, or to delete, modify or add allegations or defenses. In the event of a change in parties or a substantive amendment to the allegations or defenses immediately preceding or during the hearing, any remaining party may request that the hearing be suspended. Upon a request, the hearing officer shall suspend the hearing for up to 14 days or as agreed to by all parties to provide an opportunity for the parties to respond to the changes in parties or substantive amendments that are introduced immediately preceding or during the hearing.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.150 Burden of Proof

a) The burden of proof shall be on the Agency, unless the matter at issue is the denial of an application for licensure or accreditation, or an application for reinstatement of licensure or accreditation that has been previously revoked, suspended, or otherwise terminated. In such cases, the burden of proof shall be on the Respondent.

b) In the case of any new matter introduced in connection with any affirmative defense, the burden of proof shall be upon the party that alleges the new matter.

c) The standard of proof with respect to all hearings conducted pursuant to this Part shall be a preponderance of the evidence.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.160 Witnesses at Hearings

a) The hearing officer or the official reporter may administer oaths to witnesses.

b) Both the hearing officer and the parties or their representatives may examine witnesses.

c) A party may conduct examination and cross-examination that is shown to be necessary to a full and fair disclosure of facts bearing upon matters in issue, provided that the examination or cross-examination does not abuse or harass a witness.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.170 Evidence at Hearings

a) When the hearing results from the denial of an application for licensure or accreditation, or denial of an application for reinstatement of licensure or accreditation, the Respondent shall have the right to introduce evidence at the hearing that was not made available to the Agency at the time the application was denied. If the hearing officer determines that the additional evidence could have affected the Agency's decision to deny the application, the hearing officer shall suspend the hearing to enable appropriate representatives of the Agency to consider this additional evidence and to decide whether the decision to deny the application should be modified or reversed.

b) Irrelevant, immaterial or unduly repetitious evidence shall be excluded. The rules of evidence and privilege as applied in civil cases in the Circuit Courts of this State shall be followed. However, evidence not admissible under those rules of evidence may be admitted (except where precluded by statute) if it is of the type commonly relied upon by reasonably prudent persons in the conduct of their affairs. When the admissibility of evidence is in dispute and depends upon fairly arguable interpretations of law, the evidence shall be admitted. Objections to evidentiary offers may be made and shall be noted in the record. Subject to these requirements, when a hearing will be expedited and the interests of the parties will not be prejudiced, any part of the evidence may be received in written form. Any party may submit evidence in rebuttal.

c) Accurate summaries of voluminous documents may be admitted into evidence. The document summarized need not itself be admitted into evidence. Copies of the document need not be provided so long as all parties are accorded a reasonable opportunity to inspect the document summarized.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.180 Cross-Examination

a) Subject to the evidentiary requirements, a party may conduct cross-examination required for a full and fair disclosure of the facts.

b) If the hearing officer determines that a witness is hostile or unresponsive, the hearing officer shall authorize the examination by the party calling the witness as if under cross-examination.

c) Any party may call any adverse party as a witness and proceed to examine that adverse party as if under cross-examination except that, if the Respondent wants to call a representative of the Agency as an adverse witness, he/she may do so only if the representative was directly involved in the determinations that served as the basis for the Agency's Preliminary Order under this Part.

d) Any party calling a witness, upon a showing that he/she called the witness in good faith and is surprised by the testimony of the witness, may impeach that witness by evidence of prior inconsistent statements.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.190 Official Notice

a) Official notice may be taken of:

1. Matters of which the Circuit Courts of this State may take judicial notice; and

2. Generally recognized technical or scientific facts within the Agency's specialized knowledge.

b) Parties shall be notified before or during a hearing, or by reference in preliminary reports, or otherwise, of the material noticed, including any staff memoranda or data to be offered as evidentiary matter during the course of the hearing, and the parties shall be afforded an opportunity to contest the material so noticed. The Agency's experience, technical competence and specialized knowledge may be utilized in the evaluation of the evidence.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.200 Default

Except for good cause show, the failure of a party to appear on the date set for hearing or failure to proceed as ordered by the hearing officer or Director shall constitute a default. The Director shall thereafter enter such order as appropriate, in accordance with the Preliminary Order, pleadings and the evidence introduced at the hearing, if any.

History

• Source: Former Section 200.200 renumbered to new Section 200.230, new Section 200.200 renumbered from former Section 200.170 and amended at 10 Ill. Reg. 17200, effective September 25, 1986

32 Ill. Adm. Code 200.210 Hearing Record

a) The Agency shall designate an official reporter to make and transcribe a stenographic record of the adjudicatory proceedings.

b) A complete record of the hearing shall include:

1. all pleadings (including all notices, responses, motions, and rulings);

2. evidence received;

3. a statement of matters officially noticed;

4. offers of proof, objections and rulings on objections;

5. proposed findings and exceptions;

6. any recommended decision, opinion or report by the hearing officer;

7. staff memoranda or data submitted to the hearing officer or the Agency in connection with the consideration of the case; and

8. any ex-parte communication as defined by the Illinois Administrative Procedure Act. The communication shall not form the basis for any finding of fact.

c) A copy of the record will be reproduced at the request of any party involved. The requesting party shall bear the cost.

d) The Agency shall be the official custodian of the records of administrative hearings held before the Agency.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.220 Hearing Officer's Report

a) As soon as practicable after the close of a hearing, the hearing officer shall prepare a written report of the case, which shall be based upon the evidence adduced at the hearing or otherwise included in the record. The written report shall contain findings of fact, a recommended decision and the reasons for the decision.

b) This report shall be submitted to the Director. The hearing officer shall also send a copy of the report to the Respondent or his/her counsel and to the Agency's counsel. Both the Respondent and the Agency's counsel may file written exceptions with the Director within 10 days.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

32 Ill. Adm. Code 200.230 Final Decision of the Director

a) The Director shall reach a final decision in each proceeding that shall be specified in a written order including findings of fact and conclusions of law separately stated. Findings of fact, if set forth in statute language, shall be accompanied by a concise and explicit statement of the underlying facts supporting the findings.

b) A copy of the Final Decision of the Director shall be served personally or by certified or registered mail upon all parties to the proceeding.

c) The decision of the Director shall be considered a final and binding administrative order subject to the Administrative Review Law.

History

• Source: Amended at 33 Ill. Reg. 14137, effective September 28, 2009

Subchapter b Radiation Protection

Part 310 General Provisions for Radiation Protection

32 Ill. Adm. Code 310.10 Scope

Except as otherwise specifically provided, this Part applies to all persons who receive, possess, use, transfer, own or acquire any source of radiation within the State of Illinois; provided, however, that nothing in this Part or 32 Ill. Adm. Code 320, 326, 330, 331, 332, 335, 340, 341, 346, 350, 351, 400, 401, 405 or 601 shall apply to any person to the extent such person is subject to regulation by the U.S. Nuclear Regulatory Commission (NRC).

AGENCY NOTE: Regulation by the State of source material, byproduct material and special nuclear material in quantities not sufficient to form a critical mass is subject to the provisions of an agreement between the State and the NRC and to 10 CFR 150 of NRC's regulations.

History

• Source: Amended at 35 Ill. Reg. 2908, effective February 7, 2011

32 Ill. Adm. Code 310.15 Incorporations by Reference

All rules, standards and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified in the reference and do not include any later amendments or editions. Copies of rules, standards and guidelines that have been incorporated by reference are available for public inspection and copying at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois.

History

• Source: Amended at 29 Ill. Reg. 20748, effective December 16, 2005

32 Ill. Adm. Code 310.20 Definitions

As used in 32 Ill. Adm. Code: Chapter II, Subchapters b and d, the following terms have the definitions set forth in this Section. Additional definitions used only in a certain Part will be found in that Part.

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

"Accelerator" or "particle accelerator" means any machine capable of accelerating electrons, protons, deuterons or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 million electron volts (MeV).

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

"Act" means the Radiation Protection Act of 1990 [420 ILCS 40].

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

"Adult" means an individual 18 or more years of age.

"Agency" means the Illinois Emergency Management Agency.

"Agreement State" means any state with which the U.S. Nuclear Regulatory Commission or the U.S. Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended (42 USC 2021(b) et seq.).

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

"Airborne radioactivity area" means any room, enclosure or operating area in which airborne radioactive material, composed wholly or partly of licensed material, exists in concentrations:

in excess of the derived air concentrations (DACs) specified in appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007, exclusive of subsequent amendments or editions; or

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 percent of the annual limit on intake (ALI) or 12 DAC-hours.

"Annually" means at intervals not to exceed 1 year or once per year, at about the same time each year (plus or minus 1 month).

"As low as is reasonably achievable" or "ALARA" means making every reasonable effort to maintain exposures to radiation as far below the dose limits in 32 Ill. Adm. Code: Chapter II, Subchapters b and d 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 the state of technology, the economics of improvements in relation to benefits to the public health and safety and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest.

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

"Becquerel" or "Bq" means the SI unit of activity. One becquerel (Bq) is equal to 1 disintegration (transformation) per second (dps or tps).

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

"Brachytherapy" means a method of radiation therapy in which sources are used to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal or interstitial application.

"Brachytherapy source" means a radioactive source, a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

"By-product material" means:

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

the tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from underground solution extraction processes but not including underground ore bodies depleted by such solution extraction processes;

any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity;

any material that has been made radioactive by use of a particle accelerator and is produced, extracted, or converted after extraction before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and

any discrete source of naturally occurring radioactive material, other than source material, that is extracted or converted after extraction for use in commercial, medical, or research activity before, on, or after August 8, 2005, and which the U.S. Nuclear Regulatory Commission, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate federal agency, determines would pose a threat to the public health and safety or the common defense and security similar to the threat posed by a discrete source or radium-226. [420 ILCS 40/4(a-5)]

"Calendar quarter" means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such 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 shall change the method observed by him for determining calendar quarters except at the beginning of a year.

"Calibration" means the determination of:

the response or reading of an instrument relative to a series of known radiation values over the range of the instrument; or

the strength of a source of radiation relative to a standard.

"CFR" means Code of Federal Regulations.

"Chelating agent" means amine polycarboxylic acids (e.g., EDTA, DTPA), hydroxy-carboxylic acids, and polycarboxylic acids (e.g., citric acid, carbolic acid, and glucinic acid).

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

"Commencement of construction" means, except as specified in 32 Ill. Adm. Code 601.20, taking any action defined as "construction" or any other activity at the site of a facility subject to this Part that has a reasonable nexus to radiological health and safety.

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

"Committed effective dose equivalent" or HE,50 means 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 wTHT,50).

"Construction" means the installation of foundations or in-place assembly, erection, fabrication or testing for any structure, system, or component of a facility or activity subject to this Part that is related to radiological safety or security. The term "construction" does not include:

changes for temporary use of the land for public recreational purposes;

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

preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion control and other environmental mitigation measures, and construction of temporary roads and borrow areas;

erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to this Part;

excavation;

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

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

procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

taking any other action that has no reasonable nexus to radiological health and safety.

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

"Curie" or "Ci" means a unit of quantity of radioactivity. One curie is that quantity of radioactive material that decays at the rate of 3.7 x 1010 disintegrations (transformations) per second (dps or tps).

"Decommission" means to remove a facility or site safely from service and reduce residual radioactivity to a level that permits release of property for unrestricted use and termination of the license.

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

"Dedicated check source" means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years.

"Deep dose equivalent" or "Hd" means the dose equivalent at a tissue depth of 1 centimeter (1000 milligrams per square centimeter) from external whole-body exposure.

"Densitometer" means a device that is used to provide a quantitative measurement of the optical density of x-ray film to determine the response of the film to exposure and development.

"Depleted uranium" means 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.

"Director" means the Director of the Illinois Emergency Management Agency.

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

"Distinguishable from background" means the detectable radioactivity is statistically different from background in the vicinity of the site, or, in the case of structures, in similar materials using adequate measurement technology, survey and statistical techniques.

"Dose" or "radiation dose" means either absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent or total effective dose equivalent.

"Dose equivalent" or"HT" means the product of the absorbed dose in tissue, quality factor and all other necessary modifying factors (e.g., a distribution factor for nonuniform deposition) at the location of interest. The units of dose equivalent are the sievert (Sv) and the rem.

"Dose limits" or "limits" means the permissible upper bounds of radiation doses established by, or in accordance with, 32 Ill. Adm. Code: Chapter II, Subchapters b and d.

"Dosimetry processor" means an individual or an organization that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to those devices. Dosimetry processing not only includes physical or chemical processing of dosimetry in a laboratory setting to extract absorbed dose information from a storage medium as is the case with film or thermoluminescent dosimetry (TLD), but also includes the process of digitally extracting absorbed dose information locally from storage medium using approved algorithms and computer applications as is the case with direct ion storage (DIS) technology.

"Effective dose equivalent" or "HE" means 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 = ΣWTHT).

"Embryo/fetus" means the developing human organism from conception until the time of birth.

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

"Exposure" means:

the quotient of dQ divided 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. (See Section 310.140 for SI unit coulomb per kilogram (C/kg) and the special unit roentgen (R).); or

irradiation by ionizing radiation or radioactive material.

AGENCY NOTE: The context makes clear which is the appropriate definition.

"Exposure rate" means the exposure per unit of time, such as roentgen per minute (R/min) and milliroentgen per hour (mR/h).

"External dose" means that portion of the dose equivalent received from any source of radiation outside the body.

"Extremity" means a hand, elbow, arm below the elbow, foot, knee and leg below the knee.

"Former U.S. Atomic Energy Commission (AEC) or U.S. Nuclear Regulatory Commission (NRC) licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where AEC or NRC licenses have been terminated.

"Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (J/kg) (100 rad).

"Healing arts" means the art or science or group of arts or sciences dealing with the prevention and cure or alleviation of human ailments, diseases or infirmities, and has the same meaning as "medicine" when the latter term is used in its comprehensive sense.

"High radiation area" means any 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 0.1 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates.

"Human use" means the internal or external administration of radiation or radioactive materials to human beings.

"Individual" means any human being.

"Individual monitoring" means the assessment of:

Dose equivalent by the use of individual monitoring devices or by the use of survey data; or

Committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed (i.e., DAC-hours). (For the definition of DAC-hours, see 32 Ill. Adm. Code 340.30.)

"Individual monitoring devices" (personnel dosimeter or dosimeter) means devices designed to be worn by a single individual for the assessment of dose equivalent. Examples of individual monitoring devices are film badges, thermoluminescence dosimeters (TLDs), optically stimulated luminescence dosimeters (OSLs), pocket ionization chambers, personal air sampling devices and electronic dosimeters (e.g., silicon diode dosimeters).

"Inspection" means 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 Agency.

"Interlock" means 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.

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

"License" means any license issued by the Agency in accordance with 32 Ill. Adm. Code: Chapter II, Subchapters b and d.

"Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license issued by the Agency.

"Licensee" means any person who is licensed by the Agency in accordance with 32 Ill. Adm. Code: Chapter II, Subchapters b and d.

"Lost or missing source of radiation" means any licensed or registered source of radiation whose location is unknown. This definition includes, but is not limited to, radioactive material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.

"Major processor" means a person, other than medical programs, universities, industrial radiography services, or wireline service operations, who is licensed to process, handle, or manufacture radioactive material as unsealed sources in quantities exceeding the quantities specified in appendix C to 10 CFR 20, published at 60 Fed. Reg. 20186, April 25, 1995, exclusive of subsequent amendments or editions, by a factor of at least 103, or radioactive material as sealed sources in quantities exceeding the quantities specified in appendix C to 10 CFR 20 by a factor of at least 1010.

"Member of the public" means any individual, except an individual who is performing assigned duties for the licensee or registrant involving exposure to sources of radiation.

"Minor" means an individual less than 18 years of age.

"Monitoring" or "radiation monitoring" or "radiation protection monitoring" means 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.

"NARM" means any naturally occurring or accelerator-produced radioactive material. It does not include byproduct, source or special nuclear material.

"Natural radioactivity" means radioactivity of naturally occurring nuclides.

"Nuclear Regulatory Commission" or "NRC" means the U.S. Nuclear Regulatory Commission or its duly authorized representatives.

"Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties for the licensee or registrant involve exposure to sources of radiation. Occupational dose does not include dose received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released as authorized by the Agency, from voluntary participation in medical research programs, or as a member of the public.

"Operator" means an individual, group of individuals, partnership, firm, corporation, association, or other entity conducting the business or activities carried on within a radiation installation. [420 ILCS 40/4(d-7)]

"Package" means the packaging, together with its radioactive contents, as presented for transport.

"Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of 32 Ill. Adm. Code 341. 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.

"Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 million electron volts (MeV). For purposes of this definition, "accelerator" is an equivalent term.

"Person" means any individual, corporation, partnership, 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 foregoing, other than the United States Nuclear Regulatory Commission, or any successor thereto, and other than federal government agencies licensed by the United States Nuclear Regulatory Commission, or any successor thereto. "Person" also includes a federal entity (and its contractors) if the federal entity agrees to be regulated by the State or as otherwise allowed under federal law. [420 ILCS 40/4(e)]

"Personnel monitoring equipment" (see "Individual monitoring devices").

"PET" means positron emission tomography.

"Pharmacist" means an individual licensed by the State pursuant to the Pharmacy Practice Act [225 ILCS 85] to compound and dispense drugs, prescriptions, and poisons.

"Physician" means an individual licensed to practice a treatment of human ailments by virtue of the Medical Practice Act of 1987 [225 ILCS 60], the Illinois Dental Practice Act [225 ILCS 25] or the Podiatric Medical Practice Act of 1987 [225 ILCS 100], who may use radiation for therapeutic, diagnostic or other medical purposes within the limits of the individual's licensure.

"Positron emission tomography radionuclide production facility" means a facility operating a particle accelerator for the purpose of producing PET radionuclides.

"Protective apron" means any apron made of radiation attenuating materials, at least 0.25 millimeter lead equivalent, that may be used to reduce exposure to radiation.

"Qualified engineering expert" means any person qualified under the Illinois Architecture Practice Act of 1989 [225 ILCS 305], the Structural Engineering Licensing Act of 1989 [225 ILCS 340] and/or any required combination thereof.

"Quality factor" or "Q" means the modifying factor (listed in Section 310.140, Tables 1 and 2) that is used to derive dose equivalent from absorbed dose.

"Quarterly" means at intervals not to exceed 3 months.

"Rad" means the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram or 0.01 joule per kilogram (J/kg) (0.01 Gy).

"Radiation" or "ionizing radiation" means gamma rays and x-rays, alpha and beta particles, high-speed electrons, neutrons, protons, and other nuclear particles, or electromagnetic radiations capable of producing ions directly or indirectly in their passage through matter; but does not include sound or radio waves, or visible infrared or ultraviolet light. [420 ILCS 40/4(f)]

"Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in 1 hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.

"Radiation dose" (see "Dose").

"Radiation emergency" means the uncontrolled release of radioactive material from a radiation installation which poses a potential threat to the public health, welfare and safety. [420 ILCS 40/4(f-5)]

"Radiation Installation" is any location or facility where radiation machines are used or where radioactive material is produced, transported, stored, disposed or used for any purpose [420 ILCS 40/4(g)], except when the radioactive materials or facility are subject to regulation by the NRC.

"Radiation machine" means any device that produces radiation when in use [420 ILCS 40/4(h)], except those that produce radiation only from radioactive materials.

"Radiation safety officer" means an individual who has the knowledge and responsibility to apply appropriate radiation protection regulations and has been assigned that responsibility by the licensee or registrant.

"Radioactive material" means any solid, liquid, or gaseous substance which emits radiation spontaneously. [420 ILCS 40/4(i)] It includes material defined as "byproduct material" in the Act.

"Radioactivity" means the disintegration (transformation) of unstable atomic nuclei by the emission of radiation.

"Radiobioassay" (see "Bioassay").

"Registrant" means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to the Radiation Protection Act of 1990 [420 ILCS 40] and 32 Ill. Adm. Code 320.10.

"Registration" means registration with the Agency in accordance with 32 Ill. Adm. Code 320.10.

"Regulations of the U.S. Department of Transportation" or "regulations of USDOT" means the regulations in 49 CFR 100-189, revised November 14, 2014, exclusive of subsequent amendments or editions.

"Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sv).

"Research and development" means:

theoretical analysis, exploration, or experimentation; or

the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes.

Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

"Residual radioactivity" means radioactivity in structures, materials, soils, groundwater and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 32 Ill. Adm. Code 340 or the equivalent provisions of 10 CFR 20.

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

"Roentgen" means the special unit of exposure. One roentgen (R) equals 2.58 x 10-4 coulombs per kilogram (C/kg). (See "Exposure" and Section 310.140.)

"Sealed source" means any device containing radioactive material to be used as a source of radiation which has been constructed in such a manner as to prevent the escape of any radioactive material.

"Sealed source and device registry" means the national registry that contains all the registration certificates generated by the Agency, U.S. Nuclear Regulatory Commission or an Agreement State that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

"Sensitometer" means a device that is used to test the setup and stability of film processing procedures and equipment by providing a standard pattern of light exposure of x-ray film.

"Shallow dose equivalent" or "Hs", which applies to the external exposure of the skin or an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 milligrams per square centimeter).

"SI" means the abbreviation for the International System of Units.

"Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in grays multiplied by the quality factor (1 Sv = 100 rem).

"Source material" means:

uranium or thorium, or any combination thereof, in any physical or chemical form; or

ores that contain by weight one-twentieth of one percent (0.05 percent) or more of uranium, thorium or any combination thereof.

Source material does not include special nuclear material.

"Source of radiation" means any radioactive material or any device or equipment emitting, or capable of producing, radiation.

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

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

The piece or capsule has at least one dimension not less than 5 millimeters (0.197 inch); and

It satisfies the test requirements specified in 10 CFR 71.75 and 71.77, published at 60 Fed. Reg. 50264, September 28, 1995, exclusive of subsequent amendments or editions, except that special form radioactive material designed or constructed prior to July 1, 1985 need only meet the requirements of 10 CFR 71.75 and 71.77 in effect on June 30, 1983.

"Special nuclear material" means:

plutonium, uranium 233, uranium enriched in the isotope 233 or in the isotope 235 and any other material which the Agency declares by order to be special nuclear material after the United States Nuclear Regulatory Commission, or any successor thereto, has determined the material to be such, but does not include source material; or

any material artificially enriched by any of the foregoing, but does not include source material. [420 ILCS 40/4(l)]

"Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; U-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or any combination of them, except source material, in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified 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 shall not exceed one. For example, the following quantities in combination would not exceed the limitation and are within the formula:

175 (grams contained U-235)

50 (grams U-233)

50 (grams Pu)

=1

350

200

200

"Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of sources of radiation. Such an evaluation includes, but is not limited to, measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

"Test" means the process of verifying compliance with an applicable regulation.

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

"Total organ dose equivalent" or "TODE" means the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in 32 Ill. Adm. Code 340.1160(a)(6).

"Unrefined and unprocessed ore" means ore in its natural form prior to any processing, such as grinding, roasting or beneficiating, or any refining. Processing does not include sieving or encapsulation of ore or preparation of samples for laboratory analysis.

"Unrestricted area" means any area access to which is not controlled by the licensee or registrant for purposes of protection of individuals from exposure to radiation and radioactive material, and any area used for residential quarters.

AGENCY NOTE: Licensees or registrants may control access to certain areas for purposes other than radiation protection, but such action does not affect whether the areas are unrestricted areas as defined in this Part.

"Uranium fuel cycle" means the operations of milling of uranium ore, chemical conversion of uranium, isotopic enrichment of uranium, fabrication of uranium fuel, generation of electricity by a light-water-cooled nuclear power plant using uranium fuel and reprocessing of spent uranium fuel to the extent that these activities directly support the production of electrical power for public use. Uranium fuel cycle does not include mining operations, operations at waste disposal sites, transportation of radioactive material in support of these operations and the reuse of recovered non-uranium special nuclear and byproduct materials from the cycle.

"U.S. Department of Energy" means the agency created by the Department of Energy Organization Act (established by P.L. 95-91, 91 Stat. 565, 42 USC 7101 et seq.), to the extent that the Department of Energy, or its duly authorized representatives, exercises functions formerly vested in the U.S. Atomic Energy Commission, its Chairman, members, officers and components and transferred to the U.S. Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (P.L. 93-438, 88 Stat. 1233 at 1237, 42 USC 5814) and retransferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (P.L. 95-91, 91 Stat. 565 at 577-578, 42 USC 7151).

"Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1 meter from any surface that the radiation penetrates.

AGENCY NOTE: For very high doses received at high dose rates, units of absorbed dose (e.g., gray and rad) are appropriate rather than units of dose equivalent (e.g., sievert and rem).

"Waste" means those low-level radioactive wastes containing source, special nuclear or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in Section 4(a-5)(2) of the Act.

"Waste handling licensee" means a person licensed by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State to receive radioactive wastes for storage or treatment, or both storage and treatment, prior to disposal as well as any person licensed to receive radioactive waste for disposal away from the point of generation.

"Week" means 7 consecutive days starting on Sunday.

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

"Worker" means any individual engaged in work under a license or registration issued by the Agency and controlled by a licensee or registrant, but does not include the licensee or registrant.

"Working level" or "WL" means any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3 x 105 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

radon-220: polonium-216, lead-212, bismuth-212 and polonium-212.

"Working level month" or "WLM" means an exposure to 1 working level (WL) for 170 hours. (2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month.)

"Year" means the period of time beginning in January used to determine compliance with the provisions of 32 Ill. Adm. Code: Chapter II, Subchapters b and d. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the decision to make the change is made not later than December 31 of the previous year. If a licensee or registrant changes a year, the licensee or registrant shall assure that no day is omitted or duplicated in consecutive years.

History

• Source: Amended at 45 Ill. Reg. 9911, effective July 22, 2021

32 Ill. Adm. Code 310.30 Exemptions

a) General Provisions − The Agency may, upon application or upon its own initiative, grant such exemptions or exceptions from the requirements of 32 Ill. Adm. Code: Chapter II, Subchapters b and d as it determines are authorized by law and will not result in undue hazard to public health and safety or property.

b) U. S. Department of Energy Contractors and U. S. Nuclear Regulatory Commission Contractors − Any U. S. Department of Energy contractor or subcontractor and any U. S. Nuclear Regulatory Commission contractor or subcontractor of the following categories operating within this State is exempt from 32 Ill. Adm. Code: Chapter II, Subchapters b and d to the extent that such contractor or subcontractor under contract receives, possesses, uses, transfers or acquires sources of radiation:

1. Prime contractors performing work for the Department of Energy at U. S. 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;

2. Prime contractors of the Department of Energy performing research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof;

3. Prime contractors of the Department of Energy using or operating nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel; and

4. Any other prime contractor or subcontractor of the Department of Energy or of the Nuclear Regulatory Commission when the State and the Nuclear Regulatory Commission jointly determine:

A) 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; and

B) that the exemption of such contractor or subcontractor is otherwise appropriate.

c) Federal governmental agencies or contractors of such agencies providing training for State and local governmental entities within this State are exempt from the fee requirements in 32 Ill. Adm. Code 331 provided they meet the notification requirements in 32 Ill. Adm. Code 330.900.

History

• Source: Amended at 45 Ill. Reg. 9911, effective July 22, 2021

32 Ill. Adm. Code 310.40 Records

Each licensee and registrant shall maintain records showing the receipt, transfer, use, storage and disposal of all sources of radiation. Additional record requirements are specified elsewhere in 32 Ill. Adm. Code: Ch. II, Subchapters b and d. Each record required by this Part shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel. The microform shall be capable of producing a clear copy throughout the required retention period. Records may be stored in electronic media with the capability for producing legible, accurate and complete records during the required retention period. Records such as letters, drawings and specifications shall include all pertinent information such as stamps, initials and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records.

History

• Source: Amended at 35 Ill. Reg. 2908, effective February 7, 2011

32 Ill. Adm. Code 310.50 Inspections

a) Each person shall afford the Agency at all reasonable times opportunity to inspect radiation installations and sources of radiation and the premises and facilities in which those radiation installations and sources of radiation are used or stored. (See 420 ILCS 40/27)

b) Each person shall make available to the Agency for inspection, upon reasonable notice, records maintained pursuant to 32 Ill. Adm. Code: Chapter II, Subchapters b and d.

History

• Source: Amended at 45 Ill. Reg. 9911, effective July 22, 2021

32 Ill. Adm. Code 310.60 Tests

Each licensee and registrant shall perform upon instructions from the Agency, or shall permit the Agency to perform, such reasonable tests as the Agency deems appropriate or necessary including, but not limited to tests of:

a) sources of radiation;

b) installations in which sources of radiation are used or stored;

c) radiation detection and monitoring instruments; and

d) other equipment and devices used in connection with utilization or storage of licensed or registered sources of radiation.

History

• Source: Amended at 29 Ill. Reg. 20748, effective December 16, 2005

32 Ill. Adm. Code 310.70 Additional Requirements

a) The Agency is authorized to inspect and investigate the premises and operations and personnel of any radiation installation, whether or not the installation is required to be registered or licensed by the Agency, for the purpose of studying and evaluating the health hazards caused by the use and operation of machines and material.

b) The Agency may impose additional requirements upon any licensee or registrant if the Agency deems these requirements to be necessary to minimize the danger to public health and safety or the environment.

c) Nothing in 32 Ill. Adm. Code: Chapter II, Subchapters b and d relieves the licensee or registrant from complying with other applicable Federal, State or local requirements governing any toxic, hazardous, medical or any other property of these materials or products containing these materials.

History

• Source: Amended at 29 Ill. Reg. 20748, effective December 16, 2005

32 Ill. Adm. Code 310.74 Cost Assessment

The Agency has authority under the Radiation Protection Act of 1990 [420 ILCS 40] to take actions necessary to abate violations of the Act or any rules or regulations promulgated under the Act and may provide that all or a portion of the cost of such actions be assessed to operators of radiation installations or other persons responsible for the violation or contamination. [420 ILCS 40/36]

a) The Agency may assess all or a portion of the costs incurred to abate violations to responsible operators of radiation installations or other responsible persons. Costs that are assessed shall be based on the Agency's actual response costs, including, but not limited to:

1. Time required by the Agency professional staff to coordinate response;

2. Time spent traveling and providing administrative support;

3. Performance or oversight of decontamination activities at properties contaminated with radioactive material;

4. Performance or oversight of confirmatory environmental monitoring;

5. Performance or oversight of treatment, storage, transfer and disposal of sources of radiation;

6. Equipment and supplies; and

7. Contractual support, if any, incurred by the Agency.

AGENCY NOTE: These support service costs may include, but are not limited to, rental of specialized equipment, acquisition of additional professional expertise not available within the Agency and laboratory fees charged to the Agency.

b) Any party affected by an order of the Agency assessing cost shall have the right to a hearing before the Agency in accordance with 32 Ill. Adm. Code 200.

History

• Source: Amended at 29 Ill. Reg. 20748, effective December 16, 2005

32 Ill. Adm. Code 310.75 Emergency Response Cost Recovery

The Agency has authority under the Radiation Protection Act of 1990 [420 ILCS 40] to respond to conditions that constitute an immediate threat to health and to assess the costs of its response against the person or persons responsible for the creation or continuation of the threat. If the Agency is unable to determine who is responsible for the creation or continuation of the threat, the costs shall be assessed against the owner of the property and shall constitute a lien against the property until paid [420 ILCS 40/38(b)].

a) Costs that are assessed shall be based on:

1. The Agency's actual response costs, including, but not limited to:

A) Time required by Agency professional staff to coordinate response;

B) Time spent traveling and providing administrative support;

C) Performance or oversight of decontamination activities at properties contaminated with radioactive material;

D) Performance or oversight of confirmatory environmental monitoring;

E) Performance or oversight of treatment, storage and disposal of sources of radiation;

F) Equipment and supplies; and

G) Contractual support, if any, incurred by the Agency.

AGENCY NOTE: These support service costs may include, but are not limited to, rental of specialized equipment, acquisition of additional professional expertise not available within the Agency and laboratory fees charged to the Agency.

2. Costs incurred by other units of government while assisting the Agency, including agencies of the federal government, provided the costs are submitted as follows:

A) Unless otherwise notified by the Agency, the request for reimbursement must be received by the Agency within 45 days after the assistance is rendered to the Agency or 45 days after the costs are determined, whichever is later, but in any case, not later than one year after the assistance is rendered;

B) The request shall be in writing and shall include documentation justifying costs to be reimbursed; and

C) Reimbursable costs may include, but are not limited to, items specified in subsection (a)(1) of this Section.

b) All reimbursable costs described in a reimbursement request by a governmental unit are subject to approval by the Director of the Agency. The Agency may request additional information in support of the requested reimbursement.

c) If a request by a governmental unit for costs is denied, or denied in part, the Agency shall notify the requesting governmental unit of the decision within 30 days after the date the request was submitted.

d) Each bill for emergency response costs assessed under this Section shall identify the items claimed and the costs related to each. Payment is due to the Agency within 45 days after receipt of the bill.

e) After all emergency response costs have been paid by the responsible parties, the Agency shall pay governmental units based on approved requests.

f) Any person assessed costs under this Section shall have the right to a hearing before the Agency provided a written request for a hearing is served on the Agency within 10 days after notice of the assessment. In the absence of receipt of a request for a hearing, the affected party shall be deemed to have waived the right to a hearing [420 ILCS 40/38(b)]. Hearings shall be conducted in accordance with 32 Ill. Adm. Code 200.

History

• Source: Amended at 29 Ill. Reg. 20748, effective December 16, 2005

32 Ill. Adm. Code 310.78 Deliberate Misconduct

32 Ill. Adm. Code 310.80 Violations (repealed)

History

• Source: Repealed at 45 Ill. Reg. 9911, effective July 22, 2021

32 Ill. Adm. Code 310.81 Policy for Assessment of Civil Penalties

a) Civil penalties shall be assessed in accordance with the provisions of this Section.

b) A civil penalty will be assessed whenever the Agency, based on consideration of the factors set forth in subsection (c), determines that a civil penalty is appropriate and issues a Preliminary Order and Notice of Opportunity for Hearing, in accordance with 32 Ill. Adm. Code 200.

c) Factors to be Considered in Assessing Civil Penalties

1. The Agency shall consider the factors contained in subsection (c)(2) to determine whether a penalty should be assessed, as provided in subsection (d), and the amount of the penalty. However, if the Agency has by rule established the amount to be assessed for a particular violation, the Agency shall assess the penalty as specified in that rule without regard to the factors contained in subsection (c)(2).

AGENCY NOTE: For an example of a rule that establishes the amount of the civil penalty to be assessed, see 32 Ill. Adm. Code 401.170, which specifies the civil penalties to be assessed for violations of the Agency's radiologic technologist accreditation requirements.

2. The factors to be considered by the Agency are:

A) History of Previous Violations. The Agency shall consider the person's history of previous violations of the Radiation Protection Act of 1990, the Agency's rules promulgated under that Act (Title 32, Chapter II, Subchapters b and d) and licenses issued pursuant to the Act. Each prior violation will be considered without regard to whether it led to a civil penalty assessment. A prior violation shall not be considered, however, if the notice or order relating to the prior violation is the subject of pending administrative or judicial review, or if the time to request such review or to appeal any administrative or judicial decision relating to the prior violation has not expired. The Agency shall not consider a prior violation if a Preliminary or Final Order pertaining to that prior violation has been vacated. The Agency shall not consider previous violations that occurred more than 6 years prior to the issuance of the Preliminary Order or other action taken by the Agency for those violations.

B) Severity of the Violation. The Agency shall consider the severity of the violation, including, but not limited to, actual or potential contamination of the environment resulting from the violation and any actual or potential hazard to the health or safety of the public or to workers, resulting from the violation. When evaluating the severity of the violation, the Agency may also consider the impact that the violation has on the Agency's ability to determine compliance with requirements established by statute, regulation or license condition.

C) Culpability. The Agency shall consider whether the person to whom the Preliminary Order was issued was negligent in causing, allowing, or failing to correct the violation, condition, or practice which was cited in the Preliminary Order. The Agency shall also consider:

i) whether the violation was intentional or inadvertent;

ii) whether the violation was allowed to continue once identified;

iii) whether actions were taken to correct or mitigate the violation and the timeliness of those actions; and

iv) whether the violation was voluntarily reported to the Agency.

d) Determination of the Amount of Penalty; Assessment of Separate Violations for Each Day

1. The Agency may assess a civil penalty not to exceed $10,000 per violation for each day the violation continues. If the Agency's rules (Title 32, Chapter II, Subchapters b and d) specify the amount of the civil penalty to be assessed for a particular violation, the Agency shall assess the civil penalty in that amount so specified, without consideration of the factors listed in subsection (c) of this Section.

2. When determining the amount of penalty, the Agency shall consider each day of a continuing violation to be a separate violation. Accordingly, the Agency may assess a separate penalty, in accordance with this Section, for each day that a violation continues.

History

• Source: Amended at 45 Ill. Reg. 9911, effective July 22, 2021

32 Ill. Adm. Code 310.82 Procedures for Assessment of Civil Penalties (repealed)

History

• Source: Repealed at 45 Ill. Reg. 9911, effective July 22, 2021

32 Ill. Adm. Code 310.90 Impounding

a) Authority of Department in cases constituting an immediate threat to health. Notwithstanding any other provision of the Act, whenever the Department finds that a condition exists which constitutes an immediate threat to health due to the violation of any provisions of this Act or any code, rule, regulation or order promulgated under this Act and requiring immediate action to protect the public health or welfare, it may issue an order reciting the existence of such an immediate threat and the findings of the Department pertaining thereto. The Department may summarily cause the abatement of such violation or may direct the Attorney General to obtain an injunction against such violator. [420 ILCS 40/38]

b) Such order shall be effective immediately but shall include notice of the time and place of a public hearing before the Department to be held within 30 days of the date of such order to assure the justification of such order. On the basis of such hearing the Department shall continue such order in effect, revoke it or modify it. Any party affected by an order of the Department shall have the right to waive the public hearing proceedings. [420 ILCS 40/38]

History

• Source: Amended at 23 Ill. Reg. 14454, effective January 1, 2000

32 Ill. Adm. Code 310.100 Prohibited Uses

a) Hand-held fluoroscopic screens shall not be used with x-ray equipment.

b) Shoe-fitting fluoroscopic devices shall not be used.

History

• Source: Amended at 17 Ill. Reg. 18472, effective January 1, 1994

32 Ill. Adm. Code 310.110 Communications

All communications and reports concerning these regulations and any applications filed thereunder may be submitted to the Agency as follows:

a) By mail addressed: IEMA-Division of Nuclear Safety, 1035 Outer Park Drive, Springfield, IL 62704;

b) By hand delivery to the Agency's offices at 1035 Outer Park Drive, Springfield, IL 62704; or

c) Where practicable, by electronic submission. Electronic submission shall be made in a manner that enables the Agency to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Guidance on making electronic submissions can be obtained by contacting the appropriate Agency program.

History

• Source: Amended at 45 Ill. Reg. 9911, effective July 22, 2021

32 Ill. Adm. Code 310.120 Plans and Specifications

The Director may require the user of any new or altered radiation installation to prepare plans and specifications of the proposed installation and submit them to the Agency for review and approval prior to starting construction or operation.

History

• Source: Amended at 29 Ill. Reg. 20748, effective December 16, 2005

32 Ill. Adm. Code 310.130 The International System of Units (si) (repealed)

History

• Source: Repealed at 17 Ill. Reg. 18472, effective January 1, 1994

32 Ill. Adm. Code 310.140 Units of Exposure and Radiation Dose

a) As used in 32 Ill. Adm. Code: Chapter II, Subchapters b and d, the unit of exposure is the coulomb per kilogram (C/kg) or roentgen (R). One roentgen (R) is equal to 2.58 x 10-4 C/kg.

b) As used in 32 Ill. Adm. Code: Chapter II, Subchapters b and d, the units of radiation dose are:

1. "Gray" (Gy) is the SI unit of absorbed dose. One Gy is equal to an absorbed dose of 1 joule per kilogram (J/kg). (1 Gy = 100 rad).

2. "Rad" is the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram or 0.01 joule per kilogram (J/kg). (1 rad = 0.01 Gy).

3. "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).

4. "Sievert" (Sv) is the 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).

c) As used in 32 Ill. Adm. Code: Chapter II, Subchapters b and d, the quality factors for converting absorbed dose to dose equivalent are as follows:

Type of Radiation

Quality Factor (Q)

Absorbed Dose Equal to a Unit Dose Equivalenta

X, gamma or beta radiation and high-speed electrons

1

1

Alpha particles, multiple-charged particles, fission fragments and heavy particles of unknown charge

20

0.05

Neutrons of unknown energy

10

0.1

High-energy protons

10

0.1

a Absorbed dose in gray equal to 1 Sv or the absorbed dose in rad equal to 1 rem.

d) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in rem per hour or sievert per hour, as provided in subsection (c) of this Section, 0.01 Sv (1 rem) of neutron radiation of unknown energies may, for purposes of 32 Ill. Adm. Code: Chapter II, Subchapters b and d, 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 may convert a measured tissue dose in gray (rad) to dose equivalent in sievert (rem) by using the fluence rate per unit dose equivalent or the appropriate Q value shown below.

Neutron Energy (MeV)

Quality Factora (Q)

Fluence per Unit Dose Equivalentb (neutrons cm-2 Sv-1)

Fluence per Unit Dose Equivalentb (neutrons cm-2 rem-1)

2.5 E-8 (thermal)

2

980 E8

980 E6

1 E-7

2

980 E8

980 E6

1 E-6

2

810 E8

810 E6

1 E-5

2

810 E8

810 E6

1 E-4

2

840 E8

840 E6

1 E-3

2

980 E8

980 E6

1 E-2

2.5

1010 E8

1010 E6

1 E-1

7.5

170 E8

170 E6

5 E-1

11

39 E8

39 E6

1

11

27 E8

27 E6

2.5

9

29 E8

29 E6

5

8

23 E8

23 E6

7

7

24 E8

24 E6

10

6.5

24 E8

24 E6

14

7.5

17 E8

17 E6

20

8

16 E8

16 E6

40

7

14 E8

14 E6

60

5.5

16 E8

16 E6

1 E2

4

20 E8

20 E6

2 E2

3.5

19 E8

19 E6

3 E2

3.5

16 E8

16 E6

4 E2

3.5

14 E8

14 E6

a Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-centimeter diameter cylinder tissue-equivalent phantom.

b Monoenergetic neutrons incident normally on a 30-centimeter diameter cylinder tissue-equivalent phantom.

History

• Source: Amended at 23 Ill. Reg. 14454, effective January 1, 2000

32 Ill. Adm. Code 310.150 Units of Activity

For the purposes of 32 Ill. Adm. Code: Chapter II, Subchapters b and d, activity is expressed in the SI unit of becquerel (Bq) or in the special unit of curie (Ci), or their multiples, or disintegrations (transformations) per unit of time (dps, dpm, tps or tpm).

a) One becquerel (Bq) = 1 disintegration (transformation) per second (dps or tps).

b) One curie (Ci) = 3.7 x 1010 disintegrations (transformations) per second (dps or tps) = 3.7 x 1010 becquerel (Bq) = 2.22 x 1012 disintegrations (transformations) per minute (dpm or tpm).

History

• Source: Added at 17 Ill. Reg. 18472, effective January 1, 1994

32 Ill. Adm. Code 310.APPENDIX A Transport Grouping of Radionuclides (repealed)

History

• Source: Repealed at 10 Ill. Reg. 17259, effective September 25, 1986

32 Ill. Adm. Code 310.APPENDIX B Tests for Special Form Licensed Material (repealed)

History

• Source: Repealed at 10 Ill. Reg. 17259, effective September 25, 1986

32 Ill. Adm. Code 310.APPENDIX C Penalty Assessment Worksheet (repealed)

History

• Source: Repealed at 17 Ill. Reg. 18472, effective January 1, 1994

Part 315 Standards for Protection Against Laser Radiation

32 Ill. Adm. Code 315.10 Purpose

This Part establishes standards for protection against laser radiation and is issued pursuant to the Laser System Act of 1997 [420 ILCS 56].

32 Ill. Adm. Code 315.20 Scope

a) Except as otherwise specifically exempted, this Part applies to any location or facility where laser systems are produced, stored, disposed of, or used for any purpose [420 ILCS 56/15].

b) This Part is not intended to restrict or limit in any way the use of laser radiation, of any type, that may be intentionally administered to an individual for diagnostic, therapeutic, or medical or dental research purposes by or under the direction of a practitioner licensed to practice a treatment of human ailments by virtue of the Medical Practice Act of 1987 [225 ILCS 60], the Illinois Dental Practice Act [225 ILCS 25], the Podiatric Medical Practice Act of 1987 [225 ILCS 100] or the non-human use of lasers by veterinarians by virtue of the Veterinary Medicine and Surgery Practice Act of 1994 [225 ILCS 115].

32 Ill. Adm. Code 315.30 Incorporations by Reference

All rules, standards and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified in the reference and do not include any later amendments or editions. Copies of these rules, standards and guidelines that have been incorporated by reference are available for public inspection at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois.

AGENCY NOTE: In this Part, the Agency has incorporated by reference Title 21 of the Code of Federal Regulations, 21 CFR 1040, 2000 edition, published April 1, 2000; the American National Standard for Safe Use of Lasers, ANSI Z136.1-2000, effective June 28, 2000; the American National Standard for the Safe Use of Optical Fiber Communication Systems Utilizing Laser Diode and LED Sources, ANSI Z136.2, effective August 12, 1997; and the American National Standard for Safe Use of Lasers in Health Care Facilities, ANSI Z136.3, effective February 7, 1996.

History

• Source: Amended at 37 Ill. Reg. 20200, effective December 9, 2013

32 Ill. Adm. Code 315.40 Definitions

As used in this Part, the following definitions apply:

"Act" means the Laser System Act of 1997 [420 ILCS 56].

"Agency" means the Illinois Emergency Management Agency.

"ANSI" means the American National Standards Institute, 11 West 42nd Street, New York, New York 10036.

"Aperture" means any opening in a protective housing through which laser radiation can pass.

"Attenuation" means the decrease in the radiant power of any optical beam as it passes through an absorbing and/or scattering medium.

"Certified laser system" means that the system is certified by a manufacturer pursuant to the requirements of 21 CFR 1010.2.

"Class 1 laser" means any laser that meets the criteria of a Class 1 laser, as defined in 21 CFR 1040.

"Class 2 laser" means any laser that meets the criteria of a Class 2 laser, as defined in 21 CFR 1040.

"Class 2a laser" means any laser that meets the criteria of a Class 2a laser, as defined in 21 CFR 1040.

"Class 3 laser" means any laser that meets the criteria of a Class 3 laser, as defined in 21 CFR 1040. Class 3 lasers are separately designated as Class 3a or Class 3b.

"Class 4 laser" means any laser that meets the criteria of a Class 4 laser, as defined in 21 CFR 1040.

"Controlled area" means any area where the occupancy and access of those within is subject to control and supervision by the registrant for the purpose of protection from laser radiation hazards.

"Director" means the Director of the Illinois Emergency Management Agency.

"Embedded laser" means an enclosed laser with an assigned class number higher than the inherent capability of the laser system in which it is incorporated, where the system's lower classification (Class 1, 2, 3a or 3b) is appropriate due to the engineering features limiting accessible emission.

"Enclosed laser" means a laser that is contained within a protective housing of itself or of the laser or laser system in which it is incorporated.

"Energy" means the capacity for doing work. Energy content is commonly used to characterize the output from pulsed lasers and is generally expressed in joules (J).

"Facility" means a laser installation.

"FDA" means the Food and Drug Administration of the United States Department of Health and Human Services.

"Fire-resistant material" means a material that is not combustible when used for its intended purpose in conjunction with a laser system.

"Incident" means an event or occurrence that results in a real or suspected intentional or accidental exposure to laser radiation that caused or has the potential to cause biological damage.

"Irradiance" means the radiant power incident on an element of a surface divided by the area of that element, expressed in watts per square centimeter (W cm-2).

"Joule" or "J" means a unit of energy: 1 joule = 1 watt second.

"Laser" means any device that can produce or amplify electromagnetic radiation at wavelengths greater than 180 nanometers but less than 1 millimeter, primarily by the process of controlled stimulated emission.

"Laser installation" means a location or facility where laser systems are produced, stored, disposed of or used for any purpose [420 ILCS 56/15].

"Laser radiation" means an electromagnetic radiation emitted from a laser system and includes all reflected radiation, any secondary radiation or other forms of energy resulting from the primary laser beam [420 ILCS 56/15].

"Laser safety officer" means any individual, qualified by training and experience in the evaluation and control of laser hazards, who is designated by the registrant to have the authority and responsibility to establish and administer the laser radiation protection program for a particular laser installation.

"Laser system" means a device, machine, equipment or other apparatus that applies a source of energy to a gas, liquid, crystal, or other solid substances or combination thereof in a manner that electromagnetic radiations of a relatively uniform wave length are amplified and emitted in a cohesive beam capable of transmitting the energy developed in a manner that may be harmful to living tissues, including but not limited to electromagnetic waves in the range of visible, infrared or ultraviolet light. Such systems in schools, colleges, occupational schools, and State colleges and other State institutions are also included in the definition of "laser systems". [420 ILCS 56/15]

"Maintenance" means the performance of those adjustments or procedures by the user to keep equipment in its intended operating condition. Maintenance does not include operation or service as defined in this Section.

"Maximum permissible exposure" or "MPE" means that level of laser radiation to which persons may be exposed without adverse biological change in the eye or skin.

"Medical laser" means a laser system that is a medical device, as defined in 21 USC 321(h), and is manufactured, designed or intended for laser irradiation of any part of the human body for the purpose of diagnosis, surgery or therapy (see 21 CFR 1040.10(b)).

"Operation" means the performance of tasks required for the equipment to perform its intended functions. It does not include maintenance or service tasks as defined in this Section.

"Operator" is an individual, group of individuals, partnership, firm, corporation, or association conducting the business or activities carried on within a laser installation [420 ILCS 56/15].

"Optical density" or "OD" means a logarithmic expression of the optical attenuation afforded by a material.

OD

=

log10

incident power

transmitted power

"Optical fiber communications system" or "OFCS" means a system consisting of one or more laser transmitters, each of which is coupled to an individual optical fiber and is used for the transmission of information, e.g., voice or data.

"Person" means any individual, corporation, limited liability company, partnership, 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 foregoing.

"Protective housing" means those portions of a laser system that are designed to prevent human access to laser radiation above the applicable MPE level.

"Pulse duration" means the time increment measured between the half-peak power points at the leading and trailing edges of a pulse.

"Radiant energy" means energy emitted, transferred or received in the form of laser radiation, expressed in joules (J).

"Radiant exposure" means the radiant energy incident on an element of a surface divided by the area of that element, expressed in joules per square centimeter (J cm-2).

"Radiant power" means power emitted, transferred or received in the form of laser radiation expressed in watts (W). Radiant power also means output power.

"Registrant" means any person who registers a laser installation with the Agency pursuant to this Part.

"Scanning laser" means a laser having a time-varying direction, origin or pattern of propagation with respect to a stationary frame of reference.

"Service" means the performance of adjustments, repairs or procedures required to return equipment to its intended state. These adjustments and procedures usually require specialized training and/or tools. Service does not include operation or maintenance as defined in this Section.

"Watt" or "W" means the unit of radiant power, 1 watt = 1 joule per second (J sec1)

History

• Source: Amended at 37 Ill. Reg. 20200, effective December 9, 2013

32 Ill. Adm. Code 315.50 Exemptions

The following are exempt from the requirements of this Part:

a) All certified Class 1, Class 2, Class 2a and Class 3a lasers or laser systems, provided that the laser is maintained as a certified Class 1, Class 2, Class 2a or Class 3a laser system throughout its useful life.

b) Laser systems containing embedded Class 3b or Class 4 lasers, where the laser system's lower classification is appropriate due to engineering features limiting accessible emission.

c) A laser system being transported on railroad cars, motor vehicles, aircraft, or vessels in conformity with rules adopted by an agency having jurisdiction over safety during transportation, or laser systems that have been installed on aircraft, munitions, or other equipment that is subject to the regulations of, and approved by an appropriate agency of, the federal government [420 ILCS 56/25(2)].

d) Laser systems that are inoperable due to the absence or failure of components necessary for operation. Laser systems that are not in operation due to disconnection from an electrical supply shall be considered operable.

32 Ill. Adm. Code 315.60 Registration

a) Installation Registration

1. Any operator of a laser installation shall register the laser installation with the Agency. The operator shall register the installation before the installation is placed in operation on a form prescribed by the Agency, which shall include, but not be limited to:

A) The operator's name;

B) The location of the laser installation;

C) The classification number and room location of laser systems possessed; and

D) The name of the individual designated as the laser safety officer.

AGENCY NOTE: Prior to designation of the laser safety officer, the registrant should carefully review the requirements of Section 315.90.

2. Installation registration, as specified in subsection (a), shall be required only at the time the laser installation is placed in operation.

3. Laser systems that are located in a single building or in a group of buildings that are contiguous to one another, and used by the same operator, shall be treated as a single laser installation unless requested otherwise in writing by the operator and approved by the Agency.

b) Laser System Registration

1. Any operator of a laser installation where laser systems are located shall register the systems annually on a form prescribed by the Agency.

2. The form shall include, but not be limited to, the manufacturer, model serial number, output power, wavelength and class of each laser system.

3. Any operator of a laser installation that possesses multiple laser systems of the same manufacturer and model may register those laser systems on a single form, provided that the operator includes a listing of serial numbers for each laser system.

History

• Source: Amended at 37 Ill. Reg. 20200, effective December 9, 2013

32 Ill. Adm. Code 315.70 Amendments and Changes in Status

a) Operators of laser installations that have been registered pursuant to Section 315.60 shall notify the Agency within 30 days after the installation of new, used, relocated or reactivated laser systems.

b) If any operator discontinues using a laser system, the operator shall notify the Agency within 30 days after the discontinuance. The notification shall include the date of discontinuance, including the name, address and telephone number of the person who received the laser and the disposition of the laser system.

c) Within 30 days after changing the operator of a laser installation, the new operator shall notify the Agency in writing or by telephone or other electronic means.

History

• Source: Amended at 37 Ill. Reg. 20200, effective December 9, 2013

32 Ill. Adm. Code 315.80 Registration Requirements for Out-of-State Laser Facilities

a) Whenever any Class 3b or Class 4 laser system is to be brought into this State, for any temporary use, the person proposing to bring the laser system into this State shall:

1. Register the installation and laser systems in accordance with Section 315.60.

2. Give written notice to the Agency at least 10 working days before the laser system is to be used in this State. The notice shall:

A) Include the nature, duration and scope of use;

B) Include the exact locations where the laser system is to be used; and

C) Comply with all applicable requirements of this Part.

b) A pre-operational inspection by the Agency of the out-of-state laser system may be required within 24 hours prior to the laser system being used in this State.

History

• Source: Amended at 37 Ill. Reg. 20200, effective December 9, 2013

32 Ill. Adm. Code 315.90 Laser Safety Officer Qualifications, Duties and Responsibilities

a) Every operator of a laser installation shall ensure that the designated laser safety officer has qualifications that include training, experience and familiarity in the following areas:

1. Fundamentals of laser operation;

2. Familiarity with the type of laser equipment utilized at the facility;

3. Biological effects of laser radiation on the eye and skin;

4. Laser and laser system classification;

5. Control measures;

6. Nonradiation hazards of lasers;

7. Medical surveillance practices (if applicable);

8. Laser terminology; and

9. Maximum Permissible Exposure (MPE) levels for eye and skin for all lasers and for all conditions of use of laser systems at the facility.

b) Every operator of a laser installation shall ensure that the following specific duties are carried out by the laser safety officer:

1. Establish and implement a program of laser radiation safety for effective compliance with the requirements of this Part.

2. Ensure that instructions concerning hazards and safety practices are provided to individuals who may be exposed to laser radiation and to individuals who operate lasers.

3. Permit, on behalf of the registrant, operation of lasers only by individuals who have:

A) Been trained in the safe use of the laser in accordance with Section 315.100 of this Part; and

B) Received copies of and instruction in the registrant's operating and emergency procedures.

AGENCY NOTE: In facilities where more than one practitioner or operator may use lasers, a laser safety committee should be formed to oversee laser activity, establish use criteria and approve operating policies and procedures.

4. Ensure that all laser systems in operation meet the requirements of this Part, and that prescribed control measures are in effect. The laser safety officer may recommend and approve substitute or alternative control measures when the primary control measures are not feasible or practical. Accordingly, if alternative control measures are instituted, those personnel directly affected shall be provided appropriate training.

5. Periodically audit the functionality of control measures in use.

32 Ill. Adm. Code 315.100 General Operator Requirements

a) Administrative and Procedural Controls

1. The registrant shall provide personnel operating lasers written operating and safety procedures. These procedures shall include restrictions required for the safe operation of each laser and shall include the topics listed in the laser safety program of subsection (a)(2).

AGENCY NOTE: Sample standard operating procedures for the use of laser systems are contained in Appendix A. The Agency recommends these procedures be modified and adopted for each registrant's specific use of lasers.

2. The registrant shall provide for initial and annual in-service training in laser safety for individuals using laser systems to ensure their awareness of the registrant's laser safety practices and policies. The in-service training shall include the following topics:

A) Operating and emergency procedures for the lasers;

B) Use of laser protective devices, including selection and use of protective eyewear;

C) Clear warnings and precautions to avoid possible exposure to laser radiation in excess of the MPE; and

D) Requirements for safe operation of lasers as described in this Part.

3. Personnel operating lasers shall be instructed in and able to demonstrate competence with the registrant's operating and safety procedures.

4. Alignment of laser optical systems (e.g., mirrors, lenses and beam deflectors) shall be performed in a manner that assures that no one is exposed to laser radiation above the MPE.

5. A controlled area shall be established when exposure to laser radiation in excess of the MPE limit is possible. The controlled area shall meet the following requirements:

A) Be posted as required by Section 315.150.

B) Access shall be only by permission of the laser safety officer or a trained designated representative.

6. Unenclosed Beam Paths

A) An evaluation of the expected beam path and the potential hazards from reflective surfaces that may be encountered shall be conducted before operating the laser. All reflective surfaces shall be excluded from the beam path at all points where the laser radiation exceeds the MPE.

B) If applicable, the stability of the laser platform shall be evaluated to determine the constraints that shall be placed upon the beam traverse and the extent of the range of control.

C) No laser shall be operated or made ready for operation until the area along all points of the beam path where the laser radiation will exceed the MPE is clear of individuals, unless the individuals are wearing appropriate protective devices.

b) Requirements for Safe Operation

1. Operator Supervision

A) The laser system shall be operated at all times under the direct supervision or control of an experienced, trained operator who shall maintain visual surveillance of conditions for safe use and terminate laser emission in the event of malfunction or any other condition of unsafe use.

B) Unattended use of the laser system shall be permitted only when the laser safety officer has implemented appropriate control measures that provide adequate protection and laser safety training to those who may enter the laser controlled area during times of unattended use.

2. Maximum Permissible Exposure (MPE)

A) No individual shall be exposed to levels of laser radiation higher than the MPE, as described in Tables A and B.

B) In those cases in which MPE is known for particular wavelengths and pulse durations, exposure to laser radiation shall be prohibited.

C) Measurements and calculations performed to determine MPE limits shall be made in a manner consistent with the criteria contained in ANSI Z136.1-2000.

3. The minimum laser radiant energy or laser power level required for the application shall be used.

4. All service procedures shall be performed by qualified personnel who are trained in laser radiation protection.

5. Protective eyewear, when specified by the laser safety officer, when engineering or other procedural and administrative controls are inadequate to eliminate potential exposure in excess of the applicable MPE, shall be worn by all individuals with access to Class 3b and Class 4 levels of laser radiation. The protective eyewear devices shall meet the following requirements:

A) Provide a comfortable and appropriate fit all around the area of the eyes sufficient to protect the eyes from laser radiation.

B) Be in proper condition to ensure the optical filters and holder provide the required optical density or greater at the desired wavelengths, and retain all protective properties during use of the device.

C) Be suitable for the specific wavelength of the laser and be of optical density adequate for the energy of the laser.

D) Have the optical density or densities and associated wavelengths permanently labeled on the filters or otherwise permanently identified.

E) Be examined by the registrant's laser safety officer, or designee, at intervals not to exceed 6 months, to ensure the reliability of the protective filters and integrity of the protective filter frames.

F) Eyewear not meeting the requirements of this subsection (b)(5) shall not be utilized as protective eyewear.

6. When there is a possibility of exposure to laser radiation that exceeds the MPE limits for skin as specified in Table B, the registrant shall require the appropriate use of protective gloves, clothing and shields.

7. Laser products certified by a manufacturer to be compliant with the requirements of 21 CFR 1040 applicable at the date of manufacture shall be maintained in compliance with the requirements. Certified laser products that have been modified shall comply with this Part.

c) Engineering Controls

1. Each laser product shall have a protective housing that prevents, during operation, human access to laser radiation that exceeds the limits of a Class 1 laser (see 21 CFR 1040.10, Table I), wherever and whenever human access is not necessary in order for the laser system to perform its intended function.

2. Safety Interlocks

A) A safety interlock, which ensures that laser radiation is not accessible above MPE limits, shall be provided for any portion of the protective housing that, by design, can be removed or displaced without the use of tools during normal operation or maintenance.

B) Adjustment during operation, service, testing or maintenance of a laser containing interlocks shall not cause the interlocks to become inoperative or the laser radiation to exceed MPE limits outside the protective housing except where a controlled area, as specified in subsection (a)(5), is established.

C) For pulsed lasers, interlocks shall prevent firing of the laser.

D) For continuous wave lasers, the interlocks shall turn off the power supply or interrupt the beam.

E) An interlock shall not allow access to laser radiation in excess of MPE limits when the interlock is closed.

F) Multiple safety interlocks, or a means to preclude removal or displacement of the interlocked portion of the protective housing upon failure, shall be provided if failure of a single interlock would allow human access to levels of Class 3b or Class 4 laser radiation.

3. Viewing Optics and Windows

A) All viewing ports, viewing optics or display screens included as an integral part of an enclosed laser or laser system shall incorporate suitable means to attenuate the laser radiation transmitted through the port to less than the MPE during maintenance or operation of the laser.

B) When optical systems such as lenses, telescopes and microscopes are used that were not supplied as part of a certified laser product, the laser safety officer shall determine the potential hazard and specify administrative procedures and the use of controls such as interlocks or filters.

4. Warning Systems

A) Each laser system shall provide visual or aural indication during the emission of accessible laser radiation.

B) Any visual indicator shall be clearly visible through protective eyewear designed specifically for the wavelengths of the emitted laser radiation.

C) Visual indicators shall be positioned so that viewing does not result in exposure to laser radiation in excess of the MPE.

D) An indication shall be provided prior to emission of the radiation to allow appropriate action to avoid exposure.

5. Additional Requirements for Indoor Class 4 Laser Controlled Areas

A) Latches, interlocks or other appropriate means shall be used to restrict access to controlled areas.

B) Measures shall be designed to allow both rapid exit by the laser personnel at all times and entrance to the controlled area in an emergency condition.

C) For emergency conditions, a control-disconnect switch or equivalent device (panic button) shall be available for deactivating the laser or closing the shutter.

D) During tests requiring continuous operation, the laser safety officer or a trained designated representative shall be permitted to momentarily override the safety interlocks to allow access to other authorized personnel if it is clearly evident that:

i) There is no optical radiation hazard at the point of entry; and

ii) The necessary protective devices are being worn by the entering personnel.

E) Optical paths (e.g., windows) from an indoor facility shall be controlled in such a manner as to reduce the transmitted values of the laser radiation to levels at or below the MPE. When the laser beam must exit the indoor controlled area (as in the case of exterior atmospheric beam paths), the operator shall be responsible for ensuring that the beam path is limited to controlled air space or controlled ground space when the beam irradiance or radiant exposure is above the appropriate MPE.

History

• Source: Amended at 37 Ill. Reg. 20200, effective December 9, 2013

32 Ill. Adm. Code 315.110 Additional Requirements for Infrared Laser Systems

a) The beam from an infrared laser (wavelength greater than 710 nanometers) shall be terminated in fire-resistant material where necessary.

b) Periodic inspection of fire-resistant material shall be made to assure that the material has not degraded with use. Degraded material that could create a fire or reflection hazard shall be replaced prior to further operation of the laser.

32 Ill. Adm. Code 315.120 Additional Requirements for Optical Fiber Communications Systems

a) Laser communication systems that employ optical cables shall be considered enclosed systems with the optical cable forming part of the protective housing.

b) Disconnection of a connector resulting in access to radiation in excess of the applicable MPE shall take place only in a controlled area.

1. The use of a tool shall be required for the disconnection of a connector for service and maintenance purposes when the connector is not within a protective housing.

2. All connectors shall bear the appropriate label specified in Section 315.150 of this Part.

32 Ill. Adm. Code 315.130 Additional Requirements for Medical Laser Applications

a) Medical lasers used for human irradiation shall be calibrated in accordance with the manufacturer's specified calibration procedure at intervals not to exceed those specified by the manufacturer. Calibration records shall be maintained at the facility for inspection by the Agency.

b) Each medical laser shall incorporate a means for measurement of the level of laser radiation intended for human irradiation, with an error in measurement of no greater than plus or minus 20 percent, when calibrated in accordance with the laser manufacturer's calibration procedure.

c) Any footswitch that is used to control patient exposure to laser radiation shall have a guard mechanism to prevent inadvertent exposure.

d) The operator shall ensure that medical lasers shall not be used for human irradiation unless all applicable requirements of this Part are met.

History

• Source: Amended at 37 Ill. Reg. 20200, effective December 9, 2013

32 Ill. Adm. Code 315.140 Additional Requirements for Entertainment Laser Light Show

a) The operator shall notify the Agency in writing or facsimile, at least 10 working days in advance of the proposed laser light show, and shall include the following information:

1. Name, address and telephone number of:

A) Laser registrant;

B) Laser safety officer;

C) Individual in charge of the laser light show;

2. The location, time and date of the show;

3. Documentation that a variance has been obtained in accordance with 21 CFR 1040.11;

4. For outdoor performances, a copy of the notification to the Federal Aviation Administration;

5. Manufacturer, class, wavelength and output power of the laser systems to be used; and

6. Sketches showing the location of the laser systems, operators, performers, laser beam paths, viewing screens, walls, mirror balls and other reflective or diffusive surfaces that may be struck by the laser beam.

b) The operator shall also supply additional information as may be required by the Agency for the evaluation of the safety of the proposed laser light show.

c) Requirements for Safe Operations

1. Laser radiation emissions outside the spectral range of 400 to 700 nanometers shall not exceed the limits of a Class 1 laser.

2. Levels of laser radiation where the audience is located, and where operators, performers and employees are located if the laser radiation is intended to be viewed by them, shall not exceed the limits of a Class 1 laser.

3. Operators, performers and employees shall be able to perform their functions without being exposed to laser radiation exceeding the limits of a Class 2 laser when the laser radiation is not intended to be viewed by them.

4. Areas where levels of laser radiation exceed the limits of a Class 2 laser shall be identified by posting of warning signs and through use of barriers or guards to prevent individuals from entering these areas.

5. Scanning lasers shall not, as a result of scan failure or any other failure causing a change in either angular velocity or amplitude, permit audience exposure to laser radiation in excess of the limits of a Class 1 laser.

6. Where a mirror ball is used with a scanning laser, the conditions of subsections (c)(1) and (c)(2) shall be met with the mirror ball stationary or during any failure mode resulting in a change in rotational speed of the mirror ball.

7. Laser light shows shall be, at all times, under the direct and personal supervision of the laser operator, except:

A) In cases in which the maximum laser output power level is less than 5 milliwatts (all spectral lines);

B) When the laser beam path is located at least 6 meters above any surface upon which an individual in the audience is permitted to stand; or

C) When the laser beam path is located at least 2.5 meters in lateral separation from any position where an individual in the audience is permitted during the performance.

8. Laser radiation levels shall not exceed the limits of a Class 2 laser at any point less than 3 meters above any surface upon which any individual in the audience is permitted to stand, and 2.5 meters in lateral separation from any position where an individual in the audience is permitted, unless physical barriers are present that prevent human access to these levels.

9. All safety devices and procedures necessary to comply with this Part shall be functionally tested and evaluated after setup and prior to the laser light show to ensure compliance.

10. The laser system, when not in use, shall be secured against unauthorized operation or tampering.

11. Laser alignment procedures shall be performed with the laser output power reduced to the lowest practicable level, and protective eyewear shall be worn where necessary to prevent exposure to laser radiation levels exceeding the MPE. Unless specifically authorized by the laser safety officer, only individuals required to perform the alignment shall be present during these procedures.

12. The operator shall ensure that no laser light show is conducted except as specifically authorized in a variance issued in accordance with 21 CFR 1040.11 and applicable requirements of this Part.

History

• Source: Amended at 37 Ill. Reg. 20200, effective December 9, 2013

32 Ill. Adm. Code 315.150 Caution Signs, Labels and Postings

a) Except as otherwise authorized by the Agency, signs and labels prescribed by this Section shall use the design and colors specified in Illustration A or B of this Part.

b) Controlled areas shall be conspicuously posted with appropriate sign or signs as specified in subsection (c).

c) Labeling and Posting Laser Systems and Laser Facilities

1. Class 3b lasers shall have a label and facilities shall be posted with signs with the warning specified in Illustration A and that include the following wording:

(Position 1 on the logotype)

"LASER RADIATION − AVOID DIRECT EXPOSURE TO BEAM"

(Position 3 on the logotype)

"CLASS 3b LASER"

2. Class 4 lasers shall have a label and facilities shall be posted with signs with the warning specified in Illustration B and that include the following wording:

(Position 1 on the logotype)

"LASER RADIATION − AVOID EYE OR SKIN EXPOSURE TO

DIRECT OR SCATTERED RADIATION"

(Position 3 on the logotype)

"CLASS 4 LASER"

3. Each laser, except lasers used in the practice of medicine, shall have labels in close proximity to each aperture through which is emitted accessible laser radiation in excess of the MPE with the following wording as applicable:

A) "AVOID EXPOSURE − Laser radiation is emitted from this aperture", if the radiation emitted through the aperture is laser radiation.

B) "AVOID EXPOSURE − Hazardous electromagnetic radiation is emitted from this aperture", if the radiation emitted through the aperture is electromagnetic radiation.

C) "AVOID EXPOSURE − Hazardous x-rays are emitted from this aperture", if the radiation emitted through the aperture is x-ray radiation.

4. Each label specified in this subsection (c) shall state, at position 2 on the required warning logotype, the maximum output of laser radiation, the pulse duration when appropriate, and the laser medium or emitted wavelengths.

5. Each noninterlocked or defeatably interlocked portion of the protective housing or enclosure that is designed to be displaced or removed during normal operation, maintenance or servicing and that would permit human access to laser radiation shall have labels as follows:

A) For Class 3b laser radiation, the wording: "DANGER − Laser radiation when open, AVOID DIRECT EXPOSURE TO BEAM".

B) For Class 4 laser radiation, the wording: "DANGER − Laser radiation when open, AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION".

C) For protective housings or enclosures that provide a defeatable interlock, the phrase "and interlock defeated" shall be inserted after the word "open" on the labels specified in subsections (c)(5)(A) and (B) of this Section.

6. The word "invisible" shall precede the word "laser" on labels and signs required by this Part for wavelengths of laser radiation that are outside of the range of 400 to 710 nanometers.

7. The words "visible and invisible" shall precede the word "laser" on labels and signs required by this Part for wavelengths of laser radiation that are both within and outside the range of 400 to 710 nanometers. For laser products emitting only visible wavelengths, the phrase "laser light" may be used in lieu of "laser radiation".

8. All labels placed on lasers or signs posted in laser facilities shall be positioned so as to make unnecessary, during reading, human exposure to laser radiation in excess of the MPE.

9. Labels and signs required by this Part shall be clearly visible, legible and permanently attached to the laser or facility.

AGENCY NOTE: With respect to laser systems only, the labeling requirements found in 21 CFR 1040, and labels otherwise approved by the FDA, may be used in lieu of subsection (c).

History

• Source: Amended at 37 Ill. Reg. 20200, effective December 9, 2013

32 Ill. Adm. Code 315.160 Notifications and Reports

a) Each registrant shall notify the Agency immediately of any incident involving exposure to laser radiation that has or may have caused accidental injury to an individual in the course of use, handling, operation, manufacture or discharge of a laser system [420 ILCS 56/40], including:

1. An exposure to an individual of greater than 100 times the MPE;

2. An exposure to an individual that involves the partial or total loss of sight in either eye; or

3. An exposure to an individual that involves perforation of the skin or other serious injury exclusive of eye injury.

b) Each registrant shall notify the Agency within 24 hours of any incident involving exposure to laser radiation that has or may have caused:

1. An exposure to an individual of greater than 5 times the MPE; or

2. An exposure to an individual that involves second or third degree burns to the skin.

c) Each registrant shall make a report in writing within 30 days to the Agency of any incident for which notification is required by subsection (a) or (b).

d) Each report filed with the Agency pursuant to this Section shall include the full name of each individual exposed to laser radiation, including estimates of each individual's exposure, levels of laser radiation involved, the cause of the exposure, a description of any injuries, and corrective steps taken or planned to be taken to assure against a recurrence.

e) When a registrant is required pursuant to this Section to report to the Agency any exposure of an individual to laser radiation, the registrant shall also provide to the individual a report on that exposure data. The report to the individual shall be transmitted at a time not later than the date of transmittal to the Agency.

History

• Source: Amended at 37 Ill. Reg. 20200, effective December 9, 2013

32 Ill. Adm. Code 315.170 Records/Information

a) Each registrant shall maintain, for a period of 5 years, records that shall be kept current and available for inspection by the Agency, showing:

1. A listing of all individuals who have been authorized by the registrant to operate lasers.

2. The results of all inspections of protective eyewear required by Section 315.100.

3. The results of all instrument calibrations required by Section 315.130.

4. The reports of incidents as described under Section 315.160.

b) Each operator shall make records maintained pursuant to this Part available to the Agency for review and copying.

History

• Source: Amended at 37 Ill. Reg. 20200, effective December 9, 2013

32 Ill. Adm. Code 315.180 Inspections and Investigations

a) The Agency is authorized to enter upon, inspect, and investigate the premises and operations of all laser systems of this State, whether or not the systems are required to be registered by the Act [420 ILCS 56/35].

b) Each operator of a laser installation shall afford the Agency the opportunity to enter upon, inspect and investigate the laser installation at all reasonable times.

History

• Source: Amended at 37 Ill. Reg. 20200, effective December 9, 2013

32 Ill. Adm. Code 315.190 Annual Registration Fee

a) Each laser installation required to be registered pursuant to the Act and this Part shall pay an annual registration fee of $50. Payment of this fee is required by those laser installations that possess a laser system capable of emitting laser or laser light.

b) The Agency shall bill each laser installation as soon as practicable after October 1 of each year.

c) The appropriate fees shall be paid within 60 days after the date on the invoice issued by the Agency. Failure to pay a properly assessed fee shall result in the Agency taking action as authorized in Section 30 of the Act.

d) All fees assessed in accordance with this Section are non-refundable.

History

• Source: Added at 37 Ill. Reg. 20200, effective December 9, 2013

32 Ill. Adm. Code 315.APPENDIX A Sample Standard Operating Procedures

Standard Operating Procedures (SOPs) are governed by institutional policy and are developed, modified and maintained in accordance with the needs of individual facilities. Information relative to safety incorporated into these SOPs is gathered from a wide range of resources, including, but not limited to, the laser system manufacturer or distributor. This Appendix A contains examples of SOPs for issues associated with the use of laser systems. It is recognized that the safety needs of installations with multiple laser systems may be different from those facilities with a single laser system. The samples that follow cannot cover all situations or procedures; they are only intended as models that should be used to accommodate specific requirements. Typically, the Laser Safety Officer shall have the responsibility to see that SOPs are followed.

It is reasonable to expect that the manufacturer of the laser system shall supply safety information that can serve as the cornerstone for the generation of the SOPs. It is incumbent upon the operator to demand the information from the manufacturer. The availability of safety related information is facilitated by the FDA requirement that the manufacturer of laser products provide the user with adequate instructions for the safe operation and maintenance of all laser products.

SAMPLE 1: Controlled Access to the Laser Room

Purpose: To define the area in which control measures shall be applied and to describe the control measures necessary in order to maintain a safe environment for use of the laser system.

Policy: Class 3b and Class 4 lasers shall be operated in areas where traffic flow and compliance with all safety procedures can be monitored.

Procedure:

1. Appropriate warning signs shall be posted at eye level on all doors that access a room where a laser is to be operated. These signs shall state all required information and shall be removed when the laser is not in use.

2. Safety goggles labeled with the appropriate wavelength and optical density shall be available at the entry where each door sign is posted.

3. Glass windows shall be covered with shades or filters of appropriate optical density whenever a fiberoptic laser system is operational.

4. All safety procedures shall be followed during service, maintenance and demonstrations.

5. No one shall be allowed into a laser room unless properly authorized and protected.

6. The laser shall not be activated when it is necessary to open the door, if the controlled area extends to the doorway.

7. Laser keys shall be kept in a secured area and signed out only by those authorized to do so.

SAMPLE 2: Ocular Safety

Purpose: To prevent ocular injuries to personnel working with Class 3b and Class 4 lasers.

Policy: Within the controlled area, all personnel shall adhere to appropriate eye protection procedures during all laser applications.

NOTE: Under some conditions, the controlled area may include the entire room in which the laser procedure is performed. Under those conditions, the ocular safety procedures listed in this Sample 2 apply to the entire room. In health care facilities, ocular safety procedures shall also apply to the patient receiving laser treatment.

All personnel involved in maintenance and demonstrations of laser systems shall follow all ocular safety procedures whenever a laser is in operation in the facility.

Procedure:

1. Appropriate eyewear shall be worn by everyone in the controlled area while the laser is in operation. Appropriate eyewear consists of glasses or goggles of sufficient optical density to prevent ocular damage at the laser wavelength in use. Exception to this is the operator looking through an attached microscope with a lens that has the appropriate optical density for the laser in use.

2. Prior to use, the operator and ancillary personnel shall be responsible for selecting and examining eyewear for comfort, proper fit, and presence of labels describing both wavelength and proper optical density.

3. If eyewear is damaged, it shall not be worn and a report shall be made to the laser safety officer.

4. Contact lenses are not acceptable as protective eyewear. Prescription lens wearers shall use appropriate laser safety eyewear.

5. All goggles shall have side shields to protect from peripheral injury and impact.

6. Any articulated arm that is not shuttered shall be capped when not connected to the hand piece or the operating microscope.

7. The laser system shall be placed in standby mode when delivery optics are moved away from the target.

8. In health care facilities, patients shall be fitted with appropriately labeled eyewear, or have their eyes covered with wet cloth pads or towels. Metal or dry materials shall be placed on the patient's face or eyes only when indicated.

SAMPLE 3: Handling of Laser Fiber Delivery Systems in Health Care Facilities

Purpose: To promote safe and proper handling of laser fiber delivery systems and to limit the potential for fiber breakage, damage and reduced efficiency during clinical laser procedures.

Policy: Personnel handling laser fibers shall assure compliance with all safety procedures and shall consider the fiber an extension of the laser system, governed by applicable standards and regulations.

Procedure:

1. Appropriate eye safety filters shall be used with endo/microscopes.

2. Laser room windows shall be covered completely with appropriate filters, if necessary.

3. Fibers and associated equipment shall be positioned to allow for safe traffic patterns in the room.

4. The fiber shall be examined for breaks or damage of the distal tip, the proximal connector and the catheter sheath. Fiber shall be calibrated in accordance with manufacturer's directions. If deficiencies or damage are noted, another fiber shall be obtained.

5. Do not use clamps or other instruments to secure fiber in the operative site.

6. Always use coaxial cooling that is appropriate to the procedure. Never use gas to purge a fiber in the intrauterine cavity.

7. Never operate the laser unless the aiming beam (if used) and the tip of the fiber beyond the end of the endoscope are both visible.

8. Monitor the fiber for distortion of the beam, decreased power transmission and accumulation of debris on the tip.

9. Never reuse a disposable fiber without manufacturer's directions.

10. Always put the laser in standby when not aimed at a target.

SAMPLE 4: Non-Beam Hazards in Health Care Facilities

Purpose: To recognize and effectively deal with a variety of potential non-beam hazards that may be present during laser procedures.

Policy: Non-beam hazards are the purview of safety and industrial hygiene personnel, who will effect the appropriate hazard evaluation and control.

Procedure:

I. Fire

1. Never use alcohol in the operative field. Fibers may be rinsed in hydrogen peroxide or saline intraoperatively.

2. Never place a hot fiber directly on paper drapes. Wait until tip is cool before contact is made with flammable material.

3. Use fire-retardant drapes, damp packs or pads. Fill pelvic cavity with Ringer's, saline or other appropriate solution during surgery.

4. Put laser system in standby mode when procedure is interrupted or terminated.

5. Avoid high levels of oxygen in the operative field.

6. Avoid laser beam exposure of the sheaths of flexible fiber endoscopes, since many of the sheaths are flammable.

II. Plume Management

1. Remove laser generated airborne contaminants from the laser target area to reduce the transmission of potentially hazardous particles.

2. Position smoke evacuator in the operating room whenever a plume is anticipated.

3. Check operation of the plume management system prior to the beginning of a procedure.

4. Check the plume filter monitor and, if needed, install a clean filter.

5. In-line filters with minimum 0.3 μm filtration shall be placed between wall suction and the fluid canister for:

a) Suction line not connected to evacuator

b) Procedures producing minimal plume

c) Failure of evacuator before or during operation

6. Distal collection port shall be no more than 2 cm from impact site when practical.

7. All tubing, connectors, adaptors and wands will be changed between patients and disposed of according to biohazard procedures.

III. Electrical Shock

1. During service or maintenance, precautions shall be taken against electrical shock that may be fatal.

2. Medical lasers shall be installed and operated in conformity with the National Electrical Code.

SAMPLE 5: Work Practices for Optical Fiber Communications Systems (OFCS)

Purpose: To recognize and effectively deal with a variety of potential hazards that may be present when working on an OFCS.

Policy: Engineering controls shall not take the place of good work practices. Good work practices are essential to operating, servicing and maintaining OFCS, especially with higher power systems that utilize Class 3b and Class 4 lasers.

Procedure: The following presents some basic guidelines when working on any OFCS.

1. Trained Personnel. Only authorized, trained personnel shall be permitted to install or perform service on OFCS containing Class 3b or Class 4 lasers.

2. Unterminated Fibers

a) Do not view the end of a fiber with unprotected eye. Fiber should only be viewed with an indirect image converter or with a filtered optical instrument or optical density (OD) sufficient to reduce the exposure to levels below the appropriate MPE.

b) Always cover the ends of unterminated fibers with a splice protector, tape or end caps.

3. Splicing. Splicing on ribbon cables, fixed array cables or OFCS containing Class 3b or Class 4 lasers shall be de-energized or viewing systems incorporating personal protection shall be employed.

4. Installation and Testing. The laser source shall be first to be disconnected and last to be connected when installing and/or testing an OFCS.

5. Modifications. No modifications shall be made to the OFCS or associated equipment without management or supervision authorizations. Such modifications may alter the service group classification of the OFCS.

6. Labels. Any damaged or missing optical safety labels shall be reported immediately to the supervisor.

7. Other Hazards

a) Use of protective guards or shields shall be used during splicing and cleaving operation to prevent direct injury from small lengths or particles of fiber. Proper disposal of fiber pieces avoids subsequent embedding in clothing or skin.

b) Optical photocuring may present a UV or light source hazard. Protective filter lenses of the appropriate optical density shall be worn if viewing of the light source is probable.

AGENCY NOTE: Reproduced with permission from the American National Standard Z136.1-2000 (or American National Standards Z136.2-1997 or Z136.3-1996, as applicable). Copyright Laser Institute of America, Orlando, Florida. The complete standard may be obtained by contacting the Laser Institute of America, P.O. Box 781029, Orlando FL 32878-1029, telephone: 407-380-1553, fax: 407-380-5588, e-mail: lia@laserinstitute.org.

32 Ill. Adm. Code 315.ILLUSTRATION A Sample Warning Sign for Class 3b Laser Facilities

32 Ill. Adm. Code 315.ILLUSTRATION B Sample Warning Sign for Class 4 Laser Facilities

32 Ill. Adm. Code 315.TABLE A Mpe for Ocular Exposure (intrabeam Viewing)

Ultraviolet

Wavelength

(μ m)

Exposure

Duration, ts

MPE

(J cm-2)

(W cm-2)

0.180 to 0.302

10-9 to 3 x 104

3 x 10-3

0.303

10-9 to 3 x 104

4 x 10-3

0.304

10-9 to 3 x 104

6 x 10-3

0.305

10-9 to 3 x 104

10 x 10-3

0.306

10-9 to 3 x 104

16 x 10-3

0.307

10-9 to 3 x 104

25 x 10-3

0.308

10-9 to 3 x 104

40 x 10-3

0.309

10-9 to 3 x 104

63 x 10-3

0.310

10-9 to 3 x 104

0.1

0.311

10-9 to 3 x 104

0.16

0.312

10-9 to 3 x 104

0.25

0.313

10-9 to 3 x 104

0.40

0.314

10-9 to 3 x 104

0.63

0.315 to 0.400

10-9 to 10

0.56 t¼

0.315 to 0.400

10 x 3 x 104

1.0

NOTE: To calculate MPE, use the J cm-2 value shown or 0.56 t¼, whichever is lower.

Visible and Near Infrared

Wavelength

(μ m)

Exposure

Duration, ts

MPE

(J cm-2)

(W cm-2)

0.400 to 0.700

10-9 to 18 x 10-6

0.5 x 10-6

0.400 to 0.700

18 x 10-6 to 10

1.8 t¾ x 10-3

0.400 to 0.550

10 to 104

10 x 10-3

0.550 to 0.700

10 to T1

1.8 t¾ x 10-3

0.550 to 0.700

T1 to 104

10CB to 10-3

0.400 to 0.700

104 to 3 x 104

CB x 10-6

0.700 to 1.050

10-9 to 18 x 10-6

0.5CA x 10-6

0.700 to 1.050

18 x 10-6 to 103

1.8CA t¾ x 10-3

0.700 to 1.050

103 to 3 x 104

320CA x 10-6

1.050 to 1.400

10-9 to 50 x 10-6

5Cc x 10-6

1.050 to 1.400

50 x 10-6 to 103

9.0Cc t¾ x 10-3

1.050 to 1.400

103 to 3 x 104

1.6Cc x 10-3

NOTES:

See Section 315.Tables D & E for limiting apertures (see ANSI Z136.1 pg. 44).

For multiple pulses, apply correction factor Cp given in Section 315.Table C.

For information on correction factors T1, CB, CA, Cp and Cc, see Section 315.Table C.

Far Infrared

Wavelength

(μ m)

Exposure

Duration, ts

MPE

(J cm-2)

(W cm-2)

1.400 to 1.500

10-9 to 10-3

0.1

1.400 to 1.500

10-3 to 10

0.56 t¼

1.400 to 1.500

10 to 3 x 104

0.1

1.500 to 1.800

10-9 to 10

1.0

1.500 to 1.800

10 to 3 x 104

0.1

1.800 to 2.600

10-9 to 10-3

0.1

1.800 to 2.600

10-3 to 10

0.56 t¼

1.800 to 2.600

10 to 3 x 104

0.1

2.600 to 103

10-9 to 10-7

10 x 10-3

2.600 to 103

10-7 to 10

0.56 t¼

2.600 to 103

10 to 3 x 104

0.1

NOTES:

See Section 315.Tables D & E for limiting apertures (see ANSI Z136.1 pg. 44).

For multiple pulses, apply correction factor Cp given in Section 315.Table C.

GENERAL NOTES:

The MPE for diffuse reflections at wave lengths between 0.400 and 1.400 μm is obtained by multiplying the corresponding MPEs above by CE (see Section 315.Table C for correction factors and T1).

For repeated (pulsed) exposures, see ANSI Z136.1.

For purposes of this Section 315.Table A, the following abbreviations or symbols are used:

μm

=

micrometers

ts

=

time in seconds

J

=

joules

W

=

watts

cm

=

centimeters

32 Ill. Adm. Code 315.TABLE B Mpe for Skin Exposure

Ultraviolet

Wavelength

(μm)

Exposure

Duration, ts

MPE

(J cm-2)

(W cm-2)

0.180 to 0.302

10-9 to 3 x 104

3 x 10-3

0.303

10-9 to 3 x 104

4 x 10-3

0.304

10-9 to 3 x 104

6 x 10-3

0.305

10-9 to 3 x 104

1.0 x 10-2

0.306

10-9 to 3 x 104

1.6 x 10-2

0.307

10-9 to 3 x 104

2.5 x 10-2

0.308

10-9 to 3 x 104

4.0 x 10-2

0.309

10-9 to 3 x 104

6.3 x 10-2

0.310

10-9 to 3 x 104

1.0 x 10-1

0.311

10-9 to 3 x 104

1.6 x 10-1

0.312

10-9 to 3 x 104

2.5 x 10-1

0.313

10-9 to 3 x 104

4.0 x 10-1

0.314

10-9 to 3 x 104

6.3 x 10-1

0.315 to 0.400

10-9 to 10

0.56 t¼

0.315 to 0.400

10 x 103

1

0.315 to 0.400

103 to 3 x 104

1 x 10-3

NOTES:

To calculate MPE, use the J cm-2 value shown or 0.56 t¼, whichever is lower.

3.5 mm limiting aperture (see Section 315.Table D).

Visible and Near Infrared

Wavelength

(μm)

Exposure

Duration, ts

MPE

(J cm-2)

(W cm-2)

0.400 to 1.400

10-9 to 10-7

2CA x 10-2

10-7 to 10

1.1CA t¼

10 to 3 x 104

0.2CA

NOTE:

3.5 mm limiting aperture (see Section 315.Table D).

Far Infrared

Wavelength

(μm)

Exposure

Duration, ts

MPE

(J cm-2)

(W cm-2)

1.400 to 103

10-9 to 10-7

10-2

10-7 to 10

0.56 t¼

10

0.1

NOTE:

See Section 315.Table D for limiting apertures.

GENERAL NOTE:

For purposes of this Table, the following abbreviations are used:

μm

=

micrometers

ts

=

time in seconds

J

=

joules

W

=

watts

cm

=

centimeters

mm

=

millimeter

32 Ill. Adm. Code 315.TABLE C Parameters and Correction Factors

Correction Factor

Wavelength

(μm)

T1 = 10 x 1020l-0.550

0.550 to 0.700

CB = 1.0

0.400 to 0.500

CB = 1015 l-0.550

0.550 to 0.700

CA = 1.0

0.400 to 0.700

CA = 102 l-0.700

0.700 to 1.050

CA = 5.0

1.050 to 1.400

Cp = n-14

0.400 to 1000

CE = 1.0 a < amin

0.400 to 1.400

CE = a/amin

0.400 to 1.400

Where: amin < a <a max

CE = a2/(a max x amin)

0.400 to 1.400

Where: a > amax

Cc = 1.0

1.050 to 1.150

Cc = 1018 l -1.150

1.150 to 1.200

Cc = 8

1.200 to 1.400

NOTES:

For pulse repetition frequencies below 55 kHz (0.4 to 1.05 μm) and below 20 kHz (1.05 to 1.4 μm) see ANSI A136.1.

For wavelengths between 0.400 and 1.400 μm:

amin

=

1.5 mrad for t ≤ 0.7 s

amin

=

2 t¾ mrad for 0.7 s < t <10 s

amin

=

11 mrad for t < 10 s

amax

=

100 mrad

For purposes of this Section 315.Table C, the following abbreviations or symbols are used:

l

=

wavelength in μm

n

=

number of pulses

a

=

angular subtense (mrad)

t

=

time

ts

=

time in seconds

s

=

seconds

μm

=

micrometers

Min

=

minimum

Max

=

maximum

mrads

=

milliradians

kHz

=

kilohertz

32 Ill. Adm. Code 315.TABLE D Limiting Apertures for Hazards Evaluation and Ael Determination

Spectral Region

(μm)

Duration

(s)

Aperture Diameter (mm)

Eye

Skin

0.180 to 0.400

10-9 to 0.25

1.0

3.5

0.25 to 3 x 104

3.5

3.5

0.400 to 1.400

10-9 to 3 x 104

7.0

3.5

1.400 to 102

10-9 to 0.3

1.0

3.5

0.3 to 10

1.5 t3/8

3.5

10 to 3 x 104

3.5

3.5

102 to 103

10-9 to 3 x 104

11.0

11.0

NOTES:

Under normal conditions these exposure durations would not be used for hazard evaluation (see ANSI Z136.1 (Table 8)).

For purposes of this Section 315.Table D, the following abbreviations or symbols are used:

μm

=

micrometers

s

=

seconds

mm

=

millimeters

ts

=

time in seconds

32 Ill. Adm. Code 315.TABLE E Measurement Apertures for Classification

Spectral Region

(μm)

Duration

(s)

Aperture Diameter

(mm)

0.180 to 0.302

10-9 to 0.25

1.0

0.25 to 3 x 104

3.5

0.302 to 2.8

10-9 to 3 x 104

50.0

2.8 to 102

10-9 to 0.3

1.0

0.3 to 10

1.5 t3/8

10 to 3 x 104

3.5

102 to 103

10-9 to 3 x 104

11.0

NOTES:

These apertures are used for the measurement of optical power or energy for purposes of laser classification

When the laser output is intended to be viewed with optics (excluding ordinary eyeglasses) or the laser safety officer determines that there is reasonable probability of accidental viewing with optics, a 50 mm aperture is used if the following conditions are met.

A)

Viewing with optics presents a more severe hazard than unaided viewing.

B)

The viewing time is sufficient to constitute a hazard.

Under normal conditions these exposure durations would not be used for classification (see ANSI Z136.1 (Table 9)).

For purposes of this Section 315.Table E, the following abbreviations or symbols are used:

μm

=

micrometers

s

=

seconds

mm

=

millimeters

ts

=

time in seconds

Part 320 Registration and Operator Requirements for Radiation Installations

32 Ill. Adm. Code 320.5 Purpose and Scope

a) This Part establishes the registration requirements for radiation installations pursuant to Section 24.7 of the Radiation Protection Act of 1990 [420 ILCS 40].

b) This Part applies to all radiation installations that possess any radiation machines that electronically produce ionizing radiation.

History

• Source: Added at 49 Ill. Reg. 406, effective December 27, 2024

32 Ill. Adm. Code 320.10 Registration

a) For purposes of registration pursuant to this Part, the following definitions shall apply:

1. "Agency" means the Illinois Emergency Management Agency and Office of Homeland Security. [420 ILCS 40/4(a-2)]

2. "Inoperable radiation machine" means any radiation machine, including particle accelerators, that is not capable of producing radiation due to the absence or failure of components necessary for operation. Radiation machines that are not in operation due only to disconnection from an electrical supply shall be considered operable.

3. "Minimal threat devices" means radiation machines capable of generating or emitting fields of radiation that, during the operation of which, an individual cannot accidently place a body part in the primary beam path and no deliberate exposure or physical injury to an individual has occurred in excess of the applicable limits specified in 32 Ill. Adm. Code 340.310(a). Examples include, but are not limited to, analytical, cabinet, and baggage/package/project type fluoroscopic units; spectroscopy; facilities with x-ray machines that are incorporated in lead boxes or enclosed in a shielded room, that comply with the requirements of 32 Ill. Adm. Code 350.3050.

4. "Particle accelerator" shall have the same meaning as provided in 32 Ill. Adm. Code 310.20.

5. "Radiation installation" means any location or facility where radiation machines are used. [420 ILCS 40/4(g)]

6. "Radiation machine" means any device that produces radiation when in use, except those that produce radiation only from radioactive materials. [420 ILCS 40/4(h)]

b) Radiation Installation Registration

1. Any operator of a radiation installation shall register that radiation installation with the Agency. The operator shall register the radiation installation, before it is placed into operation, in a format prescribed by the Agency that shall include the:

A) Operator and facility name;

B) Location and confines of the radiation installation;

C) Type, manufacturer, model, serial number, and room or area location of all radiation machines possessed; and

D) Telephone number, email address, and Federal Employer Identification Number (FEIN).

2. Radiation machines that are located in a single building or in a group of buildings that are contiguous to one another, and used by the same operator, shall be treated as a single radiation installation unless requested otherwise in writing by the operator and approved by the Agency.

3. Until proper disposal occurs, all inoperable radiation machines shall be included in the registration information required by subsection (b)(1)(C).

4. Out-of-State Radiation Machines.

A) Any owner/operator of a radiation machine brought into the State of Illinois for temporary use, not to exceed 180 days in a calendar year, shall provide notice to the Agency at least three business days before the equipment is brought into the State.

B) The notice shall include the information in subsection (b)(1)(A) through (D) and:

i) Registering state and registration number of the facility, if applicable;

ii) The exact location where the radiation machine is to be used;

iii) Nature, duration, and scope of work; and

iv) Onsite contact in the State including name, telephone number, and email address.

c) Radiation Installation Classifications

Radiation installations shall be divided into the following 4 classes:

1. Class A – Class A shall include dental offices and veterinary offices with radiation machines used solely for diagnosis; nonmedical business entities that possess open radiography radiation machines used by industrial radiographers or law enforcement personnel, other non-medical registered installations including research/development, academic, industrial, law enforcement, and all other minimal threat devices used in the process of conducting their business.

2. Class B − Class B shall include offices or clinics of persons licensed under the Medical Practice Act of 1987 [225 ILCS 60] or the Podiatric Medical Practice Act of 1987 [225 ILCS 100] with radiation machines used solely for diagnosis and all radiation installations using portable radiographic/fluoroscopic units and particle accelerators.

3. Class C − Class C shall include installations using radiation machines which are unique and have potential radiation threat concerns whose operation or use may require the registrant to monitor in accordance with 32 Ill. Adm. Code 340.520. This does not include radiation installations with radiation machines that are specified as another class.

4. Class D − Class D shall include all hospitals and other facilities using mammography, computed tomography (CT), or therapeutic radiation machines.

5. Radiation installations for which more than one class is applicable shall be assigned a classification based on the radiation machines' use and associated radiation hazard.

d) Registration Fees

1. The operator of a radiation installation shall pay an annual registration fee for each radiation machine registered with the Agency on January 1 of each year. Operators of radiation installations shall annually update their registration no later than December 31 of each year with the status of each radiation machine in their possession.

2. The Agency shall bill the operator for the registration fee as soon as practical after January 1. The registration fee shall be due and payable within 60 days after the date of billing. If after 60 days the registration fee is not paid, the Agency may issue an order directing the operator of the installation to cease use of all radiation machines or take other appropriate enforcement action as provided in Section 36 of the Act. Fees collected under this Section are not refundable. [420 ILCS 40/24.7] The fees, based on the classification of radiation installation and radiation machines possessed, are as follows:

Radiation Installation Classification

Fee Per Radiation Machine

Class A – Dental and veterinary offices.

$50

Class A – Radiation installations using minimal threat devices and open radiography machines used by industrial radiographers or law enforcement personnel.

$75

Class B – Offices or clinics of persons licensed under the Medical Practice Act, and all radiation installations using portable radiographic/ fluoroscopic units or particle accelerators.

$175

Class B – Podiatric offices.

$100

Class C –

$250

Class D –

$100

e) All radiation installations are subject to inspection at all times. The frequency of inspections is based on the associated radiation hazards located at the radiation installation. Class A radiation installations should expect to be inspected approximately once every 5 years. Class B should expect to be inspected approximately once every 2 years. Class C and D radiation installations should expect to be inspected approximately once annually.

f) Operators of radiation installations shall comply with all applicable rules in 32 Ill. Adm. Code Chapter II, Subchapters b and d, including the accreditation requirements for radiologic technologists provided in 32 Ill. Adm. Code 401, certification requirements for industrial radiographers provided in 32 Ill. Adm. Code 405, and reporting requirements for any stolen, lost, or missing sources of radiation sources in accordance with 32 Ill. Adm. Code 340.1210.

History

• Source: Amended at 49 Ill. Reg. 406, effective December 27, 2024

32 Ill. Adm. Code 320.15 Incorporations by Reference (repealed)

History

• Source: Repealed at 23 Ill. Reg. 14488, effective January 1, 2000

32 Ill. Adm. Code 320.20 Amendments and Changes in Status

a) Operators of radiation installations that have been registered pursuant to Section 320.10 shall notify the Agency within 30 days after the installation of any new, used or relocated radiation machines, or the reactivation of any radiation machines.

b) If any operator discontinues using radiation machines, the operator shall notify the Agency within 30 days after the discontinuance. The notification shall include the date of discontinuance and the disposition of the radiation machines.

c) Within 30 days after changing the operator of a radiation installation, the new operator shall notify the Agency.

d) For radiation machines taken possession of as a result of foreclosure, bankruptcy, or other legal proceeding, the operator of the radiation installation shall notify the Agency within 30 days after the change in possession.

e) To comply with this Section, facilities may use the online registration system located on the Agency's website at https://iemaohs.illinois.gov/ under the heading of Nuclear & Radiation Safety.

f) Failure to comply with the requirements in this Section will result in the collection of registration fees for the years that the radiation installation was not properly registered.

History

• Source: Amended at 49 Ill. Reg. 406, effective December 27, 2024

32 Ill. Adm. Code 320.30 Discontinued Use (repealed)

History

• Source: Repealed at 23 Ill. Reg. 14488, effective January 1, 2000

32 Ill. Adm. Code 320.40 Exemptions

An operator shall be exempt from the radiation installation registration requirements of this Part for the following:

a) Electrical equipment that is manufactured for purposes other than generation of radiation, where the generation of radiation is incidental to operation (such as a television or electron microscope).

b) Radiation machines while in transit or storage incident to transit.

c) Radiation machines provided for temporary use (e.g. demonstration or to replace out-of-service equipment) and notification is provided in accordance with Section 320.10(b)(1)(C).

d) Radiation machines taken possession by a financial institution as a result of foreclosure, bankruptcy, or other legal proceeding.

History

• Source: Amended at 49 Ill. Reg. 406, effective December 27, 2024

32 Ill. Adm. Code 320.50 Noncompliance (repealed)

History

• Source: Repealed at 23 Ill. Reg. 14488, effective January 1, 2000

32 Ill. Adm. Code 320.60 Requirements for All Operators of Radiation Installations

Operators of radiation installations shall:

a) Assure that all radiation machines are maintained and operated in accordance with standards established by the Agency to protect the public health and safety as set forth in this Part and in 32 Ill. Adm. Code 310, 340, 350, 360, 370, 380, 390, 400, 401, 405 and 410.

b) Assure that all persons who use a radiation machine to administer ionizing radiation to human beings are licensed in accordance with the requirements of 32 Ill. Adm. Code 360.10, accredited by the Agency or exempt from those requirements in accordance with 32 Ill. Adm. Code 401.30.

History

• Source: Amended at 36 Ill. Reg. 17376, effective November 30, 2012

32 Ill. Adm. Code 320.70 Additional Requirements for Operators of Class D Radiation Installations

a) Each operator of a Class D radiation installation shall utilize the services of an individual, registered with the Agency pursuant to 32 Ill. Adm. Code 410, to implement and maintain a comprehensive radiation protection program. Activities related to diagnostic radiation producing machines shall be performed by a registered diagnostic imaging specialist (DIS). Activities related to therapeutic radiation machines shall be performed by a registered therapeutic radiological physicist (TRP). Each operator shall ensure that registered individuals:

1. Conduct an annual performance evaluation of all radiation machines and verify their inclusion in the radiation installation registration.

2. Determine and document in a report to the radiation installation that the radiation machines evaluated are being maintained and operated in accordance with standards established by the Agency to protect the public health as set forth in 32 Ill. Adm. Code: Chapter II, Subchapters b and d. Noncompliance items shall be readily identified in the report.

3. Establish and oversee the equipment-related quality assurance practices. Specifically, these quality assurance practices shall include as a minimum:

A) For therapeutic radiation machines, compliance with the quality assurance requirements specified in 32 Ill. Adm. Code 360.110(d) or 360.120(e).

B) For computed tomography machines, compliance with the quality assurance requirements specified in 32 Ill. Adm. Code 360.75.

C) For mammography machines, compliance with the quality assurance requirements specified in 32 Ill. Adm. Code 370.100.

4. Users of digital imaging acquisition systems shall follow a quality assurance/quality control protocol for image processing established by the manufacturer for each radiation machine. The program shall include the entire imaging chain from detector to the monitor used for interpretation and:

A) The operator of the radiation installation shall include the protocol in its operating and safety procedures. The procedures shall be in writing or electronically available for Agency review.

B) The operator of the radiation installation shall document the frequency at which the quality assurance/quality control protocol is performed. Documentation shall include the date and initials of the individual completing the document and shall be maintained at the site where performed for inspection by the Agency.

C) The protocol shall include, but not be limited to, the following:

i) Cleaning and erasure of all imaging plates used in computed radiography (CR);

ii) Quality control phantom analysis including, but not limited to, low contrast detectability, spatial resolution, and artifacts;

AGENCY NOTE: The phantom analysis can be done either by the facility or DIS. Frequency and pass/fail criteria should be based on recommendations of the manufacturer or as established by the DIS.

iii) Evaluation of repeat/reject x-ray examinations;

iv) Review of exposure index, deviation index, s-number, or dose index values from clinically acquired radiographic images.

b) Each operator of a Class D radiation installation shall maintain and have available for review by the Agency:

1. Accurate and thorough radiation machine evaluation reports.

2. Records of quality assurance testing performed.

3. Records of calibrations, maintenance or repair.

4. Records of corrective action taken for items of non-compliance.

5. Records of digital imaging quality control.

c) The records and reports required by this Section shall be maintained for a period of at least one inspection cycle.

History

• Source: Amended at 49 Ill. Reg. 406, effective December 27, 2024

Part 322 Registration and Reporting Requirements for Radiation Machine Service Providers

32 Ill. Adm. Code 322.10 Purpose and Scope

The purpose of this Part is to establish registration and reporting requirements, pursuant to the Radiation Protection Act of 1990 (Act) [420 ILCS 40] for persons who install or service radiation machines. Except as otherwise specifically exempted, this Part applies to all radiation machine service providers.

32 Ill. Adm. Code 322.20 Incorporations by Reference

All rules, standards and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified in the reference and do not include any later amendments or editions. Copies of these rules, standards and guidelines that have been incorporated by reference are available for public inspection at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield , Illinois.

History

• Source: Amended at 32 Ill. Reg. 16759, effective October 6, 2008

32 Ill. Adm. Code 322.30 Definitions

The following definitions are applicable for use in this Part only. Additional definitions for use in this Part are located in 32 Ill. Adm. Code 310.20 and 320.10.

"Installation" or "Install" means 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.

"Radiation machine" means any device that produces radiation when in use, except those devices that produce radiation only from radioactive materials and electrical equipment that is manufactured for purposes other than generaton of radiation, where the generation of radiation is incidental to operation (such as a television or electron microscope).

"Service" means 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.

"Radiation machine service provider" means any individual, company, or other entity required to be registered under this Part to install or service radiation machines (see Agency Note in Section 322.50).

32 Ill. Adm. Code 322.40 Exemptions

An operator of a radiation installation that is registered with the Agency under 32 Ill. Adm. Code 320 is not required to register pursuant to this Part to service the radiation machines that it owns or leases when the work is performed by employees of the operator.

History

• Source: Amended at 32 Ill. Reg. 16759, effective October 6, 2008

32 Ill. Adm. Code 322.50 Registration

a) Each radiation machine service provider that intends to install or service radiation machines in the State of Illinois shall register with the Agency within 60 days after February 1, 2002 or prior to initially furnishing or offering to furnish any such service and annually thereafter.

b) Registration shall be on a form prescribed by the Agency that shall include, but shall not be limited to:

1. Name, address, and telephone number of the radiation machine service provider;

2. Name, address, and telephone number of the individual responsible for the activities of the radiation machine service provider.

c) The Agency shall maintain a listing of registered radiation machine service providers.

AGENCY NOTE: Registration under this Part is required for all entities that install radiation machines. It is the Agency's intent to require registration of businesses. Individuals are not required to register unless they are radiation machine service providers engaged in business as sole proprietors.

History

• Source: Amended at 32 Ill. Reg. 16759, effective October 6, 2008

32 Ill. Adm. Code 322.60 Fees

All radiation machine service providers shall pay an annual non-refundable registration fee of $100. All new radiation machine service providers shall pay a registration fee of $100, which shall serve as the registration fee for the remainder of the calendar year. The fee shall be due and payable within 60 days after the date of billing. Failure to pay the required fee within the 60 day timeframe shall result in the removal of authorization by the Agency to provide radiation machine services in the State of Illinois or other actions consistent with the Act.

History

• Source: Amended at 32 Ill. Reg. 16759, effective October 6, 2008

32 Ill. Adm. Code 322.70 Training Requirements for Individuals Who Install or Service Radiation Machines

Each radiation machine service provider shall provide appropriate training to the individuals who install or service radiation machines for the radiation machine service provider.

32 Ill. Adm. Code 322.80 Reporting and Recordkeeping Requirements for Radiation Machine Service Providers

a) A radiation machine service provider who installs a radiation machine in the State of Illinois must report the installation to the Agency. [420 ILCS 40/25.2(b)]

1. A radiation machine service provider shall submit the following information in writing to the Agency within 15 days after installation:

A) The installation date.

B) The name, address, telephone number, and registration number of the facility where the radiation machine was installed;

C) The type of radiation machine, the manufacturer's name, model number and control panel serial number of each radiation machine; and

D) Name of the individual that installed the radiation machine.

2. In the case of diagnostic x-ray systems that contain certified components, and in lieu of subsection (a)(1), a copy of the assembler's report on United States Food and Drug Administration (FDA) form 2579, prepared in compliance with requirements of the federal diagnostic x-ray standard (21 CFR 1020.30(d)(2001)), shall be submitted to the Agency within 15 days following completion of the assembly. Such report, when completed in full, shall suffice in lieu of any other assembly report submitted by the assembler to the Agency.

b) Radiation machine service providers shall maintain a log or other record of radiation machines installed or serviced in the State of Illinois. The record shall be maintained for 5 years for inspection by the Agency and shall list the following information:

1. Date machine was installed or service was provided;

2. Name of customer, address, telephone number, and customer's radiation installation registration number;

3. The type of radiation machine, the manufacturer's name, model number and control panel serial number of each radiation machine; and

4. Name of the individual that installed the radiation machine.

c) A radiation machine service provider who services a radiation machine in a radiation installation in the State of Illinois that is not registered under Section 24.7 of the Act must report the service to the Agency. [420 ILCS 40/25.2(c)] The report shall be submitted in writing within 15 days after such service and contain the following information:

1. Date service was provided;

2. Name, address, and telephone number of the customer;

3. The type of radiation machine, the manufacturer's name, model number and control panel serial number of each radiation machine; and

4. Name of the individual that serviced the radiation machine.

History

• Source: Amended at 32 Ill. Reg. 16759, effective October 6, 2008

32 Ill. Adm. Code 322.90 Penalties

Radiation machine service providers that fail to comply with the provisions of this Part are subject to monetary and other penalties as provided for in the Act [420 ILCS 40].

Part 326 Financial Assurance Requirements

32 Ill. Adm. Code 326.10 Purpose and Scope

This Part prescribes financial assurance requirements to ensure that specific and general licensees will have sufficient funds to reclaim properties. This Part identifies which licensees must file financial assurance arrangements and describes arrangements acceptable to the Illinois Emergency Management Agency (Agency). This Part is not applicable to licensees subject to 32 Ill. Adm. Code 332 that have financial assurance arrangements on file with the Agency.

AGENCY NOTE: Throughout this Part, the use of the term "licensee" includes applicants for licensure and existing licensees.

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.20 Incorporations by Reference

All rules, standards and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified. Copies of these rules, standards and guidelines that have been incorporated by reference are available for public inspection and copying at the Agency, 1035 Outer Park Drive, Springfield, Illinois.

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.30 General Provisions

Unless specifically exempted in Section 326.50 of this Part, each general and specific licensee identified in Sections 326.60 and 326.70 of this Part shall provide satisfactory financial assurance arrangements to ensure the protection of health and safety in the event of abandonment, default or other inability of the licensee to meet the requirements of the Radiation Protection Act of 1990 (the Act) [420 ILCS 40] or 32 Ill. Adm. Code: Chapter II, Subchapters b and d. Determination of satisfactory financial assurance arrangements shall be subject to the conditions specified in this Part.

AGENCY NOTE: As used in this Part, the terms "chief executive officer" and "chief financial officer" include other persons with equivalent titles, such as "president", "administrator" or "fiscal officer".

32 Ill. Adm. Code 326.40 Definitions

As used in this Part, the following definitions apply:

"Anniversary date" means the last day of the month for each year the license is in effect, which corresponds to the last day of the month in which the license expires.

AGENCY NOTE: For purposes of this Part, the 28th will be considered the last day of the month of February.

"Category III irradiator" means a gamma irradiator in which the sealed source is contained in a storage pool (usually containing water), the sealed source is shielded at all times, and human access to the sealed source and the volume undergoing irradiation is physically restricted in its design configuration and proper mode of use.

"Category IV irradiator" means a controlled human access gamma irradiator in which the sealed source is contained in a storage pool (usually containing water), is fully shielded when not in use and is exposed within a radiation volume that is maintained inaccessible during use by an entry control system.

"Cost estimate" means a licensee's evaluation of the costs associated with reclamation of a facility or site. Cost estimates are subject to Agency review and approval.

"Educational institution" means a non-profit organization that has as its primary purpose the advancement of knowledge in one or more specific fields and which is accredited by the North Central Association Commission on Schools or the North Central Association Commission on Institutions of Higher Education.

"Financial assurance arrangement" means a method of guaranteeing that reclamation costs will be paid. A financial assurance arrangement consists of a surety bond, an irrevocable letter of credit, a certificate of deposit, a self-guarantee, a parent company guarantee, a combination of those arrangements or other financial arrangements approved in writing by the Agency.

"General licensee" means a person who possesses a generally licensed device as defined in this Section.

"Generally licensed devices" means gauges containing sealed sources equal to or greater than 37 MBq (1 mCi) of radioactive material possessed by persons licensed pursuant to 32 Ill. Adm. Code 330.220(a).

AGENCY NOTE: Although general licensees may be required to provide information to the Agency, only general licensees possessing the types of devices defined in this Section are required to address financial assurance requirements specified in this Part.

"Major possessor" means a person who is licensed to use, possess or store radioactive material with half-lives greater than 275 days, as either sealed or unsealed sources in quantities exceeding the quantities specified in Appendix A of this Part.

"Reclamation" means decontamination of facilities and sites and disposal of radioactive material so that the property is returned to a state that no longer presents a radiological health or safety hazard to persons, or a threat to the environment.

AGENCY NOTE: For purposes of this Part, the term "reclamation" includes, but is not limited to, those activities necessary to decommission the licensed facility to allow termination of the license.

History

• Source: Amended at 39 Ill. Reg. 11900, effective August 17, 2015

32 Ill. Adm. Code 326.50 Exemptions

a) Radioactive material possessed or used by the following persons is not subject to this Part:

1. All State, local or other government entities;

AGENCY NOTE: For purposes of this Section, "government entities" shall not include federal or State contractors, or non-governmental recipients of government funds.

2. Educational institutions;

3. Licensees not authorized to possess or use radioactive material in Illinois;

4. Licensees with no permanent storage or use facilities in Illinois; or

5. Licensees using radioactive material within Illinois under reciprocal recognition of an out-of-state license as specified in 32 Ill. Adm. Code 330.900.

b) Radioactive material in the following forms is not subject to this Part:

1. Radioactive material for use in gas chromatographs, benchtop analytical laboratory instruments, x-ray fluorescence analyzers, static elimination devices and self-luminous exit signs, except for radionuclides with atomic numbers greater than 82 in quantities greater than 3.7 GBq (100 mCi);

2. Sealed sources for exchange into a device, provided that the sources do not concurrently remain in the licensee's possession for more than 30 days;

3. Radioactive noble gases;

4. Depleted uranium prefabricated as shielding;

5. Radioactive material with half-lives of 30 days or less;

6. Radioactive material with atomic numbers less than or equal to 82 in the form of sealed sources, in quantities less than or equal to 37 MBq (1 mCi) per source, not to exceed 185 MBq (5 mCi) total; or

7. Radioactive material with atomic numbers greater than or equal to 83 in the form of sealed sources, in quantities less than or equal to 185 kBq (50 µCi) per source, not to exceed 37 MBq (1 mCi) total.

c) Except for low-level radioactive waste licensees as described in Section 326.60 of this Part, radioactive material with half-lives greater than 30 days, but less than or equal to 275 days, in the following forms, is not subject to this Part:

1. Radioactive material in forms other than noble gases or sealed sources, in quantities not to exceed 37 GBq (1 Ci) per nuclide; and

2. Radioactive material in the form of a sealed source.

d) Except for licensees specified in Sections 326.60 and 326.70 of this Part, specific or general licensees that possess or use radioactive material with half-lives greater than 275 days, in the form of sealed sources in quantities less than or equal to 37 GBq (1 Ci) per source, but not exceeding the applicable quantities specified in Appendix A of this Part, are not subject to this Part.

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.60 Low-Level Radioactive Waste Licensees

Waste handling licensees as defined in 32 Ill. Adm. Code 310.20, such as low-level radioactive waste treatment or disposal facilities, or centralized low-level radioactive waste storage licensees, shall submit a reclamation plan and a cost estimate for approval by the Agency as described in Section 326.80 of this Part and secure a financial assurance arrangement for the amount specified in the Agency-approved cost estimate. Such licensees shall ensure the cost estimate encompasses all radioactive material authorized by the license, except for radioactive material specifically exempted in Section 326.50(b) of this Part. The exemptions specified in Section 326.50(c) and (d) of this Part are not applicable to the licensees described in this Section.

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.70 Financial Assurance Amounts

Unless specified in Section 326.60 of this Part, the following specific and general licensees are required to secure a financial assurance arrangement in the amounts described in this Section:

a) Unless specified in subsection (b) of this Section, for specific or general licensees that possess or use radioactive material in the form of sealed sources in quantities greater than 37 GBq (1 Ci) per source, but not exceeding the quantities specified in Appendix A of this Part, the minimum amount is $25,000.

b) The following licensees shall submit a reclamation plan as described in Section 326.80 of this Part, and a cost estimate for approval by the Agency. When approved, the licensee shall secure a financial assurance arrangement in the amount specified on the Agency-approved cost estimate:

1. Major possessors as defined in Section 326.40 of this Part;

2. Persons who possess radioactive material in forms other than noble gases or sealed sources with half-lives greater than 30 days, but less than or equal to 275 days, in quantities exceeding 37 GBq (1 Ci) per nuclide;

3. Persons who possess source material tailings or sludge;

4. Category III or IV irradiators;

5. Persons who use particle accelerators to manufacture radionuclides for distribution to other licensees or customers; and

6. Facilities owned or operated by the U.S. Department of Energy (DOE) or its contractors or subcontractors, if subject to the regulatory control of the Agency. Contractors or subcontractors of DOE who may perform work that is not a direct function of the DOE operation are subject to other financial assurance requirements as provided for in this Part.

AGENCY NOTE: Licensees subject to 32 Ill. Adm. Code 332 are required to meet the financial assurance requirements specified in 32 Ill. Adm. Code 332.260, and therefore are not subject to this Part.

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.80 Cost Estimates and Reclamation Plans

a) Licensees required to perform cost estimates, as described in Sections 326.60 and 326.70(b), shall submit reclamation plans and cost estimates to the Agency for approval prior to securing financial assurance arrangements. The Agency shall allow material described in Section 326.50(b) as exempt to be excluded from all financial assurance estimates. For licensees described in Section 326.70(b), the material described in Section 326.50(c) shall also be excluded from financial assurance estimates. The plan shall describe reclamation actions to be taken in order to terminate the license in accordance with the requirements of 32 Ill. Adm. Code 330.

b) The reclamation plan and cost estimate shall include the following:

1. The probable extent of contamination resulting from the use or possession of radioactive material as authorized by a radioactive material license at the facility or site, and the probable cost of removal of the contamination in order to terminate the license in accordance with the requirements of 32 Ill. Adm. Code 330. This consideration shall encompass probable contaminating events associated with the licensee's methods or modes of operation and shall be based on factors such as quantities, half-lives, radiation hazards and toxicities, and chemical and physical forms;

2. The extent of possible offsite property damage caused by operation of the facility or site that is to be reclaimed;

3. The costs and methods of the following:

A) Removal and disposal of radioactive material and sources of radiation that are or would be generated, stored, processed or otherwise present at the facility or site, including the volume of onsite subsurface material containing residual radioactivity in order to meet 32 Ill. Adm. Code 330.325 requirements for unrestricted use; and

B) Reclamation of the site or the property where the facility is located and all other properties contaminated by radioactive material authorized by the license in order to meet 32 Ill. Adm. Code 330.325 requirements for unrestricted use;

4. The cost of an independent contractor to perform all decommissioning and decontamination activities;

5. A contingency factor of 25 percent of the total cost estimate;

6. Identification of and justification for using key assumptions contained in the reclamation plan;

7. A description of the method of assuring funds for decommissioning from the financial assurance arrangements authorized by Sections 326.100 through 326.160, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility; and

8. A certification by the licensee that the financial assurance for decommissioning has been provided in the amount of the cost for decommissioning.

c) The Agency shall consider, but is not limited to, the requirements of subsection (b) in approving the reclamation plan and cost estimates and determining the financial assurance requirements for each individual licensee.

d) At the time of license renewal and at intervals not to exceed 3 years, the reclamation funding plan shall be resubmitted to the Agency for approval, 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 reclamation funding plan is approved. The reclamation funding plan shall update the information submitted with the original or prior approved plan and shall specifically consider the effect of the following events on decommissioning costs:

1. Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

2. Waste inventory increasing above the amount previously estimated;

3. Waste disposal costs increasing above the amount previously estimated;

4. Facility modifications;

5. Changes in authorized possession limits;

6. Actual remediation costs that exceed the previous cost estimate;

7. Onsite disposal; and

8. Use of a settling pond.

History

• Source: Amended at 39 Ill. Reg. 15697, effective November 24, 2015

32 Ill. Adm. Code 326.90 Financial Assurance Arrangements

This Section shall apply to applicants for specific licenses and general and specific licensees required to secure and file financial assurance arrangements with the Agency.

a) The licensee or applicant shall choose from the financial assurance arrangements specified in Sections 326.100 through 326.160.

b) The wording of the financial assurance arrangement shall contain the provisions described in this Part, and may use wording identical to the wording of the corresponding arrangement in Appendices B through F. No additional restrictions may be placed on any financial assurance arrangement filed with the Agency.

c) A signed original of the financial assurance arrangement shall be provided to and filed with the Agency in a dollar amount greater than or equal to either the amount specified in Section 326.70(a) or the amount specified in a cost estimate approved by the Agency in order to continuously cover the cost estimate for decommissioning.

1. The cost estimate and reclamation plan shall be reviewed annually by the licensee or when required by the Agency. The Agency may require the licensee to adjust the value of the cost estimate and reclamation plan to recognize any increases or decreases resulting from inflation or deflation, changes in engineering plans, activities performed and any other condition affecting costs for reclamation. These changes will be required to ensure that sufficient financial assurance amounts are provided and retained to cover cost of reclamation.

2. When a change in activities not requiring a license amendment would raise the cost estimate for reclamation to an amount greater than the amount of the financial assurance arrangements currently filed with the Agency, the licensee shall notify the Agency within 60 days after the increase. This notification shall include submission of revised cost estimates and reclamation plans for Agency review and approval. Upon approval of the revised cost estimates, the licensee may be required to file additional financial assurance arrangements at least equal to this increase.

3. When a license amendment would raise the cost estimate for reclamation to an amount greater than the amount of the financial assurance arrangements currently filed with the Agency, the amendment shall be held until the required financial assurance arrangements are established.

4. When the current reclamation cost estimate decreases, upon the written request of the licensee, and provided that the decrease is verified by the Agency, the Agency shall authorize the reduction in the amount of financial assurance required for the facility to the amount of the approved amended reclamation cost estimate.

AGENCY NOTE: If the license is amended and the licensee no longer meets the criteria for needing a reclamation plan (specified in Section 326.60 or 326.70(b)), but still must secure financial assurance in accordance with Section 326.70(a), the licensee may substitute new arrangements to meet the requirements of Section 326.70(a).

5. For specific licensees, the term of the financial assurance arrangement shall be for the period from issuance of the license until termination of the license by the Agency in accordance with 32 Ill. Adm. Code 330.

6. For general licensees, the term of the financial assurance arrangement shall be for the period from approval of the financial assurance arrangement until all devices covered by the instrument have been properly transferred or disposed of.

7. The Agency will release all financial assurance arrangements not drawn upon pursuant to Section 326.180, upon termination of the license, or if the license is amended so that the license is no longer subject to financial assurance requirements of Section 326.60 or 326.70.

d) Use of Multiple Financial Assurance Arrangements. The licensee or applicant may utilize more than one financial assurance arrangement per facility to satisfy the requirement specified in this Section. Unless agreed otherwise by the Agency and the licensee, financial assurance arrangements may be drawn upon in any order determined by the Agency. The arrangements shall be as specified in Appendices B-F, and the sum value of all arrangements shall be in an amount greater than or equal to either the amount specified in Section 326.70(a), or the amount specified in a cost estimate approved by the Agency.

e) Use of a Financial Assurance Arrangement for Multiple Facilities or Multiple Licensees at a Facility. The licensee or applicant may use a financial assurance arrangement specified in Appendices B-F to meet the requirements of this Section for more than one license, or more than one facility owned or operated in Illinois. The arrangement submitted to the Agency shall include a list indicating, for each facility, the registration numbers, license numbers, names, addresses and amounts of funds for reclamation assured by the arrangement. The amount of funds available through the financial assurance arrangement shall not be less than the aggregate total of the funds that would be available if separate arrangement had been filed and maintained for each license or facility. If more than one license exists for a facility, the amount of funds for each license shall be specified.

f) Any applicant or licensee who fulfills the requirements of this Section by obtaining a surety bond or letter of credit will be deemed to be without the required financial assurance arrangement in the event of commencement of bankruptcy proceedings involving the issuing institution, or a suspension, termination or revocation of the authority of the institution issuing the surety bond or letter of credit to issue those instruments. The applicant or licensee shall establish other Agency-approved financial assurance arrangements within 30 days after such an event.

History

• Source: Amended at 39 Ill. Reg. 15697, effective November 24, 2015

32 Ill. Adm. Code 326.100 Surety Bond as a Financial Assurance Arrangement

If a licensee elects to satisfy the requirement of Section 326.90 of this Part by securing a surety bond, that bond shall conform to the following requirements:

a) The surety company issuing the bond shall be among those listed as acceptable sureties or reinsurers on federal bonds in Circular 570 of the U.S. Department of the Treasury, entitled "Surety Companies Acceptable On Federal Bonds", revised to the latest revision issued by the U.S. Department of the Treasury.

AGENCY NOTE: For the licensee's information, Circular 570 entitled "Surety Companies Acceptable On Federal Bonds" is updated every July and the Agency will accept the bonds on the latest July revision date issued by the U.S. Department of the Treasury.

b) The wording of the surety bond shall contain the substantive provisions specified in Appendix B of this Part. Additional conditions may be agreed to between the licensee and the surety company so long as no requirement of this Part is avoided or altered and no additional requirements are placed upon the Agency.

c) The surety bond shall guarantee that:

1. Funds will be available, whenever required by the Agency, in order to terminate the license in accordance with the requirements of 32 Ill. Adm. Code 330;

2. The surety waives notification of amendments to licenses, applicable laws, statutes, rules and regulations and agrees that no such amendment shall in any way alleviate its obligation on the bond; and

3. The licensee shall provide alternative financial assurance arrangements as specified in Section 326.170 of this Part prior to cancellation or termination of the bond.

d) Under the terms of the bond, the surety shall become liable on the bond obligation when the licensee fails to perform as guaranteed by the bond. Upon a determination by the Agency that the licensee has failed to so perform, the surety shall perform reclaiming to the satisfaction of the State as guaranteed by the bond or shall pay the amount of the penal sum to the Agency.

e) The penal sum of the bond shall be in an amount, after considering other financial assurance arrangements established in accordance with this Part, sufficient to provide the necessary funds in order to terminate the license in accordance with the requirements of 32 Ill. Adm. Code 330.

f) The surety may cancel the bond by sending notice of cancellation by certified mail, return receipt requested, to the licensee and to the Agency. Cancellation shall not occur, however, during the 180 days beginning on the date after receipt of the notice of cancellation by both the licensee and the Agency, as evidenced by the return receipts. During this period, the licensee shall obtain replacement financial assurance as provided in Section 326.170 of this Part. Upon notification by the Agency that the licensee has failed to obtain replacement financial assurance approved by the Agency, the surety shall pay the amount of the penal sum to the Agency.

g) The surety shall not be liable for the deficiency in the performance of reclaiming after the Agency has determined satisfactory reclaiming has occurred.

h) The licensee may terminate the bond by sending written notice to the surety, provided, however, that no such notice shall become effective until the surety receives written authorization from the Agency for the termination of the bond. The Agency shall not authorize termination until the licensee has either provided replacement financial assurance arrangements in accordance with Section 326.170 of this Part or the Agency has determined satisfactory reclaiming has occurred.

i) The bond shall be accompanied by a letter from the licensee referring to the bond by number, issuing institution and date and providing the following information: the radioactive material license numbers, names and addresses of the facilities and the amount of funds for each license assured for reclaiming of the facilities by the surety bond.

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.110 Letter of Credit as a Financial Assurance Arrangement

If a licensee elects to satisfy the financial assurance requirements of Section 326.90 of this Part by filing an irrevocable standby letter of credit, the irrevocable standby letter of credit supporting this guarantee shall conform to the following requirements:

a) The institution issuing the letter of credit shall be an entity that has the authority to issue letters of credit and whose letter of credit operations are regulated and examined by a federal or Illinois agency.

b) The wording of the letter of credit shall contain the substantive provisions specified in Appendix C of this Part. Additional conditions may be agreed to between the licensee and the issuing institution so long as no requirement of this Part nor required provision is avoided or altered and no additional requirements are placed on the Agency.

c) The letter of credit shall be accompanied by a letter from the licensee referring to the letter of credit by number, issuing institution and date and providing the following information: the radioactive material license numbers, names and addresses of the facilities and the amount of funds for each license assured for reclaiming of the facilities by the letter of credit.

d) The letter of credit shall be irrevocable and issued for a period of at least 1 year. The expiration date of the letter of credit shall be automatically extended for a period of at least 1 year unless, at least 180 days before the current expiration date, the issuing institution notifies both the licensee and the Agency by certified mail, return receipt requested, of a decision not to extend the expiration date. The 180 days will begin on the date when both the licensee and the Agency have received the notice, as evidenced by the return receipts. Unless released by the Agency, the Agency may draw upon this letter of credit if a new letter of credit or other financial assurance arrangements, approved in writing by the Agency, is not furnished 60 days prior to the expiration date. The Agency may delay the drawing if the issuing institution grants an extension of the term of this letter of credit. During the last 30 days of any extension, the Director may draw on this letter of credit if the licensee has failed to provide an alternative financial assurance arrangement approved in writing by the Agency.

e) The letter of credit shall be in an amount, after considering other financial assurance arrangements that are in place, sufficient to provide the necessary funds in order to terminate the license in accordance with the requirements of 32 Ill. Adm. Code 330.

f) The Director may draw on the letter of credit as provided in Section 326.180 of this Part. The Director may also draw on the letter of credit if the licensee does not establish alternative financial assurance arrangements as specified in Section 326.170 of this Part.

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.120 Certificate of Deposit as a Financial Assurance Arrangement

If a licensee elects to satisfy the financial assurance requirements of Section 326.90 of this Part by filing a certificate of deposit, the certificate of deposit supporting this guarantee shall conform to the following requirements:

a) The institution issuing the certificate of deposit shall be an entity that has the authority to issue certificates of deposit and whose certificate of deposit operations are regulated and examined by a federal or State agency.

b) The wording of the certificate of deposit shall contain the substantive provisions specified in Appendix D of this Part. Additional provisions may be included so long as no requirement of this Part is avoided or altered and no additional requirements are placed upon the Agency.

c) The certificate of deposit shall be accompanied by a letter from the licensee referring to the certificate of deposit by number, issuing institution and date and providing the following information:

1. The letter shall reference the radioactive material license numbers, names and addresses of the facilities and the amount of funds assured for reclaiming of the facilities by the certificate of deposit; and

2. The letter shall state that the licensee conveys, transfers, pledges, hypothecates and grants a security interest in and to the certificate to the Agency.

d) The certificate of deposit shall be issued for a period of at least 1 year. The certificate of deposit shall provide that the certificate will be automatically renewed for a period of 1 year unless, at least 180 days before the current expiration date, the issuing institution notifies both the licensee and the Agency by certified mail, return receipt requested, of a decision not to renew the certificate. The 180 days will begin on the date when both the licensee and the Agency have received notice, as evidenced by the return receipts. Unless the Agency provides written notice to the issuing institution that the licensee has provided substitute financial assurance acceptable to the Agency as specified in Section 326.170 of this Part, the issuing institution shall, upon maturity of a certificate of deposit that is not being renewed, pay to the Agency the amount deposited under the certificate of deposit. The Agency may delay the drawing if the issuing institution grants an extension of the term of the credit. During the last 30 days of any extension, the Director may draw on the certificate of deposit if the licensee has failed to provide alternative financial assurance arrangements as specified in Section 326.170 of this Part and obtain written approval of such arrangements from the Agency.

e) The certificate of deposit shall be in an amount, after considering other financial assurance arrangements that are in place, sufficient to provide the necessary funds in order to terminate the license in accordance with the requirements of 32 Ill. Adm. Code 330.

f) Interest accrued on a certificate of deposit shall be paid directly to the licensee and shall not automatically increase the amount of any certificate of deposit on file with the Agency.

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.130 Self-Guarantee as a Financial Assurance Arrangement

a) Except as provided in subsection (b) of this Section, each licensee electing to use self-guarantee as a financial assurance arrangement shall be subject to the following requirements:

1. The company shall not have a parent company holding majority control of its voting stock.

2. The company shall have at least one class of equity securities registered under the Securities Exchange Act of 1934.

3. The company shall submit a financial test, independently audited financial statements and other documents demonstrating that it passes the financial tests prescribed in Section 326.140 of this Part. At a minimum, documentation shall include the following:

A) A self-guarantee, as described in Appendix E of this Part, signed by the company's chief executive officer;

B) A letter, as described in Appendix E of this Part, from the company's chief executive officer;

C) A letter, as described in Appendix E of this Part, from the company's chief financial officer demonstrating that the company passes the financial tests specified in Section 326.140 of this Part;

D) The company's audited financial statements for the most recently completed fiscal year, including an independent auditor's report on the financial statements; and

E) An independent auditor's special report, as described in Appendix E of this Part, stating that the certified public accountant has compared the amounts specified in the chief financial officer's letter with corresponding amounts in the audited year-end financial statements, and found no reason to believe that the amounts in the letter from the chief financial officer need to be adjusted.

4. The company's independent certified public accountant shall have compared the data used by the company in the financial test, which is required to be derived from the independently audited year end financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the company shall inform the Agency 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 licensee no longer passes the test.

5. For commercial companies that issue bonds, the licensee shall provide notice in writing to the Agency within 20 days after publication of a change by the rating service if, at any time, the company's most recent bond issuance ceases to be rated in any category of "A" or above by either Standard and Poor's or Moody's. If the company's most recent bond issuance ceases to be rated in any category A or above by both Standard and Poor's and Moody's, the licensee no longer meets the requirement of Section 326.140(a) of this Part. The licensee shall secure replacement financial assurance arrangements in accordance with Section 326.170 of this Part.

6. After the initial financial test, the company shall repeat passage of the test within 90 days after the close of each succeeding fiscal year, and provide the documents specified in subsection (a)(3) of this Section.

7. If the licensee no longer meets the requirements of the applicable financial tests in Section 326.140 of this Part, the licensee shall send notice to the Agency of its intent to establish alternative financial assurance. The notice shall be sent by certified mail, return receipt requested, within 90 days after the end of the fiscal year for which the year end financial data demonstrates that the licensee no longer meets the financial test requirements. The licensee shall secure alternative financial assurance within 120 days after the end of such fiscal year.

8. The guarantee shall remain in force unless the licensee sends notice of cancellation by certified mail, return receipt requested, to the Agency. Cancellation shall not occur until either a replacement financial assurance arrangement is submitted and approved by the Agency or the Agency confirms that the licensee has performed reclaiming in accordance with 32 Ill. Adm. Code 330.

9. The guarantee and financial test provisions specified in Section 326.140 of this Part shall remain in effect until the Agency has terminated the license, or until a replacement financial assurance arrangement is accepted by the Agency in accordance with Section 326.170 of this Part.

b) In lieu of the requirements in subsection (a) of this Section, a hospital seeking to use self-guarantee as a financial assurance arrangement may satisfy the following requirements:

1. The hospital shall submit a financial test, independently audited financial statements, and other documents demonstrating that it passes the financial tests prescribed in Section 326.140(c) of this Part. At a minimum, documentation shall include the following:

A) A self-guarantee, as described in Appendix E, signed by the chief executive officer of the hospital;

B) A letter, as described in Appendix E, from the hospital's chief executive officer;

C) A letter, as described in Appendix E, from the hospital's chief financial officer, demonstrating that the hospital passes the financial tests specified in Section 326.140(c) of this Part;

D) The hospital's audited financial statements for the most recently completed fiscal year, including an independent auditor's report on the financial statements;

E) An independent auditor's special report, as described in Appendix E of this Part, stating that the certified public accountant has compared the amounts specified in the chief financial officer's letter with the corresponding amounts in the audited year-end financial statements, and found no reason to believe that the amounts in the letter from the chief financial officer need to be adjusted.

2. The hospital's independent certified public accountant shall have compared the data used by the licensee in the financial test, which is required to be derived from the independently audited year end financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform the Agency 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 licensee no longer passes the test.

3. For hospitals that issue bonds, if at any time the hospital's most recent bond issuance ceases to be rated in any category of "A" or above by either Standard and Poor's or Moody's, the licensee shall provide notice in writing to the Agency within 20 days after publication of a change by the rating service. If the hospital's most recent bond issuance ceases to be rated in any category A or above by both Standard and Poor's and Moody's, the licensee no longer meets the requirements of Section 326.140(b) of this Part. The licensee shall secure replacement financial assurance arrangements in accordance with Section 326.170 of this Part.

4. After the initial financial test, the hospital shall, within 90 days after the close of each succeeding fiscal year, repeat passage of the test and provide the documents specified in subsection (b)(1) of this Section.

5. If the hospital no longer meets the requirements of the applicable financial tests in Section 326.140(c) of this Part, the licensee shall send notice to the Agency of its intent to establish alternative financial assurance as specified in Section 326.170 of this Part. The notice shall be sent by certified mail, return receipt requested, within 90 days after the end of the fiscal year for which the year end financial data demonstrates that the license no longer meets the financial test requirements. The licensee shall secure alternative financial assurance within 120 days after the end of that fiscal year.

6. The guarantee shall remain in force unless the licensee sends notice of cancellation by certified mail, return receipt requested, to the Agency. Cancellation shall not occur until either a replacement financial assurance arrangement is submitted in accordance with Section 326.170 of this Part or the Agency confirms that the licensee has performed reclaiming in accordance with 32 Ill. Adm. Code 330.

7. The guarantee and financial test provisions specified in Section 326.140(b) of this Part shall remain in effect until the Agency has terminated the license or until a replacement financial assurance arrangement is accepted by the Agency in accordance with Section 326.170 of this Part.

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.140 Financial Tests for Self-Guarantee

A licensee may provide assurance of the availability of funds for reclaiming based on furnishing its own guarantee that funds will be available for reclaiming costs, provided that the licensee can demonstrate that it meets the applicable financial tests identified in this Section. For commercial corporations that issue bonds, a guarantee of funds may be used if the licensee meets the tests as specified in subsection (a) of this Section. For commercial corporations that do not issue bonds, a guarantee of funds may be used if the licensee meets the tests as specified in subsection (b) of this Section. For hospitals, a guarantee of funds may be used if the licensee meets the tests as specified in subsection (c) of this Section. A guarantee by the licensee may not be used in any situation where the licensee has a parent company holding majority control of the voting stock of the company.

a) For commercial companies that issue bonds, to pass the financial test, the company shall demonstrate it meets all of the following criteria:

1. Tangible net worth at least 10 times the total current reclaiming cost estimate for all decommissioning activities for which the company is responsible under a parent company guarantee, a self-guarantee or a commitment to another regulatory agency (e.g., USEPA).

2. Assets located in the United States amounting to at least 90 percent of total assets or at least 10 times the total current reclaiming cost estimate for all decommissioning activities for which the company is responsible under a parent company guarantee, a self-guarantee or a commitment to another regulatory agency (e.g., USEPA).

3. A current rating for its most recent uninsured, uncollateralized and unencumbered bond issuance of AAA, AA or A as issued by Standard and Poor's, or Aaa, Aa or A as issued by Moody's.

b) For commercial companies that do not issue bonds, to pass the financial test, the company shall demonstrate it meets all of the following criteria:

1. Tangible net worth greater than $10 million, or at least 10 times the totalcurrent reclaiming cost estimate, whichever is greater, for all decommissioning activities for which the company is responsible under a parent company guarantee, a self-guarantee or a commitment to another regulatory agency (e.g., USEPA).

2. Assets located in the United States amounting to at least 90 percent of total assets or at least 10 times the total current reclaiming cost estimate for all decommissioning activities for which the company is responsible under a parent company guarantee, a self-guarantee or a commitment to another regulatory agency (e.g., USEPA).

3. The (sum of net income plus depreciation, depletion and amortization) divided by total liabilities shall be greater than 0.15 and total liabilities divided by net worth shall be less than 1.5.

c) For hospitals to pass the financial test, a hospital shall meet either the criteria in subsection (c)(1) or (2) of this Section:

1. For hospitals that issue bonds, a current rating for its most recent uninsured, uncollateralized and unencumbered bond issuance of AAA, AA or A as issued by Standard and Poor's, or Aaa, Aa or A as issued by Moody's.

2. For hospitals that do not issue bonds, all of the following tests shall be met:

A) (Total revenues less total expenditures) divided by total revenues shall be equal to or greater than 0.04.

B) Long term debt divided by net fixed assets shall be less than or equal to 0.67.

C) (Current assets and depreciation fund) divided by current liabilities shall be equal to or greater than 2.55.

D) Operating revenues shall be at least 100 times the total current reclaiming cost estimate for all reclaiming activities for which the hospital is responsible under a parent company guarantee, a self-guarantee or a commitment to another regulatory agency (e.g., USEPA).

32 Ill. Adm. Code 326.150 Parent Company Guarantee as a Financial Assurance Arrangement

Each licensee electing to use a parent company guarantee as a financial assurance arrangement shall be subject to the following requirements:

a) The guarantor shall be a direct parent holding more than 50 percent of the voting stock of the licensee. A company shall not serve as a guarantor to a division of the company.

b) Each licensee electing to use a parent company guarantee as a financial assurance arrangement shall submit a financial test, independently audited financial statements and other documents demonstrating that it passes the financial tests prescribed in Section 326.160 of this Part. At a minimum, documentation shall include all of the following:

1. A parent company guarantee agreement, as described in subsection (b) of Appendix F of this Part, signed by the chief executive officer of the guarantor, that states in part that, if the licensee fails to conduct required reclamation activities, the parent company shall either:

A) Conduct the required activities, or

B) Pay the guaranteed amount to the Agency as directed by the Director;

2. A copy of corporate bylaws, a letter, or other evidence indicating that the guarantor is the parent company of the licensee and that the guarantor has majority control of the licensee's voting stock;

3. A letter, as described in subsection (a) of Appendix F of this Part, from the parent company's chief executive officer;

4. A letter from the parent company's chief financial officer, as described in subsection (a) of Appendix F of this Part, demonstrating that the company passes the financial tests specified in Section 326.160 of this Part;

5. The parent company's audited financial statements for the most recently completed fiscal year, including an independent auditor's report on the financial statements; and

6. An independent auditor's special report, as described in subsection (d) of Appendix F of this Part, stating that the certified public accountant has compared the amounts specified in the letter from the chief financial officer with corresponding amounts in the audited year-end financial statements, and found no reason to believe that the amounts in the letter from the chief financial officer need to be adjusted.

c) The parent company's independent certified public accountant shall have compared the data used by the parent company in the financial test, which shall be derived from the independently audited year end financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform the Agency 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 parent company no longer passes the test.

d) After the initial financial test, the parent company shall repeat passage of the test within 90 days after the close of each succeeding fiscal year, and shall provide the documentation specified in subsection (b) of this Section.

e) If the licensee's parent company no longer meets the requirements of the applicable financial tests in Section 326.160 of this Part, the licensee shall send notice to the Agency of its intent to establish alternative financial assurance as specified in Section 326.170 of this Part. The notice shall be sent by certified mail, return receipt requested, within 90 days after the end of the fiscal year for which the year end financial data demonstrates that the parent company no longer meets the financial test requirements. The licensee shall secure alternative financial assurance within 120 days after the end of that fiscal year.

f) The guarantee shall remain in force unless the licensee sends notice of cancellation by certified mail, return receipt requested, to the Agency. Cancellation shall not occur until either a replacement financial assurance arrangement is submitted in accordance with Section 326.170 of this Part or the Agency confirms that the licensee has performed reclaiming in accordance with 32 Ill. Adm. Code 330.

g) The guarantee and financial test provisions specified in Section 326.160 of this Part shall remain in effect until the Agency has terminated the license, or until a replacement financial assurance arrangement is accepted by the Agency in accordance with Section 326.170 of this Part.

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.160 Financial Tests for Parent Company Guarantee

A licensee may provide assurance of the availability of funds for reclaiming based on obtaining a parent company guarantee that funds will be available for reclaiming costs, provided that the parent company can demonstrate that it meets the applicable financial tests identified in this Section. To pass the financial test, the parent company shall demonstrate it meets the criteria specified in either subsection (a) or (b) of this Section.

a) The parent company shall have:

1. Two of the following three ratios:

A) A ratio of total liabilities to net worth less than 2.0;

B) A ratio of the sum of net income plus depreciation, depletion and amortization to total liabilities greater than 0.1;

C) A ratio of current assets to current liabilities greater than 1.5;

2. Net working capital and tangible net worth, each at least 6 times the total current reclamation cost estimate for all decommissioning activities for which the company is responsible under a parent company guarantee, a self-guarantee or a commitment to another regulatory agency (e.g., USEPA);

3. Tangible net worth of at least $10 million; and

4. Assets located in the United States amounting to at least 90 percent of total assets or at least 6 times the total current reclamation cost estimate for all decommissioning activities for which the company is responsible under a parent company guarantee, a self-guarantee or a commitment to another regulatory agency (e.g., USEPA).

b) Or the parent company shall have:

1. A current rating for its most recent uninsured, uncollateralized and unencumbered bond issuance of AAA, AA, A or BBB as issued by Standard and Poor's, or Aaa, Aa, A or Baa as issued by Moody's;

2. Tangible net worth of at least 6 times the total current reclamation cost estimate for all decommissioning activities for which the company is responsible under a parent company guarantee, a self-guarantee or a commitment to another regulatory agency (e.g., USEPA);

3. Tangible net worth of at least $10 million; and

4. Assets located in the United States amounting to at least 90 percent of total assets or at least 6 times the total current reclamation cost estimate for all decommissioning activities for which the company is responsible under a parent company guarantee, a self-guarantee or a commitment to another regulatory agency (e.g., USEPA).

32 Ill. Adm. Code 326.170 Modification or Replacement of Financial Assurance Arrangements

The licensee shall not substitute, modify or replace financial assurance arrangements filed with the Agency without prior approval by the Agency.

a) Substitute or replacement financial assurance arrangements shall meet the requirements of this Part.

b) Proposed modifications to financial assurance arrangements already filed with the Agency shall be submitted in writing to the Agency for approval.

c) Existing financial assurance arrangements shall not be released by the Agency until the proposed modifications or replacement financial assurance arrangements have been approved and filed in accordance with Section 326.90 of this Part.

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.180 Drawing on Financial Assurance Arrangements

If a licensee fails to perform required reclamation activities or fails to obtain substitute or replacement financial assurance arrangements approved by the Agency, the Agency will exercise its rights under the applicable financial assurance arrangement. Notice of the Agency's action shall be provided to the licensee at the address on file with the Agency.

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.190 Implementation

The following procedures shall apply in implementing this Part:

a) No new specific licenses shall be issued by the Agency after June 1, 2000, unless all financial assurance requirements have been addressed as specified in this Part.

b) For specific licenses issued after December 1, 2005, financial assurance arrangements shall be based upon the activity authorized on a specific radioactive material license.

c) All specific licensees shall review their cost estimate and reclamation plans at the time of renewal or when there is a change to the radiation safety program that would impact the amount of financial assurance on file with the Agency.

d) Financial assurance arrangements for generally licensed devices shall be due within 90 days from the date of notification by the Agency.

e) Unless the arrangement is required to be revised for another reason, previously issued financial assurance arrangements do not have to be revised specifically to substitute the Illinois Emergency Management Agency for Illinois Department of Nuclear Safety, its predecessor agency (or to substitute Agency for Department).

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.APPENDIX A Quantities of Material for Major Possessor Determination

Radionuclide

Abbrev.

UNSEALED

FORMS

SEALED

SOURCES

MBq

mCi

GBq

Ci

Actinium-227

Ac-227

0.037

0.001

370

10

Aluminum-26

Al-26

370

10

37000

1000

Americium-241

Am-241

0.037

0.001

370

10

Americium-242m

Am-242m

0.037

0.001

370

10

Americium-243

Am-243

0.037

0.001

370

10

Antimony-125

Sb-125

3700

100

37000

1000

Barium-133

Ba-133

3700

100

37000

1000

Berkelium-247

Bk-247

0.037

0.001

370

10

Berkelium-249

Bk-249

3.7

0.1

37000

1000

Beryllium-10

Be-10

37

1

37000

1000

Bismuth-207

Bi-207

370

10

37000

1000

Bismuth-210m

Bi-210m

3.7

0.1

37000

1000

Cadmium-109

Cd-109

37

1

37000

1000

Cadmium-113

Cd-113

3700

100

37000

1000

Cadmium-113m

Cd-113m

3.7

0.1

37000

1000

Calcium-41

Ca-41

3700

100

37000

1000

Californium-248

Cf-248

0.37

0.01

3700

100

Californium-249

Cf-249

0.037

0.001

370

10

Californium-250

Cf-250

0.037

0.001

370

10

Californium-251

Cf-251

0.037

0.001

370

10

Californium-252

Cf-252

0.037

0.001

370

10

Carbon-14

C-14

37000

1000

37000

1000

Cerium-144

Ce-144

37

1

37000

1000

Cesium-134

Cs-134

370

10

37000

1000

Cesium-135

Cs-135

3700

100

37000

1000

Cesium-137

Cs-137

370

10

37000

1000

Chlorine-36

Cl-36

370

10

37000

1000

Cobalt-60

Co-60

37

1

37000

1000

Curium-243

Cm-243

0.037

0.001

370

10

Curium-244

Cm-244

0.037

0.001

370

10

Curium-245

Cm-245

0.037

0.001

370

10

Curium-246

Cm-246

0.037

0.001

370

10

Curium-247

Cm-247

0.037

0.001

370

10

Curium-248

Cm-248

0.037

0.001

370

10

Einsteinium-254

Es-254

0.37

0.01

3700

100

Europium-150 (34.2y)

Eu-150

37

1

37000

1000

Europium-152

Eu-152

37

1

37000

1000

Europium-154

Eu-154

37

1

37000

1000

Europium-155

Eu-155

370

10

37000

1000

Gadolinium-148

Gd-148

0.037

0.001

370

10

Gadolinium-152

Gd-152

3700

100

37000

1000

Germanium-68

Ge-68

370

10

37000

1000

Hafnium-172

Hf-172

37

1

37000

1000

Hafnium-182

Hf-182

3.7

0.1

37000

1000

Holmium-166m

Ho-166m

37

1

37000

1000

Hydrogen-3

H-3

37000

1000

37000

1000

Indium-115

In-115

3700

100

37000

1000

Iodine-129

I-129

37

1

37000

1000

Iron-55

Fe-55

3700

100

37000

1000

Iron-60

Fe-60

37

1

37000

1000

Lanthanum-137

La-137

370

10

37000

1000

Lanthanum-138

La-138

3700

100

37000

1000

Lead-202

Pb-202

370

10

37000

1000

Lead-205

Pb-205

3700

100

37000

1000

Lead-210

Pb-210

0.37

0.01

3700

100

Lutetium-173

Lu-173

370

10

37000

1000

Lutetium-174

Lu-174

370

10

37000

1000

Lutetium-176

Lu-176

3700

100

37000

1000

Manganese-53

Mn-53

37000

1000

37000

1000

Manganese-54

Mn-54

3700

100

37000

1000

Mercury-194

Hg-194

37

1

37000

1000

Molybdenum-93

Mo-93

370

10

37000

1000

Neptunium-235

Np-235

3700

100

37000

1000

Neptunium-236 (1.15x105y)

Np-236

0.037

0.001

370

10

Neptunium-237

Np-237

0.037

0.001

370

10

Nickel-59

Ni-59

3700

100

37000

1000

Nickel-63

Ni-63

3700

100

37000

1000

Niobium-93m

Nb-93m

370

10

37000

1000

Niobium-94

Nb-94

37

1

37000

1000

Osmium-194

Os-194

37

1

37000

1000

Palladium-107

Pd-107

370

10

37000

1000

Platinum-193

Pt-193

37000

1000

37000

1000

Plutonium-236

Pu-236

0.037

0.001

370

10

Plutonium-238

Pu-238

0.037

0.001

370

10

Plutonium-239

Pu-239

0.037

0.001

370

10

Plutonium-240

Pu-240

0.037

0.001

370

10

Plutonium-241

Pu-241

0.37

0.01

3700

100

Plutonium-242

Pu-242

0.037

0.001

370

10

Plutonium-244

Pu-244

0.037

0.001

370

10

Potassium-40

K-40

3700

100

37000

1000

Promethium-144

Pm-144

370

10

37000

1000

Promethium-145

Pm-145

370

10

37000

1000

Promethium-146

Pm-146

37

1

37000

1000

Promethium-147

Pm-147

370

10

37000

1000

Protactinium-231

Pa-231

0.037

0.001

370

10

Radium-226

Ra-226

3.7

0.1

37000

1000

Radium-228

Ra-228

3.7

0.1

37000

1000

Rhenium-186m

Re-186m

370

10

37000

1000

Rhenium-187

Re-187

37000

1000

37000

1000

Rhodium-101

Rh-101

370

10

37000

1000

Rhodium-102

Rh-102

370

10

37000

1000

Rubidium-87

Rb-87

3700

100

37000

1000

Ruthenium-106

Ru-106

37

1

37000

1000

Samarium-145

Sm-145

37000

100

37000

1000

Samarium-146

Sm-146

37

1

37000

1000

Samarium-147

Sm-147

3700

100

37000

1000

Samarium-151

Sm-151

370

10

37000

1000

Selenium-79

Se-79

3700

100

37000

1000

Silicon-32

Si-32

37

1

37000

1000

Sodium-22

Na-22

370

10

37000

1000

Strontium-90

Sr-90

3.7

0.1

37000

1000

Tantalum-179

Ta-179

3700

100

37000

1000

Tantalum-180m

Ta-180m

37000

1000

37000

1000

Technetium-97

Tc-97

37000

1000

37000

1000

Technetium-98

Tc-98

370

10

37000

1000

Technetium-99

Tc-99

3700

100

37000

1000

Tellurium-123

Te-123

3700

100

37000

1000

Terbium-157

Tb-157

370

10

37000

1000

Terbium-158

Tb-158

37

1

37000

1000

Thallium-204

Tl-204

3700

100

37000

1000

Thorium-228

Th-228

0.037

0.001

370

10

Thorium-229

Th-229

0.037

0.001

370

10

Thorium-230

Th-230

0.037

0.001

370

10

Thorium-232

Th-232

3700

100

37000

1000

Thulium-171

Tm-171

370

10

37000

1000

Tin-119m

Sn-119m

3700

100

37000

1000

Tin-121m

Sn-121

37000

1000

37000

1000

Tin-126

Sn-126

370

10

37000

1000

Titanium-44

Ti-44

37

1

37000

1000

Uranium-232

U-232

0.037

0.001

370

10

Uranium-233

U-233

0.037

0.001

370

10

Uranium-234

U-234

0.037

0.001

370

10

Uranium-235

U-235

0.037

0.001

370

10

Uranium-236

U-236

0.037

0.001

370

10

Uranium-238

U-238

3700

100

37000

1000

Vanadium-49

V-49

37000

1000

37000

1000

Zirconium-93

Zr-93

37

1

37000

1000

Thorium-natural

3700

100

37000

1000

Uranium-natural

3700

100

37000

1000

When a combination of nuclides is involved, the limit for the combination shall be derived as follows: For each nuclide, the licensee shall determine the ratio between the quantity authorized on the license and the quantity established in this Appendix A for the form of the material (sealed source or unsealed material). If the sum of the ratios for all nuclides is greater than one, then the licensee shall post financial assurance arrangements.

AGENCY NOTE: Possession of special nuclear material (Plutonium, Uranium-233 and Uranium-235) is limited to quantities not sufficient to form a critical mass as defined in 32 Ill. Adm. Code 310.20.

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.APPENDIX B Wording for Surety Bonds

A surety bond guaranteeing funds for reclamation, as specified in 32 Ill. Adm. Code 326.100, shall contain the following provisions, except that the instructions in brackets are to be replaced with the relevant information and the brackets deleted:

SURETY BOND

Date bond executed:

Effective date:

Principal: [legal name and business address of licensee]

Type of organization: [insert "individual," "partnership" or "corporation"]

State of incorporation:

Surety(ies): [Name(s) and business address(es)]

License number(s), name, address and reclamation cost for each facility guaranteed by this bond:

Total penal sum of bond: $ _____

Surety's bond number:

KNOW ALL PERSONS BY THESE PRESENTS, That we, the Principal and Surety(ies) hereto, are firmly bound to the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois 62704 (hereinafter called Agency), in the above penal sum for the payment of which we bind ourselves, our heirs, executors, administrators, successors and assigns jointly and severally; provided that, where the Surety(ies) are corporations acting as co-sureties, we, the Sureties, bind ourselves in such sum "jointly and severally" only for the purpose of allowing a joint action or actions against any or all of us, and for all other purposes each Surety binds itself, jointly and severally with the Principal, for the payment of such sum only as is set forth opposite the name of such Surety, but if no limit of liability is indicated, the limit of liability shall be the full amount of the penal sum.

WHEREAS said Principal is required, under the Radiation Protection Act of 1990, to have a license in order to receive, possess, store and use radioactive material at the facility identified above; and

WHEREAS said Principal is required to provide financial assurance for reclamation as a condition of the license;

NOW, THEREFORE, the conditions of this obligation are such that if the Principal shall faithfully perform reclamation, whenever required to do so, of each facility for which this bond guarantees funds for reclamation, to the satisfaction of the Director, Illinois Emergency Management Agency, in accordance with acceptable practices for protection of health and safety pursuant to all applicable laws, statutes, rules and regulations, as such laws, statutes, rules and regulations may be amended;

OR, if the Principal shall provide alternative financial assurance as specified in 32 Ill. Adm. Code 326.170, and obtain the written approval of such assurance from the Illinois Emergency Management Agency, within 90 days after the date notice of cancellation is received by both the Principal and the Agency from the Surety(ies), then this obligation shall be null and void; otherwise, it is to remain in full force and effect.

The Surety(ies) shall become liable on this bond obligation only when the Principal has failed to fulfill the conditions described herein.

Upon notification by the Agency that the Principal has been found in violation of the reclamation requirements of the Agency, for a facility for which this bond guarantees funds for performance of reclamation, the Surety(ies) shall pay the reclamation cost amount guaranteed for the facility to the Agency as directed by the Director.

Upon notification by the Agency that the Principal has failed to provide alternative financial assurance as specified in 32 Ill. Adm. Code 326.170 and obtain written approval of such assurance from the Agency during the 120 days following receipt by both the Principal and the Director of a notice of cancellation of the bond, the Surety(ies) shall pay the amount guaranteed for the facility(ies) to the Agency as directed by the Director.

The Surety(ies) hereby waive(s) notification of amendments to licenses, applicable laws, statutes, rules and regulations and agree(s) that no such amendment shall in any way alleviate its (their) obligation on this bond.

The liability of the Surety(ies) shall not be discharged by any payment or succession of payments hereunder, unless and until such payment or payments shall amount in the aggregate to the penal sum of the bond, but in no event shall the obligation of the Surety(ies) hereunder exceed the amount of said penal sum.

The Surety(ies) may cancel the bond by sending notice of cancellation by certified mail to the licensee and to the Agency; provided, however, that cancellation shall not occur during the 180 days beginning on the date of receipt of the notice of cancellation by both the Principal and the Agency, as evidenced by the return receipts.

The Principal may terminate this bond by sending written notice to the Surety(ies); provided, however, that no such notice shall become effective until the Surety(ies) receive(s) written authorization for termination of the bond by the Agency.

IN WITNESS WHEREOF, the Principal and Surety(ies) have executed this SURETY BOND and have affixed their seals on the date set forth above.

The persons whose signatures appear below hereby certify that they are authorized to execute this surety bond on behalf of the Principal and Surety(ies).

PRINCIPAL

[Signature(s)]

[Below each signature, type or print that person's name and title]

Corporate seal:

CORPORATE SURETY(IES)

[Name and address]

State of incorporation:

Liability limit: $ _____

[Signature(s)]

[Below each signature, type or print that person's name and title]

Corporate seal:

[For every co-surety, provide signature(s), corporate seal and other information in the same manner as for the Surety above.]

Bond premium: $ _____

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.APPENDIX C Wording for Letters of Credit

A letter of credit, as specified in 32 Ill. Adm. Code 326.110, shall contain the following provisions, except that instructions in brackets are to be replaced with the relevant information and the brackets deleted:

IRREVOCABLE STANDBY LETTER OF CREDIT

Director Date:_____________

Illinois Emergency Management Agency

Dear Sir or Madam:

We hereby establish our Irrevocable Standby Letter of Credit No. _____ in your favor, at the request and for the account of [licensee's name and address] up to the aggregate amount of [in words] U.S. dollars $ _____, available upon presentation of:

A) Your sight draft, bearing reference to this letter of credit No. _____; and

B) Your signed statement reading as follows: "I certify that the amount of the draft is payable pursuant to regulations issued under authority of the Illinois Radiation Protection Act of 1990."

This letter of credit is effective as of [date] and shall expire on [date at least 1 year later], but such expiration date shall be automatically extended for a period of [at least 1 year] on [date] and on each successive expiration date, unless, at least 180 days before the current expiration date, we notify both you and [licensee's name] by certified mail that we have decided not to extend this letter of credit beyond the current expiration date. Unless released by the Illinois Emergency Management Agency (hereinafter called Agency), the Agency may draw upon this letter of credit if a new letter of credit or other financial assurance arrangement approved in writing by the Agency is not furnished 60 days prior to the expiration date. The Agency may delay the drawing if the issuing institution grants an extension of the term of this letter of credit. During the last 30 days of any extension, the Director may draw on this letter of credit if the licensee has failed to provide an alternative financial assurance arrangement approved in writing by the Agency. [Financial institution] shall give immediate notice to [licensee] and the Agency of any notice received or action filed alleging (1) the insolvency or bankruptcy of [financial institution] or (2) any violations of regulatory requirements that could result in suspension or revocation of [financial institution's] charter or license to do business. The financial institution also shall give immediate notice if [financial institution], for any reason, becomes unable to fulfill its obligation under this letter of credit.

Whenever this letter of credit is drawn on under and in compliance with the terms of the letter of credit, we shall duly honor such draft upon its presentation to us within 30 days, and we shall pay the amount of the draft to the Agency in accordance with your instructions.

Each draft must bear on its face the clause: "Drawn under Letter of Credit No. _____, dated _____, and the total of this draft and all other drafts previously drawn under this letter of credit does not exceed [fill in amount]."

[Signature(s) and title(s) of official(s) of issuing institution] [Date]

This credit is subject to [the most recent edition of the Uniform Customs and Practice for Documentary Credits, published by the International Chamber of Commerce, or the Uniform Commercial Code].

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.APPENDIX D Wording for Certificates of Deposit

A certificate of deposit, as specified in 32 Ill. Adm. Code 326.120, shall contain the following provisions, except that instructions in brackets are to be replaced with the relevant information and the brackets deleted:

CERTIFICATE OF DEPOSIT

[Name and address of financial institution]

Certificate of Deposit [insert date]

No. _____ [insert $ amount]

[Licensee name and address] has deposited not subject to check [spell out dollar amount] Dollars [insert numerical value $ ] payable to the Illinois Emergency Management Agency (hereinafter called the Agency) [insert number of months] months after date, upon presentation of this certificate properly endorsed. The funds are deposited for the purpose of providing financial assurance for the cost of reclamation as required by 32 Ill. Adm. Code 326. Accordingly, this certificate shall be renewed automatically unless (a) [financial institution] receives written notice from the Agency of (1) the default of [licensee] on these obligations, (2) the termination of the facility license, or (3) the substitution of another financial assurance arrangement; or (b) [financial institution] provides a minimum of 180 days written notice of its decision not to renew as provided in the Agency's rules. In the event the Agency notifies [financial institution] that [licensee] has not complied with its reclamation obligations under the Agency's rules or its obligation to provide replacement financial assurance acceptable to the Agency, [financial institution] shall pay the amount deposited to the Agency.

[Financial institution] waives all rights of lien which it has or might have against this certificate.

The deposit documented in this certificate is insured by the Federal Deposit Insurance Corporation.

---

(Cashier)

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.APPENDIX E Wording for Self-Guarantee Documents

a) A self-guarantee, as specified in 32 Ill. Adm. Code 326.130, shall contain letters from the chief executive officer and the chief financial officer containing the following provisions, except that instructions in brackets are to be replaced with the relevant information and the brackets deleted:

CHIEF EXECUTIVE OFFICER

I am the [chief executive officer or equivalent] of [name and address of firm], a [insert "proprietorship," "partnership," or "corporation"]. This letter is in support of this firm's use of the financial test to demonstrate financial assurance, as specified in 32 Ill. Adm. Code 326.

I hereby certify that [name of firm] is currently a going concern, and that it possesses positive tangible net worth in the amount of $__________.

This firm [insert "is required" or "is not required"] to file a Form 10K with the U.S. Securities and Exchange Commission for the latest fiscal year. The fiscal year of this firm ends on [month, day].

I hereby certify that the content of this letter is true and correct to the best of my knowledge.

[Signature]

[Below the signature, type or print that person's name and title]

[Date]

CHIEF FINANCIAL OFFICER

I am the [chief financial officer or equivalent] of [name and address of firm], a [insert "proprietorship," "partnership," or "corporation"]. This letter is in support of this firm's use of the financial test to demonstrate financial assurance, as specified in 32 Ill. Adm. Code 326.

[Complete the following paragraph regarding facility(ies) and associated cost estimates or amounts specified in 32 Ill. Adm. Code 326.70. For each facility, include its license number, name, address and current cost estimates for the specified activities.]

This firm guarantees, through the self-guarantee submitted to demonstrate compliance under 32 Ill. Adm. Code 326, the reclamation of the following facility(ies) owned or operated by this firm. The current cost estimates or amounts specified in 32 Ill. Adm. Code 326.70, so guaranteed, are shown for each facility:

Name of Facility

Location of Facility

Cost Estimate or

326.70 Amounts

This firm [insert "is required" or "is not required"] to file a Form 10K with the U.S. Securities and Exchange Commission for the latest fiscal year.

The fiscal year of this firm ends on [month, day]. The figures for the financial test required by 32 Ill. Adm. Code 326.140 are derived from this firm's independently audited, year-end financial statements and footnotes for the latest completed fiscal year, ended [date].

[Insert completed financial test applicable to licensee from subsection (c), (d) or (e) of this Appendix.]

I hereby certify that the content of this letter is true and correct to the best of my knowledge.

[Signature]

[Below the signature, type or print that person's name and title]

[Date]

b) A self-guarantee, as specified in 32 Ill. Adm. Code 326.130, shall contain the following provisions, except that instructions in brackets are to be replaced with the relevant information and the brackets deleted:

SELF-GUARANTEE

Self-guarantee made this [date] by [name and address of licensee], a [insert "proprietorship," "partnership," or "corporation"] organized under the laws of the State of [insert name of state], herein referred to as "licensee," to the Illinois Emergency Management Agency (hereinafter called the Agency).

Recitals

1. The licensee has full authority and capacity to enter into this guarantee [if guarantor is a corporation, add the following phrase "under its bylaws, articles of incorporation, and the laws of the State of [insert licensee's state of incorporation], its state of incorporation."]. [If the licensee has a Board of Directors, insert the following: "Licensee has approval from its Board of Directors to enter into this guarantee."]

2. This guarantee is being issued to comply with regulations issued by the Agency, pursuant to the Radiation Protection Act of 1990. The Agency has promulgated regulations in 32 Ill. Adm. Code 326 that require that general or specific licensees provide assurance that funds will be available when needed for reclamation activities.

3. The guarantee is issued to provide financial assurance for reclamation activities for [identify licensed facility(ies)] as required by 32 Ill. Adm. Code 326. The reclamation costs are as follows: [insert the current cost estimates or amounts specified in 32 Ill. Adm. Code 326.70 guaranteed for each identified facility].

4. The licensee meets or exceeds the financial test criteria specified in 32 Ill. Adm. Code 326.140 and agrees to comply with all notification requirements as specified in 32 Ill. Adm. Code 326.

5. Reclamation activities as used in this Appendix E refers to the activities required by 32 Ill. Adm. Code 330 for reclamation of facility(ies) identified in this Appendix E.

6. The licensee guarantees to the Agency that it will:

A) Carry out the required reclamation activities as required by 32 Ill. Adm. Code 330; or

B) Upon written notification from the Agency, pay the reclamation cost amount guaranteed for the facility(ies) to the Agency directed by the Director.

7. The licensee shall submit revised financial statements, financial test data and an auditor's special report and reconciling schedule annually within 90 days after the close of the licensee's fiscal year.

8. If, at the end of any fiscal year before termination of this guarantee, the licensee fails to meet the financial test criteria, the licensee shall send within 90 days after the end of the fiscal year, by certified mail, return receipt requested, notice to the Agency that the licensee intends to provide alternative financial assurance as specified in 32 Ill. Adm. Code 326.170. Within 120 days after the end of the fiscal year, the licensee shall provide such financial assurance.

9. The licensee shall notify the Agency promptly if the ownership of the licensee is transferred and shall maintain this guarantee until the new parent firm or the licensee provides alternative financial assurance acceptable to the Agency.

10. The licensee, as well as its successors and assigns, agrees to remain bound jointly and severally under this guarantee notwithstanding any or all of the following: amendment or modification of the license or Agency-approved reclamation funding plan for that facility, the extension or reduction of the time of performance of required activities, or any other modification or alteration of an obligation of the licensee pursuant to 32 Ill. Adm. Code 326.

11. All bound parties shall be jointly and severally liable for all litigation costs incurred by the Agency in any successful effort to enforce this guarantee.

12. The licensee shall remain bound under this guarantee for as long as the licensee must comply with the applicable financial assurance requirements of 32 Ill. Adm. Code 326 for the previously listed facility(ies), except that the licensee may cancel this guarantee by meeting the requirements of 32 Ill. Adm. Code 326.170.

13. If the licensee fails to provide alternative financial assurance as specified in 32 Ill. Adm. Code 326.170, the licensee shall make full payment under this guarantee.

14. If the licensee files financial reports with the U.S. Securities and Exchange Commission, then it shall promptly submit them to the Agency during each year in which this guarantee is in effect.

I hereby certify that the content of this guarantee is true and correct to the best of my knowledge.

Effective date:_________________

[Name of licensee]

[Signature of chief executive officer or equivalent]

[Below the signature, type or print that person's name and title]

Signature of witness or notary:_________________________

c) Financial test documentation for self-guarantee for a commercial company issuing bonds:

1. Current reclaiming and decommissioning cost estimates or certified amounts

A)

Current reclaiming cost estimate or certified amount for all decommissioning activities covered by this self-guarantee

$

B)

Total reclaiming cost estimates and certified amounts for all decommissioning activities covered by other NRC or Agreement State guarantees, parent company guarantees or self-guarantees

$

C)

Total amounts for all decommissioning activities under parent company guarantees, self-guarantees and commitments to other regulatory agencies (e.g., USEPA)

$

Total for line 1

$

2. Current bond rating of most recent unsecured issuance of this firm

Rating

Name of rating service

Date of issuance of bond

Date of maturity of bond

5)*

Tangible net worth** (if any portion of the cost estimates for reclaiming or decommissioning is included in total liabilities on your firm's financial statements, you may add the amount of that portion to this line)

$

6)*

Total assets in United States (required only if less than 90 percent of firm's assets are located in the United States)

$

Yes

No

Is line 5 at least 10 times line 1?

Are at least 90 percent of the firm's assets located in the United States? If not, complete line 9

Is line 6 at least 10 times line 1?

Is rating specified on line 2 "A" or better

Does the licensee have at least one class of equity securities registered under the Securities Exchange Act of 1934?

• Denotes figures derived from financial statements.

** Tangible net worth is defined as net worth minus goodwill, patents, trademarks and copyrights.

d) Financial test documentation for commercial companies that have no outstanding rated bonds:

1. Current reclaiming and decommissioning cost estimates or certified amounts

A)

Current reclaiming cost estimate or certified amount for all decommissioning activities covered by this self-guarantee

$

B)

Total reclaiming cost estimates or certified amounts for all decommissioning activities covered by other NRC or Agreement State guarantees, parent company guarantees or self-guarantees

$

C)

Total amounts for all decommissioning activities under parent company guarantees, self-guarantees and commitments to other regulatory agencies (e.g., USEPA)

$

Total for line 1

2)*

Total liabilities (if any portion of the cost estimates for reclaiming or decommissioning is included in total liabilities on your firm's financial statements, you may deduct the amount of that portion from this line and add that amount to lines 3 and 4)

$

3)*

Tangible net worth**

$

4)*

Net worth

$

5)*

The sum of net income plus depreciation, depletion and amortization

$

6)*

Total assets in United States (required only if less than 90 percent of firm's assets are located in the United States)

$

Yes

No

Is line 3 greater than $10 million, or at least 10 times line 1, whichever is greater

Are at least 90 percent of the firm's assets located in the United States? If not, complete line 9

Is line 6 at least 10 times line 1?

Is line 5 divided by line 2 greater than 0.15?

Is line 2 divided by line 4 less than 1.5?

• Denotes figures derived from financial statements.

** Tangible net worth is defined as net worth minus goodwill, patents, trademarks and copyrights.

e) Financial test documentation for self-guarantee for hospitals (Complete either Alternative 1 or Alternative 2):

Alternative 1

1. Current bond rating of most recent unsecured ,uncollateralized and unencumbered issuance of this institution

Rating

Name of rating service

Date of issuance of bond

Date of maturity of bond

Yes

No

Is the rating specified on line 1 "a" or better

Alternative 2

1. Current reclaiming and decommissioning cost estimates or certified amounts

A)

Current reclaiming cost estimate or certified amount for all decommissioning activities covered by this self-guarantee

$

B)

Total reclaiming cost estimates and certified amounts for all decommissioning activities covered by other NRC or Agreement State guarantees, parent company guarantees or self-guarantees

$

C)

Total amounts for all decommissioning activities under parent company guarantees, self-guarantees and commitments to other regulatory agencies (e.g., USEPA)

$

Total for line 1

$

2)*

Total revenues

$

3)*

Operating revenues

$

4)*

Total expenditures

$

5)*

Total long-term debt

$

6)*

Net fixed assets**

$

7)*

Current assets

$

8)*

Depreciation fund

$

9)*

Current liabilities

$

Yes

No

Is line 3 at least 100 times line 1?

Guarantor shall meet each of the following ratios:

Yes

No

Is (line 2 minus line 4) divided by line 2 at least 0.04?

Is line 5 divided by line 6 less than or equal to 0.67?

Is (line 7 plus line 8) divided by line 9 at least 2.55?

• Denotes figures derived from financial statements.

** Net fixed assets is defined as fixed assets minus accumulated depreciation.

f) A self-guarantee, as specified in 32 Ill. Adm. Code 326.130 and 326.140, shall include submission of an auditor's special report containing the following provisions, except that instructions in brackets are to be replaced with the relevant information and the brackets deleted:

AUDITOR'S CONFIRMATION OF CHIEF FINANCIAL OFFICER'S LETTER

We have examined the financial statements of [self-guarantor's name] for the year ended [insert date], and have issued our report thereon dated [date]. Our examination was made in accordance with generally accepted auditing standards and, accordingly, included such tests of the accounting records and such other auditing procedures as we considered necessary. [Self-guarantor's name] has prepared documents to demonstrate its financial responsibility under the Illinois Emergency Management Agency's financial assurance regulations, 32 Ill. Adm. Code 326. This letter is furnished to assist the licensee [insert IEMA license number and name] in complying with these regulations and should not be used for other purposes.

The attached schedule reconciles the specified information furnished in the chief financial officer's (CFO's) letter with the company's financial statements. In connection therewith, we have:

1. Confirmed that the amounts in the column "Per Financial Statements" agree with amounts contained in the licensee's financial statements for the year ended [date];

2. Confirmed that the amounts in the column "Per CFO's Letter" agree with the amounts in the chief financial officer's letter;

3. Confirmed that the amounts in the column "Reconciling Items" are adequately explained in the attached schedule, that each reconciling item represents an appropriate adjustment to the financial data, and that the amount of each reconciling item is accurate; and

4. Recomputed the totals and percentages.

Because the procedures in paragraphs (1)-(4) above do not constitute a full examination made in accordance with generally accepted auditing standards, we do not express an opinion on the manner in which the amounts were derived in the items referred to above. In connection with the procedures referred to above, no matters came to our attention that cause us to believe that the chief financial officer's letter and supporting information should be adjusted.

Signature

Date

AUDITOR'S SCHEDULE RECONCILING AMOUNTS IN CFO'S LETTER

[Name of self-guarantor]

Year ended [date]

Line # in CFO'S Letter

Per Financial Statements

Reconciling Items

Per CFO's Letter

6

Total current liabilities

X

Long-term debt

X

Deferred income taxes

X

XX

Accrued decommissioning cost included in current liabilities

X

Total liabilities (less accrued decommissioning cost)

X

4

Net worth

XX

Less: Cost in excess of value of tangible assets acquired

X

XX

Accrued decommissioning costs included in current liabilities

X

Tangible net worth (plus decommissioning costs)

XX

(Balance of schedule is not illustrated.)

AGENCY NOTE: This illustrates the form of schedule that is contemplated. Details and reconciling items will differ in specific situations.

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

32 Ill. Adm. Code 326.APPENDIX F Wording for Parent Company Guarantee Documents

a) A parent company guarantee, as specified in 32 Ill. Adm. Code 326.150, shall contain letters from the chief executive officer and the chief financial officer containing the following provisions, except that instructions in brackets are to be replaced with the relevant information and the brackets deleted:

CHIEF EXECUTIVE OFFICER

I am the [chief executive officer or equivalent] of [name and address of firm], a [insert "proprietorship", "partnership", or "corporation"]. This letter is in support of this firm's use of the financial test to demonstrate financial assurance, as specified in 32 Ill. Adm. Code 326.

I hereby certify that [name of firm] is currently a going concern, and that it possesses positive tangible net worth in the amount of $________.

This firm [insert "is required" or "is not required"] to file a Form 10K with the U.S. Securities and Exchange Commission for the latest fiscal year. The fiscal year of this firm ends on [month, day].

I hereby certify that the content of this letter is true and correct to the best of my knowledge.

[Signature]

[Below the signature, type or print that person's name and title]

[Date]

CHIEF FINANCIAL OFFICER

I am the [chief financial officer or equivalent] of [name and address of firm], a [insert "proprietorship", "partnership", or "corporation"]. This letter is in support of this firm's use of the financial test to demonstrate financial assurance, as specified in 32 Ill. Adm. Code 326.

[Complete the following paragraph regarding facility(ies) and associated cost estimates or amounts specified in 32 Ill. Adm. Code 326.70. For each facility, include its license number, name, address and current cost estimates for the specified activities.]

This firm guarantees, through the parent company guarantee submitted to demonstrate compliance under 32 Ill. Adm. Code 326, the reclamation of the following facility(ies) owned or operated by subsidiary(ies) of this firm. The current cost estimates or amounts specified in 32 Ill. Adm. Code 326.70, so guaranteed, are shown for each facility:

Name of Facility

Location of Facility

Cost Estimate or 326.70 Amounts

This firm [insert "is required" or "is not required"] to file a Form 10K with the U.S. Securities and Exchange Commission for the latest fiscal year.

The fiscal year of this firm ends on [month, day]. The figures for the financial test required by 32 Ill. Adm. Code 326.160 are derived from this firm's independently audited, year-end financial statements and footnotes for the latest completed fiscal year, ended [date].

[Insert completed financial test from subsection (c) of this Appendix F.]

I hereby certify that the content of this letter is true and correct to the best of my knowledge.

[Signature]

[Below the signature, type or print that person's name and title]

[Date]

b) A parent company guarantee, as specified in 32 Ill. Adm. Code 326.150, shall contain the following provisions, except that instructions in brackets are to be replaced with the relevant information and the brackets deleted:

PARENT COMPANY GUARANTEE

Guarantee made this [date] by [name of guaranteeing entity], a [insert "proprietorship," "partnership," or "corporation"] organized under the laws of the State of [insert name of state], herein referred to as "guarantor," to the Illinois Emergency Management Agency (hereinafter called the Agency), on behalf of our subsidiary [licensee] of [business address].

Recitals

1. The guarantor has full authority and capacity to enter into this guarantee [if guarantor is a corporation, add the following phrase "under its bylaws, articles of incorporation, and the laws of the State of [insert licensee's state of incorporation], its state of incorporation."]. [If the guarantor has a Board of Directors, insert the following: "Guarantor has approval from its Board of Directors to enter into this guarantee."]

2. This guarantee is being issued to comply with regulations issued by the Agency, pursuant to the Radiation Protection Act of 1990. The Agency has promulgated regulations in 32 Ill. Adm. Code 326 that require that general or specific licensees provide assurance that funds will be available when needed for reclamation activities.

3. The guarantee is issued to provide financial assurance for reclamation activities for [identify licensed facility(ies)] as required by 32 Ill. Adm. Code 326. The reclamation costs are as follows: [insert the current cost estimates or amounts specified in 32 Ill. Adm. Code 326.70 guaranteed for each identified facility].

4. The guarantor meets or exceeds the financial test criteria specified in 32 Ill. Adm. Code 326.160 and agrees to comply with all notification requirements as specified in 32 Ill. Adm. Code 326.

5. The guarantor has majority control of the voting stock for the following licensee(s) covered by this guarantee. [For each facility, include its license number, name, address and current cost estimates for the specified activities.]

6. Reclamation activities as used in this Appendix F refers to the activities required by 32 Ill. Adm. Code 330 for reclamation of facility(ies) identified in this Appendix.

7. For value received from [licensee], [if the guarantor is a corporation, add "and pursuant to the authority conferred upon the guarantor by ["the unanimous resolution of its directors" or "the majority vote of its shareholders"], a certified copy of which is attached,"] the guarantor guarantees to the Agency that if the licensee fails to perform the required reclamation activities as required by 32 Ill. Adm. Code 330, the guarantor shall:

A) Carry out the required reclamation activities; or

B) Upon written notification from the Agency, pay the reclamation cost amount guaranteed for the facility(ies) to the Agency as directed by the Director.

8. The guarantor agrees to submit revised financial statements, financial test data and an auditor's special report and reconciling schedule annually within 90 days after the close of the parent guarantor's fiscal year.

9. The guarantor agrees that if, at the end of any fiscal year before termination of this guarantee, it fails to meet the financial test criteria, the licensee shall send within 90 days after the end of the fiscal year, by certified mail, return receipt requested, notice to the Agency that the licensee intends to provide alternative financial assurance as specified in 32 Ill. Adm. Code 326.170. Within 120 days after the end of the fiscal year, the guarantor shall establish such financial assurance if [the licensee] has not done so.

10. The guarantor agrees to notify the Agency promptly if the ownership of the licensee or parent firm is transferred and to maintain this guarantee until the new parent firm or the licensee provides alternative financial assurance acceptable to the Agency.

11. The guarantor agrees that, within 30 days after it determines that it no longer meets the financial test criteria or it is disallowed from continuing as a guarantor for [the licensee], it shall establish an alternative financial assurance as specified in 32 Ill. Adm. Code 326.170 as applicable, in the name of [licensee] unless [licensee] had done so.

12. The guarantor as well as its successors and assigns shall remain bound jointly and severally under this guarantee notwithstanding any or all of the following: amendment or modification of the license or Agency-approved reclamation funding plan for that facility, the extension or reduction of the time of performance of required activities, or any other modification or alteration of an obligation of the licensee pursuant to 32 Ill. Adm. Code 326.

13. The guarantor agrees that all bound parties shall be jointly and severally liable for all litigation costs incurred by the Agency in any successful effort to enforce the agreement against the guarantor.

14. The guarantor shall remain bound under this guarantee for as long as [licensee] must comply with the applicable financial assurance requirements of 32 Ill. Adm. Code 326 for the previously listed facility(ies), except that the guarantor may cancel this guarantee by meeting the requirements of 32 Ill. Adm. Code 326.170.

15. The guarantor agrees that if [licensee] fails to provide alternative financial assurance as specified in 32 Ill. Adm. Code 326.170, the guarantor shall provide such alternative financial assurance in the name of [licensee] or make full payment under this guarantee.

16. If the guarantor files financial reports with the U.S. Securities and Exchange Commission, then it shall promptly submit them to the Department during each year in which this guarantee is in effect.

I hereby certify that the content of this guarantee is true and correct to the best of my knowledge.

Effective date: ____________________

[Name of guarantor]

[Signature of chief executive officer or equivalent]

[Below the signature, type or print that person's name and title]

Signature of witness or notary: _____________________

c) Financial test documentation for parent company guarantee (Complete either Alternative 1 or Alternative 2):

Alternative 1

1. Current reclaiming and decommissioning cost estimates or certified amounts

A)

Current reclaiming cost estimate or certified amount for all decommissioning activities covered by this parent company guarantee

$

B)

Total reclaiming cost estimates or certified amounts for all decommissioning activities covered by other NRC or Agreement State guarantees, parent company guarantees or self-guarantees

$

C)

Total amounts for all decommissioning activities under parent company guarantees, self-guarantees and commitments to other regulatory agencies (e.g., USEPA)

$

Total for line 1

$

Total liabilities (if any portion of the cost estimates for reclaiming or decommissioning is included in total liabilities on your firm's financial statements, you may deduct the amount of that portion from this line and add that amount to lines 3 and 4)

$

Tangible net worth**

$

Net worth

$

Current assets

$

Current liabilities

$

Net working capital (line 5 minus line 6)

$

The sum of net income plus depreciation, depletion and amortization

$

Total assets in United States (required only if less than 90 percent of firm's assets are located in the United States)

$

Yes

No

Is line 3 at least $10 million?

Is line 3 at least 6 times line 1?

Is line 7 at least 6 times line 1?

Are at least 90 percent of the firm's assets located in the United States? If not, complete line 14

Is line 9 at least 6 times line 1?

Guarantor shall meet two of the following three ratios:

Is line 2 divided by line 4 less than 2.0?

Is line 8 divided by line 2 greater than 0.1?

Is line 5 divided by line 6 greater than 1.5?

• Denotes figures derived from financial statements.

** Tangible net worth is defined as net worth minus goodwill, patents, trademarks and copyrights.

Alternative 2

1. Current reclaiming and decommissioning cost estimates or certified amounts

A)

Current reclaiming cost estimate or certified amount for all decommissioning activities covered by this parent company guarantee

$

B)

Total reclaiming cost estimates or certified amounts for all decommissioning activities covered by other NRC or Agreement State guarantees, parent company guarantees or self-guarantees

$

C)

Total amounts for all decommissioning activities under parent company guarantees, self-guarantees and commitments to other regulatory agencies (e.g., USEPA)

$

Total for line 1

$

2. Current bond rating of most recent unsecured, uncollateralized and unencumbered issuance of this firm

Rating

Name of rating service

Date of issuance of bond

Date of maturity of bond

Tangible net worth** (if any portion of estimates for reclaiming or decommissioning is included in total liabilities on your firm's financial statements, you may add the amount of that portion to this line)

$

Total assets in United States (required only if less than 90 percent of firm's assets are located in the United States)

$

Yes

No

Is line 5 at least $10 million?

Is line 5 at least 6 times line 1?

Are at least 90 percent of the firm's assets located in the United States? If not, complete line 10

Is line 6 at least 6 times line 1?

Is the rating specified on line 2 BBB or better (if issued by Standard & Poor's) or Baa or better (if issued by Moody's)?

• Denotes figures derived from financial statements.

** Tangible net worth is defined as net worth minus goodwill, patents, trademarks and copyrights.

d) A parent company guarantee, as specified in 32 Ill. Adm. Code 326.150, shall include submission of an auditor's special report containing the following provisions, except that instructions in brackets are to be replaced with the relevant information and the brackets deleted:

AUDITOR'S CONFIRMATION OF CHIEF FINANCIAL OFFICER'S LETTER

We have examined the financial statements of [name of parent guarantor] ("Company") for the year ended [insert date], and have issued our report thereon dated [date]. Our examination was made in accordance with generally accepted auditing standards and, accordingly, included such tests of the accounting records and such other auditing procedures as we considered necessary.

The Company has prepared documents to demonstrate its financial responsibility under the Illinois Emergency Management Agency's financial assurance regulations, 32 Ill. Adm. Code 326. This letter is furnished to assist the licensee [insert Agency license number and name] in complying with these regulations and should not be used for other purposes.

The attached schedule reconciles the specified information furnished in the chief financial officer's (CFO's) letter with the company's financial statements. In connection therewith, we have:

1. Confirmed that the amounts in the column "Per Financial Statements" agree with amounts contained in the company's financial statements for the year ended [date];

2. Confirmed that the amounts in the column "Per CFO's Letter" agree with the amounts in the chief financial officer's letter;

3. Confirmed that the amounts in the column "Reconciling Items" are adequately explained in the attached schedule, that each reconciling item represents an appropriate adjustment to the financial data, and that the amount of each reconciling item is accurate; and

4. Recomputed the totals and percentages. Because the procedures in paragraphs (1)-(4) above do not constitute a full examination made in accordance with generally accepted auditing standards, we do not express an opinion on the manner in which the amounts were derived in the items referred to above. In connection with the procedures referred to above, no matters came to our attention that cause us to believe that the chief financial officer's letter and supporting information should be adjusted.

Signature

Date

AUDITOR'S SCHEDULE RECONCILING AMOUNTS IN CFO'S LETTER

[COMPANY]

Year ended [date]

Line # in CFO's Letter

Per Financial Statements

Reconciling Items

Per CFO's Letter

6

Total current liabilities

X

Long-term debt

X

Deferred income taxes

X

XX

Accrued decommissioning costs included in current liabilities

X

Total liabilities (less accrued decommissioning costs)

X

4

Net worth

XX

Less: Cost in excess of value of tangible assets acquired

X

XX

Accrued decommissioning costs Included in current liabilities

X

Tangible net worth (plus decommissioning costs)

XX

(Balance of schedule is not illustrated.)

AGENCY NOTE: This illustrates the form of schedule that is contemplated. Details and reconciling items will differ in specific situations.

History

• Source: Amended at 29 Ill. Reg. 20781, effective December 16, 2005

Part 330 Licensing of Radioactive Material

32 Ill. Adm. Code 330.10 Purpose and Scope

a) This Part provides for the licensing of radioactive material. No person shall receive, possess, use, manufacture, distribute, transfer, own or acquire radioactive material or devices or equipment utilizing or producing such materials except as authorized in a specific or general license issued pursuant to this Part or as otherwise provided in 32 Ill. Adm. Code: Chapter II, Subchapters b and d. These requirements provide for the protection of health, safety and the environment.

b) The requirements of this Part are in addition to, and not in substitution for, others in 32 Ill. Adm. Code: Chapter II, Subchapters b and d. Additional specific requirements for certain types of licenses are found in different Parts of 32 Ill. Adm. Code.

History

• Source: Amended at 24 Ill. Reg. 8042, effective June 1, 2000

32 Ill. Adm. Code 330.15 Incorporations by Reference

All rules, standards and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified in the reference and do not include any later amendments or editions. Copies of these rules, standards and guidelines that have been incorporated by reference are available for public inspection and copying at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois.

History

• Source: Amended at 30 Ill. Reg. 8928, effective April 28, 2006

32 Ill. Adm. Code 330.20 Definitions

"Associate Radiation Safety Officer" means an individual, who for this Part only:

Meets the requirements in Sections 330.260(c)(17) and (c)(21); and

Is currently identified as an Associate Radiation Safety Officer for the types of use of radioactive material for which the individual has been assigned duties and tasks by the Radiation Safety Officer on a specific license that authorizes medical use or the practice of nuclear pharmacy issued by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State; or a permit that authorizes medical use or the practice of nuclear pharmacy issued by a U.S. Nuclear Regulatory Commission master material licensee.

"Authorized nuclear pharmacist" means a pharmacist who:

Meets the requirements in Section 330.260(c)(18)(A) and (21); or

Is identified as an authorized nuclear pharmacist on:

A specific license issued by the Nuclear Regulatory Commission or Agreement State that authorizes medical use or the practice of nuclear pharmacy; or

A permit issued by a Nuclear Regulatory Commission master material licensee that authorizes medical use or the practice of nuclear pharmacy; or

A permit issued by a Nuclear Regulatory Commission or Agreement State broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

A permit issued by a Nuclear Regulatory Commission master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or

Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or

Is designated as an authorized nuclear pharmacist in accordance with Section 330.260(c)(16).

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

"General license" means a license, as set forth in this Part and 32 Ill. Adm. Code 341, which is effective without the filing of an application to transfer, acquire, own, possess or use quantities of, or devices or equipment utilizing, radioactive material [420 ILCS 40/4(d)], although the filing of a certificate with the Agency may be required by the particular general license. The general licensee is subject to all other applicable portions of 32 Ill. Adm. Code: Chapter II and any limitations of the general license.

"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 F. 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 is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.

"Preceptor" means an individual who provides, directs or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, a Radiation Safety Officer, or an Associate Radiation Safety Officer.

"Protective actions" means actions taken by members of the public to protect themselves from radiation from an incident involving radioactive material, which may include sheltering, evacuation, relocation, control of access, administration of radiation-protective drugs, decontamination of persons, decontamination of land or property, or control of food or water.

"Specific license" means a license, issued after application, to use, manufacture, produce, transfer, receive, acquire, own, or possess quantities of, or devices or equipment utilizing, radioactive materials [420 ILCS 40/4(m)]. The licensee is subject to all applicable portions of 32 Ill. Adm. Code: Chapter II, as well as any limitations specified in the licensing document.

History

• Source: Amended at 48 Ill. Reg. 13634, effective August 29, 2024

32 Ill. Adm. Code 330.30 License Exemption - Source Material

a) Any person is exempt from this Part 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 one-twentieth of one percent (0.05 percent) of the mixture, compound, solution or alloy.

b) Any person is exempt from this Part to the extent that the person receives, possesses, uses or transfers unrefined and unprocessed ore containing source material; provided that, except as authorized in a specific license, the person shall not refine or process that ore.

c) Any person is exempt from the requirements for a license set forth in section 62 of the Atomic Energy Act of 1954, as amended, this Part and 32 Ill. Adm. Code 340 and 400 to the extent that the person receives, possesses, uses or transfers:

1. Any quantities of thorium contained in:

A) Incandescent gas mantles;

B) Vacuum tubes;

C) Welding rods;

D) Electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium;

E) Germicidal lamps, sunlamps and lamps for outdoor or industrial lighting provided that each lamp does not contain more than 2 grams of thorium;

F) Rare earth metals and compounds, mixtures and products containing not more than 0.25 percent by weight thorium, uranium or any combination of these; or

G) Personnel neutron dosimeters, provided that each dosimeter does not contain more than 50 milligrams of thorium.

2. Source material contained in the following products:

A) Glazed ceramic tableware, manufactured before August 27, 2016, provided that the glaze contains not more than 20 percent by weight source material;

B) Piezoelectric ceramic containing not more than two percent by weight source material;

C) Glassware containing not more than two percent by weight source material or, for glassware manufactured before August 27, 2016, not more than ten percent by weight source material, but not including commercially manufactured glass brick, pane glass, ceramic tile or other glass or ceramic used in construction; and

D) Glass enamel or glass enamel frit containing not more than ten percent by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before July 25, 1983.

3. Photographic film, negatives and prints containing uranium or thorium.

4. Any finished product or part fabricated of, or containing, tungsten-thorium or magnesium-thorium alloys, provided that the thorium content of the alloy does not exceed four percent by weight and that this exemption shall not be deemed to authorize the chemical, physical or metallurgical treatment or processing of the product or part.

5. Uranium contained in counterweights installed in aircraft, rockets, projectiles and missiles, or stored or handled in connection with installation or removal of those counterweights, provided that:

A) Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM";

AGENCY NOTE: The requirement specified in subsection (c)(5)(B) does not need to be met by counterweights manufactured prior to December 31, 1969; provided that the counterweights were manufactured under a specific license issued by the Atomic Energy Commission and were impressed with the legend, "CAUTION − RADIOACTIVE MATERIAL − URANIUM", as previously required by 10 CFR 40.13(c)(5)(ii), as in effect on June 30, 1969, exclusive of subsequent amendments or editions.

B) Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED"; and

AGENCY NOTE: The requirement specified in subsections (c)(5)(A) and (B) do not need to be met by counterweights manufactured prior to December 31, 1969; provided that the counterweights were manufactured under a specific license issued by the Atomic Energy Commission and were impressed with the legend, "CAUTION − RADIOACTIVE MATERIAL − URANIUM", as previously required by 10 CFR 40.13(c)(5)(ii), as in effect on June 30, 1969, exclusive of subsequent amendments or editions.

C) This exemption shall not be deemed to authorize the chemical, physical or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or covering.

6. Natural or depleted uranium metal used as shielding constituting part of any shipping container, provided that:

A) The shipping container is conspicuously and legibly impressed with the legend, "CAUTION − RADIOACTIVE SHIELDING − URANIUM"; and

B) The uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of 3.2 millimeters (⅛ inch).

7. Thorium or uranium contained in or on finished optical lenses and mirrors, provided that each lens or mirror does not contain more than ten percent by weight thorium or uranium or, for lenses manufactured before August 27, 2016, 30 percent by weight of thorium and that this exemption shall not be deemed to authorize either:

A) The shaping, grinding or polishing of the lens or mirror or manufacturing processes other than the assembly of the lens or mirror into optical systems and devices without any alteration of the lens or mirror; or

B) The receipt, possession, use or transfer of uranium or thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or other optical instruments.

8. Thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that:

A) The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide); and

B) The thorium content in the nickel-thoria alloy does not exceed four percent by weight.

9. No person may initially transfer for sale or distribution a product containing source material to persons exempt under this subsection (c) unless authorized by an NRC license issued under 10 CFR 40.52 to initially transfer such products for sale or distribution.

A) Persons initially distributing source material in products covered by the exemptions in subsection (c) before August 27, 2016 without specific authorization may continue distribution for one year beyond this date. Initial distribution may also be continued until NRC takes final action on a pending application for license or license amendment to specifically authorize distribution submitted no later than one year beyond this date.

B) Persons authorized to manufacture, process or produce these materials or products containing source material under a specific license issued by the Agency and persons who import finished products or parts, for sale or distribution, must be authorized by an NRC license issued under 10 CFR 40.52 for distribution only and are exempt from the requirements of 10 CFR 19, 20 and 40.32(b) and (c).

d) The exemptions in subsection (c) do not authorize the manufacture of any of the products described.

e) Any licensee is exempt from the requirements of this Part to the extent that its activities are subject to the requirements of 32 Ill. Adm. Code 601, except as specifically provided for in 32 Ill. Adm. Code 601.

History

• Source: Amended at 40 Ill. Reg. 12971, effective August 25, 2016

32 Ill. Adm. Code 330.40 License Exemption - Radioactive Materials Other Than Source Material

a) Exempt Concentrations

1. Any person is exempt from this Part to the extent that person receives, possesses, uses, transfers, owns or acquires products containing radioactive material introduced in concentrations not in excess of those listed in Appendix A provided they have been introduced or transferred as described in subsection (a)(2) or (3). This Section shall not be deemed to authorize the import of radioactive materials or products containing radioactive materials.

2. 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 subsection (a)(1) or equivalent regulations of the U.S. Nuclear Regulatory Commission (NRC) (10 CFR 30.14) or an Agreement State, except in accordance with a specific license issued pursuant to Section 330.280(a).

3. A manufacturer, processor or producer of a product or material is exempt from the requirements for a license set forth in this Part to the extent that person transfers radioactive material contained in a product or material in concentrations not in excess of those specified in Appendix A and introduced into the product or material by a licensee holding a specific license issued by the Agency expressly authorizing that 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.

b) Exempt Quantities

1. Except as restricted by subsections (b)(2) through (4), any person is exempt from this Part to the extent that 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 Appendix B. Furthermore, any person is exempt from this Part to the extent that person possesses, uses, transfers or owns radioactive material that was received or acquired before September 25, 1971 under the general license then provided by the regulations of the U.S. Atomic Energy Commission (10 CFR 31.4) or the equivalent regulations of an Agreement State.

AGENCY NOTE: Capsules distributed pursuant to 10 CFR 32.21 that contain carbon-14 urea are only authorized for "in-vivo" diagnostic use for humans. Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license from the Agency. Nothing in this Section relieves persons from complying with applicable federal and State requirements governing receipt, administration and use of drugs.

2. This subsection (b) does not authorize the production, packaging or repackaging of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution.

3. No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in Appendix B, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under this subsection (b) or equivalent regulations of NRC or an Agreement State, except in accordance with a specific license issued by NRC pursuant to 10 CFR 32.18 or 32.21, or by the Agency pursuant to Section 330.280(b), which states that the radioactive material may be transferred by the licensee to persons exempt under this subsection (b) or the equivalent regulations of the NRC or an Agreement State.

4. No person shall, for purposes of producing an increased radiation level, combine quantities of radioactive material covered by the exemption in subsection (b)(1) so that the aggregate quantity exceeds the limits set forth in Appendix B, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by this Part.

AGENCY NOTE: Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington DC 20555.

c) Exempt Items

1. Certain Items Containing Radioactive Material. Except for persons who apply radioactive material to, or persons who incorporate radioactive material into, the following products or persons who initially transfer for sale or distribution the following products, any person is exempt from this Part to the extent that the person receives, possesses, uses, transfers, owns or acquires the following products:

AGENCY NOTE: Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington DC 20555.

A) 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:

i) 925 MBq (25 mCi) of tritium per timepiece;

ii) 185 MBq (5 mCi) of tritium per hand;

iii) 555 MBq (15 mCi) of tritium per dial (bezels when used shall be considered as part of the dial);

iv) 3.7 MBq (100 microCi) of promethium-147 per watch or 7.4 MBq (200 microCi) of promethium-147 per any other timepiece;

v) 740 kBq (20 microCi) of promethium-147 per watch hand or 1.48 MBq (40 microCi) of promethium-147 per other timepiece hand;

vi) 2.22 MBq (60 microCi) of promethium-147 per watch dial or 4.44 MBq (120 microCi) of promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial);

vii) The radiation dose rate from hands and dials containing promethium-147 will not exceed, when measured through 50 milligrams/square centimeter of absorber: for wrist watches, 1 microGy (100 microrad)/hour at 10 centimeters from any surface; for pocket watches, 1 microGy (100 microrad)/hour at 1 centimeter from any surface; for any other timepiece, 2 microGy (200 microrad)/hour at 10 centimeters from any surface; or

viii) 37 kBq (1 microCi) of radium-226 per timepiece in intact timepieces manufactured prior to November 30, 2007.

B) Precision balances containing not more than 37 MBq (1 mCi) of tritium per balance or not more than 18.5 MBq (500 microCi) of tritium per balance part manufactured before December 17, 2007.

C) Marine compasses containing not more than 27.8 GBq (750 mCi) of tritium gas and other marine navigational instruments containing not more than 9.25 GBq (250 mCi) of tritium gas manufactured before December 17, 2007.

D) Electron tubes; provided that:

i) Each tube does not contain more than one of the following specified quantities of radioactive material:

• 5.55 GBq (150 mCi) of tritium per microwave receiver protector tube or 370 MBq (10 mCi) of tritium per any other electron tube;

• 37 kBq (1 microCi) of cobalt-60;

• 185 kBq (5 microCi) of nickel-63;

• 1.11 MBq (30 microCi) of krypton-85;

• 185 kBq (5 microCi) of cesium-137; or

• 1.11 MBq (30 microCi) of promethium-147; and

ii) The radiation dose rate from each electron tube containing radioactive material will not exceed 10 microGy (1 mrad)/hour at 1 centimeter from any surface when measured through 7 milligrams/square centimeter of absorber.

AGENCY NOTE: For purposes of subsection (c)(1)(D), "electron tubes" include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes and any other completely sealed tube that is designed to conduct or control electrical currents.

E) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that:

i) Each source contains no more than one exempt quantity set forth in Appendix B; and

ii) Each instrument contains no more than 10 exempt quantities. For purposes of this requirement, an instrument's sources may contain one or more radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in Appendix B, provided that the sum of the fractions shall not exceed unity.

AGENCY NOTE: For purposes of subsection (c)(1)(E), 1.85 kBq (50 nCi) of americium-241 is considered an exempt quantity.

F) Ionization chamber smoke detectors containing not more than 37 kBq (1 microCi) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.

G) Static elimination devices designed for use as static eliminators that contain, as a sealed source or sources, radioactive material consisting of a total of not more than 18.5 MBq (500 microCi) of polonium-210 per device.

H) Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, byproduct material consisting of a total of not more than 18.5 MBq (500 μCi) of polonium-210 per device or of a total of not more than 1.85 GBq (50 mCi) of hydrogen-3 (tritium) per device.

I) Devices described in subsections (c)(1)(G) and (H) authorized before October 23, 2015 for use under the general license then provided in Section 330.220(a) and manufactured, tested and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the Agency or the equivalent regulations of NRC or of an Agreement State.

2. Self-Luminous Products Containing Radioactive Material

A) Tritium, Krypton-85 or Promethium-147. Except for persons who manufacture, process or produce self-luminous products containing tritium, krypton-85 or promethium-147, any person is exempt from this Part to the extent that person receives, possesses, uses, transfers, owns or acquires tritium, krypton-85 or promethium-147 in self-luminous products manufactured, processed, produced, imported or transferred in accordance with a specific license, issued by NRC pursuant to 10 CFR 32.22, which authorizes the transfer of the product to persons who are exempt from regulatory requirements. The exemption in this subsection (c)(2)(A) does not apply to tritium, krypton-85 or promethium-147 used in products for frivolous purposes or in toys or adornments. NRC shall make this determination of exemption.

B) Any person who desires to manufacture, process, produce or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85 or promethium-147 for use under subsection (c)(2)(A) should apply for a license under 10 CFR 32.22 and for a certificate of registration pursuant to 10 CFR 32.210 with NRC.

C) Radium-226. Any person is exempt from this Part to the extent that person receives, possesses, uses, transfers or owns articles containing less than 3.7 kBq (100 nCi) of radium-226 that were acquired prior to May 1, 1974.

3. Gas and Aerosol Detectors Containing Radioactive Material

A) Except for persons who manufacture, process, produce or initially transfer for sale and distribution gas and aerosol detectors containing radioactive material, any person is exempt from 32 Ill. Adm. Code: Chapter II, Subchapters b and d to the extent that person receives, possesses, uses, transfers, owns or acquires radioactive material in gas and aerosol detectors designed to protect life or property from fires and airborne hazards. The detectors shall be manufactured, processed, produced or initially transferred in accordance with a specific license issued by NRC pursuant to 10 CFR 32.26 that authorizes transfer of the detectors to persons who are exempt from regulatory requirements and who have been issued a certificate of registration in accordance with 10 CFR 32.210 from NRC.

B) Gas and aerosol detectors previously manufactured and distributed to general licensees in accordance with a specific license issued by an Agreement State or a former Licensing State shall be considered exempt under subsection (c)(3)(A), provided that the device is labeled in accordance with the specific license and provided further that it meets the requirements of 10 CFR 32.26 in effect at the time of distribution. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007, in accordance with a specific license issued by an Agreement State under comparable provisions to 10 CFR 32.26 authorizing distribution to persons exempt from regulatory requirements.

4. Certain Industrial Devices

A) Except for persons who manufacture, process, produce or initially transfer for sale or distribution industrial devices containing byproduct material designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage or qualitative or quantitative chemical composition, or for producing an ionized atmosphere, any person is exempt from the requirements for a license set forth in Section 81 of the Act and from 32 Ill. Adm. Code: Chapter II, Subchapters b and d to the extent that person receives, possesses, uses, transfers, owns or acquires byproduct material, in these certain detecting, measuring, gauging or controlling devices and certain devices for producing an ionized atmosphere, and manufactured, processed, produced or initially transferred in accordance with a specific license issued under 10 CFR 32.30, which license authorized the initial transfer of the device for use under this Section. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.

B) Any person who desires to manufacture, process, produce or initially transfer for sale or distribution industrial devices containing byproduct material for use under subsection (c)(4)(A), should apply for a license under 10 CFR 32.30 and for a certificate of registration in accordance with 10 CFR 32.210.

AGENCY NOTE: Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington DC 20555.

History

• Source: Amended at 49 Ill. Reg. 1196, effective January 8, 2025

32 Ill. Adm. Code 330.200 Types of Licenses

Licenses for radioactive materials are of two types: general and specific.

History

• Source: Amended at 30 Ill. Reg. 8928, effective April 28, 2006

Chapter II Illinois Emergency Management Agency and Office of Homeland Security

Subchapter b Radiation Protection

Part 330 Licensing of Radioactive Material

32 Ill. Adm. Code 330.210 General Licenses – Source Material

a) A general license is hereby issued authorizing commercial and industrial firms; research, educational and medical institutions; and federal, State and local government agencies to receive, possess, use and transfer uranium and thorium, in their natural isotopic concentrations and in the form of depleted uranium, for research, development, educational, commercial or operational purposes in the following forms and quantities:

1. No more than 1.5 kilograms (3.3 pounds) of uranium and thorium in dispersible forms (e.g., gaseous, liquid, powder, etc.) at any one time. Any material processed by the general licensee that alters the chemical or physical form of the material containing source material must be accounted for as a dispersible form. A person authorized to possess, use and transfer source material under this subsection (a) may not receive more than a total of 7 kilograms (15.4 pounds) of uranium and thorium in any one calendar year. Persons possessing source material in excess of these limits as of August 27, 2016, may continue to possess up to 7 kilograms (15.4 pounds) of uranium and thorium at any one time for one year beyond this date, or until the Agency takes final action on a pending application submitted on or before August 27, 2017, for a specific license for that material and may receive up to 70 kilograms (154 pounds) of uranium or thorium in any one calendar year until December 31, 2017, or until the Agency takes final action on a pending application submitted on or before August 27, 2017, for a specific license for that material; and

2. No more than:

A) a total of 7 kilograms (15.4 pounds) of uranium and thorium at any one time. A person authorized to possess, use and transfer source material under this subsection (a)(2)(A) may not receive more than a total of 70 kilograms (154 pounds) of uranium and thorium in any one calendar year. A person may not alter the chemical or physical form of the source material possessed under this subsection (a)(2)(A) unless it is accounted for under the limits of subsection (a)(1); or

B) 7 kilograms (15.4 pounds) of uranium, removed during the treatment of drinking water, at any one time. A person may not remove more than 70 kilograms (154 pounds) of uranium from drinking water during a calendar year under this subsection (a)(2)(B); or

C) 7 kilograms (15.4 pounds) of uranium and thorium at laboratories for the purpose of determining the concentration of uranium and thorium contained within the material being analyzed at any one time. A person authorized to possess, use and transfer source material under this subsection (a)(2)(C) may not receive more than a total of 70 kilograms (154 pounds) of source material in any one calendar year.

b) Any person who receives, possesses, uses or transfers source material in accordance with the general license in subsection (a):

1. Is prohibited from administering source material, or the radiation therefrom, either externally or internally, to human beings, except as may be authorized by the Agency in a specific license;

2. Shall not abandon such source material. Source material may be disposed of as follows:

A) A cumulative total of 0.5 kilograms (1.1 pounds) of source material in a solid, nondispersible form may be transferred each calendar year, by a person authorized to receive, possess, use and transfer source material under the general license to persons receiving the material for permanent disposal. The recipient of source material transferred under the provisions of this subsection (b)(2)(A) is exempt from the requirement to obtain a license under this Part 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 this Subchapter b; or

B) In accordance with 32 Ill. Adm. Code 340.1010;

3. Is subject to the provisions in 32 Ill. Adm. Code 310, 330.310(a) through (c), 330.400, 330.500 and 340.1220(a) through (d);

4. Shall respond to written requests from the Agency to provide information relating to the general license within 30 calendar days after the date of the request, or other time specified in the request. If the person cannot provide the requested information within the allotted time, the person shall, within that same time period, request a longer period to supply the information by providing the Agency a written justification for the request; and

5. Shall not export such source material except in accordance with 10 CFR 110.

c) Any person who receives, possesses, uses or transfers source material in accordance with subsection (a) shall conduct activities to minimize contamination of the facility and the environment. When activities involving the source material are permanently ceased at any site, if evidence of significant contamination is identified, the general licensee shall notify the Agency about such contamination and may consult with the Agency 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 Section 330.325(b)(1)(B)(ii).

d) Any person who receives, possesses, uses or transfers source material in accordance with the general license granted in subsection (a) is exempt from the provisions of 32 Ill. Adm. Code 340 and 400 to the extent that such receipt, possession, use and transfer are within the terms of this general license, except that person shall comply with the provisions of Section 330.325(b)(1)(B)(ii) and 32 Ill. Adm. Code 340.1010 to the extent necessary to meet the provisions of subsections (b)(2) and (c) of this Section. However, this exemption does not apply to any person who also holds a specific license issued under Subchapter b.

e) No person may initially transfer or distribute source material to persons generally licensed under subsection (a)(1) or (2) unless authorized by a specific license issued in accordance with Section 330.280(o). 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 subsection (a) before August 27, 2016, without specific authorization, may continue for one year beyond that date. Distribution may also be continued until the Agency takes final action on a pending application for license or license amendment to specifically authorize distribution submitted on or before August 27, 2017.

f) A general license is hereby issued authorizing the receipt of title to source material without regard to quantity. This general license does not authorize any person to receive, possess, use or transfer source material.

g) Depleted Uranium in Industrial Products and Devices

1. A general license is hereby issued to receive, acquire, possess, use or transfer, in accordance with this subsection (g), 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.

2. The general license in subsection (g)(1) applies only to industrial products or devices that have been manufactured either in accordance with a specific license issued to the manufacturer of the products or devices pursuant to Section 330.280(l) or in accordance with a specific license issued to the manufacturer by NRC or an Agreement State that authorizes manufacture of the products or devices for distribution to persons generally licensed by NRC or an Agreement State.

3. Persons who receive, acquire, possess or use depleted uranium pursuant to the general license established by subsection (g)(1) shall:

A) File the form "Registration Certificate − Use of Depleted Uranium Under General License," with the Agency. The form shall be submitted within 30 days after the first receipt or acquisition of depleted uranium. The registrant shall furnish the following information on the form:

i) Name and address of the registrant;

ii) A statement that the registrant has developed and will maintain procedures designed to establish physical control over the depleted uranium described in subsection (g)(1) and designed to prevent transfer of the depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and

iii) Name and/or title, address and telephone number of the individual duly authorized to act for and on behalf of the registrant in supervising the procedures identified in subsection (g)(3)(A)(ii).

B) Report in writing to the Agency any changes in information furnished by the registrant in the form. The report shall be submitted within 30 days after the effective date of the change.

4. A person who receives, acquires, possesses or uses depleted uranium pursuant to the general license established by subsection (g)(1):

A) Shall not introduce the depleted uranium, in any form, into a chemical, physical or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium;

B) Shall not abandon the depleted uranium;

C) Shall transfer or dispose of the depleted uranium only in accordance with Section 330.400. When the transferee receives the depleted uranium pursuant to the general license established by subsection (g)(1), the transferor shall furnish the transferee a copy of this Part and a copy of the form, "Registration Certificate – Use of Depleted Uranium Under General License". When the transferee receives the depleted uranium pursuant to a general license contained in NRC's regulation 10 CFR 40.25(a) or Agreement State's regulation equivalent to subsection (g)(1), the transferor shall furnish the transferee a copy of this Part and a copy of the form, accompanied by a note explaining that use of the product or device is regulated by NRC or an Agreement State under requirements substantially the same as those in this Part;

D) Within 30 days after any transfer, shall report in writing to the Agency the name and address of the person receiving the depleted uranium through that transfer; and

E) Shall not export the depleted uranium except in accordance with a license issued by NRC pursuant to 10 CFR 110.

5. Any person receiving, acquiring, possessing, using or transferring depleted uranium pursuant to the general license established by subsection (g)(1) is exempt from the requirements of 32 Ill. Adm. Code 340 and 400 with respect to the depleted uranium covered by that general license.

History

• Source: Amended at 40 Ill. Reg. 12971, effective August 25, 2016

32 Ill. Adm. Code 330.220 General Licenses - Radioactive Material Other Than Source Material

a) Certain Measuring, Gauging or Controlling Devices and Certain Devices for Producing Light or an Ionized Atmosphere

1. A general license is hereby 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 receive, acquire, possess, use or transfer, in accordance with the provisions of subsections (a)(2) through (9), 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.

2. The general license provided by subsection (a)(1) applies only to radioactive material contained in devices that have been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued by the Agency pursuant to Section 330.280(d) or in accordance with the specifications contained in an equivalent specific license issued by the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State that authorizes distribution of devices to persons generally licensed by NRC, an Agreement State or a former Licensing State. The devices shall have been received from a specific licensee described in this subsection (a)(2) or through a transfer made under subsection (a)(3)(L).

AGENCY NOTE: Regulations under the Federal Food, Drug and Cosmetic Act authorizing the use of radioactive control devices in food production require certain additional labeling that is found in 21 CFR 179.21.

3. Any person who receives, acquires, possesses, uses or transfers radioactive material in a device pursuant to the general license described in subsection (a)(1):

A) Shall assure that all labels affixed to the device at the time of receipt, and bearing a statement that removal of the label is prohibited, are maintained on the device and shall comply with all instructions and precautions provided by such labels;

B) Shall assure that the device is tested for leakage of, or contamination by, radioactive material and proper operation of the on-off mechanism and indicator, if any, at no longer than 6-month intervals or at such other intervals as are specified on the device labels; however:

i) A device containing only krypton need not be tested for leakage of, or contamination by, radioactive material; and

ii) A device containing only tritium or not more than 3.7 MBq (100 µCi) of other beta and/or gamma emitting material or 370 kBq (10 µCi) of alpha emitting material or a device held in storage in the original shipping container prior to initial installation need not be tested for any purpose;

C) Shall assure that the tests required by subsection (a)(3)(B) and other testing, installation, servicing and removal from installation involving the radioactive material, its shielding or containment is performed:

i) In accordance with the instructions provided by the labels; or

ii) By a person holding an applicable specific license from the Agency, NRC or an Agreement State to perform such activities;

D) Shall maintain records showing compliance with the requirements of subsections (a)(3)(B), (C), (H) and, as applicable, (a)(6)(B). The records shall show the results of tests. The records shall also show the dates of performance of, and the names of persons performing, physical inventories, testing, installation, servicing and removal from installation of radioactive material or its shielding or containment. Any person who receives, acquires, possesses, uses or transfers radioactive material in a device pursuant to the general license provided by subsection (a)(1) shall retain these records as follows:

i) A record of a test of an on-off mechanism and indicator or a test for leakage or contamination performed in accordance with subsection (a)(3)(B) shall be retained for 5 years after the next required test is performed or until the device is transferred or disposed of; and

ii) A record of testing, installation, servicing or removal from installation performed in accordance with subsection (a)(3)(C) shall be retained for 5 years from the date of the recorded event or until the device is transferred or disposed of; and

iii) A record of transfer or disposal of a device in accordance with subsection (a)(3)(H) shall be retained for 5 years from the date of the recorded event; and

AGENCY NOTE: Note that this record must be retained after transfer of the device.

iv) A record of a quarterly physical inventory, performed for those devices in storage and not in use in accordance with subsection (a)(6)(B), shall be retained for 5 years after the next required test is performed or until the device is transferred or disposed of;

E) Shall immediately suspend operation of the device if there is a failure of or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 185 Bq (5 nCi) or more removable radioactive material. The device shall not be operated until it has been repaired by the manufacturer or other person holding an applicable specific license from the Agency, NRC or an Agreement State to repair such devices. The device and any radioactive material from the device shall be disposed of only by transfer to a person authorized by an applicable specific license to receive the radioactive material in the device or as otherwise approved by the Agency. A report containing a brief description of the event and the remedial action taken shall be furnished to the Agency within 30 days. As applicable, the following shall also be furnished to the Agency:

i) A report within 5 days (as required by 32 Ill. Adm. Code 340.1260) if detection of 185 Bq (5 nCi) or more removable radioactive material indicates that a sealed source is leaking or contaminated; and

ii) A plan within 30 days for ensuring that the person's premises and environs are acceptable for unrestricted use if 185 Bq (5 nCi) or more removable radioactive material is detected on the device or failure of or damage to a source is likely to result in contamination of the premises or the environs;

F) Shall not abandon the device containing radioactive material;

G) Shall not export the device containing radioactive material except in accordance with 10 CFR 110, published at 73 Fed. Reg. 78615, December 23, 2008, exclusive of subsequent amendments or editions;

H) Shall transfer or dispose of the device containing radioactive material only:

i) By export as provided by subsection (a)(3)(G);

ii) By transfer to another general licensee as provided by subsection (a)(3)(L);

iii) By transfer to a person authorized to receive the device by a specific license issued by the Agency pursuant to Section 330.280(d) or an equivalent specific license issued by NRC or an Agreement State;

iv) By transfer to a person authorized to perform waste collection by a specific license issued by the Agency, NRC or an Agreement State; or

v) As approved under subsection (a)(3)(K);

I) Shall furnish a written report to the Agency within 30 days after transferring or disposing of the device containing radioactive material. The notification shall include:

i) The identification of the device by manufacturer's (or initial transferor's) name, model and serial number;

ii) The name, address and license number of the transferee (license number not applicable if exported);

iii) The date of the transfer;

iv) A receipt from the transferee showing the serial number of the device and the date that it was received (not applicable if exported);

J) Shall respond to written requests from the Agency 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 shall, within that same time period, request a longer period to supply the information to the Agency, by an appropriate method listed in 32 Ill. Adm. Code 310.110.;

K) Shall obtain written approval from the Agency before transferring the device to any other specific licensee not authorized in subsections (a)(3)(H)(i) through (iv); however, a holder of a specific license may transfer a device for possession and use under its own specific license without prior approval, if, the holder:

i) Verifies that the specific license authorizes the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use;

ii) Removes, alters, covers, or clearly and unambiguously augments the existing label (otherwise required by subsection (a)(3)(A)) so that the device is labeled in compliance with 32 Ill. Adm. Code 340.940; however the manufacturer, model number, and serial number must be retained;

iii) Obtains the manufacturer's or initial transferor's information concerning maintenance that would be applicable under the specific license (such as leak testing procedures); and

iv) Reports the transfer under subsection (a)(3)(I).

L) Shall transfer the device to another general licensee only if:

i) The device remains in use at a particular location. In such case the transferor shall give the transferee a copy of subsection (a), a copy of 32 Ill. Adm. Code 310.40, 330.310, 330.500, 340.1210, 340.1220, 340.1260 and any safety documents identified in the device labels; or

ii) 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;

M) Shall furnish a report to the Agency within 30 days after transferring a device containing radioactive material as provided by subsection (a)(3)(L)(i). The notification shall include:

i) The identification of the device by manufacturer's (or initial transferor's) name, model and serial number;

ii) The transferee's name and mailing address;

iii) The address of the transferee's location of use or storage of the device; and

iv) The name, title and phone number of the responsible individual identified by the transferee in accordance with subsection (a)(3)(N) to have knowledge of, and authority to take actions to ensure compliance with, the appropriate regulations and requirements;

N) Shall 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, shall ensure 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.

4. Any person who receives, acquires, possesses or uses a device identified in subsection (a)(4)(A) shall register with the Agency in accordance with subsection (a)(4)(B):

A) A person shall register devices (i.e., an electron capture detector, gauge, x-ray fluorescence analyzer, or other measuring, gauging or controlling device) 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 (i.e., element with atomic number greater than uranium (92)), based on the activity indicated on the label;

B) A person shall register with the Agency no later than 30 days after receiving a device identified in subsection (a)(4)(A). Registration information shall be in a format prescribed by the Agency and furnished in accordance with subsection (a)(4)(C);

C) When registering with the Agency, a person shall furnish the following and any other information requested by the Agency to track the location and use of a device:

i) The name and mailing address of the general licensee;

ii) The name, title and phone number of the responsible individual designated as a representative of the general licensee in accordance with subsection (a)(3)(N);

iii) Information about each device meeting the criteria of subsection (a)(4)(A). This information shall include the manufacturer (or initial transferor), model, serial number, radionuclide and activity as indicated on the labels, and the calendar quarter and year the person received the device;

iv) The address or locations at which the devices are used or stored;

AGENCY NOTE: For portable devices, these are the addresses of the primary places of storage.

v) Certification by the responsible individual that the information about devices was verified through a physical inventory and examination of label information; and

vi) Certification by the responsible individual that the general licensee is aware of the requirements of the general license;

AGENCY NOTE: Fee requirements for general licenses are in 32 Ill. Adm. Code 331. Reporting requirements are in Section 330.310(b), and bankruptcy notification requirements are in Section 330.310(j).

D) Any person who is required by subsection (a)(4) to register with the Agency shall report a change in mailing address or address of location of use or storage. This report shall be furnished to the Agency within 30 days after the change.

AGENCY NOTE: For portable devices, this is the address of the primary place of storage.

5. A person from out of state who is generally licensed by NRC or an Agreement State with respect to a device identified in subsection (a)(4)(A) is exempt from the registration requirement in subsection (a)(4) if the device is used in areas subject to Agency jurisdiction for a period less than 180 days in any calendar year.

6. Any person who receives, acquires, possesses or uses radioactive material in a device under the general license described in subsection (a)(1) shall limit storage of a device that is not in use to a maximum of 2 years.

A) If a device with a shutter is not being used, the shutter shall be locked in the closed position. Testing for leakage of, or contamination by, radioactive material and for proper operation of the on-off mechanism and indicator is not required during the storage period. However, the testing required in subsection (a)(3)(B) shall be conducted before the device is returned to service if the device has not been tested within the required test interval.

B) A device kept in standby for future use is exempt from the 2-year storage limit if the person performs a quarterly physical inventory of the device while it is in standby. The requirements and exemption of subsection (a)(6)(A) shall apply.

AGENCY NOTE: Record keeping requirements are contained in subsection (a)(3)(D).

7. Failure of any person to comply with the requirements of this subsection (a) may cause the Agency to impose civil penalties in accordance with 420 ILCS 40/36 and 32 Ill. Adm. Code 200.

8. The general license described in subsection (a)(1) does not authorize the manufacture or import of devices containing radioactive material.

9. The general license described in subsection (a)(1) is subject to the provisions of 32 Ill. Adm. Code 310, 326, 331, 340.1210, 340.1220, 340.1260, and 341 and Sections 330.310 and 330.500. Any person who receives, acquires, possesses, uses or transfers radioactive material in a device pursuant to the general license described in subsection (a)(1) is exempt from the requirements of 32 Ill. Adm. Code 400 and 340 except for the Sections of 32 Ill. Adm. Code 340 specifically identified in subsections (a)(3)(E) and (a)(9).

b) Luminous Safety Devices for Aircraft

1. A general license is hereby issued to receive, acquire, possess and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided:

A) Each device contains not more than 370 GBq (10 Ci) of tritium or 11.1 GBq (300 mCi) of promethium-147; and

B) Each device has been manufactured, assembled or initially transferred in accordance with a specific license issued under the provisions of Section 330.280(e) or manufactured or assembled in accordance with a specific license issued by NRC or an Agreement State which authorizes manufacture or assembly of the device for distribution to persons generally licensed by the Agency.

2. Persons who receive, acquire, possess or use luminous safety devices pursuant to the general license in subsection (b)(1) are exempt from the requirements of 32 Ill. Adm. Code 340 and 400, except that they shall comply with the provisions of 32 Ill. Adm. Code 340.1210 and 340.1220.

3. This general license does not authorize the manufacture, assembly, repair, or import of luminous safety devices containing tritium or promethium-147.

4. This general license does not authorize the receipt, acquisition, possession or use of promethium-147 contained in instrument dials.

5. This general license is subject to the provisions of 32 Ill. Adm. Code 310 and 341 and Sections 330.310, 330.400 and 330.500.

c) Ownership of Radioactive Material. A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this Part, this general license does not authorize the manufacture, production, transfer, receipt, possession, use, import, or export of byproduct material.

d) Calibration and References Sources

1. A general license is hereby issued to those persons listed below to receive, acquire, possess, use and transfer, in accordance with the provisions of subsections (d)(4) and (5), americium-241 in the form of calibration or reference sources:

A) Any person who holds a specific license issued by the Agency that authorizes the licensee to receive, possess, use and transfer radioactive material; and

B) Any person who holds a specific license issued by NRC that authorizes the licensee to receive, possess, use and transfer special nuclear material.

2. A general license is hereby issued to receive, possess, use and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of subsections (d)(4) and (5) to any person who holds a specific license issued by the Agency that authorizes the licensee to receive, possess, use and transfer radioactive material.

3. A general license is hereby issued to receive, possess, use and transfer radium-226 in the form of calibration or reference sources in accordance with the provisions of subsections (d)(4) and (5) to any person who holds a specific license issued by the Agency that authorizes the licensee to receive, possess, use and transfer radioactive material.

4. The general licenses in subsections (d)(1) through (3) apply only to calibration or reference sources that have been manufactured or initially transferred in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by NRC pursuant to 10 CFR 32.57 or 70.39, or that have been manufactured in accordance with the specifications contained in a specific license issued by the Agency, or an Agreement State pursuant to licensing requirements equivalent to those contained in 10 CFR 32.57 or 70.39.

5. The general licenses provided in subsections (d)(1) through (3) are subject to the provisions of 32 Ill. Adm. Code 310, 340, 341 and 400 and Sections 330.310, 330.400 and 330.500. In addition, persons who receive, acquire, possess, use or transfer one or more calibration or reference sources pursuant to these general licenses:

A) Shall 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 or 185 kBq (5 µCi) of radium-226 in such sources;

B) Shall not receive, possess, use or transfer such source unless the source or the storage container bears a label that includes the following statement or a statement that contains the information called for in this statement:

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 or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTION – RADIOACTIVE MATERIAL – THIS SOURCE CONTAINS (AMERICIUM-241) (PLUTONIUM) (RADIUM-226). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

Name of Manufacturer or Importer

AGENCY NOTE: Showing only the name of the appropriate material.

C) Shall not transfer, abandon or dispose of the source except by transfer to a person authorized by a license from the Agency, NRC or an Agreement State to receive the source;

D) Shall store the source, except when the source is being used, in a closed container adequately designed and constructed to contain americium-241, plutonium or radium-226 that might otherwise escape during storage; and

E) Shall not use the source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

6. These general licenses do not authorize the manufacture, import, or export of calibration or reference sources containing americium-241, plutonium or radium-226.

e) General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing

AGENCY NOTE: The New Drug provisions of the Federal Food, Drug and Cosmetic Act also govern the availability and use of any specific diagnostic drugs in interstate commerce.

1. A general license is hereby issued to any physician, veterinarian, clinical laboratory or hospital to receive, acquire, possess, transfer or use, for any of the following stated tests, in accordance with the provisions of subsections (e)(2) through (6), 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 radiation therefrom, to human beings or animals:

A) Carbon-14, in units not exceeding 370 kBq (10 µCi) each.

B) Cobalt-57, in units not exceeding 370 kBq (10 µCi) each.

C) Hydrogen-3 (tritium), in units not exceeding 1.85 MBq (50 µCi) each.

D) Iodine-125, in units not exceeding 370 kBq (10 µCi) each.

E) Mock iodine-125 reference or calibration sources, in units not exceeding 1.85 kBq (50 nCi) of iodine-129 and 185 Bq (5 nCi) of americium-241 each.

F) Iodine-131, in units not exceeding 370 kBq (10 µCi) each.

G) Iron-59, in units not exceeding 740 kBq (20 µCi) each.

H) Selenium-75, in units not exceeding 370 kBq (10 µCi) each.

2. No person shall receive, acquire, possess, use or transfer radioactive material pursuant to the general license established by subsection (e)(1) until he or she has filed the Agency form entitled "Certificate – In Vitro Testing with Radioactive Material Under General License", with the Agency and received from the Agency a validated copy of the form with certification number assigned. No person shall transfer a validated copy of the form to another person without prior written consent of the Agency. The following information shall be furnished to the Agency on the form entitled "Certificate – In Vitro Testing with Radioactive Material Under General License":

A) Name and address of the physician, veterinarian, clinical laboratory or hospital;

B) The location of use; and

C) A statement that the physician, veterinarian, 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 subsection (e)(1) and that the tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive material.

3. A person who receives, acquires, possesses or uses radioactive material pursuant to the general license established by subsection (e)(1) shall comply with the following:

A) The general licensee shall not possess at any one time, pursuant to the general license in subsection (e)(1), at any one location of storage, or use a total amount of iodine-125, iodine-131, selenium‑75, iron-59 and/or cobalt-57 in excess of 7.4 MBq (200 µCi).

B) The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.

C) The general licensee shall use the radioactive material only for the uses authorized by subsection (e)(1).

D) The general licensee shall not transfer the radioactive material to a person who is not authorized to receive it pursuant to a license issued by the Agency, NRC or an Agreement State, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.

E) The general licensee shall dispose of the mock iodine-125 reference or calibration sources described in subsection (e)(1)(E) as required by 32 Ill. Adm. Code 340.1010(a).

4. The general licensee shall not receive, acquire, possess or use radioactive material pursuant to subsection (e)(1):

A) Except as prepackaged units that are labeled in accordance with the provisions of an applicable specific license issued pursuant to Section 330.280(g) or in accordance with the provisions of a specific license issued by NRC or an Agreement State that 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 this subsection (e) or its equivalent; and

B) Unless one of the following statements, as appropriate, or a statement that contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure that accompanies the package:

This radioactive material shall be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority.

Name of Manufacturer or Importer

5. The physician, veterinarian, clinical laboratory or hospital possessing or using radioactive material under the general license of subsection (e)(1) shall report in writing to the Agency, any changes in the information furnished by the licensee in the "Certificate – In Vitro Testing with Radioactive Material Under General License", Agency Form KLM.006. The report shall be furnished within 30 days after the effective date of the change.

6. Any person using radioactive material pursuant to the general license of subsection (e)(1) is exempt from the requirements of 32 Ill. Adm. Code 400 and 340, with respect to byproduct materials covered by that general license, except that such persons using the Mock Iodine-125 described in subsection (e)(1)(E) shall comply with the provisions of Sections 340.1010, 340.1210, and 340.1220.

f) Ice Detection Devices

1. A general license is hereby issued to 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 initially transferred in accordance with a specific license issued by NRC or each device has been manufactured or initially transferred in accordance with the specifications contained in a specific license issued by the Agency or an Agreement State to the manufacturer of the device pursuant to licensing requirements equivalent to those in 10 CFR 32.61.

2. Persons who receive, acquire, possess, use or transfer strontium-90 contained in ice detection devices pursuant to the general license in subsection (f)(1):

A) Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating to the device, discontinue use of the device until it has been inspected, tested for leakage or contamination and repaired by a person holding a specific license from NRC or an Agreement State to manufacture or service those devices; or shall dispose of the device pursuant to the provisions of 32 Ill. Adm. Code 340.1010(a);

B) Shall assure that all labels affixed to the device at the time of receipt, and that bear a statement that prohibits removal of the labels, are maintained on the device; and

C) Are exempt from the requirements of 32 Ill. Adm. Code 340 and 400 except that such persons shall comply with the provisions of 32 Ill. Adm. Code 340.1010(a), 340.1210, 340.1220 and 340.1260.

3. This general license does not authorize the manufacture, assembly, disassembly, repair, or import of strontium-90 in ice detection devices.

4. This general license is subject to the provisions of 32 Ill. Adm. Code 310 and 341 and Sections 330.310, 330.400 and 330.500.

g) Certain Items and Self-Luminous Products Containing Radium-226

1. A general license is hereby issued to any person to acquire, receive, possess, use or transfer, in accordance with the provisions of this subsection (g), radium-226 contained in the following products manufactured prior to November 30, 2007:

A) Antiquities originally intended for use by the general public. For the purposes of this subsection (g)(1)(A), antiquities means 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;

B) Intact timepieces containing greater than 37 kBq (1 µCi), nonintact timepieces and timepiece hands and dials no longer installed in timepieces;

C) Luminous items installed in air, marine or land vehicles;

D) All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time; and

E) Small radium sources containing no more than 37 kBq (1 µCi) of radium-226. For the purposes of this subsection (g)(1)(E), "small radium sources" means discrete survey instrument check sources, sources contained in radiation measuring instruments, sources such as cloud chambers and spinthariscopes used in educational demonstrations, electron tubes, lightning rods, ionization sources, static eliminators or sources otherwise designated by the Agency.

2. Any person who acquires, receives, possesses, uses or transfers radioactive material under the general license in subsection (g)(1) is exempt from the provisions of 32 Ill. Adm. Code 340 and 400 to the extent that the receipt, possession, use or transfer of radioactive material is within the terms of the general license. This exemption does not apply to any person specifically licensed under this Part.

3. Any person who acquires, receives, possesses, uses or transfers radioactive material in accordance with the general license in subsection (g)(1):

A) Shall notify the Agency within 30 days if there is any indication of possible damage to a product that could result in loss of radioactive material. The report shall provide a brief description of the event and the remedial action taken;

B) Shall not abandon a product containing radium-226. The product and any radioactive material from the product shall only be disposed of in accordance with subsection (g)(3)(D);

C) Shall not export a product containing radium-226, except in accordance with 10 CFR 110, published at 73 Fed. Reg. 78615, December 23, 2008, exclusive of subsequent amendments or editions; and

D) Shall dispose of a product containing radium-226 only in accordance with 32 Ill. Adm. Code 340.1010(a), or by transfer to a person specifically licensed under this Part to receive the radium-226 in the product, or as otherwise approved by the Agency in writing.

4. The general license in subsection (g)(1) does not authorize the manufacture, assembly, disassembly, repair or import of a product containing radium-226, except that timepieces may be disassembled and repaired.

History

• Source: Amended at 46 Ill. Reg. 866, effective December 21, 2021

Chapter II Illinois Emergency Management Agency

Subchapter b Radiation Protection

Part 330 Licensing of Radioactive Material

32 Ill. Adm. Code 330.240 Filing Applications for Specific Licenses

a) Application requirements:

1. Applications for the issuance, renewal or amendment of specific licenses shall be submitted in English.

AGENCY NOTE: Applications involving Agency evaluation of a sealed source or device containing radioactive material shall be in accordance with the requirements of this Section.

2. Applications for initial issuance, amendment and renewal of specific licenses shall be in the format prescribed by the Agency. Each application filed shall be complete with all requested information submitted, including all applicable attachments. The Agency may at any time after the filing of the original application, and before the expiration or termination of the license, require further statements from the applicant or licensee to enable the Agency to determine whether the application should be granted or denied or whether an existing license should be modified or revoked in accordance with Section 330.500.

3. Each application shall include all information required by this Part and any other Parts of 32 Ill. Adm. Code: Chapter II, Subchapters b and d, applicable to the requested authorizations.

4. An application may incorporate by reference information contained in previous applications, statements or reports filed with the Agency, provided the references are clear and specific.

5. Each application and each request for amendment shall be signed by the applicant, licensee, or a person duly authorized in writing to act for and on the licensee or applicant's behalf.

6. Each application shall identify the Radiation Safety Officer. The proposed activities shall be under the same administrative control for radiation safety purposes and the same radiation protection program.

7. An application may request authority to receive, possess, utilize, manufacture, distribute, transfer, own or acquire radioactive material or devices or equipment utilizing or producing radioactive materials. The request can include one or more of these activities.

8. An application for a specific license to authorize receipt, possession or use of radioactive material in the form of a sealed source or in a device that contains a sealed source:

A) Shall identify the sealed source or device that contains a sealed source by manufacturer and model as registered with the U.S. Nuclear Regulatory Commission under 10 CFR 32.210, or with an Agreement State or, for a source or device containing naturally occurring or accelerator-produced material, with a state under provisions comparable to 10 CFR 32.210; or

B) Shall contain the information identified in Section 330.280(m); or

C) Shall describe, for a sealed source or device containing radioactive material manufactured prior to October 23, 2015, that is not registered with NRC in accordance with 10 CFR 32.210 or with an Agreement State and for which the applicant is unable to provide the information described in Section 330.280(m)(3):

i) The information required by Section 330.280(m)(3) concerning the source and, if applicable, the device; and

ii) Sufficient additional information to demonstrate that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. The information shall 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; or

D) For sealed sources and devices allowed to be distributed without

registration of safety information in accordance with Section 330.280(m)(7), may describe only the manufacturer, model number, radionuclide and quantity; or

E) If it is not feasible to identify each sealed source and device individually, 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.

9. For each location to be listed on the license as an authorized use location, the applicant shall submit:

A) A statement that the applicant owns the facility where radioactive material is used or stored; or

B) A signed acknowledgement from the facility owner or authorized representative of the owner that the owner is aware radioactive material is being or will be used or stored at the facility; or

C) A copy of a letter or statement from the facility owner or authorized representative of the owner indicating that the owner is aware that radioactive material is being used or will be used or stored at the facility.

AGENCY NOTE: Subsection 10(11) of the Radiation Protection Act of 1990, 420 ILCS 40, requires the Agency to provide written notice of an application for a new license for a fixed location facility or a license amendment for a new location for a facility to the municipality, or county where appropriate, where the facility is located.

10. The applicant shall ensure that all applicable fees specified in 32 Ill. Adm. Code 331 are paid in full when due.

11. The applicant shall address the Emergency Plan requirements of Section 330.250(e), when applicable.

b) Review of application or amendment request. When evaluating an application or an amendment request, the Agency shall consider:

1. The completeness of the application or amendment request;

2. The complexity, similarity and proximity of the proposed activities;

3. The radiation protection program proposed by the applicant to ensure the protection of the licensee's personnel, the public and the environment;

4. The qualifications and experience of the applicant's proposed Radiation Safety Officer and authorized users; and

5. The applicant's history of compliance.

c) Public access to information. Public inspection of applications and other documents submitted to the Agency pursuant to this Section shall be in accordance with 2 Ill. Adm. Code 1800 and the requirements of the Freedom of Information Act [5 ILCS 140].

History

• Source: Amended at 46 Ill. Reg. 866, effective December 21, 2021

32 Ill. Adm. Code 330.250 General Requirements for the Issuance of Specific Licenses

a) A license application or a request for an amendment to an existing license will be approved only if the Agency determines that:

1. The applicant's Radiation Safety Officer and authorized users are qualified by reason of training and experience to use the material in question for the purpose requested in such a manner as to minimize danger to health and safety or property;

2. The applicant's proposed equipment, facilities and procedures are adequate to minimize danger to health and safety or property;

3. The issuance of the license will not be inimical to the health and safety of the public; and

4. The applicant satisfies any applicable special requirements in 32 Ill. Adm. Code: Chapter II, Subchapters b and d.

b) Environmental Report, Commencement of Construction

1. In the case of an application for a license to receive and possess radioactive material for commercial waste disposal by land burial, or for the conduct of any other activity the Agency determines will significantly affect the quality of the environment, a license application shall be reviewed and approved by the Agency before commencement of construction of the plant or facility in which the activity will be conducted. If the Agency, after considering the environmental, economic, technical and other benefits in comparison with the environmental costs and available alternatives, concludes that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values, it shall issue the license;

2. Commencement of construction prior to the Agency reaching the conclusion required by subsection (b)(1) shall be grounds for denial of a license to receive and possess radioactive material in the plant or facility. As used in this subsection (b), "commencement of construction" is defined in 32 Ill. Adm. Code 310.20.

c) Licensees must satisfy applicable financial assurance requirements specified in 32 Ill. Adm. Code 326.

d) Long-Term Care Requirements

1. A license application will be approved only if the Agency determines that a long-term care fund for monitoring and maintenance has been established by the waste handling applicant prior to the issuance of the license; or

2. The waste handling applicants may choose, at the time of the licensure, to provide a financial surety arrangement in lieu of a long-term care fund.

AGENCY NOTE: Long-term care funding may also be required for former U.S. Atomic Energy Commission or U.S. Nuclear Regulatory Commission licensed facilities, or persons whose activities cause situations that significantly affect health and safety, or the environment by reason of exposure to radiation or radioactive materials.

e) Emergency Plan

1. Except as exempted by subsection (e)(2), each application to possess radioactive materials in excess of the quantities in Appendix C in unsealed form or sealed in glass or on foils or plated sources shall contain either:

A) An evaluation showing that the maximum dose to an individual offsite due to a release of radioactive materials would not exceed 10 mSv (1 rem) total effective dose equivalent or 50 mSv (5 rem) effective dose equivalent to the thyroid; or

B) An emergency plan, as described in Section 330.290, for responding to a release of radioactive material.

2. The requirements of this subsection (e) do not apply to licensees that possess only radioactive waste packaged in Type B containers.

3. In evaluating the maximum dose to an individual pursuant to subsection (e)(1)(A), the applicant may take into account whether:

A) The radioactive material is physically separated so that only a portion could be involved in an accident;

B) All or part of the radioactive material is not subject to release during an accident due to the method of storage or packaging;

C) The release fraction in the respirable size range is predicted to be lower than the release fraction shown in Appendix C due to the chemical or physical form of the material;

D) The solubility of the radioactive material is predicted to reduce the dose received;

E) Facility design or engineered safety features in the facility are predicted to cause the release fraction to be lower than shown in Appendix C; or

F) Operating restrictions or procedures are predicted to prevent a release fraction as large or larger than that shown in Appendix C.

History

• Source: Amended at 38 Ill. Reg. 21451, effective October 31, 2014

32 Ill. Adm. Code 330.260 Special Requirements for Issuance of Certain Specific Licenses for Radioactive Materials

a) Specific Licenses to Medical Institutions for Human Use of Radioactive Material. A specific license allowing a medical institution to use radioactive material for medical diagnosis, medical therapy, or medical research involving humans shall be issued only if the applicant has met the requirements of this Part and 32 Ill. Adm. Code 335.

b) Specific Licenses to Individual Physicians for Human Use of Radioactive Material. An application by an individual physician or group of physicians for a specific license for human use of radioactive material shall be approved only if:

1. The applicant satisfies the general requirements specified in this Part;

2. The application is for use in the applicant's practice in an office outside a medical institution; and

3. The applicant has met the requirements of 32 Ill. Adm. Code 335.

c) Specific Licenses for Distribution or Transfer of Radiopharmaceuticals. In addition to the requirements set forth in this Part, persons licensed by the Agency for manufacture, preparation, or transfer for commercial distribution of radiopharmaceuticals containing radioactive material for medical use under 32 Ill. Adm. Code 335 shall meet the following additional requirements:

1. The applicant satisfies the general requirements specified in Section 330.250;

2. The applicant submits evidence that the applicant is at least one of the following:

A) Compliant with the U.S. Food and Drug Administration (FDA) registration requirements 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 Part 207;

B) Registered or licensed with a state agency as a drug manufacturer;

C) Licensed as a pharmacy by a state Board of Pharmacy;

D) Operating as a nuclear pharmacy within a federal medical institution; or

E) A PET drug production facility registered with a state agency;

3. The applicant submits information showing that:

A) The radiopharmaceutical containing radioactive material will be manufactured, labeled and packaged in accordance with the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301-392 or the federal Public Health Service Act, 42 U.S.C. 201-291; or

B) The manufacture and distribution of the radiopharmaceutical containing radioactive material is not subject to the federal Food, Drug, and Cosmetic Act and the federal Public Health Service Act;

4. The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees;

5. The applicant commits to the following labeling requirements:

A) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label shall 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.

B) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label shall 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;

6. A licensee described by subsection (c)(2)(C) or (D):

A) May prepare radioactive drugs for medical use, as defined in 32 Ill. Adm. Code 335.20, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in subsections (c)(6)(B) and (C), or an individual under the supervision of an authorized nuclear pharmacist as specified in subsection (c)(15).

B) May allow a pharmacist to work as an authorized nuclear pharmacist if the following conditions are met:

i) The individual qualifies as an authorized nuclear pharmacist as defined in Section 330.20;

ii) The individual meets the requirements specified in subsections (c)(18)(B) and (c)(21), and the licensee has received an approved license amendment identifying the individual as an authorized nuclear pharmacist; or

iii) The individual is designated as an authorized nuclear pharmacist in accordance with subsection (c)(6)(C).

C) May designate a pharmacist (as defined in 32 Ill. Adm. Code 310.20) as an authorized nuclear pharmacist if:

i) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material; and

ii) 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.

D) Shall provide to the Agency, no later than 30 days after the date a licensee allows an individual to work as an authorized nuclear pharmacist under subsections (c)(6)(B)(i), (c)(6)(B) (iii) or (c)(6)(C), a copy of the individual's State of Illinois pharmacist license and:

i) A copy of each individual's certification by a specialty board whose certification process has been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State as specified in subsection (c)(18)(A); or

ii) U.S. Nuclear Regulatory Commission or Agreement State license listing the individual as an authorized nuclear pharmacist; or

iii) A U.S. Nuclear Regulatory Commission master materials licensee permit listing the individual as an authorized nuclear pharmacist; or

iv) A permit issued by a licensee or U.S. Nuclear Regulatory Commission master material permittee of broad scope or authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or

v) 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;

E) Shall provide notification to the Agency no later than 30 days after an authorized user or an authorized nuclear pharmacist permanently discontinues performance of duties under the license or has a name change;

7. A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall:

A) 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

B) Check each instrument for constancy and proper operation at the beginning of each day of use;

8. Nothing in this Section relieves the licensee from complying with applicable FDA or other federal or State requirements governing radioactive drugs;

9. Radiopharmaceuticals dispensed, distributed or transferred for human use shall be either:

A) Repackaged from prepared radiopharmaceuticals that have been approved by the FDA for medical use as defined in 32 Ill. Adm. Code 335.20; or

B) Prepared from generators and reagent kits that have been approved by the FDA for medical use, or are subject to the Illinois Food, Drug and Cosmetic Act [410 ILCS 620] or the Pharmacy Practice Act of 1987 [225 ILCS 85];

10. Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, in accordance with 32 Ill. Adm. Code 335.4020. The licensee shall record the results of each test and retain each record for three years after the record is made. The licensee shall report the results of any test that exceeds the permissible concentration listed in Section 335.4020(a) at the time of generator elution, in accordance with Section 335.4020(d);

11. The licensee may distribute in vitro test kits to customers but shall neither remove any package insert nor violate the packaging;

12. The licensee shall report to the Agency, within 10 days after occurrence, any irregularities pertaining to identification, labeling, quality or assay of any radiopharmaceuticals received under the authority of this license;

13. A licensee such as a nuclear pharmacy that is authorized to distribute radiopharmaceuticals shall ensure that radiopharmaceuticals are dispensed only under the prescription of a physician who is authorized by 32 Ill. Adm. Code 335 to use the radiopharmaceuticals. The licensee shall verify that the physician is authorized to receive the prescribed radiopharmaceutical prior to transfer;

AGENCY NOTE: In accordance with 32 Ill. Adm. Code 335.40(b), licensees authorized for medical use of radiopharmaceuticals may permit work as an authorized user in limited circumstances without first obtaining an amendment. Therefore, possession of the recipient's latest radioactive material license may not list all authorized users.

14. A licensee shall apply for and shall receive a license amendment before it receives, prepares or uses radioactive material for a type of use that is permitted under this Part but that is not authorized on the licensee's current license issued under this Part;

15. Individuals Under Supervision of an Authorized Nuclear Pharmacist

A) A licensee that permits the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist as allowed by 32 Ill. Adm. Code 335.30(b)(2) shall:

i) In addition to the requirements in 32 Ill. Adm. Code 400.120, instruct the supervised individual in the preparation of radiopharmaceutical material for medical use as appropriate to that individual's involvement with radioactive material; and

ii) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, written radiation protection procedures established by the licensee, the regulations of this Section, and license conditions.

B) A licensee that permits supervised activities under this subsection (c)(15) is responsible for the acts and omissions of the supervised individual;

16. Authority and responsibilities for the radiation protection program.

A) In addition to the radiation protection program requirements in 32 Ill. Adm. Code 340.110, a licensee's management shall approve in writing:

i) Requests for a license application, renewal, or amendment before submittal to the Agency;

ii) Any individual before allowing that individual to work as an authorized nuclear pharmacist; and

iii) Radiation protection program changes that do not require a license amendment.

B) A licensee's management shall appoint a Radiation Safety Officer who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements. A licensee's management may appoint, in writing, one or more Associate Radiation Safety Officers to support the Radiation Safety Officer. The Radiation Safety Officer, with written agreement of the licensee's management, must assign the specific duties and tasks to each Associate Radiation Safety Officer. These duties and tasks are restricted to the types of use for which the Associate Radiation Safety Officer is listed on a license. The Radiation Safety Officer may delegate duties and tasks to the Associate Radiation Safety Officer but shall not delegate the authority or responsibilities for implementing the radiation protection program.

C) For up to 60 days each year, a licensee may permit an individual qualified to be a Radiation Safety Officer, under subsections (c)(17) and (c)(21), to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer, as provided in subsection (c)(16)(E), if the licensee takes the actions required in subsections (c)(16)(B), (D), (E), and (F) and notifies the Agency no later than 30 days after allowing the individual to function as a temporary Radiation Safety Officer.

D) A licensee shall establish the authority, duties, and responsibilities of the Radiation Safety Officer in writing.

E) A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources, and management prerogative, to:

i) Identify radiation safety problems;

ii) Initiate, recommend or provide corrective actions;

iii) Stop unsafe operations; and

iv) Verify implementation of corrective actions.

F) A licensee shall retain a record of actions taken under subsections (c)(16)(A), (B), and (D) as follows:

i) A licensee shall retain a record of actions taken by the licensee's management in accordance with subsection (c)(16)(A) for five years. The record must include a summary of the actions taken and a signature of licensee management.

ii) The licensee shall retain a copy of both authority, duties, and responsibilities of the Radiation Safety Officer as required by subsection (c)(16)(E), and a signed copy of each Radiation Safety Officer's agreement to be responsible for implementing the radiation safety program, as required by subsection (c)(16)(B), for the duration of the license. The records must include the signature of the Radiation Safety Officer and licensee management.

iii) For each Associate Radiation Safety Officer appointed under subsection (c)(16)(B), the licensee shall retain, for five years after the Associate Radiation Safety Officer is removed from the license, a copy of the written document appointing the Associate Radiation Safety Officer signed by the licensee's management.

17. Training for Radiation Safety Officer and Associate Radiation Safety Officer. Except as provided in subsection (c)(20), the licensee shall require an individual fulfilling the responsibilities of Radiation Safety Officer, or an individual assigned duties and tasks as an Associate Radiation Safety Officer provided in subsection (c)(16), at a nuclear pharmacy to be an individual who:

A) Is certified by a specialty board whose certification process has been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State and who meets the requirements in subsection (c)(17)(D). To have its certification process recognized, a specialty board shall require all candidates for certification to:

i) Hold a bachelor's or graduate degree from an accredited college or university in physical science, engineering or biological science with a minimum of 20 college credits in physical science; and

• 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

• Pass an examination administered by diplomates of the specialty board that 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

AGENCY NOTE: Specialty boards whose certification processes have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's website.

ii) Hold a master's or doctor's degree in physics, medical physics, or other physical science, engineering, or applied mathematics from an accredited college or university;

• Have two years of full-time practical training or supervised experience in medical physics under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State or in clinical nuclear medicine facilities providing diagnostic or therapeutic services under the direction of physicians who meet the requirements for authorized users in Section 335.9160, 335.9040, or 335.9050; and

• Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety; or

B) Has completed a structured educational program consisting of:

i) 200 hours of classroom and laboratory training in the following areas: radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology and radiation dosimetry;

ii) One year of full-time radiation safety experience under the supervision of the individual identified as the Radiation Safety Officer on an Agency, U.S. Nuclear Regulatory Commission, or Agreement State license or a permit issued by a U.S. Nuclear Regulatory Commission master material licensee that authorizes similar types and uses of radioactive material. An Associate Radiation Safety Officer may provide supervision for those areas for which the Associate Radiation Safety Officer is authorized on a U.S. Nuclear Regulatory Commission or an Agreement State license or permit issued by a U.S. Nuclear Regulatory Commission master material licensee. The full-time radiation safety experience shall involve the following:

• Shipping, receiving and performing related radiation surveys;

• Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides;

• Securing and controlling radioactive material;

• Using administrative controls to avoid mistakes in the administration of radioactive material;

• Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures;

• Using emergency procedures to control radioactive material; and

• Disposing of radioactive material; and

iii) Written attestation, signed by a preceptor Radiation Safety Officer or Associate Radiation Safety Officer who has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual is seeking approval as a Radiation Safety Officer. The written attestation must state that the individual has satisfactorily completed the requirements in subsections (c)(17)(B)(i), (B)(ii) and (D), and is able to independently fulfill the radiation safety-related duties as a Radiation Safety Officer or Associate Radiation Safety Officer for a nuclear pharmacy license; or

C) Meets the training requirements in subsection (c)(17)(D); and

i) Is a medical physicist who has been certified by a specialty board whose certification process has been recognized by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State under 32 Ill. Adm. Code 335.9150(a), 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 Radiation Safety Officer or an Associate Radiation Safety Officer; or

ii) Is an authorized nuclear pharmacist identified on a specific nuclear pharmacy license issued by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State; a nuclear pharmacy use permit issued by a U.S. Nuclear Regulatory Commission master material licensee; a permit issued by a U.S. Nuclear Regulatory Commission or an Agreement State broad scope medical use licensee; or a permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope medical use permittee; and has experience with the radiation safety aspects of similar types of use of radioactive material for which the licensee seeks the approval of the individual as the Radiation Safety Officer or Associate Radiation Safety Officer; or

iii) Has experience with the radiation safety aspects of the types of use of radioactive material for which the individual is seeking simultaneous approval both as the Radiation Safety Officer and the authorized user on the same new nuclear pharmacy license.

D) Has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval. This training requirement may be satisfied by completing training that is supervised by a Radiation Safety Officer, Associate Radiation Safety Officer, or authorized nuclear pharmacist, as appropriate, who is authorized for the types of use for which the licensee is seeking approval.

18. Training for an authorized nuclear pharmacist. Except as provided in subsection (c)(19), the licensee shall require the authorized nuclear pharmacist to be a State of Illinois licensed pharmacist who:

A) Is certified as a nuclear pharmacist by a specialty board whose certification process has been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State. To be recognized, a specialty board shall require a candidate for certification to:

i) Graduate from a pharmacy program accredited by the Accreditation Council for Pharmacy Education (ACPE) (previously named the American Council of Pharmaceutical Education) or pass the Foreign Pharmacy Graduate Examination Committee (FPGEC) examination;

ii) Hold a current, active license to practice pharmacy;

iii) Provide evidence of having acquired at least 4000 hours of training/experience 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 diplomate of the specialty board, that evaluates 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 700 hours in a structured educational program consisting of:

i) 200 hours of classroom and laboratory training in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, chemistry of radioactive material for medical use and, radiation biology; and

ii) Supervised practical experience in a nuclear pharmacy involving shipping, receiving and performing related radiation surveys; 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; calculating, assaying and safely preparing dosages for patients or human research subjects; use of administrative controls to avoid medical events in the administration of radioactive material; use of procedures to prevent or minimize radioactive contamination and use of proper decontamination procedures; and

iii) Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in subsections (c)(18)(B)(i) and (ii) and is able to independently fulfill the radiation safety-related duties as an authorized nuclear pharmacist;

19. An individual identified as an authorized nuclear pharmacist on an Agency, U.S. Nuclear Regulatory Commission, or Agreement State license or a permit issued by an Agency, U.S. Nuclear Regulatory Commission or Agreement State broad scope licensee or master materials license permit or by a master materials license permittee of broad scope on or before January 14, 2022 need not comply with the training requirements in subsection (c)(18);

20. Training for Experienced Radiation Safety Officer, nuclear pharmacist, or authorized nuclear pharmacist.

A) An individual identified on an Agency, U.S. Nuclear Regulatory Commission, or an Agreement State license or a permit issued by an Agency, U.S. Nuclear Regulatory Commission, or an Agreement State broad scope licensee or master material license permit or by a master material license permittee of broad scope as a Radiation Safety Officer, a nuclear pharmacist or an authorized nuclear pharmacist on or before January 14, 2022, need not comply with the training requirements of 32 Ill. Adm. Code 335.9010, 335.9150, or subsection (c)(18), respectively, except the Radiation Safety Officers identified in this subsection shall meet the training requirements in 32 Ill. Adm. Code 335.9010(e) or 335.9150(d) for any material or uses for which they were not authorized prior to this date.

B) 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 subsection (c)(17) to be identified as a Radiation Safety Officer or as an Associate Radiation Safety Officer on an Agency license for those materials and uses that these individuals performed on or before October 24, 2005.

C) A Radiation Safety Officer or a nuclear pharmacist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses or in the practice of nuclear pharmacy at a government agency or federally recognized Indian tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as recognized by NRC, need not comply with the training requirements of subsection (c)(17) or (c)(18), respectively, when performing the same uses. A nuclear pharmacist, who only prepared radioactive drugs containing accelerator-produced radioactive material at the locations and during the time period identified in this subsection, qualifies as an authorized nuclear pharmacist for those materials and uses performed before these dates, for the purposes of this Section.

D) Individuals who need not comply with training requirements as described in this Section may serve as preceptors for, and supervisors of, applicants seeking authorization on Agency licenses for the same uses for which these individuals are authorized.

21. Recentness of Training. The training and experience specified in subsections (c)(17) and (c)(18) shall have been obtained within the seven years preceding the date of application or the individual shall have had related continuing education and experience since the required training and experience was completed;

22. Resolution of Conflicting Requirements During Transition Period. If this Part conflicts with the licensee's radiation safety program as identified in its license, this Part shall apply unless the statements, representations, conditions and procedures in the license are more restrictive. However, if the licensee exercises its privilege to amend its license, the portion amended must comply with the requirements of this Part.

23. Licensing the production of PET radioactive drugs for noncommercial distribution within a consortium. An application from a medical facility or educational institution to produce PET radioactive drugs for noncommercial distribution within its consortium for use under 32 Ill. Adm. Code 335 or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State shall include:

A) A request for authorization to produce PET radionuclides or evidence of an existing license issued under this Part or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State; and

B) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in subsection (c)(2); and

C) If the applicant is a nuclear pharmacy:

i) Verification that the applicant satisfies the requirements of this Section that apply to nuclear pharmacies; and

ii) Identification of each individual authorized to prepare the PET radioactive drugs and documentation that each meets the requirements of an authorized nuclear pharmacist; and

D) The information required by subsection (c)(4) for each PET radioactive drug to be noncommercially distributed within the consortium; and

E) Verification that the applicant is in compliance with:

i) Applicable FDA and other Federal and State requirements governing radioactive drugs; and

ii) The labeling requirements of subsection (c)(5) for each PET radioactive drug transport radiation shield and each syringe, vial or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium; and

iii) The requirements of subsections (c)(7), (12), (13), (14), (17), and (22).

AGENCY NOTE: Subsection (c)(7) contains requirements for measuring the radioactivity of radioactive drugs.

24. A licensee shall satisfy the labeling requirements in subsection (c)(5).

d) Use of Sealed Sources in Industrial Radiography. A specific license for use of sealed sources in industrial radiography shall be issued only if the applicant has met the requirements of this Part and 32 Ill. Adm. Code 350 and 405.

e) Use of Radioactive Materials in Wireline Service Operations and Subsurface Tracer Studies. A specific license for use of radioactive material in wireline operations shall be issued only if the applicant has met the requirements of this Part and 32 Ill. Adm. Code 351.

AGENCY NOTE: Specialty boards whose certification processes have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on NRC's website.

History

• Source: Amended at 48 Ill. Reg. 13634, effective August 29, 2024

Chapter II Illinois Emergency Management Agency and Office of Homeland Security

Subchapter b Radiation Protection

Part 330 Licensing of Radioactive Material

32 Ill. Adm. Code 330.270 Special Requirements for Specific Licenses of Broad Scope

This Section prescribes requirements for the issuance of specific licenses of broad scope for radioactive material and certain regulations governing holders of those licenses.

AGENCY NOTE: Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

a) The different types of broad scope licenses are:

1. 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 multiples of gigabecquerels or curies.

2. 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 Appendix D, for any authorized purpose. The possession limit for a Type B license of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Column I of Appendix D. 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 Column I of Appendix D for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

3. 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 Appendix D, for any authorized purpose. The possession limit for a Type C license of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Column II of Appendix D. 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 Column II of Appendix D for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

b) An application for a Type A specific license of broad scope will be approved if:

1. The applicant satisfies the general requirements specified in Section 330.250;

2. The applicant has engaged in a reasonable number of activities involving the use of radioactive material;

3. The applicant has established administrative controls and provisions relating to organization and management, procedures, recordkeeping, material control and accounting and management review that are necessary to assure safe operations, including:

A) 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;

i) The Committee shall meet at least once each calendar quarter.

ii) To establish a quorum and to conduct business, at least one-half of the Committee membership must be in attendance and shall include, at a minimum, the management's representative, an authorized user and the Radiation Safety Officer. However, no more than once per year, the Radiation Safety Officer's designee may substitute for the Radiation Safety Officer, provided the designee has been given a written report. The report shall include all information necessary for that meeting, such as the minutes of the previous Committee meeting and reports by the Radiation Safety Officer. Reports by the Radiation Safety Officer shall include reports of investigations and information necessary for the reviews. To maintain membership on the Committee, a member must attend at least one-half of the meetings held in any year.

iii) The minutes of each Radiation Safety Committee meeting shall include:

• The date of the meeting;

• Members in attendance;

• Members absent;

• Summary of deliberations and discussions;

• Recommended actions and the results of all votes; and

• Documentation of the radiation protection program review required by 32 Ill. Adm. Code 340.110(c).

iv) The Committee shall provide each member with a copy of the meeting minutes before the next meeting and retain one copy for five years from the meeting date.

B) The appointment of a Radiation Safety Officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters.

C) The establishment of appropriate administrative procedures to assure:

i) Control of procurement and use of radioactive material;

ii) Completion of safety evaluations of proposed uses of radioactive material that 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

iii) Review, approval and recording by the Radiation Safety Committee of safety evaluations of proposed uses prepared in accordance with subsection (b)(3)(C)(ii) prior to use of the radioactive material; and

4. The applicant or its predecessor has been a specific licensee of the Agency for five years.

c) An application for a Type B specific license of broad scope will be approved if:

1. The applicant satisfies the general requirements specified in Section 330.250; and

2. The applicant has established administrative controls and provisions relating to organization and management, procedures, recordkeeping, material control and accounting and management review that are necessary to assure safe operations, including:

A) The nomination of a Radiation Safety Officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and

B) The establishment of appropriate administrative procedures to assure:

i) Control of procurement and use of radioactive material;

ii) Completion of safety evaluations of proposed uses of radioactive material that 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

iii) Review, approval and recording by the Radiation Safety Officer of safety evaluations of proposed uses prepared in accordance with subsection (c)(2)(B)(ii) prior to use of the radioactive material.

d) An application for a Type C specific license of broad scope will be approved if:

1. The applicant satisfies the general requirements specified in Section 330.250;

2. The applicant submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received:

A) A college degree at the bachelor level, or equivalent training and experience, in the physical, or biological sciences or in engineering; and

B) At least 40 hours of training and 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 pertinent to the type and forms of radioactive material to be used; and

3. The applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, recordkeeping, material control and accounting and management review necessary to assure safe operations.

e) Specific licenses of broad scope are subject to the following conditions:

1. Unless specifically authorized, persons licensed pursuant to this Section shall not:

A) Conduct tracer studies in the environment involving direct release of radioactive material;

B) Receive, acquire, own, possess, use or transfer devices containing 3.7 PBq (100 kCi) or more of radioactive material in sealed sources used for irradiation of materials;

C) Conduct activities for which a specific license issued by the Agency under Section 330.260 or 330.280 is required; or

D) 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.

2. Each Type A specific license of broad scope issued under this Part shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's Radiation Safety Committee.

3. Each Type B specific license of broad scope issued under this Part shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's Radiation Safety Officer.

4. Each Type C specific license of broad scope issued under this Part shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of subsection (d)(2).

f) A licensee possessing a Type A specific license of broad scope for medical use, issued under this Part, is exempt from:

1. The provisions of 32 Ill. Adm. Code 335.40(b);

2. The provisions of 32 Ill. Adm. Code 335.40(f) regarding additions to or changes in the areas of use at the addresses identified in the application or on the license;

3. The provisions of 32 Ill. Adm. Code 335.45(a);

4. The provisions of 32 Ill. Adm. Code 335.45(b)(1) for an authorized user, an authorized medical physicist, or an ophthalmic physicist; and

5. The provisions of 32 Ill. Adm. Code 335.45(b)(5).

g) A licensee possessing a Type A specific license of broad scope for use described in subsections 330.260(c)(2)(C) or (c)(2)(D) is exempt from the provisions of subsections (c)(6)(B)(ii), (c)(6)(D), (c)(6)(E), and 330.340(b)(4).

History

• Source: Amended at 48 Ill. Reg. 13634, effective August 29, 2024

32 Ill. Adm. Code 330.280 Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices That Contain Radioactive Material

a) Licensing the Introduction of Radioactive Material into Products in Exempt Concentrations

1. In addition to the requirements set forth in Section 330.250, a specific license authorizing the introduction of radioactive material into a product or material owned by or in the possession of the licensee or another and the transfer of ownership or possession of the product or material containing the radioactive material to persons exempted from this Part pursuant to Section 330.30 or 330.40(a) will be issued if:

A) The applicant submits:

i) a description of the product or material into which the radioactive material will be introduced;

ii) intended use of the radioactive material and the product or material into which it is introduced;

iii) method of introduction;

iv) initial concentration of the radioactive material in the product or material;

v) control methods to assure that no more than the specified concentration is introduced into the product or material;

vi) estimated time interval between introduction and transfer of the product or material; and

vii) estimated concentration of the radioactive material in the product or material at the time of transfer; and

B) The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in Appendix A, that reconcentration of the radioactive material in concentrations exceeding those in Appendix A is not likely, that use of lower concentrations is not feasible and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

2. Each person licensed under this subsection (a) is required to maintain records of transfer of material and shall file a report with the Agency that shall identify the following:

A) Type and quantity of each product or material into which radioactive material has been introduced during the reporting period;

B) Name and address of the person who owned or possessed the product or material, into which radioactive material has been introduced, at the time of introduction;

C) The radionuclide, activity and activity assay date of radioactive material introduced into each product or material; and

D) The initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee.

3. The licensee shall file the report within 30 days after any of the following events:

A) 5 years have passed since the preceding report was filed; or

B) The licensee has:

i) Filed an application for renewal of the license under Section 330.320; or

ii) Notified the Agency under Section 330.325(c) that the licensee has ended activities authorized under the license issued under this subsection (a).

4. The report shall cover the period between the filing of the preceding report and an occurrence specified in subsection (a)(3). If no transfers of radioactive material have been made under this subsection (a) during the reporting period, the report shall so indicate.

5. The licensee shall maintain the record of a transfer for a period of one year after the event has been included in a report to the Agency.

6. 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 Section 330.30 or 330.40(a) or the equivalent regulations of NRC (10 CFR 30.14) or of an Agreement State, except in accordance with a specific license issued under this subsection (a).

b) Licensing the Distribution of Radioactive Material in Exempt Quantities

AGENCY NOTE: Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington DC 20555.

c) Licensing the Incorporation of Naturally Occurring and Accelerator-Produced Radioactive Material into Gas and Aerosol Detectors.

AGENCY NOTE: Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington DC 20555.

d) Licensing the Manufacture and Distribution of Devices to Persons Generally Licensed Under Section 330.220(a).

AGENCY NOTE: Subsection (p) describes requirements for radioactive material transfer reports and records.

1. An application for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under Section 330.220(a) or equivalent regulations of NRC or an Agreement State will be approved if:

A) The applicant satisfies the general requirements of Section 330.250.

B) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions and potential hazards of the device to provide reasonable assurance that:

i) The device can be safely operated by persons not having training in radiological protection;

ii) 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 percent of the annual limits specified in 32 Ill. Adm. Code 340.210(a); and

iii) 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 mSv (15 rem)

Hands and forearms; feet and ankles or localized areas of skin averaged over areas no larger than one square centimeter.................................. 2 Sv (200 rem)

Other organs .......................................... 500 mSv (50 rem).

C) Each device bears a durable, legible, clearly visible label or labels approved by the Agency that contains in a clearly identified and separate statement:

i) Instructions and precautions necessary to assure safe installation, operation and servicing of the device. Documents such as operating and service manuals may be identified on the label and used to provide this information;

ii) The requirement, or lack of requirement, for testing for leakage or contamination, or for testing any on-off mechanism and indicator, including the maximum time interval for the testing, and the identification of radioactive material by radionuclide, activity and activity assay date; and

iii) The information called for in one of the following statements, as appropriate, in the same or substantially similar form:

The receipt, possession, use and transfer of this device, Model___, Serial No.____, are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or a state with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

OR

CAUTION – RADIOACTIVE MATERIAL

Name of Manufacturer or Distributor

AGENCY NOTE: The model, serial number and name of the manufacturer or distributor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.

D) Each device having a separable source housing that provides the primary shielding for the source also bears on the source housing a durable label displaying the device model and serial number, the radionuclide and activity, the words "Caution – Radioactive Material", the radiation symbol described in 32 Ill. Adm. Code 340.Illustration A and the name of the manufacturer or distributor.

E) Each device meeting the criteria of 10 CFR 31.5(c)(13)(i)(73 Fed. Reg. 42673, July 23, 2008) bears a permanent (e.g., embossed, etched, stamped or engraved) label affixed to the source housing, if separable, or the device, if the source housing is not separable, that includes the words "Caution – Radioactive Material" and, if practicable, the radiation symbol described in 32 Ill. Adm. Code 340.Illustration A.

F) The device has been registered in the Sealed Source and Device Registry in accordance with subsection (m)(2).

2. Except as provided in this subsection (d)(2), the interval between tests for proper operation of the on-off mechanism and indicator, if any, shall not exceed six months. The interval between tests for contamination of the device or for leakage of radioactive material from the device or for both shall not exceed three months for devices containing sources designed to emit alpha particles and six months for all other devices. In the event the applicant desires that the device be required to be tested at longer intervals, the applicant shall include in the application sufficient information to demonstrate that those longer intervals are justified. The information shall include a description of the performance characteristics of the device or similar devices and of design features that have a significant bearing on the probability or consequences of contamination of the device or leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material or contamination of the device, the Agency will consider information that includes, but is not limited to:

A) Primary containment or source capsule;

B) Protection of primary containment;

C) Method of sealing containment;

D) Containment construction materials;

E) Form of contained radioactive material;

F) Maximum temperature withstood during prototype tests;

G) Maximum pressure withstood during prototype tests;

H) Maximum activity of contained radioactive material;

I) Radiotoxicity of contained radioactive material; and

J) Operating experience with identical devices or similarly designed and constructed devices.

3. In the event the applicant desires that the general licensee under Section 330.220(a), or under equivalent regulations of NRC or an Agreement State, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of, or contamination by, radioactive material, service the device, test the on-off mechanism and indicator or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated annual doses associated with the activity or activities and bases for the estimates. The submitted information shall demonstrate that performance of the 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 an annual dose in excess of 10 percent of the limits specified in 32 Ill. Adm. Code 340.210(a).

4. A person licensed under this subsection (d) to distribute devices to generally licensed persons shall provide the information in this subsection (d)(4) to each person to whom a device is to be transferred for possession and use under the general license in Section 330.220(a). This information shall be provided before a device is transferred. In the case of a transfer through an intermediate person, the information shall be provided to the intended user prior to transfer to the intermediate person. The required information is:

A) A copy of Section 330.220(a);

AGENCY NOTE: If certain provisions of Section 330.220(a) do not apply to a particular device, they may be omitted; e.g., tests for leakage or contamination or proper operation of an on-off mechanism and indicator.

B) A copy of 32 Ill. Adm. Code 310.40, 330.310 and 340.1210, 340.1220 and 340.1260;

C) A list of the services that may only be performed by a specific licensee;

D) Information on acceptable disposal options, including estimated costs of disposal; and

E) A statement of the Agency's policy to take escalated enforcement action for improper disposal.

5. A person licensed under this subsection (d) to distribute devices to generally licensed persons shall provide the information in this subsection (d)(5) to each person to whom a device is to be transferred for possession and use under a general license equivalent to Section 330.220(a) in the regulations of NRC or an Agreement State. This information shall be provided before a device is transferred. In the case of a transfer through an intermediate person, the information shall be provided to the intended user prior to transfer to the intermediate person. The required information is:

A) A copy of the following regulations of NRC or the equivalent regulations of an Agreement State. NRC regulations are 10 CFR 31.5(73 Fed. Reg. 42673, July 23, 2008), 10 CFR 31.2(65 Fed. Reg. 79187, December 18, 2000), 10 CFR 30.51(61 Fed. Reg. 24673, May 16, 1996), 10 CFR 20.2201(67 Fed. Reg. 3585, January 25, 2002) and 10 CFR 20.2202(63 Fed. Reg. 39483, July 23, 1998). If NRC regulations are provided to a prospective general licensee in lieu of applicable Agreement State regulations, they shall be accompanied by a note explaining that use of the device is regulated by the Agreement State;

AGENCY NOTE: If certain provisions of the regulations do not apply to a particular device, they may be omitted; e.g., tests for leakage or contamination or proper operation of an on-off mechanism and indicator.

B) A list of the services that may only be performed by a specific licensee;

C) Information on acceptable disposal options, including estimated costs of disposal;

D) A statement of the policies of NRC and most Agreement States to take escalated enforcement action for improper disposal; and

E) The name or title, address and phone number of the contact at NRC or Agreement State regulatory agency from whom additional information may be obtained.

6. A person licensed under this subsection (d) may propose, for approval by the Agency, an alternative method of informing customers.

7. Each transferred device shall meet the labeling requirements of subsections (d)(1)(C), (D) and (E).

8. If a license is to be terminated or if notification of bankruptcy is required by Section 330.310(j), a person licensed under this subsection (d) shall, upon request, provide to the Agency, NRC or an Agreement State the records of final disposition required by subsection (p)(8).

e) Special Requirements for the Manufacture, Assembly or Repair of Luminous Safety Devices for Use in Aircraft

1. An application 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 Section 330.220(b) will be approved if:

A) The applicant satisfies the general requirements specified in Section 330.250; and

B) The applicant satisfies the requirements of the following regulations of NRC or their equivalent. The regulations are 10 CFR 32.53 (77 Fed. Reg. 43693, July 25, 2012), 10 CFR 32.54 (63 Fed. Reg. 39483, July 23, 1998) and 10 CFR 32.55 (77 Fed. Reg. 43693, July 25, 2012).

2. Each person licensed under this subsection (e) shall file an annual report with the Agency that shall state the total activity of tritium or promethium‑147 transferred to persons generally licensed under Section 330.220(b) or equivalent regulations of NRC or an Agreement State. The report shall identify each general licensee by name and address, state the kinds and numbers of luminous devices transferred and specify the activity of tritium or promethium-147 in each kind of device. Each report shall cover the year ending June 30 and shall be filed within 30 days thereafter. If no transfers have been made to a particular Agreement State during the reporting period, this information must be reported to the responsible Agreement State agency upon request of the Agency.

3. Each person licensed under this subsection (e) shall also file an annual report with the Director, Office of Nuclear Material Safety and Safeguards, ATTN: Document Control Desk/GLTS, U.S. Nuclear Regulatory Commission, Washington DC 20555 by the appropriate method listed in 10 CFR 30.6, which must state the total quantity of tritium or promethium-147 transferred to persons generally licensed under Section 330.220(b). The report shall identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. Each report shall cover the year ending June 30 and shall be filed by July 30. If no transfers have been made to persons generally licensed under Section 330.220(b) during the reporting period, the report shall so indicate.

f) Special Requirements for License to Manufacture Calibration Sources Containing Americium-241, Plutonium or Radium-226 for Distribution to Persons Generally Licensed Under Section 330.220(d). An application for a specific license to manufacture calibration and reference sources containing americium-241, plutonium or radium-226 for distribution to persons generally licensed under Section 330.220(d) will be approved if:

1. The applicant satisfies the general requirements of Section 330.250; and

2. The applicant satisfies the requirements of 10 CFR 32.57 (77 Fed. Reg. 43693, July 25, 2012) and 10 CFR 70.39 (43 Fed. Reg. 6925, February 17, 1978). The applicant shall also certify that it will satisfy, and subsequently satisfies, the requirements of 10 CFR 32.58 and 32.59 (77 Fed. Reg. 43694, July 25, 2012).

g) Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under General License. An application for a specific license to manufacture or distribute radioactive material for use under the general license of Section 330.220(e), or equivalent regulations of NRC or an Agreement State, will be approved if:

1. The applicant satisfies the general requirements specified in Section 330.250.

2. The radioactive material is to be prepared for distribution in prepackaged units of:

A) Carbon-14 in units not exceeding 370 kBq (10 µCi) each.

B) Cobalt-57 in units not exceeding 370 kBq (10 µCi) each.

C) Hydrogen-3 (tritium) in units not exceeding 1.85 MBq (50 µCi) each.

D) Iodine-125 in units not exceeding 370 kBq (10 µCi) each.

E) Mock iodine-125 in units not exceeding 1.85 kBq (50 nCi) of iodine-129 and 185 Bq (5 nCi) of americium-241 each.

F) Iodine-131 in units not exceeding 370 kBq (10 µCi) each.

G) Iron-59 in units not exceeding 740 kBq (20 µCi) each.

H) Selenium-75 in units not exceeding 370 kBq (10 µCi) each.

3. Each prepackaged unit bears a durable, clearly visible label:

A) 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 (50 nCi) of iodine-129 and 185 Bq (5 nCi) of americium-241 each; and

B) Displaying the radiation caution symbol described in 32 Ill. Adm. Code 340.910(a) and the words "CAUTION – RADIOACTIVE MATERIAL" and "Not for Internal or External Use in Humans or Animals".

4. The following statement, or a statement that 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 that accompanies the package:

This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of NRC or of a state with which NRC has entered into an agreement for the exercise of regulatory authority.

5. The label affixed to the unit, or the leaflet or brochure that accompanies the package, contains information about the precautions to be followed in handling and storing that radioactive material. In the case of the mock iodine-125 reference or calibration source, the manufacturer shall state in the directions that this item shall be disposed of in compliance with 32 Ill. Adm. Code 340.1010(a) or the equivalent regulations of NRC or an Agreement State.

h) Licensing the Manufacture and Distribution of Ice Detection Devices. An application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under Section 330.220(f) will be approved if:

1. The applicant satisfies the general requirements of Section 330.250; and

2. The criteria of 10 CFR 32.61 and 32.62(77 Fed. Reg. 43694, July 25, 2012) are met.

i) Manufacture and Distribution of Radiopharmaceuticals Containing Radioactive Material for Medical Use Under Specific Licenses. An application for a specific license to manufacture and distribute radiopharmaceuticals containing radioactive material for use by persons licensed pursuant to Section 330.260(a), (b) or (c) for the uses described in 32 Ill. Adm. Code 335.3010, 335.4010 or 335.5010 will be approved if:

1. The applicant satisfies the general requirements specified in Section 330.250;

2. The applicant submits information showing that:

A) The radiopharmaceutical containing radioactive material will be manufactured, labeled and packaged in accordance with the Federal Food, Drug, and Cosmetic Act (21 USC 301) or the Public Health Service Act (42 USC 201 et seq.); or

B) The manufacture and distribution of the radiopharmaceutical containing radioactive material is not subject to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act;

3. The applicant submits information on the radionuclide; chemical and physical form; maximum activity per vial, syringe, generator or other container of the radioactive drug; and the shielding provided by the packaging to show the packaging is appropriate for safe handling and storage of radiopharmaceuticals by medical use licensees; and

4. The label affixed to each package of the radiopharmaceutical contains information on the radionuclide, activity and activity assay date and the label affixed to each package, or the leaflet or brochure that accompanies each package, contains a statement that the radiopharmaceutical is licensed by the Agency for distribution to persons licensed pursuant to Section 330.260(a), (b) or (c) for radioactive material specified in 32 Ill. Adm. Code 335.3010, 335.4010 or 335.5010, as appropriate, or under equivalent licenses of NRC or an Agreement State. The labels, leaflets or brochures required by this subsection (i) are in addition to the labeling required by the FDA and may be separate from, or, with the approval of FDA, may be combined with the labeling required by FDA.

j) Manufacture and Distribution of Generators or Reagent Kits for Preparation of Radiopharmaceuticals Containing Radioactive Material

AGENCY NOTE: Although the Agency does not regulate the manufacture and distribution of reagent kits that do not contain radioactive material, it does regulate the use of those reagent kits for the preparation of radiopharmaceuticals containing radioactive material as part of its licensing and regulation of the users of radioactive material. Any manufacturer of reagent kits that do not contain radioactive material who desires to have those reagent kits approved by the Agency for use by persons licensed pursuant to Section 330.260(a), (b) or (c) for generators or reagent kits specified in 32 Ill. Adm. Code 335.4010 may submit the pertinent information specified in this subsection (j).

An application for a specific license to manufacture and distribute generators or reagent kits containing radioactive material for preparation of radiopharmaceuticals by persons licensed pursuant to Section 330.260(a), (b) or (c) for the uses specified in 32 Ill. Adm. Code 335.4010 will be approved if:

1. The applicant satisfies the general requirements specified in Section 330.250;

2. The applicant submits evidence that:

A) The generator or reagent kit is to be manufactured, labeled and packaged in accordance with the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act; or

B) The manufacture and distribution of the generator or reagent kit are not subject to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act;

3. The applicant submits information on the radionuclide, chemical and physical form, packaging, including maximum activity per package, and shielding provided by the packaging of the radioactive material contained in the generator or reagent kit;

4. The label affixed to the generator or reagent kit contains information on the radionuclide, activity and activity assay date; and

5. The label affixed to the generator or reagent kit, or the leaflet or brochure that accompanies the generator or reagent kit, contains:

A) Adequate information, from a radiation safety standpoint, on the procedures to be followed and the equipment and shielding to be used in eluting the generator or processing radioactive material with the reagent kit; and

B) A statement that the generator or reagent kit, as appropriate, is approved for use by persons licensed by the Agency pursuant to Section 330.260(a), (b) or (c) and 32 Ill. Adm. Code 335.4010 or under equivalent licenses of NRC or an Agreement State. The labels, leaflets or brochures required by this subsection (j) are in addition to the labeling required by the FDA and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.

k) Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical Use. An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to Section 330.260(a) or (b) for use as a calibration, transmission or reference source in 32 Ill. Adm. Code 335.2040 or for the uses listed in 32 Ill. Adm. Code 335.2140, 335.6010, 335.7010 and 335.8010 will be approved if:

1. The applicant satisfies the general requirements in Section 330.250;

2. The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

A) The radioactive material contained and its chemical and physical form and activity;

B) Details of design and construction of the source or device;

C) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;

D) For devices containing radioactive material, the radiation profile of a prototype device;

E) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;

F) Procedures and standards for calibrating sources and devices;

G) Legend and methods for labeling sources and devices as to their radioactive content; and

H) Instructions for handling and storing sources or devices from the radiation safety standpoint. These instructions shall be included on a durable label attached to each source or device or attached to a permanent storage container for the source or device; provided, that instructions that are too lengthy for the label may be summarized on the label and printed in detail on a brochure that is referenced on the label;

3. The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, activity and activity assay date, radiation symbol and/or "CAUTION – RADIOACTIVE MATERIAL", serial number, model, manufacturer name or logo, and a statement that the source or device is licensed by the Agency for distribution to persons licensed pursuant to Section 330.260(a), (b) or (c) and 32 Ill. Adm. Code 335.2040, 335.2140, 335.6010, 335.7010 and 335.8010 or under equivalent licenses of NRC or an Agreement State, provided that the labeling for sources that do not require long-term storage may be on a leaflet or brochure that accompanies the source;

4. In the event the applicant desires that the source or device be required to be tested for leakage of, or contamination by, radioactive material at intervals longer than 6 months, the applicant shall include in the application sufficient information to demonstrate that the 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 radioactive contamination or leakage of radioactive material from the source;

5. In determining the acceptable interval for tests of leakage of, or contamination by, radioactive material, the Agency will consider information that includes, but is not limited to:

A) Primary containment or source capsule;

B) Protection of primary containment;

C) Method of sealing containment;

D) Containment construction materials;

E) Form of contained radioactive material;

F) Maximum temperature withstood during prototype tests;

G) Maximum pressure withstood during prototype tests;

H) Maximum activity of contained radioactive material;

I) Radiotoxicity of contained radioactive material;

J) Operating experience with identical sources or devices or similarly designed and constructed sources or devices; and

K) Proposed use of source; and

6. The source or device has been registered in the Sealed Source and Device Registry in accordance with subsection (m)(2).

l) Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications. An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to Section 330.210(g) or equivalent regulations of NRC or an Agreement State will be approved if:

1. The applicant satisfies the general requirements specified in Section 330.250.

2. The applicant submits sufficient information relating to the design (including blueprints), manufacture (construction materials and methods), prototype testing (description of testing that will be done and the acceptance criteria), quality control procedures, labeling or marking, proposed uses and potential hazards of the industrial product or device to assure that possession, use or transfer of the depleted uranium in the product or device will not cause any individual to receive, in any period of one year, a radiation dose in excess of 10 percent of the limits specified in 32 Ill. Adm. Code 340.210(a).

3. The applicant submits information assuring that the presence of depleted uranium for a mass-volume application in the product or device will provide a unique benefit to the public, i.e., a benefit that could not be achieved but for the use of depleted uranium. The applicant's methods for use and handling of the product or device will not result in uncontrolled disposal or dispersal of depleted uranium into the environment.

4. The Agency will deny any application for a specific license under this subsection (l) if the end uses of the industrial product or device cannot be reasonably foreseen.

5. Each person licensed pursuant to this subsection (l) shall:

A) Maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device;

B) Label or mark each unit to:

i) 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 activity of depleted uranium in each product or device; and

ii) 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 NRC or an Agreement State;

C) Assure that the depleted uranium, before being installed in each product or device, has been impressed with the following legend, clearly legible through any plating or other covering: "Depleted Uranium";

D) Furnish:

i) A copy of the general license contained in Section 330.210(g) and a copy of the form "Registration Certificate – Use of Depleted Uranium Under General License", to each person to whom the licensee transfers depleted uranium in a product or device for use pursuant to the general license contained in Section 330.210(g); or

ii) A copy of the general license contained in NRC's or Agreement State's regulation equivalent to Section 330.210(g) and a copy of NRC's or Agreement State's certificate, or alternatively, furnish a copy of the general license contained in Section 330.210(g) and a copy of the form "Registration Certificate – Use of Depleted Uranium Under General License", to each person to whom he or she transfers depleted uranium in a product or device for use pursuant to the general license of NRC or an Agreement State, with a note explaining that use of the product or device is regulated by NRC or an Agreement State under requirements substantially the same as those in Section 330.210(g);

E) Report to the Agency all transfers of industrial products or devices to persons for use under the general license in Section 330.210(g). The report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the Agency and the general licensee, the type and model number of device transferred, and the activity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which the product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under Section 330.210(g) during the reporting period, the report shall so indicate;

F) File a report that identifies each general licensee by name and address, an individual by name and/or position who constitutes a point of contact between the Agency and the general licensee, the type and model number of the device transferred, and the activity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which the product or device is transferred to the generally licensed person. The licensee shall report:

i) To NRC, all transfers of industrial products or devices to persons for use under NRC general license in 10 CFR 40.25;

ii) To the responsible state agency, all transfers of devices manufactured and distributed pursuant to this subsection (l) for use under a general license in that state's regulations equivalent to Section 330.210(g);

iii) To NRC, if no transfers have been made by the licensees during the reporting period;

iv) To the responsible Agreement State agency, upon the request of that agency, if no transfers have been made to general licensees within a particular Agreement State during the reporting period; and

G) 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 pursuant to the general license provided in Section 330.210(g) or equivalent regulations of NRC or an Agreement State. The records shall be maintained for a period of 2 years and shall show the date of each transfer, the activity of depleted uranium in each product or device transferred, and compliance with the report requirements of this subsection (l).

m) Special Requirements for License to Manufacture or Initially Distribute Sealed Sources or Devices Containing Sealed Sources

1. An application for license to manufacture or initially distribute sealed sources or devices containing sealed sources for initial transfer to persons having a specific license to receive those sealed sources or devices will be approved subject to the following conditions:

A) The applicant satisfies the general requirements specified in Section 330.250;

B) The licensee subject to this subsection (m) shall not transfer a sealed source or device containing a sealed source to any person, except in accordance with the requirements of Section 330.400.

2. Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the Agency for evaluation of radiation safety information about its product and for filing an evaluation sheet in the NRC "Registry of Radioactive Sealed Sources and Devices".

3. 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 the device's 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.

4. The Agency normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the Agency formulates reasonable standards and criteria with the help of the manufacturer or distributor. The Agency shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property. Other subsections of this Section have specific criteria that apply to certain products.

5. After completion of the evaluation, the Agency 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.

6. The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with:

A) The statements and representations, including quality control program, contained in the request; and

B) The provisions of the registration certificate.

7. 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 and/or gamma emitting radionuclides; or

ii) 0.37 MBq (10 µCi), for alpha emitting radionuclides; or

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 Section 330.270

or comparable provisions of NRC or an Agreement State; or

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.

8. After the certificate is issued, the Agency may conduct an additional

review as it determines is necessary to ensure compliance with current regulatory standards. In conducting its review, the Agency will complete its evaluation in accordance with criteria specified in this Section. The Agency may request such additional information as it considers necessary to conduct its review and the certificate holder shall provide the information requested.

9. A certificate holder who no longer manufactures or initially transfers any of the sealed sources or devices covered by a particular certificate issued by the Agency shall request inactivation of the registration certificate. The request must be made to the Agency by an appropriate method listed in 32 Ill. Adm. Code 310.110 and must normally be made no later than two years after initial distribution of all the sources 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 2 years after that transfer, the certificate holder shall request inactivation of the certificate within 90 days after this determination and briefly describe the circumstances of the delay.

10. If a distribution license is to be terminated in accordance with Section 330.325, the licensee shall request inactivation of its registration certificates associated with that distribution license before the Agency will terminate the license. A request for inactivation of certificates must indicate that the license is being terminated and include the associated specific license number.

11. 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 the sources or devices for use. Servicing of devices must be in accordance with any conditions in the certificate, including in the case of an inactive certificate.

n) Manufacture and Distribution of Radioactive Material for Medical Use Under General License. A specific license authorizing the distribution of radioactive materials for diagnostic medical use by a physician under a general license shall be issued only if the applicant for the specific license satisfies the requirements of Section 330.250 and:

1. The applicant submits evidence that the radioactive material is to be manufactured, labeled and packaged in accordance with an approval by the commissioner of Food and Drugs, U.S. Food and Drug Administration, or in accordance with an approval for a biologic product issued by the Secretary, U.S. Department of Health and Human Services; and

2. The following statement, or a statement that contains the information called for in the following statement, appears on the label affixed to the container or appears in the leaflet or brochure that accompanies the package:

This radiopharmaceutical may be received, possessed and used only by physicians licensed to dispense drugs in the practice of medicine. Its receipt, possession, use and transfer are subject to the regulations and a general license or its equivalent of the NRC or of a state with which NRC has entered into an agreement for the exercise of regulatory authority.

o) Requirements for License to Initially Transfer Source Material for Use Under the "Small Quantities of Source Material" General License

1. An application for a specific license to initially transfer source material for use under Section 330.210 will be approved if:

A) The applicant satisfies the general requirements specified in Section 330.250; and

B) The applicant submits adequate information on the methods to be used for quality control, labeling and providing safety instructions to recipients.

2. Each person licensed under this subsection (o) shall label the immediate container of each quantity of source material with the type and quantity of source material and the words "radioactive material".

3. Each person licensed under this subsection (o) shall ensure that the quantities and concentrations of source material are as labeled and indicated in any transfer records.

4. Each person licensed under this subsection (o) shall provide the information specified in this subsection (o)(4) to each person to whom source material is transferred for use under Section 330.210. This information shall be transferred before the source material is transferred for the first time in each calendar year to the particular recipient. The required information includes:

A) A copy of Sections 330.210 and 330.400; and

B) Appropriate radiation safety precautions and instructions relating to handling, use, storage and disposal of the material.

5. Each person licensed under this subsection (o) shall report transfers as follows:

A) File a report with the Agency that includes the following information:

i) The name, address and license number of the person who transferred the source material;

ii) For each general licensee under Section 330.210 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 and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form and quantity of source material transferred; and

iii) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients.

B) File a report with each responsible Agreement State or NRC, as appropriate, that identifies all persons, operating under provisions equivalent to Section 330.210, to whom greater than 50 grams (0.11 pounds) of source material has been transferred within a single calendar quarter. The report shall include the following information specific to those transfers made to the Agreement State or NRC licensees:

i) The name, address and license number of the person who transferred the source material;

ii) The name and address of the general licensee to whom source material was distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form and quantity of source material transferred; and

iii) 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 NRC jurisdictions.

C) 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 Section 330.210, or equivalent Agreement State or NRC provisions, during the current period, a report shall be submitted to the Agency indicating so. If no transfers have been made to general licensees in a particular Agreement State during the reporting period, this information shall be reported to each responsible Agreement State agency or NRC upon request.

6. Each person licensed under this subsection (o) shall maintain all information that supports the reports required by subsection (o)(5) concerning each transfer to a general licensee for a period of one year after the event is included in a report to the Agreement State agency or NRC.

p) Material Transfer Reports and Records

Each person licensed under subsection (d) to distribute devices to generally licensed persons shall comply with the requirements of this subsection (p).

1. The person shall report:

A) To the Agency and to the responsible regulatory agency all transfers of devices to persons for use under the general license in Section 330.220(a) or the equivalent regulations of NRC or an Agreement State;

B) To the Agency and to the responsible regulatory agency all receipts of devices from persons generally licensed under Section 330.220(a) or the equivalent regulations of NRC or an Agreement State;

C) To the Agency if no transfers were made to or from general licensees during the reporting period; and

D) To the responsible regulatory agency upon the request of the agency if no transfers during the reporting period were made to or from general licensees in the agency's area of jurisdiction.

2. The report shall be on NRC Form 653, "Transfers of Industrial Devices Report", or in a clear and legible format containing all of the information required by the form. The report shall cover each calendar quarter, shall be filed within 30 days after the end of the calendar quarter, and shall clearly indicate the period covered.

3. For a transfer to a general licensee, the report shall provide:

A) The identity of the general licensee by name and mailing address for the location of use. If there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted, along with information on the actual location of use;

B) The name, title and phone number of the individual 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 and serial number of the device transferred; and

E) The radionuclide and activity contained in the device.

4. If one or more intermediate persons will temporarily possess a device at the intended place of use before its possession by the user, the report shall include the same information for both the intended user and each intermediate person and shall clearly designate all intermediate persons.

5. For a device received from a general licensee, the report shall provide the name and address of the general licensee and the type, model and serial number of the device and the date of receipt. For a device not initially transferred by the reporting person, the report shall provide the name of the manufacturer or distributor.

6. If the person makes a change to a device possessed by a general licensee that necessitates a change in the label, the report shall identify the general licensee, the device and the changes to information on the device label.

7. The report shall clearly identify the person licensed under subsection (d) that is furnishing the report and shall include the person's specific license number.

8. The person shall maintain all information concerning transfers and receipts of devices that supports the reports required by this subsection (p). These records shall be maintained for 5 years following the recorded event.

History

• Source: Amended at 46 Ill. Reg. 866, effective December 21, 2021

32 Ill. Adm. Code 330.290 Requirements for Emergency Plans

a) An emergency plan for responding to a release of radioactive material submitted under Section 330.250(e) of this Part shall include the following information:

1. Facility Description. A brief description of the applicant's facility and area near the site.

2. Types of Accidents. An identification of each type of radioactive materials accident for which actions may be needed to protect members of the public.

3. Classification of Accidents. A method for classifying accidents as alerts or site area emergencies as defined below:

A) "Alert" means a condition in which events may occur, are in progress, or have occurred that could lead to a release of radioactive material but in which the release is not expected to require a response by offsite response organizations to protect individuals offsite.

B) "Site area emergency" means a condition in which events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material that could require a response by offsite response organizations to protect individuals offsite.

4. Detection of Accidents. Identification of the means of detecting each type of accident in a timely manner.

5. 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.

6. Assessment of Releases. A brief description of the methods and equipment to assess releases of radioactive materials.

7. Responsibilities

A) The names and titles of the applicant's personnel responsible for developing, maintaining and updating the plan.

B) A brief description of the responsibilities of the applicant's personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations, including the Agency.

C) A list of offsite response organizations and a description of their responsibilities and anticipated actions.

8. Notification and Coordination

A) A brief description of the means, in the event of a classified accident, of promptly notifying and, if necessary, requesting assistance from the offsite response organizations listed pursuant to subsection (a)(7)(C) of this Section. The assistance requested may include, but need not be limited to, medical treatment of contaminated or injured onsite workers.

B) A description or drawing of locations designated as locations from which control and assessment of an accident would be exercised (i.e., control points).

C) Provisions for arranging notification and coordination so that unavailability of some personnel, parts of the facility, or some equipment will not prevent notification and coordination.

9. Information to be Communicated. A brief description of the information to be provided to offsite response organizations, including the Agency, in the event of a classified accident. The types of information to be provided shall include the status of the facility, a description of radioactive releases, the names and telephone numbers of onsite personnel designated as points of contact and recommendations for protective actions.

10. Training

A) A brief description of the performance objectives and plans for annual training that the applicant will provide workers on how to respond to an emergency, including any special instructions and orientation tours that the applicant will provide for fire, police, medical and other emergency personnel.

B) Provisions for familiarizing personnel with site-specific emergency procedures.

C) Provisions for preparing site personnel for their responsibilities for a range of accident scenarios for the specific site, including the use of drills, exercises and team training for such scenarios.

11. Safe Shutdown. A brief description of the means of restoring the facility to a safe condition after an accident.

12. Exercises. Provisions for:

A) Conducting quarterly communications checks with offsite response organizations that include the verification and updating of all necessary phone numbers.

B) Inviting offsite response organizations to participate in biennial exercises.

AGENCY NOTE: Participation of offsite response organizations in biennial exercises, although recommended, is not required.

C) Using accident scenarios postulated as most probable for the specific site.

D) Ensuring that accident scenarios are not known to exercise participants.

E) Providing critiques of each exercise by individuals who have no direct implementation responsibility for the plan.

b) The applicant shall allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the applicant's emergency plan before submitting it to the Agency. Significant amendments to the plan should also be provided to offsite agencies for comment before submission to the Agency. The applicant shall provide any comments received within the 60 days to the Agency with the emergency plan.

c) Hazardous Chemicals. The applicant shall certify to the Agency that it has met its responsibilities under the Emergency Planning and Community Right-to-Know Act of 1986, title III, P.L. 99-499 (42 USC 11001 et seq.), if applicable to the applicant's activities at the proposed place of use of the radioactive material.

d) The licensee shall:

1. Comply with the provisions and descriptions of the emergency plan submitted pursuant to this Section;

2. Review and update the emergency plan:

A) At intervals not to exceed 1 year;

B) Whenever the facility license is revised;

C) Whenever the existing contingency plan fails when actually applied;

D) Whenever the facility changes in a way that materially increases the potential for fires, explosions or releases of waste or waste constituents (e.g., a change of manufactured materials used, a change in facility design) or changes the response necessary in the event of an emergency;

E) Whenever the list of emergency coordinators changes; or

F) Whenever the list of emergency equipment changes.

3. If the contingency plan is amended to comply with subsection (d)(2)(A), (B), (C) or (D) of this Section, the complete plan, as amended, shall be distributed to those entities identified in subsection (d)(4) of this Section. If the plan is amended to comply with subsection (d)(2)(E) or (F) of this Section, only the revised lists need be distributed. Distribution shall be within 30 days after the update is completed.

4. Ensure copies of the contingency plan and all revisions to the plan are:

A) Maintained at the facility;

B) Submitted to the Agency; and

C) Submitted to all local police agencies, fire agencies, hospitals and State and local emergency response teams that might be called upon to provide emergency services.

5. Obtain Agency approval before implementing changes to the plan, except for updates to names, titles and telephone numbers;

6. Provide training at intervals not to exceed 1 year for all personnel with responsibilities for responding to accidents postulated as most probable for the specific site;

7. Conduct biennial onsite exercises to test the response to simulated emergencies;

8. Perform critiques of drills and exercises and ensure that such critiques evaluate the appropriateness of the emergency plan, emergency procedures, facilities, equipment, training of personnel and overall effectiveness of the response;

9. Correct deficiencies noted in critiques of drills and exercises; and

10. Notify offsite response organizations, including the Agency, immediately after the licensee declares an alert or site area emergency.

AGENCY NOTE: The reporting requirement of subsection (d)(10) of this Section does not supersede or relieve licensees from complying with the requirements of the Emergency Planning and Community Right-to-Know Act of 1986, Title III, P.L. 99-499 (42 USC 11001 et seq.) or other State or federal reporting requirements.

History

• Source: Amended at 32 Ill. Reg. 6462, effective April 7, 2008

Chapter II Illinois Emergency Management Agency

Subchapter b Radiation Protection

Part 330 Licensing of Radioactive Material

32 Ill. Adm. Code 330.300 Issuance of Specific Licenses

a) Upon a determination that an application meets the requirements of the Act and the regulations of the Agency, the Agency will issue a specific license authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary.

b) The Agency may incorporate in any license at the time of issuance, or thereafter by appropriate rule, regulation or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use and transfer of radioactive material subject to this Part as it deems appropriate or necessary in order to:

1. Minimize danger to public health and safety or property;

2. Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be appropriate or necessary; and

3. Prevent loss or theft of material subject to this Part.

History

• Source: Amended at 32 Ill. Reg. 6462, effective April 7, 2008

32 Ill. Adm. Code 330.310 Terms and Conditions of Specific and General Licenses

a) Each specific or general license issued pursuant to this Part shall be subject to all applicable license conditions, provisions of the Act, and all applicable rules, regulations and orders of the Agency.

b) Each person granted a general license by this Part shall provide information required by the Agency to track the location and use of generally-licensed radioactive material. The information shall be in the format prescribed by the Agency, shall be complete and accurate, and shall be due within the time frame indicated on the notification. In accordance with 32 Ill. Adm. Code 310.50, the Agency may inspect and investigate premises, operations or personnel and have access to or copy records:

1. Of a person who fails to provide information as required by this subsection (b); or

2. For the purpose of evaluating past, current or potential hazards to the public health, workers or the environment resulting from radiation.

c) No specific license issued or granted to any person pursuant to this Part and no right to possess or use radioactive material granted to any person by any specific license issued pursuant to this Part shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the specific license to any other person unless the Agency:

1. Is provided notification, including the identity and technical qualifications of the proposed transferee, not later than 90 days prior to the transfer;

2. Finds that the proposed transfer, assignment or disposal is in accordance with the provisions of the Act;

3. Consents in writing to the proposed transfer, assignment or disposal; and

4. Finds the transferee, when applicable, to be compliant with the requirements of 32 Ill. Adm. Code 326.

AGENCY NOTE: Agency consent is required prior to any transfer or assignment of a specific license. A purported transfer or assignment without prior written consent may subject the purported transferor or assignor to penalties for violating this Section. Likewise, a purported transferee or assignee may also be subject to penalties if it does not have a valid specific license and possesses radioactive material or performs activities requiring a valid specific license.

d) Upon approval from the Agency under subsection (c)(2) for transfer, assignment or disposal of a specific license, the transferor shall ensure the following information is provided to the transferee:

1. The radioactive material license and all documents referenced in the license;

2. Records maintained in accordance with 32 Ill. Adm. Code 340, Subpart L, inventory records, and any other records required by subsections (k) and (l); and

3. Any other information required by the Agency pursuant to the approval granted.

e) Each person licensed by the Agency pursuant to this Part shall confine use and possession of the material licensed to the locations and purposes authorized in the license and, to the extent practical, conduct operations to minimize the introduction of residual radioactivity into the site and/or facility of operation, including the subsurface.

f) Each person issued a specific license pursuant to this Part shall maintain the license in accordance with the requirements of Section 330.320.

g) When temporary jobsites are authorized on a specific license, radioactive material may be used at temporary jobsites, in areas not under exclusive federal jurisdiction, throughout the State of Illinois.

AGENCY NOTE: Authorization for use of byproduct radioactive materials at jobsites under exclusive federal jurisdiction must be obtained from NRC, either by filing an NRC Form-241 in accordance with 10 CFR 150.20(b), "Recognition of Agreement State Licenses", or by applying for a specific license from NRC. Also, specific licenses issued by the Agency do not authorize activities in other states. Before radioactive materials can be used at a temporary jobsite in another state, a license must be obtained from the appropriate state or federal regulatory agency.

h) Each person issued a specific license pursuant to this Part shall apply for an appropriate license amendment not later than 30 days after a Radiation Safety Officer permanently discontinues performance of duties under the license.

i) Notification

1. Each specific licensee shall notify the Agency in writing not later than 60 days after principal activities involving the use of radioactive materials, including sealed sources and devices, at the site or in a separate building or outdoor area have not occurred for a period of 2 years, and the licensee has not decontaminated the site or properly disposed of the sealed sources or devices.

AGENCY NOTE: Principal activities are those originally authorized on the license for that site or location. For example, licensees could not store radioactive material in an otherwise unused building to avoid end-of-use decommissioning, unless storage was a principal activity for that building.

2. This notification shall include a description of the location of the site, building or outdoor area and a plan for reclaiming or decommissioning these facilities (including a proposed schedule) for release in accordance with applicable regulations. The notification shall include an evaluation of any changes, if required, to financial assurance arrangements submitted in accordance with 32 Ill. Adm. Code 326. Upon approval of the plan by the Agency, implementation shall begin within 6 months and be completed within 24 months after approval (unless the Agency approves a different schedule).

AGENCY NOTE: 32 Ill. Adm. Code 340.1310 requires licensees to notify the Agency no less than 30 days before vacating or relinquishing possession or control of premises that may have been contaminated with radioactive material.

3. For a device with a shutter that is not being used, the shutter shall be locked in the closed position. Testing for proper operation of the on-off mechanism and indicator is not required during the storage period. However, the on-off mechanism and indicator shall be checked before the device is returned to service if the device has not been tested within the required test interval. Tests for leakage of, or contamination by, radioactive material, as applicable to devices in storage, shall be conducted in accordance with 32 Ill. Adm. Code 340.410.

4. A device kept in standby for future use is exempt from the 2-year storage limit if the person performs a quarterly physical inventory of the device while it is in standby. The requirements of subsection (i)(3) shall apply.

j) Notification of Bankruptcy

1. Each specific or general licensee shall notify the Agency, 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 the term is defined in 11 USC 101(15)) controlling the licensee or listing the license or licensee as property of the estate; or

C) An affiliate (as the term is defined in 11 USC 101(2)) of the licensee.

2. This notification shall indicate:

A) The bankruptcy court in which the petition for bankruptcy was filed;

B) The date of the filing of the petition;

C) The chapter under which the bankruptcy petition has been filed;

D) The name, address and phone number of the bankruptcy trustee (if a trustee has been named at the time of the notification);

E) Whether the licensed radiation source remains in the possession and control of the licensee and whether any change in possession or control is expected or contemplated;

F) The name of the person in possession and control of the licensed radiation source if the licensee no longer maintains possession or control; and

G) Whether the Agency has been named in the bankruptcy petition either as a creditor or in some other capacity.

k) Recordkeeping Requirements for Potentially Contaminated Areas. Except for areas containing only sealed sources, provided the sources have not leaked, or no contamination remains after any leakage, and except for areas where only radioactive materials with half-lives less than 90 days were used or stored, each specific licensee shall keep:

1. Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment or site, when contamination remains after any cleanup procedures or when there is reasonable likelihood the contaminants may have spread to inaccessible areas (as in the case of possible seepage into porous materials such as concrete). These records must include the location and any known information on identification of involved radionuclides, quantities, chemical and physical forms, and concentrations.

2. Drawings and subsequent 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 or enclosed pipes, that may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

l) Each licensee shall maintain the following records, if applicable:

1. Records of all areas where low-level radioactive wastes were buried, including areas previously authorized by and documented pursuant to 10 CFR 20.2108.

2. Records of the Agency-approved cost estimate for the amount certified for reclaiming and the associated reclamation plan, for licensees required by 32 Ill. Adm. Code 326 to secure financial assurance arrangements.

3. All records required to be maintained pursuant to 32 Ill. Adm. Code Chapter II, Subchapters b and d.

m) To lawfully obtain termination for a specific license, each licensee shall meet the termination requirements of this Part.

History

• Source: Amended at 46 Ill. Reg. 866, effective December 21, 2021

32 Ill. Adm. Code 330.320 Renewal Requirements for Specific Licenses

a) Each licensee issued a specific license shall maintain a valid specific license until the licensee completes the license termination requirements of Section 330.325 and the Agency has notified the licensee in writing that the specific license is terminated. Each specific license and any amendment to the license issued by the Agency contains an expiration date. Unless the specific license has been terminated in accordance with Section 330.325, the licensee shall, 30 days prior to the expiration date of the license, file with the Agency:

1. A complete application, in proper format, for license renewal as provided in Section 330.240; or

2. A complete application, in proper format, for a license authorizing, at a minimum, continued possession and storage of any radioactive materials possessed under the expiring specific license.

b) In any case in which a licensee, not less than 30 days prior to expiration of an existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, the existing license shall not expire until final action has been taken by the Agency.

AGENCY NOTE: Nothing in this subsection (b) is intended to limit the Agency's authority, if circumstances warrant, to take emergency action in accordance with the Act [420 ILCS 40], or other appropriate action in regard to a specific license in accordance with procedures in 32 Ill. Adm. Code 200.

c) A licensee who fails to comply with the requirements of subsection (a) shall be subject to such civil penalties and sanctions as may be appropriate to the circumstances, in accordance with the Radiation Protection Act and 32 Ill. Adm. Code 310. In addition, if the expiration date passes without license termination requirements having been met by the licensee and without a timely renewal application having been filed by the licensee before the expiration date, the authority of the licensee to engage in licensed activities as specified in the specific license shall expire at the end of the specified expiration date. The passing of the expiration date shall not relieve the licensee of the duties and responsibilities of applying for and maintaining a valid specific license, decommissioning, reclaiming, and meeting the license termination requirements of Section 330.325. Immediately upon the passing of the expiration date, a licensee that has neither met license termination requirements nor filed a timely application under subsection (a) shall:

1. Cease use of radioactive material;

2. Store all radioactive material in a secure location and limit activities involving radioactive material to those necessary for shipping, transferring and disposing of the radioactive material;

3. File either a new application for a specific license or provide information equivalent to that required on Agency Form KLM.007 (Certificate Termination and Disposition or Radioactive Material);

4. Comply with all applicable Agency regulations;

5. Comply with the license conditions of the expired license until either a new license is issued or the termination requirements of Section 330.325 are met; and

6. Comply with any orders issued by the Agency in accordance with the Act and 32 Ill. Adm. Code 200 that result from violation of subsection (a) or any other applicable provisions of Agency regulations or the Act.

History

• Source: Amended at 35 Ill. Reg. 2931, effective February 7, 2011

32 Ill. Adm. Code 330.325 Termination Requirements for Specific Licenses and Locations of Use

a) To lawfully obtain termination of a specific license or a location of use, each licensee shall meet the requirements of this Section no later than the end of the expiration date on the specific license or on any applicable amendment to the specific license unless the licensee has filed an application for renewal in accordance with Section 330.320(a) of this Part prior to the expiration date.

AGENCY NOTE: If the licensee has filed a renewal application in accordance with Section 330.320(a) of this Part and the Agency subsequently denies the application, the Agency shall, in an order issued to the licensee in accordance with the Act, the Illinois Administrative Procedure Act [5 ILCS 100] and 32 Ill. Adm. Code 200, specify the time by which the licensee must meet the requirements of this Section.

b) Requirements for Obtaining Termination of a Specific License, Removal of a Site or Location of Use from a Specific License

1. The licensee shall:

A) Cease use of radioactive material;

B) Remove radioactive contamination to levels considered acceptable for unrestricted use. A site will be considered acceptable for unrestricted use when:

i) Radioactive contamination is removed to levels outlined in 32 Ill. Adm. Code 340.Appendix A; or

ii) The residual radioactivity, excluding radon, thoron and their progeny, that is distinguishable from background radiation does not result in a total effective dose equivalent (TDE) to an average member of the critical group that exceeds 25 mrem (0.25 mSv) 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 that are ALARA must take into account consideration of any detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal;

C) Properly transfer and/or dispose of radioactive material;

D) Submit a completed Agency Form KLM.007 (Certificate Termination and Disposition of Radioactive Material) or provide equivalent information;

E) For licensees authorized to possess sealed sources, submit evidence of transfer and/or disposal of all sealed sources authorized on the license and a copy of the most recent leak test; and

F) For licensees authorized to possess radioactive material in forms other than sealed sources, submit a radiation survey report to confirm the absence of radioactive materials or to establish the levels of residual radioactive contamination, unless the licensee demonstrates the absence of residual radioactive contamination in some other manner. The radiation survey report shall specify the date of the survey and the instrumentation used and shall certify that each instrument was properly calibrated and tested. The licensee shall, as applicable, report levels or quantities of:

i) Beta and gamma radiation at 1 centimeter from surfaces in units, multiples, or subunits of Sieverts or rem per hour;

ii) Gamma radiation at 1 meter from surfaces in units, multiples, or subunits of Sieverts or rem per hour;

iii) Removable radioactivity on surfaces in units, multiples, or subunits of Becquerels or Curies per 100 square centimeters of surface area, or in disintegrations (transformations) per minute per 100 square centimeters of surface area;

iv) Fixed radioactivity on surfaces in units, multiples, or subunits of Becquerels or Curies per 100 square centimeters of surface areas or in disintegrations (transformations) per minute per 100 square centimeters of surface area;

v) Radioactivity in contaminated liquids, such as water, oils or solvents, in units, multiples, or subunits of Becquerels or Curies per milliliter of volume; and

vi) Radioactivity in contaminated solids, such as soils or concrete, in units, multiples, or subunits of Becquerels or Curies per gram of solid.

2. If no residual radioactive contamination attributable to activities conducted under the license is detected, the licensee shall submit a certification that no detectable radioactive contamination was found.

3. If detectable levels or residual radioactive contamination attributable to activities conducted under the license are found, the licensee shall:

A) In addition to the information submitted under subsections (b)(1)(D) and (b)(1)(F) of this Section, submit for Agency approval a plan for reclaiming the facility, including decontamination and removal of residual radioactive contamination;

B) Limit actions involving radioactive material to those approved under the decontamination plan in subsection (b)(3)(A) of this Section;

C) Continue to control entry to restricted areas until they are suitable for release for unrestricted use; and

D) Implement and complete the plan approved under subsection (b)(3)(A) of this Section.

c) When a licensee ends activities authorized under a specific license and has met the termination requirements of subsection (b) of this Section, the licensee shall immediately notify the Agency in writing and request that the license be terminated. This notification and request for termination shall include the documents required by subsection (b) of this Section and shall otherwise substantiate that the licensee has met all of the requirements in subsection (b) of this Section.

d) After receiving a request for license termination pursuant to subsection (c) of this Section, the Agency shall confirm, through such inspections and record reviews as may be necessary, that the licensee has met the requirements of subsection (b) of this Section. Upon confirmation, the Agency shall issue an amendment to terminate the licensee. Until issued the termination amendment, the licensee shall maintain a valid specific license in accordance with Section 330.320 of this Part.

e) A licensee who fails to comply with the pertinent requirements of this Section shall be subject to such civil penalties and sanctions as may be appropriate in accordance with the Act and 32 Ill. Adm. Code 310. The passing of the expiration date shall not relieve the licensee of the duties and responsibilities of applying for and maintaining a valid specific license in accordance with Section 330.320 of this Part, decommissioning, reclaiming, and meeting the license termination requirements of this Section. Immediately upon the passing of the expiration date, a licensee that fails to comply with subsection (a) of this Section shall comply with the requirements of Section 330.320(c) of this Part.

History

• Source: Added at 30 Ill. Reg. 8928, effective April 28, 2006

32 Ill. Adm. Code 330.330 Renewal of Licenses (repealed)

History

• Source: Repealed at 35 Ill. Reg. 2931, effective February 7, 2011

32 Ill. Adm. Code 330.340 Amendment of Licenses at Request of Licensee

a) Applications for amendment of a license shall be filed in accordance with Section 330.240 and shall specify the purpose for which the licensee desires the license to be amended and the grounds for the amendment.

b) Except as otherwise authorized by the Agency, the licensee shall receive an amendment before the licensee:

1. Receives, uses, or transfers radioactive material for a type of use not authorized on the licensee's current license.

2. Adds or changes the Radiation Safety Officer.

3. Receives radioactive material in excess of the license possession limits or in a form not stated on the current license.

4. Adds to or changes areas of use or storage locations, including change of address.

5. Revises procedures identified in the current license.

History

• Source: Amended at 46 Ill. Reg. 866, effective December 21, 2021

32 Ill. Adm. Code 330.350 Agency Action on Application to Renew and Amend

In considering an application by a licensee to renew or amend the license, the Agency will apply the criteria set forth in this Part and 32 Ill. Adm. Code: Chapter II, Subchapters b and d, as applicable.

History

• Source: Amended at 32 Ill. Reg. 6462, effective April 7, 2008

32 Ill. Adm. Code 330.360 Persons Possessing a License for Source, Byproduct, or Special Nuclear Material in Quantities Not Sufficient to Form a Critical Mass on Effective Date of This Part (repealed)

History

• Source: Repealed at 24 Ill. Reg. 8042, effective June 1, 2000

32 Ill. Adm. Code 330.370 Persons Possessing Accelerator-Produced or Naturally-Occurring Radioactive Material on Effective Date of This Part (repealed)

History

• Source: Repealed at 10 Ill. Reg. 17315, effective September 25, 1986

32 Ill. Adm. Code 330.400 Transfer of Material

a) No licensee shall transfer radioactive material except as authorized pursuant to this Section.

b) Except as otherwise provided for in the license and subject to the provisions of subsections (c) and (d), any licensee may transfer radioactive material:

1. To the Agency if prior approval has been granted by the Agency;

2. To the U.S. Department of Energy;

3. To any person exempt from the regulations in this Part to the extent permitted under the exemption;

4. To any person authorized to receive the material under terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State, or to any person otherwise authorized to receive the material by the Federal Government or any agency thereof, the Agency, or an Agreement State; or

5. As otherwise authorized by the Agency in writing.

c) Before transferring radioactive material to a specific licensee of the Agency, the NRC, or an Agreement State or to a general licensee who is required to register with the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State prior to receipt of the radioactive material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the radionuclide, form and activity of radioactive material to be transferred.

d) The following methods for the verification required by subsection (c) are acceptable:

1. The transferor may possess a current copy of the transferee's specific license or registration certificate authorizing the transferee to receive the radionuclide, form and activity of radioactive material to be transferred;

2. The transferor may possess a written certification by the transferee that the transferee is authorized by license or registration certificate to receive the radionuclide, form and activity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency and expiration date;

3. For emergency shipments, the transferor may accept oral certification by the transferee that the transferee is authorized by license or registration certificate to receive the radionuclide, form and activity 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 10 days;

4. The transferor may obtain other information compiled by a reporting service from official records of the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State regarding the identity of licensees and the scope and expiration dates of licenses and registration; or

5. When none of the methods of verification described in subsections (d)(1) through (4) are readily available or when a transferor desires to verify that information received by one of the methods is correct or up-to-date, the transferor may obtain and record confirmation from the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State that the transferee is licensed to receive the radioactive material.

e) Shipment and transport of radioactive material shall be in accordance with the provisions of 32 Ill. Adm. Code 341.

History

• Source: Amended at 48 Ill. Reg. 13634, effective August 29, 2024

32 Ill. Adm. Code 330.500 Modification and Revocation of Licenses

a) The terms and conditions of all licenses shall be subject to amendment, revision, or modification or the license may be suspended or revoked by reason of amendments to the Act, or by reason of rules, regulations, and orders issued by the Agency in accordance with 32 Ill. Adm. Code 200.

b) In accordance with 32 Ill. Adm. Code 200, any license may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or any statement of fact required under provisions of the Act, or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means that would warrant the Agency to refuse to grant a license on an original application, or for violation of, or failure to observe any of the terms and conditions of the Act, or of the license, or of any rule, regulation, or order of the Agency.

History

• Source: Amended at 32 Ill. Reg. 6462, effective April 7, 2008

32 Ill. Adm. Code 330.900 Reciprocal Recognition of Licenses

a) Subject to this Part, any person who holds a specific license from the U.S. Nuclear Regulatory Commission or an Agreement State is hereby granted a general license to conduct the activities authorized in such licensing document within this State, in areas not under exclusive federal jurisdiction, for a period not in excess of 180 days in any 12-month period, provided that:

1. A current copy of the licensing document is on file with the Agency and activities authorized by the document are not limited to specified installations or locations.

2. The out-of-state licensee notifies the Agency by telephone, facsimile, or as otherwise provided in 32 Ill. Adm. Code 310.110 prior to engaging in such activities. Notification shall indicate the following:

A) Contact person

B) Phone number of contact

C) Company name and address

D) Company contact person on-site

E) License number of applicant or registrant

F) Licensing authority

G) Expiration date of applicant's or registrant's license

H) Dates of work at temporary job site

I) Client or facility name and address

K) Client or facility contact person and phone number

L) Proposed use and names of authorized users, their unique identification that can be independently verified (e.g., driver's license number, employee ID, work permit number, etc.), or if no other identification is available, the social security number of the individual; and

M) Device manufacturer, model, radionuclide, source model, and activity.

3. If initial notification was by telephone, the out-of-state licensee shall submit to the Agency, within 10 days following notification, a letter containing the information as specified in subsection (a)(2). Upon receipt from the out-of-state licensee of a written request containing a schedule of activities to be conducted within Illinois, the Agency shall waive the requirement for additional notifications of activities on that schedule during the 12-month period following the receipt of the initial notification from a person engaging in activities under the general license provided in this Section.

4. The out-of-state licensee complies with 32 Ill. Adm. Code: Chapter II and with all the terms and conditions of the licensing document, except any terms and conditions that may be inconsistent with 32 Ill. Adm. Code: Chapter II.

5. The out-of-state licensee supplies other information as the Agency may request to show compliance with 32 Ill. Adm. Code: Chapter II.

6. The out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in this Section, except by transfer to a person:

A) Specifically licensed by the Agency, the U.S. Nuclear Regulatory Commission or another state to receive such material; or

B) Exempt from the requirements for a license for such material under Section 330.40(a).

b) In addition to the provisions of subsection (a), any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State authorizing the holder to manufacture, transfer, install or service a device described in Section 330.220(a) within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate or service the device in this State, provided that:

1. The device has been manufactured, labeled, installed and serviced in accordance with applicable provisions of the specific license issued to such person by the U.S. Nuclear Regulatory Commission or another state;

2. The person shall assure that any labels required to be affixed to the device under regulations of the authority that licensed manufacture of the device bear a statement that "Removal of this label is prohibited".

c) The Agency may withdraw, limit or qualify its acceptance of any specific license issued by the U.S. Nuclear Regulatory Commission or another state, or any product distributed pursuant to the license, if the Agency determines that had the person been licensed in Illinois by the Agency, the license would have been subject to action under Section 330.500.

History

• Source: Amended at 46 Ill. Reg. 866, effective December 21, 2021

32 Ill. Adm. Code 330.950 Nationally Tracked Sources

a) Each licensee who manufactures a nationally tracked source after April 1, 2008 shall assign a unique serial number to each nationally tracked source. Serial numbers shall be composed only of alpha-numeric characters.

b) Each licensee who manufactures a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report shall include the following information:

1. The name, address and license number of the reporting licensee;

2. The name of the individual preparing the report;

3. The manufacturer, model and serial number of the source;

4. The radioactive material in the source;

5. The initial source strength in becquerels (curies) at the time of manufacture; and

6. The manufacture date of the source.

c) Each licensee who transfers a nationally tracked source to another person shall complete and submit a National Source Tracking Transaction Report. The report shall include the following information:

1. The name, address and license number of the reporting licensee;

2. The name of the individual preparing the report;

3. The name and license number of the recipient facility and the shipping address;

4. The manufacturer, model and serial number of the source or, if not available, other information to uniquely identify the source;

5. The radioactive material in the source;

6. The initial or current source strength in becquerels (curies);

7. The date for which the source strength is reported;

8. The shipping date;

9. The estimated arrival date; and

10. For nationally tracked sources transferred as waste under a Uniform Low-Level Radioactive Waste Manifest, the waste manifest number and the container identification with the nationally tracked source.

d) Each licensee who receives a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report shall include the following information:

1. The name, address and license number of the reporting licensee;

2. The name of the individual preparing the report;

3. The name, address and license number of the person who provided the source;

4. The manufacturer, model and serial number of the source or, if not available, other information to uniquely identify the source;

5. The radioactive material in the source;

6. The initial or current source strength in becquerels (curies);

7. The date for which the source strength is reported;

8. The date of receipt; and

9. For material received under a Uniform Low-Level Radioactive Waste Manifest, the waste manifest number and the container identification with the nationally tracked source.

e) Each licensee who disassembles a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report shall include the following information:

1. The name, address and license number of the reporting licensee;

2. The name of the individual preparing the report;

3. The manufacturer, model and serial number of the source or, if not available, other information to uniquely identify the source;

4. The radioactive material in the source;

5. The initial or current source strength in becquerels (curies);

6. The date for which the source strength is reported; and

7. The disassembly date of the source.

f) Each licensee who disposes of a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report shall include the following information:

1. The name, address and license number of the reporting licensee;

2. The name of the individual preparing the report;

3. The waste manifest number;

4. The container identification with the nationally tracked source;

5. The date of disposal; and

6. The method of disposal.

g) The reports discussed in subsections (b) through (f) shall 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 shall be submitted to the National Source Tracking System by using:

1. The on-line National Source Tracking System;

2. Electronic submission in a computer-readable format;

3. Facsimile;

4. Mail to the address on the National Source Tracking Transaction Report Form (NRC Form 748); or

5. Telephone with follow up by facsimile or mail.

h) Each licensee shall correct any error in previously filed reports or file a new report for any missed transaction within 5 business days after discovery of the error or missed transaction. Such errors may be detected by a variety of methods, such as administrative reviews or physical inventories required by regulation. In addition, each licensee shall reconcile the inventory of nationally tracked sources possessed by the licensee against that licensee's data in the National Source Tracking System. The reconciliation shall be conducted during January of each year. The reconciliation process shall include resolving any discrepancies between the National Source Tracking System and the actual inventory by filing the reports identified by subsections (b) through (f). By January 31 of each year, each licensee shall submit to the National Source Tracking System confirmation that the data in the National Source Tracking System is correct.

History

• Source: Amended at 48 Ill. Reg. 13634, effective August 29, 2024

32 Ill. Adm. Code 330.1000 Transportation of Radioactive Material (repealed)

History

• Source: Repealed at 10 Ill. Reg. 17315, effective September 25, 1986

32 Ill. Adm. Code 330.APPENDIX A Exempt Concentrations

Element

(atomic

number)

Isotope

Column I

Gas Concentration1

Column II

Liquid and Solid Concentration2

Bg/ml

microCi/ml

Bg/ml

microCi/ml

Antimony (51)

Sb-122

1.11x101

3x10-4

Sb-124

7.40x100

2x10-4

Sb-125

3.70x101

1x10-3

Argon (18)

Ar-37

3.70x101

1x10-3

Ar-41

1.48x10-2

4x10-7

Arsenic (33)

As-73

1.85x102

5x10-3

As-74

1.85x101

5x10-4

As-76

7.40x100

2x10-4

As-77

2.96x101

8x10-4

Barium (56)

Ba-131

7.40x101

2x10-3

Ba-140

1.11x101

3x10-4

Beryllium (4)

Be-7

7.40x102

2x10-2

Bismuth (83)

Bi-206

1.48x101

4x10-4

Bromine (35)

Br-82

1.48x10-2

4x10-7

1.11x102

3x10-3

Cadmium (48)

Cd-109

7.40x101

2x10-3

Cd-115m

1.11x101

3x10-4

Cd-115

1.11x101

3x10-4

Calcium (20)

Ca-45

3.33x100

9x10-5

Ca-47

1.85x101

5x10-4

Carbon (6)

C-14

3.70x10-2

1x10-6

2.96x102

8x10-3

Cerium (58)

Ce-141

3.33x101

9x10-4

Ce-143

1.48x101

4x10-4

Ce-144

3.70x100

1x10-4

Cesium (55)

Cs-131

7.40x102

2x10-2

Cs-134m

2.22x103

6x10-2

Cs-134

3.3x100

9x10-5

Chlorine (17)

Cl-38

3.33x10-2

9x10-7

1.48x102

4x10-3

Chromium (24)

Cr-51

7.40x102

2x10-2

Cobalt (27)

Co-57

1.85x102

5x10-3

Co-58

3.70x101

1x10-3

Co-60

1.85x101

5x10-4

Copper (29)

Cu-64

1.11x102

3x10-3

Element

(atomic

number)

Isotope

Column I

Gas Concentration1

Column II

Liquid and Solid Concentration2

Bg/ml

microCi/ml

Bg/ml

microCi/ml

Dysprosium (66)

Dy-165

1.48x102

4x10-3

Dy-166

1.48x101

4x10-4

Erbium (68)

Er-169

3.33x101

9x10-4

Er-171

3.70x101

1x10-3

Europium (63)

Eu-152

2.22x101

6x10-4

(9.2h)

Eu-155

7.40x101

2x10-3

Fluorine (9)

F-18

7.40x10-2

2x10-6

2.96x102

8x10-3

Gadolinium (64)

Gd-153

7.40x101

2x10-3

Gd-159

2.96x101

8x10-4

Gallium (31)

Ga-72

1.48x101

4x10-4

Germanium (32)

Ge-71

7.40x102

2x10-2

Gold (79)

Au-196

7.40x101

2x10-3

Au-198

1.85x101

5x10-4

Au-199

7.40x101

2x10-3

Hafnium (72)

Hf-181

2.59x101

7x10-4

Hydrogen (1)

H-3

1.85x10-1

5x10-6

1.11x103

3x10-2

Indium (49)

In-113m

3.70x102

1x10-2

In-114m

7.40x100

2x10-4

Iodine (53)

I-126

1.11x10-4

3x10-9

7.40x10-1

2x10-5

I-131

1.11x10-4

3x10-9

7.40x10-1

2x10-5

I-132

2.96x10-3

8x10-8

2.22x101

6x10-4

I-133

3.70x10-4

1x10-8

2.59x100

7x10-5

I-134

7.40x10-3

2x10-7

3.70x101

1x10-3

Iridium (77)

Ir-190

7.40x101

2x10-3

Ir-192

1.48x101

4x10-4

Ir-194

1.11x101

3x10-4

Iron (26)

Fe-55

2.96x102

8x10-3

Fe-59

2.22x101

6x10-4

Krypton (36)

Kr-85m

3.70x10-2

1x10-6

Kr-85

1.11x10-1

3x10-6

Lanthanum (57)

La-140

7.40x100

2x10-4

Lead (82)

Pb-203

1.48x102

4x10-3

Element

(atomic

number)

Isotope

Column I

Gas Concentration1

Column II

Liquid and Solid Concentration2

Bg/ml

microCi/ml

Bg/ml

microCi/ml

Lutetium (71)

Lu-177

3.70x101

1x10-3

Manganese (25)

Mn-52

1.11x101

3x10-4

Mn-54

3.70x101

1x10-3

Mn-56

3.70x101

1x10-3

Mercury (80)

Hg-197m

7.40x101

2x10-3

Hg-197

1.11x102

3x10-3

Hg-203

7.40x100

2x10-4

Molybdenum (42)

Mo-99

7.40x101

2x10-3

Neodymium (60)

Nd-147

2.22x101

6x10-4

Nd-149

1.11x102

3x10-3

Nickel (28)

Ni-65

3.70x101

1x10-3

Niobium

3.70x101

1x10-3

(Columbium)

Nb-95

(41)

Nb-97

3.33x102

9x10-3

Osmium (76)

Os-185

2.59x101

7x10-4

Os-191m

1.11x103

3x10-2

Os-191

7.40x101

2x10-3

Os-193

2.22x101

6x10-4

Palladium (46)

Pd-103

1.11x102

3x10-3

Pd-109

3.33x101

9x10-4

Phosphorus (15)

P-32

7.40x100

2x10-4

Platinum (78)

Pt-191

3.70x101

1x10-3

Pt-193m

3.70x102

1x10-2

Pt-197m

3.70x102

1x10-2

Pt-197

3.70x101

1x10-3

Potassium (19)

K-42

1.11x102

3x10-3

Praseodymium (59)

Pr-142

1.11x101

3x10-4

Pr-143

1.85x101

5x10-4

Promethium (61)

Pm-147

7.40x101

2x10-3

Pm-149

1.48x101

4x10-4

Rhenium (75)

Re-183

2.22x102

6x10-3

Re-186

3.33x101

9x10-4

Re-188

2.22x101

1x10-4

Rhodium (45)

Rh-103m

3.70x103

1x10-1

Rh-105

3.70x101

1x10-3

Element

(atomic

number)

Isotope

Column I

Gas Concentration1

Column II

Liquid and Solid Concentration2

Bg/ml

microCi/ml

Bg/ml

microCi/ml

Rubidium (37)

Rb-86

2.59x101

7x10-4

Ruthenium (44)

Ru-97

1.48x102

4x10-3

Ru-103

2.96x101

8x10-4

Ru-105

3.70x101

1x10-3

Ru-106

3.70x100

1x10-4

Samarium (62)

Sm-153

2.96x101

8x10-4

Scandium (21)

Sc-46

1.48x101

4x10-4

Sc-47

3.33x101

9x10-4

Sc-48

1.11x101

3x10-4

Selenium (34)

Se-75

1.11x102

3x10-3

Silicon (14)

Si-31

3.33x102

9x10-3

Silver (47)

Ag-105

3.70x101

1x10-3

Ag-110m

1.11x101

3x10-4

Ag-111

1.48x101

4x10-4

Sodium (11)

Na-24

7.40x101

2x10-3

Strontium (38)

Sr-85

3.70x101

1x10-3

Sr-89

3.70x100

1x10-4

Sr-91

2.59x101

7x10-4

Sr-92

2.59x101

7x10-4

Sulfur (16)

S-35

2.22x101

6x10-4

Tantalum (73)

Ta-182

1.48x101

4x10-4

Technetium (43)

Tc-96m

3.70x103

1x10-1

Tc-96

3.70x101

1x10-3

Tellurium (52)

Te-125m

7.40x101

2x10-3

Te-127m

2.22x101

6x10-4

Te-127

1.11x102

3x10-3

Te-129m

1.11x101

3x10-4

Te-131m

2.22x101

6x10-4

Te-132

1.11x101

3x10-4

Terbium (65)

Tb-160

1.48x101

4x10-4

Thallium (81)

Tl-200

1.48x101

4x10-3

Tl-201

1.11x102

3x10-3

Tl-202

3.70x101

1x10-3

Tl-204

3.70x101

1x10-3

Element

(atomic

number)

Isotope

Column I

Gas Concentration1

Column II

Liquid and Solid Concentration2

Bg/ml

microCi/ml

Bg/ml

microCi/ml

Thulium (69)

Tm-170

1.85x101

5x10-4

Tm-171

1.85x102

5x10-3

Tin (50)

Sn-113

3.33x101

9x10-4

Sn-125

7.40x100

2x10-4

Tungsten

W-181

1.48x102

4x10-3

(Wolfram) (74)

W-187

2.59x101

7x10-4

Vanadium (23)

V-48

1.11x101

3x10-4

Xenon (54)

Xe-131m

1.48x10-1

4x10-6

Xe-133

1.11x10-1

3x10-6

X3-135

3.70x10-2

1x10-6

Ytterbium (70)

Yb-175

3.70x101

1x10-3

Yttrium (39)

Y-90

7.40x100

2x10-4

Y-91m

1.11x103

3x10-2

Y-91

1.11x101

3x10-4

Y-92

2.22x101

6x10-4

Y-93

1.11x101

3x10-4

Zinc (30)

Zn-65

3.70x101

1x10-3

Zn-69m

2.59x101

7x10-4

Zn-69

7.40x102

2x10-2

Zirconium (40)

Zr-95

2.22x101

6x10-4

Zr-97

7.40x100

2x10-4

Beta-and/or gamma-emitting radioactive material not listed above with half-life of less than 3 years.

3.70x10-6

1x10-10

3.70x102

1x10-6

1 Values are given in Column I only for those materials normally used as gases.

2 Bq or microCi/g for solids.

NOTE 1: Many radionuclides transform into nuclides that are also radioactive. In expressing the concentrations in this Appendix, the activity stated is that of the parent radionuclide and takes into account the daughters.

NOTE 2: For purposes of Section 330.40 where there is involved a combination of radionuclides, the limit for the combination should be derived as follows: Determine for each radionuclide in the product the ratio between the radioactivity concentration present in the product and the exempt radioactivity concentration established in this Appendix for the radionuclide when not in combination. The sum of such ratios may not exceed "1".

EXAMPLE:

Concentration of Nuclide A in Product

Concentration of Nuclide B in Product

≤ 1

Exempt Concentration of Nuclide A

Exempt Concentration of Nuclide B

History

• Source: Amended at 35 Ill. Reg. 2931, effective February 7, 2011

32 Ill. Adm. Code 330.APPENDIX B Exempt Quantities

Radioactive Material

kBq

microCi

Antimony-122

(Sb-122)

3,700

100

Antimony-124

(Sb-124)

370

10

Antimony-125

(Sb-125)

370

10

Arsenic-73

(As-73)

3,700

100

Arsenic-74

(As-74)

370

10

Arsenic-76

(As-76)

370

10

Arsenic-77

(As-77)

3,700

100

Barium-131

(Ba-131)

370

10

Barium-133

(Ba-133)

370

10

Barium-140

(Ba-140)

370

10

Bismuth-210

(Bi-210)

37

1

Bromine-82

(Br-82)

370

10

Cadmium-109

(Cd-109)

370

10

Cadmium-115m

(Cd-115m)

370

10

Cadmium-115

(Cd-115)

3,700

100

Calcium-45

(Ca-45)

370

10

Calcium-47

(Ca-47)

370

10

Carbon-14

(C-14)

3,700

100

Cerium-141

(Ce-141)

3,700

100

Cerium-143

(Ce-143)

3,700

100

Cerium-144

(Ce-144)

37

1

Cesium-129

(Cs-129)

3,700

100

Cesium-131

(Cs-131)

37,000

1,000

Cesium-134m

(Cs-134m)

3,700

100

Cesium-134

(Cs-134)

37

1

Cesium-135

(Cs-135)

370

10

Cesium-136

(Cs-136)

370

10

Cesium-137

(Cs-137)

370

10

Chlorine-36

(Cl-36)

370

10

Chlorine-38

(Cl-38)

370

10

Chromium-51

(Cr-51)

37,000

1,000

Cobalt-57

(Co-57)

3,700

100

Cobalt-58m

(Co-58m)

370

10

Cobalt-58

(Co-58)

370

10

Cobalt-60

(Co-60)

37

1

Copper-64

(Cu-64)

3,700

100

Dysprosium-165

(Dy-165)

370

10

Dysprosium-166

(Dy-166)

3,700

100

Erbium-169

(Er-169)

3,700

100

Erbium-171

(Er-171)

3,700

100

Europium-152

(Eu-152)(9.2h)

3,700

100

Europium-152

(Eu-152)(13 yr)

37

1

Radioactive Material

kBq

microCi

Europium-154

(Eu-154)

37

1

Europium-155

(Eu-155)

370

10

Fluorine-18

(F-18)

37,000

1,000

Gadolinium-153

(Gd-153)

370

10

Gadolinium-159

(Gd-159)

3,700

100

Gallium-67

(Ga-67)

3,700

100

Gallium-72

(Ga-72)

370

10

Germanium-68

(Ge-68)

370

10

Germanium-71

(Ge-71)

3,700

100

Gold-195

(Au-195)

370

10

Gold-198

(Au-198)

3,700

100

Gold-199

(Au-199)

3,700

100

Hafnium-181

(Hf-181)

370

10

Holmium-166

(Ho-166)

3,700

100

Hydrogen-3

(H-3)

37,000

1,000

Indium-111

(In-111)

3,700

100

Indium-113m

(In-113m)

3,700

100

Indium-114m

(In-114m)

370

10

Indium-115m

(In-115m)

3,700

100

Indium-115

(In-115)

370

10

Iodine-123

(I-123)

3,700

100

Iodiue-125

(I-125)

37

1

Iodine-126

(I-126)

37

1

Iodine-129

(I-129)

3.7

0.1

Iodine-131

(I-131)

37

1

Iodine-132

(I-132)

370

10

Iodine-133

(I-133)

37

1

Iodine-134

(I-134)

370

10

Iodine-135

(I-135)

370

10

Iridium-192

(Ir-192)

370

10

Iridium-194

(Ir-194)

3,700

100

Iron-52

(Fe-52)

370

10

Iron-55

(Fe-55)

3,700

100

Iron-59

(Fe-59)

370

10

Krypton-85

(Kr-85)

3,700

100

Krypton-87

(Kr-87)

370

10

Lanthanum-140

(La-140)

370

10

Lutetium-177

(Lu-177)

3,700

100

Manganese-52

(Mn-52)

370

10

Manganese-54

(Mn-54)

370

10

Manganese-56

(Mn-56)

370

10

Mercury-197m

(Hg-197m)

3,700

100

Mercury-197

(Hg-197)

3,700

100

Mercury-203

(Hg-203)

370

10

Radioactive Material

kBq

microCi

Molybdenum-99

(Mo-99)

3,700

100

Neodymium-147

(Nd-147)

3,700

100

Neodymium-149

(Nd-149)

3,700

100

Nickel-59

(Ni-59)

3,700

100

Nickel-63

(Ni-63)

370

10

Nickel-65

(Ni-65)

3,700

100

Niobium-93m

(Nb-93m)

370

10

Niobium-95

(Nb-95)

370

10

Niobium-97

(Nb-97)

370

10

Osmium-185

(Os-185)

370

10

Osmium-191m

(Os-191m)

3,700

100

Osmium-191

(Os-191)

3,700

100

Osmium-193

(Os-193)

3,700

100

Palladium-103

(Pd-103)

3,700

100

Palladium-109

(Pd-109)

3,700

100

Phosphorus-32

(P-32)

370

10

Platinum-191

(Pt-191)

3,700

100

Platinum-193m

(Pt-193m)

3,700

100

Platinum-193

(Pt-193)

3,700

100

Platinum-197m

(Pt-197m)

3,700

100

Platinum-197

(Pt-197)

3,700

100

Polonium-210

(Po-210)

3.7

0.1

Potassium-42

(K-42)

370

10

Potassium-43

(K-43)

370

10

Praseodymium-142

(Pr-142)

3,700

100

Praseodymium-143

(Pr-143)

3,700

100

Promethium-147

(Pm-147)

370

10

Promethium-149

(Pm-149)

370

10

Rhenium-186

(Re-186)

3,700

100

Rhenium-188

(Re-188)

3,700

100

Rhodium-103m

(Rh-103m)

3,700

100

Rhodium-105

(Rh-105)

3,700

100

Rubidium-81

(Rb-81)

370

10

Rubidium-86

(Rb-86)

370

10

Rubidium-87

(Rb-87)

370

10

Ruthenium-97

(Ru-97)

3,700

100

Ruthenium-103

(Ru-103)

370

10

Ruthenium-105

(Ru-105)

370

10

Ruthenium-106

(Ru-106)

37

1

Samarium-151

(Sm-151)

370

10

Samarium-153

(Sm-153)

3,700

100

Scandium-46

(Sc-46)

370

10

Scandium-47

(Sc-47)

3,700

100

Scandium-48

(Sc-48)

370

10

Radioactive Material

kBq

microCi

Selenium-75

(Se-75)

370

10

Silicon-31

(Si-31)

3,700

100

Silver-105

(Ag-105)

370

10

Silver-110m

(Ag-110m)

37

1

Silver-111

(Ag-111)

3,700

100

Sodium-22

(Na-22)

370

10

Sodium-24

(Na-24)

370

10

Strontium-85

(Sr-85)

370

10

Strontium-89

(Sr-89)

37

1

Strontium-90

(Sr-90)

3.7

0.1

Strontium-91

(Sr-91)

370

10

Strontium-92

(Sr-92)

370

10

Sulfur-35

(S-35)

3,700

100

Tantalum-182

(Ta-182)

370

10

Technetium-96

(Tc-96)

370

10

Technetium-97m

(Tc-97m)

3,700

100

Technetium-97

(Tc-97)

3,700

100

Technetium-99m

(Tc-99m)

3,700

100

Technetium-99

(Tc-99)

370

10

Tellurium-125m

(Te-125m)

370

10

Tellurium-127m

(Te-127m)

370

10

Tellurium-127

(Te-127)

3,700

100

Tellurium-129m

(Te-129m)

370

10

Tellurium-129

(Te-129)

3,700

100

Tellurium-131m

(Te-131m)

370

10

Tellurium-132

(Te-132)

370

10

Terbium-160

(Tb-160)

370

10

Thallium-200

(Tl-200)

3,700

100

Thallium-201

(Tl-201)

3,700

100

Thallium-202

(Tl-202)

3,700

100

Thallium-204

(Tl-204)

370

10

Thulium-170

(Tm-170)

370

10

Thulium-171

(Tm-171)

370

10

Tin-113

(Sn-113)

370

10

Tin-125

(Sn-125)

370

10

Tungsten-181

(W-181)

370

10

Tungsten-185

(W-185)

370

10

Tungsten-187

(W-187)

3,700

100

Vanadium-48

(V-48)

370

10

Xenon-131m

(Xe-131m)

37,000

1,000

Xenon-133

(Xe-133)

3,700

100

Xenon-135

(Xe-135)

3,700

100

Ytterbium-175

(Yb-175)

3,700

100

Yttrium-87

(Y-87)

370

10

Radioactive Material

kBq

microCi

Yttrium-88

(Y-88)

370

10

Yttrium-90

(Y-90)

370

10

Yttrium-91

(Y-91)

370

10

Yttrium-92

(Y-92)

3,700

100

Yttrium-93

(Y-93)

3,700

100

Zinc-65

(Zn-65)

370

10

Zinc-69m

(Zn-69m)

3,700

100

Zinc-69

(Zn-69)

37,000

1,000

Zirconium-93

(Zr-93)

370

10

Zirconium-95

(Zr-95)

370

10

Zirconium-97

(Zr-97)

370

10

Any radioactive material not listed above other than alpha-emitting radioactive material

3.7

0.1

History

• Source: Amended at 18 Ill. Reg. 5553, effective March 29, 1994

32 Ill. Adm. Code 330.APPENDIX C Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release

Section 330.TABLE A Group I (Repealed)

History

• Source: Repealed at 10 Ill. Reg. 1511, effective September 25, 1986

32 Ill. Adm. Code 330.APPENDIX C Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release

Section 330.TABLE B Group II (Repealed)

History

• Source: Repealed at 10 Ill. Reg. 1511, effective September 25, 1986

32 Ill. Adm. Code 330.APPENDIX C Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release

Section 330.TABLE D Group IV (Repealed)

History

• Source: Repealed at 10 Ill. Reg. 1511, effective September 25, 1986

32 Ill. Adm. Code 330.APPENDIX C Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release

Section 330.TABLE E Group V (Repealed)

History

• Source: Repealed at 10 Ill. Reg. 1511, effective September 25, 1986

32 Ill. Adm. Code 330.APPENDIX C Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release

Section 330.TABLE F Group VI (Repealed)

History

• Source: Repealed at 10 Ill. Reg. 1511, effective September 25, 1986

32 Ill. Adm. Code 330.APPENDIX C Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release

Radioactive Material1

Release

Fraction

Quantity

(GBq)

Quantity

(Ci)

Actinium-228

0.001

148,000

4,000

Americium-241

0.001

74

2

Americium-242

0.001

74

2

Americium-243

0.001

74

2

Antimony-124

0.01

148,000

4,000

Antimony-126

0.01

222,000

6,000

Barium-133

0.01

370,000

10,000

Barium-140

0.01

1,110,000

30,000

Bismuth-207

0.01

185,000

5,000

Bismuth-210

0.01

22,200

600

Cadmium-109

0.01

37,000

1,000

Cadmium-113

0.01

2,960

80

Calcium-45

0.01

740,000

20,000

Californium-252

0.001

333

9 (20mg)

Carbon-14 (Non-CO2)

0.01

1,850,000

50,000

Cerium-141

0.01

370,000

10,000

Cerium-144

0.01

11,100

300

Cesium-134

0.01

74,000

2,000

Cesium-137

0.01

111,000

3,000

Chlorine-36

0.5

3,700

100

Chromium-51

0.01

11,100,000

300,000

Cobalt-60

0.001

185,000

5,000

Copper-64

0.01

7,400,000

200,000

Curium-242

0.001

2,220

60

Curium-243

0.001

110

3

Curium-244

0.001

148

4

Curium-245

0.001

74

2

Europium-152

0.01

18,500

500

Europium-154

0.01

14,800

400

Europium-155

0.01

111,000

3,000

Gadolinium-153

0.01

185,000

5,000

Germanium-68

0.01

74,000

2,000

Gold-198

0.01

1,110,000

30,000

Hafnium-172

0.01

14,800

400

Hafnium-181

0.01

259,000

7,000

Holmium-166m

0.01

3,700

100

Hydrogen-3

0.5

740,000

20,000

Indium-114m

0.01

37,000

1,000

Iodine-125

0.5

370

10

Iodine-131

0.5

370

10

Iridium-192

0.001

1,480,000

40,000

Iron-55

0.01

1,480,000

40,000

Iron-59

0.01

259,000

7,000

Krypton-85

1.0

222,000,000

6,000,000

Lead-210

0.01

296

8

Manganese-56

0.01

2,220,000

60,000

Mercury-203

0.01

370,000

10,000

Molybdenum-99

0.01

1,110,000

30,000

Neptunium-237

0.001

74

2

Nickel-63

0.01

740,000

20,000

Niobium-94

0.01

11,100

300

Phosphorus-32

0.5

3,700

100

Phosphorus-33

0.5

37,000

1,000

Polonium-210

0.01

370

10

Potassium-42

0.01

333,000

9,000

Promethium-145

0.01

148,000

4,000

Promethium-147

0.01

148,000

4,000

Radium-226

0.001

3,700

100

Ruthenium-106

0.01

7,400

200

Samarium-151

0.01

148,000

4,000

Scandium-46

0.01

111,000

3,000

Selenium-75

0.01

370,000

10,000

Silver-110m

0.01

37,000

1,000

Sodium-22

0.01

333,000

9,000

Sodium-24

0.01

370,000

10,000

Strontium-89

0.01

111,000

3,000

Strontium-90

0.01

3,330

90

Sulfur-35

0.5

33,300

900

Technetium-99

0.01

370,000

10,000

Technetium-99m

0.01

14,800,000

400,000

Tellurium-127m

0.01

185,000

5,000

Tellurium-129m

0.01

185,000

5,000

Terbium-160

0.01

148,000

4,000

Thulium-170

0.01

148,000

4,000

Tin-113

0.01

370,000

10,000

Tin-123

0.01

111,000

3,000

Tin-126

0.01

37,000

1,000

Titanium-44

0.01

3,700

100

Vanadium-48

0.01

259,000

7,000

Xenon-133

1.0

33,300,000

900,000

Yttrium-91

0.01

74,000

2,000

Zinc-65

0.01

185,000

5,000

Zirconium-93

0.01

14,800

400

Zirconium-95

0.01

185,000

5,000

Any other beta-gamma emitter

0.01

370,000

10,000

Mixed fission products

0.01

37,000

1,000

Mixed corrosion products

0.01

370,000

10,000

Contaminated equipment, beta-gamma

0.001

370,000

10,000

Irradiated material, any form other than

solid noncombustible

0.01

37,000

1,000

Irradiated material, solid noncombustible

0.001

370,000

10,000

Mixed radioactive waste,2 beta-gamma

0.01

37,000

1,000

Packaged mixed waste, 2 beta-gamma

0.001

370,000

10,000

Any other alpha emitter

0.001

74

2

Contaminated equipment, Alpha

0.0001

740

20

Packaged waste, alpha2

0.0001

740

20

1 For combinations of radioactive materials, the licensee is required to consider whether an emergency plan is needed if the sum of the ratios of the quantity of each radioactive material authorized to the quantity listed for that material above exceeds one.

2 Waste packaged in Type B containers does not require an emergency plan.

History

• Source: Amended at 35 Ill. Reg. 2931, effective February 7, 2011

32 Ill. Adm. Code 330.APPENDIX D Limits for Licenses of Broad Scope (section 330.270)

Column I

Column II

Radioactive Material

GBq

Ci

GBq

Ci

Antimony-122

37

1

0.37

0.01

Antimony-124

37

1

0.37

0.01

Antimony-125

37

1

0.37

0.01

Arsenic-73

370

10

3.7

0.1

Arsenic-74

37

1

0.37

0.01

Arsenic-76

37

1

0.37

0.01

Arsenic-77

370

10

3.7

0.1

Barium-131

370

10

3.7

0.1

Barium-140

37

1

0.37

0.01

Beryllium-7

370

10

3.7

0.1

Bismuth-210

3.7

0.1

0.037

0.001

Bromine-82

370

10

3.7

0.1

Cadmium-109

37

1

0.37

0.01

Cadmium-115m

37

1

0.37

0.01

Cadmium-115

370

10

3.7

0.1

Calcium-45

37

1

0.37

0.01

Calcium-47

370

10

3.7

0.1

Carbon-14

3,700

100

37

Cerium-141

370

10

3.7

0.1

Cerium-143

370

10

3.7

0.1

Cerium-144

3.7

0.1

0.037

0.001

Cesium-131

3,700

100

37

1

Cesium-134m

3,700

100

37

1

Cesium-134

3.7

0.1

0.037

0.001

Cesium-135

37

1

0.37

0.01

Cesium-136

370

10

3.7

0.1

Cesium-137

3.7

0.1

0.037

0.001

Chlorine-36

37

1

0.37

0.01

Chlorine-38

3,700

100

37

Chromium-51

3,700

100

37

Cobalt-57

370

10

3.7

0.1

Cobalt-58m

3,700

100

37

Cobalt-58

37

1

0.37

0.01

Cobalt-60

3.7

0.1

0.037

0.001

Copper-64

370

10

3.7

0.1

Dysprosium-165

3,700

100

37

Dysprosium-166

370

10

3.7

0.1

Erbium-169

370

10

3.7

0.1

Erbium-171

370

10

3.7

0.1

Europium-152 (9.2 h)

370

10

3.7

0.1

Europium-152 (13 y)

3.7

0.1

0.037

0.001

Europium-154

3.7

0.1

0.037

0.001

Europium-155

37

1

0.37

0.01

Fluorine-18

3,700

100

37

Gadolinium-153

37

1

0.37

0.01

Gadolinium-159

370

10

3.7

0.1

Gallium-72

370

10

3.7

0.1

Germanium-71

3,700

100

37

Gold-198

370

10

3.7

0.1

Gold-199

370

10

3.7

0.1

Hafnium-181

37

1

0.37

0.01

Holmium-166

370

10

3.7

0.1

Hydrogen-3

3,700

100

37

Indium-113m

3,700

100

37

Indium-114m

37

1

0.37

0.01

Indium-115m

3,700

100

37

Indium-115

37

1

0.37

0.01

Iodine-125

3.7

0.1

0.037

0.001

Iodine-126

3.7

0.1

0.037

0.001

Iodine-129

3.7

0.1

0.037

0.001

Iodine-131

3.7

0.1

0.037

0.001

Iodine-132

370

10

3.7

0.1

Iodine-133

37

1

0.37

0.01

Iodine-134

370

10

3.7

0.1

Iodine-135

37

1

0.37

0.01

Iridium-192

37

1

0.37

0.01

Iridium-194

370

10

3.7

0.1

Iron-55

370

10

3.7

0.1

Iron-59

37

1

0.37

0.01

Krypton-85

3,700

100

37

Krypton-87

370

10

3.7

0.1

Lanthanum-140

37

1

0.37

0.01

Lutetium-177

370

10

3.7

0.1

Manganese-52

37

1

0.37

0.01

Manganese-54

37

1

0.37

0.01

Manganese-56

370

10

3.7

0.1

Mercury-197m

370

10

3.7

0.1

Mercury-197

370

10

3.7

0.1

Mercury-203

37

1

0.37

0.01

Molybdenum-99

370

10

3.7

0.1

Neodymium-147

370

10

3.7

0.1

Neodymium-149

370

10

3.7

0.1

Nickel-59

370

10

3.7

0.1

Nickel-63

37

1

0.37

0.01

Nickel-65

370

10

3.7

0.1

Niobium-93m

37

1

0.37

0.01

Niobium-95

37

1

0.37

0.01

Niobium-97

3,700

100

37

Osmium-185

37

1

0.37

0.01

Osmium-191m

3,700

100

37

Osmium-191

370

10

3.7

0.1

Osmium-193

370

10

3.7

0.1

Palladium-103

370

10

3.7

0.1

Palladium-109

370

10

3.7

0.1

Phosphorus-32

37

1

0.37

0.01

Platinum-191

370

10

3.7

0.1

Platinum-193m

3,700

100

37

Platinum-193

370

10

3.7

0.1

Platinum-197m

3,700

100

37

Platinum-197

370

10

3.7

0.1

Polonium-210

0.37

0.01

0.0037

0.0001

Potassium-42

37

1

0.37

0.01

Praseodymium-142

370

10

3.7

0.1

Praseodymium-143

370

10

3.7

0.1

Promethium-147

37

1

0.37

0.01

Promethium-149

370

10

3.7

0.1

Radium-226

0.37

0.01

0.0037

0.0001

Rhenium-186

370

10

3.7

0.1

Rhenium-188

370

10

3.7

0.1

Rhodium-103m

37,000

1,000

370

Rhodium-105

370

10

3.7

0.1

Rubidium-86

37

1

0.37

0.01

Rubidium-87

37

1

0.37

0.01

Ruthenium-97

3,700

100

37

Ruthenium-103

37

1

0.37

0.01

Ruthenium-105

370

10

3.7

0.1

Ruthenium-106

3.7

0.1

0.037

0.001

Samarium-151

37

1

0.37

0.01

Samarium-153

370

10

3.7

0.1

Scandium-46

37

1

0.37

0.01

Scandium-47

370

10

3.7

0.1

Scandium-48

37

1

0.37

0.01

Selenium-75

37

1

0.37

0.01

Silicon-31

370

10

3.7

0.1

Silver-105

37

1

0.37

0.01

Silver-110m

3.7

0.1

0.037

0.001

Silver-111

370

10

3.7

0.1

Sodium-22

3.7

0.1

0.037

0.001

Sodium-24

37

1

0.37

0.01

Strontium-85m

37,000

1,000

370

10

Strontium-85

37

1

0.37

0.01

Strontium-89

37

1

0.37

0.01

Strontium-90

0.37

0.01

0.0037

0.0001

Strontium-91

370

10

3.7

0.1

Strontium-92

370

10

3.7

0.1

Sulfur-35

370

10

3.7

0.1

Tantalum-182

37

1

0.37

0.01

Technetium-96

370

10

3.7

0.1

Technetium-97m

370

10

3.7

0.1

Technetium-97

370

10

3.7

0.1

Technetium-99m

3,700

100

37

Technetium-99

37

1

0.37

0.01

Tellurium-125m

37

1

0.37

0.01

Tellurium-127m

37

1

0.37

0.01

Tellurium-127

370

10

3.7

0.1

Tellurium-129m

37

1

0.37

0.01

Tellurium-129

3,700

100

37

Tellurium-131m

370

10

3.7

0.1

Tellurium-132

37

1

0.37

0.01

Terbium-160

37

1

0.37

0.01

Thallium-200

370

10

3.7

0.1

Thallium-201

370

10

3.7

0.1

Thallium-202

370

10

3.7

0.1

Thallium-204

37

1

0.37

0.01

Thulium-170

37

1

0.37

0.01

Thulium-171

37

1

0.37

0.01

Tin-113

37

1

0.37

0.01

Tin-125

37

1

0.37

0.01

Tungsten-181

37

1

0.37

0.01

Tungsten-185

37

1

0.37

0.01

Tungsten-187

370

10

3.7

0.1

Vanadium-48

37

1

0.37

0.01

Xenon-131m

37,000

1,000

370

Xenon-133

3,700

100

37

Xenon-135

3,700

100

37

Ytterbium-175

370

10

3.7

0.1

Yttrium-90

37

1

0.37

0.01

Yttrium-91

37

1

0.37

0.01

Yttrium-92

370

10

3.7

0.1

Yttrium-93

37

1

0.37

0.01

Zinc-65

37

1

0.37

0.01

Zinc-69m

370

10

3.7

0.1

Zinc-69

3,700

100

37

Zirconium-93

37

1

0.37

0.01

Zirconium-95

37

1

0.37

0.01

Zirconium-97

37

1

0.37

0.01

Any radioactive material other than source material, special nuclear material, or alpha emitting radioactive material not listed above.

3.7

0.1

0.037

0.001

History

• Source: Amended at 46 Ill. Reg. 866, effective December 21, 2021

32 Ill. Adm. Code 330.APPENDIX E List of Specialty Board Certifications Recognized by the Agency Until October 24, 2007 (repealed)

History

• Source: Repealed at 32 Ill. Reg. 9199, effective June 13, 2008

32 Ill. Adm. Code 330.APPENDIX F 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

Category 1

Category 2

Category 2

(TBq)

(Ci)

(TBq)

(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

27

Gadolinium-153

1,000

27,000

10

270

Iridium-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

• Source: Added at 32 Ill. Reg. 6462, effective April 7, 2008

32 Ill. Adm. Code 330.APPENDIX G Financial Surety Arrangements (section 330.250(c)(1)(d)) (repealed)

History

• Source: Repealed at 24 Ill. Reg. 8042, effective June 1, 2000

32 Ill. Adm. Code 330.APPENDIX H Wording of Financial Surety Arrangements (section 330.250(c)(1)(e)) (repealed)

History

• Source: Repealed at 24 Ill. Reg. 8042, effective June 1, 2000

Part 331 Fees for Radioactive Material Licensees

32 Ill. Adm. Code 331.10 Purpose

This Part establishes fees to cover the costs of licensure and inspection of radioactive material licenses, registration of certain types of generally licensed devices, recovery and remediation of radioactive material and evaluation and maintenance of sealed source and device evaluations conducted in support of radioactive material licenses issued by the Illinois Emergency Management Agency.

History

• Source: Amended at 33 Ill. Reg. 4298, effective March 9, 2009

32 Ill. Adm. Code 331.20 Scope

Except for persons who apply for or hold only licenses exempted in Section 331.110 of this Part, this Part applies to any person who is an applicant for, or holder of, a radioactive material license issued pursuant to 32 Ill. Adm. Code 330, 332 or 601, a sealed source or device evaluation issued to a radioactive material licensee, or to any person who possesses a generally licensed kit or device as defined in Section 331.30 of this Part.

History

• Source: Amended at 22 Ill. Reg. 6951, effective April 1, 1998

32 Ill. Adm. Code 331.30 Definitions

The following definitions are applicable for use in this Part only. Additional definitions for use in this Part are located in 32 Ill. Adm. Code 310.20.

"Application" means a request filed with the Agency for a license, amendment, termination, renewal, sealed source or device evaluation, amendment to a sealed source or device evaluation or an exemption granted by the Agency pursuant to 32 Ill. Adm. Code: Chapter II.

"Amendment" means a modification in the license document that reflects changes to a radiation safety program or modifications to a sealed source or device evaluation.

"Anniversary date" means the last day of the month for each year the license is in effect, corresponding to the month in which the license expires.

AGENCY NOTE: For purposes of this Part, the 28th shall be considered the last day of the month of February.

"Billing year" means the period of time from October 1 of one year to September 30 of the following year.

"Category I irradiator" means a gamma irradiator in which the sealed source is completely contained in a dry container constructed of solid material, the sealed source is shielded at all times, and human access to the sealed source and the volume undergoing irradiation is not physically possible because of the design of the irradiator.

"Category II irradiator" means a controlled human access gamma irradiator in which the sealed source is contained in a dry container constructed of solid materials, is fully shielded when not in use and is exposed within a radiation volume that is maintained inaccessible during use by an entry control system.

"Category III irradiator" means a gamma irradiator in which the sealed source is contained in a storage pool, the sealed source is shielded at all times, and human access to the sealed source and the volume undergoing irradiation is physically restricted in its design configuration and proper mode of use.

"Category IV irradiator" means a controlled human access gamma irradiator in which the sealed source is contained in a storage pool, is fully shielded when not in use and is exposed within a radiation volume that is maintained inaccessible during use by an entry control system.

"Confirmatory environmental monitoring" means those surveys conducted by the Agency either to establish whether the licensee has complied with the concentrations and exposure limits or dose limits specified in 32 Ill. Adm. Code 332, 340, 601 or 606, or to provide data to evaluate potential health and environmental impacts resulting from licensed activities.

"Custom sealed source or device evaluation" means a document issued by the Agency for either a sealed source or a device containing radioactive material, built to the unique specifications for use at the site specified in the evaluation.

"Dispensing" means to remove aliquots of radioactive material from bulk stock and distribute portions to another licensee or to a person exempt from licensure.

"Distribution" means the transfer of radioactive material to three or more licensees or persons exempt from licensure pursuant to 32 Ill. Adm. Code 330 or 332.

"Educational institution" means a non-profit organization that has as its primary purpose the advancement of knowledge in one or more specific fields and that is accredited by the North Central Association of Colleges and Schools or equivalent.

"Manufacture" means the dispensing or processing of radioactive material or the assembly of radioactive material as sealed sources into devices.

AGENCY NOTE: A person manufacturing or assembling devices intended to utilize radioactive sealed sources may need to obtain a license authorizing manufacturing, even if that device is to be evaluated for safety by the Agency for distribution without the radioactive component.

"Materials license" means a radioactive material license issued pursuant to 32 Ill. Adm. Code 330, 332 or 601.

"Permanent jobsite" means any location where licensed material is stored or used for more than 180 days during any consecutive 12 months, or any site listed on a specific license that authorizes receipt, use or storage of radioactive material.

AGENCY NOTE: Locations where radioactive material is received and eventually redistributed or taken to other sites for use are typically included as permanent jobsites on specific licenses.

"Primary material use category" means the category described in Appendix E that corresponds to the category of use of radioactive material with the highest fee, either authorized by the license or requested by the applicant.

"Processing" means the preparation, manipulation or conversion of radioactive material.

"Remote site" means any permanent jobsite that is located in an area that is not contiguous to the primary use location.

"Sealed source or device evaluation" means a document issued by the Agency, the Nuclear Regulatory Commission, an Agreement State or a Licensing State, indicating that the sealed source or device specified on the document has been evaluated for distribution.

"Temporary jobsite" means any location where licensed material is used or stored for 180 days or less during any consecutive 12 months, and not specifically listed on a radioactive materials license.

AGENCY NOTE: For mobile nuclear medicine licensees in fee category 208F, radioactive material can only be shipped to and received at sites specifically listed on a radioactive material license; therefore, material cannot be shipped to a temporary jobsite, but may be transported to temporary sites by the licensee.

"Treatment" means any method, technique or process, including storage for radioactive decay, designed to change the physical, chemical or biological characteristics or composition of any waste in order to render the waste safer for transport, storage or disposal, amenable to recovery, convertible to another usable material or reduced in volume. [420 ILCS 20/3]

History

• Source: Amended at 33 Ill. Reg. 4298, effective March 9, 2009

32 Ill. Adm. Code 331.110 Exemptions

No fees as described in Sections 331.115 and 331.120 shall be required for:

a) Persons who possess radioactive material pursuant to 32 Ill. Adm. Code 330.210 or 330.220, except for primary material use categories 209A and B as described in Appendix E.

b) A license for possession and use of radioactive material issued to an agency of a state, county or municipal government or any political subdivision of these governments. This exemption does not apply to licenses for which the license fee is based on full cost recovery, licenses that authorize distribution of radioactive material or licenses authorizing testing for leakage or contamination as a service, or instrument calibration services to any person other than an agency or political subdivision of a state, county or municipal government.

c) A license for possession and use of radioactive material issued to an educational institution as defined in Section 331.30. This exemption does not apply to licenses for which the license fee is based on full cost recovery, licenses authorizing commercial distribution of radioactive material, licenses authorizing human use of radioactive material, licenses authorizing veterinary use of radioactive material, or licenses authorizing remunerated testing of sealed sources for leakage or contamination or remunerated instrument calibration services to any person.

AGENCY NOTE: Commercial distribution does not include transfer of material to other licensees for the purposes of collaborative research and development.

AGENCY NOTE: Remunerated services refer to persons not affiliated with the licensee. For example, this does not include contractual arrangements between different agencies within the same licensee.

d) An application to amend a materials license for which the license fee is not based on full cost recovery, that would not change the primary material use category to a category with a higher fee or add additional permanent jobsites.

e) A general license or specific license authorizing the use of source material as prefabricated shielding only for devices and containers, provided, however, that all other licensed material in the device or container shall be subject to the fees prescribed in Appendix F.

f) An application to change the status of a sealed source or device evaluation from "active" to "inactive". Upon request of the manufacturer or distributor, an evaluation is designated "inactive" by the Agency when those sources and devices are no longer manufactured or distributed, or when the evaluation is superseded by another evaluation.

g) An application to change the company name or address listed on a sealed source or device evaluation.

History

• Source: Amended at 36 Ill. Reg. 17387, effective November 30, 2012

32 Ill. Adm. Code 331.115 Radioactive Material Recovery and Remediation Fee

All specific and general licensees subject to this Part, except those in fee category 209A, shall pay an annual fee for recovery and remediation of radioactive material for a period of two years. Persons with prepackaged units for in vitro testing, fee category 209A, shall pay the recovery and remediation fee for a period of one year. Fees are specified in Appendix F. This Agency will account separately for all such fees, which will be used only for the costs of recovery and remediation of radioactive material when the costs cannot be recovered in a timely manner from a responsible person or an available surety.

History

• Source: Amended at 33 Ill. Reg. 4298, effective March 9, 2009

32 Ill. Adm. Code 331.120 Payment of Fees

Fees shall be assessed and paid as follows:

a) For categories of specific licenses that are shown to have an annual fee in Appendix F, applicants and licensees shall be billed as described in this subsection (a). Payment is due within 60 days after the date of billing. Fees shall be assessed as follows:

1. Annual fees: Unless a license or amendment application is exempt under Section 331.110, or the license fee is to be based on full cost recovery (see Appendix F), each licensee shall be assessed the fees specified in Appendix F for the primary material use category authorized by the license annually.

2. Annual remote site fee: For each remote site listed on a specific radioactive material license, where radioactive material is stored or used under the same license, the applicant shall annually be assessed the amount specified in Appendix F for each remote site that corresponds to the highest material use category authorized by the license for each site.

3. Changing the primary material use category or a remote site category. An application for amendment to a materials license that would change the primary material use category or a remote site category to a new category with a higher fee shall be assessed fees for the incremental difference between the applicable annual fees and the portion of the billing year remaining from the time the amendment is approved by the Agency.

4. The annual and remote site fees listed in Appendix F are nonrefundable, and are assessed based on a 12 month period.

5. Applicants requesting new licenses shall be assessed fees for the applicable Primary category as specified in Appendix F. Applicants shall be assessed fees for the portion of the billing year remaining from the time the application is received in the Agency to the end of the billing year.

6. An educational institution (as defined in Section 331.30) that seeks or has a license authorizing possession and use of radioactive material for human use or veterinary use, or remunerated leak testing or instrument calibration services to others shall pay 100% of the highest primary material use category for which a fee is due.

b) Recovery and remediation fees listed in Appendix F are nonrefundable and shall be billed along with the new license application fee described in subsection (a)(5) of this Section. The second installment, if required by Section 331.115, shall be assessed at the next billing date.

c) For categories of licenses that have fees based on full cost recovery, as listed in Appendix F, fees shall be assessed for all new applications, evaluations, inspections, amendments (including amendments to terminate or renew a license) and for monitoring of unlicensed properties contaminated with byproduct material (as defined in 32 Ill. Adm. Code 332.20) and assessing the decommissioning and decontamination activities at those properties. Fees based on full cost recovery shall be assessed as follows:

1. A licensee or applicant shall be assessed the deposit prescribed in Appendix F when the first application is received by the Agency after July 1, 2001. Licensees that already have adequate deposits on file with the Agency shall not be required to resubmit a deposit except for sealed source or device evaluations as indicated in subsection (d). This deposit shall be held by the Agency until a new license request has been denied by the Agency or withdrawn by the applicant, or an existing license is terminated. The deposit shall be refunded in accordance with Section 331.130.

2. The licensee may be billed quarterly, or when the Agency has incurred unpaid full cost expenses (as defined in Section 331.200(c)) in excess of the amount of the deposit, or upon completion of a license action (such as an amendment or renewal). Each bill shall identify the actions and the costs related to each. Payment is due within 60 days after the date of billing.

d) For evaluations of new sealed sources and devices, and amendments to existing sealed sources and device evaluations, fees shall be assessed based on the full cost of review. Each application for an evaluation of a new sealed source or device, or for an amendment to an existing sealed source or device evaluation, shall be accompanied by a deposit in the amount of $500. The applicant shall be billed or issued a refund upon the completion of the review. Each bill shall identify the actions and the costs related to each. Payment is due within 60 days after the date of billing.

e) For evaluations of financial assurance reclamation plans and cost estimates submitted to the Agency, fees for Agency review shall be assessed based on the full cost of review time in excess of two hours. Payment is due within 60 days after the date of billing.

f) For categories of licenses not exempted in Section 331.110, and licenses not subject to full cost recovery as described in Appendix F, full cost recovery fees shall be assessed for Agency confirmatory measurements and Agency assessment of decommissioning and decontamination activities associated with the termination of a license or use of a site. The licensee shall be billed upon the completion of the assessment and prior to removal of a site from the license or termination of the license. Each bill shall identify the actions and the costs related to each. Payment is due within 60 days after the date of the billing.

g) General license fees. Fees are nonrefundable and payment is due within 60 days after the date of the billing. The Agency shall assess fees:

1. Annually to each person who receives, acquires, possesses or uses a prepackaged unit for in vitro clinical or laboratory testing pursuant to the general license provided by 32 Ill. Adm. Code 330.220(e)(1); and

2. Annually to each person who receives, acquires, possesses or uses a generally licensed device and is required to register pursuant to 32 Ill. Adm. Code 330.220(a)(4).

h) Sealed source and device evaluation maintenance fee. Each person having an active sealed source or device evaluation on file with the Agency, except for custom sealed source and device evaluations, shall be billed the amount specified in Appendix F annually for each active evaluation sheet on file with the Agency. Fees are nonrefundable and payment is due within 60 days after the date of the billing.

i) Reciprocity fees. Each person generally licensed under 32 Ill. Adm. Code 330.900 for reciprocal recognition of an out-of-state specific license shall be assessed fees for the applicable annual license fee for the primary material use category indicated in Appendix F. Fees are nonrefundable and payment is due within 60 days after the date of the billing. The assessed billing period shall be for the 12 consecutive months following the licensee's first use under the general license. If, at the end of the 12 month period, the licensee is not using the general license, no additional fees are due until licensed activities commence again.

AGENCY NOTE: Reciprocity licensees are also subject to recovery and remediation fees specified in Section 331.115.

j) Fee payments. Payments shall be by check or money order made payable to the Illinois Emergency Management Agency.

History

• Source: Amended at 39 Ill. Reg. 11981, effective August 17, 2015

32 Ill. Adm. Code 331.125 Implementation (repealed)

History

• Source: Repealed at 33 Ill. Reg. 4298, effective March 9, 2009

32 Ill. Adm. Code 331.130 Refunds of Full Cost Recovery Deposits

The following procedures shall be followed by the Agency when calculating refunds to licensees with full cost recovery deposits on file with the Agency:

a) In the event that the applicant withdraws or the Agency denies an application prior to issuance of a sealed source and device evaluation sheet or initial license, the Agency shall issue a refund totaling the deposit submitted for that application minus the full cost recovery expenses incurred by the Agency but not paid by the applicant. In the event the expenses incurred by the Agency exceed the deposit, the applicant shall be billed for the unpaid balance of full cost recovery expenses as defined in Section 331.200. Each bill shall identify the actions and the related costs. Payment is due within 60 days after the date of billing.

b) Upon termination of the license or issuance of a sealed source or device evaluation sheet, the Agency shall issue a refund totaling the deposit submitted, minus any outstanding full cost recovery expenses. In the event that expenses incurred exceed the deposit, the applicant shall be billed for the unpaid balance of full cost recovery expenses as defined in Section 331.200. Each bill shall identify the actions and the related costs. Payment is due within 60 days after the date of billing.

History

• Source: Amended at 33 Ill. Reg. 4298, effective March 9, 2009

32 Ill. Adm. Code 331.200 Full Cost Recovery

Initial applications, amendments and renewals for licenses designated as full cost recovery in Appendix F, and evaluations of new sealed sources and devices, or amendments to existing sealed source and device evaluations are assessed fees based on full cost recovery of review and inspection efforts. Full cost recovery fees are calculated based on the following:

a) The time required by Agency professional staff to conduct the review, including license file review, travel time, correspondence preparation and supervisory and management review of specific actions, multiplied by the rate specified in subsection (f).

b) The time required by Agency professional staff to conduct inspections or perform confirmatory environmental monitoring, including license file review, travel time, correspondence preparation and supervisory and management review of specific actions, multiplied by the rate specified in subsection (f).

c) For licenses authorizing the possession and use of source material (as defined in 32 Ill. Adm. Code 310.20) and byproduct material (as defined in 32 Ill. Adm. Code 332.20), the Agency's cost for overseeing decontamination activities at unlicensed properties contaminated with source or byproduct material, including, but not limited to, travel time, correspondence preparation, supervisory and management review of specific actions, multiplied by the rate specified in subsection (f).

d) The cost of standard lab equipment and supplies, special environmental monitoring equipment and servicing of that equipment.

e) The contractual support service costs, if any, incurred by the Agency in conjunction with the review, inspections and confirmatory environmental monitoring activities.

AGENCY NOTE: These support service costs may include, but are not limited to, rental of specialized equipment, acquisition of additional professional expertise not available within the Agency and laboratory fees charged to the Agency.

f) The hourly rate for full cost recovery shall be $263.

AGENCY NOTE: Full cost recovery activities are billed to the nearest tenth of an hour.

History

• Source: Amended at 37 Ill. Reg. 20225, effective December 9, 2013

32 Ill. Adm. Code 331.210 Schedule of Fees for Radioactive Material Licenses (repealed)

History

• Source: Repealed at 15 Ill. Reg. 90, effective January 1, 1991

32 Ill. Adm. Code 331.310 Failure by Applicant or Licensee to Pay Prescribed Fee

In any case in which the Agency finds that an applicant or licensee has failed to pay a prescribed fee required in this Part, the Agency will suspend or revoke, in accordance with 32 Ill. Adm. Code 200, authorization to use radioactive material, and any license issued to the applicant or licensee for which all required license fees have not been paid.

History

• Source: Amended at 33 Ill. Reg. 4298, effective March 9, 2009

32 Ill. Adm. Code 331.APPENDIX A Schedule of License Fees (repealed)

Section 331.TABLE A License Fees − Jan. 1, 1988 - Dec. 31, 1988 (Repealed)

Section 331.APPENDIX A Schedule of License Fees (Repealed)

Section 331.TABLE B License Fees − Jan. 1, 1989 - Dec. 31, 1989 (Repealed)

Section 331.TABLE C License Fees − Jan. 1, 1990 - Dec. 31, 1990 (Repealed)

History

• Source: Repealed at 16 Ill. Reg. 11479, effective July 7, 1992
• Source: Repealed at 16 Ill. Reg. 11479, effective July 7, 1992
• Source: Repealed at 16 Ill. Reg. 11479, effective July 7, 1992

32 Ill. Adm. Code 331.APPENDIX B Fee Schedule for Radioactive Material Licenses (repealed)

History

• Source: Repealed at 18 Ill. Reg. 12131, effective August 1, 1994

32 Ill. Adm. Code 331.APPENDIX C Fee Schedule for Sealed Source and Device Evaluations (repealed)

History

• Source: Repealed at 16 Ill. Reg. 11479, effective July 7, 1992

32 Ill. Adm. Code 331.APPENDIX D Fee Schedule for Radioactive Material Licenses (repealed)

History

• Source: Repealed at 22 Ill. Reg. 6951, effective April 1, 1998

32 Ill. Adm. Code 331.APPENDIX E Primary Material Use Categories for Radioactive Material Licensees

Fee Category

Primary Material Use Category Description

MANUFACTURING/DISTRIBUTION

201A.

Broad Scope Manufacturing and/or Distributions – licenses (as specified in 32 Ill. Adm. Code 330.270) for possession and use of radioactive material for research and development, and processing or manufacturing radioactive material or items containing radioactive material for commercial distribution, including, but not limited to, nuclear pharmacy operations, or manufacturing of a chemical mixture, compound, solution or alloy which is listed in 32 Ill. Adm. Code 330.30.

201B.

Specific Manufacturing and /or Distribution – licenses for possession and use of greater than 37 GBq (1 Ci) of radioactive material for research and development, and processing or manufacturing radioactive material or items containing radioactive material for commercial distribution, including, but not limited to, manufacturing of a chemical mixture, compound, solution or alloy which is listed in 32 Ill. Adm. Code 330.30.

201C.

Nuclear Pharmacy and Limited Manufacturing and/or Distribution – this category of radioactive material licenses addresses two similar types of licenses, either:

i)

nuclear pharmacy licenses for possession, use and distribution of radiopharmaceuticals and sealed sources to persons authorized pursuant to 32 Ill. Adm. Code 335; or

ii)

Licenses for possession and use of not more than 37 GBq (1 Ci) of radioactive material for research and development, and processing or manufacturing of radioactive material for limited commercial distribution, including, but not limited to, manufacturing of a chemical mixture, radiolabeled compound, solution or alloy that is listed in 32 Ill. Adm. Code 330.30.

201D.

Distribution – licenses authorizing receipt, storage and distribution of radioactive material or items containing radioactive material, not involving processing or manufacturing of radioactive material.

IRRADIATORS

202A.

Category I Irradiator – licenses for possession and use of radioactive material as sealed sources in a gamma irradiator in which the sealed source is completely contained in a dry container constructed of solid material, the sealed source is shielded at all times, and human access to the sealed source and the volume undergoing irradiation is not physically possible because of the design of the irradiator.

202B.

Category II, III or IV Irradiator – licenses for possession and use of less than 370 TBq (10,000 Ci) of radioactive material as sealed sources in a controlled human access gamma irradiator in which the sealed source is either:

i)

contained in a dry container constructed of solid materials, is fully shielded when not in use and is exposed within a radiation volume that is maintained inaccessible during use by an entry control system;

ii)

Contained in a storage pool, the sealed source is shielded at all times, and human access to the sealed source and the volume undergoing irradiation is physically restricted in its design configuration and proper mode of use; or

iii)

Contained in a storage pool, is fully shielded when not in use and is exposed within a radiation volume that is maintained inaccessible during use by an entry control system.

202C.

Category II, III or IV Irradiator – licenses for possession and use of 370 TBq (10,000 Ci) or more of radioactive material as sealed sources in a controlled human access gamma irradiator in which the sealed source is either:

i)

Contained in a dry container constructed of solid materials, is fully shielded when not in use and is exposed within a radiation volume that is maintained inaccessible during use by an entry control system;

ii)

Contained in a storage pool, the sealed source is shielded at all times, and human access to the sealed source and the volume undergoing irradiation is physically restricted in its design configuration and proper mode of use; or

iii)

Contained in a storage pool, is fully shielded when not in use and is exposed within a radiation volume that is maintained inaccessible during use by an entry control system.

RESEARCH AND DEVELOPMENT

203A.

Broad Scope Research and Development – licenses (as specified in 32 Ill. Adm. Code 330.270) for possession and use of radioactive material for research and development that do not authorize commercial distribution.

203B.

Other Research and Development – licenses for possession and use of radioactive material for research and development that do not authorize commercial distribution.

AGENCY NOTE: The Agency will allow the non-commercial distribution of material to other licensees for the purpose of collaborative research and development.

PORTABLE AND FIXED GAUGES

204A.

Gas Chromatographs and Fixed X-Ray Fluorescence Analyzers – specific licenses for possession and use of radioactive material in sealed sources for use in gas chromatographs or fixed x-ray fluorescence analyzers.

204B.

Portable Gauges and Portable X-Ray Fluorescence Analyzers – specific licenses for possession and use of radioactive material as sealed sources for use in portable gauges or x-ray fluorescence analyzers.

204C.

Fixed Gauges – specific licenses for possession and use of radioactive material as sealed sources for use in fixed gauges.

SERVICE

205A.

Service – licenses that authorize services for other persons, including, but not limited to, testing of sealed sources for leakage or contamination, instrument calibration and sample analysis, but not including waste disposal transportation or radioactive waste broker services. Medical service licensees include licensees that only transport sources and equipment to a client's facility, but do not authorize the medical use or administration of that material. The medical use or administration of radioactive material to humans or animals shall be performed under a specific medical use license.

205B.

Nuclear Laundries – licenses for commercial collection and laundering of items contaminated with radioactive material.

205C.

Decontamination Facilities – licenses that authorize receipt of items contaminated with radioactive material for the purpose of decontaminating such items.

WIRELINE (Well-Logging)

Wireline Service Operations (as defined in 32 Ill. Ad. Code 351) – licenses specifically authorizing use of radioactive material for wireline services, well surveys and tracer studies.

INDUSTRIAL RADIOGRAPHY

Industrial Radiography (as defined in 32 Ill. Adm. Code 350) – licenses specifically authorizing use of radioactive material for industrial radiography at permanent or temporary jobsites.

MEDICAL/VETERINARY

208A.

Broad Scope Medical/Veterinary Use – broad scope licenses (as specified in 32 Ill. Adm. Code 330.270) authorizing diagnostic and/or therapeutic veterinary or human use of radioactive material. These licenses may include research and development, or use of radioactive material in sealed sources contained in teletherapy or high dose rate remote afterloader devices.

208B.

Medical/Veterinary Use Including Teletherapy and/or High Dose Rate Remote Afterloader – licenses for diagnostic and/or therapeutic human or veterinary use of radioactive material that include authorization for possession and use of radioactive material as sealed sources contained in teletherapy or high dose rate remote afterloader devices for medical or veterinary use and for the irradiation of other items.

AGENCY NOTE: Possession of a teletherapy unit that is out of service and in storage only does not means the primary radioactive material use category is the teletherapy category described in 208B. Such licensees should review the other categories to determine their primary radioactive material use category. If this is the only material possessed under a specific license, then see category 212A.

208C.

Medical/Veterinary Use – licenses for diagnostic and/or therapeutic human or veterinary use of radioactive material (i.e., 32 Ill. Adm. Code 335.5010 and/or 335.7010).

208D.

Diagnostic Use Only – licenses restricted to only the diagnostic human or veterinary use of radioactive material for uptake, dilution, excretion, imaging or localization studies, sealed sources for diagnosis; and in vitro kits (i.e., 32 Ill. Adm. Code 335.4010), except as specified in 32 Ill. Adm. Code 330.220(e).

208E.

Limited Medical/Veterinary Use – licenses restricted to only the human or veterinary use of radioactive material for uptake, dilution and excretion studies (i.e., 32 Ill. Adm. Code 335.3010).

208F.

Mobile Nuclear Medicine – licenses authorizing the receipt, possession and use of radioactive material for diagnostic or therapeutic human or veterinary use at temporary jobsites.

AGENCY NOTE: Licensees wishing to establish mobile medical services involving High Dose Rate Remote Afterloaders for therapeutic use in humans or animals shall be licensed under Category 208B.

GENERAL LICENSES

209A.

Persons with Prepackaged Units for In Vitro Testing − persons who receive, acquire, possess or use prepackaged units for in vitro clinical or laboratory testing pursuant to the general license provided by 32 Ill. Adm. Code 330.220(e)(1).

AGENCY NOTE: Prepackaged units may be known as in vitro kits or RIA kits.

209B.

Persons with Generally Licensed Devices – persons required to register with the Agency pursuant to 32 Ill. Adm. Code 330.220(a)(4).

SOURCE MATERIAL

210A.

Possession and Use of Source Material (as defined in 32 Ill. Adm. Code 310.20) and Byproduct Material (as defined in 32 Ill. Adm. Code 332.20) – licenses for possession and use of source material in recovery operations such as milling, in-site leaching, heap-leaching, ore buying stations, ion exchange facilities and in processing of ores containing source material for extraction of metals other than uranium or thorium, including licenses authorizing the possession of byproduct waste material (tailings) from source material recovery operations as well as licenses authorizing the possession and maintenance of a facility in a standby mode.

210B.

Possession and Use of Source Material (as defined in 32 Ill. Adm. Code 310.20) – licenses for possession and use of source material that require a specific radioactive materials license. This does not include licenses authorizing manufacture and distribution of source material, no does it include specific licensees authorizing source material used for shielding or source material authorized for use in manufacturing operations as described in Material Use Categories 201A, B and C of this Section.

WASTE DISPOSAL AND TREATMENT FACILITIES

211A.

Low-Level Radioactive Waste Disposal Facilities – licenses issued pursuant to 32 Ill. Adm. Code 601 specifically authorizing the disposal of low-level radioactive waste away from the point of generation.

211B.

Low-Level Radioactive Waste Treatment Facilities – licenses specifically authorizing the receipt of low-level radioactive waste material from other persons for treatment away from the point of generation, and transfer to a person authorized to receive or dispose of the material.

211C.

Centralized Low-Level Radioactive Waste Storage Facilities – licenses specifically authorizing the receipt of low-level radioactive waste material from other persons for storage away from the point of generation, and transfer to a person authorized to receive or dispose of the material.

211D.

Other Low-Level Radioactive Waste – licenses authorizing other methodologies for disposal of low-level radioactive waste.

OTHER

212A.

Storage Only – licenses authorizing storage only of radioactive material, but does not include facilities described as Centralized Low-Level Radioactive Waste Storage Facilities.

212B.

Possession Incident to Exempt Distribution – licenses authorizing possession, receipt, storage and repackaging of byproduct radioactive material for eventual distribution to persons exempt under a specific license issued by the U.S. Nuclear Regulatory Commission.

AGENCY NOTE: The U.S. Nuclear Regulatory Commission maintains sole authority to issue licenses authorizing distribution of exempt quantities of byproduct radioactive material. However, those licenses do not authorize storage of the material at facilities in Illinois, therefore, a separate license must be obtained from the Agency for possession of the material.

212C.

Other – all other specific radioactive material licenses not specified elsewhere in this Appendix.

212D.

Reciprocity for Exhibition and Demonstration Only – licenses authorizing only exhibition or demonstration of devices for a period of not greater than 180 days in any 12-month period.

212E.

Sealed Source and Device Evaluation Maintenance Fee – a fee per active evaluation sheet maintained by the Agency excluding custom sealed source and device evaluation sheets.

History

• Source: Amended at 39 Ill. Reg. 11981, effective August 17, 2015

32 Ill. Adm. Code 331.APPENDIX F Fee Schedule for Radioactive Material Licensees

Primary

Category

Description

Annual Fee

Recovery and Remediation Fee

Remote

Site Fee

MANUFACTURING/DISTRIBUTION

201A.

Broad Scope Manufacturing and/or Distribution

$25,142

$300

$10,036

201B.

Specific Manufacturing and/or Distribution

$7,183

$300

$5,491

201C.

Nuclear Pharmacy and Limited Manufacturing and/or Distribution

$7,059

$300

$4,966

201D.

Distribution

$4,277

$300

$736

IRRADIATORS

202A.

Category I Irradiator

$1,716

$300

$806

202B.

Category II, III or IV Irradiator (less than 10,000 curies (370 TBq))

$6,741

$300

$6,929

202C.

Category II, III or IV Irradiator (10,000 curies (370 TBq) or more)

$42,270

$300

$29,589

RESEARCH AND DEVELOPMENT

203A.

Broad Scope Research and Development

$12,929

$300

$9,048

203B.

Other Research and Development

$4,752

$300

$2,054

PORTABLE AND FIXED GAUGES

204A.

Gas Chromatographs and Fixed X-Ray Fluorescence Analyzers

$1,547

$300

$419

204B.

Portable Gauges and Portable X-Ray Fluorescence Analyzers

$2,321

$300

$767

204C.

Fixed Gauges

$2,321

$300

$832

SERVICE

205A.

Service

$3,887

$300

$1,170

205B.

Nuclear Laundries

$13,830

$300

$9,681

205C.

Decontamination Facilities

$4,470

$300

$3,129

WIRELINE (Well Logging)

Wireline Service Operations

$3,757

$300

$1,287

INDUSTRIAL RADIOGRAPHY

Industrial Radiography

$9,685

$300

$6,838

MEDICAL/VETERINARY

208A.

Broad Scope Medical/ Veterinary Use

$21,801

$300

$7,462

208B.

Medical/Veterinary Use Including Teletherapy and/or High Dose Rate Remote Afterloader

$9,555

$300

$3,315

208C.

Medical/Veterinary Use

$4,310

$300

$1,373

208D.

Diagnostic Use Only

$2,652

$300

$1,014

208E.

Limited Medical/Veterinary Use

$2,392

$300

$1,066

208F.

Mobile Nuclear Medicine

$4,310

$300

$1,807

GENERAL LICENSES

209A.

Persons with Prepackaged Units for In Vitro Testing

$170

$300

N/A

209B.

Persons with Generally Licensed Devices

$400

$300

N/A

SOURCE MATERIAL

210A.

Possession and Use of Source Material and Byproduct Material (One-time Deposit of $25,000)

Full Cost

$300

Full Cost

210B.

Possession and Use of Source Material (One-time Deposit of $25,000)

Full Cost

$300

Full Cost

WASTE DISPOSAL AND TREATMENT FACILITIES

211A.

Low-Level Radioactive Waste Disposal Facilities

Full Cost

$300

Full Cost

211B.

Low-Level Radioactive Waste Treatment Facilities (One-time Deposit of $25,000)

Full Cost

$300

Full Cost

211B.

Low-Level Radioactive Waste Treatment Facilities (For all new licenses after October 1, 2013)

$13,830

$300

$9,681

211C.

Centralized Radioactive Waste Storage Facilities

$13,830

$300

$9,681

211D.

Other Low-Level Radioactive Waste (One-time Deposit of $25,000)

Full Cost

$300

Full Cost

OTHER

212A.

Storage Only

$2,321

$300

$1,092

212B.

Possession Incident to Exempt Distribution

$2,249

$300

$686

212C.

Other (uses not specified elsewhere in this schedule)

$2,301

$300

$572

212D.

Reciprocity for Exhibition and Demonstration Only

$400

N/A

N/A

212E.

Sealed Source and Device Evaluation Maintenance Fee

$845

N/A

N/A

History

• Source: Amended at 37 Ill. Reg. 20225, effective December 9, 2013

Part 332 Licensing Requirements for Source Material Milling Facilities

32 Ill. Adm. Code 332.10 Purpose and Scope

a) This Part establishes:

1. Procedural requirements and technical criteria applicable to the disposal of byproduct material as defined in this Part and provides for the protection of the public health and safety during and after source material milling operations.

2. Specific technical and financial requirements for source material milling facilities, including their construction, operation and decommissioning, decontamination, reclamation and ultimate stabilization, postclosure activities, license transfer and termination, facility ownership and ultimate custody.

3. Procedures, criteria and conditions upon which the Illinois Emergency Management Agency issues specific licenses for source material milling and disposal of the byproduct material.

b) Unless specified otherwise, source material milling licensees are subject to the requirements of 32 Ill. Adm. Code 310, 320, 330, 331, 340, 341, 400 and 601, and 35 Ill. Adm. Code 302.208, 302.304, 303.202, and 303.203. This Part does not apply to disposal of licensed material as provided in 32 Ill. Adm. Code 601.

c) This Part does not establish procedures and criteria for the issuance of licenses for materials covered under Title I of the Uranium Mill Tailings Radiation Control Act of 1978 (42 USC 7901). The regulation by the State of byproduct material as defined in Section 11e.(2) of the Atomic Energy Act (42 USC 2014(e)(2)) is subject to the provisions of an agreement between the State and the U.S. Nuclear Regulatory Commission (NRC). In the absence of an agreement, this Part shall not be enforceable against any source material milling facility.

AGENCY NOTE: The reference to byproduct material as used in this subsection (c) has the same meaning as contained in 42 USC 2014(e)(2), also referred to as section 11e.(2) of the Atomic Energy Act.

History

• Source: Amended at 32 Ill. Reg. 16765, effective October 6, 2008

32 Ill. Adm. Code 332.20 Definitions

Unless otherwise indicated, the definitions of 32 Ill. Adm. Code 310 (General Provisions for Radiation Protection) apply to this Part. As used in this Part, each of the following definitions has the specified meaning.

"Act" means the Radiation Protection Act of 1990 [420 ILCS 40].

"Active maintenance" means any activity, other than minor custodial activities, needed to preserve isolation of the byproduct material. Active maintenance includes ongoing activities such as the pumping, removal, or treatment of surface water or groundwater or one-time measures such as replacement of a disposal area cover.

"Agency" means the Illinois Emergency Management Agency.

"Aquifer" means a geologic formation, group of formations, or part of a formation capable of yielding a significant amount of groundwater to wells or springs. Any saturated zone created by uranium or thorium recovery operations would not be considered an aquifer unless the zone is or potentially is:

hydraulically interconnected to a natural aquifer,

capable of discharge to surface water, or

reasonably accessible because of migration beyond the vertical projection of the boundary of the land transferred for long-term government ownership and care in accordance with Section 332.280.

AGENCY NOTE: The determination of "significant" will be based on site specific criteria such as yield of the aquifer in volume per unit time, the degree of use or potential for future use for domestic, industrial or agricultural purposes, the availability of alternative sources and capability of users to change to alternative sources in the event groundwater protection standards are exceeded.

"Buffer zone" means the area surrounding the site used for disposal of either byproduct material or material contaminated with uranium or thorium during, or as a consequence of, source material milling operations. Use of the buffer zone is limited to those activities that would not be detrimental to containment of the wastes, environmental monitoring, interception and processing of any surface or groundwater effluents.

"Byproduct material" means, for purposes of this Part only, the tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by such solution extraction operations do not constitute byproduct material within this definition.

"Closure" means the activities following operations to decontaminate and decommission the buildings and site used to produce byproduct material, to reclaim the tailings area, to reclaim the waste disposal area and to restore the groundwater to the degree necessary to achieve compliance with the groundwater protection requirements of Section 332.230(a).

"Closure plan" means the Agency approved plan to accomplish closure.

AGENCY NOTE: The Agency will approve a closure plan if the plan describes how the licensee will decontaminate, reclaim and stabilize the licensed site in accordance with the requirements.

"Compliance period" begins when the Agency sets specific secondary groundwater protection standards in accordance with Section 332.230 and ends when the owner's or operator's license is terminated and the disposal site is transferred to the State or federal agency for long-term care.

"Control boundary" means a physical barrier that separates a restricted area from an unrestricted area.

"Decommissioning" means to remove (as a facility) safely from service and reduce residual radioactivity to a level that permits release of the property for unrestricted use and termination of the license.

AGENCY NOTE: The byproduct material disposal site is not decommissioned because it will neither be released for unrestricted use nor be unlicensed. Land ownership and custody will be maintained by the State or the federal government as required by Section 332.280. Portions of the licensed site other than the actual byproduct material disposal site are decommissioned.

"Dike" means an embankment or ridge of either natural or man-made materials used to prevent the movement of liquids, sludges, solids or other materials.

"Disposal area" means the area containing byproduct material to which the requirements of Sections 332.170 and 332.240 apply. The disposal area includes only the surface area of the land immediately underlain by byproduct material and does not include any embankments, dams or other supporting structures that surround the byproduct material.

"Disposal site" means the land transferred to the State or federal government pursuant to Section 332.280. This land includes the disposal area, any surrounding embankments or dams that contain the byproduct material.

"Existing portion" means that land surface area of an existing surface impoundment or disposal area on which significant quantities of byproduct material have been placed prior to September 30, 1983.

"Fund" means the Radiation Protection Fund (see 420 ILCS 40/35).

"Groundwater" means water below the land surface in a zone of saturation. For purposes of this Part, groundwater is the water contained within an aquifer as defined in this Section.

"Leachate" means any liquid, including any suspended or dissolved components in the liquid, that has percolated through or drained from the byproduct material.

"Licensed site" means the area contained within the boundary of a location under the control of persons generating or storing byproduct material under an Agency license.

AGENCY NOTE: The licensed site would include, at a minimum, any actual or proposed disposal areas and sites, any additional land used by the licensee for the generation or storage of byproduct material and any buffer zones. Normally, such additional land areas and buffer zones will be decommissioned and reclaimed and not subject to land transfer pursuant to Section 332.280.

"Liner" means a continuous layer of natural or man-made material beneath, or on the sides of, a surface impoundment that restricts the downward or lateral escape of byproduct material, hazardous constituents or leachate.

"Long-term care" means the period following postclosure and termination of a license issued pursuant to this Part during which surveillance and monitoring activities are conducted by a State or federal agency.

"Minor custodial activities" means maintenance activities under State specific license, not necessary to preserve the isolation of the byproduct material. These activities could include repair of fencing, repair or replacement of monitoring equipment, minor additions to or repair of disposal area cover and general disposal site upkeep such as mowing grass.

"Point of compliance" means the site specific location in the uppermost aquifer where the groundwater protection standard must be met.

"Postclosure" means the period of time from completion of the closure plan for decontamination, reclamation and stabilization of the source material milling facility, byproduct material surface impoundment and disposal area, but prior to the termination of the license.

"Reclamation" means the following activities performed at a licensed site as a part of closure:

stabilize and isolate byproduct material contained within a disposal site. This may include relocation of the byproduct material;

backfill with uncontaminated soil any disturbed areas to achieve a topography compatible with surrounding terrain;

recontour land to support surface drainage; and

revegetate as necessary.

"Source material milling" means any operation in which uranium or thorium is extracted and concentrated from ore processed primarily for its source material content. This includes solution mining and heap leaching and any other operation that generates byproduct material as defined in this Part.

"Surface impoundment" means a natural topographic depression, man-made excavation or diked area that is designed to hold an accumulation of liquid wastes or wastes containing free liquids, and that is not an injection well.

"Surveillance" means monitoring and observation of the disposal site for the purposes of visual detection of the need for maintenance, custodial care, evidence of unauthorized access and compliance with other license and regulatory requirements.

"Uppermost aquifer" means the geologic formation nearest the natural ground surface that is an aquifer, as well as lower aquifers that are hydraulically interconnected with this aquifer within the facility's property boundary.

History

• Source: Amended at 38 Ill. Reg. 21459, effective October 31, 2014

32 Ill. Adm. Code 332.30 License Required

a) No person shall operate a source material milling facility or byproduct material surface impoundment or disposal area, or receive, possess, dispose, or transfer source or byproduct material associated with such facilities, unless authorized by a license issued by the Agency pursuant to this Part and 32 Ill. Adm. Code 330.

b) Each person shall file an application with the Agency pursuant to 32 Ill. Adm. Code 330.240 and obtain a license as provided in this Part before commencement of construction of a source material milling facility, or byproduct material surface impoundment or disposal area. Failure to comply with this requirement shall be grounds for denial of a license.

c) Any person who, on the effective date of the Agreement between the State and NRC transferring regulatory authority to the State, possesses a license, issued by the NRC, to operate a source material milling facility or byproduct material surface impoundment or disposal area or to receive, possess, dispose of, or transfer source or byproduct material associated with such facilities, shall be deemed to possess a like license issued under this Part. Licenses shall expire 90 days after receipt from the Agency of a notice of expiration of the license or on the date of expiration specified in the NRC license, whichever is earlier.

History

• Source: Amended at 32 Ill. Reg. 16765, effective October 6, 2008

32 Ill. Adm. Code 332.40 Application Content and Procedure

a) In addition to the requirements set forth in 32 Ill. Adm. Code 330.250, an application filed pursuant to this Part shall contain the required information as set forth in Sections 332.50 through 332.90.

b) The Agency will review the application for completeness within 60 days after receipt of the application and will notify the applicant whether the application is acceptable for filing. This review of the application shall not constitute the Agency's approval of the adequacy of the information and data contained in the application.

c) The Agency may, at any time after the filing of the original application and before the expiration of the license, require further statements or data to enable the Agency to determine whether the application should be denied or whether a license should be granted, modified or revoked.

d) A license application may include a request for a licensee to engage in one or more activities, provided that the application specifies the additional activities for which licenses are requested and complies with regulations of the Agency as to application for those licenses.

e) In any application, the applicant may incorporate by reference information contained in previous applications, statements or reports filed by the applicant with the Agency. The reference shall identify the document being referenced by subject, date and page number.

f) All materials considered by the applicant to be proprietary or confidential in nature shall be separated and marked proprietary or confidential by the applicant before submission to the Agency. Public inspection of applications and other documents submitted to the Agency pursuant to this Section shall be in accordance with 2 Ill. Adm. Code 1800 and the requirements of the Freedom of Information Act [5 ILCS 140].

g) An application for a specific license, or an amendment to a license, shall be filed with the Agency both in hard copy and electronic form. The number of hard copies to be provided will be determined by the Agency depending on the scope of activities to be conducted under the license and the cost effectiveness of providing the copies (e.g., number of consultants or other parties involved and number of documents being submitted).

h) Each application for a specific license, or amendment to a license, shall be accompanied by the fee prescribed in 32 Ill. Adm. Code 331.

i) Each application shall be signed by the applicant or a person duly authorized to act on behalf of the applicant.

History

• Source: Amended at 39 Ill. Reg. 15719, effective November 24, 2015

32 Ill. Adm. Code 332.50 General Information

The general information shall include each of the following:

a) Identity of the applicant, including:

1. The full name, address, telephone number, and description of the business or occupation of the applicant;

2. If the applicant is a partnership, the name and address of each partner and the principal location where the partnership does business;

3. If the applicant is a corporation or an unincorporated association, the state where it is incorporated or organized, the principal location where it does business, and the names and addresses of its directors and principal officers; and

4. If the applicant is acting as an agent or representative of another person in filing the application, all information required under this subsection shall be supplied with respect to the other person.

b) Qualifications of the applicant:

1. The organizational structure of the applicant, both offsite and onsite, including a description of lines of authority and assignments of responsibilities, whether in the form of administrative directives, contract provisions, or otherwise;

2. The technical qualifications, including training and experience, of the applicant and members of the applicant's staff to engage in the proposed activities. Minimum training and experience requirements for personnel filling positions described in response to the requirements of subsection (b)(1) shall be provided;

3. A description of the applicant's program for training personnel to execute job functions in a manner consistent with the requirements of this Part and 32 Ill. Adm. Code 310, 320, 330, 340, 341, and 400.

4. The plan to maintain trained personnel to carry out;

A) Receipt, possession and transfer of source and byproduct material;

B) Source material milling;

C) Disposition of byproduct material; and

D) Closure of the licensed site, surface impoundments, and disposal areas.

c) A description of:

1. The location of the proposed source material milling facility, and byproduct material surface impoundments and disposal areas;

2. The general character of the proposed activities;

3. The types and quantities of ores, source material and byproduct material to be received, possessed, stored, transferred, or disposed of;

4. The proposed milling facilities, equipment, surface impoundment and disposal area conceptual design, and size of the licensed site through closure; and

5. The proposed schedules for construction, receipt of ores, the first processing of ores, expansion or increased capacity potential over and above the planned facilities, and the anticipated operational lifetime of the source material milling facility and surface impoundments.

32 Ill. Adm. Code 332.60 Technical Information

The application shall contain technical information demonstrating that the technical criteria of this Part will be met. Specifically, the application shall contain:

a) A description of the characteristics of the proposed licensed site as determined by selection and characterization activities. The description shall include, but need not be limited to, the following:

1. Topography, geology, geochemistry, geotechnology, seismology, hydrology, climatology, meteorology, radioactivity, toxicology and ecology;

2. History, archaeology and demography;

3. Local economy and land usage;

4. Known natural and mineral resources;

5. Proposed and available modes of transportation; and

6. A list of all endangered plant and animal species on the site and within 10 km.

b) A description of the design features of the source material milling facility and byproduct material surface impoundment and disposal area. The description shall include the following:

1. Surface and groundwater management;

2. Effluent discharges and monitoring;

3. Licensed site access protection;

4. Occupational exposure control;

5. Licensed site monitoring, closure and maintenance; and

6. Buffer zone adequacy for monitoring and potential mitigative measures.

c) A description of the design criteria and their relationship to the technical criteria.

d) A description of the natural events or phenomena, such as winds and rainstorms, tornadoes, earthquakes and extreme temperatures, used for the design and their relationship to the design criteria.

e) A description of codes and standards which the applicant has applied to the design and which will apply to construction of the source material milling facility, and any byproduct material surface impoundment and disposal area.

f) A description of the construction and operation of any byproduct material surface impoundment and disposal area. The description shall include as a minimum:

1. Method of construction;

2. Method for emplacement of byproduct material within a surface impoundment or disposal area;

3. Procedures for and areas of waste segregation;

4. Types of access control barriers;

5. Engineering quality control program;

6. Construction quality assurance program;

7. Methods and areas of waste storage;

8. Onsite traffic and drainage systems; and

9. Methods to control surface water and groundwater and precipitation access to the byproduct material.

g) A description of methods to be employed in the handling and disposal of the byproduct material including dewatering and neutralizing such materials that, because of physical or chemical properties, might affect meeting the technical criteria of this Part.

h) A description of the licensed site closure plan, including those design features which are intended to facilitate closure and to eliminate the need for active maintenance.

i) A description of the kind, amount, source, classification and specifications of the radioactive material proposed to be received, possessed, processed and disposed of at the source material milling facility, any byproduct material surface impoundment and any disposal area.

j) A description of the quality assurance program for the determination of natural characteristics of the licensed site and for the maintenance of quality control during the design, construction, operation, reclamation, decontamination, stabilization and closure of the licensed site. Audits and managerial controls including criteria and standards shall be incorporated in this program.

k) A description of the radiation safety program for controlling and monitoring radioactive effluents to ensure compliance with the technical criteria in Section 332.170 of this Part and 32 Ill. Adm. Code 340; occupational radiation exposure to ensure compliance with the requirements of 32 Ill. Adm. Code 340; and to control contamination of personnel, vehicles, equipment, buildings and the site. Both routine operations and accidents shall be addressed. The program description shall include procedures, instrumentation, facilities and equipment.

l) A description of the environmental monitoring program designed to provide data to evaluate potential health and environmental impacts and the plan for taking corrective measures if migration is indicated. Components of an environmental monitoring program generally include:

1. the sampling of air, for particulate and gaseous emissions;

2. the sampling of surface water and groundwater;

3. the sampling of soil and sediment;

4. the sampling of vegetation and animals;

5. the sampling of total radon and its daughters;

6. the sampling of direct radiation with both passive integrating devices and survey instruments; and

7. other environmental analysis that might be indicated as a result of site specific conditions.

m) A description of the proposed methods of decontamination, relcamation, stabilization and postclosure activities within the licensed site.

n) A description of each emission source and emission control device incorporated into the source material milling operations. The description shall also include the efficiency, calibration procedures and maintenance schedules for emission control devices.

o) A description of the licensee's procedure for monitoring all pathways of exposure (i.e., ingestion, inhalation, external exposures) to workers and the public. The frequency of monitoring for each pathway shall be site specific and designed to demonstrate compliance with the criteria of Section 332.170 of this Part and 32 Ill. Adm. Code 340.

p) A description of the administrative procedures that the applicant will apply to control activities at the source material milling facility and any byproduct material surface impoundment, and disposal area including, but not limited to, organization and lines of authority, management audit programs and internal inspection programs.

q) An estimate of the environmental effects of accidents on each operation.

r) A description of regional and site specific characteristics which have seasonal or cyclical variations, including the range of variations and average values. The site specific preoperational monitoring data must be based on data collected during a one year (four consecutive seasons) period or longer. This data shall be collected prior to any alteration of the environment by changes in topography, drainage or construction of the milling facility and waste disposal system.

s) A report describing methodology, calibration procedures, quality control and data analysis for each type of measurement shall be included in the application.

History

• Source: Amended at 21 Ill. Reg. 3897, effective March 13, 1997

32 Ill. Adm. Code 332.70 Technical Analyses

The technical information shall also include the following analyses needed to demonstrate that the technical criteria of this Part will be met:

a) Analysis of radiological impacts, including all pathways of exposure (i.e., ingestion, inhalation, external exposures) of an individual continuously present at the control boundary, the public and those individuals working at the licensed site, in accordance with Section 332.170 of this Part and 32 Ill. Adm. Code 340.210. The analysis of radiological impacts of the proposed project must include the construction, operation, decontamination, relcamation, stabilization and postclosure periods under both normal and low-frequency severe event conditions (e.g., floods, severe storms, earthquakes, tornadoes, extreme temperatures). In addition, the analysis shall include a description of assumptions and procedures used for determination of the source terms, concentrations and dose-conversion factors. The impact analysis shall also include the following:

1. A determination of the radiological impacts to an individual continuously present at the control boundary;

2. A determination of the health impacts to the public, based on existing population and projected population, for 100 years, within a distance of 80 km;

3. A determination of the health impacts to the public, based on existing population and projected population, for 100 years, within a distance to 5 km;

4. Radiological analyses for a period up to 100 years after the anticipated closure;

5. The radiological impacts on groundwater, estimated for a period of 1,000 years after the beginning of the operation; and

6. Identification and differentiation of the roles performed by the natural site characteristics and design features in isolating the byproduct material from environment. The analysis shall include assessments that show the exposures to humans from the release of radioactivity will not exceed the limits set forth in Section 332.170 of this Part and 32 Ill. Adm. Code 340.

b) Analyses of the protection of individuals during operations shall include assessments for expected exposures due to routine operations and accidents during operation, storage, transfer, transport and disposal of ores, products, byproducts and byproduct material as defined in this Part. The analyses shall include assessments that show that exposures will be controlled to meet the requirements of 32 Ill. Adm. Code 340.210 for individuals in the restricted area, and the requirements of Section 332.170 of this Part and 32 Ill. Adm. Code 340.310 and 340.320 for individuals outside the control boundary.

c) Evaluation of the long-term stability of the byproduct material disposal site and the need for active maintenance after closure of the source material milling facility and any byproduct material surface impoundment or disposal area shall be based upon analyses of active natural processes such as erosion, mass wasting, slope failure, settlement of byproduct material and backfill, infiltration through covers over disposal areas and adjacent soils and surface drainage of the disposal site. The analyses shall include assessments that show that, after closure, the disposal site will not require active maintenance.

d) Analysis of the protection of the disposal site from inadvertent access shall include demonstration that the site closure requirements of Section 332.180 of this Part will be met.

History

• Source: Amended at 21 Ill. Reg. 3897, effective March 13, 1997

32 Ill. Adm. Code 332.80 Institutional Information

Where the proposed disposal site is on land not owned by the federal or State government, the applicant shall submit evidence that arrangements have been made for transfer of ownership in fee to the federal or State government. The arrangements shall provide that the governmental agency assuming custody of the byproduct material and its disposal site also assume responsibility for long-term care after termination of the license issued by the Agency.

History

• Source: Amended at 32 Ill. Reg. 16765, effective October 6, 2008

32 Ill. Adm. Code 332.90 Financial Information

The financial information shall be sufficient to determine that the financial qualifications of the applicant are adequate to comply with financial surety regulations set forth at Section 332.260.

32 Ill. Adm. Code 332.100 Evaluation of License Application and Issuance of a License

a) Environmental Analysis

1. Each application for a license or license amendment must be reviewed and the license or amendment must be issued by the Agency before commencement of any major construction activity. As part of its review of applications, the Agency shall prepare a written analysis of the impact of the license, including any activities conducted pursuant to the license. The analysis shall include the following:

A) An assessment of the radiological and nonradiological impacts to the public health from the activities to be conducted pursuant to the license or amendment;

B) An assessment of any impact on any waterway and groundwater resulting from the activities conducted pursuant to the license or amendment;

C) Consideration of alternatives, including alternative sites and engineering methods, to the activities to be conducted pursuant to the license or amendment; and

D) Consideration of the long-term impacts, including decommissioning, decontamination and reclamation impacts, associated with activities to be conducted pursuant to the license or amendment.

2. Commencement of construction prior to issuance of the license or amendment shall be grounds for denial of the license or amendment.

3. The environmental analysis prepared in accordance with subsection (a)(1) of this Section shall be available to the public before the commencement of hearings regarding the merits of the application.

b) Public Participation

1. Written Comments

A) Upon completing preparation of the analysis pursuant to subsection (a) of this Section, the Agency shall publish a notice of the availability of the environmental analysis in the official State newspaper and in a newspaper published in the county or counties where the facility that is the subject of licensing action is to be located. This notice shall specify how a copy of the environmental analysis can be obtained, as well as the deadline and address for submitting written comments on the license application.

B) The Agency shall accept written comments on the license application and the environmental analysis for at least 45 days following the publication of the notice described in subsection (b)(1)(A) of this Section.

2. Hearings

A) At least 30 days prior to the issuance or renewal of a license pursuant to this Part, the Agency shall publish a Notice of Opportunity to request a hearing in the official State newspaper and in a newspaper published in the county or counties where the facility that is the subject of the license application is located. This notice shall contain:

i) a statement identifying the location of the facility,

ii) a statement of the availability of the environmental analysis,

iii) a statement of the right to request a hearing,

iv) the date by which a request for a hearing is to be submitted to the Agency; that date shall be no less than 20 days after the date of the publication of the notice, and

v) a statement of the actions that will be taken by the Agency in the event that a hearing is not requested.

B) Any person who would be adversely affected by the issuance of the license may request a hearing. The request must be in writing and must contain a brief statement of the basis upon which the issuance of the license is being challenged. If the request is not submitted by the date specified in accordance with subsection (b)(2)(A) of this Section, or if the request is submitted but later withdrawn, the Agency shall issue the license in accordance with subsection (c) of this Section.

C) If any hearing is requested in accordance with subsection (b)(2)(B) of this Section, the parties to the hearing shall be the Agency and the Respondent. The provisions of 32 Ill. Adm. Code 200.20, 200.40, 200.50, 200.80 through 200.140 and 200.160 through 200.230 shall be applicable to the hearing.

c) Upon a determination that an application meets all criteria of this Part, the Agency shall issue a specific license authorizing the construction of the source material milling facility and any byproduct material surface impoundment and disposal area. Upon completion of the construction in accordance with the license specifications, the Agency shall authorize operations at the licensed site after verification of compliance with the license specifications.

d) The Agency may incorporate in any license at the time of issuance, or thereafter by appropriate rule or order, additional requirements and conditions in order to:

1. Ensure compliance with the requirements of this Part;

2. Reduce potential hazard to public safety during operation;

3. Protect the environment; or

4. Prevent loss or theft of materials subject to this Part.

e) The Agency may require reports, examine records, perform confirmatory monitoring and inspect activities under the license as necessary to demonstrate compliance with the requirements of this Part.

f) Throughout the construction and operating phases of the source material milling facility, a monitoring program shall be conducted by the licensee in order to:

1. Demonstrate compliance with the standards of this Part and 32 Ill. Adm. Code 310, 340 and 400;

2. Evaluate the performance of control systems and procedures;

3. Evaluate environmental impacts of operation; and

4. Detect potential long-term adverse effects.

g) The source material milling facility shall be designed and operated so that effluents and emissions and the resultant dose from effluents and emissions do not exceed the limits specified in 32 Ill. Adm. Code 340.310 and 340.320 and in Section 332.170 of this Part. The licensee shall limit emissions and exposures by using emission control devices. If the licensee cannot meet the requirements using emission control devices, then institutional controls, such as extended licensed site boundaries and buffer zones, may be used to ensure that limits of dose to members of the public will be met. The licensee shall submit to the Agency proposed operation procedures and shutdown procedures as evidence that the requirements specified in 32 Ill. Adm. Code 340 will be met.

History

• Source: Amended at 32 Ill. Reg. 16765, effective October 6, 2008

32 Ill. Adm. Code 332.110 General Conditions of Licenses

a) The licensee shall be subject to the provisions of the Act and to all rules, regulations, and orders of the Agency. The terms and conditions of the license are subject to amendment, revision, or modification, by reason of amendments to, or by reason of regulations and orders issued in accordance with, the terms of the Act.

b) Each person licensed by the Agency pursuant to this Part shall confine possession and use of materials to the locations and purposes authorized in the license.

c) The licensee shall not process any ore or place any byproduct material in any surface impoundment or disposal area until the Agency has inspected the surface impoundment or disposal area and, based on the results of the inspection, has determined that the surface impoundment or disposal area conforms to the description, design and construction described in the application for the license.

d) No license issued pursuant to this Part, or any right under that license, may be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, unless the Agency finds, after securing information, that the transfer is in accordance with the provisions of the Act and gives its consent in writing in the form of a license amendment.

e) The authority to receive and process ores and to place byproduct material within any surface impoundment and disposal area expires on the date stated in the license. Any expiration date on a license applies only to the receipt and processing of ores and the emplacement of byproduct material. Failure to renew the license shall not relieve the licensee of responsibility for implementing reclamation, decontamination, stabilization and closure, postclosure observation and maintenance and transfer of the license to the ultimate governmental owner.

f) The license will terminate only on the full implementation of the final closure plan as approved by the Agency, including postclosure observation and maintenance, and meeting the requirements of Section 332.140 of this Part.

g) Notification of Bankruptcy

1. The licensee shall notify the Agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of 11 USC 101 et seq. (Bankruptcy) of the United States Code by or against:

A) The licensee;

B) An entity (as that term is defined in 11 USC 101(15)) controlling the licensee or listing the license or licensee as property of the estate; or

C) An affiliate (as that term is defined in 11 USC 101(2)) of the licensee.

2. This notification shall indicate:

A) The bankruptcy court in which the petition for bankruptcy was filed; and

B) The date of the filing of the petition.

h) The licensee shall submit written statements, as requested by the Agency at any time before termination of the license, to enable the Agency to determine whether the license should be modified, suspended or revoked.

History

• Source: Amended at 32 Ill. Reg. 16765, effective October 6, 2008

32 Ill. Adm. Code 332.120 Application for Renewal or Closure

a) At least 1 year prior to license expiration, the licensee shall notify the Agency of its intent to either renew its license or to seek an amendment authorizing closure. At least 30 days prior to license expiration, the licensee shall file with the Agency either an application for renewal of the license or an application for a license amendment authorizing closure.

b) Applications for renewal of a license shall be filed in accordance with Sections 332.40 through 332.90. All applications for closure shall be filed in accordance with Section 332.130. Information contained in previous applications, statements, or reports filed with the Agency under the license may be incorporated by reference.

c) In any case in which a licensee has filed an application in proper form for renewal of a license, the license does not expire until the Agency has taken final action on the application for renewal.

d) In determining whether a license will be renewed, the Agency will apply the criteria set forth in Section 332.100.

e) Upon evaluation of an application to amend the license for closure submitted in accordance with Section 332.130, the Agency shall issue an amendment to the license authorizing closure if the assessment of the application demonstrates that the technical criteria of Sections 332.200 through 332.240 will be met.

History

• Source: Amended at 32 Ill. Reg. 16765, effective October 6, 2008

32 Ill. Adm. Code 332.130 Contents of Application for Site Closure and Stabilization

Prior to beginning final closure of the licensed site, or as otherwise directed by the Agency, the licensee shall submit an application to amend the license for closure. The application for amendment shall include an updated closure plan and shall provide the following specific information regarding site closure.

AGENCY NOTE: Other circumstances that would cause the Agency to direct the licensee to submit an application for closure include, but are not limited to, failure to meet the technical criteria of this Part, failure to post and maintain adequate financial surety, or failure to meet the requirements of the Act.

a) Any additional geologic, hydrologic, or other data pertinent to the long-term containment of the emplaced byproduct material generated during the operational period.

b) The results of tests, experiments, or any other analyses relating to any surface impoundment and disposal area, closure, waste migration, and interaction with byproduct material or any other tests, experiments, or analyses pertinent to the long-term containment of the emplaced byproduct material within the disposal site.

c) Any proposed revision of plans for:

1. Decontamination and/or dismantlement of mill and surface impoundments;

2. Recontouring or backfilling of areas; or

3. Stabilization of the disposal area for postclosure care.

d) Any information, not previously submitted to the Agency, regarding the potential environmental impact of closure activities and long-term performance of the disposal site.

History

• Source: Amended at 32 Ill. Reg. 16765, effective October 6, 2008

32 Ill. Adm. Code 332.140 Postclosure Observation and Maintenance

a) The licensee shall observe, monitor and maintain the licensed site until closure is complete and the license is terminated under the authorization of the Agency in accordance with Section 332.150 of this Part. The licensee shall be responsible for disposal site maintenance for 15 years after completion of closure. A longer time period for postclosure observation and maintenance will be required if the Agency determines that the licensee has not designed and closed the disposal site in accordance with the closure plan specified in the license.

b) During the postclosure period, the licensee shall conduct four disposal site inspections each year, once each season. Additional inspections shall be performed after each earthquake that, at the disposal site, exceeds a level 6 on the Modified Mercalli Index, or flood or abnormal change in climate, such as precipitation in excess of 10 times the seasonal average level. The results of the inspections, the monitoring data and the evaluation of the monitoring data shall be reported to the Agency within 60 days after each inspection. The Agency shall require more frequent disposal site inspections, if necessary to establish compliance with the requirements of Section 332.100 of this Part, or if there has been unauthorized use of the disposal site.

History

• Source: Amended at 32 Ill. Reg. 16765, effective October 6, 2008

32 Ill. Adm. Code 332.150 Termination of Source Material Milling Facility License

a) Following closure and the period of postclosure observation and maintenance, the licensee may apply for termination of the license. The license shall be terminated when the Agency finds:

1. That the closure of the licensed site has been made in conformance with the licensee's closure plan, as amended and approved as part of the license;

2. That the licensee has established that the technical criteria have been met;

3. That any long-term care funds and records are transferred to the federal or State agency that will assume institutional control of the disposal site;

4. That the federal or State agency that will assume responsibility for long-term care, observation and maintenance of the disposal site is prepared to assume such responsibilities;

5. That permanent monuments or markers warning against intrusion have been installed;

6. That the U.S. Nuclear Regulatory Commission has made a determination of compliance with the decontamination, decommissioning, reclamation and stabilization standards;

7. That title to the byproduct material and to the disposal site has been transferred to the United States of America or the State; and

8. That any buildings and material have been decontaminated to criteria specified in 32 Ill. Adm. Code 330.325.

b) In addition to satisfying requirements in subsection (a), the licensed site, other than the buildings and disposal area, shall be decontaminated to the following limits prior to termination of the license:

1. Concentration of radionuclides in soil above background concentrations for total radium, averaged over areas of 100 square meters, shall not exceed:

A) 5 picocuries per gram of dry soil, averaged over the first 15 centimeters below the surface; and

B) 15 picocuries per gram of dry soil, averaged over layers of 15 centimeters thickness more than 15 centimeters below the surface.

2. The level of gamma radiation measured at a distance of 100 centimeters from the surface shall not exceed background.

3. Soil contamination levels with nonradioactive hazardous substances shall not exceed the levels specified as contamination limits in other applicable State or federal regulations.

History

• Source: Amended at 39 Ill. Reg. 15719, effective November 24, 2015

32 Ill. Adm. Code 332.160 General Requirements

Source material milling facilities, and byproduct material surface impoundments and disposal areas shall be sited, designed, operated, closed, and controlled after closure so that exposures to individuals will be within the requirements established in the technical criteria in Sections 332.170, 332.180, 332.190 and 332.240.

32 Ill. Adm. Code 332.170 Protection of the General Population from Radiation

a) At all times, concentrations of radioactive material, excluding radon, thoron and their progeny, which may be released to the general environment in groundwater, surface water, air, soil or other means:

1. Shall not result in an annual dose equivalent in excess of 25 millirem (0.25 mSv) to the whole body of any member of the public; and

2. Shall not result in an annual dose equivalent in excess of 75 millirem (0.75mSv) to the thyroid or 25 millirem (0.25 mSv) to any other organ of any member of the public.

b) Releases of radionuclides in effluents to the general environment shall be maintained as low as is reasonably achievable.

c) During the operating life and facility decommissioning, the dose to any member of the public shall not exceed the limits specified in 32 Ill. Adm. Code 340.310.

d) The disposal area shall be designed so that after reclamation and stabilization, the annual total radon release rate through the cover from the byproduct material shall not exceed two picocuries per square meter per second. Furthermore, the direct gamma exposure rate from the byproduct material shall be reduced to background levels normal for areas in the vicinity.

History

• Source: Amended at 21 Ill. Reg. 3897, effective March 13, 1997

32 Ill. Adm. Code 332.180 Protection of Individuals from Inadvertent Access

Design, operation, and closure of the facility disposal area shall protect any individual inadvertently entering onto the disposal site at any time after termination of the license by the Agency.

History

• Source: Amended at 32 Ill. Reg. 16765, effective October 6, 2008

32 Ill. Adm. Code 332.190 Protection of Individuals During Operations

Operations at a licensed site shall be conducted in compliance with the standards for radiation protection established in 32 Ill. Adm. Code 340, except that releases of radionuclides in effluents from the licensed site shall be governed by Section 332.170. Every effort shall be made to maintain radiation exposures as low as is reasonably achievable.

32 Ill. Adm. Code 332.200 Stability of the Byproduct Material Disposal Site After Closure

The disposal site shall be sited, designed, used, operated, stabilized and closed to achieve long-term stability and to eliminate the need for active maintenance following closure so that only surveillance, monitoring, or minor custodial care is required.

32 Ill. Adm. Code 332.210 Technical Criteria for Byproduct Material Disposal Sites - Siting Criteria

a) Byproduct material shall be disposed of in a manner that provides containment of the material by preventing disturbances and dispersion by natural forces, and by doing so without active maintenance. In evaluating a byproduct material disposal site, the Agency shall consider:

1. Remoteness from populated areas;

2. Hydrologic and other natural conditions as they contribute to continued immobilization and isolation of contaminants from groundwater sources; and

3. Potential for minimizing erosion, disturbances, and dispersion by natural forces over the long term.

b) The disposal site selection shall be an optimization, to the maximum extent achievable, of the features listed in subsection (a). At a minimum, however:

1. The disposal site shall not be within a distance of 2.5 km (1.5 miles) from the boundary of any municipality without the consent of the governing body of the municipality. The disposal area must incorporate a distance between any waste disposal unit and the control boundary that is of adequate dimensions to carry out required environmental monitoring activities and remediation activities if necessary. In most cases, a distance of 100 meters would be adequate;

2. The tailings and waste disposal site shall not be located in a 100-year flood plain, as defined in the rules of the Illinois Department of Transportation, 92 Ill. Adm. Code 706.Subpart C;

3. The characteristics of the disposal site shall allow prediction, analysis and monitoring of any migration of effluents, e.g., the site geology must be simple enough to allow reliable hydrological modeling;

4. The depth to the water table at the disposal site shall not permit groundwater intrusion, perennial or otherwise, into the waste;

5. The natural characteristics of the disposal site, such as hydrology, geology, and topography, shall contribute to continued immobilization and containment, and shall ensure that waste will be contained within the disposal site boundary for a period of at least 1,000 years after the decommissioning;

6. The disposal site shall not be located where other facilities, activities or land uses could adversely impact the ability of the site to meet the technical criteria of this Part, or mask the environmental impacts of the disposal area;

7. The disposal area structure shall not be located above a geologic fault system. The disposal site geology must be stable; i.e., mass wasting, erosion, slumping, or land sliding shall not adversely affect the long-term containment; and

8. The disposal area shall not be located near a capable fault that could cause a maximum credible earthquake larger than the disposal area could reasonably be expected to withstand. As used in this Part, the term "capable fault" has the same meaning as defined in section III(g) of 10 CFR 100, appendix A, in effect on January 1, 1989, exclusive of subsequent amendments or editions. The term "maximum credible earthquake" means an earthquake that would cause the maximum vibratory ground motion based upon an evaluation of earthquake potential considering the regional and local geology and seismology and specific characteristics of local subsurface material.

c) When evaluating disposal sites, the Agency shall place emphasis on containment of byproduct material, a matter having long-term impacts, as opposed to consideration only of short-term convenience, impacts or benefits. While containment of byproduct material will be a function of both site and engineering design, major consideration shall be given to siting features that pertain to the long-term nature of the hazards.

d) To avoid the proliferation of small byproduct material disposal sites and reduce perpetual surveillance obligations, byproduct material from in situ extraction operations, such as residues from solution evaporation or contaminated control processes, and wastes from small remote aboveground extraction operations shall be disposed of at existing large byproduct material disposal sites; unless, considering the nature of the wastes, such as their volume and specific activity, and the cost and environmental impacts of transporting the wastes to large disposal sites, such offsite disposal is demonstrated to be impracticable or the advantages of onsite burial clearly outweigh the benefits of reducing the perpetual surveillance obligations.

History

• Source: Amended at 32 Ill. Reg. 16765, effective October 6, 2008

32 Ill. Adm. Code 332.220 Technical Criteria for Byproduct Material Disposal Sites - Design Criteria

a) When submitting a proposed method of disposal for evaluation by the Agency, the licensee shall either:

1. Submit to the Agency a plan describing how the licensee will dispose of byproduct material and contaminants below grade; or

AGENCY NOTE: The Agency presumes that disposal of tailings by placement below grade, either in mines or in excavated pits, is the method of disposal that best furthers the objective of containment of byproduct material and contaminants without requiring active maintenance. However, below grade disposal is not the most environmentally sound approach if a groundwater formation is relatively close to the surface or not very well isolated by overlying soils and rock. Geologic and topographic conditions might make full below grade disposal impracticable.

2. Submit to the Agency data that support the licensee's conclusion that disposal below grade is not the most environmentally sound approach, as well as a description of the licensee's alternative method for tailings disposal. The alternative method shall provide for excavation to the greatest degree achievable, given the geologic and hydrologic conditions at the site, so that the size of retention structures and the steepness of slopes of associated exposed embankments shall be minimized. The licensee shall also demonstrate that its proposed above grade disposal program will provide containment of the byproduct material equivalent or superior to that which would be achieved from below grade disposal.

b) Disposal Site Surfaces

1. Embankment and cover slopes shall be relatively flat after final stabilization to minimize the potential for erosion and to provide conservative factors of safety assuring long-term stability. Final slopes shall be contoured to grades that are as close as possible to those that would be provided if byproduct material were disposed of below grade. Slopes shall not be steeper than 10 horizontal to 1 vertical.

2. All disposal site surfaces shall be contoured to avoid areas of concentrated surface runoff or abrupt or sharp changes in slope. In addition to rock cover on slopes, areas toward which surface runoff might be directed shall be well protected with rock cover or rip rap. Overall stability, erosion potential, and geomorphology of surrounding terrain must be evaluated to assure that there are not ongoing or potential processes, such as gully erosion, that would lead to disposal area instability.

c) The disposal site and area, where feasible, shall be designed to incorporate features that will promote deposition. For example, design features that promote deposition of sediment suspended in any runoff that flows into the disposal area might be utilized; the object of such a design feature would be to enhance the thickness of cover over time.

d) The disposal site shall be designed so that the upstream rainfall catchment does not increase surface erosion or flooding of the disposal site.

e) A full self-sustaining vegetative cover shall be established or rock cover employed to control wind and water erosion. However, rock covering of slopes is unnecessary where:

1. top covers are very thick (on the order of 10 m or greater);

2. impoundment slopes are very gentle (on the order of 10 horizontal:1 vertical or less);

3. bulk cover materials have inherently favorable erosion resistance characteristics;

4. there is negligible drainage catchment area upstream of the disposal site; and

5. the topographic features of the disposal site provide wind protection.

f) Where rock cover is employed, in order to avoid displacement of rock particles by human and animal traffic, root invasion, or by natural process, and to preclude undercutting and piping, the following factors shall be accounted for in the rock cover design:

1. Shape, size, composition and gradation of rock particles. Except for bedding material, average particle size shall be at least cobble size or greater;

2. Rock cover thickness and zoning of particles by size;

3. Steepness of underlying slopes; and

4. Individual rock fragments shall be dense, sound and resistant to abrasion, and shall be free from cracks, seams and other defects that would tend to unduly increase their destruction by water and frost actions. Weak, friable or laminated aggregate shall not be used.

History

• Source: Amended at 32 Ill. Reg. 16765, effective October 6, 2008

32 Ill. Adm. Code 332.230 Technical Criteria for Byproduct Material Licensed Sites - Groundwater Protection

a) In order to provide adequate protection of groundwater resources, the licensed site shall be designed, constructed, maintained and operated to conform with the requirements of criterion 5 of 10 CFR 40, appendix A, in effect on January 1, 1994, exclusive of subsequent amendments or editions. In addition, closure shall be performed to conform with the requirements of criterion 5 of 10 CFR 40, appendix A, in effect on January 1, 1994, exclusive of subsequent amendments or editions. Criterion 13 of 10 CFR 40, appendix A, in effect on January 1, 1994, identifies the constituents for which standards shall be set or complied with if the specific constituent is expected to be in or derived from the byproduct material and has been detected in groundwater.

b) The licensee shall establish a detection monitoring program needed for the Agency to set the site-specific groundwater protection standards in subsection (a). The licensee or applicant shall propose for Agency approval as license conditions which constituents are to be monitored on a site-specific basis. A detection monitoring program shall be designed and implemented to accomplish two purposes. The program shall be designed and implemented to detect leakage of the hazardous constituents from the licensed site so that the need to set groundwater protection standards is monitored. If leakage is detected, the program shall be designed and implemented to generate data and information needed for the Agency to establish the standards under subsection (a). The data and information shall provide a sufficient basis to identify those hazardous constituents that require concentration limit standards and to enable the Agency to set the limits for those constituents and the compliance period. The data and information shall also provide the basis for adjustments to the point of compliance, if necessary.

c) Once groundwater protection standards have been established pursuant to subsection (a), the licensee shall establish and implement a compliance monitoring program. The purpose of the compliance monitoring program is to determine that the hazardous constituent concentrations in groundwater continue to comply with the standards set by the Agency. In conjunction with a corrective action program, the licensee shall establish and implement a corrective action monitoring program. The purpose of the corrective action monitoring program is to demonstrate the effectiveness of the corrective actions. Any monitoring program required by this subsection (c) may be based on existing monitoring programs to the extent the existing programs can meet the stated objective for the program.

History

• Source: Amended at 32 Ill. Reg. 16765, effective October 6, 2008

32 Ill. Adm. Code 332.240 Technical Criteria for Byproduct Material Disposal Sites - Control of Radiation Hazards

a) Licensees shall place an earthen cover over byproduct material at the end of source material milling operations and shall close the disposal site in accordance with a design which assures compliance with the requirements specified in Section 332.170(d) of this Part for a period of 1,000 years. Lands not decommissioned in accordance with Section 332.150(b)(1) of this Part shall be incorporated into the disposal area. Monitoring for total radon after installation of an appropriately designed cover is not required. Total radon emissions from cover material shall be estimated as part of developing a closure plan. The standard for total radon release rate specified in Section 332.170(d) of this Part, however, applies only to emissions from byproduct material. In computing required byproduct material area cover thicknesses, average moisture in the cover shall be determined from similar soils and under similar circumstances. The effects of any synthetic layer shall not be taken into account in determining the calculated total radon release rate. If material other than soil is proposed as cover material, it shall be demonstrated that such material will not crack or degrade by differential settlement, weathering or other mechanism, over long-term time intervals. Near surface cover material within the top three meters shall not include byproduct material or rock that contains elevated levels of radium; soils used for near surface cover shall be essentially the same, as far as radioactivity is concerned, as that of surrounding surface soils.

b) The licensee shall ensure that disposal sites are closed in a manner that assures no active maintenance will be required. The licensee shall address the nonradiological hazards associated with the wastes in planning and implementing closure. To the extent necessary to prevent threats to human health and the environment, the licensee shall control or eliminate postclosure escape of nonradiological hazardous constituents, leachate, contaminated rainwater or waste decomposition products to groundwater, surface water or to the atmosphere.

History

• Source: Amended at 21 Ill. Reg. 3897, effective March 13, 1997

32 Ill. Adm. Code 332.250 Technical Criteria - Source Material Milling Operations

a) Liquids resulting from any of the mill processes shall not be released into surface streams. In addition, contaminated solutions, other than liquids resulting from any of the mill processes, shall not be released into the environment if the solutions have radionuclide concentrations in excess of those specified in 32 Ill. Adm. Code 340.320(b) and (c).

b) Byproduct material shall be chemically and physically treated to immobilize or remove the contaminants.

c) An independent quality assurance program shall be established to assure that specifications of the monitoring program detailed in the license are met. If adverse groundwater impacts or conditions conducive to adverse groundwater impacts occur, action shall be taken to alleviate the impacts or conditions and restore groundwater quality to levels as specified in accordance with Section 332.230 of this Part.

d) Source material milling operations shall be conducted so that all airborne effluent releases are reduced to levels as low as is reasonably achievable. Emissions controls shall be used. Institutional controls, such as extending the licensed site boundary and exclusion area, may be employed to ensure that offsite dose limits are met, but only after all practicable process and engineering measures have been taken to control emissions at the source. Notwithstanding the existence of individual dose standards, strict control of emissions is necessary to assure that population exposures are reduced to the maximum extent reasonably achievable and to avoid site contamination. During operations and prior to closure, radiation doses from radon emissions from surface impoundments and disposal areas containing byproduct material shall be kept as low as is reasonably achievable. Checks shall be made and logged hourly of all parameters that determine the efficiency of product stack emission control equipment operation. It shall be determined whether conditions are within a range prescribed to ensure that the equipment is operating consistently near peak efficiency. Corrective action must be taken when performance is outside of prescribed ranges. Effluent control devices must be operative at all times during drying and packaging operations and whenever air is exhausting from the product stack. Drying and packaging operations shall terminate when controls are inoperative. When checks indicate the equipment is not operating within the range prescribed for peak efficiency, actions shall be taken to restore parameters to the prescribed range. When this cannot be done without shutdown and repairs, drying and packaging operations shall cease as soon as practicable. Operations shall not be restarted after cessation due to abnormal performance until needed corrective actions have been identified and implemented. All such cessations, corrective actions and restarts shall be reported to the Agency, in writing, within 10 days after the subsequent restart.

e) To control fugitive dust from tailings, all surfaces not covered by standing liquids shall be wetted or chemically stabilized. For licenses initially granted after January 1, 1990, management of tailings shall incorporate phased-in surface stabilization and reclamation. To control dusting from diffuse sources, operators shall develop written operating procedures specifying the methods of control that will be used.

f) Byproduct material shall be managed so as to conform to the applicable provisions of 40 CFR 440, Ore Mining and Dressing Point Source Category: Effluent Limitations Guidelines and New Source Performance Standards, subpart C, Uranium, Radium, and Vanadium Ores Subcategory, in effect on July 1, 1995, exclusive of subsequent amendments or editions.

g) Licensees and applicants shall satisfy the requirements of 40 CFR 61, in effect on July 1, 1995, exclusive of subsequent amendments or editions.

h) Inspection of the byproduct material impoundments and disposal areas:

1. The licensee shall conduct daily inspections of any surface impoundment and disposal site and document the results of the inspections. Records of the inspections shall be maintained for 5 years in a format allowing for easy access and review by the Agency.

2. The licensee shall notify the Agency within 2 hours by telephone, and then within 48 hours by written report, of any failure of a byproduct material surface impoundment or disposal area that results in a release of byproduct material into unrestricted areas. The licensee shall notify the Agency in writing, immediately, of any condition that was not anticipated in the design of the byproduct material surface impoundment or disposal area and, if not corrected, could cause failure of embankments or other structures containing the byproduct material and the release of byproduct material into unrestricted areas.

3. In cases of failure of the byproduct material impoundment, the report shall be maintained for transfer to the governmental agency to which the title of the facility will be transferred.

History

• Source: Amended at 42 Ill. Reg. 10412, effective May 31, 2018

32 Ill. Adm. Code 332.260 Financial Surety Requirements

a) The license applicant shall establish financial surety arrangements, prior to the Agency authorization of commencement of operations, to assure the availability of sufficient funds for decontaminating, decommissioning and reclaiming the source material milling facility, including reclamation of any tailings or waste disposal areas, and licensed site, as well as the stabilization and closure of the byproduct material disposal site and the long-term care payment.

b) An acceptable surety arrangement may consist of cash or negotiable securities deposited with the Agency, irrevocable assignments of savings or certificates of deposit, or the deposit of an instrument executed by the applicant or licensee and a corporate surety or financial institution with the Agency designated as the beneficiary. However, self insurance, or any arrangement that essentially constitutes self insurance (e.g., a contract with a State or federal agency) will not satisfy the surety requirement since this provides no additional assurance other than that which already exists through license requirements. The value of the deposit shall be equal to or greater than the amount of the surety required by subsection (c). Any surety arrangement must be available in Illinois subject to judicial process and execution in the event required for the purposes set forth in this Part.

c) The amount of funds to be ensured by the surety arrangements shall be greater than or equal to the Agency approved decommissioning cost estimates. Each decommissioning cost estimate shall be submitted for review and Agency approval and shall contain:

1. A detailed cost estimate for the decontamination, decommissioning, restoration and reclamation of buildings and the licensed site, stabilization and closure of the disposal area and the requirements of Section 332.270 for the long-term care payment in the amount reflecting:

A) The cost of an independent contractor to perform all decommissioning activities;

B) The cost of meeting Section 332.150 for unrestricted use;

C) The volume of onsite subsurface material containing residual radioactivity that will require remediation; and

D) A contingency factor of 25 percent of the total decommissioning cost estimate.

2. Identification of and justification for using the key assumptions contained in the decommissioning cost estimate;

3. A description of the method outlined in subsection (b) that will be used to assure funds for decommissioning, 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 surety instrument obtained to satisfy the requirements of subsection (b), unless a previously submitted and accepted financial surety instrument continues to cover the cost estimate for decommissioning.

d) To avoid duplication and expense, the Agency will accept surety arrangements that have been consolidated with surety arrangements established to meet requirements of other agencies in Illinois for decontamination, reclamation, restoration and disposal, if the applicant demonstrates, in writing, that the surety provides the same or a greater degree of protection for the licensed site, provided that the arrangements are adequate to satisfy these requirements and that the portion of the surety that covers the decommissioning, decontamination, reclamation and stabilization of the site and the long-term site surveillance and control is specifically identified and committed for use in accomplishing these activities.

e) The applicant's or licensee's surety arrangements and decommissioning cost estimate will be reviewed annually and at the time of license renewal by the Agency to assure that sufficient funds will be available for completion of the closure plan if the work was to be performed by an independent contractor. The amount of surety shall be adjusted to recognize any increases or decreases resulting from inflation, changes in engineering plans, activities performed, spills, leakage or migration of radioactive material producing additional contamination in onsite subsurface material that must be remediated to meet applicable remediation criteria, waste inventory increasing above the amount previously estimated, waste disposal cost increasing above the amount previously estimated, facility modifications, changes in authorized possession limits, actual remediation costs that exceed the previous cost estimate, onsite disposal, use of settling ponds, and any other conditions affecting costs. Financial surety shall be sufficient at all times to cover the cost of decommissioning and reclamation of the areas that are expected to be disturbed before the next license renewal. Regardless of whether closure is phased through the life of the operation or takes place at the end of operations, an appropriate portion of the surety shall be retained until final compliance with the closure plan is determined by the Agency. The appropriate portion of the surety to be retained shall be determined by the Agency based on review and analysis of the decommissioning cost estimate.

f) The term of the surety mechanism shall be open-ended, unless the licensee proposes another arrangement that provides an equivalent or greater level of assurance. The surety instrument shall provide that the surety mechanism will be automatically renewed and will not be cancelled unless the surety notifies both the Agency and the licensee at least 90 days prior to cancellation. Upon notice by the surety, the licensee shall submit to the Agency an acceptable replacement surety within 30 days after the notice. Proof of forfeiture shall not be necessary to collect the surety so that, in the event the licensee could not provide an acceptable replacement surety within the required time, the surety shall be automatically collected prior to its expiration or cancellation.

History

• Source: Amended at 39 Ill. Reg. 15719, effective November 24, 2015

32 Ill. Adm. Code 332.270 Long-Term Care Fund

a) Prior to termination of a source material milling or byproduct material license, a minimum payment of $250,000 (1978 dollars − $811,000 in 2008 dollars) to cover the cost of long-term care shall be paid by the licensee. If title and custody to land and byproduct material are transferred to the State, the payment shall be made to the State agency assuming custody. If title and custody are transfered to a federal agency, the payment shall be deposited in the general treasury of the United States.

b) If the cost of long-term care is determined, on the basis of a site specific evaluation, to be greater than $250,000 (1978 dollars − $811,000 in 2008 dollars), variance in the funding requirements shall be specified by the Agency. The total amount of the payment must be such that, with an assumed 1 percent annual real interest rate, the collected funds will yield interest in an amount sufficient to cover the annual costs of long-term care. The minimum funding requirement will be adjusted annually prior to actual payment to recognize inflation. The inflation rate to be used is that indicated by the change in the Consumer Price Index published by the U.S. Department of Labor, Bureau of Labor Statistics.

History

• Source: Amended at 32 Ill. Reg. 16765, effective October 6, 2008

32 Ill. Adm. Code 332.280 Land Ownership

a) These requirements relating to ownership of byproduct material, mineral rights and disposal sites apply to all licenses terminated, issued or renewed after January 1, 1990.

b) Unless exempted by NRC, title to land (including any affected interests therein) which is used for the disposal of byproduct material, or is essential to ensure the long-term stability of the disposal area and the title to byproduct material shall be transferred to the United States of America or the State of Illinois, at the State's option, prior to the termination of the license. The applicant or licensee shall attempt to obtain ownership of severable subsurface interests and rights, and shall, in the event that certain rights cannot be obtained, provide notification in local public land records of the fact that the land is being used for the disposal of radioactive material and is subject to an NRC license prohibiting the disruption and disturbance of the radioactive material.

c) The use of the surface or subsurface estates, or both, of the lands transferred to the State or to the United States of America is prohibited unless the NRC determines by order that such use will not endanger the public health, safety, welfare or environment. The person who transferred such lands to the State or to the United States of America shall have the right of first refusal with respect to such use of such lands.

d) Byproduct material and land transferred to the United States of America or the State in accordance with this section shall be transferred without cost to the United States of America or the State other than administrative and legal costs incurred in carrying out such transfer.

e) The provisions of this Section respecting transfer of title and custody to land and byproduct material do not apply in the case of lands held in trust by the United States of America for any Indian tribe or lands owned by such Indian tribe subject to a restriction against alienation imposed by the United States of America. Where such lands are used for the disposal of byproduct material, the licensee shall enter into arrangements with the NRC as may be appropriate to assure the long-term care of such lands by the United States of America.

f) Prior to termination of the license, the licensee shall provide evidence that it will comply with ownership requirements of this Section.

History

• Source: Amended at 21 Ill. Reg. 3897, effective March 13, 1997

32 Ill. Adm. Code 332.290 Maintenance of Records, Reports, and Transfers

a) Each licensee shall maintain any records and make any reports in connection with the license activities as may be required by the conditions of the license or by the rules, regulations and orders of the Agency.

b) Records that are required to be maintained by regulation or by license conditions shall be maintained in a format allowing for easy access and review by the Agency, for a time period specified in the applicable regulation or license condition. If a record retention period is not otherwise specified, these records shall be maintained and transferred to the officials specified in subsection (d) of this Section as a condition of license termination unless the Agency otherwise authorizes their disposition.

c) Records that shall be maintained pursuant to this Part may be the original, or a reproduced copy or microfilm if this reproduced copy or microfilm is capable of producing copy that is clear and legible at the end of the required retention period.

d) Copies of records of the location and quantity of byproduct material contained in the disposal site shall be transferred upon license termination to the Agency, the agency responsible for long-term care, the U.S. Nuclear Regulatory Commission, the chief executive of the nearest municipality, the chief executive of the county in which the disposal site is located, the county zoning board or land development and planning agency and the Governor.

e) Each licensee shall file a copy of its financial report or a certified financial statement annually with the Agency in order to update the information base for determining the continued financial qualifications of the licensee.

f) Each licensee shall submit status reports to the Agency. The reports shall be submitted within 60 days after January 1 and July 1 of each year and shall cover the previous 6 months of operation. The reports shall include:

1. Specification of the quantity of each of the radionuclides released to unrestricted areas in liquid and gaseous effluents;

2. The results of the environmental monitoring program;

3. Data reported in a manner that will permit the Agency to confirm the potential annual radiation doses to the public;

4. A summary of licensee survey and maintenance activities;

5. A summary of activities and quantities of licensed material processed, stored, transferred or disposed of;

6. Any instances in which observed site, facility, process or equipment characteristics were significantly different from those described in the application for a license; and

7. If the quantities of radionuclides released are more than 25 percent greater than those anticipated in the license application, or if unanticipated maintenance is performed, a discussion of the cause of the release or the reason for the maintenance.

History

• Source: Amended at 32 Ill. Reg. 16765, effective October 6, 2008

Part 333 Fees for Calibration Services

32 Ill. Adm. Code 333.10 Purpose and Scope

Under the provisions of the Radiation Protection Act of 1990, the Illinois Department of Nuclear Safety (Department) is authorized to maintain a facility for the purpose of calibrating radiation detection and measuring instruments in accordance with national standards. The Department may make calibration services available to public or private entities within or outside of Illinois and may assess a reasonable fee for such services [420 ILCS 40/25(g)]. The Department has established such a facility, which has been accredited as a State Regional Calibration Laboratory by the Conference of Radiation Control Program Directors, Inc. This Part sets forth the procedures to be followed by persons who request the services of this facility, the terms and conditions under which such services will be provided and the fees that the Department will charge for providing calibration services.

32 Ill. Adm. Code 333.20 Procedure for Requesting Calibration Services

Any person may request the Department to perform calibration services described in this Part.

a) Requests for such services shall be in writing and addressed to the Manager, Calibration Facility, Illinois Department of Nuclear Safety, 1301 Knotts Street, Springfield, Illinois 62703.

b) The request shall specify the type of instrument for which calibration services are requested, by instrument name and model number.

32 Ill. Adm. Code 333.30 Conditions

Any person who sends an instrument to the Department for calibration shall bear the cost and risk of transporting the instrument to the Department and returning the instrument to the sender. In addition, neither the Department nor the State of Illinois, nor any of their employees, agents or assignees shall be liable for any loss or damages, including without limitation, direct, consequential or special damages that may result in connection with the performance of calibration services.

32 Ill. Adm. Code 333.40 Calibration Services

a) The Department provides the following calibration services under accreditation by the Conference of Radiation Control Program Directors, Inc.

1. X-ray Calibrations. 5 beam codes at 32 mR/sec. This service is available for the Radcal MDH 1015 x-ray monitor only. The available beam codes are:

BEAM

CODE

HALF-VALUE

LAYER

HOMOGENEITY

COEFFICIENT

L

80

1.81 mm Aluminum

0.59

L

100

2.82 mm Aluminum

0.59

M

30

0.36 mm Aluminum

0.65

M

50

1.03 mm Aluminum

0.64

M

100

4.96 mm Aluminum

0.73

2. Gamma Ray Calibrations. 1 beam code. This service is available only for ion chamber and energy compensated G-M tube instruments.

BEAM CODE

INTENSITIES

Cs-137

.005 - 40 R/hr

b) The Department also provides the following services, which are not performed under accreditation.

1. Microrem Meter Calibrations. 2 points per scale, gamma intensity range available to 0.015 mR/hr.

2. Pocket Dosimeter Calibrations. 1 point gamma radiation up to 200 R.

3. Count-Rate Instrument Calibrations. Pulse rate at 2 points per scale. Alpha probe response is checked at 2 points. Beta-gamma probes are checked at 1 point. Other checks may be performed, depending on each instrument and probe combination.

c) The Department may be able to provide additional calibration services, including but not limited to calibrations using additional beam codes. Persons desiring any calibration services are urged to contact the facility by telephone at (217) 786-7221 to determine the availability of additional services.

32 Ill. Adm. Code 333.50 Fee Schedule

a)

Radcal MDH x-ray monitor calibration (maximum 2 probes)

$235.00/ea

b)

G-M ion chamber survey instrument or microrem meter

$75.00/ea

c)

Reference quality ion chamber calibration (1 point, 1 beam quality, either gamma or x-ray)

$100.00/ea

d)

Pocket dosimeter calibration

$5.00/per dosimeter ($50 minimum charge)

e)

Count-rate instrument

$75.00/ea

each additional probe

$25.00

f)

Handling charge for any non-operational instrument received for calibration

$25.00

g)

Other services

$100.00/hour

32 Ill. Adm. Code 333.60 Other Provisions

a) The Department will not repair or service non-functioning instruments. However, if batteries or other parts are missing from instruments sent to the Department, the Department will so advise the person sending the instrument and request that the missing parts be supplied. If the person sending the instrument fails to supply the needed items, the Department will return the instrument subject to payment of the handling fee provided in this Part.

b) Upon completing the calibration services, the Department will return the instrument along with a bill for services rendered to the person seeking the calibration service.

c) Payment for services shall be by check or money order, made payable to the Illinois Department of Nuclear Safety.

d) Upon receipt of the full amount of the billing, the Department will provide a copy of the records and results of the calibration to the sender.

e) The Department upon written request may waive all or a portion of any fee established in this Part upon making a determination that such a waiver would be in the best interests of the State of Illinois. Examples of situations in which the Department may consider a waiver include:

1. When requested to service the calibration of instruments used by federal, state or local agencies in Illinois for purposes of assuring protection of the public health and safety through a cooperative agreement with the Department.

2. When the person requesting the calibration service provides a service (such as making training or other resources available) to the Department in exchange for calibration services.

Chapter II Illinois Emergency Management Agency and Office of Homeland Security

Subchapter b Radiation Protection

Part 334 Fees for by-Product Material Licenses

32 Ill. Adm. Code 334.10 Purpose and Scope

a) The purpose of this Part is to establish an annual fee which shall be imposed on the owner or operator of any property that has been used in whole or in part for the milling of source material and is being used for the storage or disposal of by-product material, equal to $2 per cubic foot of by-product material being stored or disposed of by the facility. However, no fees shall be collected from any State, county, municipal, or local governmental agency. Moneys collected shall be deposited by the Department into the By-product Material Safety Fund (Fund). [420 ILCS 42/15]

b) The Department is authorized to spend money from the Fund for the following purposes:

(1) the costs of monitoring, inspecting, and otherwise regulating the storage and disposal of by-product material, wherever located;

(2) the costs of undertaking any necessary maintenance, decommissioning activities, cleanup, responses to radiation emergencies, or remedial action that may be necessary in connection with by-product materials;

(3) the costs incurred by the Department arising from the transportation of the by-product material from a storage or unlicensed disposal location to a licensed permanent disposal facility. [420 ILCS 42/15(b)]

c) In addition, the Department may reimburse to the owner or operator of any facility used for the storage or disposal of by-product material for costs incurred by the owner or operator in connection with the decontamination or decommissioning of the storage or disposal facility or other properties contaminated with by-product material. However, the amount of the reimbursements paid to the owner or operator of a by-product material storage or disposal facility shall not exceed the amount of money paid into the Fund by that owner or operator plus the interest accrued in the Fund attributable to amounts paid by that owner or operator [420 ILCS 42/15(b)(4)]. Section 334.40 sets out the procedures to be taken by the owner or operator in requesting reimbursement from the Fund.

32 Ill. Adm. Code 334.20 Definitions

As used in this Part, the following definitions apply:

"Act" means the Uranium and Thorium Mill Tailings Control Act [420 ILCS 42].

"By-product material" means the tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from underground solution extraction processes but not including underground ore bodies depleted by such solution extraction processes.

"Department" means the Department of Nuclear Safety.

"Director" means the Director of the Department of Nuclear Safety.

"Person" means any individual, corporation, partnership, 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 foregoing, other than the United States Nuclear Regulatory Commission, or any successor thereto, and other than federal government agencies licensed by the United States Nuclear Regulatory Commission, or any successor thereto.

"Source material" means uranium, thorium, or any other material that the Department declares by order to be source material after the United States Nuclear Regulatory Commission or its successor has determined the material to be source material; or ores containing one or more of those materials in such concentration as the Department declares by order to be source material after the United States Nuclear Regulatory Commission or its successor has determined the material in such concentration to be source material.

32 Ill. Adm. Code 334.30 Payment of Fees Into the by-Product Material Safety Fund

The storage fees assessed under this Part are separate and distinct from any license fees imposed under 32 Ill. Adm. Code 331.

a) The annual fee of $2 per cubic foot shall be assessed on the quantity of by-product material in the owner or operator's possession on January 1 of each year. The Department shall provide notice of the amount of the fee to each owner by certified mail by February 1 of each year.

b) The quantity of material for the assessment in subsection (a) above does not include by-product material that has been at the facility for 180 days or less.

c) In connection with settling litigation regarding the amount of the fee to be imposed, the Director may enter into an agreement with the owner or operator of any facility specifying that the fee to be imposed shall not exceed $26,000,000 in any calendar year [420 ILCS 42/15(a)].

d) Beginning in 1995, the annual fee shall be payable in equal installments on June 1, 1995, September 1, 1995, December 1, 1995 and December 31, 1995.

e) Beginning in 1996, the annual fee shall be payable in equal quarterly installments due March 31, June 30, September 30 and December 31.

f) Payments shall be by check or money order made payable to the Illinois Department of Nuclear Safety.

g) If the owner or operator wishes to contest the annual fee assessment, the owner or operator may petition the Department to request a hearing. This petition must be received by the Department on or before the date the payment is due. If a hearing is granted, it shall be conducted in accordance with 32 Ill. Adm. Code 200.

h) Any person failing to pay the fees as specified in this Section may be issued a Preliminary Order and Notice of Opportunity for Hearing, and may be subject to a civil penalty. This civil penalty shall not exceed 4 times the amount of the fees not paid [420 ILCS 42/40(b)].

32 Ill. Adm. Code 334.40 Reimbursement of Fees from the by-Product Material Safety Fund

a) An owner or operator who incurs costs in connection with the decontamination or decommissioning of the storage or disposal facility or other properties contaminated with by-product material is entitled to have those costs promptly reimbursed from the Fund.

b) An owner or operator of a facility shall submit a request for reimbursement to the Director subject to audit by the Director.

c) The Director shall, upon receipt of a request, give written notice approving or disapproving each of the owner or operator's request for reimbursement within 60 days.

d) The Director shall approve requests for reimbursement unless:

1. The Director finds that the amount is excessive, erroneous, or otherwise inconsistent with subsection (b) above; or

2. The Director finds that the amount is inconsistent with any license or license amendments issued in connection with that owner or operator's decontamination or decommissioning plan.

e) Upon approval of a reimbursement request, the Director shall prepare and certify to the Comptroller the disbursement of the approved sums from the Fund to the owners or operators.

f) If the Director disapproves a reimbursement request, the Director shall inform the owner or operator, in writing, the reasons for disapproval.

g) The owner or operator may resubmit to the Department a disapproved reimbursement request with additional information to respond to the reasons for disapproval and for further consideration by the Director.

h) Disapproval of a reimbursement request shall constitute final action for purposes of the Administrative Review Law unless the owner or operator resubmits the denied request within 35 days after receipt of denial.

Part 335 Medical Use of Radioactive Material

32 Ill. Adm. Code 335.10 Purpose and Scope

This Part contains the requirements and provisions for the medical use of radioactive material and for issuance of specific licenses authorizing the medical use of this material. This Part allows use of radioactive material strictly for medical use as authorized by an authorized user and does not allow use for training, demonstration or other purposes unrelated to the treatment of patients. These requirements and provisions provide for the radiation safety of workers, the general public, patients and human research subjects. The requirements of this Part are in addition to, and not in substitution for, others in 32 Ill. Adm. Code: Chapter II, Subchapters b and d. The requirements of 32 Ill. Adm. Code: Chapter II, Subchapters b and d apply to applicants and licensees subject to this Part unless specifically exempted.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.15 Incorporations by Reference

All rules, standards and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified in the reference and do not include any later amendments or editions. Copies of these rules, standards and guidelines that have been incorporated by reference are available for public inspection and copying at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.20 Definitions

"Area of use" means a portion of a physical structure that has been set aside for the purpose of receiving, using or storing radioactive material.

"Associate Radiation Safety Officer" means an individual who, for this Part only, meets the requirements in Sections 335.9010 and 335.9180 and is currently identified as an Associate Radiation Safety Officer for the types of use of radioactive material for which the individual has been assigned duties and tasks by the Radiation Safety Officer on a specific medical use license issued by the Agency, U.S. Nuclear Regulatory Commission or an Agreement State or on medical use permit issued by a U.S. Nuclear Regulatory Commission master material licensee.

"Authorized user" means a physician, dentist or podiatrist who meets the requirements in Subpart J or is identified as being authorized to use radioactive material on a specific medical use license issued by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State; a medical use permit issued by a U.S. Nuclear Regulatory Commission master material licensee; a permit issued by a U.S. Nuclear Regulatory Commission or Agreement State broad scope medical use licensee; or a permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope medical use permittee.

"Authorized medical physicist" means an individual who meets the requirements in Sections 335.9150(a) and 335.9180; or is identified as an authorized medical physicist or teletherapy physicist on a specific medical use license issued by the U.S. Nuclear Regulatory Commission or an Agreement State, a medical use permit issued by a U.S. Nuclear Regulatory Commission master material licensee, a permit issued by a U.S. Nuclear Regulatory Commission or an Agreement State broad scope medical use licensee, or a permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope medical use permittee.

"Case" means the performance of a clinical procedure on a patient.

"Classroom and laboratory training" means planned instruction outlined in a syllabus and offered by an individual or organization. It is comprised of lectures, demonstrations, hands-on laboratory exercises and tests.

"Client's address" means the area of use or a temporary job site for the purpose of providing mobile medical service in accordance with Section 335.2120.

"Clinical procedure" means a method of using radioactive material for patient care in which the material or its radiation is administered to the patient. A specific clinical procedure specifies, either explicitly or in context, the indication for the procedure, the purpose (diagnosis or therapy), the radionuclide and its chemical and physical form, the dosage or dose and method of administration and patient follow-up. Diagnostic clinical procedures also include the method of collecting raw data, manipulating the data and interpreting the final results, which may be images, graphs or numbers.

"Dentist" means an individual licensed by a state or territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico to practice dentistry.

"Gamma stereotactic radiosurgery" means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume.

"High dose rate remote afterloader" means a brachytherapy device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.

"Intravascular brachytherapy" means a type of brachytherapy in which the brachytherapy sources are placed into blood vessels at the point where the dose is prescribed for the treatment of in-stent restenosis.

"Low dose rate remote afterloader" means a brachytherapy device that remotely delivers a dose rate of less than or equal to 2 gray (200 rads) per hour at the point or surface where the dose is prescribed.

"Management" means the chief executive officer or other individual having the authority to manage or administer the licensee's activities, or those individuals' delegates.

"Manual brachytherapy" means a type of brachytherapy in which the brachytherapy sources (e.g., seeds, ribbons) are manually placed topically on or inserted either into the body cavities that are in close proximity to a treatment site or directly into the tissue volume.

"Medical event" means an event that meets the criteria in Section 335.1080.

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

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

"Medium dose rate remote afterloader" means a brachytherapy device that remotely delivers a dose rate of greater than 2 gray (200 rads) per hour, but less than or equal to 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.

"Mobile medical service" means the transportation of radioactive material to, and its medical use at, the client's address.

"Ophthalmic physicist" means an individual who meets the requirements in Sections 335.7100(b) and 335.9180; and is identified as an ophthalmic physicist on a specific medical use license issued by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State; a medical use permit issued by a U.S. Nuclear Regulatory Commission master material licensee; a permit issued by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State broad scope medical use licensee; or a permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope medical use permittee.

"Output" means the exposure rate, dose rate or a quantity related in a known manner to these rates from a brachytherapy source or a teletherapy, remote afterloader or gamma stereotactic radiosurgery unit for a specified set of exposure conditions.

"Patient intervention" means actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration.

"Physically present" means within audible range and in such proximity that immediate assistance can be given if required.

"Podiatrist" means an individual licensed by a state or territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico to practice podiatry.

"Preceptor" means an individual who provides, directs, or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, a Radiation Safety Officer, or an Associate Radiation Safety Officer.

"Prescribed dosage" means the specified activity or range of activity of unsealed radioactive material as documented:

in a written directive; or

in accordance with the directions of the authorized user for procedures pursuant to Sections 335.3010 and 335.4010.

"Prescribed dose" means:

for gamma stereotactic radiosurgery, the total dose as documented in the written directive;

for teletherapy, the total dose and dose per fraction as documented in the written directive;

for manual brachytherapy and intravascular brachytherapy, either the total dose or the total source strength and exposure time, as documented in the written directive; or

for remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.

"Pulsed dose rate remote afterloader" means a special type of remote afterloading brachytherapy device that uses a single source capable of delivering dose rates in the "high dose rate" range, and:

is approximately one-tenth of the activity of typical high dose rate remote afterloader sources; and

is used to simulate the radiobiology of a low dose rate treatment by inserting the source for a given fraction of each hour.

"Radiation Safety Officer" means an individual who:

meets the requirements in Sections 335.9010 and 335.9180; or

is identified as a Radiation Safety Officer on:

a specific medical use license issued by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State; or

a medical use permit issued by a U.S. Nuclear Regulatory Commission master material licensee.

"Structured educational program" means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.

"Teletherapy" means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.

"Therapeutic dosage" means a dosage of unsealed radioactive material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.

"Therapeutic dose" means a radiation dose delivered from a source containing radioactive material to a patient or human research subject for palliative or curative treatment.

"Treatment site" means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.

"Type of use" means use of radioactive material under Section 335.2140, 335.3010, 335.4010, 335.5010, 335.6010, 335.7010 or 335.8010.

"Unit dosage" means a dosage prepared for medical use for administration as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared.

"Visiting authorized user" means a temporary (i.e., less than 60 days each year) authorized user who is not identified on the license of the licensee being visited and who has been approved by the Radiation Safety Committee in accordance with Section 335.1060(b).

"Written directive" means an authorized user's written order for the administration of radioactive material or radiation from radioactive material to a specific patient or human research subject, as specified in Section 335.1110.

History

• Source: Amended at 48 Ill. Reg. 13672, effective August 29, 2024

32 Ill. Adm. Code 335.30 License Required

a) A person shall manufacture, produce, acquire, receive, possess, prepare, use or transfer radioactive material for medical use only in accordance with a specific license issued by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State, or as allowed by subsection (b)(1) or (2) of this Section.

b) A specific license is not needed for an individual who:

1. Receives, possesses, uses or transfers radioactive material in accordance with this Part under the supervision of an authorized user as provided in Section 335.1050 unless prohibited by license condition; or

2. Prepares unsealed radioactive material for medical use in accordance with this Part under the supervision of an authorized nuclear pharmacist or authorized user as provided in Section 335.1050 unless prohibited by license condition.

History

• Source: Amended at 35 Ill. Reg. 884, effective December 30, 2010

32 Ill. Adm. Code 335.35 Suppliers for Sealed Sources or Devices for Medical Use

For medical use, a licensee shall only use:

a) Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued under 32 Ill. Adm. Code 330 or equivalent requirements of the U.S. Nuclear Regulatory Commission or an Agreement State.

b) Sealed sources or devices non-commercially transferred from an Agency, U.S. Nuclear Regulatory Commission or an Agreement State medical use licensee.

c) Teletherapy sources manufactured and distributed in accordance with a license issued under 32 Ill. Adm. Code 330 or equivalent requirements of the U.S. Nuclear Regulatory Commission or an Agreement State.

History

• Source: Added at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.40 License Amendments

For specific licenses issued pursuant to 32 Ill. Adm. Code 330.260(a) or 330.260(b), a licensee's management shall apply for and shall receive a license amendment:

a) Before using radioactive material for any use not permitted by the license;

b) Before permitting anyone to work as an authorized user, authorized medical physicist, or ophthalmic physicist under the license, except:

1. For a visiting authorized user, as described in Section 335.1060;

2. For an authorized user, an individual who meets:

A) The requirements in 335.9180; and

B) The applicable board certification requirements in subsections 335.9030(a), 335.9040(a), 335.9050(a), 335.9060(a), 335.9070(a), 335.9100(a), 335.9130(a), and 335.9140(a);

3. For an authorized medical physicist, an individual who meets the requirements in subsection 335.9150(a) and Section 335.9180;

4. An individual who is identified as an authorized user, an authorized medical physicist, or an ophthalmic physicist on an Agency, U.S. Nuclear Regulatory Commission, or Agreement State license or other equivalent permit recognized by the Agency that authorizes the use of byproduct material in medical use, on a permit issued by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State specific license of broad scope that is authorized to permit the use of byproduct material in medical use, or on a permit issued by the U.S. Nuclear Regulatory Commission master material licensee that is authorized to permit the use of byproduct material in medical use;

c) Before changing the Radiation Safety Officer, except as provided in subsection 335.1040(c);

d) Before permitting anyone to work as an Associate Radiation Safety Officer or before the Radiation Safety Officer assigns duties and tasks to an Associate Radiation Safety Officer that differ from those for which this individual is authorized on the license;

e) Before receiving radioactive material in excess of the amount, in a different form, or a different radionuclide than is authorized on the license;

f) Before adding to or changing any area of use identified on the license, including changing the shielding in any area approved on the license. This includes areas used in accordance with Section 335.3010 or 335.4010 if the change includes addition or relocation of an area where PET radionuclides are used, administered, produced, or stored. Other areas of use where radioactive material is used only in accordance with either Section 335.3010 or 335.4010 are exempt;

g) Before changing the addresses of use identified in the license;

h) Before changing statements, representations and procedures that are incorporated into the license;

i) Before receiving a sealed source from a different manufacturer or of a different model number than authorized by the license, unless the sealed source is used for manual brachytherapy, listed in the Sealed Source and Device Registry, and is in a quantity and for an isotope authorized by the license.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.45 Notifications

a) For specific licenses issued pursuant to 32 Ill. Adm. Code 330.260(a) or (b), a licensee shall provide the Agency, no later than 30 days after the date that the licensee permits an individual to work under the provisions of subsection 335.40(b) as an authorized user, authorized medical physicist, or ophthalmic physicist:

1. A copy of the board certification and, as appropriate, verification of completion of:

A) Training for the authorized medical physicist under subsection 335.9150(d);

B) Any additional case experience required in subsection 335.9050(b)(2)(F) for an authorized user under Section 335.5010; or

C) Device specific training in subsection 335.9140(d) for the authorized user under Section 335.8010; or

2. A copy of the Agency, U.S. Nuclear Regulatory Commission or Agreement State license, the permit issued by a U.S. Nuclear Regulatory Commission master material licensee, the permit issued by the Agency, U.S. Nuclear Regulatory Commission or Agreement State licensee of broad scope, or the permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope permittee for each individual whom the licensee permits to work under the provisions of this Part.

b) A licensee shall notify the Agency no later than 30 days after:

1. An authorized user, Radiation Safety Officer, Associate Radiation Safety Officer, authorized medical physicist, or ophthalmic physicist permanently discontinues performance of duties under the license or has a name change;

2. The licensee permits an individual qualified to be a Radiation Safety Officer under Sections 335.9010 and 335.9180 to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer in accordance with subsection 335.1040(c);

3. The licensee's mailing address changes;

4. The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in 32 Ill. Adm. Code 330.310(c);

5. The licensee has added to or changed the areas of use identified in the license where byproduct material is used in accordance with either Section 335.3010 or 335.4010 if the change does not include an area where PET radionuclides are used, administered, produced, or stored; or

6. The licensee obtains a sealed source for use in manual brachytherapy from a different manufacturer or with a different model number than authorized by its license for which it did not require a license amendment as provided in subsection 335.40(i). The notification must include the manufacturer and model number of the sealed source, the isotope, and the quantity per sealed source.

History

• Source: Added at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.50 Written Directives (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.60 Provisions for the Protection of Human Research Subjects

a) A licensee may conduct research involving human research subjects only if it uses the radioactive materials specified on its license for the uses authorized on its license.

b) If the research is conducted, funded, supported or regulated by another Federal agency that has implemented the Federal Policy for the Protection of Human Subjects (Federal Policy), the licensee shall, before conducting research:

1. Obtain review and approval of the research from an Institutional Review Board, as defined and described in the Federal Policy; and

2. Obtain informed consent, as defined and described in the Federal Policy, from the human research subject.

c) If the research will not be conducted, funded, supported, or regulated by another Federal agency that has implemented the Federal Policy, the licensee shall, before conducting research, apply for and receive a specific amendment to its Agency, U.S. Nuclear Regulatory Commission, Agreement State or Licensing State medical use license. The amendment request must include a written commitment that the licensee will, before conducting research:

1. Obtain review and approval of the research from an Institutional Review Board, as defined and described in the Federal Policy; and

2. Obtain informed consent, as defined and described in the Federal Policy, from the human research subject.

d) Nothing in this Section relieves licensees from complying with the other requirements in this Part.

History

• Source: Added at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.1010 Alara Program (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.1020 Radiation Safety Officer (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.1030 Radiation Safety Committee (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.1040 Authorities and Responsibilities for the Radiation Protection Program

a) In addition to the radiation protection program requirements of 32 Ill. Adm. Code 340.110, a licensee's management shall approve in writing:

1. Requests for a license application, renewal or amendment before submittal to the Agency.

2. Any individual before allowing that individual to work as an authorized user or authorized medical physicist.

b) A licensee's management shall appoint a Radiation Safety Officer who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements. A licensee's management may appoint, in writing, one or more Associate Radiation Safety Officers to support the Radiation Safety Officer. The Radiation Safety Officer, with written agreement of the licensee's management, shall assign the specific duties and tasks to each Associate Radiation Safety Officer. These duties and tasks are restricted to the types of use for which the Associate Radiation Safety Officer is listed on a license. The Radiation Safety Officer may delegate duties and tasks to the Associate Radiation Safety Officer but shall not delegate the authority or responsibilities for implementing the radiation protection program.

c) For up to 60 days each year, a licensee may permit an individual qualified to be a Radiation Safety Officer, under Sections 335.9010 and 335.9180, to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer, as provided in subsection (g), if the licensee takes the actions required in subsections (b), (e), (g), (h) and (i). The licensee shall provide notification to the Agency in accordance with subsection 335.45(b).

d) A licensee may simultaneously appoint more than one temporary Radiation Safety Officer in accordance with subsection (c), if needed to ensure that the licensee has a temporary Radiation Safety Officer that satisfies the requirements to be a Radiation Safety Officer for each of the different types of uses of radioactive material permitted by the license.

e) A licensee shall establish the authority, duties and responsibilities of the Radiation Safety Officer in writing.

f) Licensees that are authorized for two or more different types of uses of radioactive material under Subparts F, H and I or Section 335.2140 for emerging technologies, or two or more types of units under Subpart I, shall establish a Radiation Safety Committee to oversee all uses of radioactive material permitted by the license. The Committee shall include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a Radiation Safety Officer. The Committee may include other members the licensee considers appropriate.

g) A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources and management prerogative to:

1. Identify radiation safety problems;

2. Initiate, recommend or provide corrective actions;

3. Stop unsafe operations; and

4. Verify implementation of corrective actions.

h) A licensee shall retain a record of actions taken by the licensee's management in accordance with subsection (a) for 5 years. The record shall include a summary of the actions taken and a signature of licensee's management.

i) The licensee shall retain a copy of the authority, duties and responsibilities of the Radiation Safety Officer as required by subsection (e) and a signed copy of each Radiation Safety Officer's agreement to be responsible for implementing the radiation safety program, as required by subsection (b), for the duration of the license. The records shall include the signature of the Radiation Safety Officer and licensee's management.

j) For each Associate Radiation Safety Officer appointed under subsection (b), the licensee shall retain a copy of the written document appointing the Associate Radiation Safety Officer, signed by the licensee's management, for 5 years after the Associate Radiation Safety Officer is removed from the license.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.1050 Supervision

a) A licensee who permits the receipt, possession, use or transfer of radioactive material by an individual other than a physician under the supervision of an authorized user as allowed by Section 335.30 of this Part shall:

1. Document instruction provided to the supervised individual, prior to assuming duties requiring the handling of radioactive materials, regarding the principles of radiation safety appropriate to that individual's use of radioactive material;

2. Review the supervised individual's use of radioactive material, provide reinstruction and review records kept to reflect this use;

3. Require the authorized user or Radiation Safety Officer to be available to communicate with the supervised individual; and

4. Allow only those individuals who are accredited by the Agency pursuant to 32 Ill. Adm. Code 401.100 or exempt from accreditation by 32 Ill. Adm. Code 401.30, and designated in writing by the licensee, to administer radionuclides or radiation to patients.

b) A licensee who permits the receipt, possession, use or transfer of radioactive material by a physician under the supervision of an authorized user as allowed by Section 335.30 of this Part shall:

1. Review the supervised individual's use of radioactive material, provide reinstruction and review records kept to reflect this use;

2. Require the authorized user to be available to communicate with the supervised individual; and

3. Maintain a record of each supervised individual for a period of 5 years from the initiation of the supervised training. This record shall include the name of each supervised individual, the results of reviews required by subsection (b)(1) of this Section, a description of what procedures the supervised individual is approved to perform and the signature of the supervising authorized user.

c) A licensee shall require the supervised individual receiving, possessing, using or transferring radioactive material under Section 335.30 of this Part to:

1. Follow the instructions of the supervising authorized user;

2. Follow the procedures established by the Radiation Safety Officer; and

3. Comply with this Part and 32 Ill. Adm. Code 310, 330, 340, 341, 400 and 401 and the license conditions with respect to the use of radioactive material.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.1060 Authorized User and Visiting Authorized User

a) A licensee shall assure that only authorized users of radioactive material:

1. Select or establish written criteria for the selection of the patients to receive radioactive material or radiation therefrom; and

2. Prescribe the radiopharmaceutical dosage or radiation dose to be administered.

b) A licensee may permit any visiting authorized user to use licensed material for medical use under the terms of the licensee's license for up to 60 days each year without applying for a license amendment if:

1. The physician is licensed in accordance with the Medical Practice Act of 1987;

2. The visiting authorized user has the prior written permission of the licensee's management and, if the use occurs on behalf of an institution, the institution's Radiation Safety Committee;

3. The licensee has a copy of a license issued by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State that identifies the visiting authorized user by name as an authorized user; and

4. The visiting authorized user performs only those procedures for which the visiting authorized user is specifically authorized by a license described in subsection (b)(3).

c) A licensee shall retain copies of the records specified in subsection (b) for 5 years.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.1070 Mobile Nuclear Medicine Service Administrative Requirements (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.1080 Report and Notification of a Medical Event

a) A licensee shall report any event as a medical event, except for an event that results from patient intervention, in which:

1. The administration of a radioactive material or radiation from radioactive material, except permanent implant brachytherapy, results in:

A) A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 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

i) The total dose delivered differs from the prescribed dose by 20 percent or more;

ii) The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or

iii) The fractionated dose delivered differs from the prescribed dose for a single fraction, by 50 percent or more.

B) 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:

i) An administration of a wrong radioactive drug containing radioactive material or the wrong radionuclide for a brachytherapy procedure;

ii) An administration of a radioactive drug containing radioactive material by the wrong route of administration;

iii) An administration of a dose or dosage to the wrong individual or human research subject;

iv) An administration of a dose or dosage delivered by the wrong mode of treatment; or

v) A leaking sealed source.

C) A dose to the skin or an organ or tissue other than the treatment site that exceeds:

i) By 0.5 Sv (50 rem) or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration; and

ii) By 50 percent or more of the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration.

2. For permanent implant brachytherapy, the administration of radioactive material or radiation from radioactive material (excluding sources that were implanted in the correct site but migrated outside the treatment site) that results in:

A) The total source strength administered differing by 20 percent or more from the total source strength documented in the post-implantation portion of the written directive;

B) The total source strength administered outside of the treatment site exceeding 20 percent of the total source strength documented in the post-implantation portion of the written directive; or

C) An administration that includes any of the following:

i) The wrong radionuclide;

ii) The wrong individual or human research subject;

iii) Sealed sources implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or

iv) A leaking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue.

b) A licensee shall report any event resulting from intervention of a patient or human research subject in which the administration of radioactive material or radiation from radioactive material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.

c) The licensee shall notify by telephone the Agency no later than the next calendar day after discovery of the medical event.

d) By an appropriate method listed in 32 Ill. Adm. Code 310.110, the licensee shall submit a written report to the Agency within 15 days after discovery of the medical event.

1. The written report shall include:

A) The licensee's name;

B) The name of the prescribing physician;

C) A brief description of the event;

D) Why the event occurred;

E) The effect, if any, on the individual who received the administration;

F) What actions, if any, have been taken or are planned to prevent recurrence; and

G) Certification that the licensee notified the individual (or the individual's responsible relative or guardian) and, if not, why not.

2. The report may not contain the individual's name or any other information that could lead to identification of the individual.

e) The licensee shall provide notification of the event to the referring physician and also notify the individual who is the subject of the medical event no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he or she will inform the individual or that, based on medical judgment, telling the individual would be harmful. 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 shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this subsection, the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the licensee shall 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 shall provide such a written description if requested.

f) Aside from the notification requirement, nothing in this Section affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the medical event, or to those individuals' responsible relatives or guardians.

g) A licensee shall:

1. Annotate a copy of the report provided to the Agency with the:

A) Name of the individual who is the subject of the event; and

B) Identification number, or if no other identification number is available the social security number, of the individual who is the subject of the event; and

2. Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.

h) A licensee shall report to the Agency immediately upon discovery of any irregularities pertaining to identification, labeling, quality or assay of any radiopharmaceutical received under the authority of the license.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.1090 Materials Authorized for Medical Use (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.1100 Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child

a) A licensee shall report any dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.

b) A licensee shall report any dose to a nursing child that is a result of an administration of radioactive material to a breast-feeding individual that:

1. Is greater than 50 mSv (5 rem) total effective dose equivalent; or

2. Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.

c) The licensee shall notify by telephone the Agency no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in subsection (a) or (b).

d) The licensee shall submit a written report to the Agency within 15 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in subsection (a) or (b).

1. The written report shall include:

A) The licensee's name;

B) The name of the prescribing physician;

C) A brief description of the event;

D) Why the event occurred;

E) The effect, if any, on the embryo/fetus or the nursing child;

F) What actions, if any, have been taken or are planned to prevent recurrence; and

G) Certification that the licensee notified the pregnant individual or mother (or the mother's or child's responsible relative or guardian) and, if not, why not.

2. The report shall not contain the individual's or child's name or any other information that could lead to identification of the individual or child.

e) The licensee shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 hours after discovery of an event that would require reporting under subsection (a) or (b), unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. 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 shall make the appropriate notifications as soon as possible thereafter. The licensee may not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this subsection (e), the notification may be made to the mother's or child's responsible relative or guardian instead of the mother. If a verbal notification is made, the licensee shall inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide a written description if requested.

f) A licensee shall:

1. Annotate a copy of the report provided to the Agency with the:

A) Name of the pregnant individual or the nursing child who is the subject of the event; and

B) Identification number, or if no other identification number is available the social security number, of the individual who is the subject of the event; and

2. Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.1110 Written Directives

a) A written directive shall be dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 1.11 MBq (30 μCi), any therapeutic dosage of unsealed radioactive material or any therapeutic dose of radiation from radioactive material. If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive shall be documented as soon as possible in writing in the patient's record. A written directive shall be prepared within 48 hours after the oral directive.

b) The written directive shall contain the patient's or human research subject's name and the following information:

1. For any administration of quantities greater than 1.11 MBq (30 μCi) of sodium iodide I-131, the dosage.

2. For an administration of a therapeutic dosage of unsealed radioactive material other than sodium iodide I-131, the radioactive drug, dosage and route of administration.

3. For gamma stereotactic radiosurgery, the total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site.

4. For teletherapy, the total dose, dose per fraction, number of fractions and treatment site.

5. For high dose-rate remote afterloading brachytherapy, the radionuclide, treatment site, dose per fraction, number of fractions and total dose.

6. For permanent implant brachytherapy:

A) Before implantation: the treatment site, the radionuclide, and the total source strength; and

B) After implantation but before the patient leaves the post-treatment recovery area: the treatment site, the number of sources implanted, the total source strength implanted, and the date; or

7. For all other brachytherapy, including low, medium and pulsed dose rate remote afterloaders:

A) Before implantation: treatment site, the radionuclide and dose; and

B) After implantation but before completion of the procedure: the radionuclide, treatment site, number of sources, total source strength, and exposure time (or the total dose) and date.

c) A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of unsealed radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose or the next fractional dose. If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision shall be documented as soon as possible in the patient's record. A revised written directive shall be signed by the authorized user within 48 hours after the oral revision.

d) A licensee shall retain a copy of each written directive as required by subsections (a) and (c) for 5 years.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.1120 Procedures for Administrations Requiring a Written Directive

a) For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that:

1. The patient's or human research subject's identity is verified before each administration; and

2. Each administration is in accordance with the written directive.

b) At a minimum, the procedures required by subsection (a) shall

address the following items that are applicable to the licensee's use of radioactive material:

1. Verifying the identity of the patient or human research subject;

2. Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive;

3. Checking both manual and computer-generated dose calculations;

4. Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by Section 335.2140 or 335.8010;

5. Determining if a medical event, as described in Section 335.1080, has occurred;

6. Determining, for permanent implant brachytherapy, within 60 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; and

7. Determining, for administrations of I-131 in quantities greater than 1.11 MBq (30 μCi), the criteria to be used to identify patients required to be tested for pregnancy in accordance with subsection 335.5010(b), including type of pregnancy testing permitted, time in advance of I-131 administration in which the tests shall be conducted, age range of patients to be tested, and criteria a physician may use to determine that a patient is not capable of childbirth.

c) A licensee shall retain a copy of the procedures required by subsection (a) for the duration of the license.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.2010 Possession, Use and Calibration of Instruments Used to Measure the Activity of Unsealed Radioactive Material

a) For direct measurements performed in accordance with Section 335.2030, the licensee shall possess and use instrumentation to measure the activity of unsealed byproduct material before it is administered to each patient or human research subject.

b) A licensee shall calibrate the instrumentation required in subsection (a) in accordance with nationally recognized standards or the manufacturer's instructions.

c) A licensee shall maintain a record of instrument calibrations required by subsection (b) for 5 years. The records shall include the model and serial number of the instrument, the date of the calibration, the results of the calibration, the name of the individual who performed the calibration and a copy of the national standard or manufacturer's instructions used to perform the calibration.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.2020 Possession, Calibration and Check of Survey Instruments (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.2030 Assay of Radiopharmaceutical Dosages

a) A licensee shall determine and record the activity of each dosage before medical use.

b) For a unit dosage, this determination shall be made by:

1. Direct measurement of radioactivity by the licensee; or

2. For radiopharmaceuticals with a photon emitting radionuclide not requiring a written directive, a decay correction based on the activity or activity concentration determined by:

A) A manufacturer or preparer authorized under Section 335.30 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

B) An Agency, U.S. Nuclear Regulatory Commission or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or

C) A PET radioactive drug producer licensed under 32 Ill. Adm. Code 330.260(c)(23) or the equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State.

c) For other than unit dosages, this determination shall be made by:

1. Direct measurement of radioactivity by the licensee;

2. A combination of measurement of radioactivity and mathematical calculations; or

3. A combination of volumetric measurements and mathematical calculations based on the measurement made by a manufacturer or preparer licensed under Section 335.30 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements.

d) Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent.

e) A licensee shall maintain a record of dosage determinations required by subsection (a) of this Section for 5 years.

f) The record shall contain:

1. The radiopharmaceutical;

2. The patient's or human research subject's name, or identification number if one has been assigned;

3. The prescribed dosage, the determined dosage, or a notation that the total activity is less than 1.1 MBq (30 mCi);

4. The date and time of the dosage determination;

5. If more than 15 minutes have elapsed between the time of dosage determination and dosage administration, the date and time of dosage administration; and

6. The name of the individual who determined the dosage.

AGENCY NOTE: If a unit dose has been manipulated in any way, it is no longer considered a unit dose and shall be measured by the licensee before administration.

History

• Source: Amended at 35 Ill. Reg. 884, effective December 30, 2010

32 Ill. Adm. Code 335.2040 Authorization for Calibration, Transmission, Attenuation Correction and Reference Sources

Any person authorized by Section 335.30 for medical use of radioactive material may receive, possess and use the following radioactive material for check, calibration, transmission, attenuation correction and reference use. Reference sources containing radioactive material authorized under this Part shall not be used for medical use except in accordance with the requirements in Section 335.6010. Sealed sources shall not be combined (i.e. bundled or aggregated) to create an activity greater than the maximum activity of any single sealed source authorized under this Section. Sealed sources are authorized as follows:

a) Sealed sources not exceeding 1.11 GBq (30 mCi) each, manufactured and distributed by a person licensed under 32 Ill. Adm. Code 330.280(k) or equivalent U.S. Nuclear Regulatory Commission or Agreement State regulations.

b) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under 32 Ill. Adm. Code 330.280(k) or equivalent U.S. Nuclear Regulatory Commission or Agreement State regulations, providing the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions.

c) Any radioactive material with a half-life not greater than 120 days in individual amounts not to exceed 0.56 GBq (15 mCi).

d) Any radioactive material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 7.4 MBq (200 mCi) or 1000 times the quantities in Appendix B of 32 Ill. Adm. Code 330.

e) Technetium-99m in amounts as needed.

History

• Source: Amended at 48 Ill. Reg. 13672, effective August 29, 2024

32 Ill. Adm. Code 335.2050 Requirements for Possession of Sealed Sources (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.2060 Labeling and Use of Vials and Syringes

a) Each syringe and vial that contains unsealed radioactive material shall be labeled to identify the radiopharmaceutical. Each syringe shield and vial shield shall also be labeled unless the label on the syringe or vial is visible when shielded.

b) A licensee shall use syringe radiation shields unless the use of a shield is contraindicated for an individual patient.

AGENCY NOTE: The use of a syringe radiation shield could be contraindicated if a patient presented a venous anatomy poorly suited for venipuncture.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.2070 Vial Shields and Vial Shield Labels (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.2080 Monitoring for Contamination and Ambient Radiation Dose Rate

a) In addition to the monitoring required by 32 Ill. Adm. Code 340, the licensee shall measure with a radiation detection survey instrument all areas where unsealed radioactive material was prepared for use or administered at the end of use each day. However, the licensee does not need to perform the monitoring required by this Section in areas where patients or human research subjects are confined until release under Section 335.2110. The instrument shall be operable and calibrated in accordance with the requirements of 32 Ill. Adm. Code 340.510(b) and (c).

b) At least once each week, a licensee shall measure with a radiation detection survey instrument all areas where radiopharmaceuticals or radioactive wastes are stored to ensure compliance with 32 Ill. Adm. Code 340.210 and 340.310. The instrument shall be operable and calibrated in accordance with the requirements of 32 Ill. Adm. Code 340.510(b) and (c).

c) At least once each week, a licensee shall measure for removable contamination in all areas where unsealed radioactive materials are prepared for use, administered or stored.

d) A licensee shall conduct the measurements required by subsections (b) and (c) in a manner that permits detection of both external exposure rates and removable contamination that would give rise to exposures in excess of the limits specified in 32 Ill. Adm. Code 340.210 and 340.310.

e) A licensee shall retain a record of each survey required by this Section for 5 years. The record shall include the monitoring date, a description of each area monitored, the measurement results, the manufacturer, model and serial number of the instruments, and the identity of the individual who performed the monitoring.

AGENCY NOTE: For the purposes of this Section, 2000 dpm (disintegrations per minute) per 100 square centimeters of surface area may be utilized as a sufficiently sensitive detection limit for removable contamination unless the licensee has developed alternate removable contamination limits which take into consideration the unsealed radionuclides in use, their respective contribution to the dose limits in 32 Ill. Adm. Code 340.210 and 340.310, and the detection capability of the radiation detection survey instruments in use. Measurement of removable contamination shall only be performed with a survey instrument, in lieu of wipes, if the instrument is sufficiently sensitive to detect the contamination at the limits specified in this Section.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.2090 Safety Instructions for Patients Not Hospitalized and Containing Therapeutic Doses of Radiopharmaceuticals or Permanent Implants (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.2100 Admission of Patients Being Treated with Radiopharmaceuticals or Permanent Implants (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.2110 Release of Individuals Containing Unsealed Radioactive Material or Implants Containing Radioactive Material

a) A licensee may authorize the release from its control of any individual who has been administered unsealed radioactive material or implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 mSv (0.5 rem) following assessment of the patient's medical, living and working conditions.

AGENCY NOTE: U.S. Nuclear Regulatory Commission Regulatory Guide 8.39, Rev. 1, "Release of Patients Administered Radioactive Material", published April 2020, exclusive of subsequent amendments or editions, describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 mSv (0.5 rem).

b) If the total effective dose equivalent to any other individual is likely to exceed 1 mSv (0.1 rem), the licensee shall provide the released individual and, as determined appropriate by the authorized physician user, the individual's spouse, parent, guardian or other primary caregiver with verbal and written instructions on actions recommended to maintain doses to other individuals as low as is reasonably achievable. If the total effective dose equivalent to a minor, pregnant individual or nursing infant or child could exceed 1 mSv (0.1 rem), assuming there were no interruptions of breast-feeding, the instructions shall also include:

1. Guidance on the interruption or discontinuation of breast-feeding;

2. Guidance on minimizing close or extended contact; and

3. Information on the potential consequences, if any, of failure to follow the guidance.

c) Release of the patient pursuant to this Section shall be approved by an authorized physician user who is approved for the applicable use of radioactive material under Subpart F or H. The authorized user physician shall state in writing that he or she is satisfied that patient compliance with necessary instructions is likely and that the patient is suitable for release.

d) A licensee shall retain a record for five years after the release of the individual for the following:

1. The basis for authorizing the release of an individual in accordance with subsections (a) and (b) of this Section to include the assessment and evaluation criteria for the patient's medical, living and working conditions, activities of radioactive material used (i.e., retained or administered activity), occupancy factors, biological or effective half-life of radioactive material, shielding by tissue, and means of estimating doses to any other individual and the physicians.

2. The instructions for each patient required by subsection (b) of this Section.

3. The physician's certification for patient release required by subsection (c) of this Section.

History

• Source: Amended at 48 Ill. Reg. 13672, effective August 29, 2024

32 Ill. Adm. Code 335.2120 Mobile Medical Service Requirements

A licensee providing mobile medical service shall:

a) Prior to bringing radioactive material into a remote use location, obtain a letter, signed by the management of the client for whom services are rendered, that clearly delineates the authority and responsibility of the licensee and the client and authorizes use of radioactive material at the client's address of use.

b) Transport to each address of use only those syringes or vials containing prepared radiopharmaceuticals or radiopharmaceuticals that are intended for reconstitution of radiopharmaceutical kits.

c) Provide services in accordance with the client's specific medical license, when providing services that the client is also authorized to provide.

d) Check instruments used to measure the activity of unsealed radioactive material for proper function before medical use at each client's address or on each day of use, whichever is more frequent. At a minimum, the check for proper function required by this subsection shall include a constancy check.

e) Before releasing a use location for unrestricted use, monitor all areas of use with a radiation detection survey instrument to ensure that all radioactive materials and all associated radioactive wastes have been removed.

AGENCY NOTE: 32 Ill. Adm. Code 340, Appendix A may be used as a guideline for this purpose.

f) Check survey instruments for proper operation with a dedicated check source before use at each client's address.

g) Secure or keep under constant surveillance and control all radioactive material when in transit and at a location of use.

h) Not have radioactive material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the radioactive material. Radioactive material delivered to the client shall be received and handled in conformance with the client's license.

i) Retain the letter required in subsection (a) of this Section and the record of monitoring required in this Section in accordance with Section 335.2080(e) of this Part.

j) Retain a copy of each letter that permits the use of radioactive material at a client's address as required by subsection (a) of this Section. Each letter must clearly delineate the authority and responsibility of the licensee and the client and shall be retained for 5 years after the last provision of service.

k) Retain the record of monitoring required by subsection (e) of this Section for 5 years. The record shall include the monitoring date, an annotated diagram of each area that was monitored, the measured dose rate at several points in each area of use expressed in units, multiples or subunits of Sieverts (or rem) per hour, the manufacturer, model and serial number of the instrument used to perform the monitoring and the identity of the individual who performed the monitoring.

l) Retain a record of all dosages administered under the service's license for 5 years after the date of administration. This record shall include the radiopharmaceutical name, the clinical procedure, the activity administered, the name of the authorized user, the date of administration and the identity of the individual performing the administration.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.2130 Storage of Volatiles and Gases (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.2140 Other Medical Uses of Radioactive Material or Radiation from Radioactive Material (emerging Technologies)

A licensee may use radioactive material or a radiation source that is not specifically addressed in Subparts D through I, or if the use is inconsistent with those Subparts, if:

a) The licensee has submitted the information required by 32 Ill. Adm. Code 330.250 and any other necessary information consistent with 32 Ill. Adm. Code 330;

b) The application contains at least the following:

1. A request signed by management that is consistent with the requirements of 32 Ill. Adm. Code 340.310(b);

2. A description of:

A) The facilities, with a diagram;

B) The necessary equipment and its calibration or maintenance; and

C) Training and experience qualifications of the Radiation Safety Officer, Associate Radiation Safety Officers, authorized users, authorized medical physicists, and ophthalmic physicists, if not already previously submitted;

3. Procedures, as applicable, that describe:

A) The radionuclide, form and activity;

B) The expected levels of contamination and the procedures to control them;

C) The general safety precautions;

D) The safety instructions to be provided to staff that are specific to the proposed use; and

E) The methodology for measurement of dosages or doses to be administered to patients or human research subjects;

4. If applicable, a description of the sealed source and/or device as per 32 Ill. Adm. Code 330.280(i) and (k), as applicable, or, alternately, identification of the product in the Sealed Source and Device Registry.

c) In addition to the requirements in subsection (b)(2), an application for a license or amendment for medical use of radioactive material as described in this Section shall also include information regarding any aspects of the medical use of radioactive material that are applicable to radiation safety that is not addressed in Subparts A through C.

d) The applicant or licensee has provided any other information requested by the Agency in its review of the application.

e) The licensee has received written approval from the Agency in the form of a license amendment and uses the material in accordance with the regulations and specific conditions the Agency considers necessary for the safe use of the material.

AGENCY NOTE: The FDA accepted protocols may be submitted as partial application towards the information requested in this Section.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.2150 Additional Technical Requirements for Intravascular Brachytherapy Units

In addition to other provisions required by this Part, the licensee authorized to use an intravascular brachytherapy unit for medical use shall:

a) Have a treatment team consisting of, at a minimum, an interventional cardiologist, an authorized user and an authorized medical physicist and that, at a minimum, an interventional cardiologist and an authorized user will be physically present in the treatment suite during all radioactive procedures.

AGENCY NOTE: The requirements of 32 Ill. Adm. Code 401 regarding radiation therapists must also be met.

b) Independently verify source strength and uniformity. Dwell time at the treatment location must be monitored and recorded. Source uniformity or strength must not differ by more that 10 percent of the expected values.

c) For devices requiring additional shielding, demonstrate compliance with 32 Ill. Adm. Code 340.210 and 340.310 requirements.

d) Inspect sealed sources, source trains or ribbons before each use and ensure sources are removed from service at intervals established by the manufacturer (i.e., confirm that source trains will not be used after the "use by" date, at intervals not to exceed two months from the date of shipment, or when evidence of degradation is observed, whichever comes first).

e) Inspect and service devices containing sealed sources at intervals established by the manufacturer, and ensure that maintenance and repair of the device is performed only by the manufacturer or persons specifically authorized by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to perform such service.

f) Prohibit cuts, alterations or splicing of the sealed sources, source trains or ribbons, except in situations involving an emergency where the source wire cannot be returned to its normal safe position. If such cuts, alterations or splicing are necessary, notification in accordance with Section 335.1080 or 32 Ill. Adm. Code 340.1220 shall be made to the Agency.

g) Use only manufacturer provided inducer sheaths, catheters and accessories to ensure their demonstrated equivalents will be used with the devices.

h) Ensure the daily operational checks will be performed prior to patient treatment. At a minimum, they should include position verification, source uniformity, dwell time function, indicator lamps and other status/operational displays, and visual inspection for integrity of all applicators and catheters to be used for the treatment.

i) Perform tests following source or device exchange in accordance with the manufacturer's instruction manual for:

1. Timer accuracy/constancy, if appropriate;

2. Calibration of the source output following the manufacturer's instructions; and

3. Interlock/interrupt checks (i.e., interrupt test, cartridge lock test, emergency retraction test and catheter connection test), if appropriate.

j) The licensee shall retain a record of each item in subsections (b), (d), (e), (h) and (i) for intravascular brachytherapy units for five years. The records shall include:

1. The date of the verification, inspection or check.

2. The manufacturer's name, model and serial number of the intravascular brachytherapy unit.

3. Results of the verification, inspection or check.

4. Notations indicating the operability of each component.

5. The identity of the individual who performed the check.

History

• Source: Amended at 48 Ill. Reg. 13672, effective August 29, 2024

32 Ill. Adm. Code 335.3010 Use of Unsealed Radioactive Material for Uptake, Dilution and Excretion Studies for Which a Written Directive Is Not Required

Except for quantities that require a written directive under subsection 335.1110(a), a licensee may use any unsealed radioactive material prepared for medical use for uptake, dilution or excretion studies that is:

a) Obtained from a person specified in Section 335.30, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

b) Excluding production of PET radionuclides, prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements in Section 335.9040, or a combination of Section 335.9050 and subsection 335.9040(c)(1)(B)(vii) or an individual under the supervision of either as specified in Section 335.1050; or

c) Obtained from and prepared by an Agency, U.S. Nuclear Regulatory Commission or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an application or protocol accepted by the FDA; or

d) Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an application or a protocol accepted by the FDA.

AGENCY NOTE: Participation in FDA research trials involving human subjects does not relieve the licensee from following all Agency regulations, whether or not they are included in the trial protocols. This includes participation in trials using "blind" research protocols.

History

• Source: Amended at 35 Ill. Reg. 884, effective December 30, 2010

32 Ill. Adm. Code 335.4010 Use of Unsealed Radioactive Material for Imaging and Localization Studies for Which a Written Directive Is Not Required

Except for quantities that require a written directive under subsection 335.1110(a), a licensee may use any unsealed radioactive material prepared for medical use for imaging and localization studies that is:

a) Obtained from a person specified in Section 335.30 of this Part, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

b) Excluding production of PET radionuclides, prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in Section 335.9040 or a combination of Section 335.9050 and subsection 335.9040(c)(1)(B)(vii) or an individual under the supervision of either as specified in Section 335.1050; or

c) Obtained from and prepared by an Agency, U.S. Nuclear Regulatory Commission or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an application or protocol accepted by the FDA; or

d) Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an application or a protocol accepted by the FDA.

History

• Source: Amended at 35 Ill. Reg. 884, effective December 30, 2010

32 Ill. Adm. Code 335.4020 Permissible Concentrations of Molybdenum-99, Strontium-82 and Strontium-85

a) A licensee shall not administer to humans a radiopharmaceutical that contains more than:

1. 0.15 kBq of molybdenum-99 per MBq of technetium-99m (0.15µCi of molybdenum-99 per mCi of technetium-99m);

2. 0.02 kBq of strontium-82 per MBq of rubidium-82 chloride injection (0.02 µCi of strontium-82 per mCi of rubidium-82); or

3. 0.2 kBq of strontium-85 per MBq of rubidium-82 chloride injection (0.2 µCi of strontium-85 per mCi of rubidium-82.

b) To demonstrate compliance with subsection (a), a licensee shall measure:

1. The concentration of molybdenum-99 in each eluate from a molybdenum-99/technetium-99m generator; and

2. The concentration of strontium-82 and strontium-85 before the first patient use of the day on each day that a strontium-82/rubidium-82 generator is used.

c) A licensee shall maintain a record of the concentration tests required by subsection (b) for 5 years. The record shall include for each measurement, the time and date of the measurement, the name of the individual who made the measurement and, for the corresponding measurement in subsection (b):

1. The ratio of the measure expressed as kBq of molybdenum per MBq of technetium-99m (or µCi of molybdenum per mCi of technetium); or

2. The ratios of the measures expressed as kBq of strontium-82 per MBq of rubidium-82 and kBq of strontium-85 per MBq of rubidium-82 (or µCi of strontium per mCi of rubidium).

d) A licensee shall notify the Agency and the distributor of the generator for each occurrence of a concentration exceeding the limits specified in subsection (a) as follows:

1. Notification by telephone within 7 days after the discovery that an eluate exceeded the permissible concentration. The notification shall 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.

2. By an appropriate method listed in 32 Ill. Adm. Code 310.110, the licensee shall submit a written report to the Agency within 30 days after discovery that an eluate exceeded the permissible concentration at the time of generator elution. The written report shall 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 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 subsection (d)(1).

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.4030 Control of Aerosols and Gases (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.5010 Use of Unsealed Radioactive Material for Which a Written Directive Is Required

a) A licensee may use any unsealed radioactive material identified in subsection 335.9050(b)(2)(F) prepared for medical use and for which a written directive is required that is:

1. Obtained from a person specified in Section 335.30 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements;

2. Excluding production of PET radionuclides, prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in Section 335.9040, 335.9050, or an individual under the supervision of either as specified in Section 335.1050; or

3. Obtained from and prepared by an Agency, U.S. Nuclear Regulatory Commission or Agreement State licensee for use in research in accordance with a protocol accepted by FDA; or

4. Prepared by the licensee for use in research in accordance with an application or a protocol accepted by FDA.

b) Prior to any administration of quantities greater than 1.11 MBq (30 μCi) of sodium iodide I-131 to a patient capable of childbirth, the licensee shall conduct a pregnancy test and obtain those results to determine pregnancy. If the delay caused by conducting a pregnancy test would jeopardize the patient's health, the test may be forgone provided that action is noted by the authorized user on the written directive required by Section 335.1110. The written directive must also indicate the patient was informed of the decision to forego the pregnancy test or the reason for omission of the patient notification. Nothing in this Section relieves the licensee from meeting the requirements of Section 335.1100 regarding reporting of exposures to a fetus/embryo.

c) Records of the pregnancy test in subsection (b) shall contain the patient's name, identification number if one has been assigned, the type of test performed, results of the test, the date of the test, date the results became available if different from the test date, and identity of the licensee's staff interpreting the test or, as applicable, the determination by a physician that pregnancy test was not required.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.5020 Safety Instruction

In addition to the requirements of 32 Ill. Adm. Code 400.120:

a) A licensee shall provide radiation safety instruction, prior to beginning work and at least annually, to personnel caring for patients or human research subjects who have been administered radioactive materials requiring a written directive. To satisfy this requirement, the instructions shall be commensurate with the duties of the personnel and shall include:

1. Patient or human research subject control;

2. Visitor control, including:

A) Routine visitation to hospitalized individuals in accordance with 32 Ill. Adm. Code 340.310(a)(1); and

B) Visitation authorized in accordance with 32 Ill. Adm. Code 340.310(c);

3. Contamination control;

4. Waste control; and

5. Notification of the Radiation Safety Officer or his or her designee and the authorized user if the patient or the human research subject has a medical emergency or dies.

b) A licensee shall maintain a record of safety instructions required by this Section for 5 years. The record shall include a list of the topics covered, the date of the instruction, the names of the attendees and the names of the individuals who provided the instruction.

History

• Source: Amended at 35 Ill. Reg. 884, effective December 30, 2010

32 Ill. Adm. Code 335.5030 Safety Precautions

a) For each patient or human research subject who cannot be released under Section 335.2110 of this Part, the licensee shall:

1. Perform radiation monitoring as required by 32 Ill. Adm. Code 340.510 for use in determining when the licensee shall supply appropriate personnel with individual monitoring devices as required by 32 Ill. Adm. Code 340.520. Records of the radiation monitoring indicating the date and time of the monitoring, an annotated diagram of the area and a list of points monitored, the measured dose rate, the manufacturer, model and serial number of the instrument used to perform the monitoring and the identity of the individual who performed the monitoring shall be maintained for 5 years. This radiation monitoring shall include, as a minimum, the dose rate in units, multiples or subunits of Sieverts or rem per hour at:

A) The patient's bedside;

B) 1 meter from the patient;

C) The patient's hospital room door; and

D) Contiguous restricted and unrestricted areas. However, radiation monitoring of adjoining rooms is not required if a calculation of the dose rate to a patient in the adjoining room is made based on measurements obtained pursuant to subsection (a)(1)(A) or (B) of this Section.

2. Prevent any patient who is not receiving radiopharmaceutical therapy, but who is occupying a room that adjoins the room of a patient who is receiving radiopharmaceutical therapy, to receive a dose greater than 1 mSv (100 mrem) during the patient's entire stay from radiation emitted by any therapy patient. The licensee shall verify compliance by performing radiation surveys based on the monitoring required by subsection (a)(1) of this Section.

3. Prevent the placement of a therapy patient in the same room with a patient who is not receiving radiopharmaceutical therapy unless the licensee demonstrates, by monitoring or surveys, compliance with the requirements of 32 Ill. Adm. Code 340.310 at a distance of 1 meter from the therapy patient.

4. Provide each therapy patient's room with a private sanitary facility.

5. Post the patient's door with a "Caution: Radioactive Materials" sign. The posted sign shall indicate that pregnant women, or women who suspect that they are pregnant, shall contact the attendant staff for additional safety instructions or precautions. Also, a note shall appear on the door and on the patient's chart which states where and how long visitors may stay in the patient's room.

6. Authorize visits by individuals under age 18 only on a patient-by-patient basis with the approval of the radiation therapy physician after consultation with the Radiation Safety Officer.

7. Maintain and make available nursing instructions for the attendant nursing staff that list any restrictions and instructions that shall be followed regarding the care of therapy patients.

8. Either monitor all items removed from the patient's room to determine that any contamination 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 other than a plastic or cloth bag or handle all items removed from the patient's room as radioactive waste.

9. Advise attendant nursing staff to notify the Radiation Safety Officer or the radiation therapy physician immediately if the therapy patient dies or has a medical emergency.

10. Monitor the patient's room and sanitary facility for removable contamination. The room shall not be re-assigned until the requirements of 32 Ill. Adm. Code 340.320 and 340.510 have been met.

b) The licensee shall implement the precautions required by subsections (a)(1) through (10) of this Section until all of the requirements of Section 335.2110 of this Part can be met.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.6010 Use of Sealed Sources for Diagnosis

a) A licensee shall 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 shall be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.

b) A licensee shall 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 shall be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.

c) Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of Section 335.35 are met.

History

• Source: Amended at 48 Ill. Reg. 13672, effective August 29, 2024

32 Ill. Adm. Code 335.7010 Use of Sealed Sources for Brachytherapy

A licensee shall use only brachytherapy sources for therapeutic medical uses:

a) That are:

1. Obtained from a person specified in Section 335.35, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; and

2. Approved in the Sealed Source and Device Registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the Sealed Source and Device Registry, but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry; or

b) That are used in research to deliver therapeutic doses for medical use in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of Section 335.35 are met.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.7020 Safety Instruction

In addition to the requirements of 32 Ill. Adm. Code 400.120:

a) The licensee shall provide radiation safety instruction, prior to their assuming duties and at least annually, to personnel caring for patients or human research subjects who are receiving brachytherapy and cannot be released under Section 335.2110 of this Part. To satisfy this requirement, the instructions must be commensurate with the duties of the personnel and include the:

1. Size and appearance of the brachytherapy sources;

2. Safe handling and shielding instructions;

3. Patient or human research subject control;

4. Visitor control, including both:

A) Routine visitation of hospitalized individuals in accordance with 32 Ill. Adm. Code 340.310(a)(1); and

B) Visitation authorized in accordance with 32 Ill. Adm. Code 340.310(c); and

5. Notification of the Radiation Safety Officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.

b) A licensee shall maintain a record of safety instructions required by this Section for 5 years. The record must include a list of the topics covered, the date of the instruction, the names of the attendees and the names of the individuals who provided the instruction.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.7030 Safety Precautions

a) For each patient or human research subject who is receiving brachytherapy and cannot be released under Section 335.2110 of this Part, a licensee shall:

1. Not quarter the patient or the human research subject in the same room as an individual who is not receiving brachytherapy;

2. Authorize visits by individuals under age 18 only on a patient-by-patient basis with the approval of the authorized user after consultation with the Radiation Safety Officer;

3. Conspicuously post the patient's or human research subject's room with a "Caution – Radioactive Materials" sign bearing the radiation symbol;

4. 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

5. Note on the door or in the patient's or human research subject's chart safety instruction noted in Section 335.7020 of this Part.

b) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source:

1. Dislodged from the patient; and

2. Lodged within the patient following removal of the source applicators.

c) A licensee shall notify the Radiation Safety Officer, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.7040 Accountability and Security of Brachytherapy Sources

a) A licensee shall maintain security and accountability at all times for all brachytherapy sources in storage or use.

b) As soon as possible after removing sources from a patient or a human research subject, a licensee shall return brachytherapy sources to a secure storage area.

c) A licensee shall maintain a record of brachytherapy source accountability required by this Section for 5 years. The record must include:

1. For temporary implants:

A) 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

B) 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.

2. For permanent implants:

A) 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;

B) 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

C) The number and activity of sources permanently implanted in the patient or human research subject.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.7050 Discharge of Patients Treated with Temporary Implants (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.7060 Surveys After Source Implant and Removal

a) Immediately after implanting sources in a patient or a human research subject, the licensee shall monitor the area 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, the licensee shall monitor the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed.

c) A licensee shall maintain a record of the monitoring required by this Section for 5 years. The record shall include the monitoring date, the measured dose rate at several points in each area, expressed in units, multiples or subunits of Sieverts or rem per hour, the manufacturer, model and serial number of the survey instrument used to perform the monitoring, and the identity of the person who performed the monitoring.

History

• Source: Added at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.7070 Calibration Measurements of Brachytherapy Sources

a) Before the first medical use of a brachytherapy source, a licensee shall have:

1. Determined the source output or activity using a dosimetry system that meets the requirements of subsection 335.8080(a);

2. Determined source positioning accuracy within applicators; and

3. Used published protocols currently accepted by nationally recognized bodies to meet the requirements of subsections (a)(1) and (a)(2). Copies of these protocols shall be maintained on file by the licensee for 5 years after the discontinuation of use of brachytherapy sources.

b) A licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine or other calibration laboratory approved by the Agency that are made in accordance with subsection (a).

c) A licensee shall mathematically correct the outputs or activities determined in subsection (a) for physical decay at intervals consistent with 1 percent physical decay.

d) A licensee shall maintain a record of the calibrations of brachytherapy sources required by this Section for 5 years after the last use of the source. The record shall include the:

1. Date of the calibration;

2. Manufacturer's name, model number, and serial number for the source, and the instruments used to calibrate the source;

3. Source output or activity;

4. Source positioning accuracy within the applicators; and

5. Name of the individual, source manufacturer, or the calibration laboratory that performed the calibration.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.7080 Decay of Brachytherapy Sources

a) Only an authorized user qualified under Section 335.9100 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, or an authorized medical physicist shall calculate the activity of each brachytherapy source that is used to determine the treatment times for brachytherapy treatments. The decay must be based on the activity determined under Section 335.7070 of this Part.

b) A licensee shall maintain a record of the activity of all brachytherapy sources required by this Section for the life of the source. The record must include:

1. The manufacturer, model and serial number (or lot number for permanent implants) of the sources;

2. The date and initial activity of the source as determined under Section 335.7070 of this Part; and

3. For each decay calculation, the date and the source activity as determined under this Section.

History

• Source: Amended at 48 Ill. Reg. 13672, effective August 29, 2024

32 Ill. Adm. Code 335.7090 Therapy-Related Computer Systems for Manual Brachytherapy

The licensee shall:

a) Perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:

1. The source-specific input parameters required by the dose calculation algorithm;

2. The accuracy of dose, dwell time, and treatment time calculations at representative points;

3. The accuracy of isodose plots and graphic displays; and

4. The accuracy of the software used to determine sealed source positions from radiographic images.

b) Maintain a record of acceptance testing and copies of the protocols used for acceptance testing in accordance with this Section for 5 years after discontinuation of use of the treatment planning system.

History

• Source: Added at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.7100 Strontium-90 Sources for Ophthalmic Treatments

Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in subsection (c) are performed by either:

a) An authorized medical physicist; or

b) An individual who:

1. is identified as an ophthalmic physicist on a specific medical use license issued by the Agency, U.S. Nuclear Regulatory Commission, or Agreement State; a permit issued by the Agency, U.S. Nuclear Regulatory Commission, or Agreement State broad scope medical use licensee; a medical use permit issued by a U.S. Nuclear Regulatory Commission master material licensee; or permit issued by a U.S. Nuclear Regulatory Commission master material licensee broad scope medical use permittee; and

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; and

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; and

4. Has documented training in:

A) The creation, modification, and completion of written directives;

B) Procedures for administrations requiring a written directive; and

C) Performing the calibration measurements of brachytherapy sources as detailed in Section 335.7070.

c) The individuals who are identified in subsections (a) and (b) shall:

1. Calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay shall be based on the activity determined under Section 335.7070; and

2. Assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the written directive. These procedures shall include the frequencies that the individual meeting the requirements in subsection (a) or (b) will observe treatments, review the treatment methodology, calculate treatment time for the prescribed dose, and review records to verify that the administrations were in accordance with the written directives.

d) Licensees must retain a record of the activity of each strontium-90 source. The record shall include:

1. The date and initial activity of the source as determined under Section 335.7070; and

2. For each decay calculation, the date and the source activity as determined under this section.

History

• Source: Added at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.8010 Use of a Sealed Source in Remote Afterloader Units, Teletherapy Units or Gamma Stereotactic Radiosurgery Units

a) A licensee shall only use sealed sources:

1. Obtained from a person specified in Section 335.35, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

2. Approved and as provided for in the Sealed Source and Device Registry , in photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units to deliver therapeutic doses for medical uses; or

3. In research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration, provided the requirements of Section 335.35 are met.

b) A licensee shall use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:

1. Approved in the Sealed Source and Device Registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the Sealed Source and Device Registry, but must be used in accordance with radiation safety conditions and limitations described in the Sealed Source and Device Registry; or

2. In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of Section 335.35 are met.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.8020 Installation, Maintenance, Adjustment and Repair Restrictions

a) Only a person specifically licensed by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State shall install, maintain, adjust or repair a remote afterloader unit, intravascular brachytherapy unit, teletherapy unit or gamma stereotactic radiosurgery unit that involves work on the sources shielding, the sources driving unit or other electronic or mechanical component that could expose the sources, reduce the shielding around the sources, or compromise the radiation safety of the unit or the sources.

b) Except for a low dose-rate remote afterloader unit and intravascular brachytherapy unit, only a person specifically licensed by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, intravascular brachytherapy units, teletherapy units or gamma stereotactic radiosurgery units.

c) For a low dose-rate remote afterloader unit and intravascular brachytherapy unit, only a person specifically licensed by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State or an authorized medical physicist shall install, replace, relocate or remove a sealed source contained in the unit.

d) A licensee shall retain a record of the installation, maintenance, adjustment and repair of remote afterloader units, intravascular brachytherapy units, teletherapy units and gamma stereotactic radiosurgery units as required by this Section for 5 years. For each installation, maintenance, adjustment and repair, the record must include the date, description of the service, names of the individuals who performed the work, and a copy of the specific license authorizing the service.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8030 Amendments to Teletherapy Licenses (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8040 Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units and Gamma Stereotactic Radiosurgery Units

a) A licensee using sealed sources in remote afterloader units, teletherapy units or gamma stereotactic radiosurgery units for therapeutic medical uses shall:

1. Secure the unit, the console, the console keys and the treatment room when not in use or unattended, if applicable;

2. Permit only individuals approved by the authorized user, Radiation Safety Officer or authorized medical physicist to be present in the treatment room during treatment or emergencies with the sources;

3. Prevent dual operation of more than one radiation producing device in a treatment room, if applicable; and

4. Develop, implement and maintain written procedures for responding to an abnormal situation when the operator is unable to place the 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 shall include:

A) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;

B) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and

C) The names and telephone numbers of the authorized users, the authorized medical physicist and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.

b) A copy of the procedures required by subsection (a)(4) and the manufacturer's instruction manual shall be physically located at the unit console.

c) A licensee shall post instructions at the unit console to inform the operator of:

1. The procedures located there as required by subsection (b); and

2. The names and telephone numbers of the authorized users, the authorized medical physicist and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.

d) Operational and Safety Training

1. Prior to the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit, the licensee shall ensure that vendor operational and safety training is provided to all individuals who will operate the unit. The vendor operational and safety training must be provided by the device manufacturer or by an individual certified by the device manufacturer to provide the operational and safety training.

2. Initially and at least annually, the licensee shall provide operational and safety instructions to all individuals who operate the unit at the facility, as appropriate to the individual's assigned duties, in:

A) The procedures identified in subsection (a)(4); and

B) The operating procedures for the unit.

e) A licensee shall ensure that operators, authorized medical physicists and authorized users participate in drills of the emergency procedures, initially and at least annually.

f) A licensee shall retain a record of the instruction required by subsection (d). The record shall be retained for five years and include a list of the topics covered, the date of the instruction, the names of the attendees and the names of the individuals who provided instruction.

g) A licensee shall retain a copy of the procedures required by subsections (a)(4) and (d)(2)(B) until the licensee no longer possesses the remote afterloader, teletherapy unit or gamma stereotactic radiosurgery unit.

h) A licensee shall maintain a copy of the record documenting results of the drills of emergency procedures required by subsection (e) for five years.

History

• Source: Amended at 48 Ill. Reg. 13672, effective August 29, 2024

32 Ill. Adm. Code 335.8050 Safety Precautions for Remote Afterloader Units, Teletherapy Units and Gamma Stereotactic Radiosurgery Units

a) A licensee shall control access to the treatment room by a door at each entrance.

b) A licensee shall equip each entrance to the treatment room with an electrical interlock system that shall:

1. Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

2. Cause the sources to be shielded when an entrance door is opened; and

3. Prevent the sources from being exposed following an interlock interruption until all treatment room entrance doors are closed and the sources on-off control is reset at the console.

c) A licensee shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.

d) Except for low-dose remote afterloader units, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.

e) For licensed activities where sources are placed within the patient's or human research subject's body, a licensee shall only conduct treatments that allow for expeditious removal of a decoupled or jammed source.

f) In addition to the requirements specified in subsections (a) through (e) of this Section, a licensee shall:

1. For medium dose-rate and pulsed dose-rate remote afterloader units, require:

A) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation of, and emergency response for, the unit to be physically present during the initiation of all patient treatments involving the unit; and

B) An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who has been trained to remove the source applicators in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments involving the unit.

2. For high dose-rate remote afterloader units, require:

A) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and

B) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during continuation of all patient treatments involving the unit.

3. For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit.

4. Notify the Radiation Safety Officer, or his/her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

g) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source:

1. Remaining in the unshielded position; or

2. Lodged within the patient following completion of the treatment.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8060 Radiation Monitoring Device for Teletherapy Units and Gamma Stereotactic Radiosurgery Units

a) A licensee shall have in each teletherapy or gamma stereotactic radiosurgery room a permanent radiation monitor capable of continuously monitoring the status of the beam.

b) Each radiation monitor shall be capable of providing visible indication of a teletherapy or gamma stereotactic radiosurgery unit malfunction that results in an exposed or partially exposed source. The visible indicator of high radiation levels shall be observable by an individual entering the teletherapy or gamma stereotactic radiosurgery room.

c) Each radiation monitor shall be equipped with an auxiliary power supply separate from the power supply to the teletherapy or gamma stereotactic radiosurgery unit. This auxiliary power supply may be a battery system.

d) The radiation monitor shall be checked with a dedicated check source for proper operation each day before the teletherapy or gamma stereotactic radiosurgery unit is used for treatment of patients.

AGENCY NOTE: Exposing the source and remotely viewing the instrument response is an acceptable method for checking the monitor with a "dedicated check source".

e) A licensee shall maintain a record of the check required by subsection (d) of this Section for 5 years. The record shall include the date of the check, a notation that the monitor indicated when the source was exposed and the identity of the individual who performed the check.

f) If the radiation monitor is inoperable, the licensee shall require any individual entering the teletherapy or gamma stereotactic radiosurgery room to use either a survey instrument or a personal dosimeter with an audible alarm to monitor for any malfunction of the source exposure mechanism that may result in an exposed or partially exposed source. The instrument or dosimeter shall be checked with a dedicated check source for proper operation at the beginning of each day of use. The licensee shall keep a record as described in subsection (e) of this Section.

g) If the radiation monitor is inoperable, the licensee shall take action within 24 hours to repair or replace the radiation monitor. At a minimum, such action shall include the scheduling for the repair or replacement of the inoperable monitor.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8070 Viewing System for Teletherapy (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8080 Dosimetry Equipment

a) A licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions shall be met:

1. The system shall have been calibrated by the National Bureau of Standards, by the National Institute of Standards and Technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration shall have been performed within the previous 2 years and after any servicing that may have affected system calibration; or

2. The system shall have been calibrated within the previous 4 years; 18 to 30 months after that calibration, the system shall have been compared with another dosimetry system that was calibrated within the past 24 months by the National Bureau of Standards, by the National Institute of Standards and Technology or by a calibration laboratory accredited by the AAPM. The dosimetry system shall be considered calibrated if a comparison is performed at a meeting sanctioned by a calibration laboratory or radiological physics center accredited by the AAPM and the results of the comparison indicate that the calibration factor of the licensee's system has not changed by more than two percent. The licensee shall not use the comparison result to change the calibration factor. When comparing dosimetry systems to be used for calibrating cobalt-60 teletherapy units, the licensee shall use a teletherapy unit with a cobalt-60 source. When intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility.

b) The licensee shall have available for use a calibrated dosimetry system for spot-check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with subsection (a) of this Section. This comparison shall have been performed within the previous year and after each servicing that may have affected calibration of the calibrated system. The spot-check system may be the same system used to meet the requirements in subsection (a) of this Section.

c) The licensee shall retain a record of each calibration and comparison for the duration of the license. For each calibration or comparison, the record shall include the date, the manufacturer, the model and serial number of the instruments that were calibrated or compared as required by subsections (a) and (b) of this Section, the correction factors that were deduced, the names of the individuals who performed the calibration or comparison and evidence that the comparison meeting was sanctioned by a calibration laboratory or radiological physics center accredited by AAPM.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8090 Full Calibration Measurements for Teletherapy

a) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements as described in subsection (b) of this Section, on each teletherapy unit:

1. Before the first medical use of the unit; and

2. Before medical use under the following conditions:

A) Whenever spot-check measurements indicate that the output differs by more than five percent from the output obtained at the last full calibration, corrected mathematically for radioactive decay;

B) Following replacement of the source or following reinstallation of the teletherapy unit in a new location;

C) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

3. At intervals not exceeding 1 year.

b) To satisfy the requirement of subsection (a) of this Section, full calibration measurements shall include determination of:

1. The output, within three percent, for the range of field sizes and for the distance or range of distances used for medical use;

2. The coincidence of the radiation field and the field indicated by the light beam localizing device;

3. The uniformity of the radiation field and its dependence on the orientation of the useful beam;

4. Timer constancy and linearity over the range of use;

5. On-off error; and

6. The accuracy of all distance measuring and localization devices in medical use.

c) A licensee shall use the dosimetry system described in Section 335.8080 of this Part to measure the output for one set of exposure conditions. The remaining radiation measurements required by subsection (b)(1) of this Section may then be made using a dosimetry system that indicates relative dose rates.

d) A licensee shall make full calibration measurements required by subsection (a) of this Section in accordance with published protocols accepted by nationally recognized bodies.

e) A licensee shall mathematically correct for physical decay the outputs determined in subsection (b)(1) of this Section. These corrections shall be for intervals not exceeding 1 month for cobalt-60 and intervals not exceeding 6 months for cesium-137 or at intervals consistent with 1 percent decay for all other nuclides.

f) Full calibration measurements required by subsection (a) of this Section and physical decay corrections required by subsection (e) of this Section shall be performed by an authorized medical physicist.

g) A licensee shall retain a record of each calibration for the duration of the license. The record shall include the date of the calibration, the manufacturer's name, model and serial numbers for both the teletherapy unit and the source, the model and serial numbers of the instruments used to calibrate the teletherapy unit, tables that describe the output of the unit over the range of field sizes and for the range of distance used in radiation therapy, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, an assessment of timer constancy and linearity, the calculated on-off error, the determined accuracy of each distance measuring or localization device and the signature or initials of the authorized medical physicist.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8100 Periodic Spot-Checks for Teletherapy

a) A licensee authorized to use teletherapy units for medical use shall perform spot-checks on each teletherapy unit at intervals not to exceed 1 month.

b) To satisfy the requirement of subsection (a) of this Section, spot-checks shall include the taking of measurements that permit the determination of:

1. Timer constancy and linearity over the range of use;

2. On-off error;

3. The coincidence of the radiation field and the field indicated by the light beam localization device;

4. The accuracy of all distance measuring and localization devices used for medical use;

5. The output for one typical set of operating conditions; and

6. The difference between the measurement made in subsection (b)(5) of this Section and the anticipated output, expressed as a percentage of the anticipated value obtained at the last full calibration corrected mathematically for physical decay.

c) A licensee shall use the dosimetry system described in Section 335.8080 of this Part to make the measurement required in subsection (b)(5) of this Section.

d) A licensee shall perform measurements required by subsection (a) of this Section in accordance with written procedures established by the authorized medical physicist. The authorized medical physicist does not need to actually perform the spot-check measurements.

e) A licensee shall have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall, within 15 days, notify the licensee in writing of the results of each spot-check. The licensee shall keep a copy of each written notification for 5 years.

f) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility at intervals not to exceed 1 month. To satisfy this requirement, checks shall assure proper operation of:

1. Electrical interlocks at each teletherapy room entrance;

2. Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (i.e., restriction of source housing angulation or elevation, carriage or stand travel, operation of the beam on-off mechanism);

3. Beam condition indicator lights on the teletherapy unit, on the control console and in the facility;

4. Viewing systems;

5. Treatment room doors from inside and outside the treatment room; and

6. Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.

g) If the results of the checks required in subsection (f) of this Section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace or check the malfunctioning system.

h) A licensee shall retain a record of each spot-check required by subsections (a) and (f) of this Section for 5 years. The record shall include the date of the spot-check, the model and serial number for both the teletherapy unit and source, the model and serial number of the instrument used to measure the output of the teletherapy unit, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, an assessment of timer constancy and linearity, the calculated on-off error, the determined accuracy of each distance measuring or localization device, the difference between the anticipated output and the measured output, notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors and the identity 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.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8110 Radiation Monitoring

a) In addition to the monitoring requirements in 32 Ill. Adm. Code 340.510, a person licensed under this Subpart shall monitor to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the sources in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry.

b) The licensee shall monitor, as required by subsection (a) of this Section, at installations of a new source and following repairs to the source's shielding, the source's driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source, or compromise the radiation safety of the unit or the source.

c) A licensee shall maintain a record of the radiation monitoring of treatment units made in accordance with this Section for the duration of use of the unit. The record must include:

1. The date of the measurement;

2. The manufacturer's name, model and serial number of the treatment unit, source and instrument used to measure radiation levels;

3. Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and

4. The signature of the individual who performed the test.

History

• Source: Amended at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8120 Safety Checks for Teletherapy Facilities (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8130 Modification of Teletherapy Unit or Room Before Beginning a Treatment Program (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8140 Reports of Teletherapy Monitoring, Checks, Tests and Measurements (repealed)

History

• Source: Repealed at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8150 Full-Inspection Servicing for Teletherapy and Gamma Stereotactic Radiosurgery Units

a) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during each source replacement to assure proper functioning of the source exposure mechanism and other safety components. The interval between each full-inspection servicing shall not exceed 5 years for each teletherapy unit and shall not exceed 7 years for each gamma stereotactic radiosurgery unit.

b) This inspection and servicing may only be performed by persons specifically licensed to do so by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State.

c) A licensee shall maintain a record of the inspection and servicing for teletherapy and gamma stereotactic radiosurgery units required by this Section for the duration of use of the unit.

d) The record shall contain:

1. The inspector's radioactive materials license number;

2. The date of the inspection;

3. The manufacturer's name and model number and serial number of both the treatment unit and source;

4. A list of components inspected and serviced and the type of service; and

5. The signature of the inspector.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.8160 Full Calibration Measurements on Remote Afterloader Units

a) A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit:

1. Before the first medical use of the unit;

2. Before medical use under the following conditions:

A) Following replacement of the source or following reinstallation of the unit in a new location outside the facility;

B) Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly;

3. At intervals not exceeding 1 quarter for high dose-rate, medium dose-rate and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and

4. At intervals not exceeding 1 year for low dose-rate remote afterloader units.

b) To satisfy the requirement of subsection (a) of this Section, full calibration measurements shall include, as applicable, determination of:

1. The output within ± 5 percent;

2. Source positioning accuracy to within ± 1 millimeter;

3. Source retraction with backup battery upon power failure;

4. Length of the source transfer tubes;

5. Timer accuracy and linearity over the typical range of use;

6. Length of the applicators; and

7. Function of the source transfer tubes, applicators and transfer tube-applicator interfaces.

c) A licensee shall use the dosimetry system described in subsection 335.8080(a) to measure the output.

d) A licensee shall make full calibration measurements required by subsection (a) of this Section in accordance with published protocols accepted by nationally recognized bodies.

e) In addition to the requirements for full calibrations for low dose-rate remote afterloader units in subsection (b) of this Section, a licensee shall perform an autoradiograph of the sources to verify inventory and sources arrangement at intervals not exceeding 1 quarter.

f) For low dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with subsections (a) through (e) of this Section.

g) A licensee shall mathematically correct the outputs determined in subsection (b)(1) of this Section for physical decay at intervals consistent with 1 percent physical decay.

h) Full calibration measurements required by subsection (a) of this Section and physical decay corrections required by subsection (g) of this Section shall be performed by the authorized medical physicist.

i) A licensee shall maintain a record of the remote afterloader unit full calibrations required by this Section for 5 years.

j) The records shall include for each full calibration required by subsection (a) of this Section:

1. The date of the calibration;

2. The manufacturer's name, model and serial number of the remote afterloader unit, together with the sources and the instruments used to calibrate it;

3. The results and an assessment of the full calibrations;

4. The results of the autoradiograph required for low dose-rate remote afterloader units; and

5. The signature of the authorized medical physicist who performed the full calibration.

History

• Source: Amended at 35 Ill. Reg. 884, effective December 30, 2010

32 Ill. Adm. Code 335.8170 Periodic Spot-Checks for Remote Afterloader Units

a) A licensee authorized to use a remote afterloader unit for medical use shall perform spot-checks of each remote afterloader facility and on each unit:

1. Before the first use of a high dose-rate, medium dose-rate or pulsed dose‑rate remote afterloader unit on a given day;

2. Before each patient treatment with a low dose-rate remote afterloader unit; and

3. After each source installation.

b) A licensee shall perform the measurements required by subsection (a) of this Section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot-check measurements.

c) A licensee shall have the authorized medical physicist review the results of each spot‑check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.

d) To satisfy the requirements of subsection (a) of this Section, spot-checks must, at a minimum, assure proper operation of:

1. Electrical interlocks at each remote afterloader unit room entrance;

2. Source exposure indicator lights on the remote afterloader unit, on the control console and in the facility;

3. Viewing and intercom systems in each high dose-rate, medium dose-rate and pulsed dose-rate remote afterloader facility;

4. Emergency response equipment;

5. Radiation monitors used to indicate the source position;

6. Timer accuracy;

7. Clock (date and time) in the unit's computer; and

8. Decayed sources activity in the unit's computer.

e) If the results of the checks required in subsection (d) of this Section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace or check the malfunctioning system.

f) A licensee shall retain a record of each spot-check for remote afterloader units required by this Section for 5 years.

g) The record must include, as applicable:

1. The date of the spot-check;

2. The manufacturer's name, model and serial number for the remote afterloader unit and source;

3. An assessment of timer accuracy;

4. Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems and clock and decayed source activity in the unit's computer; and

5. The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

h) A licensee shall retain a copy of the procedures required by subsection (b) of this Section until the licensee no longer possesses the remote afterloader unit.

History

• Source: Added at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8180 Monitoring of Patients and Human Research Subjects Treated with a Remote Afterloader Unit or Intravascular Brachytherapy Unit

a) Before releasing a patient or a human research subject from licensee control, a licensee shall monitor the patient or the human research subject and the remote afterloader or intravascular brachytherapy unit with a portable radiation detection survey instrument to confirm that the sources have been removed from the patient or human research subject and returned to the safe shielded position.

b) A licensee shall maintain a record of the monitors required by this Section for 5 years. Each record must include the date and results of the monitoring, the manufacturer, model and serial numbers of the survey instrument used and the name of the individual who performed the monitoring.

History

• Source: Added at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8190 Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units

a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit:

1. Before the first medical use of the unit;

2. Before medical use under the following conditions:

A) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

B) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and

C) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and

3. At intervals not exceeding 1 year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.

b) To satisfy the requirement of subsection (a) of this Section, full calibration measurements must include determination of:

1. The output within ± 3 percent;

2. Relative helmet factors;

3. Isocenter coincidence;

4. Timer accuracy and linearity over the range of use;

5. On-off error;

6. Trunnion centricity;

7. Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

8. Helmet microswitches;

9. Emergency timing circuits; and

10. Stereotactic frames and localizing devices (trunnions).

c) A licensee shall use the dosimetry system described in Section 335.8080(a) of this Part to measure the output for one set of exposure conditions. The remaining radiation measurements required in subsection (b)(1) of this Section may be made using a dosimetry system that indicates relative dose rates.

d) A licensee shall make full calibration measurements required by subsection (a) of this Section in accordance with published protocols accepted by nationally recognized bodies.

e) A licensee shall mathematically correct the outputs determined in subsection (b)(1) of this Section at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides.

f) Full calibration measurements required by subsection (a) of this Section and physical decay corrections required by subsection (e) of this Section must be performed by the authorized medical physicist.

g) A licensee shall maintain a record of the gamma stereotactic radiosurgery unit full calibrations required by this Section for 5 years.

h) The record must include:

1. The date of the calibration;

2. The manufacturer's name, model and serial number of the gamma stereotactic radiosurgery units, the sources, and the instruments used to calibrate the units;

3. The results and an assessment of the full calibrations; and

4. The signature of the authorized medical physicist who performed the full calibration.

History

• Source: Added at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8200 Periodic Spot-Checks for Gamma Stereotactic Radiosurgery Units

a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit:

1. Monthly;

2. Before the first use of the unit on a given day; and

3. After each source installation.

b) A licensee shall:

1. Perform the measurements required by subsection (a) of this Section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot-check measurements.

2. Have the authorized medical physicist review the results of each spot‑check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot‑check.

c) To satisfy the requirements of subsection (a)(1) of this Section, spot-checks must, at a minimum:

1. Assure proper operation of:

A) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

B) Helmet microswitches;

C) Emergency timing circuits; and

D) Stereotactic frames and localizing devices (trunnions).

2. Determine:

A) The output for one typical set of operating conditions measured with the dosimetry system described in Section 335.8080(b) of this Part;

B) The difference between the measurement made in subsection (c)(2)(A) of this Section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay);

C) Source output against computer calculation;

D) Timer accuracy and linearity over the range of use;

E) On-off error; and

F) Trunnion centricity.

d) To satisfy the requirements of subsections (a)(2) and (a)(3) of this Section, spot-checks must assure proper operation of:

1. Electrical interlocks at each gamma stereotactic radiosurgery room entrance;

2. Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console and in the facility;

3. Viewing and intercom systems;

4. Timer termination;

5. Radiation monitors used to indicate room exposures; and

6. Emergency off buttons;

e) A licensee shall arrange for the repair of any system identified in subsection (c) of this Section that is not operating properly as soon as possible.

f) If the results of the checks required in subsection (d) of this Section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace or check the malfunctioning system.

g) A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery units required by this Section for 5 years.

1. The record must include:

A) The date of the spot-check;

B) The manufacturer's name, model 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.

2. A licensee shall retain a copy of the procedures required by subsection (b) of this Section until the licensee no longer possesses the gamma stereotactic radiosurgery unit.

History

• Source: Added at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8210 Additional Technical Requirements for Mobile Remote Afterloader Units

a) A licensee providing mobile remote afterloader service shall:

1. Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and

2. Account for all sources before departure from a client's address of use.

b) In addition to the periodic spot-checks required by Section 335.8170 of this Part, a licensee authorized to use mobile afterloaders for medical use shall perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks must be made to verify the operation of:

1. Electrical interlocks on treatment area access points;

2. Source exposure indicator lights on the remote afterloader unit, on the control console and in the facility;

3. Viewing and intercom systems;

4. Applicators, source transfer tubes and transfer tube-applicator interfaces;

5. Radiation monitors used to indicate room exposures;

6. Source positioning (accuracy); and

7. Radiation monitors used to indicate whether the source has returned to a safe shielded position.

c) In addition to the requirements for checks in subsection (b) of this Section, a licensee shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.

d) If the results of the checks required in subsections (b) and (c) of this Section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace or check the malfunctioning system.

e) A licensee shall retain a record of each check for mobile remote afterloader units required by this Section for 5 years.

f) The record must include:

1. The date of the check;

2. The manufacturer's name, model and serial number of the remote afterloader unit;

3. Notations accounting for all sources before the licensee departs from a facility;

4. Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators, source transfer tubes, transfer tube applicator interfaces, and source positioning accuracy; and

5. The signature of the individual who performed the check.

History

• Source: Added at 30 Ill. Reg. 9029, effective April 28, 2006

32 Ill. Adm. Code 335.8220 Additional Technical Requirements for Intravascular Brachytherapy Units (repealed)

History

• Source: Repealed at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.8230 Therapy-Related Computer Systems for Remote Afterloader Units, Teletherapy Units and Gamma Stereotactic Units

The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:

a) The source-specific input parameters required by the dose calculation algorithm;

b) The accuracy of dose, dwell time and treatment time calculations at representative points;

c) The accuracy of isodose plots and graphic displays;

d) The accuracy of the software used to determine sealed source positions from radiographic images; and

e) The accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.9010 Training for Radiation Safety Officer and Associate Radiation Safety Officer

Except as provided in Section 335.9160, the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer or an individual assigned duties and tasks as an Associate Radiation Safety Officer under the requirement in subsection 335.1040(b) to be an individual who:

a) Is certified by a specialty board whose certification process has been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State and who meets the requirements described in subsection (f). To have its certification process recognized, a specialty board shall require all candidates for certification to meet the following requirements:

1. The candidate shall:

A) Hold a bachelor's or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of 20 college credits in physical science;

B) 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

C) Pass an examination administered by diplomates of the specialty board that evaluates knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology and radiation dosimetry; or

2. The candidate shall:

A) Hold a master's or doctorate degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;

B) Have two years of full-time practical training or supervised experience in medical physics:

i) Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the Commission or an Agreement State; or

ii) In clinical nuclear medicine facilities providing diagnostic or therapeutic services under the direction of physicians who meet the requirements for authorized users in Sections 335.9040, 335.9050 or 335.9160; and

iii) Pass an examination administered by diplomates of the specialty board that evaluates knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety; or

b) Has successfully completed a structured educational program consisting of both subsections (b)(1) and (b)(2):

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 Radiation Safety Officer on an Agency, U.S. Nuclear Regulatory Commission, or Agreement State license or permit issued by a U.S. Nuclear Regulatory Commission master material licensee that authorizes similar types and uses of radioactive material. An Associate Radiation Safety Officer may provide supervision for those areas for which the Associate Radiation Safety Officer is authorized on an Agency, U.S. Nuclear Regulatory Commission, or Agreement State license or permit issued by a master material licensee. The full-time radiation safety experience shall involve the following:

A) Shipping, receiving and performing related radiation monitoring;

B) Using and performing checks for proper operation of instruments used to determine the activity of dosages, instruments used to measure radionuclides and survey meters;

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

3. This individual must obtain a written attestation, signed by a preceptor Radiation Safety Officer or Associate Radiation Safety Officer who has experience with the radiation safety aspects of similar types of use of radioactive material for which the individual is seeking approval as a Radiation Safety Officer or an Associate Radiation Safety Officer, that the individual has satisfactorily completed the requirements in subsections (b)(1), (b)(2) and (f) and is able to independently fulfill the radiation safety-related duties as a Radiation Safety Officer or as an Associate Radiation Safety Officer for a medical use license; or

c) Is a medical physicist who has been certified by a specialty board whose certification process has been recognized by the Agency under subsection 335.9150(a) or the U.S. Nuclear Regulatory Commission or an Agreement State and has experience with the radiation safety aspects of similar types of use of radioactive material for which approval of the individual as Radiation Safety Officer or Associate Radiation Safety Officer is sought and meets the requirements in subsection (f); or

d) Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on an Agency, U.S. Nuclear Regulatory Commission, or Agreement State license, a permit issued by a U.S. Nuclear Regulatory Commission master material licensee, a permit issued by an Agency, U.S. Nuclear Regulatory Commission, or an Agreement State licensee of broad scope, or a permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope permittee; has experience with the radiation safety aspects of similar types of use of radioactive material for which the licensee seeks the approval of the individual as Radiation Safety Officer or an Associate Radiation Safety Officer; and meets the requirements in subsection (f); or

e) Has experience with the radiation safety aspects of the types of use of radioactive material for which the individual is seeking simultaneous approval both as the Radiation Safety Officer and the authorized user on the same new medical use license or new medical use permit issued by a U.S. Nuclear Regulatory Commission master material licensee. The individual must also meet the requirements in paragraph (f) of this Section.

f) Has received training in radiation safety, regulatory issues and emergency procedures for the types of use for which approval is sought. This training requirement may be satisfied by completing training that is supervised by a Radiation Safety Officer, Associate Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is authorized for the types of use for which the licensee is seeking approval.

AGENCY NOTE: Specialty boards whose certification processes have been recognized by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State will be posted on the NRC's website.

History

• Source: Amended at 48 Ill. Reg. 13672, effective August 29, 2024

32 Ill. Adm. Code 335.9020 Training for Experienced Radiation Safety Officer (repealed)

History

• Source: Repealed at 27 Ill. Reg. 10057, effective June 30, 2003

32 Ill. Adm. Code 335.9030 Training for Uptake, Dilution or Excretion Studies

Except as provided in Section 335.9160, a licensee shall require the authorized user of unsealed radioactive material for the uses authorized under Section 335.3010 not requiring a written directive to be a physician who:

a) Is certified by a medical specialty board whose certification process has been recognized by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State. To have its certification process recognized, a specialty board shall require all candidates for certification to meet the following requirements:

1. 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 subsections (c)(1) and (2); and

2. Pass an examination administered by diplomates of the specialty board, that evaluates knowledge and competence in radiation safety, radionuclide handling and quality control; or

b) Is an authorized user who meets the requirements of Section 335.9040 or 335.9050 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

c) Has successfully completed a structured educational program consisting of:

1. 60 hours of training and experience, including a minimum of 8 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 classroom and laboratory training shall include, at a minimum:

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;

E) Radiation biology; and

2. Work experience under the supervision of an authorized user who meets the requirements in this Section, Section 335.9040, 335.9050 or 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements involving:

A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation monitoring;

B) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey instruments;

C) Calculating, measuring and safely preparing patient or human research subject dosages;

D) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

E) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

F) Administering dosages of radioactive drugs to patients or human research subjects; and

3. Has obtained written attestation that the individual has satisfactorily completed the requirements in subsection (c) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized by Section 335.3010. The attestation shall be obtained from either:

A) A preceptor authorized user who meets the requirements in this Section or Section 335.9040, 335.9050 or 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

B) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this Section, Sections 335.9040, 335.9050 or 335.9160, or equivalent Agreement State requirements, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and work experience specified in subsections (c)(1) and (c)(2).

AGENCY NOTE: Specialty boards whose certification processes have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's website.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.9040 Training for Imaging and Localization Studies

Except as provided in Section 335.9160, a licensee shall require the authorized user of unsealed radioactive material for the uses authorized under Section 335.4010 not requiring a written directive to be a physician who:

a) Is certified by a medical specialty board whose certification process has been recognized by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State. To have its certification process recognized, a specialty board shall require all candidates for certification to meet the following requirements:

1. 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 subsection (c); and

2. Pass an examination administered by diplomates of the specialty board, that evaluates knowledge and competence in radiation safety, radionuclide handling and quality control; or

b) Is an authorized user who meets the requirements of Section 335.9050 and meets the requirements in subsection (c)(1)(B)(vii) or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

c) Has successfully completed 700 hours of training and experience, including 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.:

1. The training and experience shall include at a minimum:

A) Classroom and laboratory training in the following areas:

i) Radiation physics and instrumentation;

ii) Radiation protection;

iii) Mathematics pertaining to the use and measurement of radioactivity;

iv) Chemistry of radioactive material for medical use;

v) Radiation biology; and

B) Work experience under the supervision of an authorized user who meets the requirements in this Section, Section 335.9160 or Section 335.9050, together with subsection (c)(1)(B)(vii), or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, involving:

i) Ordering, receiving and unpacking radioactive materials safely and performing the related radiation monitoring;

ii) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey instruments;

iii) Calculating, measuring and safely preparing patient or human research subject dosages;

iv) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

v) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures;

vi) Administering dosages of radioactive drugs to patients or human research subjects;

vii) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring, and testing the eluate for radionuclidic purity and processing the eluate with reagent kits to prepare labeled radioactive drugs; and

2. Has obtained written attestation that the individual has satisfactorily completed the requirements described in subsection (c)(1) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under Sections 335.3010 and 335.4010. The attestation shall be obtained from either:

A) A preceptor authorized user who meets the requirements in this Section, Section 335.9160 or Section 335.9050 together with subsection (c)(1)(B)(vii) or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

B) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this Section, Section 335.9160 or Section 335.9050, together with subsection (c)(1)(B)(vii) or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in subsections (c) and (c)(1).

AGENCY NOTE: Specialty boards whose certification processes have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's website.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.9050 Training for Use of Unsealed Radioactive Material for Which a Written Directive Is Required

Except as provided in Sections 335.9060, 335.9070, 335.9080 and 335.9160, a licensee shall require the authorized user of unsealed radioactive material for the uses authorized under Section 335.5010 to be a physician who:

a) Is certified by a medical specialty board whose certification process has been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State and who meets the requirements in subsection (b)(2)(F). To be recognized, a specialty board shall require all candidates for certification to meet the following requirements:

1. Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty that includes 700 hours of training and experience as described in subsection (b)(1) through (b)(2)(E). Eligible training programs shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association;

2. Pass an examination administered by diplomates of the specialty board that evaluates knowledge and competence in radiation safety, radionuclide handling, quality assurance and clinical use of unsealed radioactive materials; or

AGENCY NOTE: Specialty boards whose certification processes have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's website.

b) Has successfully 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 shall 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;

E) Radiation biology; and

2. Work experience under the supervision of an authorized user who meets the requirements in this Section, Section 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements. A supervising authorized user who meets the requirements in subsection (b) shall have experience in administering dosages in the same dosage category or categories (i.e., subsection (b)(2)(F)) as the individual requesting authorized user status. The work experience shall involve:

A) Ordering, receiving and unpacking radioactive materials safely, and performing the related radiation monitoring;

B) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey instruments;

C) Calculating, measuring and safely preparing patient or human research subject dosages;

D) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

E) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures;

F) Administering dosages of radioactive drugs to patients or human research subjects involving 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;

AGENCY NOTE: Experience with at least 3 cases described in subsection (b)(2)(F)(ii) satisfies the requirement in subsection (b)(2)(F)(i).

iii) Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required; and

3. Written attestation that the individual has satisfactorily completed the requirements in subsections (b)(1) and (b)(2) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under Section 335.5010 for which the individual is requesting authorized user status. The attestation shall be signed by either:

A) A preceptor authorized user who meets the requirements in this Section, Section 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; or

B) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this Section, Section 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in subsections (b)(1) and (b)(2).

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.9060 Training for the Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Less Than or Equal to 1.22 Gbq (33 Mci)

Except as provided in Section 335.9160, the licensee shall require the authorized user for oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 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 subsections (c)(1) and (c)(2) and whose certification has been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State; or

b) Is an authorized user who meets the requirements of Section 335.9070 or Section 335.9050 for the uses identified in subsection 335.9050(b)(2)(F)(i) or (ii) or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

c) Has successfully completed a structured educational program consisting of:

1. 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 shall include:

A) Radiation physics and instrumentation;

B) Radiation protection;

C) Mathematics pertaining to the use and measurement of radioactivity;

D) Chemistry of radioactive material for medical use;

E) Radiation biology; and

2. Work experience under the supervision of an authorized user who meets the requirements of this Section, Section 335.9050, 335.9070, 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements. A supervising authorized user who meets the requirements of subsection 335.9050(b) shall have experience in administering the dosages identified in subsection 335.9050(b)(2)(F)(i) or (ii). The work experience shall involve:

A) Ordering, receiving and unpacking radioactive materials safely, and performing the related radiation monitoring;

B) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey instruments;

C) Calculating, measuring and safely preparing patient or human research subject dosages;

D) Using administrative controls to prevent a medical event involving the use of radioactive material;

E) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures;

F) Administering dosages to patients or human research subjects and shall include at least 3 cases involving the oral administration of less than or equal to 1.22 GBq (33 mCi) of sodium iodide I-131; and

3. Written attestation that the individual has satisfactorily completed the requirements in subsections (c)(1) and (c)(2) 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 GBq (33 mCi) of sodium iodide I-131 for medical uses authorized under Section 335.5010. The attestation shall be obtained from either:

A) A preceptor authorized user who meets the requirements in this Section, Section 335.9050, 335.9070, 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements and has experience in administering the dosages identified in subsection 335.9050(b)(2)(F)(i) or (ii); or

B) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in Section 335.9050, 335.9070, 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements and has experience in administering the dosages identified in subsection 335.9050(b)(2)(F)(i) or (ii) and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in subsections (c)(1) and (c)(2).

AGENCY NOTE: Specialty boards whose certification processes have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's website.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.9070 Training for the Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Greater Than 1.22 Gbq (33 Mci)

Except as provided in Section 335.9160, the licensee shall require the authorized user for the oral administration of sodium iodide I-131 requiring a written directive 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 subsections (c)(1) and (c)(2) and whose certification has been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State; or

AGENCY NOTE: Specialty boards whose certification processes have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's website.

b) Is an authorized user who meets the requirements of Section 335.9050 for the uses identified in subsection 335.9050(b)(2)(F)(ii), or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

c) Has successfully completed a structured educational program consisting of:

1. 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 shall include:

A) Radiation physics and instrumentation;

B) Radiation protection;

C) Mathematics pertaining to the use and measurement of radioactivity;

D) Chemistry of radioactive material for medical use;

E) Radiation biology; and

2. Work experience under the supervision of an authorized user who meets the requirements in this Section, Section 335.9050, 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements. A supervising authorized user who meets the requirements of Section 335.9050(b) shall have experience in administering the dosages identified in subsection 335.9050(b)(2)(F)(ii). The work experience shall involve:

A) Ordering, receiving and unpacking radioactive materials safely, and performing the related radiation monitoring;

B) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey instruments;

C) Calculating, measuring and safely preparing patient or human research subject dosages;

D) Using administrative controls to prevent a medical event involving the use of radioactive material;

E) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures;

F) Administering dosages to patients or human research subjects and shall include at least 3 cases involving the oral administration of greater than 1.22 GBq (33 mCi) of sodium iodide I-131; and

3. Written attestation that the individual has satisfactorily completed the requirements in subsections (c)(1) and (2) and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 1.22 GBq (33 mCi) of sodium iodide I-131 for medical uses authorized under Section 335.5010. The attestation shall be obtained from either:

A) A preceptor authorized user who meets the requirements in this Section, Section 335.9050, 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements and has experience in administering the dosages identified in subsection 335.9050(b)(2)(F)(ii); or

B) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this Section, Section 335.9050, 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, has experience in administering the dosages identified in subsection 335.9050(b)(2)(F)(ii), and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in subsections (c)(1) and (c)(2).

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.9080 Training for the Parenteral Administration of Unsealed Radioactive Material Requiring a Written Directive

Except as provided in Section 335.9160, the licensee shall require an authorized user for the parenteral administration requiring a written directive to be a physician who:

a) Is an authorized user who meets the requirements of Section 335.9050 for a use identified in subsection 335.9050(b)(2)(F)(iii) or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

b) Is an authorized user under Section 335.9100 or 335.9140 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements and who meets the requirements in subsection (d); or

c) Is certified by a medical specialty board whose certification process has been recognized by the Agency under Section 335.9100 or 335.9140 or by the U.S. Nuclear Regulatory Commission or an Agreement State and who meets the requirements in subsection (d).

d) The physician shall have:

1. Successfully completed 80 hours of classroom and laboratory training applicable to parenteral administrations listed in subsection 335.9050(b)(2)(F)(iii). The training shall include:

A) Radiation physics and instrumentation;

B) Radiation protection;

C) Mathematics pertaining to the use and measurement of radioactivity;

D) Chemistry of radioactive material for medical use; and

E) Radiation biology.

2. Work experience under the supervision of an authorized user who meets the requirements in this Section, Section 335.9050, 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements in the parenteral administrations listed in subsection 335.9050(b)(2)(F)(iii). A supervising authorized user who meets the requirements in this Section, Section 335.9050, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements shall have experience in administering dosages in the same category or categories as the individual requesting authorized user status. The work experience shall involve:

A) Ordering, receiving and unpacking radioactive materials safely, and performing the related radiation surveys;

B) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;

C) Calculating, measuring and safely preparing patient or human research subject dosages;

D) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

E) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

F) Administering dosages to patients or human research subjects that include at least 3 cases of the parenteral administrations as specified in subsection 335.9050(b)(2)(F)(iii); and

3. Obtained written attestation that the individual has satisfactorily completed the requirements in subsections (d)(1) and (d)(2) 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 shall be obtained from either:

A) A preceptor authorized user who meets the requirements in this Section, Section 335.9050, 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements. A preceptor authorized user who meets the requirements in this Section or Section 335.9050, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, shall have experience in administering dosages in the same category or categories as the individual requesting authorized user status; or

B) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this Section, Section 335.9050, 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in subsection (d)(1) and (d)(2).

AGENCY NOTE: Specialty boards whose certification processes have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's website.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.9090 Training for Therapeutic Use of Colloidal Chromic Phosphorus-32 Labeled Phosphate Compound or Gold-198 (repealed)

History

• Source: Repealed at 27 Ill. Reg. 10057, effective June 30, 2003

32 Ill. Adm. Code 335.9100 Training for Use of Manual Brachytherapy Sources

Except as provided in Section 335.9160, the licensee shall require the authorized user of a manual brachytherapy source under the provisions and requirements of Subpart H to be a physician who:

a) Is certified by a medical specialty board whose certification process has been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State. To have its certification process recognized, a specialty board shall require all candidates for certification to:

1. Successfully complete a minimum of 3 years of residency training in a radiation oncology program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association; and

2. Pass an examination administered by diplomates of the specialty board that evaluates knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of manual brachytherapy sources; or

AGENCY NOTE: Specialty boards whose certification processes have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's website.

b) The physician has:

1. Completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes:

A) 200 hours of classroom and laboratory training in the following areas:

i) Radiation physics and instrumentation;

ii) Radiation protection;

iii) Mathematics pertaining to the use and measurement of radioactivity;

iv) Radiation biology; and

B) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in this Section or Section 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, at a medical facility authorized to use radioactive material under Subpart H. The work experience shall include:

i) Ordering, receiving and unpacking radioactive materials safely and performing the related radiation monitoring;

ii) Checking survey instruments for proper operation;

iii) Preparing, implanting and removing brachytherapy sources;

iv) Maintaining running inventories of material on hand;

v) Using administrative controls to prevent medical events involving radioactive material;

vi) Using emergency procedures to control radioactive material; and

2. Completed 3 years of supervised clinical experience in radiation oncology under an authorized user who meets the requirements in this Section or Section 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements. The experience shall be obtained as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by subsection (b)(1)(B); and.

3. Obtained written attestation that the individual has satisfactorily completed the requirements in subsections (b)(1) and (b)(2) and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources under Subpart H. The attestation shall be obtained from either:

A) A preceptor authorized user who meets the requirements in this Section, Section 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

B) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this Section, Section 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in subsections (b)(1) and (b)(2).

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.9120 Training for Ophthalmic Use of Strontium-90

Except as provided in Section 335.9160, the licensee shall require the authorized user using only strontium-90 for ophthalmic radiation therapy to be a physician who:

a) Is an authorized user who meets the requirements of Section 335.9100 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

b) Has:

1. Completed 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiation therapy. The training shall include:

A) Radiation physics and instrumentation;

B) Radiation protection;

C) Mathematics pertaining to the use and measurement of radioactivity;

D) Radiation biology; and

2. Completed clinical training in ophthalmic radiation therapy 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 5 individuals. The supervised clinical training shall include:

A) Examination of each individual to be treated;

B) Calculation of the dose to be administered;

C) Administration of the dose; and

D) Follow-up and review of each individual's case history; and

3. Obtained written attestation that the individual has satisfactorily completed the requirements in subsections (b)(1) and (b)(2) and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use. The attestation shall be signed by a preceptor authorized user who meets the requirements in this Section, Section 335.9100, 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.9130 Training for Use of Sealed Sources for Diagnosis

Except as provided in Section 335.9160, the licensee shall require the authorized user of a diagnostic sealed source or a device authorized in Section 335.6010 to be a physician, dentist or podiatrist who:

a) Is certified by a specialty board whose certification process includes all of the requirements in subsection (c) and whose certification has been recognized by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State; or

b) Is an authorized user for uses listed in Section 335.4010 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

c) Has completed 8 hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training shall include:

1. Radiation physics and instrumentation;

2. Radiation protection;

3. Mathematics pertaining to the use and measurement of radioactivity;

4. Radiation biology; and

5. Training in the use of the device for the uses requested; and

d) Has completed training in the use of the device for the uses requested.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.9140 Training for Use of Remote Afterloader Units, Teletherapy Units and Gamma Stereotactic Radiosurgery Units

Except as provided in Section 335.9160, the licensee shall require the authorized user of a sealed source under the provisions and requirements of Subpart I to be a physician who:

a) Is certified by a medical specialty board whose certification process has been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State and who meets the requirements in subsection (d). To have its certification process recognized, a specialty board shall require all candidates for certification to:

1. Successfully complete a minimum of 3 years of residency training in a radiation therapy program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association; and

2. Pass an examination administered by diplomates of the specialty board that evaluates 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

AGENCY NOTE: Specialty boards whose certification processes have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's website.

b) Has:

1. Completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes:

A) 200 hours of classroom and laboratory training in the following areas:

i) Radiation physics and instrumentation;

ii) Radiation protection;

iii) Mathematics pertaining to the use and measurement of radioactivity;

iv) Radiation biology; and

B) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in this Section, Section 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, at a medical institution that is authorized to use radioactive materials under Subpart I. The work experience shall include:

i) Reviewing full calibration measurements and periodic spot-checks;

ii) Preparing treatment plans and calculating treatment doses and times;

iii) Using administrative controls to prevent a medical event involving the use of radioactive material;

iv) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console;

v) Checking and using survey instruments;

vi) Selecting the proper dose and how it is to be administered; and

2. Completed 3 years of supervised clinical experience in radiation therapy under an authorized user who meets the requirements of this Section or Section 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State or requirements. The experience shall be obtained as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by subsection (b)(1)(B); and

3. Obtained written attestation that the individual has satisfactorily completed the requirements in subsections (b)(1), (b)(2), and (c) and is able to independently fulfill the radiation safety-related duties as an authorized user for the type of therapeutic medical unit for which the individual is requesting authorized user status. The attestation shall be obtained from either:

A) A preceptor authorized user who meets the requirements in this Section, Section 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements for each type of therapeutic medical unit for which the individual is requesting authorized user status; or

B) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this Section, Section 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements for the 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 shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in subsections (b)(1) and (b)(2).

c) Has received training in device operation, safety procedures and clinical use for the types of therapeutic medical unit for which authorization is sought. This training requirement may be met 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 types of use for which the individual is seeking authorization.

AGENCY NOTE: The term "type of therapeutic medical unit" refers to a type of use identified in this Section. It applies to this Section only. Training for therapeutic medical units is not manufacturer-specific. Training for one brand of therapeutic medical unit is acceptable for another brand of the same type of unit.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.9150 Training for Authorized Medical Physicist

Except as provided in Section 335.9160, the licensee shall require the authorized medical physicist to be an individual who:

a) Is certified by a specialty board whose certification process has been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State and who meets the requirements in subsection (d). To be recognized, a specialty board shall require all candidates for certification to:

1. Hold a master's degree or doctorate in physics, medical physics, other physical science, engineering or applied mathematics from an accredited college or university;

2. Have 2 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 physics by a specialty board recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State; or

B) In clinical radiation facilities providing high energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services under the direction of physicians who meet the requirements for authorized users in Section 335.9100, 335.9140 or 335.9160;

3. Pass an examination administered by diplomates of the specialty board that evaluates knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance, and treatment planning for external beam therapy, brachytherapy and stereotactic radiosurgery; or

AGENCY NOTE: Specialty boards whose certification processes have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's website.

b) Holds a master's degree or doctorate in physics, medical physics or 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 of use for which the individual is seeking authorization. This training and work experience shall be conducted in clinical radiation facilities that provide high energy, external beam therapy and brachytherapy services and shall 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;

4. Conducting radiation monitoring around external beam treatment units, stereotactic radiosurgery units and remote afterloading units, as applicable; and

c) Has obtained written attestation that the individual has satisfactorily completed the requirements in subsections (b) and (d) and is able to independently fulfill the radiation safety-related duties as an authorized medical physicist for each type of use for which the individual is requesting authorized medical physicist status. The attestation shall be signed by a preceptor authorized medical physicist who meets the requirements of this Section or Section 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements for an authorized medical physicist for each type of use for which the individual is requesting authorized medical physicist status.

d) Has training in the type of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily completing either a training program provided by an equipment supplier or by training supervised by an authorized medical physicist authorized for the type of use for which the individual is seeking authorization.

History

• Source: Amended at 46 Ill. Reg. 966, effective December 21, 2021

32 Ill. Adm. Code 335.9160 Training for Experienced Radiation Safety Officer, Authorized Medical Physicist or Authorized User

a) For experienced Radiation Safety Officers and Authorized Medical Physicists:

1. An individual identified as a Radiation Safety Officer or an authorized medical physicist on an Agency, U.S. Nuclear Regulatory Commission or Agreement State license or a permit issued by an Agency, U.S. Nuclear Regulatory Commission or Agreement State broad scope licensee or master material license permit or by a master material license permittee of broad scope on or before January 14, 2022 need not comply with the training requirements of Sections 335.9010 and 335.9150, respectively, except the Radiation Safety Officers and authorized medical physicists identified in this subsection shall meet the training requirements in subsections 335.9010(e) and 335.9150(d), as appropriate, for any material or uses for which they were not authorized prior to this date.

2. Any individual certified by the American Board of Health Physics in Comprehensive Health Physics, the American Board of Radiology, the American Board of Nuclear Medicine, the American Board of Science in Nuclear Medicine, the Board of Pharmaceutical Specialties in Nuclear Pharmacy, the American Board of Medical Physics in radiation oncology physics, the Royal College of Physicians and Surgeons of Canada in nuclear medicine, the American Osteopathic Board of Radiology, or the American Osteopathic Board of Nuclear Medicine on or before October 24, 2007 need not comply with the training requirements of Section 335.9010 to be identified as a Radiation Safety Officer or as an Associate Radiation Safety Officer on a U.S. Nuclear Regulatory Commission or an Agreement State license or U.S. Nuclear Regulatory Commission master material license permit for those materials and uses that these individuals performed on or before October 24, 2007.

3. 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, 2007 need not comply with the training requirements for an authorized medical physicist described in Section 335.9150, for those materials and uses that these individuals performed on or before October 24, 2007.

b) For physicians, dentists or podiatrists:

1. Physicians, dentists or podiatrists identified as authorized users for the medical use of radioactive material on a license issued by the Agency, U.S. Nuclear Regulatory Commission or Agreement State, a permit issued by a U.S. Nuclear Regulatory Commission master material licensee, a permit issued by an Agency, U.S. Nuclear Regulatory Commission or Agreement State broad scope licensee, or a permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope permittee on or before January 14, 2022 who perform only those medical uses for which they were authorized on or before that date need not comply with the training requirements of Sections 335.9030 through 335.9140.

2. Physicians, dentists or podiatrists not identified as authorized users for the medical use of radioactive material on a license issued by the Agency, U.S. Nuclear Regulatory Commission or Agreement State, a permit issued by a U.S. Nuclear Regulatory Commission master material licensee, a permit issued by the Agency, U.S. Nuclear Regulatory Commission or Agreement State broad scope licensee, or a permit issued in accordance with a U.S. Nuclear Regulatory Commission master material broad scope license on or before October 24, 2007 need not comply with the training requirements of Sections 335.9030 through 335.9140 for those materials and uses that these individuals performed on or before October 24, 2007, as follows:

A) For uses authorized under Sections 335.3010, 335.4010, 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, 2007 in nuclear medicine by the American Board of Nuclear Medicine, diagnostic radiology by the American Board of Radiology, diagnostic radiology or radiology by the American Osteopathic Board of Radiology, nuclear medicine by the Royal College of Physicians and Surgeons of Canada, or the American Osteopathic Board of Nuclear Medicine in nuclear medicine;

B) For uses authorized under Section 335.5010, a physician who was certified on or before October 24, 2007 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 Sections 335.7010 and 335.8010, a physician who was certified on or before October 24, 2007 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 Section 335.6010, a physician who was certified on or before October 24, 2007 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.

c) Individuals who are not subject to the training requirements in this Section may serve as preceptors for and supervisors of applicants seeking authorization on Agency licenses for the same uses for which these individuals are authorized.

d) Individuals that qualify under this Section need to comply with Section 335.9180.

History

• Source: Amended at 48 Ill. Reg. 13672, effective August 29, 2024

32 Ill. Adm. Code 335.9170 Physician Training in a 3-Month Program (repealed)

History

• Source: Repealed at 27 Ill. Reg. 10057, effective June 30, 2003

32 Ill. Adm. Code 335.9180 Recentness of Training

The training and experience specified in Subpart J of this Part shall have been obtained within the 7 years preceding the date of application or the individual shall have had related continuing education and experience since the required training and experience was completed.

History

• Source: Amended at 27 Ill. Reg. 10057, effective June 30, 2003

32 Ill. Adm. Code 335.9190 Resolution of Conflicting Requirements During Transition Period

If this Part conflicts with the licensee's radiation safety program as identified in its license, this Part shall apply, unless the statements, representations, conditions and procedures in the license are more restrictive. However, if that licensee exercises its privilege to amend its license, the portion amended must comply with the requirements of this Part.

History

• Source: Amended at 32 Ill. Reg. 9247, effective June 13, 2008

32 Ill. Adm. Code 335.APPENDIX A List of Specialty Board Certifications Recognized by the Agency Until October 24, 2007 (repealed)

History

• Source: Repealed at 32 Ill. Reg. 9247, effective June 13, 2008

Part 337 Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material

32 Ill. Adm. Code 337.10 Purpose

This Part contains 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 A. These requirements provide reasonable assurance of the security of the category 1 or category 2 quantities of radioactive material by protecting these materials from theft, sabotage or diversion. Specific requirements for access, use, transfer and transport of material are included. No provision of this Part authorizes possession of licensed material. The requirements in this Part are in addition to, and not in substitution for, other requirements in 32 Ill. Adm. Code: Chapter II, Subchapters b and d. All applicants for a license and existing licensees are subject to this Part, unless specifically exempted.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.20 Scope

a) Subparts B and C apply to any person who possesses or uses at any site, an aggregated category 1 or category 2 quantity of radioactive material.

b) Subpart D applies to any person who:

1. Transports or delivers a category 1 or category 2 quantity of radioactive material to a carrier for transport in a single shipment; or

2. Imports or exports a category 1 or category 2 quantity of radioactive material.

AGENCY NOTE: The provisions of this Part only apply to the domestic portion of the transport.

c) Each licensee is responsible for ensuring that persons performing activities under a radioactive material license issued by IEMA comply with 32 Ill. Adm. Code: Chapter II, Subchapters b and d, conditions of the license and any orders issued by IEMA.

32 Ill. Adm. Code 337.30 Incorporations by Reference

All rules, standards and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified in the reference and do not include any later amendments or additions. Copies of rules, standards or guidelines that have been incorporated by reference are available for public inspection and copying at IEMA, 1035 Outer Park Drive, Springfield, Illinois.

32 Ill. Adm. Code 337.40 Definitions

As used in this Part:

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

"Aggregated" means accessible by the breach of a single physical barrier that would allow access to radioactive material in any form, including any devices that contain the radioactive material, when the total activity equals or exceeds a category 2 quantity of radioactive material.

"Approved individual" means an individual whom the licensee has determined to be trustworthy and reliable for unescorted access in accordance with Subpart B and who has completed the training required by Section 337.2020(c). This does not mean the individual has met the requirements to be an approved authorized user of radioactive material.

"Atomic Energy Act of 1954" means 42 USC 2169.

"Background investigation" means the investigation required by Section 337.1030 and conducted by a licensee or applicant for a license to support the determination of trustworthiness and reliability.

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

"Category 1 quantity of radioactive material" means a quantity of radioactive material meeting or exceeding the category 1 threshold in Table 1 of Appendix A. 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.

"Category 2 quantity of radioactive material" means a quantity of radioactive material meeting or exceeding the category 2 threshold but less than the category 1 threshold in Table 1 of Appendix A. 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.

"Diversion" means the unauthorized movement of radioactive material subject to this Part to a location different from the material's authorized destination inside or outside of the site that the material is used or stored.

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

"FBI" means the Federal Bureau of Investigation.

"Fingerprint Orders" means the orders issued by the U.S. Nuclear Regulatory Commission (NRC) or the legally binding requirements issued by 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.

"IEMA" means the Illinois Emergency Management Agency.

"License issuing authority" means the licensing agency that issued the license (i.e., the U.S. Nuclear Regulatory Commission, the Illinois Emergency Management Agency or the appropriate agency of another Agreement State).

"Local law enforcement agency" or "LLEA" means a public or private organization that has been approved by a federal, state or local government to carry firearms and make arrests. The LLEA 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.

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

"Movement control center" means an operations center that is remote from transport activity and 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 requests and coordinates appropriate aid.

"No-later-than arrival time" means the date and time that the shipping licensee and receiving licensee have established as the time that 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.

"Reviewing official" means the individual who shall make the trustworthiness and reliability determination of an individual to determine whether the individual may have, or continue to have, unescorted access to the category 1 or category 2 quantities of radioactive material that is possessed by the licensee. The reviewing official may have unescorted access to the category 1 or category 2 quantities of radioactive material only if his or her job duties require unescorted access to category 1 or category 2 quantities of radioactive material. If the job duties require access to the material, the reviewing official shall also meet the training requirements for use of that radioactive material.

"Sabotage" means 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.

"Safeguards information" means information not classified as National Security Information or Restricted Data, that specifically identifies a licensee's or applicant's detailed control and accounting procedures for the physical protection of special nuclear material in quantities determined by the U.S. Nuclear Regulatory Commission through order or regulation to be significant to the public health and safety or the common defense and security; detailed security measures (including security plans, procedures and equipment) for the physical protection of source, byproduct, or special nuclear material in quantities determined by NRC through order or regulation to be significant to the public health and safety or the common defense and security; security measures for the physical protection of and location of certain plant equipment vital to the safety of production or utilization facilities; and any other information within the scope of section 147 of the Atomic Energy Act of 1954, as amended, the unauthorized disclosure of which, as determined by NRC through order or regulation, could reasonably be expected to have a significant adverse effect on the health and safety of the public or the common defense and security by significantly increasing the likelihood of sabotage or theft or diversion of source, byproduct, or special nuclear material.

"Safeguards information – modified handling" is the designation or marking applied to safeguards information that NRC has determined requires handling requirements modified from the specific safeguards information handling requirements that are applicable to safeguards information needing a higher level of protection.

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

"Security zone" means 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.

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

"Trustworthiness and reliability" are 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. For this purpose, a determination of trustworthiness and reliability is based upon the results of a background investigation and certification by the reviewing official.

"Unescorted access" means solitary access to an aggregated category 1 or category 2 quantity of radioactive material or the devices that contain the material.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.50 Specific Exemptions

A licensee that possesses radioactive waste that contains category 1 or category 2 quantities of radioactive material is exempt from the requirements of Subparts B, C and D; except that any radioactive waste that contains discrete sources, ion-exchange resins or activated material that weighs less than 2,000 kg (4,409 lbs) is not exempt from the requirements. The licensee shall implement the following requirements to secure the radioactive waste:

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. Immediately after initiating a response, but not at the expense of causing delay or interfering with the LLEA response to the event, the licensee shall notify IEMA at (217)782-7860 or (800)782-7860. In no case shall the notification to IEMA be made later than one hour after the discovery of any attempted or actual theft, sabotage or diversion.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.1010 Personnel Access Authorization Requirements for Category 1 or Category 2 Quantities of Radioactive Material

a) General

1. Each licensee that possesses an aggregated quantity of radioactive material at or above the category 2 threshold shall establish, implement and maintain its access authorization program in accordance with the requirements of this Subpart.

2. An applicant for a new license and each licensee that would become newly subject to the requirements of this Subpart upon application for modification of its license shall implement the requirements of this Subpart, as appropriate, before taking possession of an aggregated category 1 or category 2 quantity of radioactive material.

3. Any licensee that has not previously implemented the Security Orders, legally binding requirements of the Agreement States or been subject to the provisions of this Subpart B shall implement the provisions of this Subpart B before aggregating radioactive material to a quantity that equals or exceeds the category 2 threshold.

AGENCY NOTE: Security orders refers to any order that was issued by the NRC or an amendment to a license issued by IEMA that required fingerprints and an FBI criminal history records check for access to safeguards information, safeguards information-modified handling, or risk significant material.

b) General Performance Objective

The licensee's access authorization program shall ensure that the individuals specified in subsection (c)(1) are trustworthy and reliable.

c) Applicability

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

A) Any individual whose assigned duties require unescorted access to category 1 or category 2 quantities of radioactive material or to any device that contains the radioactive material; and

B) Reviewing officials.

2. Licensees need not subject the categories of individuals listed in Section 337.1050(a) to the investigation elements of the access authorization program identified in Section 337.1030.

3. Licensees shall 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.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.1020 Access Authorization Program Requirements

a) Granting Unescorted Access Authorization

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

2. Individuals who have been determined to be trustworthy and reliable shall also complete the security training required by Section 337.2020(c) before being allowed unescorted access to category 1 or category 2 quantities of radioactive material.

b) Reviewing Officials

1. Reviewing officials are the only individuals who may make trustworthiness and reliability determinations that allow individuals to have unescorted access to category 1 or category 2 quantities of radioactive material possessed by the licensee.

2. Each licensee shall name one or more individuals to be reviewing officials. After completing the background investigation on the reviewing official, the licensee shall provide, under oath or affirmation, a certification that the reviewing official is deemed trustworthy and reliable by the licensee. The fingerprints of the named reviewing official shall be taken by a law enforcement agency, federal agency or state agency that provides fingerprinting services to the public or by commercial fingerprinting services authorized by a state to take fingerprints. The licensee shall recertify that the reviewing official is deemed trustworthy and reliable every 10 years in accordance with Section 337.1030(e).

3. Reviewing officials shall be permitted to have unescorted access to category 1 or category 2 quantities of radioactive material if their job duties require unescorted access to category 1 or category 2 quantities of radioactive material as referenced in Section 337.1010(c)(3).

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

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

A) The individual has previously 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

B) The individual falls within a category listed in Section 337.1050(a).

c) Informed Consent

1. Licensees may not initiate a background investigation without the informed and signed consent of the subject individual. This consent shall include authorization to share personal information with other individuals or organizations as necessary to complete the background investigation. Before a final adverse determination, the licensee shall provide the individual with an opportunity to correct any inaccurate or incomplete information that is developed during the background investigation. Licensees do not need to obtain signed consent from those individuals that meet the requirements of Section 337.1030(d). A signed consent shall be obtained prior to any reinvestigation.

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

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

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

d) Personal History Disclosure

Any individual who is applying for unescorted access authorization shall disclose the personal history information that is required by the licensee's access authorization program for the reviewing official to make a determination of the individual's trustworthiness and reliability. Refusal to provide, or the falsification of, any personal history information required by this Subpart is sufficient cause for denial or termination of unescorted access.

e) Determination Basis

1. The reviewing official shall determine whether to permit, deny, unfavorably terminate, maintain or administratively withdraw an individual's unescorted access authorization based on an evaluation of all of the information collected to meet the requirements of this Subpart.

2. The reviewing official may not permit any individual to have unescorted access until the reviewing official has evaluated all of the information collected to meet the requirements of this Subpart and determined that the individual is trustworthy and reliable. The reviewing official may deny unescorted access to any individual based on information obtained at any time during the background investigation.

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

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

5. Licensees shall maintain a list of persons currently approved for unescorted access authorization. When a licensee determines that a person no longer requires unescorted access or meets the access authorization requirement, the licensee shall remove the person from the approved list as soon as possible, but no later than 7 working days after the determination, and take prompt measures to ensure that the individual is unable to have unescorted access to the material.

f) Procedures. Licensees shall develop, implement and maintain written procedures for implementing the access authorization program. The procedures shall include provisions for:

1. The notification of individuals who are denied unescorted access;

2. The review, at the request of the affected individual, of a denial or termination of unescorted access authorization;

3. Ensuring that the individual is informed of the grounds for the denial or termination of unescorted access authorization; and

4. Allowing the individual an opportunity to provide additional relevant information.

g) Right to Correct and Complete Information

1. Prior to any final adverse determination, licensees shall provide each individual subject to this Subpart with the right to complete, correct and explain information obtained as a result of the background investigation. Confirmation of receipt by the individual of this notification shall be maintained by the licensee for a period of one year from the date of the notification.

2. If, after reviewing his or her criminal history record, an individual believes that it is incorrect or incomplete 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 submitting agency verify or correct the challenged entry. Upon receipt of an official communication directly from the submitting agency that contributed the original information, the FBI Identification Division should make any necessary changes in accordance with the information supplied by that submitting agency. Licensees shall provide at least 10 business days for an individual to initiate action to challenge the results of an FBI criminal history records check after the record is made available for his or her review. The licensee shall make a final adverse determination based upon the criminal history records only after receipt of the FBI's confirmation or correction of the record.

h) Records

1. The licensee shall retain documentation regarding the trustworthiness and reliability of individual employees for 3 years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material.

2. The licensee shall retain a copy of the current access authorization program procedures as a record for 3 years after the procedure is no longer needed. If any portion of the procedure is superseded, the licensee shall retain the superseded material for 3 years after the record is superseded.

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

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.1030 Background Investigations

a) 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 shall complete a background investigation of the individual seeking unescorted access authorization. The scope of the investigation shall encompass at least the 7 years preceding the date of the background investigation or since the individual's 18th birthday, whichever is shorter. The background investigation shall include, at a minimum:

1. Fingerprinting and an FBI identification and criminal history records check in accordance with Section 337.1040;

2. Verification of True Identity. Licensees shall verify the true identity of the individual who is applying for unescorted access authorization to ensure that the applicant is who he or she claims to be. A licensee shall review official identification documents (e.g., driver's license; passport; government identification and/or certificate of birth issued by the state, province or country of birth) and compare the documents to personal information provided by the individual to identify any discrepancy in the information. Licensees shall document the type, expiration and identification number of the identification document or maintain a photocopy of identifying documents on file in accordance with Section 337.1060. Licensees shall certify in writing that the identification was properly reviewed and shall maintain the certification and all related documents for review upon inspection;

3. Employment History Verification. Licensees shall complete an employment history verification, including military history. Licensees shall verify the individual's employment with each previous employer for the most recent 7 years before the date of application or since the individual's 18th birthday, whichever is shorter;

4. Verification of Education. Licensees shall verify that the individual participated in the education process during the claimed period; and

5. Character and Reputation Determination. Licensees shall complete reference checks to determine the character and reputation of the individual who has applied for unescorted access authorization. Unless other references are not available, reference checks may not be conducted with any person who is known to be a close member of the individual's family, including, but not limited to, the individual's spouse, parents, siblings or children or any individual who resides in the individual's permanent household. Reference checks under this Subpart shall be limited to whether the individual has been and continues to be trustworthy and reliable.

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

c) 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 (no less than 10 business days after the request) or if the licensee is unable to reach the entity, the licensee shall document the refusal, unwillingness or inability in the record of investigation and attempt to obtain the information from an alternate source.

d) Grandfathering

1. Individuals who were previously 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. These individuals shall be subject to the reinvestigation requirement.

2. Individuals who have been determined to be trustworthy and reliable under the provisions of a security order 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 shall document that the individual was determined to be trustworthy and reliable under the provisions of a security order. These individuals shall be subject to the reinvestigation requirement.

AGENCY NOTE: Security order, in this context, refers to any order that was issued by the NRC or an amendment to a license issued by IEMA that required fingerprints and an FBI criminal history records check for access to safeguards information, safeguards information – modified handling or risk significant material.

e) Reinvestigations

Licensees shall conduct a reinvestigation every 10 years for any individual with unescorted access to category 1 or category 2 quantities of radioactive material. The reinvestigation shall consist of fingerprinting and an FBI identification and criminal history records check in accordance with Section 337.1040. The reinvestigations shall be completed within 10 years after the date that these elements were last completed.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.1040 Requirements for Criminal History Records Checks of Individuals Granted Unescorted Access to Category 1 or Category 2 Quantities of Radioactive Material

a) General Performance Objective and Requirements

1. Except for those individuals listed in Section 337.1050 and those individuals grandfathered under Section 337.1030(d), each licensee subject to the provisions of this Subpart shall fingerprint each individual who is to be permitted unescorted access to category 1 or category 2 quantities of radioactive material. Licensees shall transmit all collected fingerprints to the NRC for transmission to the FBI. The licensee shall use the information received from the FBI as part of the required background investigation to determine whether to grant or deny further unescorted access to category 1 or category 2 quantities of radioactive material for that individual.

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

3. Fingerprinting is not required if:

A) A licensee is reinstating an individual's unescorted access authorization to category 1 or category 2 quantities of radioactive material;

B) The individual returns to the same facility that granted unescorted access authorization within 365 days after termination of the individual's unescorted access authorization; and

C) The previous unescorted access authorization was terminated under favorable conditions.

4. Fingerprints are not required 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 this Subpart, the Fingerprint Orders or 10 CFR 73. An existing criminal history records check file may be transferred, in accordance with Section 337.1060(c), to the licensee asked to grant unescorted access.

5. Licensees shall use the information obtained as part of a criminal history records check solely for the purpose of determining an individual's suitability for unescorted access authorization to category 1 or category 2 quantities of radioactive material.

b) Prohibitions

1. Licensees may not 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:

A) An arrest more than one year old in which there is no information of the disposition of the case; or

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

2. Licensees may not use information received from a criminal history records check obtained under this Subpart in a manner that would infringe upon the rights of any individual under the First Amendment to the Constitution of the United States nor shall licensees use the information in any way that would discriminate among individuals on the basis of race, religion, national origin, gender or age.

c) Procedures for Processing of Fingerprint Checks

1. For the purpose of complying with this Subpart, licensees shall 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 MD 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 emailing MAILSVS.Resource@nrc.gov. Guidance on submitting electronic fingerprints can be found at https://www.nrc.gov/security/chp.html.

2. Fees for the processing of fingerprint checks are due upon application. Licensees shall submit payment with the application for the processing of fingerprints through corporate check, certified check, cashier's check, money order or electronic payment made payable to "U.S. NRC". Combined payment for multiple applications is acceptable. The amount of the fingerprint check application fee is available on NRC's website. To find the current fee amount, go to the Electronic Submittals page at http://www.nrc.gov/site-help/e-submittals.html and see the link for the Criminal History Program under Electronic Submission Systems.

AGENCY NOTE: For guidance on making electronic payments, contact the Security Branch, Division of Facilities and Security at (301) 415-1491.

3. NRC will forward to the submitting licensee all data received from the FBI as a result of the licensee's applications for criminal history records checks.

History

• Source: Amended at 48 Ill. Reg. 13701, effective August 29, 2024

32 Ill. Adm. Code 337.1050 Relief from Fingerprinting, Identification, Criminal History Records Checks and Other Elements of Background Investigations for Designated Categories of Individuals Permitted Unescorted Access to Certain Radioactive Material

a) 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 material:

1. 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;

2. A member of Congress;

3. An employee of a member of Congress or Congressional committee who has undergone fingerprinting for a prior U.S. government criminal history records check;

4. The Governor of Illinois or his or her designated State employee representative;

5. Federal, State of Illinois or local law enforcement personnel;

6. The IEMA Director and State Homeland Security Advisor or their designated State employee representatives;

7. IEMA employees conducting security inspections on behalf of the NRC under an agreement executed under section 274.i of the Atomic Energy Act of 1954;

8. Representatives of the International Atomic Energy Agency (IAEA) engaged in activities associated with the U.S./IAEA Safeguards Agreement who have been certified by the NRC;

9. Emergency response personnel who are responding to an emergency;

10. Commercial vehicle drivers for road shipments of category 1 and category 2 quantities of radioactive material;

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

12. Any individual who has an active federal security clearance, provided that he or she makes available the appropriate documentation. Written confirmation from the agency/employer that granted the federal security clearance or reviewed the criminal history records check shall be provided to the licensee. The licensee shall retain this documentation for a period of 3 years from the date the individual no longer requires unescorted access authorization to category 1 or category 2 quantities of radioactive material; and

13. Any individual employed by a service provider licensee that 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 shall be provided to the licensee. The licensee shall retain the documentation for a period of 3 years from the date the individual no longer requires unescorted access authorization to category 1 or category 2 quantities of radioactive material.

b) Fingerprinting and the identification and criminal history records checks required by Section 149 of the Atomic Energy Act of 1954, as amended, are not required for an individual who has had a favorably adjudicated U.S. Government criminal history records check within the last 5 years under a comparable U.S. Government program involving fingerprinting and an FBI identification and criminal history records check provided that he or she makes available the appropriate documentation. Written confirmation from the agency/employer that reviewed the criminal history records check shall be provided to the licensee. The licensee shall retain this documentation for a period of 3 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:

1. National Agency Check;

2. Transportation Worker Identification Credentials (TWIC) under 49 CFR 1572;

3. Bureau of Alcohol, Tobacco, Firearms and Explosives background check and clearances under 27 CFR 555;

4. Health and Human Services security risk assessments for possession and use of select agents and toxins under 42 CFR 73;

5. Hazardous material security threat assessment for hazardous material endorsement to commercial driver's license under 49 CFR 1572; and

6. Customs and Border Protection's Free and Secure Trade (FAST) Program.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.1060 Protection of Information

a) Each licensee who obtains background information on an individual under this Subpart shall establish and maintain a system of files and written procedures for protection of the record and the personal information from unauthorized disclosure.

b) The licensee shall not disclose the record or personal information collected and maintained to persons other than the subject individual, his or her representative, or 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. No individual authorized to have access to the information shall disseminate the information to any other individual who does not have a need to know.

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

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

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

d) The licensee shall make background investigation records obtained under this Subpart available for examination by an authorized representative of IEMA to determine compliance with the law.

e) The licensee shall retain all fingerprint and criminal history records received from the FBI, including data indicating no record, or a copy of these records if the individual's file has been transferred. The records shall be retained for 3 years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.1070 Access Authorization Program Review

a) Each licensee shall be responsible for the continuing effectiveness of the access authorization program. Each licensee shall ensure that access authorization programs are reviewed to confirm compliance with the requirements of this Subpart and that comprehensive actions are taken to correct any noncompliance that is identified. The review program shall evaluate all program performance objectives and requirements. Each licensee shall periodically, not to exceed 12 months, review the access program content and implementation.

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

c) Review records shall be maintained for 3 years.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.2010 Security Program

a) Applicability

1. Each licensee that possesses an aggregated category 1 or category 2 quantity of radioactive material shall establish, implement and maintain a security program in accordance with the requirements of this Subpart.

2. An applicant for a new license and each licensee that would become newly subject to the requirements of this Subpart upon application for modification of its license shall implement the requirements of this Subpart, as appropriate, before taking possession of an aggregated category 1 or category 2 quantity of radioactive material.

3. Any licensee that has not previously implemented the security requirements or been subject to the provisions of Subpart C shall provide written notification to IEMA at the address specified in 32 Ill. Adm. Code 310.110 at least 90 days before aggregating radioactive material to a quantity that equals or exceeds the category 2 threshold.

b) General Performance Objective

Each licensee shall establish, implement and maintain a security program that is designed to monitor and, without delay, detect, assess and respond to an actual or attempted unauthorized access to category 1 or category 2 quantities of radioactive material.

c) Program Features

Each licensee's security program shall include the program features, as appropriate, described in Sections 337.2020 through 337.2080.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.2020 General Security Program Requirements

a) Security Plan

1. Each licensee identified in Section 337.2010(a) shall develop a written security plan specific to its facilities and operations. The purpose of the security plan is to establish the licensee's overall security strategy to ensure the integrated and effective functioning of the security program required by this Subpart. The security plan shall, at a minimum:

A) Describe the measures and strategies used to implement the requirements of this Subpart; and

B) Identify the security resources, equipment and technology used to satisfy the requirements of this Subpart.

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

3. A licensee shall revise its security plan as necessary to ensure the effective implementation of this Part. The licensee shall ensure that:

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

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

4. The licensee shall retain a copy of the current security plan as a record for 3 years after the security plan is no longer required. If any portion of the plan is superseded, the licensee shall retain the superseded portion for 3 years after the record is superseded.

b) Implementing Procedures

1. The licensee shall develop and maintain written procedures that document how the requirements of this Subpart and the security plan will be met.

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

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

c) Training

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

A) The licensee's security program and procedures to secure category 1 or category 2 quantities of radioactive material and the purposes and functions of the security measures employed;

B) The responsibility to promptly report to the licensee any condition that causes or may cause a violation of this Part;

C) The responsibility of the licensee to promptly report to the LLEA and licensee any actual or attempted theft, sabotage or diversion of category 1 or category 2 quantities of radioactive material; and

D) The appropriate response to security alarms.

2. In determining those individuals who shall be trained on the security program, the licensee shall consider each individual's assigned activities during authorized use and response to potential situations involving actual or attempted theft, diversion or sabotage of category 1 or category 2 quantities of radioactive material. The extent of the training shall be commensurate with the individual's potential involvement in the security of category 1 or category 2 quantities of radioactive material.

3. Refresher training shall be provided at a frequency not to exceed 12 months and when significant changes have been made to the security program. This training shall include:

A) Review of the training requirements of subsection (c) and any changes made to the security program since the last training;

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

C) Relevant results of IEMA inspections; and

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

4. The licensee shall maintain records of the initial and refresher training for 3 years from the date of the training. The training records shall include dates of the training, topics covered, a list of licensee personnel in attendance and related information.

d) Protection of Information

1. Licensees authorized to possess category 1 or category 2 quantities of radioactive material shall limit access to and unauthorized disclosure of their security plan, implementing procedures and the list of individuals that have been approved for unescorted access.

2. Efforts to limit access shall include the development, implementation and maintenance of written policies and procedures for controlling access to, and for proper handling and protection against unauthorized disclosure of, the security plan and implementing procedures.

3. Before granting an individual access to the security plan or implementing procedures, licensees shall:

A) Evaluate an individual's need to know the security plan or implementing procedures; and

B) 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 shall complete a background investigation to determine the individual's trustworthiness and reliability. A trustworthiness and reliability determination shall be conducted by the reviewing official and shall include the background investigation elements contained in Section 337.1030(a)(2) through (a)(5), (b) and (c).

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

A) The categories of individuals listed in Section 337.1050(a); or

B) Security service provider employees, if written verification that the employee has been determined to be trustworthy and reliable, by the required background investigation in Section 337.1030(a)(2) through (a)(5), (b) and (c) has been provided by the security service provider.

5. The licensee shall document the basis for concluding that an individual is trustworthy and reliable and should be granted access to the security plan or implementing procedures.

6. Licensees shall maintain a list of persons currently approved for access to the security plan or implementing procedures. When a licensee determines that a person no longer needs access to the security plan or implementing procedures, or no longer meets the access authorization requirements for access to the information, the licensee shall remove the person from the approved list as soon as possible, but no later than 7 business days, and take prompt measures to ensure that the individual is unable to obtain the security plan or implementing procedures.

7. When not in use, the licensee shall store its security plan and implementing procedures in a manner designed to prevent unauthorized access. Information stored in nonremovable electronic form shall be password protected.

8. The licensee shall retain as a record for 3 years after the document is no longer needed:

A) A copy of the information protection procedures; and

B) The list of individuals approved for access to the security plan or implementing procedures.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.2030 Llea Coordination

a) A licensee subject to this Subpart shall coordinate, to the extent practicable, with an LLEA for responding to threats to the licensee's facility, including any necessary armed response. The information provided to the LLEA shall include:

1. A description of the facilities and the category 1 and category 2 quantities of radioactive material, along with a description of the licensee's security measures that have been implemented to comply with this Subpart; and

2. A notification that the licensee will request a timely armed response by the LLEA to any actual or attempted theft, sabotage or diversion of category 1 or category 2 quantities of radioactive material.

b) The licensee shall notify IEMA within 3 business days if:

1. The LLEA has not responded to the request for coordination within 60 days of the coordination request; or

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

c) The licensee shall document its efforts to coordinate with the LLEA. The documentation shall be kept for 3 years.

d) The licensee shall 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.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.2040 Security Zones

a) Licensees shall 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.

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

c) Security zones shall, at a minimum, allow unescorted access only to approved individuals through:

1. Isolation of category 1 and category 2 quantities of radioactive material 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;

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

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

d) For category 1 quantities of radioactive material during periods of maintenance, source receipt, preparation for shipment, installation or source removal or exchange, the licensee shall, at a minimum, provide sufficient individuals approved for unescorted access to maintain continuous surveillance of sources in temporary security zones and in any security zone where physical barriers or intrusion detection systems have been disabled to allow those activities.

e) Individuals not approved for unescorted access to category 1 or category 2 quantities of radioactive material shall be escorted by an approved individual when in a security zone.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.2050 Monitoring, Detection and Assessment

a) Monitoring and Detection

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

2. Monitoring and detection shall be performed by:

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

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

C) A monitored video surveillance system;

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

E) Direct visual surveillance by a licensee-designated individual located outside the security zone.

3. A licensee subject to this Subpart shall also have a means to detect unauthorized removal of the radioactive material from the security zone. This detection capability shall provide:

A) For category 1 quantities of radioactive material, immediate detection of any attempted unauthorized removal of the radioactive material from the security zone. Immediate detection capability shall be provided by:

i) Electronic sensors linked to an alarm;

ii) Continuous monitored video surveillance; or

iii) Direct visual surveillance.

B) 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.

b) Assessment

Licensees shall immediately assess each actual or attempted unauthorized entry into the security zone to determine whether the unauthorized access was an actual or attempted theft, sabotage or diversion.

c) Personnel Communications and Data Transmission

For personnel and automated or electronic systems supporting the licensee's monitoring, detection and assessment systems, licensees shall:

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

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

d) Response

Licensees shall immediately respond to any actual or attempted unauthorized access to the security zones or actual or attempted theft, sabotage or diversion of category 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 shall include requesting, without delay, an armed response from the LLEA.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.2060 Maintenance and Testing

a) Each licensee subject to this Subpart shall implement a maintenance and testing program to ensure that intrusion alarms, associated communication systems and other physical components of the systems used to secure or detect unauthorized access to radioactive material are maintained in operable condition and are capable of performing their intended function when needed. The equipment relied on to meet the security requirements shall be inspected and tested for operability and performance at the manufacturer's suggested frequency. If there is no manufacturer's suggested frequency, the testing shall be performed at least annually, not to exceed 12 months.

b) The licensee shall maintain records on the maintenance and testing activities for 3 years.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.2070 Requirements for Mobile Devices

Each licensee that possesses mobile devices containing category 1 or category 2 quantities of radioactive material shall:

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

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

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.2080 Security Program Review

a) Each licensee shall be responsible for the continuing effectiveness of the security program. Each licensee shall ensure that the security program is reviewed to confirm compliance with the requirements of this Subpart and that comprehensive actions are taken to correct any noncompliance that is identified. The review shall include the radioactive material security program content and implementation. Each licensee shall periodically, not to exceed 12 months, review the security program content and implementation.

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

c) The licensee shall maintain the review documentation for 3 years.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.2090 Reporting of Events

a) The licensee shall immediately notify the LLEA after determining that an unauthorized entry resulted in an actual or attempted theft, sabotage or diversion of a category 1 or category 2 quantity of radioactive material. Immediately after initiating a response, but not at the expense of causing delay or interfering with the LLEA response to the event, the licensee shall notify IEMA at (217)782-7860 or (800)782-7860. In no case shall the notification to IEMA be later than one hour after the discovery of any attempted or actual theft, sabotage or diversion.

b) The licensee shall assess any suspicious activity related to possible theft, sabotage or diversion of a category 1 or category 2 quantity of radioactive material and notify the LLEA as appropriate. As soon as possible, but not later than one hour after notifying the LLEA, the licensee shall notify IEMA at (217)782-7860 or (800)782-7860.

c) Written Reports. A licensee required to make a notification pursuant to subsection (a) or (b) shall, within 30 days after making the notification, submit a written report to IEMA regarding the suspicious activity or the actual or attempted theft, sabotage or diversion. The written report shall include sufficient information for IEMA analysis and evaluation, including:

1. A description of the source of radiation involved, including the kind, quantity and chemical and physical form;

2. A description of the circumstances under which the actual or attempted theft, sabotage or diversion of a category 1 or category 2 quantity of radioactive material occurred;

3. A statement of disposition, or probable disposition, of the source of radiation involved;

4. Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas;

5. Actions that have been taken, or will be taken, to recover the source of radiation; and

6. Corrective actions taken, or that will be taken, to protect against a recurrence of a theft, sabotage or diversion of a category 1 or category 2 quantity of radioactive material.

d) Subsequent to filing the written report, the licensee shall also report any additional substantive information on the actual or attempted theft, sabotage or diversion of a category 1 or category 2 quantity of radioactive material within 30 days after the licensee learns of that information.

e) The licensee shall prepare any report filed with IEMA pursuant to this Section so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the written report.

AGENCY NOTE: Notification under this Part satisfies the requirements of 32 Ill. Adm. Code 340.1205 and 340.1210 for category 1 and category 2 quantities of radioactive material. Licensees should be aware that there are additional reporting requirements in 32 Ill. Adm. Code 340.1220 for other events involving radioactive material.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.3010 Additional Requirements for Transfer of Category 1 and Category 2 Quantities of Radioactive Material

A licensee transferring category 1 or category 2 quantities of radioactive material to a licensee of the NRC or another Agreement State shall meet the license verification provisions listed in this Section instead of those listed in 32 Ill. Adm. Code 330.400.

a) Any licensee transferring category 1 quantities of radioactive material to a licensee of the NRC or an Agreement State, prior to conducting that transfer, shall verify with 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 shall document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.

b) Any licensee transferring category 2 quantities of radioactive material to a licensee of the NRC or an Agreement State, prior to conducting that transfer, shall verify with 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 shall document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.

c) In an emergency in which 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 shall include the license number, current revision number, issuing authority, expiration date and, for category 1 shipments, the authorized address. The licensee shall keep a copy of the certification. The certification shall 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.

d) The transferor shall keep a copy of the verification documentation as a record for 3 years.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.3020 Applicability of Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material During Transit

a) For shipments of category 1 quantities of radioactive material, each shipping licensee shall comply with the requirements for physical protection contained in Sections 337.3030(a) and (e), 337.3040, 337.3050(a)(1), (b)(1) and (c) and 337.3060(a), (c), (e), (g) and (h).

b) For shipments of category 2 quantities of radioactive material, each shipping licensee shall comply with the requirements for physical protection contained in Sections 337.3030(b) through (e), 337.3050(a)(2), (a)(3), (b)(2) and (c), and 337.3060(b), (d), (f), (g) and (h). For those shipments of category 2 quantities of radioactive material that meet the criteria of 10 CFR 71.97(b), the shipping licensee shall also comply with the advance notification provisions of 10 CFR 71.97.

c) The shipping licensee shall be responsible for meeting the requirements of this Subpart unless the receiving licensee has agreed in writing to arrange for the in-transit physical protection required under this Subpart.

d) Each licensee that imports or exports category 1 quantities of radioactive material shall comply with the requirements for physical protection during transit contained in Sections 337.3030(a)(2) and (e), 337.3040, 337.3050(a)(1), (b)(1) and (c), and 337.3060(a), (c), (e), (g) and (h) for the domestic portion of the shipment.

e) Each licensee that imports or exports category 2 quantities of radioactive material shall comply with the requirements for physical protection during transit contained in Sections 337.3050(a)(2), (a)(3) and (b)(2) and 337.3060(b), (d), (f), (g) and (h) for the domestic portion of the shipment.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.3030 Preplanning and Coordination of Shipment of Category 1 or Category 2 Quantities of Radioactive Material

a) 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 shall:

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

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

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

B) Identify safe havens; and

3. Document the preplanning and coordination activities.

b) Each licensee that plans to transport, or deliver to a carrier for transport, licensed material that is a category 2 quantity of radioactive material outside the confines of the licensee's facility or other place of use or storage shall coordinate the shipment no-later-than arrival time and the expected shipment arrival with the receiving licensee. The licensee shall document the coordination activities.

c) Each licensee who receives a shipment of a category 2 quantity of radioactive material shall confirm receipt of the shipment with the originator. If the shipment has not arrived by the no-later-than arrival time, the receiving licensee shall notify the originator.

d) Each licensee who transports or plans to transport a shipment of a category 2 quantity of radioactive material and determines that the shipment will arrive after the no-later-than arrival time provided pursuant to subsection (b), shall promptly notify the receiving licensee of the new no-later-than arrival time.

e) The licensee shall retain a copy of the documentation for preplanning and coordination, and any revision thereof, as a record for 3 years.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.3040 Advance Notification of Shipment of Category 1 Quantities of Radioactive Material

As specified in subsections (a) and (b), each licensee shall provide advance notification to IEMA 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.

a) Procedures for Submitting Advance Notification

1. The notification shall be made to IEMA and to the office of each appropriate governor or governor's designee.

A) Notifications for the Governor of the State of Illinois and IEMA shall be sent to Illinois Emergency Management Agency, ATTN: Radiological Field Services Unit Supervisor, Bureau of Radiation Safety, 1301 Knotts Street, Springfield IL 62703. The notifications may also be made by email or by facsimile. For the correct email or facsimile number, call, prior to sending notification, (217)782-7860 or (800)782-7860.

B) The contact information, including telephone and mailing addresses, of governors and governors' designees, is available on NRC's website at https://scp.nrc.gov/special/designee.pdf. A list of the contact information is also available upon request from the Director, Division of Material Safety, State, Tribal, and Rulemaking Programs, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

2. A notification delivered by mail shall be postmarked at least 7 calendar days before transport of the shipment commences at the shipping facility.

3. A notification delivered by any means other than mail must reach IEMA at least 4 business days before the transport of the shipment commences and must reach the office of a governor or the governor's designee at least 4 business days before transport of a shipment within or through a state.

b) Information to be Furnished in Advance Notification of Shipment

Each advance notification of shipment of category 1 quantities of radioactive material shall contain the following information, if available at the time of notification:

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

2. The license numbers of the shipper and receiver;

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

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

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

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

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

c) Revision Notice

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

2. A licensee shall promptly notify the governor of each state, or the governor's designee, of any changes to the information provided in accordance with subsections (b) and (c)(1). The licensee shall also immediately notify IEMA of the changes.

d) Cancellation Notice

Each licensee that cancels a shipment for which advance notification has been sent shall send a cancellation notice to the governor of each state, or to the governor's designee, previously notified and to IEMA. The licensee shall send the cancellation notice before the shipment would have commenced or as soon thereafter as possible. The licensee shall state in the notice that it is a cancellation and identify the advance notification that is being cancelled.

e) Records

The licensee shall retain a copy of the advance notification and any revision and cancellation notices as a record for 3 years.

f) Protection of Information

State officials, State employees and any other individuals, whether or not licensees of NRC or an Agreement State, who receive schedule information of the kind specified in subsection (b) shall protect that information against unauthorized disclosure as specified in Section 337.2020(d).

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.3050 Requirements for Physical Protection of Category 1 and Category 2

Quantities of Radioactive Material During Shipment

a) Shipments by Road

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

A) Ensure that movement control centers are established that maintain position information from a remote location. These control centers shall monitor shipments 24 hours a day, 7 days a week, and have the ability to communicate immediately, in an emergency, with the appropriate law enforcement agencies.

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

C) Ensure that shipments are continuously and actively monitored by a telemetric position monitoring system or an alternative tracking system reporting to a movement control center. A movement control center shall provide positive confirmation of the location, status and control over the shipment. The movement control center shall 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 shall include, but are not limited to, the identification of and contact information for the appropriate LLEA along the shipment route.

D) Provide an individual to accompany the driver for those highway shipments with a driving time period greater than the maximum number of allowable hours of service in a 24-hour duty day as established by the U.S. Department of Transportation's Federal Motor Carrier Safety Administration. The accompanying individual may be another driver.

E) Develop written normal and contingency procedures to address:

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

ii) Communication Protocols

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

iii) Loss of communications; and

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

F) Each licensee who makes arrangements for the shipment of category 1 quantities of radioactive material shall ensure that drivers, accompanying personnel and movement control center personnel have access to the normal and contingency procedures.

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

3. Each licensee who delivers to a carrier for transport, in a single shipment, a category 2 quantity of radioactive material shall:

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

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

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

b) Shipments by Rail

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

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

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

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

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

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

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

c) Investigations

Each licensee who makes arrangements for the shipment of category 1 quantities of radioactive material shall immediately conduct an investigation upon the discovery that category 1 shipment is lost or missing. Each licensee who makes arrangements for the shipment of category 2 quantities of radioactive material shall immediately conduct an investigation, in coordination with the receiving licensee, of any shipment that has not arrived by the designated no-later-than arrival time.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.3060 Reporting of Events

a) The shipping licensee shall notify the appropriate LLEA and IEMA's 24-hour emergency number at (217)782-7860 or (800)782-7860 within one hour after 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 Section 337.3050(c), the shipping licensee will provide agreed upon updates on the status of the investigation to the IEMA 24-hour emergency number.

b) The shipping licensee shall notify IEMA's 24-hour emergency number (217)782-7860 or (800)782-7860 within 4 hours after its determination that a shipment of category 2 quantities of radioactive material is lost or missing. If, 24 hours after its determination that the shipment is lost or missing, the radioactive material has not been located and secured, the licensee shall immediately notify IEMA's 24-hour emergency number.

c) The shipping licensee shall notify the designated LLEA along the shipment route, as soon as possible after 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 category 1 quantities of radioactive material. As soon as possible after notifying the LLEA, the licensee shall notify IEMA's 24-hour emergency number at (217)782-7860 or (800)782-7860 upon discovery of any actual or attempted theft or diversion of a shipment, or any suspicious activity related to the shipment, of category 1 quantities of radioactive material.

d) The shipping licensee shall notify IEMA's 24-hour emergency number at (217)782-7860 or (800)782-7860 as soon as possible after 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.

e) The shipping licensee shall notify the LLEA and IEMA's 24-hour emergency number as soon as possible after recovery of any lost or missing category 1 quantities of radioactive material.

f) The shipping licensee shall notify IEMA's 24-hour emergency number as soon as possible after recovery of any lost or missing category 2 quantities of radioactive material.

g) Written Reports

Each licensee required to make a notification pursuant to subsections (a) through (d) shall, within 30 days after making that notification, submit a written report to IEMA for incidents involving an actual or attempted theft, loss or diversion of radioactive material. A written report is not required for notifications on suspicious activities reported pursuant to subsections (c) and (d). The written report shall include:

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

2. A description of the circumstances under which the actual or attempted loss, theft or diversion occurred;

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

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

5. Corrective actions taken, or will be taken, to ensure against a recurrence of a loss, theft or diversion of licensed material.

h) Subsequent to filing the written report, the licensee shall also report any additional substantive information on the actual or attempted loss, theft or diversion within 30 days after the licensee learns of the information.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.5010 Form of Records

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

32 Ill. Adm. Code 337.5020 Record Retention

Licensees shall maintain the records that are required in this Part for the period specified by the appropriate section. If a retention period is not otherwise specified, these records shall be retained until IEMA terminates the facility's license pursuant to 32 Ill. Adm. Code 330.325. IEMA may, in writing, approve or require a shorter or longer retention period, depending on whether the records are needed to determine compliance.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.6010 Resolution of Requirements During Transition Period

If this Part conflicts with the licensee's radiation safety program as identified in its license or legally binding orders, this Part shall apply, unless the statements, representations, conditions and procedures in the license are more restrictive. However, if that licensee exercises its privilege to amend its license, the portion amended must comply with this Part.

History

• Source: Amended at 42 Ill. Reg. 42 Ill. Reg. 7485, effective April 4, 2018

32 Ill. Adm. Code 337.APPENDIX A Category 1 and Category 2 Radioactive Material

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.

Category 1

Category 1

Category 2

Category 2

Radioactive material

(TBq)

(Ci)

(TBq)

(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.

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 shall 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 apply.

II. First determine the total activity for each radionuclide from Table 1. 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 in the numerator of the equation and the corresponding threshold activity from Table 1 in the denominator of the equation. Calculations shall be performed in metric values (i.e., TBq) and the numerator and denominator values shall be in the same units.

where:

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

• Source: Amended at 48 Ill. Reg. 13701, effective August 29, 2024

Part 340 Standards for Protection Against Radiation

32 Ill. Adm. Code 340.10 Purpose

a) This Part establishes standards for protection against ionizing radiation resulting from activities conducted pursuant to licenses or registrations issued by the Illinois Emergency Management Agency (Agency). This Part is issued pursuant to the Radiation Protection Act of 1990 [420 ILCS 40].

b) The requirements of this Part are designed to control the receipt, possession, use, transfer, and disposal of sources of radiation by any licensee or registrant so that 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 this Part. However, nothing in this Part shall be construed as limiting actions that may be necessary to protect health and safety in an emergency.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.20 Scope

Except as specifically provided in other regulations of the Agency, this Part applies to persons licensed or registered by the Agency to receive, possess, use, transfer or dispose of sources of radiation pursuant to 32 Ill. Adm. Code: Chapter II, Subchapters b and d. The limits in this Part 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 under 32 Ill. Adm. Code 335 or to voluntary participation in medical research programs.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.25 Incorporations by Reference

All rules, standards and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified in the reference and do not include any later amendments or editions. Copies of rules, standards and guidelines that have been incorporated by reference are available for public inspection and copying at the Agency, 1035 Outer Park Drive, Springfield, Illinois.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.30 Definitions

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

"Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 Sv (5 rem) or a committed dose equivalent of 0.5 Sv (50 rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in table 1, columns 1 and 2 of appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007, exclusive of subsequent amendments or editions.

"Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly trained and fitted users.

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

"Chelating agent" means amine polycarboxylic acids (e.g., EDTA, DTPA), hydroxy-carboxylic acids, and polycarboxylic acids (e.g., citric acid, carbolic acid, and glucinic acid).

"Class" (lung class or inhalation class) means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W or Y, which applies to a range of clearance half-times: for Class D (Days) of less than 10 days, for Class W (Weeks) from 10 to 100 days, and for Class Y (Years) of greater than 100 days.

"Collector" means a licensee 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 land disposal facility.

"Consignee" means the designated receiver of a shipment of low-level radioactive waste.

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

"Demand respirator" means 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.

"Derived air concentration" or "DAC" means the concentration of a given radionuclide in air, which, if breathed by the reference man for a working year of 2,000 hours under conditions of light work would result in an intake of one ALI. For purposes of this definition, the condition of light work is an inhalation rate of 1.2 cubic meters of air per hour for 2,000 hours in a year. DAC values are given in table 1, column 3 of appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007, exclusive of subsequent amendments or editions.

"Derived air concentration-hour" or "DAC-hour" means 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 (expressed in hours). A licensee may take 2,000 DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (5 rem).

"Disposal container" means a container principally used to confine low-level radioactive waste during disposal operations at a land disposal facility (also see "high integrity container"). Note that, for some shipments, the disposal container may be the transport package.

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

"EPA identification number" means the number received by a transporter following application to the Administrator of USEPA as required by 40 CFR 263.

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

"Fit factor" means a 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.

"Fit Test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

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

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

"Inhalation class" (see "class").

"Land disposal facility" means the land, buildings, structures and equipment which are intended to be used for the disposal of radioactive wastes.

"Lens dose equivalent" or "LDE" applies to the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).

"Loose-fitting face piece" means a respiratory inlet covering designed to form a partial seal with the face.

"Lung class" (see "class").

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

"Nonstochastic effect" (deterministic effect) means 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 an example of a nonstochastic effect.

"Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or to radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or another 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 under 32 Ill. Adm. Code 335, from voluntary participation in medical research programs or as a member of the public.

"Physical description" means the items called for on NRC Form 541 to describe a low-level radioactive waste.

"Planned special exposure" means an infrequent exposure to radiation, the dose from which is separate from and in addition to the annual occupational dose limits.

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

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

"Pressure demand respirator" means a positive pressure atmosphere-supplying respirator that admits breathing air to the face piece when the positive pressure is reduced inside the face piece by inhalation.

"Public dose" means the dose received by a member of the public from exposure to radiation or to radioactive material released by a licensee or to any other source of radiation under the control of a licensee. 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 under 32 Ill. Adm. Code 335, or from voluntary participation in medical research programs.

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

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

"Reference Man" means a 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.

AGENCY NOTE: 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."

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

"Sanitary sewerage" means 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.

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

"Shipping paper" means NRC Form 540 and, if required, NRC Form 540A, which includes the information required by DOT in 49 CFR 172, revised October 1, 2008, exclusive of subsequent amendments or editions.

"Stochastic effect" (probabilistic effect) means 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 examples of stochastic effects.

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

"Tight-fitting face piece" means a respiratory inlet covering that forms a complete seal with the face.

"Uniform Low-Level Radioactive Waste Manifest" or "uniform manifest" means the combination of NRC Forms 540, 541 and, if necessary, 542, and their respective continuation sheets as needed, or equivalent.

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

"Waste description" means the physical, chemical and radiological description of a low-level radioactive waste as called for on NRC Form 541.

"Waste processor" means an entity, operating under an Agency, 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 land disposal facility.

"Waste type" means a waste within a disposal container having a unique physical description (i.e., a specific waste descriptor code or description or a waste sorbed on or solidified in a specifically defined media).

"Weighting factor" (wT), means the proportion of the risk of stochastic effects resulting from irradiation of an organ or tissue (T) 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 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

a0.30 results from 0.06 for each of 5 "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

bFor 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.

History

• Source: Amended at 35 Ill. Reg. 934, effective December 30, 2010

32 Ill. Adm. Code 340.40 Implementation

Any existing license condition that is more restrictive than this Part remains in force until there is an amendment or renewal of the license.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

32 Ill. Adm. Code 340.110 Radiation Protection Programs

a) Each licensee or registrant shall develop, document, and implement a radiation protection program that ensures compliance with the provisions of this Part. (See Section 340.1120 for recordkeeping requirements relating to these programs.)

b) The licensee or registrant shall use, to the extent practicable, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and public doses that are as low as is reasonably achievable (ALARA).

c) The licensee shall review, at least annually, the radiation protection program content and implementation.

d) To implement the ALARA requirements of Section 340.110(b) and notwithstanding the requirements in Section 340.310, a constraint on air emissions of radioactive materials to the environment, excluding radon-222 and its daughters, shall be established by licensees so that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent (TEDE) 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 shall report the excess as provided in Section 340.1230 and promptly take appropriate corrective action to ensure against recurrence.

e) The registrant shall review, at intervals not to exceed 1 inspection cycle as specified in 32 Ill. Adm. Code 320, the radiation protection program content and implementation.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

32 Ill. Adm. Code 340.210 Occupational Dose Limits for Adults

a) The licensee or registrant shall control the occupational dose to individual adults, except for planned special exposures pursuant to Section 340.260, to the following dose limits:

1. An annual limit, which is the more limiting of:

A) The total effective dose equivalent being equal to 0.05 Sv (5 rem); or

B) The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 Sv (50 rem).

2. The annual limits to the lens of the eye, to the skin and to the extremities which are:

A) A lens dose equivalent of 0.15 Sv (15 rem); and

B) A shallow dose equivalent of 0.5 Sv (50 rem) to the skin or to any extremity.

b) Doses received in excess of the annual limits, including doses received during accidents, emergencies and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime (see Section 340.260(e)).

c) When the external exposure is determined by measurement with an external personal monitoring device, the deep dose equivalent shall be used in place of the effective dose equivalent unless the effective dose equivalent is determined by a dosimetry method approved by the Agency. The assigned deep dose equivalent shall be for the portion of the body receiving the highest exposure. The assigned shallow dose equivalent shall be the dose averaged over the contiguous 10 square centimeters of skin receiving the highest dose.

AGENCY NOTE: The deep dose equivalent, lens dose equivalent or 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.

d) 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.

e) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in table 1 of appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007, exclusive of subsequent amendments or editions, and may be used to determine the individual's dose (see Section 340.1160) and to demonstrate compliance with the occupational dose limits.

f) Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to 10 milligrams in a week in consideration of chemical toxicity (see footnote 3 of appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007, exclusive of subsequent amendments or editions.)

g) The licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person during the current year (see Section 340.250(a) and (d)).

AGENCY NOTE: The purpose of this requirement is to ensure that no individual receives an annual occupational dose in excess of the occupational dose limits set forth in this Section.

History

• Source: Amended at 35 Ill. Reg. 934, effective December 30, 2010

32 Ill. Adm. Code 340.220 Compliance with Requirements for Summation of External and Internal Doses

a) General Requirement. If the licensee is required to monitor individual occupational dose pursuant to both Section 340.520(a) and (b) of this Part, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee or registrant is required to monitor individual occupational dose only pursuant to Section 340.520(a) of this Part or only pursuant to Section 340.520(b) of this Part, 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 pursuant to subsections (b), (c) and (d) of this Section. 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.

b) 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:

1. The sum of the fractions of the inhalation ALI for each radionuclide; or

2. The total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000; or

3. The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using 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 factor (wT) and the committed dose equivalent, HT,50, per unit intake is greater than ten percent of the maximum weighted value of HT,50 (i.e., wTHT,50) per unit intake for any organ or tissue.

c) Intake by Oral Ingestion. If the occupationally exposed individual receives an intake of radionuclides by oral ingestion greater than ten percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits.

d) Intake Through Wounds or Absorption Through Skin. The licensee shall evaluate and, to the extent practicable, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated or accounted for pursuant to this subsection.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.230 Determination of External Dose from Airborne Radioactive Material

a) Licensees shall, 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 footnotes 1 and 2 of appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007, exclusive of subsequent amendments or editions).

b) Airborne radioactivity measurements and DAC values shall 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 shall be based upon measurements using instruments or individual monitoring devices.

History

• Source: Amended at 35 Ill. Reg. 934, effective December 30, 2010

32 Ill. Adm. Code 340.240 Determination of Internal Exposure

a) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required pursuant to Section 340.520, take measurements of:

1. Concentrations of radioactive materials in air in work areas during conditions of operations; or

2. Quantities of radionuclides in the body after exposure to materials that could result in an intake; or

3. Quantities of radionuclides excreted from the body after exposure to materials that could result in an intake; or

4. Combinations of these measurements.

b) Unless respiratory protective equipment is used, as provided in Section 340.730, or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

c) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may:

1. Use that information to calculate the committed effective dose equivalent, and if used, the licensee shall document that information in the individual's record; and

2. Upon prior approval of the Agency, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material (e.g., aerosol size distribution or density); and

3. Separately assess the contribution of fractional intakes of Class D, W or Y compounds of a given radionuclide (see appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007, exclusive of subsequent amendments or editions) to the committed effective dose equivalent.

d) If the licensee chooses to assess intakes of Class Y material using the measurements specified in subsections (a)(2) or (3), the licensee may delay the recording and reporting of the assessments for periods up to 7 months, unless otherwise required by Sections 340.1220 or 340.1230.

AGENCY NOTE: This delay permits the licensee to make additional measurements basic to the assessments.

e) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:

1. The sum of the ratios of the concentration to the appropriate DAC value (e.g., D, W or Y) from appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007, exclusive of subsequent amendments or editions, for each radionuclide in the mixture; or

2. The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

f) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall be the most restrictive DAC of any radionuclide in the mixture.

g) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if:

1. The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in Section 340.210 and in complying with the monitoring requirements in Section 340.520(b);

2. The concentration of any radionuclide disregarded is less than 10 percent of its DAC; and

3. The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30 percent.

h) When determining the committed effective dose equivalent, the following information may be considered:

1. In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of 2,000 DAC-hours, results in a committed effective dose equivalent of 0.05 Sv (5 rem) for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent.

2. For an ALI (and the associated 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 ALI) is listed in parentheses in table 1 of appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007, exclusive of subsequent amendments or editions. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in Section 340.210(a)(1)(B) is met.

History

• Source: Amended at 35 Ill. Reg. 934, effective December 30, 2010

32 Ill. Adm. Code 340.250 Determination of Prior Occupational Dose

a) 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 pursuant to Section 340.520 of this Part, the licensee or registrant shall determine the occupational radiation dose received during the current year prior to allowing such individual to enter a restricted area. In order to comply with this requirement, a licensee or registrant may 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 employers for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year. To accomplish this, a licensee or registrant may use the NRC Form 5 or submit equivalent information.

AGENCY NOTE: Licensees and registrants also should attempt to obtain the records of cumulative occupational radiation dose.

b) Prior to permitting an individual to participate in a planned special exposure, the licensee shall:

1. Determine the cumulative occupational radiation dose.

A) In order to comply with this requirement, a licensee may accept, as the record of cumulative radiation dose, an up-to-date NRC Form 4, 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 employers (if the individual is not employed by the licensee); and

B) Obtain reports of the individual's dose equivalent for the time period subsequent to that included in NRC Form 4, or equivalent, as specified in subsection (b)(1)(A) of this Section. Such reports shall be signed by the individual and countersigned by an appropriate official of the most recent employers for work involving radiation exposure, or the individual's current employers (if the individual is not employed by the licensee). The information shall be recorded on NRC Form 5, or equivalent.

2. Determine the internal and external doses from all previous planned special exposures.

3. Determine all doses in excess of the limits received during the lifetime of the individual, including doses received during accidents and emergencies.

c) The licensee or registrant shall record the exposure history, as required by subsections (a) and (b) of this Section, on NRC Form 4 or 5, or equivalent, as applicable, or other clear and legible record containing all of the information required on that form.

1. The form or record shall show each period in which the individual received occupational exposure to sources of radiation and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing the exposure history. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on the exposure history indicating the periods of time for which data are not available.

2. For the purpose of complying with this requirement, licensees or registrants are not required to reevaluate the separate external dose equivalents and internal committed dose equivalents or intakes of radionuclides assessed before January 1, 1994. Further, although occupational exposure histories obtained and recorded before January 1, 1994, would not have included effective dose equivalent, such histories may be used in the absence of specific information on the intake of radionuclides by the individual.

d) 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:

1. When establishing administrative controls pursuant to Section 340.210(g) of this Part for the current year, shall assume that the allowable dose limit for the individual is reduced by 12.5 mSv (1.25 rem) for each calendar quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

2. Shall not authorize the individual to receive any planned special exposures.

e) Records shall be retained in accordance with the requirements of Section 340.1140(a) of this Part.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.260 Planned Special Exposures

A licensee may authorize an adult worker to receive doses in addition to, and accounted for separately from, the doses received under the limits specified in Section 340.210 of this Part, provided that each of the following conditions are satisfied:

a) The licensee 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 management official of the licensee and employer, if the employer is not the licensee, specifically authorize the planned special exposure, in writing, before the exposure occurs.

c) Before a planned special exposure, the licensee ensures that each individual involved is:

1. Informed of the purpose of the planned operation; and

2. 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

3. Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present.

d) Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains previous doses received during the lifetime of the individual as required by Section 340.250(b) of this Part.

e) Subject to Section 340.210(b) of this Part, the licensee shall not authorize a planned special exposure that would cause an individual's dose from all planned special exposures and all doses in excess of the limits to exceed:

1. The numerical values of any of the dose limits in Section 340.210(a) of this Part in any year; and

2. Five times the annual dose limits in Section 340.210(a) of this Part during the individual's lifetime.

f) The licensee maintains records of the conduct of a planned special exposure in accordance with Section 340.1150 of this Part and submits a written report in accordance with Section 340.1240 of this Part.

g) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within 30 days from the date of the planned special exposure. The dose from planned special exposure need not be considered in controlling future occupational dose of the individual pursuant to Section 340.210(a) of this Part but shall be included in evaluations required by subsections (d) and (e) of this Section.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.270 Occupational Dose Limits for Minors

The annual occupational dose limits for minors are ten percent of the annual occupational dose limits specified for adult workers in Section 340.210 of this Part.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.280 Dose Equivalent to an Embryo/Fetus

a) Except as otherwise provided in subsections (d) and (e) of this Section, the licensee or registrant shall 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). (For recordkeeping requirements, see Section 340.1160(d) of this Part.)

b) The dose equivalent to an embryo/fetus shall be taken as the sum of:

1. The deep dose equivalent to the declared pregnant woman during the entire pregnancy; and

2. The dose equivalent to the embryo/fetus from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman during the entire pregnancy.

c) The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in subsection (a) of this Section.

AGENCY NOTE: The National Council on Radiation Protection and Measurements report entitled "Recommendations on Limits for Exposure to Ionizing Radiation", NCRP 91, published June 1, 1987, recommends that no more than 0.5 mSv (0.05 rem) of the allowed dose to the embryo/fetus be received during any one month during a declared pregnancy.

d) If the declared pregnant woman has not notified the licensee or registrant of the estimated date of conception, the licensee or registrant shall ensure that the dose equivalent to an embryo/fetus, as specified in subsection (b) of this Section, due to occupational exposure of the declared pregnant woman does not exceed 0.5 mSv (0.05 rem) per month, during the remainder of the pregnancy. If after initially declaring her pregnancy, a declared pregnant woman advises the licensee or registrant of the estimated date of conception, the dose limits specified in subsections (a) and (e) of this Section shall apply.

AGENCY NOTE: The Agency encourages licensees and registrants to explain to declared pregnant workers that providing an estimated date of conception will enable the licensee or registrant to more accurately assess the radiation dose equivalent to the embryo/fetus and assist the licensee or registrant in determining appropriate precautions to be taken for the remainder of the pregnancy.

e) If by the time the woman informs the licensee or registrant of the estimated date of conception the dose equivalent to the embryo/fetus has exceeded 4.5 mSv (0.45 rem), the licensee or registrant shall be deemed to be in compliance with subsection (a) of this Section if the additional dose equivalent to the embryo/fetus as specified in subsection (b) of this Section does not exceed 0.5 mSv (0.05 rem) during the remainder of the pregnancy.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.310 Dose Limits for Individual Members of the Public

a) Each licensee or registrant shall conduct operations so that:

1. The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with 32 Ill. Adm. Code 335, does not exceed 0.02 mSv (0.002 rem) in any one hour; and

2. The total effective dose equivalent to individual members of the public from a radiation machine does not exceed:

A) 5 mSv (0.5 rem) in any year at any location within a facility where a radiation machine was installed before January 1, 1994, and the use of the radiation machine does not change on or after January 1, 1994; or

B) 1 mSv (0.1 rem) in any year at any location within a facility where a radiation machine is installed or where the radiation machine or its use changes on or after January 1, 1994.

AGENCY NOTE: It is the Agency's intent to allow registrants using radiation machines in facilities designed to the 5 mSv (0.5 rem) limit to continue to use the 5 mSv (0.5 rem) total effective dose equivalent limit for a member of the public. This includes locations where the intensity of the radiation machine is not increased beyond the design basis, the type of radiation machine use is not changed and the type of facility use is not changed; or

3. The total effective dose equivalent to individual members of the public from a licensed operation does not exceed 1 mSv (0.1 rem) in any year, exclusive of the dose contribution from:

A) Background radiation;

B) Any medical administration the individual has received;

C) Exposure to individuals administered radioactive material and released in accordance with 32 Ill. Adm. Code 335;

D) Voluntary participation in medical research programs; and

E) A licensee's disposal of radioactive material into sanitary sewerage in accordance with Section 340.1030 of this Part.

b) A licensee may apply for prior Agency authorization to operate up to an annual dose limit for an individual member of the public of 5 mSv (0.5 rem). This application shall include the following information:

1. Demonstration of the need for and the expected duration of operations in excess of the limit in subsection (a)(3) of this Section;

2. The licensee's or registrant's program to assess and control dose within the 5 mSv (0.5 rem) annual limit; and

3. The procedures to be followed to maintain the dose ALARA.

c) Prior to allowing a member of the public to enter a restricted area, the licensee or registrant shall give instructions on radiation hazards and protective measures to that individual.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.320 Compliance with Dose Limits for Individual Members of the Public

a) The licensee or registrant shall make or cause to be made surveys of radiation levels in unrestricted areas. In addition, licensees shall survey radioactive materials in effluents released to unrestricted areas. These surveys are to demonstrate compliance with the dose limits for individual members of the public in Section 340.310.

b) A licensee or registrant shall show compliance with the annual dose limit in Section 340.310 by:

1. 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

2. Demonstrating that:

A) 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 2 of appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007, exclusive of subsequent amendments or editions; and

B) 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.

c) Upon approval from the Agency, the licensee may adjust the effluent concentration values in table 2 of appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007, exclusive of subsequent amendments or editions, for members of the public to take into account the actual physical and chemical characteristics of the effluents (e.g., aerosol size distribution, solubility, density, radioactive decay equilibrium and chemical form).

History

• Source: Amended at 35 Ill. Reg. 934, effective December 30, 2010

32 Ill. Adm. Code 340.410 Testing for Leakage or Contamination of Sealed Sources

a) The licensee in possession of any sealed source shall assure that:

1. Each sealed source, except as specified in subsection (b) of this Section, is tested for leakage or contamination and the test results that confirm that the sealed source is not leaking or contaminated are received before the sealed source is put into use, unless the licensee has a certificate from the transferor indicating that the sealed source was tested within 6 months for beta and gamma emitting sources, or within 3 months for sources designed to emit alpha particles, before transfer to the licensee.

2. Each sealed source that is not designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed 6 months or at alternative intervals approved by the Agency, pursuant to 32 Ill. Adm. Code 330.280(m), the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.

3. Each sealed source that is designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed 3 months or at alternative intervals approved by the Agency, pursuant to 32 Ill. Adm. Code 330.280(m), the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.

4. Each sealed source that is required to be tested for leakage or contamination shall be removed from service if there is reason to suspect that the sealed source may have been damaged or may be leaking or contaminated. The source shall be kept out of service until test results that confirm there is no leakage or contamination are received.

5. Tests for leakage for all sealed sources, except brachytherapy sources manufactured to contain radium, shall be capable of detecting the presence of 185 Bq (0.005 µCi) of radioactive material on a test sample. Test samples shall be taken from the sealed source or from the surfaces of the container in which the sealed source is stored or mounted on which one might expect contamination to accumulate. For a sealed source contained in a device, test samples shall be obtained when the source is in the "off" position. If setting the source to the "off" position would disrupt the licensee's activities, test samples may be obtained while the source is in the "on" position, provided that the dose likely to be received by the individual while obtaining the samples will not be so great as to require monitoring pursuant to Section 340.520(a) of this Part.

6. The test for leakage for brachytherapy sources manufactured to contain radium shall 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.

7. Tests for contamination from radium daughters shall be taken on the interior surface of brachytherapy source storage containers and shall be capable of detecting the presence of 185 Bq (0.005 µCi) of a radium daughter which has a half-life greater than 4 days.

b) A licensee need not perform tests for leakage or contamination on the following sealed sources:

1. Sealed sources containing only radioactive material with a half-life of less than 30 days;

2. Sealed sources containing only radioactive material as a gas;

3. 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;

4. Sealed sources containing only hydrogen-3;

5. Seeds of iridium-192 encased in nylon ribbon;

6. Sealed sources, except teletherapy and brachytherapy sources, that are stored, not being used and identified as in storage. The licensee shall, however, test each such sealed source for leakage or contamination and receive the test results that confirm that the sealed source is not leaking or contaminated before any use or transfer unless it has been tested for leakage or contamination within 6 months for beta and gamma emitting sources, or within 3 months for sources designed to emit alpha particles, before the date of use or transfer; and

7. Sealed sources distributed under a license issued pursuant to 32 Ill. Adm. Code 330.280(m), but only if the evaluation sheet for those sealed sources, as filed in the "Radioactive Material Reference Manual" maintained by the Department of Health and Human Services or in the "Registry of Radioactive Sealed Sources and Devices" maintained by the U.S. Nuclear Regulatory Commission, specifies that testing for leakage or contamination is not required.

c) Tests for leakage or contamination from sealed sources shall be performed by persons specifically authorized by the Agency, an Agreement State, a Licensing State or the Nuclear Regulatory Commission to perform such services.

d) Test results shall be kept as specified in Section 340.1135 of this Part.

e) The following shall be considered evidence that a sealed source is leaking:

1. The presence of 185 Bq (0.005 µCi) or more of removable contamination on any test sample.

2. Leakage of 37 Bq (0.001 µCi) of radon-222 per 24 hours for brachytherapy sources manufactured to contain radium.

3. The presence of removable contamination resulting from the decay of 185 Bq (0.005 µCi) or more of radium.

f) The licensee shall immediately withdraw a leaking or contaminated sealed source from use and shall take action to prevent the spread of contamination. The leaking or contaminated sealed source shall be repaired, decontaminated or disposed of in accordance with this Part.

g) Reports of test results for leaking or contaminated sealed sources shall be made pursuant to Section 340.1260 of this Part.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.510 General

a) Each licensee or registrant shall make, or cause to be made, surveys, including surveys of the subsurface, where appropriate:

1. That demonstrate compliance with this Part; and

2. That evaluate:

A) The extent of radiation levels;

B) Concentrations or quantities of radioactive material; and

C) The potential radiological hazards of radiation levels and residual radioactivity detected.

b) The licensee or registrant shall ensure that instruments and equipment used for quantitative radiation measurements (e.g., dose rate and effluent monitoring) are calibrated at intervals not to exceed 12 months for the radiation measured or at alternative intervals specified in regulations of the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State. To satisfy this requirement, the licensee shall:

1. Post a legible note on the instrument showing the date of calibration; and

2. Ensure that instrument calibrations are performed by persons specifically licensed by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to perform such calibrations.

c) On each day of use, prior to using an instrument to perform required monitoring, the licensee or registrant shall verify that the instrument is operational. Operational checks for radiation measurement or radiation detection instruments shall include verification of response to a source of radiation.

d) Except for those dosimeters used to measure the dose to any extremity, personnel dosimeters that require processing to determine the radiation dose and that are used by licensees or registrants to comply with Section 340.210, with other applicable provisions of 32 Ill. Adm. Code: Chapter II, Subchapters b and d or with conditions specified in a license shall be processed and evaluated by a qualified dosimetry processor. A dosimetry processor is qualified if:

1. It holds current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and

2. It is approved by NVLAP for the type of radiation or radiations that most closely approximate the type of radiation or radiations for which the individual wearing the dosimeter is monitored.

e) A licensee or registrant shall obtain Agency approval prior to using pocket ionization chambers or electronic dosimeters to determine radiation dose, to comply with Section 340.210, or with other applicable provisions of 32 Ill. Adm. Code: Chapter II, Subchapters b and d or with conditions specified in a license. The Agency will grant approval provided the licensee or registrant submits information describing the type and range of the dosimeters and describes a program to ensure the accuracy, reliability, precision and security of the dosimetry data.

f) The licensee or registrant shall ensure that adequate precautions are taken to prevent deceptive exposure of an individual monitoring device.

History

• Source: Amended at 39 Ill. Reg. 15728, effective Novermber 24, 2015

32 Ill. Adm. Code 340.520 Conditions Requiring Individual Monitoring of External and Internal Occupational Dose

Each licensee or registrant shall monitor doses from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of this Part. As a minimum:

a) Each licensee or registrant shall monitor occupational dose from sources of radiation and shall supply and require the use of individual monitoring devices by:

1. Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in Section 340.210(a);

2. Minors likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of any of the applicable limits in Section 340.270;

3. 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); and

4. Individuals entering a high or very high radiation area.

b) Each licensee shall monitor, to determine compliance with Section 340.240, the occupational intake of radioactive material by and assess the committed effective dose equivalent to:

1. Adults likely to receive, in 1 year, an intake in excess of 10 percent of the applicable ALIs in table 1, columns 1 and 2 of appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007, exclusive of subsequent amendments or editions; and

2. Minors and declared pregnant women likely to receive, in 1 year, a committed effective dose equivalent in excess of 0.5 mSv (0.05 rem).

History

• Source: Amended at 35 Ill. Reg. 934, effective December 30, 2010

32 Ill. Adm. Code 340.530 Location of Individual Monitoring Devices

Each licensee or registrant shall ensure that individuals who are required to monitor occupational doses in accordance with Section 340.520(a) of this Part wear individual monitoring devices as follows:

a) An individual monitoring device used for monitoring the dose to the whole body shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck (collar).

b) An individual monitoring device used for monitoring the dose to an embryo/fetus of a declared pregnant woman, pursuant to Section 340.280(a) of this Part, shall be located at the waist under any protective apron being worn by the woman.

c) An individual monitoring device used for monitoring the eye dose equivalent, to demonstrate compliance with Section 340.210(a)(2)(A) of this Part, shall be located at the neck (collar), outside any protective apron being worn by the monitored individual, or at an unshielded location closer to the eye.

d) An individual monitoring device used for monitoring the dose to the extremities, to demonstrate compliance with Section 340.210(a)(2)(B) of this Part, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device shall be oriented to measure the highest dose to the extremity being monitored.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.540 Calibration of Survey Instruments

a) Unless specified in another Part, a licensee shall have each survey instrument used to show compliance with this Part calibrated before first use, annually and following a repair that affects the calibration. A licensee shall:

1. Calibrate all scales with readings up to 10 mSv (1000 mrem) per hour with a radiation source;

2. Calibrate two separated readings on each scale or decade that will be used to show compliance; and

3. Conspicuously note on the instrument the date of calibration.

b) A licensee may not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than 20 percent.

History

• Source: Added at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.610 Control of Access to High Radiation Areas

a) The licensee shall ensure that each entrance or access point to a high radiation area has one or more of the following features:

1. 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 1 hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates; or

2. 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

3. Entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry.

b) In place of the controls required by subsection (a) of this Section for a high radiation area, the licensee may substitute continuous direct or electronic surveillance to enable action to be taken to prevent unauthorized entry.

c) The licensee may apply to the Agency for approval of alternative methods for controlling access to high radiation areas.

d) The licensee shall establish the controls required by subsections (a) and (c) of this Section in a way that does not prevent individuals from leaving a high radiation area.

e) 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:

1. The packages do not remain in the area longer than 3 days; and

2. The dose rate at 1 meter from the external surface of any package does not exceed 0.1 mSv (0.01 rem) per hour.

f) 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, as required by 32 Ill. Adm. Code 335, to prevent the exposure of individuals to radiation or radioactive material in excess of the limits established in this Part and to operate within the ALARA provisions of the licensee's radiation protection program.

g) The registrant shall control entrance or access to rooms or other areas containing sources of radiation capable of producing a high radiation area as described in this Section in accordance with the requirements for access and control specified in other applicable Parts of 32 Ill. Adm. Code: Chapter II, Subchapters b and d (i.e., 32 Ill. Adm. Code 350 for industrial radiography, 32 Ill. Adm. Code 360 for use of x-rays in the healing arts and 32 Ill. Adm. Code 390 for particle accelerators).

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.620 Control of Access to Very High Radiation Areas

In addition to the controls required by Section 340.610 of this Section, the licensee or registrant shall 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.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.630 Control of Access to Very High Radiation Areas – Irradiators

a) This Section applies to licensees or registrants with sources of radiation in irradiators that are not self-shielded. This Section 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 is both stored and operated within the same radiation shielding barrier and, in the designed configuration of the irradiator, is always physically inaccessible to any individual and cannot create a radiation level of 5 Gy (500 rad) or more in 1 hour at 1 meter in an area that is accessible to any individual.

b) 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 matter shall meet the following requirements:

1. Each entrance or access point shall be equipped with entry control devices that:

A) Function automatically to prevent any individual from inadvertently entering a very high radiation area;

B) 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

C) 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.

2. Additional control devices shall be provided so that, upon failure of the entry control devices to function as required by subsection (b)(1) of this Section:

A) 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

B) Conspicuous visible and audible alarm signals are generated to make an individual attempting to enter the area aware of the hazard. The alarm signals shall be located so that at least one other authorized individual, who is physically present, familiar with the activity, and prepared to render or summon assistance, is made aware of the failure of the entry control devices.

3. The licensee or registrant shall provide control devices so that, upon failure or removal of any physical radiation barriers, other than the shielded storage container for sealed sources:

A) 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

B) 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.

4. When the shield for the stored sealed source is a liquid, the licensee shall provide means to monitor the integrity of the shield and to signal, automatically, loss of adequate shielding.

5. Physical radiation barriers that comprise permanent structural components, such as walls, that have no credible probability of failure or removal in ordinary circumstances need not meet the requirements of subsections (b)(3) and (4) of this Section.

6. Each area shall 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 that can prevent the source of radiation from being put into operation.

7. Each area shall be controlled by use of devices and administrative procedures that ensure that the area is cleared of personnel prior to each use of the source of radiation.

8. Each area shall 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.

9. The entry control devices required in subsection (b)(1) of this Section shall be tested for proper functioning (see Section 340.1190 of this Part for recordkeeping requirements).

A) Testing shall be conducted prior to initial operation with the source of radiation on any day, unless operations were continued uninterrupted from the previous day;

B) Testing shall be conducted prior to resumption of operation of the source of radiation after any unintentional interruption; and

C) The licensee or registrant shall submit and adhere to a schedule for periodic tests of the entry control and warning systems.

10. The licensee or registrant shall 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.

11. Entry and exit portals that are used in transporting matter to and from the irradiation area, and that are not intended for use by individuals, shall 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. Exit portals for irradiated matter shall be equipped to detect and signal the presence of any loose sealed sources that are carried toward such an exit and to automatically prevent loose sealed sources from being carried out of the area.

c) Registrants, licensees or applicants for licenses for sources of radiation that are within the purview of subsection (b) of this Section and that will be used in a variety of positions or in locations (e.g., open fields or forests) that make it impracticable to comply with certain requirements of subsection (b) of this Section, such as those for the automatic control of radiation levels, may apply to the Agency for approval of alternative safety measures. Alternative safety measures shall provide personnel protection at least equivalent to those specified in subsection (b) of this Section. At least one of the alternative measures shall 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.

d) The entry control devices required by subsections (b) and (c) of this Section shall be established in such a way that no individual will be prevented from leaving the area.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.710 Use of Process or Other Engineering Controls

a) The licensee shall use, to the extent practicable, process or other engineering controls (e.g., containment or ventilation) to control the concentrations of radioactive material in air.

b) The licensee shall measure airflow rates initially and semiannually thereafter to assure proper ventilation system performance. Records of the evaluation of ventilation system performance shall be maintained for Agency inspection and shall include:

1. The date of evaluation;

2. Results of ventilation rate measurements;

3. Manufacturer, model and serial number of the measurement instrument used; and

4. The identity of the individual performing the measurements.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.720 Use of Other Controls

a) When it is not practical to apply process or other engineering controls to control the concentrations of radioactive material in air to values below those that define an airborne radioactivity area, the licensee shall, consistent with maintaining the total effective dose equivalent ALARA, increase monitoring and limit intakes by one or more of the following means:

1. Control of access; or

2. Limitation of exposure times; or

3. Use of respiratory protection equipment; or

4. Other controls.

b) If the licensee performs an ALARA analysis to determine whether respirators shall be used, the licensee may consider safety factors other than radiological factors. The licensee shall also consider the impact of respirator use on workers' industrial health and safety.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.730 Use of Individual Respiratory Protection Equipment

a) If the licensee assigns or permits the use of respiratory protection equipment to limit the intake of radioactive material then:

1. Except as provided in subsection (a)(2), the licensee shall use only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health (NIOSH).

2. The licensee may use equipment that has not been tested or certified by NIOSH, or for which there is no schedule for testing or certification, provided the Agency has approved an application for authorized use of that equipment. The application shall 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 shall be demonstrated either by licensee testing or on the basis of reliable test information.

3. The licensee shall implement and maintain a respiratory protection program that includes:

A) Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate doses.

B) Surveys and bioassays, as necessary, to evaluate actual intakes.

C) Testing of respirators for operability (user seal check for face sealing devices and functional check for others) immediately prior to each use.

D) Written procedures regarding:

i) Monitoring, including air sampling and bioassays;

ii) Supervision and training of respirator users;

iii) Fit testing;

iv) Respirator selection;

v) Breathing air quality;

vi) Inventory and control;

vii) Storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment;

viii) Recordkeeping; and

ix) Limitations on periods of respirator use and relief from respirator use.

E) Determination by a physician that the individual user is medically fit to use respiratory protection equipment:

i) Before the initial fitting of a face sealing respirator;

ii) Before the first field use of non-face sealing respirators; and

iii) Either every 12 months thereafter or periodically at a frequency determined by a physician.

F) Fit testing, with a fit factor > 10 times the 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 1 year. Fit testing must be performed with the facepiece operating in the negative pressure mode.

4. The licensee shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.

5. The licensee shall consider limitations appropriate to the type and mode of use. When selecting respiratory devices the licensee shall provide for vision correction, adequate communication, low temperature work environments, and the concurrent use of other safety or radiological protection equipment. The licensee shall use equipment in such a way as not to interfere with the proper operation of the respirator.

6. Standby rescue persons are required whenever one-piece atmosphere-supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment are used from which an unaided individual would have difficulty extricating himself or herself. The standby persons shall be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication with the workers (visual, voice, signal line, telephone, radio, or other suitable means), and be immediately 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 shall be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed.

7. Atmosphere-supplying respirators must be supplied with respirable air of grade D quality or better as defined by the Compressed Gas Association in publication G-7.1, "Commodity Specification for Air", 1997 and included in the regulations of the Occupational Safety and Health Administration at 29 CFR 1910.134(i)(1)(ii)(A) through (E) (2019). 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.

8. The licensee shall ensure that no objects, materials, or substances, such as facial hair, or any conditions that interfere with the face, facepiece seal, or valve function, under the control of the respirator wearer, are present between the skin of the respirator wearer's face and the sealing surface of a tight-fitting respirator facepiece.

b) When estimating the dose to individuals from intake of airborne radioactive materials, the concentration of radioactive material in the air that is inhaled when respirators are worn is initially assumed to be the ambient concentration in air without respiratory protection, divided by the assigned protection factor. If the dose is later found to be greater than the estimated dose, the corrected value shall be used; if the dose is later found to be less than the estimated dose, the corrected value may be used. Protection factors for respirators are specified in Appendix A to 10 CFR 20 (1999).

c) The licensee shall obtain authorization from the Agency before using assigned protection factors in excess of those specified in Appendix A to 10 CFR 20 (1999). The Agency may authorize a licensee to use higher assigned protection factors on receipt of an application that:

1. Describes the situation for which a need exists for higher protection factors; and

2. Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.

d) The Agency may impose restrictions in addition to the provisions of this Section, Section 340.720, and Appendix A to 10 CFR 20 (1999) in order to ensure the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of airborne radioactive materials consistent with maintaining total effective dose equivalent ALARA and limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

32 Ill. Adm. Code 340.810 Security and Control of Licensed or Registered Sources of Radiation

a) The licensee shall secure licensed radioactive material from unauthorized removal or access.

b) The licensee shall maintain constant surveillance and use devices or administrative procedures to prevent unauthorized use of licensed radioactive material that is in an unrestricted area and that is not in storage.

c) Unless otherwise specified in 32 Ill. Adm. Code 335, 350, or 351 or by the Agency, the licensee shall conduct a physical inventory at intervals not to exceed 6 months to account for each sealed source received and possessed under the license schedule item and shall maintain a record that includes the:

1. Radionuclide;

2. Activity;

3. Activity assay date;

4. Manufacturer;

5. Model and serial number;

6. Location of the sealed source;

7. Date of the inventory; and

8. Identity of the individuals performing the inventory.

d) For sources that are removed from storage for use or transport, the record shall include:

1. The number and activity of sources removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use; and

2. The number and activity of sources returned to storage, the time and date they were returned to storage, and the name of the individual who returned them to storage.

e) Records of inventories shall be maintained for 5 years from the date of each inventory.

f) The registrant shall use devices or administrative procedures to prevent unauthorized use of registered radiation machines.

g) Security requirements for portable gauges. Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal whenever portable gauges are not under the control and constant surveillance of the licensee.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

32 Ill. Adm. Code 340.820 Storage of Volatiles and Gases

a) A licensee shall store unopened radioactive gases and volatile radioactive material, including iodine as sodium iodide, in the shipper's radiation shield and container; or

b) A licensee shall store opened containers from which material is extracted in a properly functioning, ventilated device such as a glove box or fume hood.

History

• Source: Added at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.830 Control of Volatiles and Gases

a) A licensee who uses or stores radioactive volatile materials or gases shall do so with a system that will keep airborne concentrations within the limits prescribed in this Part.

b) The system shall either be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the volatile material or gas in a shielded container.

c) A licensee shall use or store radioactive gases only in rooms that are at negative pressure compared to surrounding rooms or hallways.

d) A licensee shall post, at the areas of use and storage, emergency procedures to be followed in the event of a gas spill.

e) In the event of evacuation because of a spill or leak, the licensee shall use a radiation detection survey instrument upon room re-entry to ensure radiation levels have returned to background levels.

f) A licensee shall check the operation of reusable collection systems monthly and measure the ventilation rates available in areas of use at intervals not to exceed 6 months. The licensee shall maintain a record of these checks and measurements for 5 years. The record shall include the model and serial number of the collection system, results of all checks recommended by the manufacturer of the collection system, the ventilation rates measured, the date of the checks and measurements, and the identity of the individual who performed the checks and measurements.

g) Contaminated charcoal trap filters, air handling systems, and respiratory equipment shall be disposed of in accordance with this Part.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

32 Ill. Adm. Code 340.910 Caution Signs

a) Standard Radiation Symbol. Unless otherwise authorized by the Agency, the symbol prescribed by this Part shall use the colors magenta, purple or black on yellow background. The symbol prescribed by this Part is the three-bladed design shown in Illustration A of this Part.

b) Exception to Color Requirements for Standard Radiation Symbol. Notwithstanding the requirements of subsection (a) of this Section, 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.

c) Additional Information on Signs and Labels. In addition to the contents of signs and labels prescribed in this Part, the licensee or registrant may provide, on or near the required signs and labels, information to make individuals aware of potential radiation exposures and to minimize the exposures.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.920 Posting Requirements

a) Posting of Radiation Areas. The licensee or registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA".

b) Posting of High Radiation Areas. The licensee or registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA".

c) Posting of Very High Radiation Areas. The licensee or registrant shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words "GRAVE DANGER, VERY HIGH RADIATION AREA".

d) Posting of Airborne Radioactivity Areas. The licensee shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY AREA".

e) Posting of Areas or Rooms in Which Licensed Material is Used or Stored. The licensee shall post each area or room in which there is used or stored an amount of licensed material exceeding ten times the quantity of such material specified in Appendix C to 10 CFR 20, effective January 1, 2004, exclusive of subsequent amendments or editions, with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)".

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.930 Exceptions to Posting Requirements

a) A licensee or registrant is not required to post caution signs in areas or rooms containing sources of radiation for periods of less than 8 hours, if each of the following conditions is met:

1. 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 this Part; and

2. The area or room is subject to the licensee's or registrant's control.

b) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to Section 340.920 of this Part provided that the patient door posting requirements of 32 Ill. Adm. Code 335.5030(a)(5) or 335.7030(b) are met.

c) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs, provided that:

1. A patient being treated with a permanent implant could be released from confinement pursuant to 32 Ill. Adm. Code 335.2110; or

2. A patient being treated with a therapeutic radiopharmaceutical could be released from confinement pursuant to 32 Ill. Adm. Code 335.5030(b).

d) 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 (12 inches) from the surface of the sealed source container or housing does not exceed 0.05 mSv (0.005 rem) per hour.

e) A room or area is not required to be posted with a caution sign because of the presence of radiation machines used solely for diagnosis in the healing arts.

f) If a room or area in which radioactive material or radiation machines are used for the treatment of patients is required to be posted with the words, "GRAVE DANGER, VERY HIGH RADIATION AREA" in accordance with 340.920(c) of this Part, the following words may be substituted: "DANGER, VERY HIGH RADIATION AREA".

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.940 Labeling Containers and Radiation Machines

a) The licensee shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL". The label shall also provide information (such as the radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials and mass enrichment) to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.

b) Each licensee shall, 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.

c) Each registrant shall ensure that each radiation machine is labeled in a manner that cautions individuals that radiation is produced when it is energized.

32 Ill. Adm. Code 340.950 Exemptions to Labeling Requirements

A licensee is not required to label:

a) Containers holding licensed material in quantities less than the quantities listed in appendix C to 10 CFR 20, published at 60 Fed. Reg. 20186, April 25, 1995; or

b) Containers holding licensed material in concentrations less than those specified in Table 3 of appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007; or

c) Containers attended by an individual who takes the precautions (e.g., controlling access) necessary to prevent the exposure of individuals in excess of the limits established by this Part; or

d) Containers when they are in transport, provided the containers are packaged and labeled in accordance with the regulations of the U.S. Department of Transportation; or

AGENCY NOTE: 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 49 CFR 173.403 and 173.421 through 173.424, revised October 1, 2008.

e) Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record (examples of containers of this type are containers in locations such as water-filled canals, storage vaults or hot cells). The record shall be retained as long as the containers are in use for the purpose indicated on the record; or

f) Installed manufacturing or process equipment, such as piping and tanks.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

32 Ill. Adm. Code 340.960 Procedures for Receiving and Opening Packages

a) Each licensee who is authorized to receive a package containing quantities of radioactive material in excess of a Type A quantity, as defined in 49 CFR 173.403 and listed in 49 CFR 173.435 (2020), shall:

1. Make arrangements to receive the package when the carrier offers it for delivery; or

2. Make arrangements to receive the notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously.

b) Each licensee shall:

1. Monitor the external surfaces of a labeled package for radioactive contamination unless the package contains only radioactive material in the form of a gas or in special form radioactive material as defined in 32 Ill. Adm. Code 310.20;

AGENCY NOTE: Labeled means labeled with a Radioactive White I, Radioactive Yellow II or Radioactive Yellow III label as specified in U.S. Department of Transportation regulations, 49 CFR 172.403 and 172.436-440, published October 1, 2004.

2. Monitor the external surfaces of a labeled package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity; and

3. Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as packages that are crushed, wet or damaged.

c) The licensee shall perform the monitoring required by subsection (b) as soon as practicable after receipt of the package, but not later than 3 hours after the package is received at the licensee's facility if it is received during the licensee's normal working hours or if there is evidence of degradation of package integrity, such as a package that is crushed, wet or damaged. If a package is received after working hours, and has no evidence of degradation of package integrity, the package shall be monitored no later than 3 hours from the beginning of the next working day.

d) The licensee shall immediately notify the final delivery carrier and the Agency by telephone at (217) 782-7860, and shall confirm the initial contact within 24 hours by overnight letter or telefacsimile to the Agency, when:

1. Removable radioactive surface contamination exceeds the limits of 32 Ill. Adm. Code 341.10 (49 CFR 173.443 (2014)); or

2. External radiation levels exceed the limits of 32 Ill. Adm. Code 341.10 (49 CFR 173.441 (2004)).

e) Each licensee shall:

1. Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and

2. Ensure that the procedures are followed and that special instructions for the type of package being opened are adhered to.

f) Licensees transferring special form sources in licensee-owned or licensee-operated vehicles to and from a work site are exempt from the contamination monitoring requirements of subsection (b), but are not exempt from the survey requirement in subsection (b) for measuring radiation levels that is required to ensure that the source is still properly lodged in its shield.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

32 Ill. Adm. Code 340.1010 General Requirements

a) A licensee shall dispose of licensed material only:

1. By transfer to an authorized recipient as provided in Section 340.1060 or in 32 Ill. Adm. Code 330, 332 or 601, or to the U.S. Department of Energy; or

2. By release in effluents within the limits in Section 340.310; or

3. As authorized pursuant to Sections 340.1020, 340.1030, 340.1040, 340.1045, or 340.1050.

b) A person shall be specifically licensed by the Agency prior to receiving waste containing licensed material from any other point of generation for:

1. Storage for decay; or

2. Treatment prior to disposal; or

3. Treatment or disposal by incineration; or

4. Disposal at a land disposal facility licensed pursuant to 32 Ill. Adm. Code 601; or

5. Storage until transferred to a disposal facility authorized to receive the waste.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

32 Ill. Adm. Code 340.1020 Method for Obtaining Approval of Proposed Disposal Procedures

A licensee or applicant for a license may apply to the Agency for approval of proposed procedures, not otherwise authorized in 32 Ill. Adm. Code: Chapter II, Subchapters b and d, to dispose of licensed material generated in the licensee's operations. Each application shall include:

a) A description of the waste containing licensed material to be disposed of, including the physical and chemical properties that have an impact on risk evaluation, and the proposed manner and conditions of waste disposal;

b) An analysis and evaluation of pertinent information on the nature of the environment;

c) The nature and location of other potentially affected facilities; and

d) Analyses and procedures to ensure that doses are maintained ALARA and within the dose limits in this Part.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1030 Disposal by Release Into Sanitary Sewerage

a) A licensee may discharge licensed material into sanitary sewerage if each of the following conditions is satisfied:

1. The material is readily soluble, or is readily dispersible biological material, in water;

2. The quantity of licensed radioactive material that the licensee releases into the sewer in 1 month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in table 3 of appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007, exclusive of subsequent amendments or editions;

3. If more than one radionuclide is released, the following conditions must also be satisfied:

A) The licensee shall determine the fraction of the limit in table 3 of appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007, exclusive of subsequent amendments or editions, represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in table 3 of appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007, exclusive of subsequent amendments or editions; and

B) The sum of the fractions for each radionuclide required by subsection (a)(3)(A) of this Section does not exceed unity;

4. The total quantity of licensed radioactive material that the licensee releases into sanitary sewerage 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; and

5. In determining compliance with subsections (a)(1) through (4), the licensee shall not include the activity from radioactive material excluded by subsection (b).

b) Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained in subsection (a).

History

• Source: Amended at 35 Ill. Reg. 934, effective December 30, 2010

32 Ill. Adm. Code 340.1040 Treatment or Disposal by Incineration

A licensee may treat or dispose of licensed material by incineration only in the amounts and forms specified in Section 340.1050 of this Part or as specifically approved by the Agency pursuant to Section 340.1020 of this Part.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1045 Decay-in-Storage

A licensee may store waste containing or composed of radioactive material with a physical half-life of less than 120 days for "decay-in-storage" before disposal as normal waste without regard to its radioactivity if it:

a) Holds the radioactive material for a minimum of 10 half-lives; and

b) Pursuant to Section 340.510(a) and (b), performs radiation surveys prior to disposal of the radioactive material to ensure that the material's radioactivity cannot be distinguished from background radiation levels. The package/container surface shall be surveyed with an appropriate radiation detection survey instrument set on its most sensitive scale, with no interposed shielding between the detector and the material, in a low background radiation environment; and

c) Maintains records of monitoring to include: date of disposal; date placed in storage; manufacturer, model and serial number of the survey instrument used; background radiation levels; and measured radiation levels; and

d) Records the identity of the individual performing the monitoring; and

e) Removes or obliterates all radiation labels.

History

• Source: Amended at 35 Ill. Reg. 934, effective December 30, 2010

32 Ill. Adm. Code 340.1050 Disposal of Specific Wastes

a) A licensee may dispose of the following licensed material as if it were not radioactive:

1. 1.85 kBq (0.05 µCi), or less, of hydrogen-3, carbon-14 or iodine-125 per gram of medium used for scintillation counting; and

2. 1.85 kBq (0.05 µCi), or less, of hydrogen-3, carbon-14 or iodine-125 per gram of animal tissue, averaged over the weight of the entire animal.

b) A licensee shall not dispose of tissue pursuant to subsection (a)(2) of this Section in a manner that would permit its use either as food for humans or as animal feed.

c) The licensee shall maintain records in accordance with Section 340.1180 of this Part.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1052 Classification of Radioactive Waste for Land Disposal

a) 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.

b) Classes of waste.

1. Class A waste is waste that is usually segregated from other waste classes at the disposal site. The physical form and characteristics of Class A waste must meet the minimum requirements set forth in Section 340.1055(a) of this Part. If Class A waste also meets the stability requirements set forth in Section 340.1055(b) of this Part, it is not necessary to segregate the waste for disposal.

2. Class B waste is waste that must meet more rigorous requirements on waste form to ensure stability (as defined in 32 Ill. Adm. Code 601.20) after disposal. The physical form and characteristics of Class B waste must meet both the minimum and stability requirements set forth in Section 340.1055 of this Part.

3. Class C waste is waste that not only must meet more rigorous requirements on waste form to ensure stability but also requires additional measures at the disposal facility to protect against inadvertent intrusion. The physical form and characteristics of Class C waste must meet both the minimum and stability requirements set forth in Section 340.1055 of this Part.

c) Classification determined by long-lived radionuclides. If the radioactive waste contains only radionuclides listed in Table 1 of this Section, classification shall be determined as follows:

1. If the concentration does not exceed 0.1 times the value in Table 1, the waste is Class A.

2. If the concentration exceeds 0.1 times the value in Table 1, but does not exceed the value in Table 1, the waste is Class C.

3. If the concentration exceeds the value in Table 1, the waste is not generally acceptable for land disposal.

4. For wastes containing mixtures of radionuclides listed in Table 1, the total concentration shall be determined by the sum of fractions rule described in subsection (g) of this Section.

Table 1

Radionuclide

Concentration curies/cubic meter

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

AGENCY NOTE: Units are nanocuries per gram.

d) Classification determined by short-lived radionuclides. If the waste does not contain any of the radionuclides listed in Table 1, classification shall be determined based on the concentrations shown in Table 2 of this Section. However, as specified in subsection (f) of this Section, if radioactive waste does not contain any nuclides listed in either Table 1 or Table 2, it is Class A.

1. If the concentration does not exceed the value in Column 1, the waste is Class A.

2. If the concentration exceeds the value in Column 1 but does not exceed the value in Column 2, the waste is Class B.

3. If the concentration exceeds the value in Column 2 but does not exceed the value in Column 3, the waste is Class C.

4. If the concentration exceeds the value in Column 3, the waste is not generally acceptable for near-surface disposal.

5. For wastes containing mixtures of the radionuclides listed in Table 2, the total concentration shall be determined by the sum of fractions rule described in subsection (g) of this Section.

Table 2

Radionuclide

Concentration (curies/cubic meter)

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

AGENCY NOTE: 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 2 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 1 and some of which are listed in Table 2, classification shall be determined as follows:

1. If the concentration of a radionuclide listed in Table 1 is less than 0.1 times the value listed in Table 1, the class shall be that determined by the concentration of radionuclides listed in Table 2.

2. If the concentration of a radionuclide listed in Table 1 exceeds 0.1 times the value listed in Table 1, but does not exceed the value in Table 1, the waste shall be Class C, provided the concentration of radionuclides listed in Table 2 does not exceed the value shown in Column 3 of Table 2.

f) Classification of wastes with radionuclides other than those listed in Tables 1 and 2. If the waste does not contain any radionuclides listed in either Tables 1 or 2, it is Class A.

g) 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 50 Ci/m3 and Cs-137 in a concentration of 22 Ci/m3. Since the concentrations both exceed the values in Column 1, Table 2, 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.

h) 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 nano-curies per gram.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1055 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.

1. Wastes shall 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 this Part, the site license conditions shall govern.

2. Wastes shall not be packaged for disposal in cardboard or fiberboard boxes.

3. Liquid waste shall be packaged in sufficient absorbent material to absorb twice the volume of the liquid.

4. Solid waste containing liquid shall 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.

5. Waste shall not be readily capable of detonation or of explosive decomposition or reaction at normal pressures and temperatures, or of explosive reaction with water.

6. Waste shall 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 subsection (a)(8).

7. Waste must not be pyrophoric. Pyrophoric materials contained in wastes shall be treated, prepared, and packaged to be nonflammable.

8. Wastes in a gaseous form shall be packaged at an absolute pressure that does not exceed 1.5 atmospheres at 20°C (68°F). Total activity shall not exceed 100 Ci per container.

9. Wastes containing hazardous, biological, pathogenic, or infectious material shall 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.

1. Waste shall 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.

2. Notwithstanding the provisions in subsections (a)(3) and (a)(4), liquid wastes, or wastes containing liquid, shall 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.

3. Void spaces within the waste and between the waste and its package shall be reduced to the extent practicable.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

32 Ill. Adm. Code 340.1057 Labeling

Each package of waste shall be clearly labeled to identify whether it is Class A, Class B or Class C waste, in accordance with Section 340.1052 of this Part.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1060 Transfer for Disposal and Manifests

a) Each licensee who transports or offers for transportation low-level radioactive waste intended for ultimate disposal at a licensed low-level radioactive waste disposal facility shall prepare a manifest reflecting information requested on the applicable NRC Forms 540 (Uniform Low-Level Radioactive Waste Manifest-Shipping Paper) and 541 (Uniform Low-Level Radioactive Waste Manifest-Container and Waste Description) and, if necessary, on an applicable NRC Form 542 (Uniform Low-Level Radioactive Waste Manifest-Manifest Index and Regional Compact Tabulation).

AGENCY NOTE: For guidance in completing these forms, refer to the instructions that accompany the forms. NRC Forms 540, 540A, 541, 541A, 542, and 542A and the accompanying written instructions may be obtained from the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-5877, or http://www.nrc.gov.

b) NRC Forms 540 and 540A shall be completed and shall physically accompany each low-level radioactive waste shipment. Each licensee shipping low-level radioactive waste shall transfer manifest information to the consignee.

c) Upon agreement between the shipper and the consignee, NRC Forms 541, 541A, 542, or 542A may be completed, transmitted, and stored in electronic media with the capability of producing legible, accurate, and complete records on the respective forms. Copies of manifests required by this Section may be legible carbon copies, photocopies, or computer printouts that reproduce the data in the format of the uniform manifest.

d) Licensees are exempt from the manifesting requirements of this Section when shipping:

1. Low-level radioactive waste for processing and when they expect its return (i.e., for storage under their license) prior to disposal at a licensed disposal facility;

2. Low-level radioactive waste that is being returned to the licensee who is the waste generator; or

3. Radioactively contaminated material to a waste processor that becomes the processor's residual waste.

e) Each licensee shipping low-level radioactive waste shall also comply with the reporting requirements specified in 32 Ill. Adm. Code 609.

f) Each shipper of radioactive waste shall provide the following information regarding the waste shipment on the uniform manifest:

1. The name, facility address, and telephone number of the licensee shipping the waste;

2. An explicit declaration indicating whether the shipper is acting as a waste generator, collector or processor, or a combination of these identifiers, for purposes of the manifested shipment;

3. The name, address, and telephone number, or the name and USEPA identification number, for the carrier transporting the waste;

4. The date of the waste shipment;

5. The total number of packages/disposal containers;

6. The total disposal volume and disposal weight in the shipment;

7. The total radionuclide activity in the shipment;

8. The activity of each of the radionuclides H-3, C-14, Tc-99 and I-129 contained in the shipment; and

9. The total masses of U-233, U-235, and plutonium in special nuclear material, and the total mass of uranium and thorium in source material.

AGENCY NOTE: The reporting requirements of the uniform manifest meet the reporting requirements of USDOT for the shipments of waste. Therefore, no additional USDOT forms are required for shipments of low-level radioactive waste. However, the uniform manifest does not meet the reporting requirements of USEPA for the shipment of hazardous, medical, or other waste. Any additional USEPA requirements shall be met by using an additional USEPA manifest. In addition, the uniform manifest reporting requirements do not meet the tracking requirements of 32 Ill. Adm. Code 609.

g) For waste shipments in disposal containers, each shipper shall provide the following information on the uniform manifest regarding the waste and each disposal container of waste in the shipment:

1. An alphabetic or numeric identification that identifies each disposal container in the shipment;

2. A physical description of the disposal container, including the manufacturer and model of any high integrity container;

3. The volume displaced by the disposal container;

4. The gross weight of the disposal container, including the waste;

5. For waste consigned to a disposal facility, the maximum radiation level at the surface of each disposal container;

6. A physical and chemical description of the waste;

7. The total weight percentage of chelating agent for any waste containing more than 0.1 percent chelating agent by weight, plus the identity of the principal chelating agent;

8. The approximate volume of waste within a container;

9. The sorbing or solidification media, if any, and the identity of the manufacturer of the solidification media and brand name;

10. The identities and activities of individual radionuclides contained in each container, the masses of U-233, U-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material. For discrete waste types (i.e., activated materials, contaminated equipment, mechanical filters, sealed sources/devices, and wastes in solidification/ stabilization media), the identities and activities of individual radionuclides associated with or contained in these waste types within a disposal container shall be reported;

11. The total radioactivity within each container; and

12. For wastes consigned to a disposal facility, the classification of the waste shall be identified on the manifest pursuant to Section 340.1052. Waste not meeting the structural stability requirements of Section 340.1055(b) shall also be identified on the manifest.

h) For waste shipments delivered without a disposal container, the shipper of the radioactive waste shall provide the following information on the uniform manifest:

1. The approximate volume and weight of the waste;

2. A physical and chemical description of the waste;

3. The total weight percentage of chelating agent for any waste containing more than 0.1 percent chelating agent by weight, plus the identity of the principal chelating agent;

4. For wastes consigned to a disposal facility, the classification of the waste shall be identified on the manifest pursuant to Section 340.1052. Waste not meeting the structural stability requirements of Section 340.1055(b) shall also be identified on the manifest;

5. The identities and activities of individual radionuclides contained in the waste, the masses of U-233, U-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material; and

6. For waste consigned to a disposal facility, the maximum radiation levels at the surface of the waste.

i) For waste comprised of mixtures of waste originating from different waste generators, the shipper shall provide the following information on the uniform manifest:

AGENCY NOTE: The origin of the low-level radioactive waste resulting from a processor's activities may be attributable to one or more "waste generators" as defined in this Part.

1. 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 waste generator.

2. 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 (i.e., activated materials, contaminated equipment, mechanical filters, sealed source/devices and wastes in solidification/stabilization media), the identities and activities of individual radionuclides contained on these waste types within the disposal container. For each waste generator, provide the following:

A) The volume of waste;

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 waste containing more than 0.1 percent 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 Section 340.1055(b); and

E) Radionuclide identities and activities contained in the waste, the masses of U-233, U-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material if contained in the waste.

j) An authorized representative of the licensee shall 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 requirements of USDOT regulations and this Part. A collector, in signing the certification, is certifying that nothing has been done to the collected waste that would invalidate the waste generator's certification.

k) Any licensee who transfers radioactive waste to a land disposal facility or a licensed waste collector shall comply with the requirements in subsections (k)(1) through (9). Any licensee who transfers waste to a licensed waste processor for waste treatment or repackaging shall comply with the requirements of subsections (k)(4) through (9). The licensee shall:

1. Prepare all wastes so that the waste is classified according to Section 340.1052 and meets the waste characteristics requirements in Section 340.1055;

2. 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, in accordance with Section 340.1052;

3. Conduct a quality assurance program to assure compliance with Sections 340.1052 and 340.1055 (the program shall include management evaluation of audits);

4. Prepare the appropriate NRC Uniform Low-Level Radioactive Waste Manifest form as required by this Part;

5. Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that receipt of the manifest precedes the low-level radioactive waste shipment, or the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using either or both of these methods is acceptable;

6. Include NRC Form 540 (and NRC Form 540A, if required) with the shipment regardless of the option chosen in subsection (k)(5);

7. Receive acknowledgement of the receipt of the shipment in the form of a signed copy of NRC Form 540;

8. Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgement of receipt as the record of transfer of licensed material as required by the Agency; and

9. For any shipments or any part of a shipment for which acknowledgement of receipt has not been received within the times set forth in this Part, conduct an investigation in accordance with Section 340.1270.

l) Any waste collector licensee who handles only prepackaged waste shall comply with subsections (l)(1) and (2) and (l)(7) through (12). Any licensed waste processor who treats or repackages waste shall comply with subsections (l)(1) and (l)(3) through (12).

1. Acknowledge receipt of the waste from the shipper within one week after receipt by returning a signed copy of NRC Form 540 to the shipper;

2. Prepare a new manifest to reflect consolidated shipments that meet the requirements of this Part. The waste collector shall ensure that, for each container of waste in the shipment, the manifest identifies the generator of that container of waste;

3. Prepare a new manifest that meets the requirements of this Part. 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 shall identify the waste generators, the preprocessed waste volume, and the other information required in subsection (i);

4. Prepare all wastes so that the waste is classified according to Section 340.1052 and meets the waste characteristics requirements in Section 340.1055;

5. Label each package of waste to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with Sections 340.1052 and 340.1055;

6. Conduct a quality assurance program to assure compliance with Sections 340.1052 and 340.1055 (the program shall include management evaluation of audits);

7. Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that receipt of the manifest precedes the low-level radioactive waste shipment, or the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using either or both of these methods is acceptable;

8. Include NRC Form 540 (and NRC Form 540A, if required) with the shipment regardless of the option chosen in subsection (l)(7);

9. Receive acknowledgement of the receipt of the shipment in the form of a signed copy of NRC Form 540;

10. Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgement of receipt as the record of transfer of licensed material as required by the Agency;

11. For any shipments or any part of a shipment for which acknowledgement of receipt has not been received within the times set forth in this Part, conduct an investigation in accordance with Section 340.1270; and

12. Notify the shipper and the Agency 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 cancelled.

m) Any licensed land disposal facility operator shall:

1. Acknowledge receipt of low-level radioactive waste within 1 week after receipt by returning, at a minimum, a signed copy of NRC Form 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 shall be returned indicating the discrepancy;

2. Maintain copies of all completed manifests until the Agency terminates the license; and

3. Notify the shipper and the Agency 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 cancelled.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

32 Ill. Adm. Code 340.1070 Compliance with Environmental and Health Protection Regulations

Nothing in this Subpart K relieves the licensee from complying with other applicable federal, State and local regulations governing any other toxic or hazardous properties of materials that are disposed of pursuant to this Subpart.

32 Ill. Adm. Code 340.1110 General Provisions

a) Each licensee or registrant shall use the SI units becquerel, gray, sievert and coulomb/kilogram or the special units curie, rad, rem and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this Part.

b) The licensee or registrant shall make a clear distinction among the quantities entered on the records required by this Part (e.g., total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, committed effective dose equivalent).

c) No licensee or registrant shall subtract radiation exposures from official personnel monitoring records without the prior written approval of the Agency.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1120 Records of Radiation Protection Programs

a) Each licensee or registrant shall maintain records of the radiation protection program required pursuant to Section 340.110 of this Part, including:

1. The provisions of the program; and

2. Audits and other reviews of program content and implementation.

b) The licensee or registrant shall retain the records required by subsection (a)(1) of this Part until the Agency terminates each license or registration for which the record is required. The licensee or registrant shall retain the records required by subsection (a)(2) of this Section for 5 years after the record is made.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1130 Records of Surveys and Calibrations

a) Each licensee or registrant shall maintain records showing the results of surveys and calibrations required by Sections 340.510 and 340.960(b). The licensee or registrant shall retain these records for 5 years after the record is made.

1. Records of surveys shall include:

A) The location and date of the survey and the model and serial number of the instrument used to perform the survey;

B) The identity of the individual performing the survey; and

C) The results of the survey and any corrective actions that were taken as a result.

2. For each survey instrument calibrated in accordance with Section 340.510(b), the licensee shall maintain the following records:

A) A copy of the licensee's own calibration procedures or a copy of a license issued by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State authorizing the person that performed the calibrations to perform calibrations as a customer service; and

B) A record identifying the manufacturer, model, and serial number of the instrument that was calibrated, the calibration results, the identity of the individual who performed the calibration, and the date of the calibration.

3. Each licensee authorized to perform instrument calibrations shall maintain a copy of each calibration document created in accordance with subsection (a)(2)(B) and a copy of the procedures followed to perform that calibration.

4. The licensee shall retain a record of each check required in Section 340.510(c) for 5 years.

b) The licensee or registrant shall retain each of the following records until the Agency terminates each license or registration for which the record is required:

1. Records of the results of surveys to determine the dose from external sources of radiation that are used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents;

2. Records of the results of measurements and calculations that are used to determine individual intakes of radioactive material and that are used in the assessment of internal dose;

3. Records showing the results of air sampling, surveys, and bioassays required pursuant to Section 340.730(a)(3)(A) and (B);

4. Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment; and

5. Records from surveys describing the location and amount of subsurface residual radioactivity identified at the site.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

32 Ill. Adm. Code 340.1135 Records of Tests for Leakage or Contamination of Sealed Sources

a) Records of tests for leakage or contamination required by Section 340.410 of this Part shall be kept in units of becquerel or microcurie and maintained for inspection by the Agency for 5 years after the records are made.

b) The records of tests for leakage and/or contamination shall contain the manufacturer, model and serial number, if assigned, of each source tested, the identity of each source radionuclide, the results for each test sample expressed in Bq or µCi, the date the sample was collected, the date the sample was analyzed, the identity of the individual who collected the samples and the identity of the individual who analyzed the samples.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1140 Records of Prior Occupational Dose

a) The licensee or registrant shall retain the records of prior occupational dose and exposure history as specified in Section 340.250 of this Part until the Agency terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing the prior occupational dose and exposure history for 3 years after the record is made.

b) Upon termination of the license or registration, the records of prior occupational dose and exposure history shall be transferred to the Agency.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1150 Records of Planned Special Exposures

a) For each use of the provisions of Section 340.260 of this Part for planned special exposures, the licensee shall maintain records that describe:

1. The exceptional circumstances requiring the use of a planned special exposure;

2. The name of the management official who authorized the planned special exposure and a copy of the signed authorization;

3. What actions were necessary;

4. Why the actions were necessary;

5. What precautions were taken to assure that doses were maintained ALARA;

6. What individual and collective doses were expected to result; and

7. The doses actually received in the planned special exposure.

b) The licensee shall retain the records until the Agency terminates each license for which these records are required.

c) Upon termination of the license, the records of doses received during planned special exposures shall be transferred to the Agency.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1160 Records of Individual Monitoring Results

a) Recordkeeping Requirement. Each licensee or registrant shall maintain records of doses received by all individuals for whom monitoring was required pursuant to Section 340.520, and records of doses received during planned special exposures, accidents, and emergency conditions. These records shall include, when applicable:

1. The deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;

2. The estimated intake of radionuclides (see Section 340.220);

3. The committed effective dose equivalent assigned to the intake of radionuclides;

4. The specific information used to calculate the committed effective dose equivalent pursuant to Section 340.240(c);

5. The total effective dose equivalent when required by Section 340.220; and

6. The total of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest total dose.

b) Recordkeeping Frequency. The licensee or registrant shall make entries of the records specified in subsection (a) at least annually.

c) Recordkeeping Format. The licensee or registrant shall maintain the records specified in subsection (a) on NRC Form 5, in accordance with the instructions for NRC Form 5, or in clear and legible records containing all the information required by NRC Form 5.

d) The licensee or registrant shall maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy, and the estimated date of conception, shall also be kept on file, but may be maintained separately from the dose records.

e) The licensee or registrant shall retain each required form or record until the Agency terminates each license or registration for which the record is required.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

32 Ill. Adm. Code 340.1170 Records of Dose to Members of the Public

a) Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public (see Sections 340.310 and 340.320 of this Part).

b) The licensee or registrant shall retain the records required by subsection (a) of this Section until the Agency terminates each license or registration for which the record is required.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1180 Records of Waste Disposal

a) Each licensee shall maintain records of the disposal of licensed materials made pursuant to Sections 340.1020 through 340.1052 and 340.1060 and 32 Ill. Adm. Code 601. Each licensee shall also maintain records of disposal by burial in soil, including burials authorized before January 28, 1981, pursuant to 10 CFR 20.304.

AGENCY NOTE: Prior to January 28, 1981, the U.S. Nuclear Regulatory Commission permitted licensees to dispose of small quantities of licensed materials by burial in soil without specific Nuclear Regulatory Commission authorization. This was authorized pursuant to 10 CFR 20.304, which has been rescinded.

b) The licensee shall retain the records required by subsection (a) until the Agency terminates each license for which the record is required.

History

• Source: Amended at 35 Ill. Reg. 934, effective December 30, 2010

32 Ill. Adm. Code 340.1190 Records of Testing Entry Control Devices for Very High Radiation Areas

a) Each licensee or registrant shall maintain records of tests made pursuant to Section 340.630(b)(9) of this Part on entry control devices for very high radiation areas. These records must include the date, time and results of each such test of function.

b) The licensee or registrant shall retain the records required by subsection (a) of this Section for 3 years after the record is made.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1195 Form of Records (repealed)

History

• Source: Repealed at 35 Ill. Reg. 934, effective December 30, 2010

32 Ill. Adm. Code 340.1205 Notification of Credible Threats

Upon notification to or by any Federal, State or local law enforcement agency or the U.S. Department of Homeland Security that radioactive material in possession by the licensee is the subject of a credible threat, the licensee shall:

a) follow the instructions from the law enforcement agency; and

b) notify the Agency within 1 hour by calling the Agency's 24-hour emergency number at (217)782-7860 or (800)782-7860. This notification is required unless otherwise instructed by the law enforcement agency.

AGENCY NOTE: "Credible threat" means any threat to radioactive material that a licensee believes warrants notice to law enforcement or any threat that law enforcement believes warrants notice to a licensee.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1210 Reports of Stolen, Lost, or Missing Sources of Radiation

a) Telephone Reports. Each licensee or registrant shall report to the Agency by telephone at (217) 782-7860 each stolen, lost, or missing source of radiation immediately after its absence becomes known to the licensee or registrant. This requirement does not apply to sources of radiation that are not required to be licensed or registered.

b) Written Reports. Each licensee or registrant required to make a report pursuant to subsection (a) shall, within 30 days after making the telephone report, make a written report to the Agency setting forth the following information:

1. A description of the source of radiation involved, including for radioactive material, the kind, quantity, and chemical and physical form; and, for radiation machines, the type of unit, the manufacturer, model, and serial number;

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

3. A statement of disposition, or probable disposition, of the source of radiation involved;

4. Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas;

5. Actions that have been taken, or will be taken, to recover the source of radiation; and

6. Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the theft or loss of sources of radiation.

c) Subsequent to filing the written report, the licensee or registrant shall also report any additional substantive information on the loss or theft within 30 days after the licensee or registrant learns of such information.

d) The licensee or registrant shall prepare any report filed with the Agency pursuant to this Section so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

32 Ill. Adm. Code 340.1220 Notification of Incidents

a) Immediate Notification. Notwithstanding any other requirements for notification, each licensee or registrant shall immediately report to the Agency discovery of an event that prevents immediate protective actions necessary to avoid releases of radioactive material or doses in excess of the regulatory limits, or each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions:

1. An individual to receive:

A) A total effective dose equivalent of 0.25 Sv (25 rem) or more; or

B) A lens dose equivalent of 0.75 Sv (75 rem) or more; or

C) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 2.5 Gy (250 rad) or more; or

2. 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 ALI, except the provisions of this subsection (a) do not apply to locations where personnel are not normally stationed during routine operations, such as hot cells or process enclosures.

b) 24 Hour Notification. Each licensee or registrant shall, within 24 hours of discovery of the event, report to the Agency each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause, any of the following conditions:

1. An individual to receive, in a period of 24 hours:

A) A total effective dose equivalent exceeding 0.05 Sv (5 rem); or

B) A lens dose equivalent exceeding 0.15 Sv (15 rem); or

C) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 0.5 Sv (50 rem); or

2. 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 ALI, except the provisions of this subsection (b) do not apply to locations where personnel are not normally stationed during routine operations, such as hot cells or process enclosures.

c) Additional 24 Hour Notifications for Licensees. Each licensee shall notify the Agency within 24 hours after the discovery of any of the following events involving radioactive material:

1. An unplanned contamination event that:

A) Requires access to the contaminated area by workers or the public to be restricted for more than 24 hours by imposing radiological controls in addition to those established by the licensee prior to the event or by prohibiting entry into the area;

B) Involves a quantity of material greater than five times the lowest annual limit on intake specified in 10 CFR 20, appendix B, published at 72 Fed. Reg. 55922, October 1, 2007, for the material; and

C) Results in access to the area being restricted for a reason other than to comply with operating procedures established by the licensee or to allow radionuclides with a half-life of less than 24 hours to decay prior to decontamination.

2. An event in which equipment is disabled or fails to function as designated when:

A) The equipment is required by regulation or license condition to prevent releases or doses exceeding regulatory limits, or to mitigate the consequences of an accident;

B) The equipment is required to be available and operable when it is disabled or fails to function; and

C) No redundant equipment is available and operable to perform the required safety function.

3. An event that requires unplanned medical treatment at a medical facility of an individual with radioactive contamination on the individual's clothing or body.

4. An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

A) The quantity of material involved is greater than five times the lowest annual limit on intake specified in 10 CFR 20, appendix B, published at 72 Fed. Reg. 55922, October 1, 2007, for the material; and

B) The damage affects the integrity of the licensed material or its container.

d) Licensees or registrants shall make the reports required by subsections (a) through (c) by initial contact by telephone to the Agency at (217) 782-7860 and shall confirm the initial contact within 24 hours by overnight letter or telefacsimile to the Agency.

e) The licensee or registrant shall prepare each written report filed with the Agency pursuant to this Section so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.

f) The provisions of this Section 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 pursuant to Section 340.1240.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

32 Ill. Adm. Code 340.1230 Reports of Exposures, Radiation Levels and Concentrations of Radioactive Material Exceeding the Constraints or Limits

a) Reportable Events. In addition to the notification required by Section 340.1220 of this Part, each licensee or registrant shall submit a written report to the Agency within 30 days after learning of any of the following occurrences:

1. Incidents for which notification is required by Section 340.1220 of this Part; or

2. Doses in excess of any of the following:

A) The occupational dose limits for adults in Section 340.210 of this Part; or

B) The occupational dose limits for a minor in Section 340.270 of this Part; or

C) The limits for an embryo/fetus of a declared pregnant woman in Section 340.280 of this Part; or

D) The limits for an individual member of the public in Section 340.310 of this Part; or

E) Any applicable limit in the license; or

F) The ALARA constraints for air emissions established pursuant to Section 340.110(d) of this Part; or

3. Levels of radiation or concentrations of radioactive material in:

A) A restricted area in excess of any applicable limit in the license; or

B) An unrestricted area in excess of ten times any applicable limit set forth in this Part or ten times any applicable limit set forth in the license, whether or not involving exposure of any individual in excess of the limits in Section 340.310.

b) Contents of Reports

1. Each report required by subsection (a) of this Section shall include a description of the event, including the date, time and location of the event, the manufacturer and model number of any equipment that failed or malfunctioned and the identity, quantities and chemical forms of any radionuclides involved. Each report shall also describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:

A) Estimates of each individual's dose;

B) The levels of radiation and concentrations of radioactive material involved;

C) The cause of the elevated exposures, dose rates or concentrations; and

D) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, generally applicable environmental standards and associated license conditions.

2. Each report filed pursuant to subsection (a) of this Section shall include for each individual exposed: the name, Social Security account number and date of birth. With respect to the limit for the embryo/fetus in Section 340.280 of this Part, the identifiers shall be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable portion of the report.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1240 Reports of Planned Special Exposures

The licensee shall submit a written report to the Agency within 30 days following any planned special exposure conducted in accordance with Section 340.260 of this Part, informing the Agency that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by Section 340.1150 of this Part.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1250 Notifications and Reports to Individuals

a) Requirements for notification and reports to individuals of exposure to radiation or radioactive material are specified in 32 Ill. Adm. Code 400.130.

b) When a licensee or registrant is required by Section 340.1230 or 340.1240 to report to the Agency an exposure of an individual to radiation or radioactive material, the licensee or registrant shall also notify the individual. The notice shall be transmitted at a time not later than the transmittal to the Agency and shall comply with the provisions of 32 Ill. Adm. Code 400.130(a).

History

• Source: Amended at 35 Ill. Reg. 934, effective December 30, 2010

32 Ill. Adm. Code 340.1260 Reports of Leaking or Contaminated Sealed Sources

The licensee shall file a report within 5 days with the Agency if the test for leakage or contamination required pursuant to Section 340.410 of this Part indicates a sealed source is leaking or contaminated. The report shall describe the equipment involved, the test results and the corrective action taken.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1270 Reports of Missing Waste Shipments

Any shipment or part of a shipment for which acknowledgement is not received within the times set forth in Subpart K shall:

a) Be investigated by the shipper if the shipper has not received notification or receipt within 20 days after transfer; and

b) Be traced and reported. The investigation shall include tracing the shipment and each licensee who conducts a trace investigation shall file a written report with the Agency within 2 weeks after completion of the investigation.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

32 Ill. Adm. Code 340.1310 Vacating Premises

Each specific licensee shall, 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 his activities, notify the Agency in writing of intent to vacate.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.1320 Removal of Radioactive Contamination

Notwithstanding any exemptions contained in this Part, any person who uses, possesses, or stores radioactive material in such a manner as to cause uncontrolled contamination of any area shall, upon order of the Agency, remove or provide for the removal of such contaminants at his own expense through the use of an authorized transferee and shall decontaminate the installation to the lowest practicable level. Unless another value is specified in 32 Ill. Adm. Code 332, the values specified in Appendix A of this Part may be used as guidelines for this purpose. These values, however, may be modified at specific installations at the discretion of the Agency.

History

• Source: Amended at 29 Ill. Reg. 20841, effective December 16, 2005

32 Ill. Adm. Code 340.APPENDIX A Decontamination Guidelines

a) Surface Contamination Guide

Alpha Emitters:

Removable

555 mBq (15 pCi) per 100 cm2

33 dpm per 100 cm2

average over any one surface

1.67 Bq (45 pCi) per 100 cm2

100 dpm per 100 cm2

maximum

Total Fixed

16.7 Bq (450 pCi) per 100 cm2

1,000 dpm per 100 cm2

average over any one surface

83.3 Bq (2,250 pCi) per 100 cm2

5,000 dpm per 100 cm2

maximum

Beta-Gamma Emitters:

Removable

(all beta-gamma emitters except hydrogen-3)

3.7 Bq (100 pCi) per 100 cm2

222 dpm per 100 cm2

average over any one surface

18.5 Bq (500 pCi) per 100 cm2

1,110 dpm per 100 cm2

maximum

Removable

(hydrogen-3)

37 Bq (1,000 pCi) per 100 cm2

2,220 dpm per 100 cm2

average over any one surface

185 Bq (5,000 pCi) per 100 cm2

maximum

Total Fixed

2.5 microSv (250 microrem) per hour at 1 cm from surface

b) Concentration in air and water: tables I and II of appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007.

c) Concentrations in soil and other materials except water:

1. Radioactive material except source material and radium: Column II of 32 Ill. Adm. Code 330.Appendix A.

2. Source material and radium: Concentration of radionuclides above background concentrations for total radium, averaged over areas of 100 square meters, shall not exceed:

A) 185 mBq (5 pCi) per gram of dry soil, averaged over the first 15 centimeters below the surface; and

B) 185 mBq (5 pCi) per gram of dry soil, averaged over layers of 15 centimeters thickness more than 15 centimeters below the surface.

d) The level of gamma radiation measured at a distance of 100 centimeters from the surface shall not exceed background.

AGENCY NOTE: This appendix shall be used only as a guide. The Agency may require lower values in specific instances, depending upon radionuclides, type of surface, intended present and future use, etc.

History

• Source: Amended at 35 Ill. Reg. 934, effective December 30, 2010

32 Ill. Adm. Code 340.ILLUSTRATION A Radiation Symbol

1. Cross-hatched area is to be magenta, purple, or black.

2. Background is to be yellow.

History

• Source: Amended at 47 Ill. Reg. 9163, effective June 22, 2023

Part 341 Radioactive Materials Transportation

32 Ill. Adm. Code 341.10 Scope

a) This Part applies to each licensee who transports licensed material outside the site where the licensee is authorized to possess and use the material or who transports the material on public highways or who delivers the material to a carrier for transport. The licensee shall comply with the regulations in this Part, the applicable requirements of the U.S. Nuclear Regulatory Commission (NRC) in 10 CFR 71, in effect as of December 30, 2019, and the applicable requirements of the U.S. Department of Transportation (USDOT) regulations appropriate to the mode of transport in 49 CFR 170-189, in effect as of December 30, 2019.

AGENCY NOTE: Where the words "NRC", "Commission", "Nuclear Regulatory Commission", "United States Nuclear Regulatory Commission" or "Administrator of the appropriate Regional Office" appear in 10 CFR 71, substitute the words "Illinois Emergency Management Agency (Agency or IEMA)" except when used in 10 CFR 71.5(b), 71.10, 71.17(c)(3) and (e), 71.85 (c), 71.88(a)(4), 71.93(c), 71.95, 71.97(c), (c)(3)(iii) and (f). In addition, the terms "certificate of compliance, compliance holder or applicant" apply to the NRC as they are the sole authority for issuing a package Certificate of Compliance.

b) When the licensee is not in areas under the jurisdiction of USDOT or NRC, but is in an area of jurisdiction of the State of Illinois as described in subsection (a) of this Section, the licensee shall comply with the following portions of USDOT and NRC regulations, as applicable:

1. Packaging, 49 CFR 173, subparts A, B and I;

2. Marking and labeling, 49 CFR 172, subpart D, paragraphs 172.400-172.407, 172.436-172.440 and subpart E;

3. Placarding, 49 CFR 172, subpart F, paragraphs 172.500-172.519 and 172.556; and appendices B and C;

4. Shipping papers and emergency information, 49 CFR 172, subparts C and G;

5. Accident reporting, 49 CFR 171.15 and 171.16;

6. Hazardous material shipper/carrier requirements, 49 CFR 107, subpart G;

7. Hazardous material employee training, 49 CFR 172, subpart H;

8. Definitions, 10 CFR 71.4;

9. Transportation of licensed material, 10 CFR 71.5;

10. Exemptions for low level material, 10 CFR 71.14(a);

11. General license: NRC-approved package, 10 CFR 71.17;

12. Previously approved package, 10 CFR 71.19(a) and (b);

13. General license: USDOT specification container material, 10 CFR 71.20;

14. General license: Use of foreign approved package, 10 CFR 71.21;

15. General license: Fissile material, 10 CFR 71.22;

16. External radiation standards for all packages, 10 CFR 71.47;

17. Assumptions as to unknown properties, 10 CFR 71.83;

18. Preliminary determinations, 10 CFR 71.85;

19. Routine determinations, 10 CFR 71.87;

20. Air transportation of plutonium, 10 CFR 71.88;

21. Opening instructions, 10 CFR 71.89;

22. Advance notification of shipment of irradiated reactor fuel and nuclear waste, 10 CFR 71.97;

23. Quality assurance requirements, 10 CFR 71.101(a), (b), (c), (f) and (g);

24. Quality assurance organization, 10 CFR 71.103;

25. Quality assurance program, 10 CFR 71.105; and

26. Determination of A1 and A2, 10 CFR 71, appendix A.

c) The licensee shall also comply with USDOT regulations pertaining to the following modes of transportation:

1. Rail, 49 CFR 174, subparts A-D and K;

2. Air, 49 CFR 175;

3. Vessel, 49 CFR 176, subparts A-F and M; and

4. Public highway, 49 CFR 177 and 390-397.

d) If USDOT regulations are not applicable to a shipment of licensed material as described in subsection (a), the licensee shall conform to the standards and requirements of USDOT specified in subsection (a) to the same extent as if the shipment or transportation were subject to USDOT 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 Agency.

e) Common and contract carriers, freight forwarders, warehousemen and the U.S. Postal Service are exempt from the requirements for a license set forth in 420 ILCS 40/10, 11 and 12 and in 32 Ill. Adm. Code 330, 335, 337, 346, 350 and 351 to the extent that they transport or store byproduct material in the regular course of carriage for another or storage incident to that carriage.

History

• Source: Amended at 44 Ill. Reg. 12733, effective July 17, 2020

32 Ill. Adm. Code 341.20 Incorporations by Reference

All rules, standards, and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified in the reference and do not include any later amendments or editions. Copies of these rules, standards or guidelines that have been incorporated by reference are available for public inspection and copying at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois.

32 Ill. Adm. Code 341.25 Definitions

Definition of terms used in this Part are those in 49 CFR and 10 CFR 71.4, except that whenever a definition refers to evaluation or approval by the U.S. DOT or NRC and such evaluation or approval is the jurisdiction of the State of Illinois because it is an Agreement State, the Agency shall perform the evaluation and approval.

AGENCY NOTE: Some terms, such as Agency, that are not defined in 49 CFR or 10 CFR 71.4 may be found in Agency rules at 32 Ill. Adm. Code 310.

32 Ill. Adm. Code 341.30 General License

a) A general license is hereby issued to any licensee of the Agency to transport, or to deliver to a carrier for transport, licensed material in a package that meets the requirements of U.S. DOT.

b) The general license issued under subsection (a) of this Section applies only to a licensee who, prior to the licensee's first use of a package, has registered with the NRC.

32 Ill. Adm. Code 341.40 Records

a) Each licensee shall maintain, for radioactive waste, a record of each shipment of radioactive material not exempt pursuant to USDOT regulations, such as the shipping paper copy, for three years after the material is accepted by the initial carrier. For all other radioactive materials not exempt pursuant to USDOT regulations, each licensee shall maintain a record of each shipment of radioactive material, such as the shipping paper copy, for 375 days after the material is accepted by the initial carrier. The record of each shipment shall show, where applicable:

1. Identification of the packaging by model and serial number;

2. Verification that there are no significant defects in the packaging as shipped;

3. Volume and identification of coolant;

4. Type and quantity of licensed material in each package and the total quantity of each shipment;

5. Date of the shipment;

6. Name and address of the transferee;

7. Address to which the shipment was made;

8. Results of the determinations required by Section 341.10(b)(19) of this Part and by the conditions of the package approval; and

9. In addition, for each item of irradiated fissile material:

A) Identification by model and serial number;

B) Irradiation and decay history to the extent appropriate to demonstrate that its nuclear and thermal characteristics comply with license conditions; and

C) Any abnormal or unusual condition relevant to radiation safety.

b) The licensee shall make available to the Agency for inspection, at any time during shipment or upon 3 days notice after shipment, all records required by this Part. Records are only valid if stamped, initialed or signed and dated by authorized personnel or otherwise authenticated.

c) The licensee shall maintain sufficient written records to furnish evidence of the quality of packaging. The records to be maintained include results of the determinations required by Section 341.10(b)(19) of this Part; 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. The records must be retained for 3 years after the life of the packaging to which they apply.

History

• Source: Amended at 30 Ill. Reg. 9160, effective April 28, 2006

32 Ill. Adm. Code 341.50 Reports

The licensee shall report to the Agency within 30 days:

a) Any instance in which there is significant reduction in the effectiveness of any approved Type B or fissile packaging during use;

b) Details of any defects with safety significance in Type B or fissile packaging after first use, with the means employed to repair the defects and prevent their recurrence; and

c) Instances in which the conditions of approval in the certificate of compliance were not observed in making a shipment.

Part 346 Licenses and Radiation Safety Requirements for Irradiators

32 Ill. Adm. Code 346.10 Purpose

This Part contains requirements for the issuance of a license by the Illinois Emergency Management Agency (Agency), authorizing the use of sealed sources containing radioactive materials in irradiators used to irradiate objects or materials using gamma radiation. Also included are radiation safety requirements for irradiators currently in operation.

32 Ill. Adm. Code 346.20 Scope

a) This Part is in addition to, and not in substitution for, other Parts in 32 Ill. Adm. Code: Chapter II, Subchapter b. The requirements of 32 Ill. Adm. Code: Chapter II, Subchapter b apply to applicants and licensees subject to this Part. Nothing in this Part relieves the licensee from complying with other applicable Federal, State and local regulations governing the siting, zoning, land use and building code requirements for industrial facilities.

b) This Part also applies to panoramic irradiators that have either dry or wet storage of the radioactive sealed sources and to underwater irradiators in which both the source and the product being irradiated are under water. Irradiators whose dose rates exceed 5 grays (500 rads) per hour at 1 meter from the radioactive sealed sources in air or in water, as applicable to the irradiator type, are covered by this Part.

c) This Part 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.

32 Ill. Adm. Code 346.30 Incorporations by Reference

All rules, standards and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified in the reference and do not include any later amendments or editions. Copies of rules, standards or guidelines that have been incorporated by reference are available for public inspection and copying at the Agency, 1035 Outer Park Drive, Springfield, Illinois.

AGENCY NOTE: In this Part, the Agency has incorporated by reference Title 10 of the Code of Federal Regulations (10 CFR 36; 2004).

32 Ill. Adm. Code 346.40 Definitions

"Doubly encapsulated sealed source" means a sealed source in which the radioactive material is sealed within a capsule and that capsule is sealed within another capsule.

"Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding 5 grays (500 rads) per hour exist at 1 meter from the sealed radioactive sources in air or water, as applicable to the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

"Irradiator operator" means an individual who has successfully completed the training and testing described in Section 346.510 and is authorized by the terms of the license to operate the irradiator without a supervisor present.

"Panoramic dry-source-storage irradiator" means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which sources are stored in shields made of solid materials. The term includes beam-type dry-source-storage irradiators in which only a narrow beam of radiation is produced for performing irradiations.

"Panoramic irradiator" means an irradiator in which the irradiations are done in air and in areas potentially accessible to personnel. The term includes beam-type irradiators.

"Panoramic wet-source-storage irradiator" means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored under water in a storage pool.

"Pool irradiator" means any irradiator at which the sources are stored or used in a pool of water, including panoramic wet-source-storage irradiators and underwater irradiators.

"Product conveyor system" means a system for moving the product to be irradiated to, from and within the area where irradiation takes place.

"Radiation room" means a shielded room in which irradiations take place. Underwater irradiators do not have radiation rooms.

"Sealed source" means any radioactive material that is used as a source of radiation and is encased in a capsule designed to prevent leakage or escape of the radioactive material.

"Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in 250 years is greater than 10 percent, as designated by the U.S. Geological Survey.

"Underwater irradiator" means an irradiator in which the sources always remain shielded under water and personnel do not have access to the sealed sources or the space subject to irradiation without entering the pool.

History

• Source: Amended at 47 Ill. Reg. 9201, effective June 22, 2023

32 Ill. Adm. Code 346.110 Application for Specific License

A person, as defined in 32 Ill. Adm. Code 310.20, may file an application for a specific license authorizing the use of sealed sources in an irradiator on the Agency's application form entitled "Application Form for Non-Medical Radioactive Material License". Applications shall be filed in accordance with 32 Ill. Adm. Code 330.240.

32 Ill. Adm. Code 346.130 Specific License for Irradiators

The Agency will approve an application for a specific license to operate an irradiator if the applicant meets the requirements contained in this Section.

a) The applicant shall satisfy the general requirements specified in 32 Ill. Adm. Code 330.250 and the requirements contained in this Part.

b) The application shall describe the training provided to irradiator operators including:

1. Classroom training;

2. On-the-job or simulator training;

3. Safety reviews;

4. Means employed by the applicant to test each operator's understanding of the Agency's regulations and licensing requirements and the irradiator operating and emergency procedures; and

5. Minimum training and experience of personnel who may provide training.

c) The application shall include an outline of the written operating and emergency procedures listed in Section 346.530 of this Part that describe the radiation safety aspects of the procedures.

d) The application shall describe the organizational structure for managing the irradiator, specifically the radiation safety responsibilities and authorities of the radiation safety officer and those management personnel who have important radiation safety responsibilities or authorities. In particular, the application shall specify who, within the management structure, has the authority to stop unsafe operations. The application shall also describe the training and experience required for the position of radiation safety officer.

e) The application shall include a description of the access control systems required by Section 346.230 of this Part, the radiation monitors required by Section 346.290 of this Part, the method of detecting leaking sources required by Section 346.590 of this Part, including the sensitivity of the method, and a diagram of the facility that shows the location of all required interlocks and radiation monitors.

f) An application for a panoramic irradiator shall include a description of the facility shielding and fire protection system.

g) An application for a pool irradiator shall include a description of the irradiator pool construction, water level indicators, purification systems and source rack and protection system.

h) If the applicant intends to perform leak testing of dry-source-storage sealed sources, the applicant shall establish procedures for leak testing and submit a description of these procedures to the Agency. The description shall include the:

1. Instruments to be used;

2. Methods of performing the analysis; and

3. Pertinent experience of the personnel analyzing the samples.

i) If the licensee's personnel are to load or unload sources, the applicant shall describe the qualifications and training of the personnel and the procedures to be used. If the applicant intends to contract for source loading or unloading at its facility, the loading or unloading shall be done by an organization specifically authorized by the Agency, U.S. Nuclear Regulatory Commission or an Agreement State to load or unload irradiator sources.

j) The applicant shall describe the inspection and maintenance checks, including the frequency of the checks required by Section 346.610 of this Part.

k) A professional engineer licensed in Illinois shall seal all construction and design plans and specification documents submitted for review by the Agency.

l) Appropriate Agency license fees, as specified in 32 Ill. Adm. Code 331: Appendix F, shall be paid prior to the approval of the specific license.

32 Ill. Adm. Code 346.150 Commencement of Construction

Commencement of construction of a new irradiator may not occur prior to submission to the Agency of an application for a license for the irradiator. As used in this Section, the term "construction" is defined in 32 Ill. Adm. Code 310.20. Any activities undertaken prior to the issuance of a license are entirely at the risk of the applicant and have no bearing on the issuance of a license with respect to the requirements of the Radiation Protection Act of 1990 and regulations and orders issued under the Act. Commencement of construction as defined in 32 Ill. Adm. Code 310.20 may include non-construction activities if the activity has a reasonable nexus to radiological safety and security.

History

• Source: Amended at 47 Ill. Reg. 9201, effective June 22, 2023

32 Ill. Adm. Code 346.210 Performance Criteria for Sealed Sources

a) Requirements. Sealed sources installed after December 1, 2005:

1. Shall have an evaluation sheet issued by the Agency, an Agreement State, a Licensing State or the U.S. Nuclear Regulatory Commission;

2. Shall be doubly encapsulated;

3. Shall use radioactive material that is as nondispersible as practical and that is as insoluble as practical if the source is used in a wet-source-storage or wet-source-change irradiator. Cs-137 sources are prohibited from use in a wet-source-storage or wet-source-change irradiator;

4. Shall be encapsulated in a material resistant to general corrosion and to localized corrosion, such as 316L stainless steel or other material with equivalent resistance, if the sources are for use in irradiator pools;

5. In prototype testing of the sealed source, shall have been leak tested and found leak-free after each of the tests described in subsections (b) through (g) of this Section.

b) Temperature. The test source shall be held at -40ºC for 20 minutes, 600ºC for one hour, and then be subjected to a thermal shock test with a temperature drop from 600ºC to 20ºC within 15 seconds.

c) Pressure. The test source shall be twice subjected for at least 5 minutes to an external pressure (absolute) of 2 million newtons per square meter.

d) Impact. A 2-kilogram steel weight, 2.5 centimeters in diameter, shall be dropped from a height of 1 meter onto the test source.

e) Vibration. The test source shall be subjected 3 times for 10 minutes each to vibrations sweeping from 25 hertz to 500 hertz with a peak amplitude of 5 times the acceleration of gravity. In addition, each test source shall be vibrated for 30 minutes at each resonant frequency found.

f) Puncture. A 50-gram weight and pin (0.3-centimeter pin diameter) shall be dropped from a height of 1 meter onto the test source.

g) Bend. If the length of the source is more than 15 times larger than the minimum cross-sectional dimension, the test source shall be subjected to a force of 2000 newtons at its center, equidistant from the two support cylinders, the distance between which is 10 times the minimum cross-sectional dimension of the source.

32 Ill. Adm. Code 346.230 Access Control

a) Each entrance to a radiation room at a panoramic irradiator shall have a door or other physical barrier to prevent inadvertent entry of personnel if the sources are not in the shielded position. Product conveyer systems may serve as barriers as long as they reliably and consistently function as a barrier. It shall 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 shall cause the sources to return promptly to their shielded position. The personnel entrance door or barrier shall have a lock that is operated by the same key used to move the sources. The doors and barriers shall not prevent any person in the radiation room from leaving.

b) In addition, each entrance to a radiation room at a panoramic irradiator shall have an independent backup access control to detect personnel entry while the sources are exposed. Detection of entry while the sources are exposed shall cause the sources to return to their fully shielded position and shall also activate a visible and audible alarm to make the person entering the room aware of the hazard. The alarm shall also alert at least one other person who is onsite of the entry. That person shall be trained on how to respond to the alarm and prepared to promptly render or summon assistance.

c) A radiation monitor shall be provided to detect the presence of high radiation levels in the radiation room of a panoramic irradiator before personnel entry. The monitor shall be integrated with a personnel access door to prevent room access when radiation levels are high. Attempted personnel entry while the monitor measures high radiation levels shall activate the alarm described in subsection (b). The monitor may be located in the entrance (normally referred to as the maze) but not in the direct radiation beam.

d) Before the sources move from their shielded position in a panoramic irradiator, the source control shall automatically activate conspicuous visible and audible alarms to alert personnel in the radiation room that the sources will be moved from their shielded position. The alarms shall give personnel enough time to leave the room before the sources leave the shielded position.

e) Each radiation room at a panoramic irradiator shall have a clearly visible and readily accessible control that would allow a person in the room to make the sources return to their fully shielded position.

f) Each radiation room of a panoramic irradiator shall contain a control that prevents the sources from moving from the shielded positions unless the control has been activated and the door or barrier to the radiation room has been closed within a pre-set time after activation of the control.

g) Each entrance to the radiation room of a panoramic irradiator and each entrance to the area within the personnel access barrier of an underwater irradiator shall be posted as required by 32 Ill. Adm. Code 340.920. Radiation postings for panoramic irradiators shall comply with the posting requirements of 32 Ill. Adm. Code 340.920, except that signs may be removed, covered, or otherwise made inoperative when the sources are fully shielded.

h) If the radiation room of a panoramic irradiator has roof plugs or other movable shielding, it shall not be possible to operate the irradiator unless the shielding is in its proper location. This requirement may be met by interlocks that prevent operation if shielding is not placed properly or by an operating procedure requiring inspection of shielding before operating.

i) Underwater irradiators shall have a personnel access barrier around the pool that shall be locked to prevent access when the irradiator is not attended. Only operators and facility management shall have access to keys to the personnel access barrier. There shall be an intrusion alarm to detect unauthorized entry when the personnel access barrier is locked. Activation of the intrusion alarm shall alert a person (not necessarily onsite) who is prepared to respond or summon assistance.

History

• Source: Amended at 47 Ill. Reg. 9201, effective June 22, 2023

32 Ill. Adm. Code 346.250 Shielding

a) The radiation dose rate in areas that are normally occupied during operations 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 shall be averaged over an area not to exceed 100 square centimeters having no linear dimensions greater than 20 cm. Areas where the radiation dose rate exceeds 0.02 millisievert (2 millirems) per hour shall be locked, roped off or posted.

b) 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 fully shielded position.

c) 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.

History

• Source: Amended at 47 Ill. Reg. 9201, effective June 22, 2023

32 Ill. Adm. Code 346.270 Fire Protection

a) The radiation room at a panoramic irradiator shall have heat and smoke detectors. The detectors shall activate an audible alarm. The alarm shall be capable of alerting personnel prepared to summon assistance promptly. The sources shall automatically become fully shielded if a fire is detected.

b) The radiation room at a panoramic irradiator shall be equipped with a fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room. The system for the radiation room shall have a shut-off valve to control flooding into unrestricted areas.

c) For fire suppression systems using an extinguishing gas, the radiation room ventilation system shall automatically shut down when the suppression system is activated.

32 Ill. Adm. Code 346.290 Radiation Monitors

a) Irradiators with automatic product conveyor systems shall have a radiation monitor with an audible alarm located to detect loose radioactive sources that are carried toward the product exit. If the monitor detects a source, an alarm shall sound and product conveyors shall stop automatically and the sources shall become fully shielded. The alarm shall be capable of alerting personnel in the facility who are prepared to summon assistance. Underwater irradiators in which the product moves within an enclosed stationary tube are exempt from the requirements of this subsection.

b) Underwater irradiators that are not in a shielded radiation room shall have a radiation monitor over the pool to detect abnormal radiation levels. The monitor shall 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 shall be capable of alerting personnel who are prepared to respond promptly.

32 Ill. Adm. Code 346.310 Control of Source Movement

a) The mechanism that moves the source of a panoramic irradiator shall require a key to actuate. Actuation of the mechanism shall cause an audible signal to indicate that the sources are leaving the shielded position. Only one key may be in use at any time, and only operators or facility management may possess it. The key shall be attached to a portable radiation survey meter by a chain or cable. The lock for source control shall be designed so that the key may not be removed if the sources are in an unshielded position. The personnel entrance door or barrier to the radiation room shall require the same key.

b) The console of a panoramic irradiator shall have a source position indicator that indicates when the sources are in the fully shielded position, when the sources are in transit and when the sources are exposed.

c) The control console of a panoramic irradiator shall have a control that promptly returns the sources to the shielded position.

d) Each control for a panoramic irradiator shall be clearly marked as to its function.

32 Ill. Adm. Code 346.330 Irradiator Pools

a) For licenses initially issued after December 1, 2005, irradiator pools shall either:

1. Have a water-tight stainless steel liner or a liner metallurgically compatible with other components in the pool; or

2. Be constructed so that there is a low likelihood of substantial leakage and have a surface designed to facilitate decontamination.

In either case, the licensee shall have a method to safely store the sources during repair of the pool.

b) For licenses initially issued after December 1, 2005, irradiator pools shall have no outlets more than 0.5 meter below the normal low water level that could allow water to drain out of the pool. Pipes that have intakes more than 0.5 meter below the normal low water level and that could act as siphons shall have siphon breakers to prevent the siphoning of pool water.

c) A means shall be provided to replenish water losses from the pool.

d) A visible indicator shall be provided in a clearly visible location to indicate if the pool water level is below the normal low water level or above the normal high water level.

e) Irradiator pools shall be equipped with a purification system designed to be capable of maintaining the water during normal operation at a conductivity of 20 microsiemens per centimeter or less and with a clarity so that the sources can be seen clearly.

f) A physical barrier, such as a railing or cover, shall be used around or over radiator pools during normal operation to prevent personnel from accidentally falling into the pool. The barrier may be removed during maintenance, inspection and service operations.

g) If long handled tools or poles are used in irradiator pools, the radiation dose rate in the handling areas of the tools may not exceed 0.02 millisievert (2 millirems) per hour.

History

• Source: Amended at 47 Ill. Reg. 9201, effective June 22, 2023

32 Ill. Adm. Code 346.350 Source Rack Protection

If the product to be irradiated moves on a product conveyor system, the source rack and the mechanism that moves the rack shall be protected by a barrier or guides to prevent products and product carriers from hitting or touching the rack or mechanism.

History

• Source: Amended at 47 Ill. Reg. 9201, effective June 22, 2023

32 Ill. Adm. Code 346.370 Power Failures

a) If electrical power at a panoramic irradiator is lost for longer than 10 seconds, the sources shall automatically return to the shielded position.

b) The lock on the door of the radiation room of a panoramic irradiator shall not be deactivated by a power failure.

c) During a power failure, the area of any irradiator where the sources are located may be entered only when using an operable and calibrated radiation survey meter.

d) If non-electrical power is used to control or operate any irradiator safety feature, failure of that power source shall automatically return the radiation sources to their fully shielded position.

32 Ill. Adm. Code 346.390 Design Requirements

Irradiators whose construction begins after December 1, 2005, shall meet the design requirements of this Section.

a) Shielding. For panoramic irradiators, the licensee shall 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 Section 346.250. If the irradiator will use more than 2 x 1017 becquerels (5 million curies) of activity, the licensee shall evaluate the effects of heating of the shielding by the irradiator sources.

b) Foundations. For panoramic irradiators, the licensee shall design the foundation, with consideration given to soil characteristics, to ensure it is adequate to support the weight of the facility shield walls.

c) Pool integrity. For pool irradiators, the licensee shall design the pool to assure that it is leak resistant, that it is strong enough to bear the weight of the pool water and shipping casks, that a dropped cask would not fall on sealed sources, that all outlets or pipes meet the requirements of Section 346.330(b) and that metal components are metallurgically compatible with other components in the pool.

d) Water handling system. For pool irradiators, the licensee shall verify that the design of the water purification system is adequate to meet the requirements of Section 346.330(e). The system shall be designed so that water leaking from the system does not drain to unrestricted areas without being monitored.

e) Radiation monitors. For all irradiators, the licensee shall evaluate the location and sensitivity of the monitor to detect sources carried by the product conveyor system as required by Section 346.290(a). The licensee shall verify that the product conveyor is designed to stop before a source on the product conveyor would cause a radiation overexposure to any person. For pool irradiators, if the licensee uses radiation monitors to detect contamination under Section 346.590(b), the licensee shall verify that the design of radiation monitoring systems to detect pool contamination included sensitive detectors located close to where contamination is likely to concentrate.

f) Source rack. For pool irradiators, the licensee shall verify that there are no crevices on the source or between the source and source holder that would promote corrosion on a critical area of the source. For panoramic irradiators, the licensee shall determine that source rack drops due to loss of power will not damage the source rack and that source rack drops due to failure of cables (or alternative means of support) will not cause loss of integrity of sealed sources. For panoramic irradiators, the licensee shall review the design of the mechanism that moves the sources to assure that the likelihood of a stuck source is low and that, if the rack sticks, a means exists to free it with minimal risk to personnel.

g) Access control. For panoramic irradiators, the licensee shall verify from the design and logic diagram that the access control system will meet the requirements of Section 346.230.

h) Fire protection. For panoramic irradiators, the licensee shall verify that the number, location and spacing of the smoke and heat detectors are appropriate to detect fires and that the detectors are protected from mechanical and radiation damage. The licensee shall verify that the design of the fire extinguishing system provides the necessary discharge patterns, densities, and flow characteristics for complete coverage of the radiation room and that the system is protected from mechanical and radiation damage.

i) Source return. For panoramic irradiators, the licensee shall verify that the source rack will automatically return to the fully shielded position if offsite power is lost for more than 10 seconds.

j) Seismic. For panoramic irradiators to be built in seismic areas, the licensee shall design the reinforced concrete radiation shields to retain their integrity in the event of an earthquake by designing to the seismic requirements of an appropriate source, such as Chapter 21, "Special Provisions for Seismic Design", of the American Concrete Institute Standard "Building Code Requirements for Reinforced Concrete" (ACI 318-89) or local building codes, whichever is most current.

k) Wiring. For panoramic irradiators, the licensee shall verify that electrical wiring and electrical equipment in the radiation room are selected to minimize failures due to prolonged exposure to radiation.

History

• Source: Amended at 47 Ill. Reg. 9201, effective June 22, 2023

32 Ill. Adm. Code 346.410 Construction Monitoring and Acceptance Testing

The requirements of this Section shall be met by irradiators whose construction begins after December 1, 2005. The requirements shall be met prior to loading sources.

a) Shielding. For panoramic irradiators, the licensee shall monitor the construction of the shielding to verify that its construction meets design specifications and generally accepted building code requirements for reinforced concrete.

b) Foundations. For panoramic irradiators, the licensee shall monitor the construction of the foundations to verify that their construction meets design specifications.

c) Pool integrity. For pool irradiators, the licensee shall verify that the pool meets design specifications and shall test the integrity of the pool. The licensee shall verify that outlets and pipes meet the requirements of Section 346.330(b) of this Part.

d) Water handling systems. For pool irradiators, the licensee shall verify that the water purification system, the conductivity meter and the water level indicators operate properly.

e) Radiation monitors. For all irradiators, the licensee shall verify the proper operation of the monitor to detect sources carried on the product conveyor system and the related alarms and interlocks required by Section 346.290(a) of this Part. For pool irradiators, the licensee shall verify the proper operation of the radiation monitors and the related alarm if used to meet Section 346.590(b) of this Part. For underwater irradiators, the licensee shall verify the proper operation of the over-the-pool monitor, alarms, and interlocks required by Section 346.290(b) of this Part.

f) Source rack. For panoramic irradiators, the licensee shall test the movement of the source racks for proper operation prior to source loading. Testing shall include source rack lowering due to simulated loss of power. For all irradiators with product conveyor systems, the licensee shall observe and test the operation of the conveyor system to assure that the requirements in Section 346.350 of this Part are met for protection of the source rack and the mechanism that moves the rack. Testing shall include tests of any limit switches and interlocks used to protect the source rack and mechanism that moves the rack from moving product carriers.

g) Access control. For panoramic irradiators, the licensee shall test the completed access control system to assure that it functions as designed and that all alarms, controls and interlocks work properly.

h) Fire protection. For panoramic irradiators, the licensee shall 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 shall test the operability of the fire extinguishing system.

i) Source return. For panoramic irradiators, the licensee shall demonstrate that the source racks can be returned to their fully shielded positions without offsite power.

j) Computer systems. For panoramic irradiators that use a computer system to control the access control system, the licensee shall verify that the access control system will operate properly if offsite power is lost and shall verify that the computer has security features that prevent an irradiator operator from commanding the computer to override the access control system when it is required to be operable.

k) Wiring. For panoramic irradiators, the licensee shall verify that the electrical wiring and electrical equipment that were installed meet the design specifications.

32 Ill. Adm. Code 346.510 Training

a) Before personnel are permitted to operate an irradiator without a supervisor present, they shall be instructed in:

1. The fundamentals of radiation protection applied to irradiators (including the differences between external radiation and radioactive contamination; units of radiation dose; IEMA, Division of Nuclear Safety, dose limits; why large radiation doses shall be avoided; how shielding and access controls prevent large doses; how an irradiator is designed to prevent contamination; the proper use of survey meters and personnel dosimeters; other radiation safety features of an irradiator; and the basic function of the irradiator);

2. The requirements of this Part and 32 Ill. Adm. Code 340 and 400 that are relevant to the irradiator;

3. The operation of the irradiator;

4. Those operating and emergency procedures listed in Section 346.530 that the person is responsible for performing;

5. Case histories of accidents or problems involving irradiators.

b) Before personnel are permitted to operate an irradiator without a supervisor present, they shall pass a written test on the instruction received consisting primarily of questions based on the licensee's operating and emergency procedures that the person is responsible for performing and other operations necessary to safely operate the irradiator without supervision.

c) Before personnel are permitted to operate an irradiator without a supervisor present, they shall have received on-the-job training or simulator training in the use of the irradiator as described in the license application, and shall also demonstrate the ability to perform those portions of the operating and emergency procedures that they are to perform.

d) The licensee shall conduct safety reviews for irradiator operators at least annually. The licensee shall give each operator a brief written test on the information. Each safety review shall include, to the extent appropriate, each of the following:

1. Changes in operating and emergency procedures since the last review, if any;

2. Changes in regulations and license conditions since the last review, if any;

3. Reports on recent accidents, mistakes or problems that have occurred at irradiators, if any;

4. Relevant results of inspections of operator safety performance;

5. Relevant results of the facility's inspection and maintenance checks; and

6. A drill to practice an emergency or abnormal event procedure.

e) The licensee shall evaluate the safety performance of each irradiator operator at least annually to ensure that regulations, license conditions and operating and emergency procedures are followed. The licensee shall discuss the results of the evaluation with the operator and shall instruct the operator on how to correct any mistakes or deficiencies observed.

f) Personnel who will be permitted unescorted access to the radiation room of the irradiator or the area around the pool of an underwater irradiator, but who have not received the training required for the operators and the radiation safety officer, shall be instructed and tested in any precautions they should take to avoid radiation exposure, any procedures or parts of procedures listed in Section 346.530 that they are expected to perform or comply with, and their proper response to alarms required in this Part. Tests may be oral.

g) Personnel who shall be prepared to respond to alarms required by Sections 346.230(b), 346.230(i), 346.270(a), 346.290(a), 346.290(b), and 346.590(b) shall be trained and tested on how to respond. Each person shall be retested at least once a year. Tests may be oral.

History

• Source: Amended at 47 Ill. Reg. 9201, effective June 22, 2023

32 Ill. Adm. Code 346.530 Operating and Emergency Procedures

a) The licensee shall have and follow written operating procedures for:

1. Operation of the irradiator, including entering and leaving the radiation room;

2. Use of personnel dosimeters;

3. Surveying the shielding of panoramic irradiators;

4. Monitoring pool water for contamination while the water is in the pool and before release of pool water to unrestricted areas;

5. Leak testing of sources;

6. Inspection and maintenance checks required by Section 346.610 of this Part;

7. Loading, unloading and repositioning sources, if the operations will be performed by the licensee; and

8. Inspection of movable shielding required by Section 346.230(h) of this Part, if applicable.

b) The licensee shall have and follow emergency or abnormal event procedures, appropriate for the irradiator type, for:

1. Sources stuck in the unshielded position;

2. Failure of hoists or cables involving the source racks;

3. Personnel overexposures;

4. A radiation alarm from the product exit portal monitor or pool monitor;

5. Detection of leaking sources, pool contamination or alarm caused by contamination of pool water;

6. A low or high water level indicator or an abnormal water loss or leakage from the source storage pool;

7. A prolonged loss of electrical power;

8. A fire alarm or explosion in the radiation room;

9. An alarm indicating unauthorized entry into the radiation room, area around the pool or another alarmed area;

10. Natural phenomena, including an earthquake, tornado, flooding or other phenomena as appropriate for the geological location of the facility; and

11. The jamming of automatic conveyor systems.

32 Ill. Adm. Code 346.550 Personnel Monitoring

a) Irradiator operators shall wear a personnel dosimeter while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. The personnel dosimeter must be capable of detecting high energy photons in the normal and accident dose ranges. Personnel monitoring shall be provided in accordance with the requirements of 32 Ill. Adm. Code 340.510(d), (e) and (f).

b) Each dosimeter shall be assigned to and worn by only one person. Film badges shall be processed at least monthly and all other personnel dosimeters that require replacement shall be replaced at least quarterly. All personnel dosimeters shall be evaluated at least quarterly or promptly after replacement, whichever is more frequent.

c) Other personnel who enter the radiation room of a panoramic irradiator shall wear a dosimeter, which may be a pocket dosimeter. For groups of visitors, only 2 people who enter the radiation room are required to wear dosimeters. If pocket dosimeters are used to meet the requirements of this subsection, a check of their response to radiation shall be done at intervals not to exceed 12 months. Acceptable dosimeters shall read within ±30 percent of the true radiation dose.

History

• Source: Amended at 47 Ill. Reg. 9201, effective June 22, 2023

32 Ill. Adm. Code 346.570 Radiation Surveys

a) A radiation survey of the area outside the shielding of the radiation room of a panoramic irradiator shall be conducted with the sources in the exposed position before the facility starts to operate. A radiation survey of the area about the pool of pool irradiators shall be conducted after the sources are loaded but before the facility starts to operate. Additional radiation surveys of the shielding shall be performed at intervals not to exceed 3 years and before resuming operation after addition of new sources or any modification to the radiation room shielding or structure that might increase dose rates.

b) If the radiation levels specified in Section 346.250 are exceeded, the facility shall be modified to comply with the requirements in Section 346.250.

c) Portable radiation survey meters used for required surveys shall be calibrated at intervals not to exceed 12 months to an accuracy of ±20% for the gamma energy of the sources in use. The calibration shall 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 shall be a type that does not saturate and read zero at high radiation dose rate.

d) Water from the irradiator pool, other potentially contaminated liquids and sediments from pool vacuuming shall be monitored for radioactive contamination before release to unrestricted areas. Radioactive concentrations shall not exceed those specified in table 2, column 2, or table 3 of Appendix B to 10 CFR 20, "Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage.", published at 72 Fed. Reg. 55922, October 1, 2007.

e) Before releasing resins for unrestricted use, the resins shall be monitored 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 shall be capable of detecting radiation levels of 0.5 microsievert (0.05 millirem) per hour.

f) For pool irradiators, all empty or loaded source transport containers shall be surveyed for removable contamination prior to insertion into the pool.

History

• Source: Amended at 47 Ill. Reg. 9201, effective June 22, 2023

32 Ill. Adm. Code 346.590 Detection of Leaking Sources

a) Each dry-source-storage sealed source shall be tested for leakage in accordance with the requirements of 32 Ill. Adm. Code 340.410.

b) For pool irradiators, sources may not be put into the pool unless the licensee tests the sources for leaks or has a certificate from a transferor that a leak test has been done within the 6 months before the transfer. Water from the pool shall be checked for contamination each day the irradiator operates. The check may be done either by using a radiation monitor on a pool water circulating system or by analysis of a sample of pool water. If a check for contamination is done by analysis of a sample of pool water, the results of the analysis shall 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 shall activate an alarm. The alarm set-point shall be set as low as practical, but high enough to avoid false alarms. The licensee may reset the alarm set-point to a higher level if necessary to operate the pool water purification system to clean up contamination in the pool if specifically provided for in written emergency procedures.

c) If a leaking source is detected, the licensee shall arrange to remove the leaking source from service and have it decontaminated, repaired or disposed of by an Agency, U.S. Nuclear Regulatory Commission, or Agreement State licensee that is authorized to perform these functions. The licensee shall promptly check its personnel, equipment, facilities and irradiated product for radioactive contamination. No product may be shipped until the product has been checked and found free of contamination. If a product has been shipped that may have been inadvertently contaminated, the licensee shall arrange to locate and survey that product for contamination. If any personnel are found to be contaminated, decontamination shall be performed promptly. If contaminated equipment, facilities or products are found, the licensee shall have them decontaminated or disposed of by an Agency, U.S. Nuclear Regulatory Commission, or Agreement State licensee that is authorized to perform these functions. If a pool is contaminated, the licensee shall arrange to clean the pool until the contamination levels do not exceed the appropriate concentration in table 2, column 2, of Appendix B to 10 CFR 20, published at 72 Fed. Reg. 55922, October 1, 2007. (See 32 Ill. Adm. Code 340.1220 for reporting requirements.)

History

• Source: Amended at 47 Ill. Reg. 9201, effective June 22, 2023

32 Ill. Adm. Code 346.610 Inspection and Maintenance

a) The licensee shall perform inspection and maintenance checks that include, at a minimum, each of the following at the frequency specified in the license or license application:

1. Operability of each aspect of the access control system required by Section 346.230 of this Part.

2. Functioning of the source position indicator required by Section 346.310(b) of this Part.

3. Operability of the radiation monitor for radioactive contamination in pool water required by Section 346.590(b) of this Part using a radiation check source, if applicable.

4. Operability of the over-pool radiation monitor at underwater irradiators as required by Section 346.290(b) of this Part.

5. Operability of the product exit monitor required by Section 346.290(a) of this Part.

6. Operability of the emergency source return control required by Section 346.310(c) of this Part.

7. Leak-tightness of systems through which pool water circulates (visual inspection).

8. Operability of heat and smoke detectors and extinguisher systems required by Section 346.270 of this Part (but without turning extinguishers on).

9. Operability of the mean of pool water replenishment required by Section 346.330(c) of this Part.

10. Operability of the indicators of high and low pool water levels required by Section 346.330(d) of this Part.

11. Operability of the intrusion alarm required by Section 346.230(i) of this Part, if applicable.

12. Functioning and wear of the system, mechanisms and cables used to raise and lower sources.

13. Condition of the barrier to prevent products from hitting the sources or source mechanism as required by Section 346.350 of this Part.

14. Amount of water added to the pool to determine if the pool is leaking.

15. Electrical wiring on required safety systems for radiation damage.

16. Pool water conductivity measurements and analysis as required by Section 346.630(b) of this Part.

b) Malfunctions and defects found during inspection and maintenance checks shall be repaired without undue delay.

32 Ill. Adm. Code 346.630 Pool Water Purity

a) Pool water purification system shall 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 shall take prompt actions to lower the pool water conductivity and shall take corrective actions to prevent future recurrences.

b) The licensee shall measure the pool water conductivity frequently enough, but no less than weekly, to assure that the conductivity remains below 20 microsiemens per centimeter. Conductivity meters shall be calibrated at least annually.

32 Ill. Adm. Code 346.650 Attendance During Operation

a) Both an irradiator operator and at least one other person, trained on how to respond and prepared to promptly render or summon assistance if the access control alarm sounds, shall be present onsite:

1. Whenever the irradiator is operated using an automatic product conveyor system; and

2. Whenever the product is moved into or out of the radiation room when the irradiator is operated in a batch mode.

b) At a panoramic irradiator at which static irradiations (no movement of the product) are occurring, personnel who have received the training on how to respond to alarms described in Section 346.510(g) of this Part shall be onsite.

c) At an underwater irradiator, an irradiator operator shall be present at the facility whenever the product is moved into or out of the pool. Personnel who move the product into or out of the pool of an underwater irradiator need not be qualified as irradiator operators; however, they shall have received the training described in Section 346.510(f) and (g) of this Part. Static irradiations may be performed without personnel present at the facility.

32 Ill. Adm. Code 346.670 Entering and Leaving the Radiation Room

a) Upon first entering the radiation room of a panoramic irradiator after an irradiation, the irradiator operator shall use a survey meter to determine that the source has returned to its fully shielded position. The operator shall check the functioning of the survey meter with a radiation check source prior to entry.

b) Before exiting from and locking the door to the radiation room of a panoramic irradiator prior to a planned irradiation, the irradiator operator shall:

1. Visually inspect the entire radiation room to verify that no one else is in it; and

2. Activate a control in the radiation room that permits the sources to be moved from the shielded position only if the door to the radiation room is locked within a pre-set time after setting the control.

c) During a power failure, the area around the pool of an underwater irradiator may not be entered without using an operable and calibrated radiation survey meter, unless the over-the-pool monitor required by Section 346.290(b) is operating with backup power.

History

• Source: Amended at 47 Ill. Reg. 9201, effective June 22, 2023

32 Ill. Adm. Code 346.690 Irradiation of Explosive or Flammable Materials

a) Irradiation of explosive material is prohibited unless the licensee has received prior written authorization from the Agency. Authorization will not be granted unless the licensee can demonstrate that detonation of the explosive would not rupture the sealed sources, injure personnel, damage safety systems or cause radiation overexposure of personnel.

b) Irradiation of more than small quantities of flammable material (flashpoint below 140°F) is prohibited in panoramic irradiators unless the licensee has received prior written authorization from the Agency. 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 overexposure of licensee or offsite responding personnel.

32 Ill. Adm. Code 346.810 Records and Retention Periods

The licensee shall maintain the following records at the irradiator for the periods specified.

a) A copy of the license, license conditions, documents incorporated into a license by reference and amendments to these materials, until superseded by new documents or until the Agency terminates the license for documents not superseded.

b) Records of each individual's training, tests and safety reviews provided to meet the requirements of Section 346.510(a), (b), (c), (d), (f), and (g), until 5 years after the individual terminates work.

c) Records of the annual evaluations of the safety performance of irradiator operators required by Section 346.510(e), for 5 years after the evaluation.

d) A copy of the current operating and emergency procedures required by Section 346.530, until superseded or the Agency terminates the license.

e) Evaluations of personnel dosimeters required by Section 346.550, until the Agency terminates the license.

f) Records of radiation surveys required by Section 346.570, for 5 years from the date of the survey.

g) Records of radiation survey meter calibrations required by Section 346.570 and pool water conductivity meter calibrations required by Section 346.630(b), until 5 years from the date of each test.

h) Records of the results of leak tests required by Section 346.590(a) and the results of contamination checks required by Section 346.590(b), for 5 years from the date of each test.

i) Records of inspection and maintenance checks required by Section 346.610, for 5 years.

j) Records of major malfunctions, significant defects, operating difficulties or irregularities and major operating problems that involve required radiation safety equipment, for 5 years after repairs are completed.

k) Records of the receipt, transfer and disposal of all licensed sealed sources as required by 32 Ill. Adm. Code 310.40. The licensee shall retain each record of receipt of byproduct material as long as the material is possessed and for 5 years following transfer or disposal of the material. The licensee who disposed of the material shall retain each record of disposal of byproduct material until the Agency terminates each license that authorizes disposal of the material.

l) Records on the design checks required by Section 346.390 and the construction control checks as required by Section 346.410, until the license is terminated. The records shall be signed and dated. The title or qualifications of the personnel signing the record shall be included.

m) Records related to decommissioning of the irradiator as required by 32 Ill. Adm. Code 330.310 and 330.320.

History

• Source: Amended at 47 Ill. Reg. 9201, effective June 22, 2023

32 Ill. Adm. Code 346.830 Reports

a) In addition to the reporting requirements in other Parts of Agency regulations, the licensee shall report the following events if not reported under other Parts of Agency regulations:

1. Source stuck in an unshielded position.

2. Any fire or explosion in a radiation room.

3. Damage to the source racks.

4. Failure of cable or drive mechanism used to move the source racks.

5. Inoperability of the access control system.

6. Detection of radiation source by the product exit monitor.

7. Detection of radioactive contamination attributable to licensed radioactive material.

8. Structural damage to the pool liner or walls.

9. Abnormal water loss or leakage from the source storage pool.

10. Pool water conductivity exceeding 100 microsiemens per centimeter.

b) The report shall include a telephone report within 24 hours as described in 32 Ill. Adm. Code 340.1220 and a written report within 30 days as described in 32 Ill. Adm. Code 340.1230.

History

• Source: Amended at 47 Ill. Reg. 9201, effective June 22, 2023

Part 350 Radiation Safety Requirements for Industrial Radiographic Operations

32 Ill. Adm. Code 350.10 Purpose

This Part establishes radiation safety requirements for persons using sources of radiation for industrial radiography. The requirements of this Part are in addition to, and not in substitution for, other applicable requirements of 32 Ill. Adm. Code: Chapter II, Subchapters b and d.

History

• Source: Amended at 18 Ill. Reg. 7263, effective May 2, 1994

32 Ill. Adm. Code 350.20 Scope

This Part shall apply to all licensees or registrants who use sources of radiation for industrial radiography. Except when the requirements of this Part are clearly applicable only to sealed radioactive sources, or to radiation machines, the requirements of this Part apply to both sealed radioactive sources and radiation machines used for performing industrial radiography procedures. Section 350.3050 contains special requirements for enclosed radiography and cabinet x-ray systems. Section 350.3090 contains special requirements for underwater and lay-barge radiography. Nothing in this Part shall apply to the use of sources of radiation for medical use. Each licensee and registrant is responsible for ensuring that persons performing activities under a license or certificate of registration comply with 32 Ill. Adm. Code: Chapter II, Subchapters b and d, license conditions, if any, and orders of the Agency.

History

• Source: Amended at 47 Ill. Reg. 9221, effective June 22, 2023

32 Ill. Adm. Code 350.25 Incorporations by Reference

a) All rules, standards and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified in the reference and do not include any later amendments or editions. Copies of these rules, standards and guidelines that have been incorporated by reference are available for public inspection and copying at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois.

b) In addition, copies of ANSI standards may be obtained directly from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402 and from the American National Standards Institute, Inc., 1430 Broadway, New York, New York 10018.

History

• Source: Amended at 30 Ill. Reg. 9167, effective April 28, 2006

32 Ill. Adm. Code 350.30 Definitions

As used in this Part, the following definitions apply:

"Agency" means the Illinois Emergency Management Agency.

"ALARA" means as low as is reasonably achievable as defined in 32 Ill. Adm. Code 310.20.

"Annual refresher safety training" means a review conducted or provided by the licensee or registrant for its employees on radiation safety aspects of industrial radiography.

"Associated equipment" means equipment used in conjunction with a radiographic exposure device to make radiographic exposures where the equipment drives, guides, or comes into contact with the source (e.g., guide tube, control tube, control device cable, removable source stop, "J" tube and collimator when it is used as an exposure head).

"Cabinet radiography" means industrial radiography conducted in an enclosure or cabinet so shielded that doses to individual members of the public at every location on the exterior meet the limitations specified in 32 Ill. Adm. Code 340.310(a).

"Cabinet x-ray system" means an x-ray system with the x-ray tube installed in an enclosure which, independent of existing architectural structures except the floor on which it may be placed, is intended to contain at least that portion of a material being irradiated, provide radiation attenuation and exclude personnel from its interior during generation of x radiation. Included are all x-ray systems designed primarily for the inspection of carry-on baggage at airline, railroad and bus terminals and in similar facilities. An x-ray tube used within a shielded part of a building or x-ray equipment which may temporarily or occasionally incorporate portable shielding is not considered a cabinet x-ray system.

"Certifying entity" means an independent certifying organization meeting the requirements in Appendix A of 10 CFR 34 or an Agreement State meeting the requirements in Appendix A, Parts II and III of 10 CFR 34.

"Collimator" means a radiation shield of lead or other heavy metal which is placed on the end of a guide tube or directly onto a radiographic exposure device to restrict the size and shape of the radiation beam when the sealed source is moved into position to make a radiographic exposure.

"Control cable" or "Drive cable" means the cable that is connected to the source assembly and used to drive the source to and from the exposure location.

"Control drive mechanism" means a device that enables the source assembly to be moved to and from the exposure device.

"Control tube" means a protective sheath for guiding the control cable. The control tube connects the control drive mechanism to the radiographic exposure device.

"Drive cable" (see "Control cable").

"Enclosed radiography" means industrial radiography conducted in an enclosed cabinet or room and includes cabinet radiography and shielded-room radiography.

"Exposure head" or "Source stop" means a device that locates the gamma radiography sealed source in the selected working position.

"Field examination" or "Practical examination" means a demonstration through practical application of the safety rules and principles of industrial radiography, including use of all appropriate equipment and procedures.

"Field station" means a facility where licensed material may be stored or used and from which equipment is dispatched.

"GED" means general equivalency diploma.

"Guide tube" or "Projection sheath" means a flexible or rigid tube (i.e., "J" tube) for guiding the source assembly and the attached control cable from the exposure device to the exposure head. The guide tube may also include the connections necessary for attachment to the exposure device and to the exposure head.

"Hands-on experience" means experience in all of those areas considered to be directly involved in the radiography process, and includes 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, etc., as applicable. Excessive time spent in only one or two of these areas, such as film development or radiation area surveillance, should not be counted toward the 2 years of experience required for a radiation safety officer in Section 350.4020(b)(3) or the experience for a radiographer as required by 32 Ill. Adm. Code 405.80.

"Independent certifying organization" means an independent organization that meets all the criteria of Appendix A of 10 CFR 34.

"Industrial radiography" or "radiography" means an examination of the structure of materials by non-destructive methods, utilizing ionizing radiation to make radiographic images.

"Lay-barge radiography" means industrial radiography performed on any water vessel used for laying pipe.

"Lixiscope" means a portable light-intensified imaging device using a sealed source. Lixiscopes are exempted from the requirements of this Part.

"Lock-out survey" means a radiation survey performed to determine that a sealed source is in its shielded position. The lock-out survey is performed before moving the radiographic exposure device or source changer to a new location. The lock-out survey is also performed when securing the radiographic exposure device or source changer against unauthorized removal.

"Permanent radiographic installation" means an enclosed shielded room, cell, or vault, not located at a temporary jobsite, in which radiography is performed.

"Permanent use or storage location" means a location listed on a radioactive material license or a certificate of registration where sources of radiation are used or stored.

"Personal supervision" means the provision of guidance and instruction to a radiographer trainee by a radiographer who is:

physically present at the site;

in visual contact with the radiographer trainee while the trainee is using sources of radiation; and

in such proximity that immediate assistance can be given if required.

"Pigtail" (see "Source assembly").

"Pill" (see "Sealed source").

"Projection sheath" (see "Guide tube").

"Radiation safety officer for industrial radiography" means an individual with the responsibility for the overall radiation safety program on behalf of the licensee and who meets the requirements in Section 350.4020.

"Radiographer" means any individual who performs or personally supervises industrial radiographic operations. Radiographers shall meet the requirements of Section 350.2010(a) and shall comply with the requirements of 32 Ill. Adm. Code: Chapter II, Subchapters b and d, all license conditions, if any, and orders of the Agency.

"Radiographer certification" means written approval, received from the Agency in accordance with 32 Ill. Adm. Code 405, stating that an individual has satisfactorily met certain established radiation safety and experience criteria.

"Radiographer trainee" means any individual who uses sources of radiation and related handling tool or radiation survey instruments under the personal supervision of a radiographer. Radiographer trainees shall meet the requirements of Section 350.2010(b) and shall comply with the requirements of 32 Ill. Adm. Code: Chapter II, Subchapters b and d, all license conditions, if any, and orders of the Agency.

"Radiographic exposure device" means any instrument containing a sealed source fastened or contained therein, in which the sealed source or shielding thereof may be moved or otherwise changed from a shielded to an unshielded position for purposes of making a radiographic exposure (i.e, camera).

"Radiographic operations" means all activities associated with the presence of radioactive sources in a radiographic exposure device during use of the device or transport (except when being transported by a common or contract transport) to include surveys to confirm the adequacy of boundaries, setting up equipment and any activity inside restricted area boundaries.

"Radiography" (see "Industrial radiography").

"S-tube" means a tube through which the radioactive source travels when inside a radiographic exposure device.

"Sealed source" or "Pill" means any capsule or matrix as defined in 32 Ill. Adm. Code 310.20.

"Shielded position" means the location within the radiographic exposure device or storage container which, by manufacturer's design, is the proper location for storage of the sealed source.

"Shielded-room radiography" means industrial radiography conducted in a room so shielded that doses to individual members of the public at every location on the exterior meet the limitations as specified in 32 Ill. Adm. Code 340.310(a) (i.e., bay, bunker, cell).

"Source assembly" or "Pigtail" means an assembly that consists of the sealed source and a connector that attaches the source to the control cable. The source assembly may also include a stop ball used to secure the source in the shielded position.

"Source changer" means a device designed and used for replacement of sealed sources in radiographic exposure devices, including those source changers also used for transporting and storage of sealed sources.

"Storage container" means the structure in which sealed sources are secured and stored at a permanent storage location as described in Section 350.4010(c)(5).

"Source stop" (see "Exposure head").

"Temporary jobsite" means any location where licensed material is used or stored for 180 days or less during any consecutive 12 months, and not specifically listed on a radioactive material license.

"Transport container" means a package that is designed and constructed to provide radiation safety and security when sealed sources are transported and meets all applicable regulations of the U.S. Department of Transportation.

"Underwater radiography" means industrial radiography performed when the radiographic exposure device and related equipment are beneath the surface of water.

History

• Source: Amended at 47 Ill. Reg. 9221, effective June 22, 2023

32 Ill. Adm. Code 350.40 Exemptions

a) The following are exempt from the requirements of this Part:

1. Cabinet x-ray systems designed to exclude individuals, except that the systems must satisfy the provisions of Section 350.3050(c) of this Part, which apply specifically to cabinet x-ray systems; and

2. Lixiscopes used in industrial applications.

b) Devices exempted by subsection (a) of this Section are subject to the requirements of 32 Ill. Adm. Code 320 and 330 and other applicable provisions of 32 Ill. Adm. Code: Chapter II, Subchapters b and d.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.50 Receipt, Transfer and Disposal of Sources of Radiation

Each licensee or registrant shall maintain records showing the receipt, transfer and disposal of sources of radiation. These records shall include the date of receipt, transfer or disposal, the name of the individual making the record, the radionuclide, the number of gigabecquerels or curies and the make, model and serial number of each source of radiation and device, as appropriate. Records shall be maintained for Agency inspection until the radioactive material license or certificate of registration is terminated.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.60 Form and Location of Records

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

b) Each licensee or registrant shall maintain copies of records required by this Part and other applicable Parts of 32 Ill. Adm. Code at the location(s) specified in Section 350.4010(c)(7) of this Part.

History

• Source: Added at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.1000 Requirements for Radiography Equipment Using Radiographic Exposure Devices

a) Equipment used in industrial radiographic operations involving the use of radiographic exposure devices shall meet the following minimum criteria:

1. Each radiographic exposure device, source assembly, or sealed source and all associated equipment:

A) Manufactured on or before July 1, 1994, and used after January 10, 1996, shall 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 January 1981, as NBS Handbook 136, exclusive of subsequent amendments or editions. This publication may be purchased from the American National Standards Institute, Inc., 25 West 43rd Street, New York NY 10036; Telephone: (212) 642-4900. However, equipment used in industrial radiographic operations need not comply with section 8.9.2(c) of the Endurance Test in 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 realistically exert on the lever or crankshaft of the drive mechanism; and/or

B) Manufactured after July 1, 1994, and used after January 10, 1996, shall meet the requirements specified in ANSI N43.9-1991, "American National Standard for Gamma Radiography – Specifications for Design and Testing of Apparatus", published 1991, exclusive of subsequent amendments or editions.

2. Each radiographic exposure device shall have attached to it one or more durable, legible, clearly visible labels bearing the:

A) Chemical symbol and mass number of the radionuclide in the device;

B) Activity of the sealed source and the date this activity was last measured;

C) Model and serial number of the sealed source;

D) Manufacturer of the sealed source; and

E) Licensee's name, address and telephone number.

3. Each radiographic exposure device intended for use as a Type B transport container shall meet the applicable requirements of 32 Ill. Adm. Code 341.

4. Radiographic exposure devices, source assemblies, source changers and associated equipment that allow the source to be moved out of the device for routine operation shall meet the following additional requirements:

A) The coupling between the source assembly and the control cable shall be designed in a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling shall be such that it cannot be unintentionally disconnected under normal conditions.

B) The device shall automatically secure the source assembly when it is cranked back into the shielded position within the device. This securing system shall only be released by means of a deliberate operation of the exposure device.

C) The outlet fittings, lock box and drive cable fittings on each radiographic exposure device shall be equipped with safety plugs or covers, which shall 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 shall have attached to it, or engraved in it, a durable, legible, visible label with the words: "DANGER-RADIOACTIVE". The label shall not interfere with the safe operation of the exposure device or associated equipment.

E) The guide tube, if manufactured on or before July 1, 1994, and used after January 10, 1996, shall have passed a kinking test that closely approximates the kinking forces likely to be encountered during use and the crushing tests for the control units specified in ANSI N432-1980, "Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography", published January 1981, as NBS Handbook 136, exclusive of subsequent amendments or editions. Guide tubes manufactured after July 1, 1994, and used after January 10, 1996, shall have passed a kinking test that closely approximates the kinking forces likely to be encountered during use and the crushing tests for the control units specified in ANSI N43.9-1991, "American National Standard for Gamma Radiography – Specifications for Design and Testing of Apparatus", published 1991, exclusive of subsequent amendments or editions.

F) Use of a guide tube shall be necessary to move the source out of the device.

G) An exposure head, endcap or similar device designed to prevent the source assembly from extending beyond the end of the guide tube shall be attached to the outermost end of the guide tube during radiographic operations.

H) The guide tube exposure head connection, if these parts were manufactured on or before July 1, 1994, and used after January 10, 1996, shall be able to withstand the tensile test for control units specified in ANSI N432-1980, "Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography", published January 1981, as NBS Handbook 136, exclusive of subsequent amendments or editions If these parts were manufactured after July 1, 1994, and used after January 10, 1996, the guide tube exposure head connection shall be able to withstand the tensile test for control units specified in ANSI N43.9-1991, "American National Standard for Gamma Radiography – Specifications for Design and Testing of Apparatus", published 1991, exclusive of subsequent amendments or editions.

I) Source changers shall provide a system for assuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the drive cable to or from a source assembly.

b) Modification of any radiographic exposure device, source assembly, source changer and associated equipment is prohibited unless the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State has determined that the design of any replacement component, including source holder, source assembly, control or guide tube would not compromise the design safety features of the system.

c) Each radiographic exposure device, source changer and storage container shall be provided with a lock or lockable outer container designed to prevent unauthorized or accidental removal or exposure of a sealed source.

d) Each radiographic exposure device and each transport container shall bear a permanent, durable, legible, clearly visible marking or label that has, as a minimum, the standard radiation caution symbol, depicted in 32 Ill. Adm. Code 340.Illustration A, and the following wording:

CAUTION (OR DANGER)

RADIOACTIVE MATERIAL

NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY)

In addition, transport containers shall meet the applicable requirements of 32 Ill. Adm. Code 341.

History

• Source: Amended at 39 Ill. Reg. 9935, effective July 1, 2015

32 Ill. Adm. Code 350.1005 Requirements for Radiography Equipment Using Radiation Machines

The control panel of each radiation machine used in industrial radiographic operation shall be equipped with:

a) A locking device to prevent the unauthorized use of the x-ray system or the accidental production of x-rays; and

b) A device that will give a positive indication of the production of x-rays whenever the radiation machine is energized.

History

• Source: Added at 18 Ill. Reg. 7263, effective May 2, 1994

32 Ill. Adm. Code 350.1010 Limits on Levels of Radiation for Radiographic Exposure Devices, Source Changers and Transport Containers

a) Radiographic exposure devices manufactured prior to July 1, 1994, shall not be used for industrial radiography unless they meet the following minimum criteria:

1. Radiographic exposure devices and source changers measuring less than 10 centimeters (4 inches) from the sealed source storage position to any exterior surface of the device shall have no radiation level in excess of 12.9 µC/kg (50 mR) per hour at 15 centimeters (6 inches) from any exterior surface of the device.

2. Radiographic exposure devices measuring a minimum of 10 centimeters (4 inches) from the sealed source storage position to any exterior surface of the device shall not have radiation levels in excess of 2 mSv (equivalent to 200 mrem, 200 mR, or 51.6 µC/kg) per hour at any exterior surface, and 0.1 mSv (equivalent to 10 mrem, 10 mR, or 2.58 µC/kg) per hour at 1 meter (39.4 inches) from any exterior surface.

3. The radiation levels specified in subsections (1) and (2) of this Section shall be determined with the sealed source in the shielded position (i.e., "off").

b) Radiographic exposure devices, source changers and transport containers manufactured on or after July 1, 1994, and used after January 10, 1996, shall not have a maximum exposure rate in excess of 2 mSv (200 mrem) per hour at any exterior surface and 0.1 mSv (10 mrem) per hour at 1 meter from any exterior surface with the sealed source in the shielded position.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.1020 Locking of Sources of Radiation

a) Each radiographic exposure device, source changer and storage container shall be kept locked at all times except when under the direct surveillance of a radiographer or radiographer trainee, or as authorized pursuant to Section 350.3010 of this Part.

b) Each radiographic exposure device and source changer shall be locked and the key removed from any keyed lock prior to being moved or transported and also prior to being stored at a given location.

c) Each sealed source shall be secured in its shielded position by locking the radiographic exposure device or source changer each time the sealed source is returned to its shielded position.

d) Radiation machines shall be locked and the key removed at all times except when under the direct surveillance of a radiographer or a radiographer trainee or as may be otherwise authorized pursuant to Section 350.3010 of this Part.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.1030 Storage Precautions

Locked radiographic exposure devices, source changers, storage containers, transport containers that contain sealed sources and radiation machines shall be secured to prevent tampering or removal by unauthorized personnel. The licensee shall store radioactive material in a manner that will minimize danger from explosion or fire.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.1040 Radiation Survey Instruments

a) The licensee or registrant shall maintain sufficient calibrated and operable radiation survey instruments to make physical radiation surveys as required by this Part and 32 Ill. Adm. Code 340.510(a). Instrumentation required by this Section shall have a range that 0.02 mSv (0.516 µC/kg, 2 mrem or 2 mR) per hour through 0.01 Sv (258 µC/kg or 1 R) per hour can be measured.

b) Each radiation survey instrument shall be calibrated:

1. At energies appropriate for use;

2. At intervals not to exceed 6 months and after each instrument servicing other than battery replacement;

3. To accuracy that can be demonstrated within plus or minus 20 percent;

4. At two or more widely separated points, other than zero, on each scale, or one point of each scale for digital devices. For instruments without multiple scales, calibration shall be performed at six points equally spaced across the range of 0.02 mSv (0.516 µC/kg 2 mrem or 2 mR) per hour to 0.01 Sv (258 µC/kg, 1 rem or 1 R) per hour; and

5. By a person licensed by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to perform such service.

c) Records of calibrations shall be maintained for 5 years after the calibration date for inspection by the Agency.

d) Immediately prior to use, a radiation survey instrument shall be checked to ensure that it is operating properly by bringing it near a source of radiation and observing a response. Instruments that fail to respond shall not be used.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.1050 Testing for Leakage or Contamination, Repair, Tagging, Opening, Modification and Replacement of Sealed Sources

a) The licensee shall permit only persons specifically authorized by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to:

1. Replace any sealed source fastened to or contained in a radiographic device;

2. Test a sealed source for leakage or contamination; or

3. Repair, tag, open or modify any sealed source.

b) An applicant that desires to conduct its own tests for leakage or contamination shall establish procedures to be followed when testing sealed sources for leakage or contamination and shall submit a description of such procedures to the Agency for approval. The description shall include the:

1. Instrumentation to be used;

2. Method of performing the tests; and

3. Pertinent experience of the individual(s) who will perform the test.

c) Each sealed source shall be tested for leakage or contamination in accordance with 32 Ill. Adm. Code 340.410. In the absence of a certificate from a transferor indicating that a test has been made within the 6-month period prior to the transfer, the sealed source shall not be put into use until tested and the test results confirm that the sealed source is not leaking or contaminated.

d) An acceptable leak test for sealed sources in the possession of a radiography licensee would be to test at the nearest accessible point to the sealed source storage position, or other appropriate measuring point, by a procedure approved pursuant to subsection (b) of this Section. Records of tests for leakage or contamination shall be kept in accordance with 32 Ill. Adm. Code 340.1135.

e) If in accordance with 32 Ill. Adm. Code 340.410 a sealed source is determined to be leaking or contaminated, the licensee shall immediately withdraw the equipment involved from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with 32 Ill. Adm. Code 340. Within 5 days after obtaining results of a test showing a sealed source to be leaking or contaminated, the licensee shall file a report with the Agency in accordance with 32 Ill. Adm. Code 340.1260.

f) A sealed source that is not fastened to or contained in a radiographic exposure device shall have permanently attached to it a durable tag at least 2.54 centimeters (1 inch) square bearing the prescribed radiation caution symbol in conventional colors, magenta or purple on a yellow background, and at least the instructions:

DANGER

RADIOACTIVE MATERIAL

DO NOT HANDLE

NOTIFY CIVIL AUTHORITIES IF FOUND

g) Each exposure device using depleted uranium (DU) shielding and an “S” tube configuration shall be tested for DU contamination at intervals not to exceed 12 months. The analysis shall be capable of detecting the presence of 185 Bq (0.005 μCi) of radioactive material on the test sample, and shall be performed by a person specifically authorized by the Agency, the U.S. Nuclear Regulatory Commission or another Agreement State to perform the analysis. Should the testing reveal the presence of DU contamination, the exposure device shall be removed from use until an evaluation of the wear of the S-tube has been made. Should the evaluation reveal that the S-tube is worn through, the device shall not be used again. DU shielded devices do not have to be tested for DU contamination while not in use and in storage. Before using or transferring the device, however, the device shall be tested for DU contamination, if the interval of storage exceeds 12 months. A record of the DU leak test shall be made and kept in units of becquerel (Bq) or microcurie (μCi) and maintained for inspection by the Agency for 5 years after the records are made or until the source in storage is removed, whichever time interval is longer. Licensees shall be in compliance with the DU leak testing requirement of this subsection beginning October 1, 2004.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.1060 Quarterly Inventory

Each licensee or registrant shall conduct a physical inventory at intervals not to exceed 3 months to account for all sources of radiation it has received or possesses. The inventory shall cover all sources of radiation not exempted by Section 350.40 of this Part, including, but not limited to, sealed sources, radiation machines and radiographic exposure devices containing depleted uranium. The records of the inventories shall be maintained for 5 years from the date of the inventory for inspection by the Agency and shall include the manufacturer, model, serial number, radionuclide and number of gigaBequerels or curies or mass for DU in each device, if applicable, location of each source of radiation, date of the inventory and the name of the individual performing the inventory.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.1070 Utilization Logs

Each licensee or registrant shall maintain current logs, which shall be kept available for inspection by the Agency for 5 years from the date of the recorded event, showing for each source of radiation the following information:

a) A unique identifying number or code (e.g., serial number) for each radiation machine. For each radiographic exposure device, a description, make, model and serial number of the radiographic exposure device, or transport or storage container in which the sealed source is located;

b) The name of the radiographer using the radiation machine. For radiographic exposure device, the identity and signature of the radiographer to whom assigned;

c) The locations where used and dates each source of radiation is removed from storage and returned to storage; and

d) For radiation machines used in permanent radiographic installations, the date(s)each radiation machine is energized.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.1080 Inspection and Maintenance

a) Each licensee or registrant shall ensure that visual and operability checks for obvious defects in survey instruments, radiation machines, radiographic exposure devices, transport and storage containers, associated equipment, source changers, source guide tubes and crank-out devices are performed at the beginning of each day of use, or work shift, to ensure that:

1. The equipment is in good working condition;

2. The sources are adequately shielded; and

3. Required labeling is present.

b) Each licensee or registrant shall conduct a program of at least quarterly inspection and maintenance of radiation machines, radiographic exposure devices, transport containers and source changers to assure proper functioning of components listed in Appendix B of this Part. All appropriate parts shall be maintained in accordance with manufacturer's specifications. Records of inspection and maintenance shall be maintained for inspection by the Agency for 5 years.

c) If any inspection conducted pursuant to subsection (a) or (b) of this Section reveals damage to components listed in Appendix B of this Part, the device shall be labeled as defective and shall be removed from service until repairs have been made.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.1090 Permanent Radiographic Installations

Permanent radiographic installations using radiographic exposure device(s) having high radiation area entrance controls of the type described in 32 Ill. Adm. Code 340.610(a)(2), 340.610(a)(3) and 340.610(b) shall also meet the following requirements:

a) Each entrance that is used for personnel access to the high radiation area shall have both visible and audible warning signals to warn of the presence of radiation. The visible signal shall be activated by radiation. The audible signal shall be activated when an attempt is made to enter the installation while the source is exposed.

b) The entrance control device or alarm system shall be tested for proper operation prior to beginning operations on each day of use. The radiography system shall not be used if any entrance control device or alarm system is operating improperly. If an entrance control device or alarm system is operating improperly, it shall be labeled as defective immediately and repaired. Before the radiography system is returned to service, the radiation safety officer shall retest the entrance control device or alarm system and approve the repair.

c) Records of tests performed pursuant to subsection (b) of this Section shall be maintained for inspection by the Agency for 5 years.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.2010 Training and Testing

a) The licensee or registrant shall not permit any individual to act as a radiographer, as defined in this Part, until such individual:

1. Has been certified by the Agency pursuant to 32 Ill. Adm. Code 405.90(a) for the class of radiography (i.e., radioactive materials, radiation machines, or both) that the licensee or registrant is authorized to perform and the certification has neither expired nor been suspended or revoked by the Agency;

2. Has received copies of this Part, 32 Ill. Adm. Code 340 and 400, a copy of the license or certificate of registration issued to the licensee or registrant and copies of and instructions in the licensee's or registrant's operating and emergency procedures;

3. Has been instructed in the use of the licensee's or registrant's sources of radiation, radiographic exposure devices, related handling tools and radiation survey instruments; and

4. Has demonstrated, to the satisfaction of the licensee or registrant, an understanding of the instructions provided pursuant to subsections (a)(2) and (3) of this Section as evidenced by having successfully completed a written test and a field examination.

b) The licensee or registrant shall not permit any individual to act as a radiographer trainee, as defined in this Part, until such individual:

1. Has been certified by the Agency pursuant to 32 Ill. Adm. Code 405.90(b) for the class of radiography (i.e., radioactive materials, radiation machines, or both) that the licensee or registrant is authorized to perform and the certification has neither expired nor been suspended or revoked by the Agency; and

2. Has met the requirements of subsections (a)(2) through (a)(4) of this Section.

c) Records of the training specified in this Section, including copies of written tests and dates of oral tests and field examinations, shall be maintained for inspection by the Agency for 3 years following termination of employment or until the radioactive material license or certificate of registration is terminated.

d) Except as provided in subsection (f) of this Section, each licensee or registrant shall conduct an internal audit program to ensure that the Agency's radioactive material license conditions and the licensee's or registrant's operating and emergency procedures are followed by each radiographer and radiographer trainee. The licensee or registrant shall audit the job performance of each radiographer and radiographer trainee. The internal audit program shall:

1. Include observation by the licensee or registrant of the job performance of each radiographer and radiographer trainee during an actual industrial radiographic operation at intervals not to exceed 6 months.

2. Provide that, if a radiographer or a radiographer trainee has not participated in an industrial radiographic operation for more than 6 months since the last audit, the individual's job performance shall be observed and recorded by the licensee or registrant when the individual next participates in an industrial radiographic operation.

e) Records of these audits shall be maintained for inspection by the Agency for 5 years from the date of the audit.

f) In those operations where a single individual serves as both radiographer and radiation safety officer, and performs each radiography operation, an internal audit program is not required.

g) The licensee or registrant shall provide annual refresher safety training for each radiographer and radiographer trainee at intervals not to exceed 12 months. The review shall include, as a minimum, the results of internal audits, new procedures or equipment, new or revised regulations, accidents or errors that have been observed and shall also provide opportunities for employees to ask safety questions.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.2020 Operating and Emergency Procedures

The licensee's or registrant's operating and emergency procedures shall include instructions in at least the following:

a) Handling and use of sources of radiation to be employed such that no individual is likely to be exposed to radiation doses in excess of the limits established in 32 Ill. Adm. Code 340;

b) Methods and occasions for conducting radiation surveys;

c) Methods for controlling access to radiographic areas;

d) Methods and occasions for locking and securing sources of radiation;

e) Personnel monitoring and the use of individual monitoring devices, including steps that shall be taken immediately by radiographic personnel in the event that an ionization chamber (i.e., pocket dosimeter) is found to be off-scale;

f) Transportation to field locations, including packing of sources of radiation in the vehicles, placarding of vehicles and control of sources of radiation during transportation;

g) Methods or procedures for minimizing exposure of individuals in the event of an accident, including procedures to follow in the event of a disconnect accident, a transportation accident and loss of a sealed source;

h) The procedure for notifying proper personnel in the event of an accident or loss of a sealed source;

i) Maintenance of records (see Appendix C of this Part); and

j) The inspection and maintenance of radiographic exposure devices, source changers, storage containers, transport containers, source guide tubes, crank-out devices and radiation machines.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.2030 Personnel Monitoring Control

a) The licensee or registrant shall not permit any individual to act as a radiographer or as a radiographer trainee unless, at all times during radiographic operations, each individual wears, on the trunk of the body, a direct reading pocket ionization chamber (i.e., pocket dosimeter) and an individual monitoring device (i.e., personnel dosimeter). Each device shall be assigned to and worn by only one individual.

b) Pocket ionization chambers (i.e., pocket dosimeters) shall meet the criteria in ANSI N322-1997, "Inspection, Test, Construction, and Performance Requirements for Direct Reading Electrostatic/Electroscope Type Dosimeters", published in 1997.

c) The use of pocket ionization chambers (i.e., pocket dosimeters) is subject to the following requirements:

1. Pocket ionization chambers (i.e., pocket dosimeters) must have a range from zero to 2 millisieverts (200 millirems). Pocket ionization chambers shall be recharged at least daily or at least at the start of each work shift. Electronic personal dosimeters may only be used in place of ion-chamber pocket dosimeters;

2. Pocket ionization chambers shall be read and exposures recorded at least at the beginning and end of each worker's shift involving the use of a source of radiation;

3. Pocket dosimeters, or electronic personal dosimeters, must be checked at periods not to exceed 12 months for correct response to radiation. Acceptable dosimeters shall read within plus or minus 20 percent of the true radiation exposure. Records of pocket ionization chamber (i.e., pocket dosimeter) calibrations shall be maintained for inspection by the Agency for 5 years; and

4. If an individual's pocket ionization chamber is discharged beyond its range (i.e., goes "off-scale"), or if an individual's electronic personal dosimeter reads greater than 2 millisieverts (200 millirems), and the possibility of radiation exposure cannot be ruled out as the cause, the individual's personnel dosimeter that requires processing must be sent for processing and evaluation within 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. The determination must be made by the RSO or the RSO's designee. The results of this determination must be included in records maintained in accordance with subsection (d).

d) Records of individual monitoring device (i.e., personnel dosimeter) results; records of daily pocket ionization chamber (i.e., pocket dosimeter) readings, records of estimates of exposures associated with off-scale pocket ionization chambers; and/or lost or damaged individual monitoring devices shall be kept for inspection by the Agency until the radioactive material license or certificate of registration is terminated.

e) Individual monitoring devices (i.e., personnel dosimeters) that require replacement shall be replaced at periods not to exceed one month. After replacement, each individual monitoring device shall be returned to the supplier for evaluation no later than 14 calendar days of the exchange date specified by the personnel monitoring supplier or as soon as practicable. In circumstances that make it impossible to return each individual monitoring device within the required time period, such circumstances shall be documented and available for review by the Agency.

f) If the individual monitoring device (i.e., personnel dosimeter) that is required by subsection (a) is lost or damaged, the worker shall cease work immediately until a replacement monitoring device meeting the requirements in subsection (a) is provided and the exposure is calculated for the time period from issuance to loss or damage of the individual monitoring device. The results of this calculated exposure and the time period for which the individual monitoring device was lost or damaged must be included in the records maintained in accordance with subsection (d).

g) In addition to other requirements of this Section, each individual performing radiography with sealed sources at a location other than a permanent radiography installation shall wear an alarm ratemeter. Each alarm ratemeter shall:

1. Be checked prior to use at the start of each shift to ensure that the alarm functions properly (sounds);

2. Be set to give an alarm signal at a preset dose rate of 5mSv (500 mrem) per hour or less;

3. Require special means to change the preset alarm function; and

4. Be calibrated, at periods not to exceed 1 year, for correct response to radiation. Ratemeters shall alarm within plus or minus 20 percent of the true radiation dose rate. Records of alarm ratemeter calibrations shall be maintained for inspection by the Agency for 5 years.

h) The alarm ratemeter shall be used in addition to, and not as a substitute for, the portable survey instrument required by Section 350.3030. The alarm ratemeter is intended to provide additional assurance that the radiation exposure levels are within regulatory limits.

History

• Source: Amended at 47 Ill. Reg. 9221, effective June 22, 2023

32 Ill. Adm. Code 350.2040 Supervision of Radiographer Trainees

Except when under the personal supervision of a radiographer, a radiographer trainee shall not use radiographic exposure devices, sealed sources, or related source handling tools or conduct radiation surveys required by Sections 350.3030(b) and 350.3030(c) of this Part to determine that the sealed source has returned to the shielded position after an exposure. The personal supervision shall include, at a minimum:

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 radiographer trainee's performance of the operations referred to in this Section.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.3010 Access Control and Security

a) During each radiographic operation, the radiographer or radiographer trainee shall maintain a direct surveillance of the operation to protect against unauthorized entry into a high radiation area, as defined in 32 Ill. Adm. Code 310, except:

1. Where the high radiation area is equipped with a control device or alarm system as described in 32 Ill. Adm. Code 340.610(a), or

2. Where the high radiation area is locked to protect against unauthorized or accidental entry.

b) Sources of radiation shall not be left unattended except when secured against unauthorized use, access or removal.

History

• Source: Amended at 19 Ill. Reg. 8250, effective June 12, 1995

32 Ill. Adm. Code 350.3020 Posting

Notwithstanding any provisions in 32 Ill. Adm. Code 340.930(a), areas in which radiography is being performed shall be conspicuously posted as follows:

a) Each high radiation area shall be conspicuously posted with a sign or signs bearing the radiation caution symbol and the words:

CAUTION (OR DANGER)

HIGH RADIATION AREA

b) Each radiation area shall be conspicuously posted with a sign or signs bearing the radiation caution symbol and the wording required in subsection (a) of this Section, or the words:

CAUTION (OR DANGER)

RADIATION AREA

c) Whenever practicable, ropes or barriers shall be used in addition to appropriate signs to designate radiation areas and to help prevent unauthorized entry.

d) Notwithstanding the requirements of 32 Ill. Adm. Code 340.920(a), each radiation area may be posted in accordance with 32 Ill. Adm. Code 340.920(b) (i.e., both signs may be posted at the same location at the boundary of the radiation area).

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.3030 Radiation Surveys and Survey Records

a) No industrial radiographic operation shall be conducted unless at least one calibrated and operable radiation survey instrument, as described in Section 350.1040 of this Part, is available and used at each site where radiographic exposures are made.

b) A survey with a radiation survey instrument shall be made after each use of a radiographic exposure device to determine that the sealed source has been returned to its shielded position. The entire circumference of the radiographic exposure device shall be surveyed. If the radiographic exposure device has a source guide tube, the survey shall also include the source guide tube and any attached collimator.

c) A lock-out survey, in which all accessible surfaces of the radiographic exposure device or source changer are surveyed with a radiation survey instrument, shall be made to determine that each sealed source is in its shielded position prior to securing the radiographic exposure device or source changer as specified in Section 350.1020 of this Part.

d) A physical radiation survey shall be made after each radiographic exposure using a radiation machine to determine that the machine is "off".

e) Radiation surveys shall be performed in areas where industrial radiography operations are to be performed and shall meet the following requirements:

1. Before industrial radiographic operations begin, all radiation areas and high radiation areas (as determined by calculated exposure rates) in which radiographic operations are to be performed shall be posted in accordance with Section 350.3020 of this Part. An area survey shall be performed during the first radiographic exposure (i.e., with the sealed source in the exposed position) to confirm that the requirements specified in Section 350.3020 of this Part have been met and that doses to individual members of the public do not exceed the limits specified in 32 Ill. Adm. Code 340.310(a).

2. The survey required in subsection (e)(1) of this Section shall be repeated each time the exposure device is relocated or the exposed position of the sealed source is changed.

3. The requirements specified in subsection (e)(2) of this Section do not apply to repetitive industrial radiographic operations when the conditions of exposure, including, but not limited to, the radiographic exposure device, duration of exposure, source strength, pipe size and pipe thickness, remain constant.

f) If a vehicle is to be used for storage of radioactive material, a vehicle survey shall be performed after securing radioactive material in the vehicle and before commencement of transport to ensure that doses to individual members of the public do not exceed the limits specified in 32 Ill. Adm. Code 340.310(a) at the exterior surface of the vehicle.

g) Surveys shall be performed on storage containers to ensure that doses to individual members of the public do not exceed the limits specified in 32 Ill. Adm. Code 340.310(a). These surveys shall be performed initially with the maximum amount of radioactive material present in the storage location and thereafter at the time of the quarterly inventory and whenever storage conditions change.

h) A survey meeting the requirements of subsection (b) of this Section shall be performed on the radiographic exposure device and the source changer after every sealed source exchange.

i) Records shall be kept of the surveys required by subsections (c) through (h) of this Section. The records shall be maintained for inspection by the Agency for 5 years after completion of the survey. If the survey was used to determine an individual's exposure, however, the records of the survey shall be maintained until the radioactive material license or certificate of registration is terminated or until the Agency authorizes their disposition, in writing, following a determination by the Agency that the records contain inaccurate information that could result in an inaccurate determination of an individual's exposure.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.3040 Records Required at Temporary Job Sites

Each licensee or registrant using a source of radiation at a temporary job site shall maintain and have available at the temporary job site, for inspection by the Agency, the following records:

a) The radioactive material license, certificate of registration or equivalent document;

b) Operating and emergency procedures;

c) Relevant regulations of the Agency;

d) Survey records required pursuant to Section 350.3030 of this Part for the period of operation at the site;

e) Daily pocket ionization chamber (i.e., pocket dosimeter) records for the period of operation at the site;

f) If using radioactive material, daily alarm ratemeter records for the period of operation at the site; and

g) Both the latest instrument calibration records and sealed source leakage or contamination test records for specific devices in use at the site. Acceptable records include tags or labels that are affixed to the device or survey meter and decay charts showing leakage or contamination test results for sources that have been manufactured within the last 6 months.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.3045 Operating Requirements

a) When radiography is performed at a location other than a permanent radiographic installation, a minimum of two radiographic personnel shall be present to operate the radiographic exposure device. At least one of the radiographic personnel shall be a radiographer. The other radiographic personnel may be either a radiographer or radiographer trainee.

b) Collimators shall be used in industrial radiographic systems that use crank-out devices except when physically impossible.

c) Other than a radiographer, or a radiographer trainee who is under the personal supervision of a radiographer, no person shall manipulate controls or operate equipment used in industrial radiographic operations.

d) At each job site, the following shall be supplied by the licensee or registrant:

1. The appropriate barrier ropes and signs;

2. At least one operable, calibrated survey instrument;

3. A current whole body individual monitoring device for each worker; and

4. An operable, calibrated pocket ionization chamber (i.e., pocket dosimeter) with a range of zero to 2 mSv (51.6 µC/kg, 200 mrem or 200 mR) for each worker.

e) Each worker who performs industrial radiography with a sealed source at a location other than a permanent radiography installation shall have on his or her person an operable, calibrated alarm ratemeter.

f) Each radiographer or radiographer trainee at a job site shall have on his or her person a valid industrial radiographer certification card issued by the Agency pursuant to the provisions of 32 Ill. Adm. Code 405.

g) Industrial radiographic operations shall not be performed if any of the items in subsections (d), (e) and (f) of this Section are unavailable at the job site or are inoperable.

h) The licensee shall not transport radioactive material unless the material is packaged, and the package is labeled, marked and accompanied with appropriate shipping papers in accordance with 32 Ill. Adm. Code 341.

i) The licensee shall 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.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.3048 Notification of Incidents

a) The licensee or registrant shall notify the Agency of stolen, lost or missing sources of radiation, overexposures, excessive radiation levels and leakage or contamination of sealed sources in accordance with 32 Ill. Adm. Code 340.1210 through 340.1230 and 340.1260. In addition, each licensee or registrant shall submit a written report within 30 days to the Agency whenever one of the following events occurs:

1. A sealed source cannot be returned to the shielded position and properly secured;

2. A sealed source becomes disconnected from a drive cable;

3. Failure of any component necessary for safe operation of a device to properly perform its intended function; or

4. An indicator on a radiation machine fails to show that radiation is being produced or an exposure switch fails to terminate production of radiation when turned to the "off" position.

b) The licensee or registrant shall include the following information in each report submitted pursuant to subsection (a) of this Section that involves failure of safety components of radiography equipment:

1. Description of the equipment problem;

2. Cause of each incident, if known;

3. Name of the manufacturer and model of equipment involved in the incident;

4. Place, date and time of the incident;

5. Actions taken to establish normal operations;

6. Corrective actions taken or planned to prevent recurrence; and

7. Names and qualifications of personnel involved in the incident.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.3050 Special Requirements and Exemptions for Enclosed Radiography Systems

a) Except as exempted by subsection (c) of this Section, the following additional requirements apply to enclosed radiography systems, including systems used in shielded-room radiography. Enclosed radiography systems (including cabinet systems) that are designed to allow admittance of individuals shall be designed and constructed so that:

1. All requirements of this Part and of 32 Ill. Adm. Code 340.310(a) and 340.320 are complied with;

2. Each door fastening mechanism will allow the door to be opened from the inside at all times;

3. Visible and audible alarms are installed and are activated immediately prior to each initiation of an exposure; and

4. A reliable interlock or other mechanism is installed at each means of access to the enclosure which will preclude access to an area of radiation hazard either by preventing entry or by automatically reducing the hazard.

b) Each system for enclosed radiography specified in subsection (a) of this Section shall be evaluated initially by the licensee or registrant and at intervals not to exceed 1 year to assure compliance with the requirements of this Part and 32 Ill. Adm. Code 340.310(a) and 340.320. Records of these evaluations shall be maintained for inspection by the Agency for a period of 5 years after the evaluation.

c) Cabinet x-ray systems designed to exclude individuals are exempt from the requirements of this Part except that:

1. The registrant shall comply with the requirements of 32 Ill. Adm. Code 320 and 340;

2. The registrant shall not permit any individual to operate a cabinet x-ray system until the individual has been instructed in the operating and emergency procedures for the unit and has demonstrated, to the satisfaction of the registrant, competence in its use;

3. Each cabinet x-ray system shall be manufactured and assembled in conformance with the regulations in 21 CFR 1020.40, published April 1, 2002, exclusive of subsequent amendments or editions;

4. The registrant shall maintain for review by the Agency information regarding the operating parameters and workload of each cabinet system; and

5. Tests for proper operation of interlocks installed in accordance with 21 CFR 1020.40 shall be conducted and recorded in accordance with Section 350.1090 of this Part.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.3060 Special Requirements and Exemptions for Enclosed Radiography Systems, Other Than Those Described in Section 350.3050 That Are Designed to Allow Admittance of Individuals (repealed)

History

• Source: Repealed at 18 Ill. Reg. 7263, effective May 2, 1994

32 Ill. Adm. Code 350.3070 Special Requirements and Exemptions for Certified and Non-Certified Cabinet X-Ray Systems Designed to Exclude Individuals (repealed)

History

• Source: Repealed at 18 Ill. Reg. 7263, effective May 2, 1994

32 Ill. Adm. Code 350.3080 Special Requirements for Mobile or Portable Radiation Machines (repealed)

History

• Source: Repealed at 18 Ill. Reg. 7263, effective May 2, 1994

32 Ill. Adm. Code 350.3090 Special Requirements for Underwater and Lay-Barge Radiography

a) Underwater radiography or lay-barge radiography shall not be performed unless specifically authorized in a radioactive material license issued by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State in accordance with Section 350.4010 of this Part or equivalent.

b) In addition to the other requirements of this Part, the following rules apply to the performance of lay-barge radiography:

1. Cobalt-60 sources with activities in excess of 740 GBq (20 Ci) (nominal) and iridium-192 sources with activities in excess of 3.70 TBq (100 Ci) (nominal) shall not be used in the performance of lay-barge industrial radiography.

2. Collimators shall be used in the performance of lay-barge radiography.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.4000 Prohibitions

Retrieval of disconnected sealed sources of radioactive material or sealed sources that cannot be returned by normal means to a shielded position or properly secured shall not be performed unless specifically authorized by a radioactive material license issued by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.4010 Licensing and Registration Requirements for Industrial Radiographic Operations

a) Radioactive material used in industrial radiographic operations shall be licensed in accordance with 32 Ill. Adm. Code 330.

b) Radiation machines used in industrial radiographic operations shall be registered in accordance with 32 Ill. Adm. Code 320.

AGENCY NOTE: If a licensee does not use radiation machines and uses only radioactive material, then the licensed activities do not need to be registered in accordance with the requirements of 32 Ill. Adm. Code 320.

c) In addition to the licensing requirements in 32 Ill. Adm. Code 330, an application for a license shall include the following information:

1. A schedule or description of the program for training radiographic personnel that specifies:

A) Initial training;

B) Periodic training;

C) On-the-job training; and

D) Methods to be used by the licensee or registrant to determine the knowledge, understanding and ability of radiographic personnel to comply with Agency rules, licensing or registration requirements, and the operating and emergency procedures of the applicant;

2. Written operating and emergency procedures, including all items listed in Section 350.2020 of this Part;

3. A description of the internal inspection system or other management control to ensure that radiographic personnel comply with license conditions, regulations and orders of the Agency and the applicant's operating and emergency procedures;

4. A description of the organization of the industrial radiographic program, including delegation of authority and responsibility for operation of the radiation safety program;

5. A list of proposed permanent radiographic installations and descriptions of proposed permanent storage and use locations. Radioactive material shall not be stored at a permanent storage location or used at a permanent use location unless the storage or use location is specifically authorized by the license. A storage or use location is permanent if radioactive material is stored or used at the location for more than 180 days during any consecutive 12 months;

6. A description of the program for inspection and maintenance of radiographic exposure devices, transport containers and storage containers (including applicable items in Sections 350.1080 and Appendix B of this Part);

7. The location(s), i.e., address, where all records required by this Part and other applicable Parts of 32 Ill. Adm. Code will be maintained;

8. For applicants seeking authorization to perform underwater radiography, a description of:

A) Radiation safety procedures and radiographer responsibilities unique to the performance of underwater radiography;

B) Radiographic equipment and radiation safety equipment unique to underwater radiography; and

C) Methods for watertight encapsulation of equipment; and

9. For applicants seeking authorization to perform lay-barge radiography, a description of:

A) Transport procedures for radioactive material to be used in industrial radiographic operations;

B) Storage facilities for radioactive material; and

C) Methods for restricting access to radiation areas.

d) Each licensee or registrant shall maintain a copy of its license or registration, documents incorporated by reference, amendments to each of these items and the application for each of these items until 3 years after being superseded by new documents approved by the Agency, or until the Agency terminates the license or registration.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.4020 Radiation Safety Officer

a) Each licensee or registrant performing industrial radiography shall designate a Radiation Safety Officer (RSO).

AGENCY NOTE: The Agency will list the name of the RSO on each radioactive material license.

b) The RSO's qualifications shall include, but not be limited to:

1. Possession of a high school diploma or a certificate of high school equivalency based on the GED test;

2. Completion of the training and testing requirements of Section 350.2010(a)(2), (3) and (4) of this Part;

3. 2 years of documented experience related to radiation protection, including knowledge of industrial radiographic operations; and

4. For licensees only, the RSO shall also maintain certification as an industrial radiographer as specified in Section 350.2010(a)(1) of this Part.

c) The specific duties of the RSO shall include, but need not be limited to, the following:

1. Establish and oversee operating, emergency and ALARA procedures, and review them at least annually to ensure that the procedures are current and conform with 32 Ill. Adm. Code: Chapter II, Subchapters b and d;

2. Oversee the radiation protection training program for radiographic personnel;

3. Ensure that required radiation surveys and leak tests are performed and documented in accordance with 32 Ill. Adm. Code: Chapter II, Subchapters b and d;

4. Ensure that corrective measures are taken when levels of radiation exceed established limits;

5. Ensure that individual monitoring devices are calibrated and used properly by industrial radiographic personnel, that records are kept of the monitoring results and that timely notifications are made as required by this Part and 32 Ill. Adm. Code 400;

6. Ensure that required interlock switches and warning signals are functioning and that radiation signs, ropes and barriers are properly posted and positioned;

7. Investigate and report to the Agency each known or suspected case of excessive radiation exposure to an individual or radiation level detected in excess of limits established by 32 Ill. Adm. Code: Chapter II, Subchapters b and d and each theft or loss of sources of radiation, determine the cause and take steps to prevent recurrence;

8. Assume control and have the authority to institute corrective actions in emergency situations or unsafe conditions;

9. Maintain records as required by 32 Ill. Adm. Code: Chapter II, Subchapters b and d (see Appendix C of this Part);

10. Ensure proper storage, labeling, transport and use of exposure devices and sources of radiation;

11. Ensure that quarterly inventory and inspection and maintenance programs are performed in accordance with Sections 350.1060 and 350.1080 of this Part; and

12. Ensure that personnel comply with 32 Ill. Adm. Code: Chapter II, Subchapters b and d, the conditions of the license and the operating and emergency procedures of the licensee or registrant.

d) The licensee or registrant shall ensure that the duties in subsection (c) of this Section are executed.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

32 Ill. Adm. Code 350.4030 Reciprocity

The Agency shall grant reciprocal recognition of radioactive material licenses in accordance with 32 Ill. Adm. Code 330.900.

History

• Source: Amended at 28 Ill. Reg. 12598, effective October 1, 2004

Chapter II Illinois Emergency Management Agency

Subchapter b Radiation Protection

Part 350 Radiation Safety Requirements for Industrial Radiographic Operations

32 Ill. Adm. Code 350.APPENDIX A Subjects to Be Covered During the Instruction of Radiographers (repealed)

History

• Source: Repealed at 19 Ill. Reg. 8250, effective June 12, 1995

Chapter II Illinois Emergency Management Agency and Office of Homeland Security

Subchapter b Radiation Protection

Part 350 Radiation Safety Requirements for Industrial Radiographic Operations

32 Ill. Adm. Code 350.APPENDIX B General Requirements for Inspection of Industrial Radiographic Equipment

a) Panoramic devices (devices in which the sealed source is physically removed from the shielded container during exposure) shall be inspected for:

1. Radiographic Exposure Unit

A) Abnormal surface radiation levels anywhere on camera, collimator or guide tube;

B) Condition of safety plugs;

C) Proper operation of locking mechanism;

D) Condition of pigtail connector;

E) Condition of carrying device (e.g., straps, handle, etc.); and

F) Proper labeling.

2. Source Guide Tube

A) Rust, dirt or sludge buildup inside the source tube;

B) Condition of source tube connector;

C) Condition of source stop;

D) Kinks or damage that could prevent proper operation; and

E) Presence of radioactive contamination.

3. Control Cables and Drive Mechanism

A) Proper drive mechanism with camera, as appropriate;

B) Changes in general operating characteristics;

C) Conditions of connector on drive cable;

D) Drive cable flexibility, wear and rust;

E) Excessive wear or damage to crank assembly parts;

F) Damage to drive cable conduit that could prevent the cable from moving freely;

G) Connection of the control cable connector with the pigtail connector for proper mating;

H) Proper operation of source position indicator, if applicable; and

I) Presence of radioactive contamination.

b) Directional beam devices containing radioactive material shall be inspected for:

1. Abnormal surface radiation;

2. Changes in the general operating characteristics of the device;

3. Proper operation of shutter mechanism;

4. Chafing or binding of shutter mechanism;

5. Damage to the device which might impair its operation;

6. Proper operation of locking mechanism;

7. Proper drive mechanism with camera, as appropriate;

8. Condition of carrying device (e.g., strap, handle, etc.); and

9. Proper labeling.

c) X-ray equipment shall be inspected for:

1. Change in the general operating characteristics of the device;

2. Wear of electrical cables and connectors;

3. Proper labeling of console;

4. Proper console with machine, as appropriate;

5. Proper operation of locking mechanism;

6. Timer run-down cutoff;

7. Damage to tube head housing that might result in excessive radiation levels; and

8. Positive indication of x-ray production.

Source: Added at 18 Ill. Reg. 7263, effective May 2, 1994)

32 Ill. Adm. Code 350.APPENDIX C Retention Requirements for Records

Specific Section

Name of Record

Record Retention Period

350.50

Receipt, Transfer and Disposal

Until the radioactive material license or certificate of registration is terminated

350.1040(c)

Survey Instrument Calibration

5 years

350.1050(c)

Leakage or Contamination Tests

5 years

350.1060

Quarterly Inventory

5 years

350.1070

Utilization Logs

5 years

350.1080

Quarterly Inspection and Maintenance

5 years

350.1090

High Radiation Area Control Devices or Alarm Systems

5 years

350.2010(c)

Training and Testing Records

Until the radioactive material license or certificate of registration is terminated. 3 years after termination of employment

350.2010(d)

Internal Audit Program

5 years

350.2030(c)

Pocket Ionization Chamber (i.e., Pocket Dosimeter) Calibrations

5 years

350.2030(d)

Personnel Monitoring Records Pocket Ionization Chamber (i.e., Pocket Dosimeter) Readings

Until the radioactive material license or certificate of registration is terminated

350.2030(g)(4)

Alarm Ratemeter Calibrations

5 years

350.3030

Radiation Surveys

5 years or until the radioactive material license or certificate of registration is terminated if a survey was used to determine an individual's exposure

350.3040

Records at Temporary Job Sites

During temporary job site operations

350.3050

Initial and Annual Evaluations of Enclosed Radiography Systems

5 years

350.4010

License, documents incorporated by reference and amendments to each of these items

Until the radioactive material license is terminated by the Agency or until 3 years after being superseded by new documents approved by the Agency

History

• Source: Amended at 47 Ill. Reg. 9221, effective June 22, 2023

Chapter II Illinois Emergency Management Agency

Subchapter b Radiation Protection

Part 351 Radiation Safety Requirements for Wireline Service Operations and Subsurface Tracer Studies

32 Ill. Adm. Code 351.10 Purpose

This Part establishes radiation safety requirements for individuals using sources of radiation for wireline service operations, including mineral logging, radioactive markers and subsurface tracer studies. The requirements of this Part are in addition to, and not in substitution for, the requirements of 32 Ill. Adm. Code: Chapter II, Subchapters b and d.

History

• Source: Amended at 18 Ill. Reg. 3344, effective February 22, 1994

32 Ill. Adm. Code 351.20 Scope

The regulations in this Part apply to all licensees or registrants who use sources of radiation for wireline service operations, including mineral logging, radioactive markers, or subsurface tracer studies.

32 Ill. Adm. Code 351.25 Incorporations by Reference

All rules, standards and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified in the reference and do not include any later amendments or editions. Copies of these rules, standards and guidelines that have been incorporated by reference are available for public inspection at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.30 Definitions

As used in this Part, the following definitions apply:

"Agency" means the Illinois Emergency Management Agency.

"Energy compensation source (ECS)" means a small sealed source, with an activity not exceeding 3.7 MBq (100 microcuries), used within a logging tool, or other tool components, to provide a reference standard to maintain the tool's calibration when in use.

"Field station" means a facility where radiation sources may be stored or used and from which equipment is dispatched to temporary jobsites.

"Irretrievable well-logging source" means 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.

"Injection tool" means a device used for controlled subsurface injection of radioactive tracer material.

"Logging supervisor" means the individual who provides personal supervision of the utilization of sources of radiation at the well site.

"Logging tool" means a device used subsurface to perform well-logging.

"Mineral logging" means any logging performed for the purpose of mineral exploration other than oil or gas.

"Personal supervision" means guidance and instruction by the supervisor who is physically present at the jobsite and watching the performance of the operation in such proximity that visual contact can be maintained and immediate assistance given as required.

"Radioactive marker" means radioactive material placed subsurface or on a structure intended for subsurface use for the purpose of depth determination or direction orientation.

"Source holder" means a housing or assembly into which a radioactive source is placed for the purpose of facilitating the handling and use of the source in well-logging operations.

"Subsurface tracer study" means the release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the well-bore or adjacent formation.

"Temporary jobsite" means a location to which radioactive materials have been dispatched to perform wireline service operations or subsurface tracer studies.

"Tritium neutron generator target source" means a tritium (hydrogen-3) source used within a neutron generator tube to produce neutrons for use in well-logging applications.

"Well-bore" means a drilled hole in which wireline service operations and subsurface tracer studies are performed.

"Well-logging" means the lowering and raising of measuring devices or tools which may contain sources of radiation into well-bores or cavities for the purpose of obtaining information about the well and/or adjacent formations.

"Wireline" means a cable containing one or more electrical conductors which is used to lower and raise logging tools in the well-bore.

"Wireline service operation" means any evaluation or mechanical service which is performed in the well-bore using devices on a wireline.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.40 Prohibition

No licensee or registrant shall perform wireline service operations with sealed source(s) unless, prior to commencement of the operation, the licensee has a written agreement with the well operator, well owner, drilling contractor or land owner that:

a) In the event a sealed source is lodged downhole, efforts at recovery will be made that are commensurate with the circumstances of the specific case, e.g., quantity and half-life of the radionuclide, depth of the source and presence of potable water aquifers; and

b) In the event a decision is made to abandon the sealed source downhole, the requirements of Section 351.5010(d) of this Part shall be met within 30 days after a decision by the licensee to abandon the source has been approved by the Illinois Emergency Management Agency (Agency).

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.1010 Limits on Levels of Radiation

Sources of radiation shall be used, stored and transported in a manner that the transportation requirements of 32 Ill. Adm. Code 341 and the dose limitation requirements of 32 Ill. Adm. Code 340 are met.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.1020 Storage Precautions

a) Each source of radiation, except accelerators, shall be provided with a storage and/or transport container. The container shall be provided with a lock, or tamper seal for calibration sources, to prevent unauthorized removal of, or exposure to, the source of radiation.

b) When in storage, sources of radiation shall be isolated from flammable or explosive substances.

32 Ill. Adm. Code 351.1030 Transport Precautions

Transport containers shall be physically secured to the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal.

32 Ill. Adm. Code 351.1040 Radiation Survey Instruments

a) The licensee or registrant shall maintain sufficient calibrated and operable radiation survey instruments at each field station to make physical radiation surveys as required by this Part and by 32 Ill. Adm. Code 340.510(a). Instrumentation shall be capable of measuring 0.001 mSv (0.1 mrem) per hour through at least 0.5 mSv (50 mrem) per hour. This range is considered equivalent to 25.8 nC/kg (100 microR) per hour through at least 5.16 microC/kg (20 mR) per hour for the gamma radiation sources typically used in well-logging.

b) Each radiation survey instrument shall be calibrated:

1. At intervals not to exceed 6 months and after each instrument servicing (e.g., electronic repair);

2. At energies and radiation levels equivalent to those to be encountered during use; and

3. So that accuracy within plus or minus 20 percent of the true radiation level can be demonstrated on each scale.

c) Calibration records shall be maintained for a period of 2 years for inspection by the Agency.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.1050 Testing for Leakage or Contamination of Sealed Sources

a) Testing for leakage or contamination of sealed sources shall be performed in accordance with 32 Ill. Adm. Code 340.410. Test samples shall be taken from the surfaces of sources or source holders or from the surfaces of devices in which sources are mounted and on which one might expect contamination to accumulate. The wipe of a sealed source must be performed using a leak test kit approved by the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.

b) Each energy compensation source that is not exempt from testing for leakage or contamination in accordance with 32 Ill. Adm. Code 340.410(b) shall be tested at intervals not to exceed 3 years. In the absence of a certificate from a transferor that a test has been made within the 3 years before the transfer, the energy compensation source shall not be used until tested in accordance with 32 Ill. Adm. Code 340.410.

c) If a sealed source is found to be leaking in accordance with 32 Ill. Adm. Code 340.410, the licensee shall check the equipment associated with the leaking source for radioactive contamination and, if contaminated, have it decontaminated or disposed of by persons specifically authorized by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to perform such services.

d) The licensee shall maintain records of testing for leakage or contamination of sealed sources in accordance with 32 Ill. Adm. Code 340.1135.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.1060 Quarterly Inventory

Each licensee or registrant shall conduct a quarterly physical inventory to account for all sources of radiation. If all sources are not accounted for during the inventory, the licensee or registrant shall notify the Agency in accordance with the requirements of 32 Ill. Adm. Code 340.1210. Records of inventories shall be maintained for 2 years from the date of inventory for inspection by the Agency and shall include the quantities and kinds of sources of radiation, the location where sources of radiation are assigned, the date of the inventory and the name of the individual conducting the inventory.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.1070 Utilization Records

Each licensee or registrant shall maintain current records, which shall be kept available for inspection by the Agency for 2 years from the date of the recorded event, showing the following information for each source of radiation:

a) Make, model number and a serial number or a description of each source of radiation used;

b) The identity of the well-logging supervisor or field unit to whom assigned;

c) Locations where used and dates of use; and

d) In the case of tracer materials and radioactive markers, the utilization record shall indicate the radionuclide and activity used in a particular well.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.1080 Design and Performance Criteria for Sealed Sources Used in Downhole Operations

a) A licensee may not use a sealed source in well-logging unless:

1. The sealed source is doubly encapsulated;

2. The sealed source contains radioactive material whose chemical and physical forms are insoluble and non-dispersible; and

3. A prototype of the sealed source has been tested and meets the performance standards for oil well-logging sources contained in either the United States of America Standards Institute (USASI) Standard No. N5.10-1968, "Classification of Sealed Radioactive Sources", or the revision of N5.10-1968, which is American National Standards Institute (ANSI) Standard No. N542-1977 (1978 edition), "Sealed Radioactive Sources, Classification", which was reaffirmed and redesignated ANSI N43.6-1977(R 1989), exclusive of subsequent amendments or editions, or the sealed source prototype has been tested and found to maintain its integrity after each of the following tests:

A) Temperature. The test source was held at minus 40 degrees Celsius for 20 minutes, 600 degrees Celsius for 1 hour and then subjected to a thermal shock test with a temperature drop from 600 degrees Celsius to 20 degrees Celsius within 15 seconds.

B) Impact test. A 5 kg steel hammer, 2.5 cm in diameter, was dropped from a height of 1 m onto the test source.

C) Vibration test. The test source was subjected to a vibration from 25 Hz to 500 Hz at an amplitude of 5 times the acceleration of gravity for 30 minutes.

D) Puncture test. A 1 gram hammer and pin, 0.3 cm pin diameter, was dropped from a height of 1 m onto the test source.

E) Pressure test. The test source was subjected to an external pressure of 16.95 MPascals (24,600 pounds per square inch absolute).

b) The requirements of subsection (a) of this Section do not apply to sealed sources that contain licensed material in gaseous form or to energy compensation sources (ECS). ECSs shall be registered with the Agency, the U.S. Nuclear Regulatory Commission or another Agreement State pursuant to the equivalent of 32 Ill. Adm. Code 330.280(m)(2), e.g., 10 CFR 32.210.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.1090 Labeling

a) Sources, Source Holders or Logging Tools

1. Each source, source holder or logging tool containing radioactive material shall bear a durable, legible and clearly visible marking or label which has, as a minimum, the standard radiation caution symbol (as described in 32 Ill. Adm. Code 340.910), without the conventional color requirement and the following wording:

DANGER*

RADIOACTIVE

*AGENCY NOTE: or CAUTION.

2. This labeling shall be on every component transported as a separate piece of equipment.

b) Transport Containers. Each transport container shall have permanently attached to it a durable, legible and clearly visible label which has, as a minimum, the standard radiation caution symbol (as described in 32 Ill. Adm. Code 340.910) and the following wording:

DANGER*

RADIOACTIVE

NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY)

*AGENCY NOTE: or CAUTION.

c) Uranium sinker bars. A well-logging licensee may use a uranium sinker bar in well-logging applications only if it is legibly impressed with the following wording:

CAUTION

RADIOACTIVE-DEPLETED URANIUM

NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY) IF FOUND

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.1100 Inspection and Maintenance

a) Each licensee or registrant shall conduct, at intervals not to exceed6 months, a program of inspection and maintenance of source holders, logging tools, source handling tools, storage containers, transport containers and injection tools to assure proper labeling and physical condition. Records of inspection and maintenance shall be maintained for a period of 2 years for inspection by the Agency.

b) If any inspection conducted pursuant to subsection (a) of this Section reveals damage to labeling or components that could result in release of radioactive material into the environment, or loss of control of radioactive material or that could otherwise create a risk of increase in radiation exposure, the device shall be removed from service until repairs have been made.

c) The repair, opening or modification of any sealed source shall be performed only by persons specifically authorized to do so by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.2010 Training Requirements

a) No licensee or registrant shall permit any individual to act as a logging supervisor as defined in this Part until the individual has:

1. Received 40 hours of instruction in the subjects outlined in Appendix A of this Part and has demonstrated to the satisfaction of the licensee or registrant an understanding thereof by successful completion of a written examination administered by the licensee or registrant;

2. Read and received instruction in the regulations contained in this Part and the applicable Sections of 32 Ill. Adm. Code 310, 340 and 400 or the equivalent state or federal regulations, conditions of appropriate license or certificate of registration, and the licensee's or registrant's operating and emergency procedures and demonstrated to the satisfaction of the licensee or registrant an understanding thereof; and

3. Demonstrated to the satisfaction of the licensee or registrant competence to use sources of radiation, related handling tools and radiation survey instruments which will be used on the job.

b) No licensee or registrant shall permit any individual to assist in the handling of sources of radiation until the individual has:

1. Read or received instruction in the licensee's or registrant's operating and emergency procedures and demonstrated to the satisfaction of the licensee or registrant an understanding thereof; and

2. Demonstrated to the satisfaction of the licensee or registrant competence to use, under the personal supervision of the logging supervisor, the sources of radiation, related handling tools and radiation survey instruments which will be used on the job.

c) The licensee or registrant shall maintain employee training records for inspection by the Agency for 2 years following termination of employment.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.2020 Operating and Emergency Procedures

The licensee's or registrant's operating and emergency procedures shall include instructions in at least the following:

a) Handling and use of sources of radiation to be employed so that no individual is likely to be exposed to radiation doses in excess of the standards established in 32 Ill. Adm. Code 340;

b) Methods and occasions for conducting radiation surveys, including surveys for detecting contamination as required by Section 351.4010(a) through (e) of this Part;

c) Methods and occasions for locking and securing sources of radiation;

d) Personnel monitoring and the use of personnel monitoring equipment;

e) Transportation to temporary jobsites and field stations, including the packaging and placing of sources of radiation in vehicles, placarding of vehicles and securing sources of radiation during transportation to prevent accidental loss, tampering or unauthorized removal;

f) Minimizing exposure of individuals in the event of an accident and from inhalation and ingestion of radioactive tracer materials;

g) Procedure for notifying proper personnel in the event of an accident;

h) Maintenance of records;

i) Inspection and maintenance of sealed sources, source holders, logging tools, source handling tools, storage containers, transport containers and injection tools;

j) Procedure to be followed in the event a sealed source is lodged downhole or likely to be leaking;

k) Procedures to be used for picking up, receiving and opening packages containing radioactive material in accordance with 32 Ill. Adm. Code 340.960;

l) Use of sealed sources in wells without surface casing for protecting fresh water aquifers, if appropriate;

m) Use of remote handling tools for handling sealed sources and radioactive tracer material, except low activity calibration sources; and

n) Decontamination of the environment, equipment and personnel if radioactive tracer material is used.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.2030 Personnel Monitoring

a) No licensee or registrant shall permit any individual to act as a logging supervisor or to assist in the handling of sources of radiation unless each individual wears an individual monitoring device provided and evaluated by a qualified dosimetry processor as described in 32 Ill. Adm. Code 340.510(d). Each device shall be assigned to and worn by only one individual.

b) Records of individual monitoring results shall be retained in accordance with 32 Ill. Adm. Code 340.1160.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.3010 Security

During each logging or tracer application, the logging supervisor or other designated employee shall maintain direct surveillance of the operation to protect against unauthorized and/or unnecessary entry into a restricted area, as defined in 32 Ill. Adm. Code 310.

32 Ill. Adm. Code 351.3020 Handling Tools

The licensee or registrant shall provide and require the use of tools that will assure remote handling of sealed sources other than low-activity calibration sources.

32 Ill. Adm. Code 351.3022 Tritium Neutron Generator Target Source

a) Use of a tritium neutron generator target source, containing quantities not exceeding 1,110 MBq (30 Ci) for well-logging in a well with a surface casing to protect fresh water aquifers, is subject to the requirements of this Part, except Sections 351.40, 351.1080 and 351.5010 of this Part. Film badges must be replaced at least monthly and other individual monitoring devices replaced at least quarterly. After replacement, each individual monitoring device must be promptly processed.

b) Either use of a tritium neutron generator target source containing quantities exceeding 1,110 MBq (30 Ci) or use of a tritium neutron generator target source containing quantities not exceeding 1,110 MBq (30 Ci) in a well without a surface casing to protect fresh water aquifers is subject to the requirements of this Part, except Section 351.1080 of this Part.

History

• Source: Added at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.3025 Energy Compensation Source (ecs)

a) The licensee may use an ECS that is contained within a logging tool, or other tool components, only if the ECS contains quantities of radioactive material not exceeding 3.7 MBq (100 microCi).

b) For well-logging applications with a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of Sections 351.1050, 351.1060 and 351.1070 of this Part.

c) For well-logging applications without a surface casing for protecting fresh water aquifers, use of the ECS is subject to the requirements of Sections 351.40, 351.1050, 351.1060, 351.1070, 351.3030(b)(2) and 351.5010 of this Part.

History

• Source: Added at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.3027 Well-Logging in a Well Without a Surface Casing

The licensee may use a sealed source in a well without a surface casing for protecting fresh water aquifers only if the licensee follows a procedure for reducing the probability of the sealed source becoming lodged in the well. The procedure shall be approved by the Agency pursuant to Section 351.2020(l) of this Part.

History

• Source: Added at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.3030 Subsurface Tracer Studies

a) All personnel handling radioactive tracer material shall be required to use protective gloves, protective clothing and equipment which prevents the spread of contamination. Precautions shall be taken by the licensee or registrant to prevent ingestion or inhalation of radioactive material.

b) No licensee or registrant shall cause the injection of radioactive material into potable aquifers without specific license authorization issued by the Agency pursuant to 32 Ill. Adm. Code 330.250. The authorization will be issued only if:

1. The applicant's proposed procedures will prevent tracer concentrations at the most exposed drinking water source or public water supply inlet from exceeding the Illinois Environmental Protection Agency's drinking water quality standards in 35 Ill. Adm. Code 604; and

2. The applicant's proposed procedures will be performed:

A) On an underground injection well for which a U.S. Environmental Protection Agency underground injection control program permit has been issued pursuant to 40 CFR 124 or 40 CFR 144 revised as of July 1, 1990, or pursuant to 35 Ill. Adm. Code 705 or 62 Ill. Adm. Code 240; or

B) On a well for which the Illinois Environmental Protection Agency has otherwise approved a subsurface radioactive tracer study pursuant to 35 Ill. Adm. Code 704; or

C) On a well for which the Illinois Department of Natural Resources has otherwise approved a subsurface radioactive tracer study pursuant to 62 Ill. Adm. Code 240.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.3040 Particle Accelerators

No licensee or registrant shall 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 that the requirements of 32 Ill. Adm. Code 340.210 and 340.310, as applicable, are met.

History

• Source: Amended at 18 Ill. Reg. 3344, effective February 22, 1994

32 Ill. Adm. Code 351.4010 Radiation Surveys

a) Radiation surveys and/or calculations shall be made and recorded for each area where radioactive materials are stored.

b) Radiation surveys and/or calculations shall be made and recorded for the radiation levels in occupied positions and on the exterior of each vehicle used to transport radioactive material. The surveys and/or calculations shall include each source of radiation or combination of sources to be transported in the vehicle.

c) After removal of the sealed source from the logging tool and before departing the jobsite, the logging tool detector shall be energized, or a radiation survey meter used, to assure that the logging tool is free of contamination.

d) If the licensee has reason to believe that, as a result of any operation involving a sealed source, the encapsulation of the sealed source could be damaged by the operation, the licensee shall conduct a radiation survey, including a contamination survey, during and after the operation.

e) Radiation surveys shall be made and recorded at the jobsite or wellhead for each tracer operation, except those using hydrogen-3, carbon-14 and sulfur-35. These surveys shall include measurements of radiation levels before and after the operation.

f) Records required pursuant to subsections (a) through (e) of this Section shall include the dates, the identification of individual(s) making the survey, the identification of survey instrument(s) used and an exact description of the location of the survey. Records of these surveys shall be maintained for inspection by the Agency for 5 years after completion of the survey.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.4020 Documents and Records Required at Field Stations

Each licensee or registrant shall maintain, for inspection by the Agency, the following documents and records for the specific devices and sources used at the field station:

a) Appropriate license, certificate of registration or equivalent document issued by the Nuclear Regulatory Commission, an Agreement State or Licensing State;

b) Operating and emergency procedures required by Section 351.2020 of this Part;

c) 32 Ill. Adm. Code: Chapter II, Subchapters b and d;

d) Records of the latest survey instrument calibrations pursuant to Section 351.1040 of this Part;

e) The dates of the latest tests for leakage or contamination performed on the sealed sources and the results of the tests;

f) Quarterly inventories required pursuant to Section 351.1060 of this Part;

g) Utilization records required pursuant to Section 351.1070 of this Part;

h) Records of inspection and maintenance required pursuant to Section 351.1100 of this Part; and

i) Survey records required pursuant to Section 351.4010 of this Part.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.4030 Documents and Records Required at Temporary Jobsites

Each licensee or registrant conducting operations at a temporary jobsite shall have the following documents and records available at that site for inspection by the Agency:

a) Operating and emergency procedures required by Section 351.2020 of this Part;

b) Survey records required pursuant to Section 351.4010 of this Part for the period of operation at the site;

c) Evidence of current calibration for the radiation survey instruments in use at the site;

d) The licensee's radioactive material license, including all appropriate amendments;

e) When operating in the State under reciprocity as provided for in 32 Ill. Adm. Code 330.900, a copy of the appropriate license, certificate of registration or equivalent documents; and

f) The dates of the latest tests for leakage or contamination performed on the sealed sources and the results of the tests.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

32 Ill. Adm. Code 351.5010 Notification of Incidents, Abandonment and Lost Sources

a) Notification shall be made to the Agency whenever an incident has occurred as described in 32 Ill. Adm. Code 340.1220 or 340.1230. Notification shall also be made to the Agency whenever a source is leaking or contaminated in accordance with 32 Ill. Adm. Code 340.1260 or stolen, missing or lost, other than in downhole logging operations, in accordance with 32 Ill. Adm. Code 340.1210.

b) Whenever a sealed source is separated from the logging tool and is lost downhole, the licensee shall notify the Agency immediately by telephone prior to beginning source recovery operations.

c) Whenever a sealed source or device containing radioactive material is lodged downhole, the licensee or registrant shall:

1. Monitor at the surface for the presence of radioactive contamination with a radiation survey instrument or logging tool during logging tool recovery operations; and

2. Notify the Agency immediately by telephone if radioactive contamination is detected at the surface or if the source is likely to have been ruptured.

d) When efforts to recover the radioactive source are not successful, the licensee or registrant shall:

1. Advise the well operator of the regulations of the Illinois Emergency Management Agency regarding abandonment and the method of abandonment, which shall include:

A) The immobilization and sealing in place of the radioactive source with a cement plug;

B) The means to prevent inadvertent intrusion on the source, unless the source is not accessible to any subsequent drilling operations, such as setting of a whipstock or other deflection device; and

C) The mounting of a permanent identification plaque, at the surface of the well, containing the appropriate information required by subsection (g) of this Section;

2. Notify the Agency immediately by telephone, and by mail within 10 calendar days, giving the circumstances of the loss and requesting approval of the adopted abandonment procedures; and

3. File a written report with the Agency within 30 days of the abandonment, setting forth the following information:

A) Date of occurrence and a brief description of attempts to recover the source;

B) A description of the radioactive source involved, including radionuclide, quantity, and chemical and physical form;

C) Surface location and identification of well;

D) Results of efforts to immobilize and seal the source in place;

E) Depth of the radioactive source;

F) Depth of the top of the cement plug;

G) Depth of the well; and

H) Information contained on the permanent identification plaque.

e) The Agency will provide written approval of the request by the licensee pursuant to subsection (d)(2) of this Section if the Agency determines that accepted industry methods for recovery have been unsuccessful and the proposed abandonment procedures satisfy the requirements of subsection (d)(1) of this Section.

f) If the licensee believed there was an immediate threat to public health and safety and the licensee implemented abandonment procedures before receiving Agency approval to implement abandonment procedures, the licensee shall notify the Agency immediately by telephone, and by mail within 10 calendar days, giving the circumstances and reasons why an immediate threat to public health and safety was determined to exists and who made the determination.

g) Whenever a sealed source containing radioactive material is abandoned downhole, the licensee shall provide a permanent plaque for posting the well or well-bore. This plaque shall:

AGENCY NOTE: An example of a suggested plaque is shown in Appendix B of this Part.

1. Be constructed of long-lasting material, such as stainless steel or monel; and

2. Contain the following information engraved on its face:

A) The word "CAUTION";

B) The radiation symbol without the conventional color requirement;

C) The date of abandonment;

D) The name of the well operator or well owner;

E) The well name and well identification number(s) or other

designation;

F) The sealed sources by radionuclide and quantity of activity;

G) The source depth and the depth to the top of the plug; and

H) An appropriate warning, depending on the specific circumstances of each abandonment.

AGENCY NOTE: Appropriate warnings may include: "Do not drill below plug back depth"; "Do not enlarge casing"; or "Do not re-enter the hole" followed by the words, "before contacting the Illinois Emergency Management Agency ".

h) The licensee or registrant shall notify the Agency immediately by telephone, and by mail within 10 calendar days, if the licensee knows or has reason to believe that radioactive material has been lost in or to an underground potable water source. The notice shall designate the well location and shall describe the magnitude and extent of loss of radioactive material, assess the health and environmental consequences of the loss and explain efforts planned or being taken to mitigate these consequences.

History

• Source: Amended at 28 Ill. Reg. 12643, effective October 1, 2004

Chapter II Illinois Emergency Management Agency and Office of Homeland Security

Subchapter b Radiation Protection

Part 351 Radiation Safety Requirements for Wireline Service Operations and Subsurface Tracer Studies

32 Ill. Adm. Code 351.10 Purpose

This Part establishes requirements for the issuance of a license authorizing the use of licensed materials including sealed sources, radioactive tracers, radioactive markers, and uranium sinker bars in well logging in a single well. This Part also establishes radiation safety requirements for persons using licensed materials in these operations. The requirements of this Part are in addition to, and not in substitution for, the requirements of 32 Ill. Adm. Code: Chapter II, Subchapters b and d.

32 Ill. Adm. Code 351.20 Scope

This Part applies to all licensees or registrants who use sources of radiation for wireline service operations, including mineral logging, radioactive markers, or subsurface tracer studies.

32 Ill. Adm. Code 351.25 Incorporations by Reference

a) All rules, standards, and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified in the reference and do not include any later amendments or editions. Copies of these rules, standards, and guidelines that have been incorporated by reference are available for public inspection at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois.

b) Incorporated Materials

1. "Classification of Sealed Radioactive Sources" (1968), Standard N5.10-1968, United States of America Standards Institute (USASI) (now American National Standards Institute (ANSI)), 1899 L Street, NW, 11th Floor, Washington, DC 20036; (202) 293-8020; https://www.ansi.org.

2. "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Well Logging, Tracer, and Field Flood Study Licenses: Final Report" (2018), NUREG-1556, Vol. 14, Rev. 1, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; (800) 368-5642; available at https://www.nrc.gov/docs/ML1812/ML18120A129.pdf.

3. "Sealed Radioactive Sources – Classification" (1997), Standard N43.6-1997, American National Standards Institute/Health Physics Society (ANSI/HPS)), 1899 L Street, NW, 11th Floor, Washington, DC 20036; (202) 293-8020; https://www.ansi.org.

32 Ill. Adm. Code 351.30 Definitions

As used in this Part, the following definitions apply:

"Agency" means the Illinois Emergency Management Agency.

"Energy compensation source (ECS)" means a small sealed source, with an activity not exceeding 3.7 MBq (100 microcuries), used within a logging tool, or other tool components, to provide a reference standard to maintain the tool's calibration when in use.

"Field station" means a facility where radiation sources may be stored or used and from which equipment is dispatched to temporary jobsites.

"Fresh water aquifer" means a geological formation that is capable of yielding fresh water to a well or spring.

"Injection tool" means a device used for controlled subsurface injection of radioactive tracer material.

"Irretrievable well logging source" means 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.

"Logging assistant" means any individual who, under the personal supervision of a logging supervisor, handles sealed sources or tracers that are not in logging tools or shipping containers or who performs surveys required by Section 351.670.

"Logging supervisor" means an individual who uses licensed material or provides personal supervision in the use of licensed material at a temporary jobsite and who is responsible to the licensee for assuring compliance with the requirements of the Agency's regulations and the conditions of the license.

"Logging tool" means a device used subsurface to perform well logging.

"Mineral logging" means any logging performed for the purpose of mineral exploration other than oil or gas.

"Personal supervision" means guidance and instruction by a logging supervisor, who is physically present at a temporary jobsite, who is in personal contact with logging assistants, and who can give immediate assistance.

"Radioactive marker" means licensed material used for depth determination or direction orientation. For purposes of this Part, this term includes radioactive collar markers and radioactive iron nails.

"Safety review" means a periodic review provided by the licensee for its employees on radiation safety aspects of well logging. The review may include, as appropriate, the results of internal inspections, new procedures or equipment, accidents or errors that have been observed, and opportunities for employees to ask safety questions.

"Source holder" means a housing or assembly into which a sealed source is placed to facilitate the handling and use of the source in well logging operations.

"Subsurface tracer study" means the release of unsealed licensed material or a substance labeled with licensed material in a single well for the purpose of tracing the movement or position of the material or substance in the well or adjacent formation.

"Surface casing for protecting fresh water aquifers" means a pipe or tube used as a lining in a well to isolate fresh water aquifers from the well.

"Temporary jobsite" means any location where licensed material is used or stored for 180 days or less during any consecutive 12 months, and not specifically listed on a radioactive material license.

"Tritium neutron generator target source" means a tritium (hydrogen-3) source used within a neutron generator tube to produce neutrons for use in well logging applications.

"Uranium sinker bar" means a weight containing depleted uranium used to pull a logging tool toward the bottom of a well.

"Well" means a drilled hole in which well logging may be performed. As used in this Part, "well" includes drilled holes for the purpose of disposal or oil, gas, mineral, groundwater, or geological exploration.

"Well-bore" means a drilled hole in which wireline service operations and subsurface tracer studies are performed.

"Well logging" means all operations involving the lowering and raising of measuring devices or tools which contain licensed material or are used to detect licensed materials in wells for the purpose of obtaining information about the well or adjacent formations which may be used in oil, gas, mineral, groundwater, or geological exploration.

"Wireline" means a cable containing one or more electrical conductors which is used to lower and raise logging tools in the well-bore.

"Wireline service operation" means any evaluation or mechanical service which is performed in the well-bore using devices on a wireline.

32 Ill. Adm. Code 351.110 Application for a Specific License

A person, as defined in 32 Ill. Adm. Code 310.20, may apply for a specific license authorizing the use of licensed material in well logging. Applications shall be filed in accordance with 32 Ill. Adm. Code 330.240.

32 Ill. Adm. Code 351.130 Specific License for Well Logging

The Agency will approve an application for a specific radioactive material license in well logging if the applicant meets the following requirements:

a) Complies with the general requirements specified in 32 Ill. Adm. Code 330.250.

b) Develops and submits to the Agency a program for training logging supervisors and logging assistants which specifies the details of:

1. Initial training;

2. On-the-job training;

3. Annual safety reviews to be provided by the licensee;

4. The means the applicant will use to demonstrate the logging supervisor's knowledge and understanding of and ability to comply with the Agency's regulations and licensing requirements and the Applicant's operating and emergency procedures; and

5. The means the applicant will use to demonstrate the logging assistant's knowledge and understanding of and ability to comply with the Agency's rules, license conditions, and the applicant's operating and emergency procedures.

c) Submits written operating and emergency procedures as required in Section 351.630.

d) Establishes and submits to the Agency a program for annual inspections of the job performance of each logging supervisor to ensure that the Agency's regulations, license conditions, and the applicant's operating and emergency procedures are followed. The applicant's annual inspection program shall include provisions to retain inspection records for 3 years after each annual internal inspection.

e) Submits a description of the overall organizational structure as it applies to the radiation safety responsibilities in well logging and specifies delegations of authority and responsibility.

f) If the Applicant intends to perform leak testing of sealed sources, establishes and submits to the Agency procedures for leak testing that include the following information:

1. The instruments to be used;

2. The methods of performing the analysis; and

3. The pertinent experience of the person who will analyze the wipe samples.

32 Ill. Adm. Code 351.150 Agreement with Well Owner or Operator

a) A licensee may perform well logging with a sealed source only after the licensee has a written agreement with the employing well owner or operator. This written agreement shall identify who will meet the following requirements:

1. If a sealed source becomes lodged in the well, a reasonable effort will be made to recover it.

2. A person may not attempt to recover a sealed source in a manner which, in the licensee's opinion, could result in its rupture.

3. Radiation monitoring required in Section 351.690(a).

4. If the environment, any equipment, or personnel are contaminated with licensed material, they must be decontaminated before release from the site or release for unrestricted use.

5. If the sealed source is classified as irretrievable after reasonable efforts at recovery have been expended, the following requirements shall be implemented within 30 days:

A) Each irretrievable well logging source shall be immobilized and sealed in place with a cement plug;

B) A means to prevent inadvertent intrusion on the source shall be established unless the source is not accessible to any subsequent drilling operations; and

C) A permanent identification plaque, constructed of long-lasting material such as stainless steel, brass, bronze, or monel, shall 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 cm (7 inches) square and 3 mm (⅛ inch) thick. The plaque shall contain:

i) The word "CAUTION";

ii) The radiation symbol (the color requirement in 32 Ill. Adm. Code 340.910(a) need not be met);

iii) The date the source was abandoned;

iv) The name of the well owner or well operator, as appropriate;

v) The well name and well identification number or other designation;

vi) An identification of the sealed source by radionuclide and quantity;

vii) The depth of the source and depth to the top of the plug; and

viii) An appropriate warning, such as, "DO NOT RE-ENTER THIS WELL."

b) The licensee shall retain a copy of the written agreement for 3 years after the completion of the well logging operation.

c) A licensee may request Agency approval, on a case-by-case basis, of proposed procedures to abandon an irretrievable well logging source in a manner not otherwise authorized in subsection (a)(5).

d) A written agreement between the licensee and the well owner or operator is not required if the licensee and the well owner or operator are part of the same corporate structure or otherwise similarly affiliated. However, the licensee shall still meet the requirements in subsections (a)(1) through (a)(5).

32 Ill. Adm. Code 351.310 Labels, Security, and Transportation Precautions

a) Labels

1. The licensee may not use a source, source holder, or logging tool that contains licensed material unless the smallest component that is transported as a separate piece of equipment with the licensed material inside bears a durable, legible, and clearly visible marking or label. The marking or label must contain the radiation symbol specified in 32 Ill. Adm. Code 340.910(a), without the conventional color requirements, and the wording "DANGER (or CAUTION) RADIOACTIVE MATERIAL."

2. The licensee may not use a container to store licensed material unless the container has a securely attached label that is durable, legible, and clearly visible. The label must contain the radiation symbol specified in 32 Ill. Adm. Code 340.910(a) and the wording "CAUTION (or DANGER), RADIOACTIVE MATERIAL, NOTIFY CIVIL AUTHORITIES (or NAME OF COMPANY)."

3. The licensee may not transport licensed material unless the material is packaged, labeled, marked, and accompanied with appropriate shipping papers pursuant to 32 Ill. Adm. Code 341.

b) Security Precautions During Storage and Transportation

1. The licensee shall store each source containing licensed material in a storage container or transportation package. The container or package shall be locked and physically secured to prevent tampering or removal of licensed material from storage by unauthorized personnel. The licensee shall store licensed material in a manner which will minimize danger from explosion or fire.

2. The licensee shall lock and physically secure the transport package containing licensed material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal of the licensed material from the vehicle.

32 Ill. Adm. Code 351.330 Radiation Detection Instruments

a) The licensee or registrant shall keep sufficient calibrated and operable radiation survey instruments at each field station and temporary jobsite to make physical radiation surveys as required by this Part and by 32 Ill. Adm. Code 340.510(a). Instrumentation shall be capable of measuring 0.001 mSv (0.1 mrem) per hour through at least 0.5 mSv (50 mrem) per hour.

b) The licensee shall have available additional calibrated and operable radiation detection instruments sensitive enough to detect the low radiation and contamination levels that could be encountered if a sealed source ruptured. The licensee may own the instruments or may have a procedure to obtain them quickly from a second party.

c) The licensee must have each radiation survey instrument required under subsections (a) and (b) calibrated:

1. At intervals not to exceed 6 months and after each instrument servicing (e.g., electronic repair);

2. For linear scale instruments, at two points located approximately ⅓ and ⅔ of full-scale on each scale; for logarithmic scale instruments, at midrange of each decade, and at two points of at least one decade; and for digital instruments, at appropriate points; and

3. So that accuracy within plus or minus 20 percent of the calibration standard can be demonstrated on each scale.

d) The licensee shall retain calibration records for a period of 3 years after the date of calibration for inspection by the Agency.

32 Ill. Adm. Code 351.350 Leak Testing of Sealed Sources

a) Testing and Recordkeeping Requirements. Each licensee who uses a sealed source shall have the source tested for leakage as described in subsection (c). The licensee shall keep a record of leak test results under 32 Ill. Adm. Code 340.1135.

b) Method of Testing. The wipe of a sealed source shall be performed using a leak test kit or method approved by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State. The wipe sample shall be taken from the nearest accessible point to the sealed source where contamination might accumulate. The wipe sample shall be analyzed for radioactive contamination. The analysis shall be capable of detecting the presence of 185 Bq (0.005 microcuries) of radioactive material on the test sample and shall be performed by a person approved by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State to perform the analysis.

c) Test Frequency

1. Each sealed source, except an energy compensation source (ECS), shall be tested at intervals not to exceed 6 months. In the absence of a certificate from a transferor that a test has been made within the 6 months before the transfer, the sealed source may not be used until tested.

2. Each ECS that is not exempt from testing pursuant to subsection (e) shall be tested at intervals not to exceed 3 years. In the absence of a certificate from a transferor that a test has been made within the 3 years before the transfer, the ECS may not be used until tested.

d) Removal of Leaking Source from Service

1. If the test conducted pursuant to subsections (a) and (b) reveals the presence of 185 Bq (0.005 microcuries) or more of removable radioactive material, the licensee shall remove the sealed source from service immediately and have it decontaminated, repaired, or disposed of by an Agency, U.S. Nuclear Regulatory Commission, or Agreement State licensee that is authorized to perform these functions. The licensee shall check the equipment associated with the leaking source for radioactive contamination and, if contaminated, have it decontaminated or disposed of by an Agency, U.S. Nuclear Regulatory Commission, or Agreement State licensee that is authorized to perform these functions.

2. Reports of test results for leaking or contaminated sealed sources shall be made pursuant to 32 Ill. Adm. Code 340.1260.

e) Exemptions from Testing Requirements. The following sealed sources are exempt from the periodic leak test requirements set out in subsections (a) through (d):

1. Hydrogen-3 (tritium) sources;

2. Sources containing licensed material with a half-life of 30 days or less;

3. Sealed sources containing licensed material in gaseous form;

4. Sources of beta- or gamma-emitting radioactive material with an activity of 3.7 MBq (100 microcuries) or less; and

5. Sources of alpha- or neutron-emitting radioactive material with an activity of 0.37 MBq (10 microcuries) or less.

32 Ill. Adm. Code 351.370 Quarterly Physical Inventory

Each licensee or registrant shall conduct a quarterly physical inventory to account for all sources of radiation. If all sources are not accounted for during the inventory, the licensee or registrant shall notify the Agency in accordance with the requirements of 32 Ill. Adm. Code 340.1210. Records of inventories shall be maintained for 3 years from the date of inventory for inspection by the Agency and shall include the quantities and kinds of sources of radiation, the location of the sources of radiation, the date of the inventory, and the name of the individual conducting the inventory. Physical inventory records may be combined with leak test records, as appropriate.

32 Ill. Adm. Code 351.390 Records of Use for Radioactive Material

a) Each licensee or registrant shall maintain records for each use of licensed material, including:

1. The make, model number, and a serial number or a description of each sealed source of radiation used;

2. In the case of unsealed licensed material used for subsurface tracer studies, the radionuclide and quantity of activity used in a particular well and the disposition of any unused tracer materials;

3. The identity of the logging supervisor who is responsible for the licensed material and the identity of logging assistants present; and

4. The location and date of use of the licensed material.

b) The licensee or registrant shall retain the use records for 3 years from the date of the recorded event and make them available for inspection by the Agency.

32 Ill. Adm. Code 351.410 Design and Performance Criteria for Sources

a) A licensee may not use a sealed source in well logging unless:

1. The sealed source is doubly encapsulated;

2. The sealed source contains licensed material whose chemical and physical forms are as insoluble and non-dispersible as practical; and

3. The sealed source meets the requirements of subsection (b), (c), or (d).

b) For a sealed source manufactured on or before July 14, 1989, a licensee may use the sealed source in well logging applications only if it meets the requirements of the United States of America Standards Institute (USASI) N5.10-1968, "Classification of Sealed Radioactive Sources", incorporated by reference in Section 351.25, or the requirements in subsection (c) or (d).

c) For a sealed source manufactured after July 14, 1989, a licensee may use the sealed source in well logging applications if it meets the oil well logging requirements of the American National Standards Institute/Health Physics Society (ANSI/HPS) N43.6-1997, "Sealed Radioactive Sources − Classification."

d) For a sealed source manufactured after July 14, 1989, a licensee may use the sealed source, for well logging applications only if a prototype of the sealed source has been tested and found to maintain its integrity after each of the following tests:

1. Temperature. The test source was held at -40 °C for 20 minutes, 600 °C for 1 hour, and then subjected to a thermal shock test with a temperature drop from 600 °C to 20 °C within 15 seconds.

2. Impact Test. A 5 kg steel hammer, 2.5 cm in diameter, was dropped from a height of 1 m onto the test source.

3. Vibration Test. The test source was subjected to a vibration from 25 Hz to 500 Hz at an amplitude of 5 times the acceleration of gravity for 30 minutes.

4. Puncture Test. A 1-gram hammer and pin, 0.3 cm pin diameter, was dropped from a height of 1 m onto the test source.

5. Pressure Test. The test source was subjected to an external pressure of 16.95 MPascals (24,600 pounds per square inch absolute).

e) The requirements of subsections (a), (b), (c), and (d) do not apply to sealed sources that contain licensed material in gaseous form.

f) The requirements of subsections (a), (b), (c), and (d) do not apply to energy compensation sources (ECSs). ECSs shall be registered with the Agency, the U.S. Nuclear Regulatory Commission, or another Agreement State pursuant to the equivalent of 32 Ill. Adm. Code 330.280(m)(2) and 10 CFR 32.210.

32 Ill. Adm. Code 351.430 Inspection, Maintenance, and Opening of a Sealed Source or Source Holder

a) Each licensee or registrant shall visually check source holders, logging tools, and source handling tools for defects before each use to ensure that the equipment is in good working condition and required labeling is present. If defects are found, the equipment shall be removed from service until repaired and a record must be made listing the date of the check, name of the inspector, equipment involved, defects found, and repairs made. Records shall be retained for 3 years after the defect is found.

b) Each licensee or registrant shall have a program for semiannual 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 that the required labeling is legible and no physical damage is visible. If defects are found, the equipment shall be removed from service until repaired and a record made listing the date, equipment involved, inspection and maintenance operations performed, any defects found, and any actions taken to correct the defects. Records shall be retained for 3 years after the defect is found.

c) Removal of a sealed source from a source holder or logging tool and maintenance on sealed sources or holders in which sealed sources are contained may not be performed by the licensee unless a written procedure developed pursuant to Section 351.630 has been approved by the Agency pursuant to Section 351.130(c) or by the U.S. Nuclear Regulatory Commission or an Agreement State.

d) If a sealed source is stuck in the source holder, the licensee may not perform any operation, such as drilling, cutting, or chiseling, on the source holder unless the licensee is specifically approved by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State to perform this operation.

e) The repair, opening, or modification of any sealed source shall be performed only by persons specifically authorized to do so by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State.

32 Ill. Adm. Code 351.450 Subsurface Tracer Studies

a) All personnel handling radioactive tracer material shall be required to use protective gloves and, if required by the license, other protective clothing and equipment. Precautions shall be taken by the licensee to avoid ingestion or inhalation of radioactive tracer material and to avoid contamination of field stations and temporary jobsites.

b) A licensee may not knowingly inject licensed material into fresh water aquifers without specific license authorization issued by the Agency pursuant to 32 Ill. Adm. Code 330.250. The authorization will be issued only if the Applicant's proposed procedures will:

1. Prevent tracer concentrations at the most exposed drinking water source or public water supply inlet from exceeding the Illinois Pollution Control Board's maximum contaminant levels for radionuclides in 35 Ill. Adm. Code 611.330; and

2. Be performed:

A) On an underground injection well for which a U.S. Environmental Protection Agency underground injection control program permit has been issued pursuant to 40 CFR 124 or 40 CFR 144, 35 Ill. Adm. Code 705, or 62 Ill. Adm. Code 240; or

B) On a well for which the Illinois Department of Natural Resources has approved a subsurface radioactive tracer study pursuant to 62 Ill. Adm. Code 240.

32 Ill. Adm. Code 351.470 Radioactive Markers

A licensee or registrant may use radioactive markers in wells only if the individual markers contain quantities of licensed material not exceeding the quantities specified in Appendix B of 32 Ill. Adm. Code Part 330. The use of markers is subject only to the requirements of Section 351.370.

32 Ill. Adm. Code 351.490 Uranium Sinker Bars

A licensee or registrant 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."

32 Ill. Adm. Code 351.510 Use of a Sealed Source in a Well Without Surface Casing

The licensee may use a sealed source in a well without a surface casing for protecting fresh water aquifers only if the licensee follows a procedure for reducing the probability of the sealed source becoming lodged in the well. The procedure shall be approved by the Agency pursuant to Section 351.130(c) or by the U.S. Nuclear Regulatory Commission or an Agreement State.

32 Ill. Adm. Code 351.530 Energy Compensation Source (ecs)

a) The licensee may use an ECS that is contained within a logging tool, or other tool components only if the ECS contains quantities of licensed material not exceeding 3.7 MBq (100 microCi).

b) For well logging applications with a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of Sections 351.350, 351.370, and 351.390.

c) For well logging applications without a surface casing for protecting fresh water aquifers, use of the ECS is subject to the requirements of Sections 351.150, 351.350, 351.370, 351.390, 351.510, and 351.770.

32 Ill. Adm. Code 351.550 Tritium Neutron Generator Target Source

a) Use of a tritium neutron generator target source, containing quantities not exceeding 1,110 GBq (30 Ci) in a well with a surface casing to protect fresh water aquifers, is subject to the requirements of this Part except Sections 351.150, 351.410, and 351.770.

b) Either use of a tritium neutron generator target source containing quantities exceeding 1,110 GBq (30 Ci) or in a well without a surface casing to protect fresh water aquifers is subject to the requirements of this Part, except Section 351.410.

32 Ill. Adm. Code 351.610 Training

a) No licensee or registrant shall permit any individual to act as a logging supervisor as defined in this Part until the individual has:

1. Completed 24 hours of training in the subjects outlined in Section 351.Appendix A;

2. Read and received instruction in the regulations contained in this Part and the applicable Sections of 32 Ill. Adm. Code 310, 340, and 400; the license under which the logging supervisor will perform well logging; and the licensee's or registrant's operating and emergency procedures required by Section 351.630;

3. Completed on-the-job training and demonstrated competence in the use of licensed materials, remote handling tools, and radiation survey instruments by a field evaluation; and

4. Demonstrated understanding of the requirements in subsections (a)(1) and (2) by successfully completing a written exam.

b) No licensee or registrant shall permit any individual to act as a logging assistant until the individual has:

1. Received instruction in the applicable Sections of 32 Ill. Adm. Code 340 and 400;

2. Received copies of, and instruction in, the licensee's operating and emergency procedures required by Section 351.630;

3. Demonstrated understanding of the materials listed in subsections (b)(1) and (2) by successfully completing a written or oral exam; and

4. Received instruction in the use of licensed material, remote handling tools, and radiation survey instruments, as appropriate for the logging assistant's intended job responsibilities.

c) The licensee or registrant shall provide safety reviews for logging supervisors and logging assistants at least once during each calendar year.

d) The licensee or registrant shall maintain a record of each logging supervisor's and logging assistant's training and annual safety review. The training records shall include copies of written tests and dates of oral tests given after July 14, 1987. The training records shall be retained until 3 years following the termination of employment. Records of annual safety reviews shall list the topics discussed and be retained for 3 years.

32 Ill. Adm. Code 351.630 Operating and Emergency Procedures

Each licensee or registrant shall develop and follow written operating and emergency procedures that cover at least the following:

a) Handling and use of licensed material, including the use of sealed sources in wells without a surface casing for protecting fresh water aquifers, if appropriate;

b) The use of remote handling tools for handling sealed sources and radioactive tracer material except for low-activity calibration sources;

c) Methods and occasions for conducting radiation surveys, including surveys for detecting contamination as required by Sections 351.670(c) through (e);

d) Minimizing personnel exposure, including exposures from inhalation and ingestion of licensed tracer materials;

e) Methods and occasions for locking and securing stored licensed material;

f) Personnel monitoring and the use of personnel monitoring equipment;

g) Transportation of licensed materials to field stations or temporary jobsites, packaging of licensed materials for transport in vehicles, placarding of vehicles when needed, and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss, tampering, or unauthorized removal;

h) Picking up, receiving, and opening packages containing licensed material, in accordance with 32 Ill. Adm. Code 340.960;

i) For the use of tracers, 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 Section 351.430;

l) Identifying and reporting to the Agency defects and noncompliance as required by 32 Ill. Adm. Code 340;

m) Actions to be taken if a sealed source is lodged in a well;

n) Procedure for notifying proper personnel in the event of an accident; and

o) Actions to be taken if a sealed source is ruptured, including actions to prevent the spread of contamination, minimize the inhalation and ingestion of licensed material, and obtain suitable radiation survey instruments as required by Section 351.330(b).

32 Ill. Adm. Code 351.650 Personnel Monitoring

a) No licensee or registrant shall permit any individual to act as a logging supervisor or logging assistant unless each individual wears an individual monitoring device (i.e., personnel dosimeter) at all times during the handling of licensed radioactive material. Each personnel dosimeter shall be assigned to and worn by only one individual. Film badges shall be replaced at least monthly and all other personnel dosimeters that require replacement shall be replaced at least quarterly. All personnel dosimeters shall be evaluated at least quarterly or promptly after replacement, whichever is more frequent.

b) The licensee shall provide bioassay services to individuals using licensed materials in subsurface tracer studies if required by the license.

c) The licensee shall retain records of personnel dosimeters required by subsection (a) and bioassay results in accordance with 32 Ill. Adm. Code 340.1160.

32 Ill. Adm. Code 351.670 Radiation Surveys

a) The licensee shall make radiation surveys, including but not limited to the surveys required under subsections (b) through (e), of each area where licensed material is used and stored.

b) Before transporting licensed material, the licensee shall make a radiation survey of the position occupied by each person in the vehicle and of the exterior of each vehicle used to transport the licensed material. The surveys and calculations shall include each source of radiation or combination of sources to be transported in the vehicle.

c) If the sealed source assembly is removed from the logging tool before departure from the temporary jobsite, the licensee shall confirm that the logging tool is free of contamination by energizing the logging tool detector or by using a survey meter.

d) If the licensee has reason to believe that, as a result of any operation involving a sealed source, the encapsulation of the sealed source could be damaged by the operation, the licensee shall conduct a radiation survey, including a contamination survey, during and after the operation.

e) The licensee shall make a radiation survey at the temporary jobsite before and after each subsurface tracer study to confirm the absence of contamination.

f) The results of the radiation surveys required under subsections (a) through (e) must be recorded and shall include the date of the survey, the names of the individuals making the survey, the identification of the survey instruments used, and an exact description of the location of the survey. The licensee shall retain records of these radiation surveys for inspection by the Agency for 5 years after completion of the survey.

32 Ill. Adm. Code 351.690 Radioactive Contamination Control

a) If the licensee detects evidence that a sealed source has ruptured or licensed material has caused contamination, the licensee shall immediately initiate the emergency procedures required by Section 351.630.

b) If contamination results from the use of licensed material in well logging, the licensee shall decontaminate all work areas, equipment, and unrestricted areas.

c) During efforts to recover a sealed source lodged in the well, the licensee shall continuously monitor, with an appropriate radiation detection instrument or a logging tool with a radiation detector, the circulating fluids from the well, if any, to check for contamination resulting from damage to the sealed source.

32 Ill. Adm. Code 351.695 Particle Accelerators

No licensee or registrant shall 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 that the requirements of 32 Ill. Adm. Code 340.210 and 340.310, as applicable, are met.

32 Ill. Adm. Code 351.710 Security

a) A logging supervisor shall be physically present at a temporary jobsite whenever licensed materials are being handled or are not stored and locked in a vehicle or storage place. The logging supervisor may leave the jobsite to obtain assistance if a source becomes lodged in a well and another logging supervisor or logging assistant trained under this Part has been designated to provide oversight.

b) During well logging, except when radiation sources are below ground or in shipping or storage containers, the logging supervisor or other individual designated by the logging supervisor shall maintain direct surveillance of the operation to prevent unauthorized entry into a restricted area, as defined in 32 Ill. Adm. Code 310.

32 Ill. Adm. Code 351.730 Documents and Records Required at Field Stations

Each licensee or registrant shall maintain, for inspection by the Agency, the following documents and records for the specific devices and sources used at the field station:

a) A copy of this Part and 32 Ill. Adm. Code 340 and 400;

b) A copy of the license or certificate of registration, as applicable;

c) Operating and emergency procedures required by Section 351.630;

d) Records of the latest survey instrument calibrations required by Section 351.330;

e) The record of leak test results required by Section 351.350, including the dates they were performed on the sealed sources and the test results;

f) Physical inventory records required by Section 351.370;

g) Use records required by Section 351.390;

h) Records of inspection and maintenance required by Section 351.430;

i) Training records required by Section 351.610(d); and

j) Radiation survey records required by Section 351.670.

32 Ill. Adm. Code 351.750 Documents and Records Required at Temporary Jobsites

Each licensee or registrant conducting operations at a temporary jobsite shall have the following documents and records available at that site for inspection by the Agency:

a) Operating and emergency procedures required by Section 351.630;

b) Evidence of the most recent calibration of the radiation survey instruments in use at the jobsite as required by Section 351.330;

c) The latest radiation survey records required by Section 351.670(b), (c), and (e) for the period of operation at the site;

d) The shipping papers for the transportation of radioactive material required by 32 Ill. Adm. Code 341;

e) When operating in the State under reciprocity as provided for in 32 Ill. Adm. Code 330.900, a copy of the appropriate license, certificate of registration, or equivalent documents authorizing the use of licensed material;

f) The dates and results of the most recent tests for leakage or contamination performed on the sealed sources; and

g) A copy of the licensee's radioactive material license, including all appropriate amendments.

32 Ill. Adm. Code 351.770 Notification of Incidents and Lost Sources; Abandonment Procedures for Irretrievable Sources

a) The licensee shall immediately notify the Agency by telephone and, subsequently within 30 days, by confirmation in writing, using an appropriate method listed in 32 Ill. Adm. Code 310.110, if the licensee knows or has reason to believe that a sealed source has been ruptured. The written confirmation shall designate the well or other location, describe the magnitude and extent of the escape of licensed material, assess the consequences of the rupture, and explain efforts planned or being taken to mitigate these consequences.

b) The licensee shall notify the Agency of the theft or loss of radioactive material, radiation overexposures, excessive levels and concentrations of radiation, and certain other accidents as required by 32 Ill. Adm. Code 340.1205, 340.1210, 34.1220, and 340.1230.

c) If a sealed source becomes lodged in a well, and when it becomes apparent that efforts to recover the sealed source will not be successful, the licensee shall:

1. Notify the Agency by telephone at (217) 782-7860 of the circumstances that resulted in the inability to retrieve the source and:

A) Obtain Agency approval to implement abandonment procedures; or

B) Explain that the licensee implemented abandonment procedures before receiving Agency approval because the licensee believed there was an immediate threat to public health and safety;

2. Advise the well owner or operator, as appropriate, of the abandonment procedures under subsection 351.150(a) or (c); and

3. Either ensure that abandonment procedures are implemented within 30 days after the sealed source has been classified as irretrievable or request an extension of time if unable to complete the abandonment procedures.

d) The licensee shall, within 30 days after a sealed source has been classified as irretrievable, make a report in writing to the Agency. The licensee shall send a copy of the report to each appropriate State or federal agency that issued permits or otherwise approved of the drilling operation. The report shall contain the following information:

1. Date of occurrence;

2. A description of the irretrievable well logging source involved, including radionuclide, quantity, and chemical and physical form;

3. Surface location and identification of well;

4. Results of efforts to immobilize and seal the source in place;

5. A brief description of the attempted recovery effort;

6. Depth of the radioactive source;

7. Depth of the top of the cement plug;

8. Depth of the well;

9. The immediate threat to public health and safety justification for implementing abandonment if prior Agency approval was not obtained under subsection (c)(1)(A);

10. Any other information, such as a warning statement, contained on the permanent identification plaque; and

11. A list of the State and federal agencies receiving a copy of this report.

32 Ill. Adm. Code 351.APPENDIX A Subjects to Be Included in Training Courses for Logging Supervisors

AGENCY NOTE: Licensees may wish to refer to Section 8.8 and Appendix F of the U.S. Nuclear Regulatory Commission's NUREG 1556 Volume 14, Rev. 1 for additional guidance on training requirements, expectations on course length, duration of on-the-job training for both well logging supervisors and logging assistants, instructor minimum qualifications, and additional information to be submitted for Agency evaluation.

a) Fundamentals of Radiation Safety

1. Characteristics of radiation

2. Units of radiation dose and quantity of radioactivity

3. Significance of radiation dose

A) Radiation protection standards

B) Biological effects of radiation dose

4. Levels of radiation from licensed material

5. Methods of minimizing radiation dose

A) Working time

B) Working distances

C) Shielding

6. Radiation safety practices, including prevention of contamination, and methods of decontamination.

b) Radiation Detection Instrumentation to be Used

1. Use of radiation survey instruments

A) Operation

B) Calibration

C) Limitations

2. Radiation Survey Techniques

3. Use of personnel monitoring equipment

c) Equipment to be Used

1. Operation of equipment, including source handling equipment and remote handling tools;

2. Storage, control, and disposal of licensed material; and

3. Maintenance of equipment

d) The Requirements of Pertinent State Regulations

e) Case histories of accidents in well logging.

32 Ill. Adm. Code 351.APPENDIX B Example of Plaque for Identifying Wells Containing Sealed Sources Containing Radioactive Material Abandoned Downhole

The size of the plaque should be convenient for use on active or inactive wells, e.g., a 17-centimeter (7-inch) square and 3 mm (⅛ inch) thick. Letter size of the word "CAUTION" should be approximately twice the letter size of the rest of the information, e.g., 12-millimeter (½-inch) and 6-millimeter (¼-inch) letter size, respectively. Quantities and distances may be expressed either in SI units or in special and English units or in dual units.

Part 360 Use of X-Rays in the Healing Arts Including Medical, Dental, Podiatry, and Veterinary Medicine

32 Ill. Adm. Code 360.10 Scope

a) This Part establishes requirements for use of x-ray producing devices in the healing arts by a practitioner licensed to practice a treatment of human ailments by virtue of the Medical Practice Act of 1987 [225 ILCS 60], the Illinois Dental Practice Act [225 ILCS 25], or the Podiatric Medical Practice Act of 1987 [225 ILCS 100], or by a medical radiographer or radiation therapist accredited in accordance with the provisions of 32 Ill. Adm. Code 401.100 or an individual exempt from the provisions of 32 Ill. Adm. Code 401, by Section 401.30 of that Part, acting under the supervision, prescription or direction of such licensed person or the non-human use of x-ray by veterinarians by virtue of the Veterinary Medicine and Surgery Practice Act of 1983 [225 ILCS 115]. The provisions of this Part are in addition to, and not in substitution for, other applicable provisions of 32 Ill. Adm. Code 310, 320, 340, 400 and 410.

b) It is recognized that some installations and equipment designed before the adoption of this Part, coupled with conditions of use, may be adequate to achieve minimum doses. Request for exemption from some provisions of this Part will be considered in accordance with 32 Ill. Adm. Code 310.30(a).

History

• Source: Amended at 22 Ill. Reg. 5904, effective March 13, 1998

32 Ill. Adm. Code 360.20 Definitions

As used in this Part, the following definitions apply:

"Accelerator" (also "particle accelerator") means any therapeutic machine capable of producing a useful beam of x-rays or charged particles with energies of 1 MeV or greater. Accelerators include cyclotrons, betatrons and linear accelerators.

"Accelerator facility" means the location at which one or more particle accelerators are installed and are operated under the same administrative control.

"Agency" means the Illinois Emergency Management Agency.

"Aluminum equivalent" means the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question. The nominal chemical composition of type 1100 aluminum alloy is 99.00 percent minimum aluminum, 0.12 percent copper.

"Applicator" means a structure which determines the extent of the treatment field at a given distance from the source of the beam.

"Attenuation block" means a block or stack, having dimensions 20 centimeters by 20 centimeters by 3.8 centimeters, of aluminum equivalent. Copper may be substituted for aluminum if an appropriate thickness is used for the kVp selected, as indicated below:

kVp

Millimeters of Copper Equivalent to 3.8 centimeters of aluminum

99 or less

2.0

100 to 125

2.5

greater than 125

3.0

"Automatic exposure control" means a device that automatically controls one or more technique factors in order to obtain at a preselected location or locations a required quantity of radiation (see "Phototimer").

"Barrier" (see "Protective barrier").

"Beam" means a flow of electromagnetic or particulate radiation that passes through the opening in the beam limiting device and that is used for diagnosis or treatment.

"Beam axis" (see "Central axis of the beam").

"Beam-limiting device" means a device that provides a means to restrict the dimensions of the x-ray field (see "Collimator", "Diaphragm" and "Shutter").

"Beam monitoring system" means a system of devices that will monitor the useful beam during irradiation and will terminate irradiation when a preselected number of monitor units has been accumulated.

"Beam scattering filter" means a filter placed in an electron beam in order to scatter the beam and provide a more uniform distribution of electrons in the beam.

"Central axis of the beam" means the line passing through the source of the beam and the center of the plane formed by the edge of the first beam-limiting device.

"Charged particle beam" (see "Beam").

"Coefficient of variation" means the ratio of the standard deviation to the mean value of a population of observations.

"Collimator" means a device or mechanism by which the x-ray beam is restricted in size (see "Beam-limiting device").

"Computed tomography" or "CT" means the production of a tomogram by the acquisition and computer processing of x-ray transmission data.

"Computed tomography dose index" or "CTDI" means the integral of the dose profile along a line perpendicular to the tomographic plane divided by the product of the nominal tomographic section thickness and the number of tomograms produced in a single scan.

"Contact hour" means the number of hours an individual is in contact with an instructor. One contact hour equals 50 minutes.

"Contact therapy system" means an x-ray system used for therapy that is designed for very short treatment distances (5 centimeters or less), usually employing peak tube potentials in the range of 20 to 50 kVp.

"Control panel" means that part or parts of the x-ray system upon which are mounted the switches, knobs, pushbuttons and other hardware necessary for setting the technique factors prior to initiating an x-ray exposure.

"CT gantry" means the tube housing assemblies, beam-limiting devices, detectors and the supporting structures and frames that hold these components.

"Dead-man switch" means a switch constructed so that a circuit-closing contact can be maintained only by continuous pressure on the switch by the operator.

"Diagnostic imaging specialist" means a person who possesses the knowledge, training and experience to apply the principles of radiological physics to diagnostic x-ray applications. The diagnostic imaging specialist shall be approved and registered by the Agency pursuant to 32 Ill. Adm. Code 410.

"Diagnostic source assembly" means an x-ray tube housing assembly, designed for use in diagnostic x-ray applications, with a beam-limiting device attached.

"Diaphragm" means a device or mechanism by which the x-ray beam is restricted in size (see "Beam-limiting device").

"Direct supervision" means an individual is in the physical presence of a licensed practitioner who assists, evaluates and approves of the individual's performance of the various tasks involved in the application of ionizing radiation.

"Electronic brachytherapy" means a method of radiation therapy in which an electrically generated source of ionizing radiation is placed in or near the tumor or target tissue to deliver a therapeutic radiation dosage.

"Electronic brachytherapy device" means the system used to produce and deliver therapeutic radiation, including x-ray tube, the control mechanism, the cooling system and the power source.

"Electronic brachytherapy device operator" means a radiation therapist accredited in accordance with 32 Ill. Adm. Code 401 or a physician.

"Electronic brachytherapy source" means the x-ray tube component used in an electronic brachytherapy device.

"Field flattening filter" means a filter used to provide dose uniformity over the area of a useful beam of x-rays at a specified depth.

"Filter" means material placed in the useful beam to absorb, preferentially, radiations based on energy level or to modify the spatial distribution of the beam.

"Gantry" means that part of the system supporting and allowing possible movements of the radiation head.

"General purpose x-ray system" means any radiographic x-ray system that, by design, is not limited to radiographic examination of specific anatomical regions.

"Gonad shield" means a protective device for the testes or ovaries that provides a minimum of 0.5 millimeter lead equivalent protection.

"Half-value layer" or "HVL" means the thickness of a specified material that attenuates the beam of radiation to an extent such that the exposure rate is reduced to one-half of its original value.

AGENCY NOTE: The contribution of all scattered radiation, other than any that might be present initially in the beam concerned, should be minimized.

"Healing arts screening" means the examination of human beings using x-ray machines for the detection or evaluation of potential diseases when the examinations are not specifically ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray examinations for the purpose of diagnosis or treatment. However, healing arts screening does not include mammography on self-referred patients.

"Image intensifier" means a device, installed in a housing, that converts an x-ray pattern into a corresponding light image, usually by electronic means.

"Image receptor" means any device, such as a fluorescent screen or radiographic film, that transforms incident x-ray photons either into a visible image or into another form that can be made into a visible image by further transformations.

"Institutional review board" means a committee that has been formally designated by the registrant to approve, monitor and review biomedical and behavioral research involving humans.

"Interlock" means 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.

"Isocenter" means a fixed point in space located at the center of the smallest sphere through which the central axis of the useful beam passes at any beam orientation.

"Kilovolts peak" or "kVp" means the crest value, in kilovolts, of the electric potential applied to the x-ray tube between the cathode and anode of a pulsating electric potential generator.

"Lead equivalent" means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.

"Leakage radiation" means all radiation emanating from the diagnostic source assembly except for:

The useful beam; and

The radiation produced when the exposure switch or timer is not activated.

"Leakage technique factors" means the technique factors used to measure leakage radiation from the diagnostic source assembly. They are defined as follows:

For capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in 1 hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being 10 millicoulombs, i.e., 10 milliampere-seconds, or the minimum obtainable from the unit, whichever is larger.

For field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of x-ray pulses in 1 hour for operation at the maximum-rated peak tube potential.

For all other equipment, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential.

"Light field" means that area of the intersection of the light beam from the beam-limiting device and any one of the sets of planes parallel to and including the plane of the image receptor. The edge of the light field is defined as the locus of points at which the illumination is 25 percent of that at the center of the light field.

"Medical event" means an event that meets the criteria in Section 360.120(i)(3).

"Medical radiographer" means a person other than a licensed practitioner, accredited in accordance with the provisions of 32 Ill. Adm. Code 401, or an individual exempt from the provisions of 32 Ill. Adm. Code 401, who performs medical radiation procedures and applies x-radiation, to any part of the human body, for diagnostic purposes while under the supervision of a licensed practitioner.

"Mobile equipment" (see "X-ray equipment").

"Monitor unit" means a unit response from the beam monitoring system from which the absorbed dose can be calculated.

"Moving beam therapy" means radiation therapy in which there is displacement of the useful beam relative to the patient. Moving beam therapy includes arc therapy, skip therapy and rotational beam therapy.

"Operator" means an individual who applies ionizing radiation for diagnostic or therapeutic purposes.

"Phototimer" means a method for controlling radiation exposures to image receptors by the amount of radiation that reaches a radiation monitoring devices. The radiation monitoring devices is part of an electronic circuit that controls the duration of time the tube is activated (see "Automatic exposure control").

"Portable equipment" (see "X-ray equipment").

"Portable x-ray service provider" means a registrant who, under a physician's authorization, provides x-ray procedures with hand-held or mobile radiographic equipment in a patient's place of residence.

"Position indicating device" means a device on intraoral dental x-ray equipment used to indicate the beam position and to establish a definite source-skin distance.

"Prescribed dose" means the total dose and dose per fraction as documented in the written directive. The prescribed dose is an estimation from measured data from a 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.

"Primary protective barrier" (see "Protective barrier").

"Protective apron" means an apron of radiation absorbing materials, at least 0.25 millimeter lead equivalent, used to reduce exposure from leakage and scatter radiation.

"Protective barrier" means a barrier of radiation absorbing materials used to reduce radiation dose. The types of protective barriers are as follows:

"Primary protective barrier" means the material, excluding filters, placed in the useful beam to reduce the radiation dose.

"Secondary protective barrier" means a barrier sufficient to attenuate the leakage and scatter radiation to the required degree.

"Protective glove" means a glove made of radiation absorbing materials, at least 0.25 millimeter lead equivalent, used to reduce dose from leakage and scatter radiation.

"Radiation beam" (see "Beam").

"Radiation therapy simulation system" means a radiographic/ fluoroscopic x-ray system used exclusively for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.

"Radiologist assistant" means a person, other than a licensed practitioner, who, as a medical radiographer with advanced-level training and certification, performs a variety of activities under the supervision of a radiologist certified by the American Board of Radiology or the American Osteopathic Board of Radiology, in the areas of patient care, patient management, clinical imaging and interventional procedures. The radiologist assistant may not interpret images, make diagnoses or prescribe medications or therapies.

"Reference plane" means a plane that is displaced from and parallel to the tomographic plane.

"Scan" means the complete process of collecting x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.

"Scan increment" means the amount of relative displacement of the patient support device with respect to the CT x-ray system between successive scans measured along the direction of such displacement.

"Scatter radiation" means radiation that, during passage through matter, has been deviated in direction.

"Secondary protective barrier" (see "Protective barrier").

"Shadow tray" means a device attached to the radiation head to support auxiliary beam-limiting material.

"Shutter" means an adjustable beam-limiting or attenuating device, usually made of lead, fixed to an x-ray tube housing to intercept or collimate the useful beam (see "Beam-limiting device").

"SID" means source-image receptor distance (see "Source-image receptor distance").

"Source" means the focal spot of the x-ray tube.

"Source-image receptor distance" means the distance from the source to the center of the input surface of the image receptor.

"Source to skin distance" or "SSD" means the distance measured along the central ray from the center of the front surface of the x-ray focal spot to the surface of the irradiated object.

"Special purpose x-ray system" means any radiographic x-ray system that, by design, is limited to radiographic examination of a specific anatomical region or to the extremities collectively.

"Spot film" means a radiograph that is made during a fluoroscopic examination to permanently record conditions that exist during that fluoroscopic procedure.

"Stationary beam therapy" means radiation therapy in which there is no displacement of the useful beam relative to the patient during irradiation.

"Stationary equipment" (see "X-ray equipment").

"Supervision" means responsibility for and control of quality, radiation safety and protection, and technical aspects of the application of ionizing radiation to human beings for diagnostic and/or therapeutic purposes.

"Technique factors" means the electrical potential (kilovolts), current (milliamperes), exposure time parameters (seconds or pulses) or a combination thereof, selectable at the control panel of an x-ray system (see "Control panel").

"Therapeutic radiological physicist" means an individual who has the knowledge, training and experience to measure ionizing radiation, evaluate safety techniques, advise regarding radiation protection needs and apply the principles of radiological physics to clinical radiation therapy. The therapeutic radiological physicist shall be approved and registered by the Agency pursuant to 32 Ill. Adm. Code 410.

"Tomogram" means the depiction of the x-ray attenuation properties of a section through the body.

"Tomographic plane" means that geometric plane that is identified as corresponding to the output tomogram.

"Tomographic section" means the volume of an object whose x-ray attenuation properties are imaged in a tomogram.

"Useful beam" (see "Beam").

"X-ray equipment" means an x-ray system, sub-system or component thereof. Types of x-ray equipment are as follows:

"Mobile x-ray equipment" means x-ray equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled. Mobile x-ray equipment includes x-ray equipment permanently mounted in vehicles.

"Portable x-ray equipment" means x-ray equipment designed to be hand-carried.

"Stationary x-ray equipment" means x-ray equipment that is installed in a fixed location.

"X-ray field" means, for diagnostic purposes, that area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor. The edge of the x-ray field is defined as the locus of points at which the exposure is 25 percent of that at the center of the x-ray field.

"X-ray system" means an assemblage of components for the controlled production of x-rays. It includes minimally an x-ray high-voltage generator, an x-ray control panel, an x-ray tube housing assembly, a beam-limiting device and the necessary supporting structures. Additional components that function with the system are considered integral parts of the system. X-ray systems include diagnostic systems, therapeutic systems and accelerator systems.

History

• Source: Amended at 38 Ill. Reg. 12031, effective May 29, 2014

32 Ill. Adm. Code 360.30 General Requirements and Administrative Controls

The requirements in this Section apply to all uses of x-rays in veterinary medicine and to all uses of x-rays in the healing arts including the use of x-rays for both diagnostic and therapeutic purposes. Additional requirements for all diagnostic x-ray systems are in Section 360.40 and specific equipment application classes are contained in Sections 360.41 through 360.100. For therapeutic x-ray systems also see Sections 360.110 and 360.120.

a) Registrant. The registrant shall:

1. Direct the operation of the x-ray systems;

2. Register with the Agency, in accordance with the provisions of 32 Ill. Adm. Code 320, all x-ray equipment which is used at the facility and all portable or mobile x-ray equipment used by the registrant;

3. Verify that each individual required to be accredited by 32 Ill. Adm. Code 401 to apply x-rays for either diagnostic or therapeutic purposes is properly accredited with the Agency prior to allowing the individual to apply medical radiation procedures on human beings;

4. Permit operation of the x-ray systems only by individuals who are licensed in accordance with State law (see Section 360.10(a)), or who are accredited by the Agency pursuant to 32 Ill. Adm. Code 401 or who are exempt from such requirements in accordance with the provisions of 32 Ill. Adm. Code 401.

b) Shielding. Each installation shall be provided with such primary barriers and/or secondary barriers as are necessary to assure compliance with the provisions of 32 Ill. Adm. Code 340.210, 340.270, 340.280 and 340.310.

c) An x-ray system which does not meet the provisions of this Part shall not be operated for diagnostic or therapeutic purposes.

d) If an x-ray system is identified as not being in compliance with the provisions of this Part and if that system is accessible for use, it shall be rendered inoperable (i.e., dismantle the x-ray source from the source support assembly) if so ordered by the Director.

e) Prohibitions

1. Unauthorized Exposure. Individuals shall not be exposed to the useful beam except for healing arts purposes and only when the exposure has been authorized by a licensed practitioner of the healing arts. A physician assistant or an advanced practice nurse may give authorization as long as he or she is acting under the supervision or direction of a licensed physician. This provision specifically prohibits deliberate exposure for the following purposes:

A) Exposure of individuals for training, demonstration or other non-healing arts purposes.

B) Exposure of individuals for the purpose of "healing arts screening" (see Section 360.20).

2. Fluoroscopy shall not be used as a substitute for radiography or in lieu of proper anatomical positioning/centering procedures prior to radiographic studies.

3. Fluoroscopic equipment using phosphorescent screens shall not be used. Image intensification shall be utilized on all fluoroscopic equipment.

4. The use of direct exposure x-ray film (without intensifying screens) for routine diagnostic radiological imaging procedures, other than intraoral dental radiography and therapeutic portal imaging, is prohibited.

AGENCY NOTE: Therapeutic portal imaging is a technique used in radiation therapy to verify correct alignment of therapy beams with the patient's anatomy.

5. The use of photofluorographic systems is prohibited.

6. The use of an individual accredited as a limited diagnostic radiographer by the Agency pursuant to 32 Ill. Adm. Code 401 by a portable x-ray service provider is prohibited.

AGENCY NOTE: Photofluorography is frequently called mass miniature radiography. In this technique the image of a fluorescent screen is recorded on film by means of a camera.

f) Individual Monitoring and Reporting Requirements. All persons who are associated with the operation of an x-ray system are subject to the radiation dose standards, requirements for the determination of the doses, requirements for individual monitoring and requirements for reporting of radiation doses that are contained in 32 Ill. Adm. Code 340.

g) The registrant shall comply with the requirements of the Agency's rules entitled Notices, Instructions and Reports to Workers; Inspections (32 Ill. Adm. Code 400).

h) Records and Associated Information. The registrant shall maintain at the facility, for a period of at least one inspection cycle (see 32 Ill. Adm. Code 320.10(c)), records showing the receipt, transfer, storage and disposal of all sources of radiation in accordance with the provisions of 32 Ill. Adm. Code 310 and 320.

i) Staff Qualifications. The registrant shall maintain at the facility, for review by the Agency, current certificates of accreditation (clear, legible copies are acceptable), issued by the Agency in accordance with the provisions of 32 Ill. Adm. Code 401, for all individuals who are required to be so accredited.

j) Radiation Safety Procedures. The registrant shall provide to each individual who operates x-ray equipment at the facility written operating and safety procedures. These procedures shall include restrictions required for the safe operation of each radiation machine and shall include the topics listed in the radiation safety program of subsection (k).

k) Radiation Safety Program. The registrant shall provide for initial and annual in-service training in radiation safety for individuals (excluding licensed practitioners) that apply ionizing radiation at the facility, to ensure their awareness of the registrant's radiation safety practices and policies. The in-service training shall include the following topics:

1. Operating and emergency procedures for the radiation machines;

2. Use of personnel and patient protective devices;

3. Procedures to minimize patient and occupational doses, including procedures for selecting personnel to support patients or film, as required by Section 360.40;

4. Use of individual monitoring devices (if such devices are used at the facility);

5. Film processing procedures; and

6. Prohibited uses of x-ray machines, as described in subsection (e).

l) Operator Training. Individuals who operate radiation machines shall be instructed in and able to demonstrate competence with the registrant's operating and safety procedures.

History

• Source: Amended at 38 Ill. Reg. 12031, effective May 29, 2014

32 Ill. Adm. Code 360.40 General Equipment and Operation Requirements for Diagnostic X-Ray Systems

The requirements of this Section apply to all diagnostic x-ray systems. Additional requirements for specific equipment application classes are in Sections 360.41 through 360.100 of this Part.

a) Half-Value Layer

1. The half-value layer of the useful beam for a given x-ray tube potential shall not be less than the values shown in Section 360. Table B of this Part.

2. For capacitor energy storage equipment, compliance with the requirements of this subsection (a) shall be determined with the system fully charged and a setting of 10 mAs for each exposure.

b) Beam-On Indicators

1. The control panel shall include a device (usually a milliammeter or labeled indicator lamp) which will give positive indication of the production of x-rays whenever the x-ray tube is energized.

2. Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes which have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the x-ray control panel and at or near the tube housing assembly which has been selected.

c) Mechanical Support of Tube Head. The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the x-ray system. The tube housing assembly supports shall not be hand-held unless the manufacturer has specifically designed the system to be operated while hand-held.

d) Diagnostic Source Assembly Leakage Radiation Limits. The leakage radiation measured at a distance of 1 meter from the source shall not exceed 25.8 microC/kg (100mR) in 1 hour when the tube is operated at its leakage technique factors.

e) Radiation From Capacitor Energy Storage X-ray Equipment in Standby Status. Radiation emitted from the x-ray tube when the exposure switch or timer is not activated shall not exceed a rate of 0.516 microC/kg (2mR) per hour at 5 centimeters from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open.

f) Technique Indicators

1. The technique factors to be used during an exposure shall be indicated at the control panel before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated at the control panel.

2. The requirement of subsection (f)(1) of this Section may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator's position except in the case of spot films.

3. The indicated technique factors of exposure time and kilovolts peak (kVp) shall correspond to the actual exposure factors within ten percent of the indicated values.

g) Reproducibility of Exposures

1. For any specific combination of selected technique factors utilized, the coefficient of variation of radiation exposures shall not exceed 0.05 for any specific combination of selected technique factors.

AGENCY NOTE: It will not be necessary to calculate the coefficient of variation if for the first four measurements the value of the average exposure (Eavg) is greater than or equal to ten times the maximum exposure (Emax) minus the minimum exposure (Emin). This requirement is mathematically represented by the following:

Eavg = 10 (Emax - Emin)

2. For systems using automatic exposure control (AEC) (i.e., systems employing photo-multiplier tubes, or ionization chambers to terminate the x-ray exposure), compliance measurements shall be performed with the system operating in the AEC mode. Attenuating material shall be placed in the beam to provide exposure times in the range of those used clinically.

AGENCY NOTE: The intent of this subsection (g) is to require testing of the system in a manner that is clinically relevant. Reproducibility of exposures should be measured at technique factors that are commonly used and are subject to variation. For AEC systems, commonly used settings in combination with an appropriate thickness of attenuating material should be used to provide exposure times in the clinical range.

h) Patient or Film Support

1. When a patient or film must be provided with auxiliary support during a radiation exposure:

A) No person shall be used routinely to hold film or patients; and

B) Unless the procedure precludes their use, mechanical holding devices shall be used to restrain patients. For example, mechanical holding devices could not be used if the devices would preclude clear visualization of the tissue being examined.

2. When a patient or film must be held by an individual, written safety procedures, as required by Section 360.30(j) of this Part, shall indicate the criteria for selecting a holder and the procedure the holder shall follow.

AGENCY NOTE: The radiation dose received by radiation workers, patients and the general public can be reduced if mechanical patient and film support devices are used for radiographic and fluoroscopic procedures. In the event that an individual must be used in lieu of mechanical patient or film support devices to hold patients or films, every effort should be made to limit the individual's radiation dose. This can be accomplished by not assigning to a single individual the task of supporting patients and films during radiographic and fluoroscopic examinations. Rather, a number of individuals may be rotated through the assignment, thereby reducing the radiation dose to one individual.

i) Personnel Protection

1. Except for patients who cannot be moved out of the room, only the individuals required for the medical procedure or training shall be in the room during the radiographic/flouroscopic exposure.

2. Individuals who must be in the room with the patient being radiographed or fluoroscoped shall be protected by 0.25 millimeter lead equivalent apparel or device or shall be positioned at a distance such that the individual does not receive a radiation dose in excess of the limits specified in 32 Ill. Adm. Code 340.310.

j) Technique Guides

1. In the vicinity of each radiographic x-ray system's control panel, a technique guide shall be provided which specifies for routine examinations performed with that system, the following information:

A) Patient's anatomical size versus technique factors to be utilized;

B) Type of screen-film combination utilized, if more than one; and

C) SID to be used.

2. For automatic exposure control (AEC) systems with selectable exposure detectors and density settings, the technique guide shall also specify the appropriate exposure detectors and density setting to be utilized for each radiographic examination listed.

3. For AEC systems, if operated in a non-automatic mode, the technique guide shall specify the requirements of subsections (j)(1)(A) through (C) of this Section to be followed.

AGENCY NOTE: The Agency recognizes that alternate means may be available at the control panel to indicate technique factors for computerized imaging systems.

k) Patient Dose Criteria. Procedures and auxiliary equipment designed to minimize patient and occupational dose commensurate with needed diagnostic information shall be used.

AGENCY NOTE: It is the intent of this subsection (k) to provide for the optimum optical density, resolution and contrast on the film while minimizing patient dose. X-ray films, intensifying screens and other image recording devices should be as sensitive as is consistent with the requirements of the examination.

l) X-ray Film Processing Systems. The darkroom safe light illumination shall be adequate for the film speeds and the darkroom operating procedures used to prevent fogging of unprocessed film. The following additional requirements apply to film processing systems:

1. Manual film processing systems shall be monitored by the registrant to assure:

A) The use of a dedicated darkroom timer with an adjustable preset function. The timer shall be used to adjust film processing time according to solution temperature.

B) The use of a dedicated darkroom thermometer. The thermometer shall be used to adjust the film processing time according to solution temperature.

C) The use of a film processing guide. The guide shall contain, at a minimum, information regarding times and temperatures (as recommended by the film manufacturer) used by the registrant to develop radiographs.

D) The frequency at which film processing chemicals are changed is appropriate for the conditions of use.

2. Automated film processing shall be monitored by the registrant to assure:

A) The temperature of film processing chemicals and the film transport speed is appropriate for the type of films being utilized.

B) The film processing chemicals used and their replenishing rate (if applicable) are appropriate for the type of films and quantity processed.

m) Gonadal Shielding. Except for cases in which it would interfere with the diagnostic procedure, gonadal shielding of not less than 0.5 millimeter of lead equivalent shall be used for patients (who have not passed the reproductive age) during those radiographic procedures in which the gonads are in the useful beam.

AGENCY NOTE: Protection of the embryo or fetus from radiation dose during radiological examination or treatment of a woman of childbearing age (potentially pregnant) should be given special consideration.

History

• Source: Amended at 32 Ill. Reg. 3693, effective February 29, 2008

32 Ill. Adm. Code 360.41 Additional Requirements for Use of Diagnostic X-Ray Systems in the Healing Arts of Medicine, Podiatry and Chiropractic

a) Viewing System. Windows, mirrors, closed circuit television or an equivalent system shall be provided to permit the operator to continuously observe the patient during irradiation.

b) The operator shall be able to maintain aural contact with the patient.

c) Each x-ray control shall be located in such a way as to meet the following requirements:

1. Stationary x-ray systems and mobile or portable x-ray systems used as stationary x-ray systems shall be required to have the x-ray exposure switch permanently mounted behind a protective barrier.

2. For mobile and portable single event exposures and configuration, the x-ray control shall be positioned so that the operator is at least 1.83 meters (6 feet) away from the tube housing and the patient during an exposure.

3. Stationary podiatric x-ray systems are exempt from the requirements of subsection (c)(1) of this Section, provided that the x-ray control meets the requirements of subsection (c)(2) of this Section.

d) Portable or mobile x-ray equipment shall be used only for examinations where it is impractical to transfer the patient(s) to a stationary x-ray installation.

History

• Source: Amended at 23 Ill. Reg. 14516, effective January 1, 2000

32 Ill. Adm. Code 360.50 Fluoroscopic Systems

In addition to the provisions of Sections 360.10, 360.30, 360.40 and 360.41 of this Part, the requirements of this Section apply to x-ray equipment and associated facilities used for fluoroscopy.

a) Beam Limitation. The x-ray field shall be limited by stepless adjustable shutters. In addition:

1. The minimum field size at the greatest SID shall be no greater than 5 centimeters by 5 centimeters.

2. The mechanisms (manual/automatic mode selectors) provided for activating and positioning the beam-limiting shutters shall function properly. This requirement applies to shutters used in fluoroscopic procedures or spot filming procedures or both fluoroscopic and spot filming procedures.

3. Neither the length nor the width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than three percent of the SID. The sum of the excess length and the excess width shall be no greater than four percent of the SID. This requirement applies to field sizes for fluoroscopic procedures or spot filming procedures or both fluoroscopic and spot filming procedures.

4. For fluoroscopic equipment with only a manual mode of beam limitation, the x-ray field produced shall be limited to the area of the spot film cassette at 40.6 centimeters (16 inches) above the tabletop. Additionally, during fluoroscopy, the operator shall restrict the beam to the area of the input phosphor.

5. Spot film devices shall meet the following additional requirements:

A) Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the image receptor to the size which has been selected on the spot film selector. Such adjustment shall be accomplished automatically except when the x-ray field size in the plane of the image receptor is smaller than that selected;

B) The center of the x-ray field in the plane of the image receptor shall be aligned with the center of the selected portion of the film to within two percent of the SID; and

C) If the angle between the plane of the image receptor and beam axis is variable, a device shall be provided to visually indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor.

6. The beam limitation requirements of this subsection shall not apply to fluoroscopic systems specifically designed for examination of extremities only and meeting the requirement of subsection (l) of this Section.

b) Fluoroscopic Timer. A manual reset, cumulative timing device shall be used which will either indicate elapsed on-time by an audible signal or turn off the system when the total exposure time exceeds a predetermined limit not exceeding 5 minutes in one or a series of exposures.

c) Primary Barrier/Interlock. These devices shall be provided and shall function so that:

1. The entire cross section of the useful beam is intercepted by the primary protective barrier of the fluoroscopic image assembly at any SID; and

2. The fluoroscopic tube is interlocked to prevent the unit from producing x-rays unless the primary barrier is in position to intercept the useful beam, as specified in subsection (1) of this Section, at all times.

d) Source-Skin Distance. The SSD shall not be less than:

1. 38 centimeters (15 inches) on all stationary fluoroscopes;

2. 20 centimeters (8 inches) on all mobile fluoroscopes; and

3. 9 centimeters (3.5 inches) for fluoroscopes specifically designed for examination of extremities only and meeting the requirements of subsection (l) of this Section.

e) Indication of Potential and Current. During fluoroscopy and recording of fluoroscopic images, the kVp and the mA shall be continuously indicated at the control panel and/or the operator's position.

f) Activation of the Fluoroscopic Tube. X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure. When recording serial fluoroscopic images, the operator shall be able to terminate the x-ray exposures at any time, but means may be provided to permit completion of any single exposure of the series in process.

g) Entrance Exposure Requirements

1. Maximum Exposure Rate. Fluoroscopic systems shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 2.58 mC/kg (10 R) per minute at the point where the center of the useful beam enters the patient, except:

A) During recording of fluoroscopic images; or

B) When an optional high level control is activated (see subsection (g)(2)).

2. When a high level control is activated, the equipment shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 5.15 mC/kg (20 R) per minute at the point where the center of the useful beam enters the patient. In addition, the following requirements apply to high level controls:

A) Separate means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator.

B) A continuous signal audible to the operator shall indicate that the high level control is being employed.

3. Compliance with the requirements of subsections (g)(1) and (2) of this Section shall be determined using technique factors that produce the maximum exposure rate. For systems employing automatic exposure rate control, material having an equivalency of at least 3 millimeters of lead shall be placed in the primary beam between the image receptor and the radiation measuring device. The lead or equivalent material shall be positioned to ensure that the entire primary beam is blocked.

AGENCY NOTE: Many fluoroscopic systems do not yield their maximum exposure rate at the maximum tube potential or tube current. The exposure rate should be checked at various kVp and mA settings to establish the maximum exposure rate for the system.

4. Fluoroscopic systems shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 1.29 mC/kg (5 R) per minute at the point where the center of the useful beam enters the patient, when measured under the following conditions:

A) Movable grids and compression devices shall be removed from the useful beam during the measurement.

B) For systems without automatic exposure rate control, the measurement shall be performed using technique factors clinically used for a standard adult patient thickness of 23 centimeters.

AGENCY NOTE: An attenuation block or other suitable material should be placed in the beam to protect the imaging system.

C) For systems with automatic exposure rate control, the measurement shall be performed with a 2.5 millimeter thick sheet of copper in the beam between the radiation measuring device and the image receptor.

AGENCY NOTE: Use of a 2.5 millimeter thick sheet of copper approximates the attenuation of a standard adult patient thickness of 23 centimeters, and assures consistency in the measurement of fluoroscopic exposure rate.

AGENCY NOTE: The Agency recommends additional measurements be made of the entrance exposure rate for fluoroscopic systems capable of recording fluoroscopic images, and the entrance exposure for spot film techniques for fluoroscopic systems with that modality. In either case, measurements should be made under the conditions specified in subsection (g)(4)(B) of this Section.

D) The requirements of subsection (g)(4) of this Section shall not apply to fluoroscopes specifically designed for examination of extremities only and meeting the requirements of subsection (1) of this Section.

5. Measurements performed pursuant to the requirements of subsections (g)(1) through (4) of this Section shall meet the following additional requirements:

A) If the source is below the table, the exposure rate shall be determined for the center of the useful beam 1 centimeter above the tabletop or cradle, with the input surface of the fluoroscopic imaging assembly positioned 30 centimeters (12 inches) above the tabletop.

B) If the source is above the table, the exposure rate shall be determined at 30 centimeters (12 inches) above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.

C) For a fixed SID C-arm type of fluoroscope, the exposure rate shall be determined 30 centimeters (12 inches) from the input surface of the fluoroscopic imaging assembly.

D) For a variable SID C-arm type of fluoroscope, the exposure rate shall be determined 30 centimeters (12 inches) from the input surface of the fluoroscopic imaging assembly with the end of the beam-limiting device or spacer positioned as close as possible to the point of measurement.

E) For a lateral type fluoroscope, the exposure rate shall be determined on the central axis of the primary beam at a point 15 centimeters (6 inches) from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 centimeters to the centerline of the x-ray table.

AGENCY NOTE: A lateral type fluoroscope is a fluoroscope that cannot be rotated so that the source or the fluoroscopic imaging assembly can be positioned below the fluoroscopic table or cradle.

F) For a fluoroscopic system specifically designed for examination of extremities only, the exposure rate shall be determined for the minimum source-skin distance.

6. The measurements required by this subsection (g) shall be performed when the system is inspected as specified in 32 Ill. Adm. Code 410 as well as after any maintenance of the system which might affect the exposure rate.

7. The results of the measurements required by subsections (g)(1), (2) and (4) of this Section shall be posted or available at the control panel. The measurement results shall be stated in millicoulombs per kilogram (roentgens) per minute or microcoulombs per kilogram (milliroentgens) per second and shall include the technique factors used in determining such results. The name of the individual performing the measurements and the date the measurements were performed shall be included in the results.

AGENCY NOTE: The resolution and efficiency of the fluoroscopic imaging system should be evaluated periodically, whenever deterioration in the imaging system is suspected and when the measured exposure rate exceeds the standards of this Section.

h) Barrier Transmitted Radiation Rate Limits

1. The exposure rate due to transmission through the primary protective barrier shall not exceed 0.516 microC/kg (2mR) per hour at 10 centimeters from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor per 258 microC/kg (1R) per minute of entrance exposure rate.

2. Measuring Compliance of Barrier Transmission

A) The exposure rate due to transmission through the primary protective barrier shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

B) If the source is below the tabletop, the exposure rate shall be determined with the input surface of the fluoroscopic imaging assembly positioned 30 centimeters above the tabletop.

C) If the source is above the tabletop and the SID is variable, the exposure rate shall be determined with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 centimeters.

D) Movable grids and compression devices shall be removed from the useful beam during the measurement.

E) An attenuation block shall be positioned in the useful beam 10 centimeters from the point of measurement of entrance exposure rate and between this point and the input surface of the fluoroscopic imaging assembly.

i) Staff and Ancillary Personnel Protection. The operator, assistants and observers allowed in the examining room shall be protected from scatter radiation by protective aprons of not less than 0.25 millimeter lead equivalent or whole body protective barriers or shall be positioned at a sufficient distance to ensure that the individual does not receive a radiation dose in excess of the limits specified in 32 Ill. Adm. Code 340.310.

j) Control of Scattered Radiation

1. For fluoroscopic systems utilizing an x-ray tube that is mounted below the table, the table shall be provided with shielding (bucky slot cover) equivalent to 0.25 millimeter lead equivalent to attenuate scattered radiation emanating from below the table.

2. A shield of at least 0.25 millimeter lead equivalent, such as overlapping protective drapes or hinged or sliding panels, shall be provided and used to intercept scatter radiation which would otherwise reach the operator and others near the machine. This shielding shall not be a substitute for the wearing of a protective apron (0.25 millimeter lead equivalent) for protection against scattered radiation.

3. Where sterile fields or special procedures prohibit the use of protective barriers or drapes, subsection (j)(2) of this Section shall not apply.

k) Additional Requirements for Stationary Fluoroscopic Systems Used for Cardiac Catheterization Procedures

1. Protective barriers shall be available for use by individuals whose presence is required in the room during activation of the x-ray tubes. If a protective barrier includes or consists of a transparent viewing panel, the viewing panel shall afford protection of not less than 0.5 millimeter of lead equivalent.

2. Protective aprons of not less than 0.25 millimeter of lead equivalent shall be worn in the fluoroscopy room by all individuals (except the patient).

AGENCY NOTE: Because modern equipment allows great flexibility in the direction of the beam, individuals in the room should step back from the x-ray system and behind protective barriers during activation of the x-ray tubes.

l) Additional Requirements for Fluoroscopic Systems Specifically Designed for Examination of Extremities Only

1. The radiation safety procedures required pursuant to Section 360.30(j) of this Part shall include the following:

A) A warning concerning the potential for, and the hazards of, increased patient radiation dose associated with x-ray systems employing short source-skin distances;

B) Procedures for obtaining imaging magnification with minimum patient dose, including imaging systems or screen-film combinations;

C) Technique factors for specific examinations for which the system is designed;

D) Radiation exposure data, including skin entrance exposure for each set of technique factors used.

2. The x-ray system shall be clearly labeled as follows: "For Examination of Extremities Only."

3. Fluoroscopic systems specifically designed for examination of extremities only shall be used solely for examination of extremities.

m) Radiation Therapy Simulation Systems. Radiation therapy simulation systems shall be exempt from the requirements of subsections (a), (b), (c), (g) and (h) of this Section provided that:

1. Such systems are designed and used in such a manner that no individual other than the patient is in the x-ray room during periods of time when the system is producing x-rays; and

2. Such systems that do not meet the requirements of subsection (b) of this Section are provided with a means of indicating the cumulative time that an individual patient has been exposed to x-rays. Procedures shall require in such cases that the timer be reset between examinations.

n) Operator Restrictions. No person shall intentionally administer radiation to a human being with a fluoroscopic radiation machine unless such person is licensed to practice a treatment of human ailments under the Medical Practice Act of 1987, the Illinois Dental Practice Act or the Podiatric Medical Practice Act of 1987, except:

1. An accredited medical radiographer may operate a fluoroscope for static functions when diagnostic interpretation of the fluoroscopic image is not required by the radiographer and only under the supervision of a licensed practitioner; or

2. An accredited medical radiographer may operate a fluoroscope as directed by, and under the direct supervision of, a licensed practitioner who is physically present and participating in the procedure; or

3. An accredited medical radiographer or radiation therapist may operate a fluoroscope for radiation therapy simulation procedures under the supervision of a licensed practitioner; or

4. An accredited radiologist assistant may operate a fluoroscope under the supervision of a licensed practitioner certified by the American Board of Radiology or the American Osteopathic Board of Radiology.

History

• Source: Amended at 32 Ill. Reg. 3693, effective February 29, 2008

32 Ill. Adm. Code 360.60 Radiographic Systems Other Than Fluoroscopic, Dental, Veterinary or Computed Tomography Systems

In addition to the provisions of Sections 360.10, 360.30, 360.40 and 360.41 of this Part, the requirements of this Section apply to x-ray equipment and associated facilities used in the healing arts of medicine, chiropractic and podiatry. It does not apply to fluoroscopic, dental, veterinary or computed tomography systems.

a) Beam Limitation. The useful beam shall be limited to the area of clinical interest.

1. Stationary General Purpose and Mobile/Portable X-Ray Systems

A) Variable X-Ray Field Limitation. An adjustable collimator shall be provided with means for independent stepless adjustment of the size of the x-ray field.

B) Visual Indication of Field Size. Means shall be provided for visually defining the perimeter of the x-ray field. The total misalignment of the edges of the visually defined field, with respect to the edges of the x-ray field, along either the length or the width of the visually defined field, shall not exceed two percent of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam.

AGENCY NOTE: When a light localizer is used to define the x-ray field, it should provide an average illumination of not less than 100 lux (9 footcandles) at 100 centimeters or at the maximum SID, whichever is less.

2. Special Purpose X-Ray Systems

A) Means shall be provided to limit the x-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than two percent of the SID when the axis of the x-ray beam is perpendicular to the plane of the image receptor.

B) The requirements of subsection (a)(2)(A) of this Section may be met:

i) With a system that meets the requirements specified in subsection (a)(1) of this Section; or

ii) With an assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is used, with each such device having permanent, clearly legible markings, in centimeters and/or inches, to indicate the image receptor size and SID for which it is designed; or

iii) With a beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is used. Permanent, clearly legible markings, in centimeters and/or inches, shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.

3. Radiation therapy simulation systems shall be exempt from the beam limitation requirements of this Section.

b) Radiation Exposure Control Devices

1. Timers. Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, preset number of pulses or preset radiation exposure to the image receptor. Also, it shall not be possible to make an exposure when the timer is set to a zero or off position if either position is provided.

2. X-Ray Control

A) An x-ray control shall be incorporated into each x-ray system such that an exposure can be terminated by the operator at any time except for:

i) Exposures of 0.5 second or less; or

ii) During serial radiography when means shall be provided to permit completion of any single exposure of the series in process.

B) The exposure switch shall be a dead-man switch.

3. Automatic Exposure Controls (AEC). Systems which are provided with automatic exposure control devices shall incorporate a back-up timer to terminate the radiation exposure in the event of AEC failure. In addition, they shall meet the following requirements:

A) Indication shall be made on the control panel when this mode of operation is selected; and

B) A visible signal shall indicate when an exposure has been terminated by the back-up timer, and manual resetting shall be required before further automatically timed exposures can be made.

c) Source-Skin Distance (SSD). All mobile or portable radiographic systems shall be provided with means to limit the SSD to 30 centimeters or greater.

d) Linearity. For equipment that is operated at more than one x-ray tube current or current-time product setting, the average ratios of exposure (microcoulombs per kilogram or milliroentgens) to the indicated milliampere-seconds (mAs) product obtained at any two tube current or current-time product settings utilized shall not differ by more than 0.10 times their sum. This requirement is mathematically represented by the following:

[]≤[]

where and are the average microC/kg/mAs or mR/mAs values obtained at any two tube current or current-time product settings utilized. Compliance shall be determined at any fixed x-ray tube potential within the rage of 40 percent to 100 percent of the maximum rated tube potential.

e) Medical Radiographic Entrance Exposure Limits. The in-air exposure determined for the technique used for the specified average adult patient for routine medical radiography shall not exceed the entrance exposure limits shown below: (See Section 360.Appendix A of this Part for measurement protocol and calculation of exposure at skin entrance.)

Technique

Thickness (cm)

Exposure Limit (microC/kg)

(mR)

Chest (PA), Grid

23

9

35

Chest (PA), Non-Grid

23

8

30

Abdomen (KUB)

23

155

600

Lumbo-Sacral Spine (AP)

23

206

800

Cervical Spine (AP)

13

52

200

Skull (lateral)

15

65

250

Foot (D/P)

8

26

100

AGENCY NOTE: These exposures are maximums. With careful selection of technique factors, adjustment of film processing systems, and choice of film and screen-film combinations, patient exposures can be further reduced.

f) SID Indication

1. Means shall be provided to indicate the SID.

2. SIDs shall be indicated in centimeters and/or inches and the measured SID shall correspond to the indicated value to within two percent.

g) X-Ray Field/Image Receptor Alignment. Means shall be provided to:

1. Indicate when the axis of the x-ray field is perpendicular to the plane of the image receptor; and

2. Align the center of the x-ray field with respect to the center of the image receptor to within two percent of the SID.

History

• Source: Amended at 23 Ill. Reg. 14516, effective January 1, 2000

32 Ill. Adm. Code 360.70 Mobile/Portable Radiographic Systems Other Than Systems Used Solely for Mammography (repealed)

History

• Source: Repealed at 17 Ill. Reg. 17972, effective October 15, 1993

32 Ill. Adm. Code 360.71 Additional Requirements for Facilities Performing Mammography (repealed)

History

• Source: Repealed at 23 Ill. Reg. 14516, effective January 1, 2000

32 Ill. Adm. Code 360.75 Computed Tomography (ct) Systems

a) Requirements for Equipment

1. Termination of Exposure

A) In the event of equipment failure affecting data collection, means shall be provided to terminate the x-ray exposure automatically, either by de-energizing the x-ray source or by shuttering the x-ray beam, through the use of either a back-up timer or devices that monitor equipment function.

B) A visible signal shall indicate when the x-ray exposure has been terminated through the means required by subsection (a)(1)(A).

C) The operator shall be able to terminate the x-ray exposure at any time during a scan, or series of scans, of greater than 0.5 second duration.

2. Tomographic Plane Indication and Alignment

A) Means shall be provided to permit visual determination of the location of a reference plane. This reference plane can be offset from the location of the tomographic planes.

B) If a device using a light source is used to satisfy subsection (a)(2)(A), the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux (45 footcandles).

C) The total error in the indicated location of the tomographic plane or reference plane shall not exceed 5 millimeters.

D) The deviation of indicated scan increment versus actual increment shall not exceed plus or minus 1 millimeter with a typical patient mass resting on the patient support device. The patient support device shall be moved incrementally from a typical starting position to the maximum incremental distance or 30 centimeters, whichever is less, and then returned to the starting position. If the CT system has the capability of variable gantry angles, the compliance measurements shall be performed with the CT gantry positioned at zero degrees.

3. Beam-On and Shutter Status Indicators. The CT x-ray control panel and gantry shall provide visual indication whenever x-rays are produced and, if applicable, whether the shutter is open or closed.

4. Technique Indicators. The CT x-ray control panel shall provide visual indication of the technique factors, tomographic section thickness and scan increment prior to the initiation of a scan or a series of scans.

b) Facility Design Requirements

1. The control panel shall be located behind a protective barrier.

2. Communication. Provision shall be made for two-way aural communication between the patient and the operator at the control panel.

3. Viewing Systems. Windows, mirrors, closed-circuit television or an equivalent system shall be provided to permit continuous observation of the patient during irradiation and shall be located so that the operator can observe the patient from the control panel.

c) Radiation dose measurements shall be performed by a diagnostic imaging specialist on each CT x-ray system. The measurements shall be specified in terms of the computed tomography dose index (CTDI), for the head and abdomen, using a head or abdomen phantom, respectively, and the facility's technique factors most frequently used for a CT examination of the head or abdomen, respectively, and shall be performed:

1. At least annually by a diagnostic imaging specialist and after any change or replacement of components that could cause a change in the radiation output;

2. With a dosimetry system that has been calibrated within the preceding 12 months. The calibration of such system shall have no more than a three-step (tertiary) calibration, traceable to the National Institute of Standards and Technology; and

3. Using the computed tomography dose measurement protocol found in Report 111 of the American Association of Physicists in Medicine (AAPM), entitled "Comprehensive Methodology for the Evaluation of Radiation Dose in X-Ray Computed Tomography" published by AAPM, February 2010, exclusive of subsequent amendments or editions. A copy of this report is available for public inspection at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois or may also be obtained directly from the AAPM, One Physics Ellipse, College Park MD 20740-3846.

AGENCY NOTE: The Agency recognizes that other phantoms and protocols are available to provide accurate dose measurements as specified in this Section. The Agency will consider use of such phantoms and protocols as satisfying this Section if the intent of the regulation is met.

d) Diagnostic Imaging Specialists who perform radiation dose measurements and develop quality assurance procedures for CT systems shall have CT training as follows:

1. Individuals certified in diagnostic radiological physics or radiological physics by either the American Board of Radiology or the American Board of Medical Physics shall have 20 contact hours of documented specialized training in conducting surveys of CT equipment;

2. Individuals not certified as specified in subsection (d)(1) shall have 40 contact hours of documented specialized training in conducting surveys of CT equipment.

e) Documentation of the training required by subsection (d) shall be available for review at the facility by January 1, 2015. Documentation shall include the name of the individual performing the CT training.

f) Quality assurance procedures shall be conducted on each CT system and shall meet the following requirements:

1. The quality assurance procedures shall be in writing and shall have been developed by a diagnostic imaging specialist. The procedures shall include, but need not be limited to, the following:

A) Specifications of the tests that are to be performed, including instructions to be employed in the performance of those tests; and

B) Specifications of the frequency at which tests are to be performed, the acceptable tolerance for each parameter measured and actions to be taken if tolerances are exceeded.

2. Quality assurance procedures shall include acquisition of images using a CT phantom that has the capability of providing an indication of the resolution capability of the system. Quality assurance procedures shall include, at a minimum:

A) Image quality evaluation, including CT number uniformity, noise, and low and high contrast resolution;

B) Quantitative accuracy including CT number calibration and constancy;

C) Image display evaluation, including visual and hard copy output.

g) Operating Procedures. Information shall be available at the control panel regarding the operation of the system. The information shall include written quality assurance procedures, as required in subsection (f)(1).

History

• Source: Amended at 38 Ill. Reg. 12031, effective May 29, 2014

32 Ill. Adm. Code 360.80 Photofluorographic Systems (repealed)

History

• Source: Repealed at 17 Ill. Reg. 17972, effective October 15, 1993

32 Ill. Adm. Code 360.90 Dental Radiographic Systems

In addition to the provisions of Sections 360.10, 360.30 and 360.40 of this Part, the requirements of this Section apply to x-ray equipment and associated facilities used for dental radiography. Refer to Section 360.50 of this Part for requirements for dental fluoroscopic systems.

a) General Requirements

1. Timers. Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, preset number of pulses or preset radiation exposure to the image receptor. Also, it shall not be possible to make an exposure when the timer is set to a zero or off position if either position is provided.

2. X-Ray Control. An x-ray control shall be incorporated into each x-ray system such that an exposure can be terminated by the operator at any time except for exposures of 0.5 second or less.

3. Exposure Switch Arrangement. The exposure switch shall be a dead-man switch and shall be arranged so that the operator can be behind a protective barrier or at least 1.83 meters (6 feet) from the patient and the tube housing during an exposure.

b) Additional Requirements for Dental Intraoral Systems

1. Source-Skin Distance (SSD). X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit the SSD to not less than:

A) 18 centimeters if operable above 50 kVp; or

B) 10 centimeters if operable at 50 kVp and below.

2. Beam Limitation. Radiographic systems designed for use with an intraoral image receptor shall be provided with means to limit the x-ray beam such that the x-ray field, at the minimum SSD, shall be containable in a circle having a diameter of no more than 7 centimeters.

3. Dental Radiographic Exposure Limits (Single Film). The entrance exposure to an adult patient for a routine intraoral bitewing exam shall not exceed the limit specified for the kVp used in the table below. Exposures are specified as free-in-air exposures without backscatter.

Tube Potential

(KVP)

"D" Speed Film

"E" Speed Film

(microC/kg)

(mR)

(microC/kg)

(mR)

50

142

550

72

280

55

134

520

65

250

60

121

470

57

220

65

107

415

49

190

70

93

360

43

165

75

80

310

36

140

80

67

260

30

115

85

61

235

27

105

90

54

210

25

95

95

50

195

22

85

100

46

180

18

70

Linear extrapolation or interpolation shall be used for an x-ray tube potential (kVp) not listed in the table.

AGENCY NOTE: The exposures specified in the above table were empirically determined by a panel of dentists in a U.S. FDA study.

4. The kVp shall be measured at the time the entrance exposure is determined pursuant to subsection (b)(3) of this Section to determine the correct exposure limit to be applied.

c) Beam Limitation Requirements for Dental Extraoral Systems

1. Dental rotational panoramic systems shall be provided with means to limit the x-ray beam to the imaging slit in the transverse axis and shall not exceed a total of 13 millimeters (0.5 inch) larger than the imaging slit in the vertical axis.

2. All other dental extraoral radiographic systems (e.g., cephalometric) shall be provided with means to both size and align the x-ray field so that it does not exceed each dimension of the image receptor by more than two percent of the SID when the axis of the x-ray beam is perpendicular to the plane of the image receptor.

d) Additional Requirements for Dental Radiography

1. Patient and film holding devices shall be used when the techniques permit;

2. The tube housing and the position indicating device shall not be hand-held during an exposure;

3. The x-ray system shall be operated in such a manner that the useful beam at the patient's skin does not exceed the criteria specified in subsection (b)(2) of this Section;

4. Personnel Protection. The operator shall be behind a protective barrier or be provided with a protective apron of not less than 0.25 millimeter lead equivalent, or at least 1.83 meters (6 feet) from the patient and the tube housing during an exposure. Individuals whose presence is required in the room during an x-ray examination shall be protected from leakage and scatter radiation by protective aprons of not less than 0.25 millimeter lead equivalent or a protective barrier or shall be positioned at a sufficient distance to ensure that the individual does not receive a radiation dose in excess of the limits specified in 32 Ill. Adm. Code 340.310.

AGENCY NOTE: Strict adherence to radiation protection practices should minimize occupational dose and may eliminate the need for individual monitoring. The requirements for individual monitoring are specified in 32 Ill. Adm. Code 340.520.

History

• Source: Amended at 22 Ill. Reg. 5904, effective March 13, 1998

32 Ill. Adm. Code 360.100 Veterinary Radiographic Systems

In addition to the provisions of Sections 360.10, 360.30 and 360.40 (except Section 360.40(a)) of this Part, the requirements of this Section apply to x-ray equipment and associated facilities used for radiography with veterinary systems.

a) Beam Limitation. The useful beam shall be limited to the area of clinical interest. The size of the image receptor used for each radiographic projection shall be consistent with the objectives of the examination.

1. Limitation Criteria. Means shall be provided to limit the x-ray field in the plane of the image receptor so that the field does not exceed each dimension of the image receptor by more than two percent of the SID when the axis of the x-ray beam is perpendicular to the plane of the image receptor.

2. Means shall be provided to align the center of the x-ray field with the center of the image receptor to within two percent of the SID.

3. The requirements of subsection (a)(1) of this Section may be met with:

A) An adjustable collimator with a field defining light; or

B) An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is used, with each such device having permanent, clearly legible markings in centimeters and/or inches, to indicate the image receptor size and SID for which it is designed; or

C) A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is used. Permanent, clearly legible markings, in centimeters and/or inches, shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.

4. SID Indication

A) Means shall be provided to indicate the SID.

B) SIDs shall be indicated in centimeters and/or inches and the measured SID shall correspond to the indicated value to within two percent.

b) Exposure Switch Arrangement. The exposure control switch shall be arranged so the operator can be at least 1.83 meters (6 feet) from the animal, the x-ray tube and the useful beam.

c) Radiation Exposure Control Devices

1. Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, preset number of pulses or preset radiation exposure to the image receptor. Also, it shall not be possible to make an exposure when the timer is set to a zero or off position if either position is provided.

2. The exposure switch shall be a dead-man switch.

d) Veterinary fluoroscopic, computed tomography and therapy systems shall meet the requirements specified in Sections 360.50, 360.75, 360.110 and 360.120 of this Part, except that the requirements pertaining to aural communication specified in Sections 360.75(b)(2), 360.110(a)(8) and (e)(5) and 360.120(a)(6) and (g)(1)(H) of this Part, need not be satisfied unless a human is used to hold the animal.

e) Additional Requirements for Veterinary X-Ray Systems

1. All individuals whose presence is required during an x-ray examination shall be protected from scatter radiation by protective aprons or gowns of not less than 0.25 millimeter lead equivalent or whole body protective barriers.

2. All exams and retakes shall be ordered by the veterinarian.

3. Unless required to restrain an animal, the operator shall stand at least 1.83 meters (6 feet) away from the useful beam and the animal during radiographic exposures.

4. No individual, other than the operator, shall be in the x-ray room or area while exposures are being made unless such individual's assistance is required.

5. When an animal must be held in position during radiography, mechanical supporting or restraining devices shall be used when technique permits.

6. When a person is required to hold an animal during a radiographic procedure, the individual shall be protected with appropriate shielding devices, such as protective gloves and apron, and the person shall be so positioned that no part of his/her body except hands and arms will be struck by the useful beam.

AGENCY NOTE: Veterinarians should review 32 Ill. Adm. Code 340.520 to determine if individuals who hold animals will need to use individual monitoring devices.

History

• Source: Amended at 22 Ill. Reg. 5904, effective March 13, 1998

32 Ill. Adm. Code 360.110 Therapy Systems Operating Below 1 Mev

In addition to the provisions of Sections 360.10 through 360.30 of this Part, the requirements of this Section apply to x-ray therapy systems and associated facilities operating at energies less than 1 MeV.

a) Facility Design

1. A therapeutic radiological physicist shall be consulted in the design of an x-ray therapy installation.

2. Shielding requirements

A) Each x-ray therapy installation shall be provided with such primary and secondary barriers as are necessary to assure compliance with 32 Ill. Adm. Code 340.

B) For all x-ray therapy systems capable of operating above 150 kVp installed after October 15, 1993, facility design information shall be submitted to the Agency for review prior to installation of the x-ray therapy system. Information submitted to the Agency shall include, but need not be limited to, the following:

i) Name and address of the planned installation.

ii) Name, address and telephone number of the therapeutic radiological physicist who was consulted in the design of the installation.

iii) A scale drawing that includes the location of the therapy system, control panel and doors to the room.

iv) The structural composition and thickness of all walls, doors, partitions, floor and ceiling of the installation.

v) The occupancy of areas adjacent to the installation.

vi) Calculations that demonstrate the adequacy of the amount of shielding specified for each primary and secondary protective barrier.

vii) Projected weekly dose rates in areas adjacent to the installation.

3. Interlock. X-ray therapy systems operating at greater than 150 kVp shall have an interlock installed on each door of the therapy room. The interlock shall be wired into the electrical circuit in such a manner that when the door is opened, for any reason, the generation of x-rays will automatically be terminated and irradiation can be resumed only by manually resetting the controls on the control panel after the door is closed.

4. Doors. The doors to the therapy room shall be designed and installed to allow opening from the inside at all times and shall be capable of being opened manually.

5. Warning Lights. X-ray therapy systems operating above 150 kVp, and all therapy rooms to which access is possible through more than one entrance shall be provided with warning lights in a readily observable position near the outside of all access doors. The warning lights shall indicate when the useful beam is on.

6. Operator and control position

A) X-ray Therapy Systems Operating at 150 kVp and Below. The control panel and operator shall be located either outside the therapy room or behind a protective barrier within the room.

B) X-ray Therapy Systems Operating Above 150 kVp. The control panel and operator shall be located outside the therapy room.

7. Viewing System. Windows, mirrors, closed-circuit television or an equivalent system shall be provided to permit continuous visual observation of the patient during irradiation and shall be located so that the operator can observe the patient from the control panel.

AGENCY NOTE: When the primary viewing system is electronic, a back-up system should be available for use in the event of failure of the primary system in order to ensure compliance with the requirements of subsection (e)(5) of this Section.

8. Communication. The facility design shall permit two-way aural communications between the patient and the operator at the control panel.

9. Signs required by 32 Ill. Adm. Code 340.920 shall be posted in the facility.

b) Equipment Requirements

1. Leakage Radiation. When the tube is operated at its maximum rated continuous current for the maximum rated tube potential, the leakage radiation shall not exceed the value specified in the table below at the distance specified in the table for the classification of that x-ray system. Radiation measurements shall be averaged over an area up to, but not exceeding, 100 square centimeters.

X-Ray System

Leakage Limit

Measurement Location

Contact Therapy

25.8 microC/kg (0.1 R) per hour

5 centimeters from the tube housing

0 - 499 kVp

258 microC/kg (1 R) per hour

1 meter from the source

500 kVp - 999 kVp

0.1 percent of useful beam or 258 microC/kg (1 R) per hour, whichever is greater

1 meter from the source

2. Beam-Limiting Devices

A) Permanent fixed diaphragms or cones used for limiting the useful beam shall provide the same or a higher degree of protection as required for the tube housing assembly.

B) Removable beam-limiting devices shall, for the portion of the useful beam to be blocked by these devices, transmit not more than one percent of the useful beam at the maximum kilovoltage and maximum treatment filter. This requirement does not apply to auxiliary blocks or materials placed in the useful beam to shape the useful beam to the individual patient.

C) Adjustable beam-limiting devices installed after October 15, 1993 shall meet the requirements of subsection (b)(2)(B) of this Section.

D) Adjustable beam-limiting devices installed on or before October 15, 1993 shall, for the portion of the x-ray beam to be blocked by these devices, transmit not more than five percent of the useful beam at the maximum kilovoltage and maximum treatment filter.

3. Filter System. The filter system shall be designed so that:

A) The filters are securely positioned and will not become dislodged when the machine is positioned at any possible orientation;

B) The radiation dose at one meter from the filter insertion slot opening does not exceed 258 mC/kg (1 R) per hour when the machine is operated at its maximum current and maximum tube potential;

C) Each filter is labeled with its composition and thickness (for wedge filters, the wedge angle and maximum design field size shall appear on the wedge or wedge tray);

D) If the x-ray therapy system uses changeable filters, there is a filter indication system which permits recognition of any added filter in place and indicates from the control panel the presence of a particular filter or absence of any filter; and

E) For x-ray therapy systems installed after October15, 1993, an interlock prevents irradiation if the selected filter is not installed.

4. Tube/Aperture Alignment. The x-ray tube shall be mounted so that it cannot turn or slide with respect to the housing aperture.

5. Tube Housing Stability. The tube housing shall remain stable during treatment unless tube housing movement is a designed function of the system.

6. Source-Skin Distance (SSD) Indication

A) Means shall be provided to indicate the SSD.

B) The SSD shall be indicated in centimeters and/or inches and the measured SSD shall correspond to the indicated value to within 0.5 percent.

7. Timer. A timer, which has a display at the control panel, shall be provided and shall meet the following requirements:

A) The timer shall be activated with the production of radiation;

B) For systems equipped with a shutter mechanism to control irradiation, the timer shall be activated when the shutter is opened;

C) The timer shall terminate irradiation when a preselected time has elapsed;

D) The timer shall permit presetting and determination of exposure times at least as short as 1 second; and

E) The timer shall not permit an exposure if the operator has not selected a time for the exposure.

AGENCY NOTE: The control panel should be equipped with a count-up timer to serve as a back-up to the control timer.

8. Control Panel Functions. The control panel, in addition to the displays required in other provisions of this Section, shall have:

A) An indication of whether x-rays are being produced;

B) A means for indicating x-ray tube potential and current; and

C) A means for terminating an exposure at any time.

9. Shutters. Equipment that is provided with shutters shall meet the following requirements:

A) The shutters shall have a lead equivalency not less than that of the tube housing assembly;

B) The shutter shall be controlled electrically by the operator at the control panel; and

C) An indication of shutter position shall appear at the control panel.

10. Multiple Tubes. Control panels capable of energizing more than one x-ray tube shall meet the following requirements:

A) It shall be possible to energize only one x-ray tube at any time;

B) There shall be an indication at the control panel identifying which x-ray tube is energized; and

C) There shall be an indication at the tube housing assembly when that tube is energized.

11. Low-Filtration X-Ray Tubes. Each x-ray therapy system equipped with a beryllium window shall be clearly labeled as such upon the tube housing assembly and at the control panel.

c) Radiation Protection Survey. A radiation protection survey shall be performed by a therapeutic radiological physicist on each x-ray therapy system. The registrant shall maintain at the facility a copy of the most recent radiation protection survey report for review by the Agency. Radiation protection surveys shall meet the following additional requirements:

1. X-ray therapy systems installed after October 15, 1993 shall have a radiation protection survey performed by a physicist before the therapy system is first used for irradiation of a patient.

2. For all x-ray therapy systems, a radiation protection survey shall be performed by a physicist after any change in the x-ray therapy system or facility that might produce a radiation hazard. The survey shall be performed before the therapy system is used to treat patients.

3. Survey reports shall include, but need not be limited to, the following:

A) A diagram of the facility that details building structures and the position of the control panel, x-ray therapy system and associated equipment;

B) A description of the x-ray therapy system, including the manufacturer, model number and range of kilovolt potential;

C) A description of the instrumentation used to determine radiation measurements, including the date and source of the most recent calibration for each instrument used;

D) Conditions under which radiation measurements were taken; and

E) Survey data including:

i) Projected weekly dose equivalent in areas adjacent to the therapy room; and

ii) A description of workload, use and occupancy factors employed in determining the projected weekly dose equivalent.

4. The registrant shall retain a copy of the radiation protection survey report and a copy of the report shall be provided to the Agency within 30 days after completion of the survey.

5. Any deficiencies detected during the radiation protection survey that would constitute or result in a violation of 32 Ill. Adm. Code 340 shall be corrected prior to using the machine for treatment of patients.

6. The facility shall be operated in compliance with any limitations indicated by the therapeutic radiological physicist as a result of the radiation protection survey required by the Agency.

d) Calibrations and Quality Assurance Checks.

1. Each x-ray therapy system installed after October 15, 1993 shall be calibrated by a therapeutic radiological physicist before the therapy system is first used for irradiation of a patient. The calibration of the x-ray therapy system shall include, but need not be limited to, determination of the following:

A) The radiation output, expressed as exposure rate in air or dose rate in tissue, as a function of distance, field size, x-ray tube potential and current, filters and treatment applicators used;

B) The half-value layer for each kilovoltage setting and filter combination used;

C) The degree of congruence between the radiation field and the field indicated by each beam-limiting device; and

D) An evaluation of the uniformity of the radiation field.

2. Quality assurance checks shall be made by a therapeutic radiological physicist at intervals not to exceed 1 year. Quality assurance checks shall include, but need not be limited to, determination of the following:

A) The radiation output for a set of operating conditions specified by the therapeutic radiological physicist;

B) The coincidence of the radiation field and the field indicated by the beam-limiting device, except for systems equipped with fixed diaphragms or cones; and

C) The therapeutic radiological physicist shall establish criteria for quality assurance check measurements and shall determine corrective actions to be implemented if the criteria are exceeded.

AGENCY NOTE: Quality assurance checks should be performed at a frequency which is appropriate for the particular therapy system, as determined by the therapeutic radiological physicist and based on the history of stability of the radiation output of the machine. A suggested frequency is one that would result in a quality assurance check being performed at least once during a typical patient's course of treatment.

3. Whenever service or maintenance is performed on the therapy system, a therapeutic radiological physicist shall be notified and shall determine whether a calibration or quality assurance check is necessary to verify the characteristics of the beam.

4. Measurements of the radiation output of the x-ray therapy system shall be performed using a dosimetry system that has been calibrated by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). Calibration of the dosimetry system shall have been performed using a radiation beam of comparable half-value layer to the x-ray system to be calibrated. The dosimetry system shall meet one of the two conditions below:

A) The calibration of the dosimetry system shall have been performed within the previous 2 years and after any servicing that may have affected the calibration of the dosimetry system; or

B) The dosimetry system shall have been calibrated within the previous 4 years and shall have been subjected to a protocol which provides for checks of dosimetry constancy and provides for corrective action when results deviate by more than two percent from the expected values.

5. The registrant shall maintain at the facility records of machine calibrations, quality assurance checks and instrument calibrations for inspection by the Agency for a period of 5 years. Records to be maintained by the registrant shall include, but need not be limited to, the following:

A) Records of machine calibrations and quality assurance checks shall include identification of the x-ray therapy system, radiation measurements, the date the measurements were performed and the signature of the therapeutic radiological physicist who performed the measurements.

B) Instrument calibration records shall include the date of the last calibration and identity of the calibration laboratory. If a dosimetry system has been subjected to a protocol as described in subsection (d)(4)(B) of this Section, records shall be maintained that show the date and results of each constancy check performed on the system.

e) Operating Procedures

1. No x-ray therapy system shall be left unattended unless the system is secured against unauthorized use.

2. When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used.

3. Other than the patient, no individual shall be in the therapy room unless such individual is protected by a barrier sufficient to meet the requirements of 32 Ill. Adm. Code 340.

4. Other than the patient, no individual shall be in the therapy room during exposures from x-ray therapy systems operating above 150 kVp.

5. The x-ray therapy system shall not be used for treatment of patients unless the operator can maintain visual observation of the patient and audible communication with the patient.

6. On contact therapy systems, a shield of at least 0.5 millimeter lead equivalency at 100 kVp shall be positioned over the entire useful beam exit port during periods when the tube is energized and the beam is not being used.

7. The tube housing assembly shall not be held by hand during operating unless the x-ray therapy system is designed to require such holding and the peak tube potential of the system does not exceed 50 kilovolts. In such cases, the person holding the tube shall wear protective gloves and apron of not less than 0.5 millimeter lead equivalency at 100 kVp.

History

• Source: Amended at 32 Ill. Reg. 3693, effective February 29, 2008

32 Ill. Adm. Code 360.120 Therapy Systems Operating at 1 Mev or Greater

In addition to the provisions of Sections 360.10 through 360.30, the requirements of this Section apply to particle accelerator systems operating at energies of 1 MeV or greater. Accelerator systems capable of producing radioactive materials in excess of the exempt quantities specified in 32 Ill. Adm. Code 330.Appendix B shall also be licensed pursuant to the provisions of 32 Ill. Adm. Code 330.

a) Facility Design

1. The registrant shall consult a therapeutic radiological physicist in the design of a particle accelerator installation.

2. Shielding Requirements

A) Each accelerator installation shall be provided with such primary and secondary barriers as are necessary to assure compliance with 32 Ill. Adm. Code 340.

B) Facility design information for all accelerators installed after October 15, 1993 shall be submitted to the Agency for review prior to installation. Information submitted to the Agency shall include, but need not be limited to, the following:

i) Name and address of the planned installation;

ii) Name, address and telephone number of the therapeutic radiological physicist who was consulted in the design of the installation;

iii) A scale drawing that includes the location of the accelerator, control panel and doors to the room;

iv) The structural composition and thickness of all walls, doors, partitions, floor and ceiling of the installation;

v) The occupancy of areas adjacent to the installation;

vi) Calculations that demonstrate the adequacy of the amount of shielding specified for each primary and secondary protective barrier; and

vii) Projected weekly dose rates in areas adjacent to the installation.

3. Interlock. An interlock shall be installed on each door of the therapy room. The interlock shall be wired into the electrical circuit in such a manner that when the door is opened for any reason, the generation of radiation beams will automatically be terminated and irradiation can be resumed only by manually resetting the controls on the control panel after the door is closed.

4. Warning lights that indicate when the beam is on shall be provided in a readily observable position near the outside of all access doors to the therapy room.

5. Viewing System. Windows, mirrors, closed-circuit television or an equivalent system shall be provided to permit continuous visual observation of the patient during irradiation and shall be located so that the operator can observe the patient from the control panel.

AGENCY NOTE: When the primary viewing system is electronic, a back-up system should be available for use in the event of failure of the primary system in order to ensure compliance with the requirements of subsection (g)(1)(H).

6. The facility design shall permit two-way aural communications between the patient and the operator at the control panel.

7. Signs required by 32 Ill. Adm. Code 340.920 shall be posted in the facility.

8. The control panel shall be outside the therapy room.

9. The facility design shall include emergency off buttons, at locations that allow shutting off the machine from inside the therapy room and at the control panel.

10. The doors to the therapy room shall be designed to allow opening from the inside at all times and shall be capable of being opened manually.

b) Equipment Requirements

1. Leakage radiation to the patient area shall be measured for each accelerator. Measurements shall be repeated following maintenance or service performed on the accelerator, as determined by a therapeutic radiological physicist.

A) For operating conditions producing maximum leakage radiation, the absorbed dose due to leakage radiation, excluding neutrons, at any point in a circular plane of 2 meters radius centered on and perpendicular to the central axis of the beam at the isocenter or normal treatment distance and outside the maximum useful beam size shall not exceed 0.1 percent of the maximum absorbed dose of the unattenuated useful beam measured at the point of intersection of the central axis of the beam and the plane surface. Radiation measurements shall be averaged over an area up to but not exceeding 100 square centimeters.

B) Records of the most recent radiation leakage measurements and the machine parameters used during the survey shall be maintained at the facility for inspection by the Agency.

2. Beam-Limiting Devices. Adjustable or interchangeable beam-limiting devices shall transmit no more than two percent of the useful beam at the normal treatment distance for the portion of the useful beam that is to be attenuated by the beam-limiting device. The neutron component of the useful beam shall not be subject to this requirement. This requirement does not apply to auxiliary blocks or materials placed in the useful beam to shape the useful beam to the individual patient.

3. Source-Skin Distance (SSD) Indication

A) Means shall be provided to indicate the SSD.

B) The SSD shall be indicated in centimeters and/or inches and the measured SSD shall correspond to the indicated value to within 0.5 percent.

4. Filters

A) Each filter that is removable from the system shall be clearly marked with an identification number. Documentation available at the control panel shall contain a description of the filter. For wedge filters, the wedge angle and maximum design field size shall appear on the wedge or wedge tray.

B) If the machine calibration measurements required by subsection (d) relate exclusively to operation with an x-ray field flattening filter or electron beam scattering filter in place, such filters shall be removable from the machine only by the use of tools.

C) Equipment utilizing a system of wedge filters, interchangeable field flattening filters or interchangeable beam scattering filters shall meet the following requirements:

i) The equipment shall have an interlock that prevents irradiation if any filter selection operation carried out in the therapy room is not consistent with the selection of filter, beam type or beam energy at the control panel; and

ii) The equipment shall have an interlock system that prevents irradiation if any selected filter is not in the correct position.

5. Beam Monitoring System. All accelerator systems shall be provided with a beam monitoring system in the radiation head capable of monitoring and terminating irradiation.

A) Each beam monitoring system shall have a display at the treatment control panel which shall register accumulated monitor units.

B) The beam monitoring system shall terminate irradiation when the preselected number of monitor units has been detected by the system.

C) Accelerator systems manufactured after October 15, 1993 shall be equipped with a primary and a secondary beam monitoring system. Each beam monitoring system shall be independently capable of monitoring and terminating irradiation.

D) For units with a secondary beam monitoring system, the primary beam monitoring system shall terminate irradiation when the preselected number of monitor units has been detected. The secondary beam monitoring system shall terminate irradiation if the primary system fails.

E) An interlock device shall prevent irradiation if any beam monitoring system is inoperable.

F) In the event of power failure, the display information required in subsection (b)(5)(A), shall be retrievable in at least one system for 20 minutes.

6. Beam Symmetry. For equipment equipped with beam bending magnets, the symmetry of the radiation beam in two orthogonal directions shall be monitored before the beam passes through the beam-limiting device. The equipment shall provide means of terminating irradiation automatically if the difference in dose rate between one region and another region exceeds criteria specified by the manufacturer.

7. Control Panel

A) Selection and Display of Monitor Units

i) Irradiation shall not be possible until a selection of a number of monitor units has been made at the control panel.

ii) The selected number of monitor units shall be displayed at the control panel until reset.

iii) After completion of irradiation, it shall be necessary to reset the accumulated beam monitor units before treatment can be restarted.

B) Termination of Irradiation. It shall be possible to terminate irradiation and equipment movements at any time from the operator's position at the control panel.

C) Selection of Radiation Type. Equipment capable of both photon and electron therapy shall meet the following requirements:

i) Irradiation shall not be possible until the radiation type has been selected and displayed at the control panel.

ii) An interlock shall be provided to ensure that the machine will emit only the radiation type that has been selected.

iii) An interlock shall be provided to prevent irradiation with x-rays, except to obtain port films, when electron applicators are installed.

iv) An interlock shall be provided to prevent irradiation with electrons if accessories specific for x-ray therapy are installed.

D) Selection of Radiation Energy. Equipment capable of producing radiation beams of different energies shall meet the following requirements:

i) Irradiation shall not be possible until a selection of energy has been made at the control panel.

ii) An interlock shall be provided to ensure that the machine will emit only the nominal energy of radiation that has been selected.

iii) The nominal value of the energy selected shall be displayed at the treatment control panel.

E) Selection of Stationary or Moving Beam Therapy. Equipment capable of both stationary and moving beam therapy shall meet the following requirements:

i) Irradiation shall not be possible unless either stationary therapy or moving beam therapy has been selected at the control panel. The selection of stationary therapy may be performed as a default selection if moving beam therapy is not selected.

ii) An interlock shall be provided to ensure that the machine will operate only in the mode that has been selected.

iii) An interlock shall be provided to terminate irradiation if the gantry fails to move properly during moving beam therapy.

iv) Means shall be provided to prevent movement of the gantry during stationary therapy.

v) The mode of operation shall be displayed at the control panel.

F) Timers. A timer shall be provided with a display at the treatment control panel, as a back-up device to the beam monitoring system.

i) The timer shall permit presetting and determination of exposure times.

ii) The timer shall be a cumulative timer which activates with the production of radiation and retains its reading after irradiation is interrupted or terminated.

iii) The timer shall terminate irradiation when a preselected time has elapsed if the beam monitoring system has not previously terminated irradiation. If set at zero, the timer shall not permit irradiation.

G) Security. The control panel shall be capable of being locked to prevent unauthorized use.

c) Radiation Protection Survey. A radiation protection survey shall be performed by a therapeutic radiological physicist on each accelerator. The registrant shall maintain at the facility a copy of the most recent radiation protection survey report for review by the Agency. Radiation protection surveys shall meet the following additional requirements:

1. For each accelerator installed after October 15, 1993, a radiation protection survey shall be performed by a physicist before the system is first used for irradiation of a patient. The physicist who performs the radiation protection survey shall be a person who did not consult in the design of the accelerator installation (see subsection (a)) and is not employed by or within any corporation or partnership with the person who consulted in the design of the installation.

2. A radiation protection survey shall be performed by a physicist after any change in the accelerator or facility that might produce a radiation hazard. Such survey shall be performed before the system is used to treat patients.

3. The survey report shall include, but need not be limited to, the following:

A) A diagram of the facility which details building structures and the position of the control panel, accelerator and associated equipment;

B) A description of the accelerator system including the manufacturer, model number, beam type and beam energy range;

C) A description of the instrumentation used to determine radiation measurements, including the date and source of the most recent calibration for each instrument used;

D) Conditions under which radiation measurements were taken;

E) Survey data including:

i) Projected weekly dose equivalent in areas adjacent to the therapy room; and

ii) A description of workload, use and occupancy factors employed in determining the projected weekly dose equivalent.

4. The registrant shall retain a copy of the radiation protection survey report and a copy of the report shall be provided to the Agency within 30 days after completion of the survey.

5. Any deficiencies detected during the radiation protection survey that would constitute or result in a violation of 32 Ill. Adm. Code 340 shall be corrected prior to using the machine for treatment of patients.

6. The facility shall be operated in compliance with any limitations indicated by the therapeutic radiological physicist as a result of the radiation protection survey.

d) Machine Calibration. Calibration measurements shall be performed on each accelerator system by a therapeutic radiological physicist before the therapy system is first used for irradiation of a patient. Subsequent calibrations shall be performed at intervals not exceeding 1 year.

1. Calibration measurements shall include, but need not be limited to, the following determinations:

A) Verification that the equipment is operating in compliance with the design specifications concerning the light localizer, variation in the axes of rotation for the table, gantry and jaw system and the beam flatness and symmetry at the specified depth;

B) The absorbed dose rate at various depths in water for the range of field sizes used, for each beam type and energy;

C) The uniformity of the radiation field and any dependency upon the direction of the beam;

D) Verification that existing depth-dose data and isodose charts applicable to the specific machine continue to be valid or are updated to existing machine conditions; and

E) Verification of transmission factors for all accessories such as wedges, shadow trays and compensators, as applicable.

2. Calibration radiation measurements shall be performed using a dosimetry system that has been calibrated by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM), and meets the requirements of either subsection (d)(2)(A) or (B):

A) The calibration shall have been performed within the previous 2 years and after any servicing that may have affected calibration of the dosimetry system; or

B) The dosimetry system shall have been calibrated within the previous 4 years and shall have been:

i) Compared at annual intervals following the calibration to a dosimetry system with calibration obtained within the previous 2 years from a calibration laboratory accredited by the AAPM, and the results of the comparison indicate the calibration factor has not changed by more than two percent; or

ii) Subjected to a testing protocol that has been established by a therapeutic radiological physicist and that provides for checks of dosimetry constancy and provides for corrective action when results deviate more than two percent from the expected values.

AGENCY NOTE: Redundancy is a basic tenet of radiation dosimetry, therefore the therapeutic radiological physicist should establish a program of inter-comparison and constancy testing of calibrated dosimetry instruments to assure, as much as possible, the accuracy, reliability and reproducibility of the measurements performed with those instruments.

3. Calibration of the radiation output of the accelerator shall be performed in accordance with:

A) The protocol of Task Group 21, Radiation Therapy Committee, American Association of Physicists in Medicine (AAPM), entitled "A Protocol for the Determination of Absorbed Dose from High-Energy Photon and Electron Beams" published in Medical Physics, Volume 10, pages 741-771 (1983), exclusive of subsequent amendments or editions; or

B) The protocol of the Scientific Committee on Radiation Dosimetry of the AAPM, entitled "Protocol for the Dosimetry of X and Gamma Ray Beams with Maximum Energies Between 0.6 and 50 MeV", published in Physics, Medicine, and Biology, Volume 16, pages 379-396 (1971), exclusive of subsequent amendments or editions; or

C) Other machine calibration protocols provided that the registrant has submitted the protocols to the Agency and the protocols cover the same topics as those contained in subsections (d)(3)(A) and (B).

AGENCY NOTE: Copies of the two protocols referenced in subsections (d)(3)(A) and (B) are available for public inspection at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois. The protocols may also be obtained directly from the AAPM, One Physics Ellipse, College Park MD 20740-3846.

4. The radiation output of each therapy system shall be independently verified at intervals not to exceed 2 years. Independent verification shall consist of:

A) Verification of the machine output by a therapeutic radiological physicist who is not employed at the facility and does not perform the annual calibration; or

B) Alternate methods of verification of machine output, such as the use of mailed dosimetry devices, that use devices and procedures approved by the AAPM.

5. Machine calibration records shall include identification of the accelerator calibrated, the results of the tests specified in subsection (d)(1) and shall be signed and dated by the therapeutic radiological physicist who performed the calibration.

6. The registrant shall maintain at the facility, for a period of 5 years, records of machine calibrations, instrument calibrations and independent verifications of machine output for inspection by the Agency.

e) Quality Assurance Checks. A quality assurance (QA) check shall be performed by a therapeutic radiological physicist on each therapy system each calendar month. The interval between QA checks shall not exceed 45 days. QA checks shall also be performed after any change which could affect the radiation output, spatial distribution or other characteristics of the therapy beam, as determined by the physicist. Quality assurance checks shall also meet the following requirements:

1. Quality assurance checks shall include determination of:

A) The radiation output for a set of operating conditions specified by a therapeutic radiological physicist; and

B) The coincidence of the radiation field and the field indicated by the localizing device.

2. Radiation measurements shall be obtained using a dosimetry system that:

A) Meets the requirements of subsection (d)(2); or

B) Has been directly compared by a therapeutic radiological physicist within the previous year with a dosimetry system which meets the requirements of subsection (d)(2).

3. The therapeutic radiological physicist shall establish criteria for quality assurance check measurements and shall determine corrective actions to be implemented if the criteria are exceeded.

4. The registrant shall retain a record of quality assurance check measurements for inspection by the Agency for a period of 5 years. The record shall include the date of the quality assurance check, identification of the accelerator, results of the quality assurance check measurements and the signature of the individual who performed the quality assurance check.

f) Quality Control. A comprehensive quality control program shall be implemented as specified by a therapeutic radiological physicist and shall meet the following requirements:

1. The program shall be designed to test the operation and performance of the accelerator in order to maintain radiation safety and clinical reliability. The program shall include as a minimum the items listed in Section 360.Appendix E.

2. The physicist shall specify the tolerance and frequency of performance for each item of the quality control program.

3. The physicist shall specify what actions are to be taken for any item exceeding the specified tolerance.

4. The physicist shall review, sign and date the results of the quality control program each calendar month.

AGENCY NOTE: The elements of a comprehensive quality control program are described in Report No. 13 published by the AAPM, entitled "Physical Aspects of Quality Assurance in Radiation Therapy" (1984). A copy of this report is available for public inspection at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois. Report No. 13 may also be obtained directly from the AAPM, One Physics Ellipse, College Park MD 20740-3846.

g) Operating Procedures. The registrant shall have a therapeutic radiological physicist establish written operating and emergency procedures and shall ensure that the procedures are implemented before the accelerator is used for treatment of patients. Operators of accelerators shall receive training in the application of the procedures before using the accelerator to irradiate patients. A copy of the current operating and emergency procedures shall be maintained at the treatment control panel for use and review.

1. Operating procedures to be implemented shall include instructions that:

A) The accelerator is used in such a manner that patients, workers and the general public are protected from radiation hazards and the provisions of 32 Ill. Adm. Code 340 are met;

B) No accelerator shall be left unattended unless it is secured against unauthorized use;

C) The safety interlock system shall not be used to turn off the beam except in an emergency;

D) The safety interlocks and warning systems required in subsections (a)(3), (a)(4) and (a)(9) shall be tested for proper operation at monthly intervals;

E) Mechanical supporting or restraining devices shall be used when a patient must be held in position for radiation therapy;

F) No individual other than the patient shall be in the therapy room during irradiation;

G) Start-up procedures for the accelerator, specified by the therapeutic radiological physicist, shall be performed daily prior to treatment of patients; and

H) The accelerator shall not be used for treatment of patients unless the operator can maintain visual observation of the patient and audible communication with the patient.

2. Emergency procedures shall include instructions for alternate methods for termination of irradiation and machine movements.

AGENCY NOTE: The operating and emergency procedures should contain as a minimum the machine manufacturer's operations manual for the accelerator.

3. Operating and emergency procedures shall include instructions for contacting the therapeutic radiological physicist when operational problems or emergencies occur and the actions that are to be taken until the physicist can be contacted.

h) Machine Maintenance. The therapeutic radiological physicist shall establish accelerator maintenance procedures that meet the following requirements:

1. Whenever service or maintenance is performed on the accelerator, a therapeutic radiological physicist shall be notified of such service or maintenance.

2. Following completion of service or maintenance involving radiation beam generation, beam steering or monitoring of the beam, but before the accelerator is again used for treatment of patients, the therapeutic radiological physicist shall review the service or maintenance report and shall determine whether a calibration or quality assurance check is necessary to verify the characteristics of the beams. If the therapeutic radiological physicist determines that a calibration or quality assurance check is necessary, the calibration or quality assurance check shall be performed before the accelerator is again used for treatment of patients.

3. The therapeutic radiological physicist shall establish the frequency of routine maintenance and ensure that records of all service and maintenance performed on the machine are maintained at the facility.

4. The therapeutic radiological physicist shall sign and date records of all service and maintenance performed on the machine.

5. The therapeutic radiological physicist shall specify the qualifications of maintenance personnel and prohibit non-qualified personnel from repairing the machine or adjusting parameters on the machine.

6. Circuit diagrams of the accelerator and interlock systems shall be maintained at the facility and kept current.

i) Quality Management Program. Each registrant shall develop, implement, and maintain a quality management program to provide high confidence that radiation will be administered as directed by the physician. The quality management program shall address, as a minimum, the following specific objectives:

1. Written Directives. A written directive must be dated and signed by a physician prior to the administration of radiation.

A) A written directive must contain the patient or human research subject's name, the type and energy of the beam, the total dose, dose per fraction, treatment site, and number of fractions.

B) A written revision to an existing written directive may be made provided that the revision is dated and signed by a physician prior to the administration of the external beam dose, or the next fractional dose.

C) An oral revision to an existing written directive is acceptable provided that:

i) a delay in providing a written revision would jeopardize the patient's health; and

ii) the oral revision is documented as soon as possible in writing in the patient's record; and

iii) a revised written directive is signed by a physician within 48 hours after the oral revision.

D) The registrant shall retain a copy of each written directive for 3 years.

2. Procedures for Administrations. The registrant shall develop, implement, and maintain written procedures to provide high confidence that:

A) 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;

B) Each administration is in accordance with the written directive;

C) External beam radiation therapy final plans of treatment and related calculations are in accordance with the respective written directives;

D) Any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken; and

E) The registrant retains a copy of the procedures for administrations for three years.

3. Reports and Notifications of Medical Events

A) A registrant shall report any event 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.

B) Other than events that result from intervention by a patient or human research subject, a registrant shall report any event in which:

i) The administration of a therapeutic radiation machine therapy dose involves the wrong patient, wrong treatment modality, or wrong treatment site; or

ii) The calculated weekly administered dose differs from the weekly prescribed dose by more than (30%); or

iii) The calculated total administered dose differs from the total prescribed dose by more than (20%) of the total prescribed dose;

C) The registrant shall notify the Agency by telephone no later than the next calendar day after the discovery of a medical event.

D) The registrant shall submit a written report to the Agency within 15 days after the discovery of a medical event. 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 individuals who received the administration;

vi) Actions, if any, that have been taken, or are planned, to prevent recurrence;

vii) Certification that the registrant notified the individual (or the individual's responsible relative or guardian) and if not, why not.

E) The report shall not contain the individual's name or any other information that could lead to the identification of the individual.

F) The registrant shall provide notification of the event to the referring physician and shall notify the individual who is the subject of the medical event no later than 24 hours after its discovery, unless the referring physician personally informs the registrant either that he or she will inform the individual or that, based on 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 shall notify the individual as soon as possible thereafter. The registrant may not delay any appropriate medical care for the individual, including any necessary remedial care required as a result of the medical event, because of any delay in notification. To meet the requirements of this subsection (i)(3)(F), the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the registrant shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the registrant upon request. The registrant shall provide the written description if requested.

G) Aside from the notification requirement, nothing in this Section affects any rights or duties of registrants and physicians in relation to each other, to an individual affected by the medical event, or to that individual's responsible relatives or guardians.

H) The registrant shall retain a record of a medical event in accordance with subsection (i)(4). A copy of the record required shall be provided to the referring physician, if other than the registrant, within 15 days after discovery of the medical event.

I) The registrant shall annotate a copy of the report provided to the Agency with:

i) The name of the individual who is the subject of the event;

ii) The social security number or other identification number, if one has been assigned, of the individual who is the subject of the event; and

iii) A copy of the annotated report to the referring physician, if other than the registrant, no later than 15 days after the discovery of the event.

4. Records of Medical Events. A registrant shall retain a record of medical events for 3 years. The record must contain the following:

A) The registrant's name and the names of the individuals involved;

B) The social security number or other identification number, if one has been assigned, of the individual who is the subject of the medical event;

C) A brief description of the event; why it occurred; the effect, if any, on the individual;

D) The actions, if any, taken or planned to prevent recurrence; and

E) Whether the registrant 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.

History

• Source: Amended at 38 Ill. Reg. 12031, effective May 29, 2014

32 Ill. Adm. Code 360.130 Electronic Brachytheraphy

a) Applicability. Electronic brachytherapy devices shall be subject to the requirements of this Section and shall be exempt from the requirements of Section 360.110, unless otherwise noted in this Section.

1. An electronic brachytherapy device that does not meet the requirements of this Section shall not be used for irradiation of patients; and

2. An electronic brachytherapy device shall only be utilized for human use applications specifically approved by the U.S. Food and Drug Administration (FDA) unless participating in a research study approved by the registrant's Institutional Review Board.

b) Possession of Survey Instruments. Each registrant using an electronic brachytherapy device in accordance with this Section shall possess appropriately calibrated portable monitoring equipment. At a minimum, the monitoring equipment shall include 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 survey instruments shall be operable and calibrated within the prior 12 months for the applicable electronic brachytherapy source energy.

c) Facility Design Requirements for Electronic Brachytherapy Devices. Each electronic brachytherapy installation shall be provided with such primary and secondary barriers as are necessary to assure compliance with 32 Ill. Adm. Code 340.

1. If applicable, provision shall be made to prevent simultaneous operation of more than one therapeutic radiation machine in a treatment room.

2. Access to the treatment room shall be controlled by a door at each entrance.

3. Each treatment room shall have provisions to permit continuous aural communication and visual observation of the patient from the treatment control panel during irradiation. The electronic brachytherapy device shall not be used for patient irradiation unless the patient can be observed.

d) Control Panel Functions. The control panel, in addition to the displays required by other provisions in this Section, shall:

1. Provide an indication of whether electrical power is available at the control panel and if activation of the electronic brachytherapy source is possible;

2. Provide an indication of whether x‑rays are being produced;

3. Provide a means for indicating electronic brachytherapy source potential and current;

4. Provide a means for terminating an exposure at any time; and

5. Include an access control (locking) device that will prevent unauthorized use of the electronic brachytherapy device.

e) Timer. A suitable irradiation control device (timer) shall be provided to terminate the irradiation after a pre-set time interval or integrated charge on a dosimeter-based monitor. The timer shall operate according to the manufacturer's design specifications.

f) Therapeutic Radiological Physicist Support. The services of a therapeutic radiological physicist shall be required in facilities having electronic brachytherapy devices. The therapeutic radiological physicist shall be responsible for:

1. Evaluation of the output from the electronic brachytherapy source;

2. Generation of the necessary dosimetric information;

3. Supervision and review of treatment calculations prior to initial treatment of any treatment site;

4. Establishing the periodic and day-of-use quality assurance checks and reviewing the data from those checks as required in subsection (j);

5. Consultation with the physician in treatment planning, as needed;

6. Performing calculations/assessments regarding patient treatments that may constitute a misadministration.

7. Determination of the need for shielding or safe distances for individuals in the room during electronic brachytherapy treatments, in accordance with the radiation dose limits of 32 Ill. Adm. Code Part 340;

8. Implementation of the use of shielding or safe distances as determined in subsection (f)(7).

g) Operating Procedures

1. Only individuals approved by the physician or therapeutic radiological physicist shall be present in the treatment room during treatment.

2. Electronic brachytherapy devices shall not be made available for medical use unless the requirements of this Section have been met.

3. The electronic brachytherapy device shall be inoperable, either by hardware or password, when unattended by qualified staff or service personnel.

4. During operation, the therapeutic radiologic physicist shall ensure that all persons in the treatment room, and all persons entering the treatment room, are prevented from exceeding the radiation dose limits of 32 Ill. Adm. Code Part 340.

5. If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used.

6. Written procedures shall be developed, implemented, and maintained for responding to an abnormal situation. These procedures shall include:

A) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; and

B) The names and telephone numbers of the physician and the therapeutic radiological physicist to be contacted if the device or console operates abnormally.

7. A copy of the current operating and emergency procedures shall be physically located at the electronic brachytherapy device control console.

8. Instructions shall be posted at the electronic brachytherapy device control console to inform the electronic brachytherapy device operator of the names and telephone numbers of the physician and the therapeutic radiological physicist to be contacted if the device or console operates abnormally.

h) Safety Precautions for Electronic Brachytherapy Devices

1. A therapeutic radiological physicist shall determine which persons in the treatment room require radiation monitoring when the beam is energized.

2. A physician and a therapeutic radiological physicist shall be physically present during the initiation of all patient treatments involving the electronic brachytherapy device.

3. A therapeutic radiological physicist and either a physician or an electronic brachytherapy device operator, under the supervision of a physician, who has been trained in the operation of, and emergency response for, the electronic brachytherapy device, shall be physically present during continuation of all patient treatments involving the electronic brachytherapy device.

4. A therapeutic radiological physicist shall designate shield locations or safe distances sufficient to meet the requirements of 32 Ill. Adm. Code 340 for any individual, other than the patient, in the treatment room;

5. All personnel in the treatment room are required to remain behind shielding or at a safe distance specified by the therapeutic radiological physicist during treatment. A therapeutic radiological physicist shall approve any deviation from this requirement and shall designate alternative radiation safety protocols, compatible with patient safety, to provide an equivalent degree of protection.

i) Electronic Brachytherapy Source Calibration Measurements

1. Calibration of the electronic brachytherapy source output for an electronic brachytherapy device shall be performed by, or under the direct supervision of, a therapeutic radiological physicist.

2. Calibration of the electronic brachytherapy source output shall be made for each electronic brachytherapy source, or after any repair affecting the x-ray beam generation, or when indicated by the electronic brachytherapy source quality assurance checks.

3. Calibration of the electronic brachytherapy source output shall utilize a dosimetry system that meets the requirements of subsection 360.110(d)(4).

4. Calibration of the electronic brachytherapy source output shall include, as applicable, determination of:

A) The output within 2% of the expected value, if applicable, or determination of the output if there is no expected value;

B) Timer accuracy and linearity over the typical range of use;

C) Proper operation of back-up exposure control devices;

D) Evaluation that the relative dose distribution about the source is within 5% of that expected; and

E) Source positioning accuracy to within one millimeter within the applicator.

5. Calibration of the x-ray source output shall be in accordance with the manufacturer's calibration protocol.

6. The registrant shall maintain a record of each calibration in an auditable form for 5 years. The record shall include: the date of the calibration; the manufacturer's name, model number and serial number for the electronic brachytherapy device and a unique identifier for its electronic brachytherapy source; the model numbers and serial numbers of the instruments used to calibrate the electronic brachytherapy device; and the name and signature of the therapeutic radiological physicist responsible for performing the calibration.

j) Periodic and Day-of-Use Quality Assurance Checks for Electronic Brachytherapy Devices

1. Quality assurance checks shall be performed on each electronic brachytherapy device:

A) At the beginning of each day of use;

B) Each time the device is moved to a new room or site; and

C) After each x-ray tube installation.

2. The registrant shall perform periodic quality assurance checks required by subsection (j)(1) in accordance with procedures established by the therapeutic radiological physicist;

3. Quality assurance checks shall include, at a minimum:

A) Verification that output of the electronic brachytherapy source falls within 3% of expected values, as appropriate for the device, as determined by:

i) Output as a function of time; or

ii) Output as a function of setting on a monitor chamber.

B) Verification of the consistency of the dose distribution to within 3% of that found during calibration required by subsection (i); and

C) Validation of the operation of positioning methods to ensure that the treatment dose exposes the intended location within 1 mm.

4. The registrant shall use a dosimetry system that has been intercompared within the previous 12 months with the dosimetry system described in subsection (i)(3) to make the quality assurance checks required in this subsection (j).

5. The registrant shall review the results of each radiation output quality assurance check according to the following procedures:

A) A physician and therapeutic radiological physicist shall be immediately notified if any parameter is not within its acceptable tolerance. The electronic brachytherapy device shall not be made available for subsequent medical use until the therapeutic radiological physicist has determined that all parameters are within their acceptable tolerances; and

B) The therapeutic radiological physicist shall review and sign the results of each radiation output quality assurance check at intervals not to exceed 30 days.

6. Quality assurance checks shall, at a minimum, assure:

A) Proper operation of radiation exposure indicator lights on the electronic brachytherapy device and on the control console;

B) Proper operation of viewing and intercom systems in each electronic brachytherapy facility, if applicable;

C) Proper operation of radiation monitors, if applicable;

D) The integrity of all cables, catheters or parts of the device that carry high voltages; and

E) Connecting guide tubes, transfer tubes, transfer-tube-applicator interfaces, and treatment spacers are free from any defects that interfere with proper operation.

7. If the results of the safety device quality assurance checks indicate the malfunction of any system, a registrant shall secure the control console in the OFF position and not use the electronic brachytherapy device except as may be necessary to repair, replace, or check the malfunctioning system.

8. The registrant shall maintain a record of each quality assurance check in an auditable form for 3 years.

A) The record shall include the date of the quality assurance check; the manufacturer's name, model number and serial number for the electronic brachytherapy device; the name and signature of the individual who performed the periodic quality assurance check; and the name and signature of the therapeutic radiological physicist who reviewed the quality assurance check; and

B) The record shall also include the unique identifier for the electronic brachytherapy source; the manufacturer's name; and the model number and serial number for the instruments used to measure the radiation output of the electronic brachytherapy device.

k) Therapy-Related Computer Systems. The registrant shall perform acceptance testing on the treatment planning system of electronic brachytherapy-related computer systems in accordance with the manufacturer's acceptance testing protocol.

1. Acceptance testing shall be performed by, or under the direct supervision of, a therapeutic radiological physicist. At a minimum, the acceptance testing shall include, as applicable, verification of:

A) The source-specific input parameters required by the dose calculation algorithm;

B) The accuracy of dose, dwell time, and treatment time calculations at representative points;

C) The accuracy of isodose plots and graphic displays;

D) The accuracy of the software used to determine radiation source positions from radiographic images; and

E) If the treatment planning system is different from the treatment delivery system, the accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

2. The position indicators in the applicator shall be compared to the actual position of the source or planned dwell positions, as appropriate, at the time of commissioning.

3. Prior to each patient treatment regimen, the parameters for the treatment shall be evaluated and approved by the physician and the therapeutic radiological physicist for correctness through means independent of that used for the determination of the parameters.

l) Training

1. A registrant shall provide instruction, initially and at least annually, to all individuals who operate the electronic brachytherapy device, as appropriate to the individual's assigned duties, in the operating procedures identified in subsection (g). If the interval between patients exceeds one year, retraining of the individuals shall be provided.

2. Physicians, therapeutic radiological physicists, and electronic brachytherapy device operators shall receive device specific instruction initially from the manufacturer and annually from either the manufacturer or other qualified trainer. The training shall be of a duration recommended by the manufacturer's training protocol. The training shall include, but not be limited to:

A) Device-specific radiation safety requirements;

B) Device operation;

C) Clinical use for the types of use approved by the FDA;

D) Emergency procedures, including an emergency drill; and

E) The registrant's quality assurance program.

3. A registrant shall retain a record of individuals receiving instruction required by this subsection (l) for 3 years. The record shall include a list of the topics covered, the date of the instruction, the names of the attendees, and the names of the individuals who provided the instruction.

m) Mobile Electronic Brachytherapy Service. A registrant providing mobile electronic brachytherapy service shall, as a minimum:

1. Check all radiation survey instruments before medical use at each address of use or on each day of use, whichever is more restrictive.

2. Account for the electronic brachytherapy source in the electronic brachytherapy device before departure from the client's address.

3. Perform, at each location on each day of use, all of the required quality assurance checks specified in subsection (j) to assure proper operation of the device.

History

• Source: Added at 38 Ill. Reg. 12031, effective May 29, 2014

32 Ill. Adm. Code 360.APPENDIX A Medical Radiographic Entrance Exposure Measurement Protocol

The following protocol shall be used for measuring and calculating entrance skin exposures (ESE) for routine diagnostic examinations. Radiation measurements shall be performed with a calibrated radiation measuring device that is sufficiently sensitive to determine compliance with the criteria specified in Section 360.60(e) of this Part. The instrument shall have been calibrated within the previous 12 months with devices which have no more than a three-step (tertiary) calibration, traceable to the National Institute of Standards and Technology. Patients are not involved in the measurement protocol.

a) Position the x-ray tube at the source-image receptor distance (SID) routinely used and adjust the collimation to the active portion of a radiation measuring device.

b) Measure the distance from the x-ray source to the source against which the patient rests. Subtract the thickness of the patient to obtain the source-skin distance (SSD). The standard patient thickness for each projection to be measured shall be the following:

Projection

Thickness (cm)

Chest (PA), Grid

23

Chest (PA), Non-Grid

23

Abdomen (KUB)

23

Lumbo-Sacral Spine (AP)

23

Cervical Spine (AP)

13

Skull (lateral)

15

Foot (D/P)

8

c) Place a radiation measuring device in the center of the useful beam, measure and record the distance from the source to the device (SDD). Use of a test stand to position the device away from the table will reduce backscatter contribution. Placing the radiation measuring device at the actual source-skin distance (SSD) will accomplish this and allow direct reading of the ESE.

d) Set the exposure technique as follows:

1. For non-phototimed x-ray systems, set the controls to the exposure technique used by the x-ray operator for the standard patient thickness specified in subsection (b) of this Section.

2. For phototimed x-ray systems, set the controls to the exposure technique used by the x-ray operator for the standard patient thickness specified in subsection (b) of this Section, and use one of the two methods below:

A) Place an appropriate phantom (simulating body attenuation) in the useful beam between the radiation measuring device and the radiographic tabletop; or

B) Set an appropriate exposure technique in the manual mode (without activation of the phototimer).

AGENCY NOTE: Specifications for appropriate phantoms are included in the American Association of Physicists in Medicine (AAPM) Report No. 31, entitled "Standardized Methods for Measuring Diagnostic X-Ray Exposures" (July 1990). A copy of this report is available for public inspection at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, IL. Copies of this report may also be obtained from the AAPM, One Physics Ellipse, College Park MD 20740-3846.

e) Make a radiographic exposure (without patient) and record the reading obtained from the radiation measuring device

f) Calculate the entrance skin exposure for the specific examination, using the radiation exposure reading from subsection (e) of this Section and the equation in this subsection (f) below (if a direct result was not obtained with the dosimeter at the SSD). The entrance skin exposure equals the product of the radiation exposure reading from subsection (e) of this Section multiplied by the square of the ratio of the SDD, to the SSD. This expression is mathematically represented by the equation below (if a direct result was not obtained with the dosimeter at the SSD):

ESE = (Dosimeter Reading) x

where:

SDD = source-radiation measuring device distance

SSD = source to skin distance

g) Compare the results of the calculation from subsection (f) of this Section with the criteria specified in Section 360.60(e) of this Part to determine compliance.

AGENCY NOTE: There are many different techniques for measuring ESE that may result in significant differences in measured values. Factors that can cause variations include instrument calibration, backscatter, collimation, estimation of focal spot location, choice of phantom, location of dosimeter in the primary beam, etc. Because of these variations, the procedure for determining the ESE should be performed with strict attention to each detail noted above.

History

• Source: Amended at 32 Ill. Reg. 3693, effective February 29, 2008

32 Ill. Adm. Code 360.APPENDIX B Mammography Dose Measurement Protocol (repealed)

History

• Source: Repealed at 23 Ill. Reg. 14516, effective January 1, 2000

32 Ill. Adm. Code 360.APPENDIX C Mammography Phantom Image Evaluation (repealed)

History

• Source: Repealed at 23 Ill. Reg. 14516, effective January 1, 2000

32 Ill. Adm. Code 360.APPENDIX D Computed Tomography Dose Measurement Protocol (repealed)

History

• Source: Repealed at 38 Ill. Reg. 12031, effective May 29, 2014

32 Ill. Adm. Code 360.APPENDIX E Minimum Quality Control Program for Medical Accelerators

a) Mechanical tests

1. Patient support assembly motions

2. Gantry angle indicators

3. Optical distance indicator

4. Alignment lights

5. Congruence of radiation beam and light field

6. Accuracy of field size indicators

7. Mechanical isocenter - gantry and collimator

8. Mechanical interlocks

b) Radiation beam tests

1. Machine operating parameters

2. Dose per monitor unit for x-ray and electron beams

3. Dose per degree for moving beam therapy

4. Radiation isocenter

5. Flatness and symmetry

6. Wedge transmission factors

7. Shadow tray transmission factors

8. Energy check on central axis

9. Radiation output versus field size

c) Control panel checks

1. Radiation "ON" condition

2. Indicator lamp check

3. Computer control of accelerator

d) Facility checks

1. Patient audio-visual communication

2. Entrance door interlock

3. Warning lights

4. Emergency off buttons

e) Control Panel

1. Digital displays

2. Analog displays

3. Status displays

4. Interlock displays

5. Reset display

f) Patient Dosimetry Calculations

1. Calculation of patient treatment times

2. Computer calculations of patient treatment times

History

• Source: Added at 17 Ill. Reg. 17972, effective October 15, 1993

32 Ill. Adm. Code 360.ILLUSTRATION A Thimble and Pancake Chamber-Radiation Measuring Devices (repealed)

History

• Source: Repealed at 23 Ill. Reg. 14516, effective January 1, 2000

32 Ill. Adm. Code 360.ILLUSTRATION B Mammography Dose Evaluation Graph (repealed)

History

• Source: Repealed at 17 Ill. Reg. 17972, effective October 15, 1993

32 Ill. Adm. Code 360.TABLE A Mammography Dose Evaluation Table (repealed)

History

• Source: Repealed at 23 Ill. Reg. 14516, effective January 1, 2000

32 Ill. Adm. Code 360.TABLE B Half-Value Layer as a Function of Tube Potential

X-ray Tube Voltage (kilovolt peak)

Minimum HVL (mm of Al)1

Designed operating range

Measured Operating Potential

Specified Dental Systems2

Other X-Ray Systems3

Below 50

30

1.5

0.3

40

1.5

0.4

49

1.5

0.5

50 to 70

50

1.5

1.2

60

1.5

1.3

70

1.5

1.5

Above 71

71

2.1

2.1

80

2.3

2.3

90

2.5

2.5

100

2.7

2.7

110

3.0

3.0

120

3.2

3.2

130

3.5

3.5

140

3.8

3.8

150

4.1

4.1

1 Linear extrapolation or interpolation may be made for an x-ray tube potential (kVp) not listed in the table above (e.g., in the column entitled "Other X-ray Systems" operated at 20 kVp and 95 kVp, the minimum HVL required would be 0.2 and 2.6 millimeters of aluminum respectively).

2 "Specified Dental Systems" means any dental x-ray system designed for use with intraoral image receptors and manufactured after December 1, 1980.

3 "Other X-Ray Systems" means all x-ray systems required to meet the provisions of Sections 360.50, 360.60, 360.75, 360.90 (except "Specified Dental Systems") and 360.100 of this Part. Half-value layer requirements for mammography systems are specified in Section 360.71(e) of this Part.

History

• Source: Amended at 22 Ill. Reg. 5904, effective March 13, 1998

32 Ill. Adm. Code 360.TABLE C Entrance Exposure Limits Per Intraoral Bitewing Film (repealed)

History

• Source: Repealed at 17 Ill. Reg. 17972, effective October 15, 1993

Part 370 Quality Standards and Certification Requirements for Facilities Performing Mammography

32 Ill. Adm. Code 370.10 Scope

This Part establishes quality standards and certification requirements for facilities performing mammography to ensure that all mammography facilities are adequately and consistently evaluated for compliance with the standards provided in this Part. The provisions of this Part are in addition to and not in substitution for other applicable provisions of 32 Ill. Adm. Code 310, 320, 340, 400, 401 and 410.

History

• Source: Amended at 24 Ill. Reg. 18258, effective December 1, 2000

32 Ill. Adm. Code 370.20 Definitions

As used in this Part, the following definitions apply:

"Accreditation body" or "body" means an entity that has been approved by FDA to accredit mammography facilities.

"Action limits" or "action levels" means the minimum and maximum values of a quality assurance measurement that can be interpreted as representing acceptable performance with respect to the parameter being tested. Values less than the minimum or greater than the maximum action limit or level indicate that corrective action shall be taken by the facility. Action limits or levels are also sometimes called control limits or levels.

"Adverse event" means an undesirable experience associated with mammography activities that include but are not limited to:

Poor image quality;

Failure to send mammography reports within 30 days to the referring physician or in a timely manner to the self-referred patient; and

Use of personnel that do not meet the requirements of Section 370.70 of this Part.

"Agency" means the Illinois Emergency Management Agency.

"Air kerma" means kerma in a given mass of air. The unit used to measure the quantity of air kerma is the Gray (Gy). For x-rays with energies less than 300 kiloelectronvolts (keV), 1 Gy = 100 rad.

"Breast implant" means a prosthetic device implanted in the breast.

"Calendar quarter" means any one of the following time periods during a given year: January 1 through March 31, April 1 through June 30, July 1 through September 30 or October 1 through December 31.

"Category I" means medical educational activities that have been designated as Category I by the Accreditation Council for Continuing Medical Education (ACCME), the American Osteopathic Association (AOA), a state medical society or an equivalent organization.

"Certificate" means the certificate described in Section 370.50 of this Part.

"Certification" means the process of approval of a facility by the Agency to provide mammography services.

"Clinical image" means a mammogram.

"Consumer" means an individual who chooses to comment or complain in reference to a mammography examination, including the patient or representative of the patient (e.g., family member or referring physician).

"Continuing education unit" or "continuing education credit" means one contact hour of training.

"Contact hour" means an hour of training received through direct instruction.

"Diagnostic mammography" means mammography performed on a patient with:

clinical signs, symptoms or physical findings suggestive of breast cancer;

an abnormal or questionable screening mammogram;

a history of breast cancer with breast conservation surgery regardless of absence of clinical breast signs, symptoms or physical findings; or

augmented breasts regardless of absence of clinical breast signs, symptoms or physical findings.

AGENCY NOTE: Diagnostic mammography is also called problem-solving mammography or consultative mammography. This definition excludes mammography performed during invasive interventions for localization or biopsy procedures.

"Direct instruction" means:

Face-to-face interaction between instructor and students, as when the instructor provides a lecture, conducts demonstrations or reviews student performance; or

The administration and correction of student examinations by an instructor with subsequent feedback to the students.

"Direct supervision" means that:

During joint interpretation of mammograms, the supervising interpreting physician reviews, discusses, and confirms the diagnosis of the physician being supervised and signs the resulting report before it is entered into the patient's records; or

During the performance of a mammography examination or survey of the facility's equipment and quality assurance program, the supervisor is present to observe and correct, as needed, the performance of the individual being supervised who is performing the examination or conducting the survey.

"Director" means the Director of the Illinois Emergency Management Agency.

"Established operating level" means the value of a particular quality assurance parameter that has been established as an acceptable normal level by the facility's quality assurance program.

"Facility" or "mammography installation" means a hospital, outpatient department, clinic, radiology practice, mobile unit, office of a physician or other facility that conducts mammography activities, including operation of equipment to produce a mammogram, processing of the mammogram, initial interpretation of the mammogram and maintaining viewing conditions for that interpretation.

"First allowable time" means the earliest time a resident physician is eligible to take the diagnostic radiology boards from an FDA-designated certifying body.

"FDA" means the U.S. Food and Drug Administration.

"Interim regulations" means the regulations entitled "Requirements for Accrediting Bodies of Mammography Facilities" (58 FR 67558-67565) and "Quality Standards and Certification Requirements for Mammography Facilities" (58 FR 67565-67572), published by FDA on December 21, 1993, and amended on September 30, 1994 (59 FR 49808-49813). These regulations established the standards that had to be met by mammography facilities in order to lawfully operate between October 1, 1994 and April 28, 1999.

"Interpreting physician" means a licensed physician who interprets mammograms and who meets the requirements of Section 370.70(a) of this Part.

"Lead interpreting physician" means the interpreting physician assigned the general responsibility for ensuring that a facility's quality assurance program meets all of the requirements of Sections 370.100, 370.110, 370.120(b) and (c) and 370.130 of this Part. The administrative title and other supervisory responsibilities of the individual, if any, are left to the discretion of the facility.

"Mammogram" means radiographic image produced through mammography.

"Mammographic modality" means a technology for radiography of the breast. Examples are screen-film mammography and digital mammography.

"Mammography" means radiography of the breast.

"Mammography equipment evaluation" means an onsite assessment of mammography unit or image processor performance by a medical physicist for the purpose of making a preliminary determination as to whether the equipment meets all of the applicable standards in this Part.

"Mammography medical outcomes audit" means a systematic collection of mammography results and the comparison of those results with outcomes data.

"Mammography unit" or "units" means an assemblage of components for the production of x-rays for use during mammography, including, at a minimum, an x-ray generator, an x-ray control, a tube housing assembly, a beam limiting device and the supporting structures for these components.

"Mean optical density" means the average of the optical densities (OD) measured using phantom thicknesses of 2, 4 and 6 centimeters with values of kilovolt peak (kVp) clinically appropriate for those thicknesses.

"Medical physicist" means a person trained in evaluating the performance of mammography equipment and facility quality assurance programs and who meets the qualifications set forth in Section 370.70(c) of this Part.

"MQSA" means the federal Mammography Quality Standards Act of 1992, as amended by the Mammography Quality Standards Reauthorization Act of 1998.

"Multi-reading" means two or more physicians, at least one of whom is an interpreting physician, interpreting the same mammogram.

"Patient" means any individual who undergoes a mammography evaluation in a facility.

"Phantom" means a test object used to simulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer. It is equivalent to a nominal 4.2 centimeter compressed breast of average density (i.e., 50 percent adipose and 50 percent glandular tissue) and shall contain the following objects:

Spherical masses, composed of phenolic plastic, with thicknesses of: 2.00, 1.00, 0.75, 0.50 and 0.25 millimeter;

Specks, composed of aluminum oxide, with diameters of: 0.54, 0.40, 0.32, 0.24 and 0.16 millimeter;

Fibers, composed of nylon, with thicknesses of: 1.56, 1.12, 0.89, 0.75, 0.54 and 0.40 millimeter.

AGENCY NOTE: The Mammographic Accreditation Phantom Model 156, manufactured by Radiation Measurements, Inc., meets the above criteria and was chosen for use by the American College of Radiology's Mammography Accreditation Program.

"Phantom image" means a radiographic image of a phantom.

"Physical science" means physics, chemistry, radiation science (including medical physics and health physics) and engineering.

"Positive mammogram" means a mammogram that has an overall assessment of findings that are either "suspicious" or "highly suggestive of malignancy."

"Provisional certificate" means the provisional certificate described in Section 370.50(b) of this Part.

"Qualified instructor" means an individual whose training and experience adequately prepares him or her to carry out specified training assignments. Interpreting physicians, radiologic technologists or medical physicists who meet the requirements of Section 370.70 of this Part would be considered qualified instructors in their respective areas of mammography. Other examples of individuals who may be qualified instructors for the purpose of providing training to meet the requirements of this Part include, but are not limited to, instructors in a post-high school training institution and manufacturer's representatives.

"Quality control technologist" means an individual meeting the requirements of Section 370.100(a)(4) of this Part who is responsible for those quality assurance responsibilities not assigned to the lead interpreting physician or to the medical physicist.

"Radiologic technologist" means an individual specifically trained in the use of radiographic equipment and the positioning of patients for radiographic examinations and when performing mammography without direct supervision, also meets the requirements set forth in Section 370.70(b) of this Part.

"Screening mammography" means mammography performed on an asymptomatic patient to detect the presence of breast cancer at an early stage.

"Serious adverse event" means an adverse advent that may significantly compromise clinical outcomes, or an adverse event for which a facility fails to take appropriate corrective action in a timely manner.

"Serious complaint" means a report of a serious adverse event.

"Standard breast" means a 4.2 centimeter (cm) thick compressed breast consisting of 50 percent glandular and 50 percent adipose tissue.

"Survey" means an onsite physics consultation and evaluation of a facility quality assurance program performed by a medical physicist.

"Time cycle" means the film development time.

"Traceable to a national standard" means an instrument is calibrated at either the National Institute of Standards and Technology (NIST) or at a calibration laboratory that participates in a proficiency program with NIST at least once every 2 years and the results of the proficiency test conducted within 24 months of calibration show agreement within plus or minus 3 percent of the national standard in the mammography energy range.

History

• Source: Amended at 29 Ill. Reg. 20963, effective December 16, 2005

32 Ill. Adm. Code 370.30 Incorporations by Reference

All rules, standards and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified in the reference and do not include any later amendments or editions. Copies of rules, standards and guidelines that have been incorporated by reference are available for public inspection and copying at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois.

History

• Source: Amended at 29 Ill. Reg. 20963, effective December 16, 2005

32 Ill. Adm. Code 370.40 Exemptions

a) Mammography units used only during invasive interventions for localization or biopsy procedures are exempt from the requirements of this Part, except that such systems shall satisfy the criteria specified in Section 370.170 of this Part.

b) Each mobile mammography facility based outside of Illinois that operates in Illinois and that has not been certified by the Agency is exempt from the requirements of Sections 370.50 and 370.60 of this Part, provided that:

1. The mobile mammography facility is certified to perform mammography by FDA or other FDA-approved certifying agency at all times while conducting operations in Illinois; and

2. The mobile mammography facility meets the requirements of Section 370.145 of this Part.

AGENCY NOTE: Mobile mammography facilities exempt under this subsection (b) shall meet the standards of this Part except those Sections specifically exempted.

History

• Source: Amended at 29 Ill. Reg. 20963, effective December 16, 2005

32 Ill. Adm. Code 370.50 Requirements for Certification

a) Except as otherwise provided in subsection (b)(1)(C) and Section 370.40, a certificate issued by the Agency is required for lawful operation of all mammography facilities subject to the provisions of this Part. Facilities performing mammography shall meet the requirements of Sections 370.70, 370.80, 370.90, 370.100, 370.110, 370.120 and 370.130 and be accredited by an FDA-approved accreditation body. Each mammography unit shall be accredited by or have an application pending for accreditation with an FDA-approved accrediting body.

AGENCY NOTE: Currently, the only FDA-approved accrediting body in Illinois is the American College of Radiology.

AGENCY NOTE: Except for provisional certificates and interim notices, the term of certificates issued under this Section shall be for 3 years.

b) Application.

1. Certificates.

A) In order to qualify for a certificate, a facility shall apply to an accreditation body.

B) Following the Agency's receipt of the accreditation body's decision to accredit a facility, the Agency may issue a certificate to the facility, or renew an existing certificate, if the Agency determines that the facility has satisfied the requirements for certification or recertification.

C) An interim notice authorizes the facility to perform mammography until the facility receives its certificate but in no case for more than 45 days. No more than one interim notice may be issued to a facility per application for certification. The Agency may issue an interim notice of mammography certification by facsimile to a facility if a delay is anticipated in providing a certificate to the facility under one or more of the following circumstances:

i) The Agency has been notified by an accreditation body that the facility meets the requirements for a provisional or provisional reinstatement certificate and delivery of the certificate may take more than 24 hours;

ii) The Agency has been notified by an accreditation body that the facility has completed accreditation or reaccreditation and delivery of the certificate to the facility may take more than 24 hours; or

iii) The Agency has been notified by an accreditation body that the facility has timely submitted an application for accreditation or reaccreditation but the completion of the accreditation process may extend beyond the expiration date of a facility's existing certificate through no fault of the facility.

2. Provisional certificates. A new facility is eligible to apply for a provisional certificate. The provisional certificate will enable the facility to perform mammography and to obtain the clinical images needed to complete the accreditation process.

A) To receive a provisional certificate, a facility shall apply and submit the required information to an FDA-approved accreditation body.

B) Following the Agency's receipt of the accreditation body's decision that a facility has submitted the required information, the Agency may issue a provisional certificate to a facility upon determination that the facility has satisfied the requirements for provisional certification. A provisional certificate shall be effective for up to 6 months from the date of issuance. A provisional certificate cannot be renewed, but a facility may apply for a 90 day extension of the provisional certificate.

C) In the event the facility is denied accreditation by the accrediting body with time remaining on the provisional certificate, the provisional certificate expires immediately with the denial and the facility must stop performing mammography.

3. Extension of provisional certificate.

A) To apply for a 90 day extension to a provisional certificate, a facility shall submit to its accreditation body a statement of what the facility is doing to obtain certification and evidence that there would be a significant adverse impact on access to mammography in the geographic area served if such facility did not obtain an extension.

B) Following the Agency's receipt of the accreditation body's decision that a facility has submitted the required information, the Agency may issue a 90 day extension of the provisional certificate to the facility upon determination that the facility has satisfied the requirements for the 90 day extension.

C) There can be no renewal of a provisional certificate beyond the 90-day extension.

c) Reinstatement policy. A previously certified facility that has allowed its certificate to expire, that has been refused a renewal of its certificate by FDA or the Agency, or that has had its certificate suspended or revoked by FDA or the Agency, may apply for reinstatement. If reinstated, the facility will be eligible for a provisional certificate.

1. Unless prohibited from reinstatement under subsection (c)(4), a facility applying for reinstatement shall:

A) Contact an FDA-approved accreditation body to determine the requirements for reapplication for accreditation;

B) Fully document its history as a previously provisionally certified or certified mammography facility, including the following information:

i) Name and address of the facility under which it was previously provisionally certified or certified;

ii) Name of previous owner/lessor;

iii) Facility identification number assigned to the facility under its previous certification; and

iv) Expiration date of the most recent provisional certificate or certificate; and

C) Justify application for reinstatement of accreditation by submitting to the accreditation body a corrective action plan that details how the facility has corrected deficiencies that contributed to the lapse, denial of renewal or revocation of its certificate.

2. The Agency may issue a provisional certificate to a previously certified facility:

A) Following the Agency's receipt of the accreditation body's decision that a facility has adequately corrected, or is in the process of correcting, pertinent deficiencies at the facility; and

B) The Agency determines that the facility has taken sufficient corrective action since the lapse, denial of renewal or revocation of its previous certificate.

3. After receiving the provisional certificate, the facility may lawfully resume performing mammography services while completing the requirements for certification.

4. If a facility's certificate was revoked on the basis of an act described in Section 370.160, no person who owned or operated that facility at the time the act occurred may own or operate a mammography facility within 2 years after the date of revocation.

d) Appeals of adverse accreditation or reaccreditation decisions. The appeals procedures described in this subsection (d) are available only for adverse accreditation or reaccreditation decisions that preclude certification or recertification by the Agency.

1. Upon learning that a facility has failed to become accredited or reaccredited, the Agency will notify the facility that the Agency is unable to certify that facility without proof of accreditation.

2. A facility that has been denied accreditation or reaccreditation is entitled to an appeals process from the accreditation body. A facility shall avail itself of the accreditation body's appeal process before appealing that decision to the FDA.

3. In the event that a facility, after availing itself of the accreditation body's appeal process, receives an adverse accreditation or reaccreditation decision, the facility may appeal that decision to the FDA. In order to appeal, the facility shall send a request for reconsideration to the FDA

History

• Source: Amended at 36 Ill. Reg. 17392, effective November 30, 2012

32 Ill. Adm. Code 370.60 Fees

a) Except as provided in subsection (b), the Agency shall assess each certified mammography installation an annual certification fee of $1,300 in each State fiscal year (July 1-June 30). The Agency shall bill the mammography installation for the annual fee after July 1. The annual fee shall be due and payable within 60 days after the date of billing. Failure to pay the required fee may result in revocation of the certificate.

AGENCY NOTE: The annual fee described in subsection (a) applies to both fully and provisionally certified mammography installations.

b) A new mammography installation issued an initial provisional certificate after December 31 of any State fiscal year shall not be required to pay a certification fee for that State fiscal year.

History

• Source: Amended at 36 Ill. Reg. 17392, effective November 30, 2012

32 Ill. Adm. Code 370.70 Personnel Requirements

Personnel. The following requirements apply to all personnel involved in any aspect of mammography, including the production, processing, and interpretation of mammograms and related quality assurance activities:

a) Interpreting physicians. All physicians interpreting mammograms shall meet the following qualifications:

1. Initial qualifications. Unless the exemption in subsection (a)(3) of this Section applies, before beginning to interpret mammograms independently, the interpreting physician shall:

A) Be a physician licensed under the Medical Practice Act of 1987 to practice medicine in all its branches [225 ILCS 60];

B) Be certified in diagnostic radiology by either the American Board of Radiology, the American Osteopathic Board of Radiology, or Royal College of Physicians and Surgeons of Canada or have had at least 3 months of documented formal training in the interpretation of mammograms and in topics related to mammography. The training shall include instruction in radiation physics, including radiation physics specific to mammography, radiation effects and radiation protection. The mammographic interpretation component shall be under the direct supervision of a physician who meets the requirements of subsection (a) of this Section;

C) Have a minimum of 60 hours of documented medical education in mammography, which shall include instruction in the interpretation of mammograms and education in basic breast anatomy, pathology, physiology, technical aspects of mammography and quality assurance and quality control in mammography. All 60 of these hours shall be Category I and at least 15 of the Category I hours shall have been acquired within the 3 years immediately prior to the date that the physician qualifies as an interpreting physician. Hours spent in residency specifically devoted to mammography will be considered as equivalent to Category I continuing medical education credits and will be accepted if documented in writing by the appropriate representative of the training institution; and

D) Unless the exemption in subsection (a)(3) of this Section applies, have interpreted or multi-read at least 240 mammographic examinations within the 6 month period immediately prior to the date that the physician qualifies as an interpreting physician. This interpretation or multi-reading shall be under the direct supervision of an interpreting physician.

2. Continuing experience and education. All interpreting physicians shall maintain their qualifications by meeting the following requirements:

A) Following the second anniversary date of the end of the calendar quarter in which the requirements of subsection (a)(1) of this Section were completed, the interpreting physician shall have interpreted or multi-read at least 960 mammographic examinations during the 24 months immediately preceding the date of the facility's annual MQSA inspection, or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility will choose one of these dates to determine the 24 month period.

B) Following the third anniversary date of the end of the calendar quarter in which the requirements of subsection (a)(1) of this Section were completed, the interpreting physician shall have taught or completed at least 15 Category I continuing medical education units in mammography during the 36 months immediately preceding the date of the facility's annual MQSA inspection, or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility will choose one of these dates to determine the 36 month period. This training shall include at least 6 Category I continuing medical education credits in each mammographic modality used by the interpreting physician in his or her practice.

C) Before an interpreting physician may begin independently interpreting mammograms produced by a new mammographic modality, that is, a mammographic modality in which the physician has not previously been trained, the interpreting physician shall have at least 8 hours of training in the new mammographic modality.

D) Units earned through teaching a specific course can be counted only once towards the 15 units required by subsection (a)(2) of this Section, even if the course is taught multiple times during the previous 36 months.

3. Exemptions.

A) Those physicians who qualified as interpreting physicians under FDA's interim regulations prior to April 28, 1999, are considered to have met the initial requirements of subsection (a)(1) of this Section. These physicians may continue to interpret mammograms provided they continue to meet the requirements of subsection (a)(1) of this Section and the continuing experience and education requirements of subsection (a)(2) of this Section.

B) Physicians who have interpreted or multi-read at least 240 mammographic examinations under the direct supervision of an interpreting physician in any 6 month period during the last 2 years of a diagnostic radiology residency and who become appropriately board certified at the first allowable time, as defined by an eligible certifying body, are otherwise exempt from subsection (a)(1)(D) of this Section.

4. Reestablishing qualifications. Interpreting physicians who fail to maintain the required continuing experience or continuing education requirements of subsection (a)(2) of this Section, shall reestablish their qualifications before resuming the independent interpretation of mammograms as follows:

A) Interpret or multi-read at least 240 mammographic examinations under the direct supervision of an interpreting physician, or interpret or multi-read a sufficient number of mammographic examinations, under the direct supervision of an interpreting physician, to bring the physician's total up to 960 examinations for the prior 24 months, whichever is less.

B) Interpreting physicians who fail to meet the continuing education requirements of subsection (a)(2)(B) of this Section shall obtain a sufficient number of additional Category I continuing medical education credits in mammography to bring their total up to the required 15 credits in the previous 36 months before resuming independent interpretation.

C) The interpretations required under this Section shall be done within the 6 months immediately prior to resuming independent interpretation.

b) Radiologic technologists who perform mammographic examinations shall be accredited by the Agency and shall meet the following:

1. Training requirements.

A) Have, prior to April 28, 1999, qualified as a radiologic technologist under FDA's interim regulations; or

B) Complete at least 40 contact hours of documented training specific to mammography under the supervision of a qualified instructor. The hours of documented training shall include, but not necessarily be limited to:

i) Training in breast anatomy and physiology, positioning and compression, quality assurance/quality control techniques and imaging of patients with breast implants;

ii) The performance of a minimum of 25 examinations under the direct supervision of an individual qualified under subsection (b) of this Section; and

iii) At least 8 hours of training in each mammography modality to be used by the technologist in performing mammography exams.

2. Continuing education requirements.

A) Following the third anniversary date of the end of the calendar quarter in which the requirements of subsection (b)(1) of this Section were completed, the radiologic technologist who performs mammography shall have taught or completed at least 15 continuing education units in mammography during the 36 months immediately preceding the date of the facility's annual MQSA inspection, or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility will choose one of these dates to determine the 36 month period.

B) Units earned through teaching a specific course can be counted only once towards the 15 hours of continuing education requirements required in subsection (b)(2) of this Section, even if the course is taught multiple times during the previous 36 months.

C) At least 6 of the continuing education units required in subsection (b)(2) of this Section shall be related to each mammographic modality used by the technologist.

D) Requalification. Radiologic technologists who fail to meet the continuing education requirements of subsection (b)(2)(A) of this Section shall obtain a sufficient number of continuing education units in mammography to bring their total up to at least 15 in the previous 3 years, at least 6 of which shall be related to each modality used by the technologist in mammography. The technologist shall not resume performing unsupervised mammography examinations until the continuing education requirements are completed.

E) Before a radiologic technologist may begin independently performing mammography examinations using a mammographic modality other than one of those for which the technologist received training under subsection (b)(1)(B)(iii) of this Section, the technologist shall have at least 8 hours of continuing education units in the new modality.

3. Continuing experience requirements.

A) Following the second anniversary date of the end of the calendar quarter in which the requirements of subsection (b)(1) of this Section were completed or of April 28, 1999, whichever is later, the radiologic technologist shall have performed a minimum of 200 mammography examinations during the 24 months immediately preceding the date of the facility's annual MQSA inspection, or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility will choose one of these dates to determine the 24 month period.

B) Requalification. Radiologic technologists who fail to meet the continuing experience requirements of subsection (b)(3)(A) of this Section shall perform a minimum of 25 mammography examinations under the direct supervision of a qualified radiologic technologist before resuming the performance of unsupervised mammography.

C) Programs, courses or other activities intended to meet the requirement for initial, or requalification, mammography training or continuing education in mammography shall be approved by the Agency.

D) Completion of initial, or requalification, mammography training and continuing education in mammography shall be verified to the Agency.

c) Medical physicists. All medical physicists conducting surveys of mammography facilities and providing oversight of the facility quality assurance program shall be approved by the Agency as diagnostic imaging specialists pursuant to 32 Ill. Adm. Code 410, and meet the following:

1. Initial qualifications.

A) Be certified in diagnostic radiological physics or radiological physics by either the American Board of Radiology (ABR) or the American Board of Medical Physics (ABMP);

B) Have a masters degree or higher in a physical science from an accredited institution, with no less than 20 semester hours or equivalent (e.g., 30 quarter hours) of college undergraduate or graduate level physics;

C) Have 20 contact hours of documented specialized training in conducting surveys of mammography facilities; and

D) Have the experience of conducting surveys of at least 1 mammography facility and a total of at least 10 mammography units. No more than one survey of a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement. After April 28, 1999, experience conducting surveys shall be acquired under the direct supervision of a medical physicist who meets all the requirements of subsections (c)(1), (c)(2) and (c)(3) of this Section.

2. Alternative initial qualifications.

A) Have qualified as a medical physicist under FDA's interim regulations and retained that qualification by maintenance of the active status of any licensure, approval or certification required;

B) Have, prior to April 28, 1999, obtained a bachelor's degree or higher in a physical science from an accredited institution with no less than 10 semester hours or equivalent of college undergraduate or graduate level physics;

C) Have 40 contact hours of documented specialized training in conducting surveys of mammography facilities; and

D) Have the experience of conducting surveys of at least 1 mammography facility and a total of at least 20 mammography units. No more than one survey of a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement. The training and experience requirements shall be met after fulfilling the degree requirement.

3. Continuing education and experience. All medical physicists shall maintain their qualifications by meeting the following requirements:

A) Continuing education. Beginning 3 years after the end of the calendar quarter in which the requirements of subsection (c)(1) or (c)(2) of this Section were completed, the medical physicist shall have taught, or completed, at least 15 continuing education units in mammography during the 36 months immediately preceding the date of the facility's annual inspection, or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility shall choose one of these dates to determine the 36 month period. This continuing education shall include hours of training appropriate to each mammographic modality evaluated by the medical physicist during his or her surveys or oversight of quality assurance programs. Units earned through teaching a specific course can be counted only once towards the required 15 continuing education units in a 36 month period, even if the course is taught multiple times during the 36 months.

B) Continuing experience. Beginning 2 years after the end of the calendar quarter in which the requirements of subsection (c)(1) or (c)(2) of this Section were completed or of April 28, 1999, whichever is later, the medical physicist shall have surveyed at least 2 mammography facilities and a total of at least 6 mammography units during the 24 months immediately preceding the date of the facility's annual MQSA inspection, or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility shall choose one of these dates to determine the 24 month period. No more than one survey of a specific facility within a 10 month period or a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement.

C) Before a medical physicist may begin independently performing mammographic surveys of a new mammographic modality, that is, a mammographic modality other than one for which the physicist received training to qualify under subsection (c)(1) or (c)(2) of this Section, the physicist shall receive at least 8 hours of training in surveying units of the new mammographic modality.

4. Reestablishing qualifications. Medical physicists who fail to maintain the required continuing education and experience qualifications of subsection (c)(3) of this Section may not perform the MQSA surveys without the supervision of a qualified medical physicist. Before independently surveying another facility, medical physicists shall reestablish their qualifications, as follows:

A) Medical physicists who fail to meet the continuing educational requirements of subsection (c)(3)(A) of this Section shall obtain a sufficient number of continuing education units to bring their total units up to the required 15 units in the previous 3 years.

B) Medical physicists who fail to meet the continuing experience requirement of subsection (c)(3)(B) of this Section shall complete a sufficient number of surveys under the direct supervision of a medical physicist who meets the qualifications of subsection (c)(1) or (c)(2) of this Section, to bring their total surveys up to the required 2 facilities and 6 units in the previous 24 months. No more than one survey of a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement.

d) Retention of personnel records. Facilities shall maintain records to document the qualifications of all personnel who worked at the facility as interpreting physicians, radiologic technologists or medical physicists. These records shall be available for review by the Agency. Records of personnel no longer employed by the facility shall not be discarded until the next annual inspection has been completed and the Agency has determined that the facility is in compliance with the personnel requirements of this Section.

History

• Source: Amended at 29 Ill. Reg. 20963, effective December 16, 2005

32 Ill. Adm. Code 370.80 Equipment Requirements

The equipment requirements of this Section are intended to ensure that mammography equipment is capable of producing quality mammograms over the full range of clinical conditions.

a) Prohibited equipment. Radiographic equipment designed for general purpose shall not be used for mammography. Mammography shall only be performed with a special purpose radiation machine specifically designed for and used solely for mammography procedures.

b) General. All radiographic equipment used for mammography shall be certified under the "Performance Standards for Diagnostic X-Ray Systems and their Major Components", published at 21 CFR 1020.30, effective as of April 1, 2012. Each radiographic unit used for mammography shall be accredited by an approved accrediting body or have an application for accreditation pending with an approved accrediting body.

c) Motion of tube-image receptor assembly.

1. The assembly shall be capable of being fixed in any position where it is designed to operate. Once fixed in any such position, it shall not undergo unintended motion.

2. The mechanism ensuring compliance with subsection (c)(1) shall not fail in the event of power interruption.

d) Image receptor sizes.

1. Systems using screen-film image receptors shall provide, at a minimum, for operation with image receptors of 18 x 24 centimeters (cm) and 24 x 30 cm.

2. Systems using screen-film image receptors shall be equipped with moving grids matched to all image receptor sizes provided.

3. Systems used for magnification procedures shall be capable of operation with the grid removed from between the source and image receptor.

e) Beam limitation and light fields.

1. All systems shall have beam-limiting devices.

2. For any mammography system with a light beam that passes through the x-ray beam-limiting device, the light shall provide an average illumination of not less than 160 lux (15 foot candles) at 100 cm or the maximum source-image receptor distance (SID), whichever is less.

f) Magnification.

1. Systems used to perform noninterventional problem solving procedures shall have radiographic magnification capability available for use by the operator.

2. Systems used for magnification procedures shall provide, at a minimum, at least one magnification value within the range of 1.4 to 2.0.

g) Focal spot selection.

1. When more than one focal spot is provided, the system shall indicate, prior to exposure, which focal spot is selected.

2. When more than one target material is provided, the system shall indicate, prior to exposure, the preselected target material.

3. When the target material and/or focal spot is selected by a system algorithm that is based on the exposure or on a test exposure, the system shall display, after the exposure, the target material and/or focal spot actually used during the exposure.

h) Compression. All mammography systems shall incorporate a compression device.

1. Application of compression. Each system shall provide:

A) An initial power-driven compression activated by hands-free controls operable from both sides of the patient; and

B) Fine adjustment compression controls operable from both sides of the patient.

2. Compression paddle.

A) Systems shall be equipped with different sized compression paddles that match the sizes of all full-field image receptors provided for the system. Compression paddles for special purposes, including those smaller than the full size of the image receptor (for "spot compression") may be provided. The compression paddles for special purposes are not subject to the requirements of subsections (h)(2)(D) and (h)(2)(E).

B) Except as provided in subsection (h)(2)(C), the compression paddle shall be flat and parallel to the breast support table and shall not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied.

C) Equipment intended by the manufacturer's design to not be flat and parallel to the breast support table during compression shall meet the manufacturer's design specifications and maintenance requirements.

D) The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor.

E) The chest wall edge may be bent upward to allow for patient comfort but shall not appear on the image.

i) Technique factor selection and display.

1. Manual selection of milliampere seconds (mAs) or at least one of its component parts (milliampere (mA) and/or time) shall be available.

2. The technique factors (peak tube potential in kilovolt (kV) and either tube current in mA and exposure time in seconds or the product of tube current and exposure time in mAs) to be used during an exposure shall be indicated before the exposure begins, except when automatic exposure controls (AEC) are used, in which case the technique factors that are set prior to the exposure shall be indicated.

3. Following AEC mode use, the system shall indicate the actual kilovoltage peak (kVp) and mAs used during the exposure. The mAs may be displayed as mA and time.

j) Automatic exposure control.

1. Each screen-film system shall provide an AEC mode that is operable in all combinations of equipment configuration provided, e.g., grid, nongrid, magnification, nonmagnification and various target-filter combinations.

2. The positioning or selection of the detector shall permit flexibility in the placement of the detector under the target tissue.

A) The size and available positions of the detector shall be clearly indicated at the x-ray input surface of the breast compression paddle.

B) The selected position of the detector shall be clearly indicated.

3. The system shall provide means for the operator to vary the selected optical density from the normal (zero) setting.

k) X-ray film. The facility shall use x-ray film for mammography that has been designated by the film manufacturer as appropriate for mammography.

l) Intensifying screens. The facility shall use intensifying screens for mammography that have been designated by the screen manufacturer as appropriate for mammography and shall use film that is matched to the screen's spectral output as specified by the manufacturer.

m) Film processing solutions. For processing mammography films, the facility shall use chemical solutions that are capable of developing the films used by the facility in a manner equivalent to the minimum requirements specified by the film manufacturer.

n) Lighting. The facility shall make special lights for film illumination, i.e., hot-lights, capable of producing light levels greater than that provided by the view box, available to the interpreting physicians.

o) Film masking devices. Facilities shall ensure that film masking devices that can limit the illuminated area to a region equal to or smaller than the exposed portion of the film are available to all interpreting physicians interpreting for the facility.

History

• Source: Amended at 36 Ill. Reg. 17392, effective November 30, 2012

32 Ill. Adm. Code 370.90 Medical Records and Mammography Reports

a) Contents and terminology. Each facility shall prepare a written report of the results of each mammography examination performed under its certificate. The mammography report shall include the following information:

1. The name of the patient and an additional patient identifier;

2. Date of examination;

3. The name of the interpreting physician who interpreted the mammogram;

4. Overall final assessment of findings, classified in one of the following categories:

A) "Negative." Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be explained);

B) "Benign." Also a negative assessment;

C) "Probably Benign." Finding(s) has a high probability of being benign;

D) "Suspicious." Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;

E) "Highly suggestive of malignancy." Finding(s) has a high probability of being malignant;

5. In cases where no final assessment category can be assigned due to incomplete work-up, "Incomplete: Need additional imaging evaluation" shall be assigned as an assessment and reasons why no assessment can be made shall be stated by the interpreting physician; and

6. Recommendations made to the health care provider about what additional actions, if any, should be taken. All clinical questions raised by the referring health care provider shall be addressed in the report to the extent possible, even if the assessment is negative or benign.

b) Communication of mammography results to the patient. Each facility shall send each patient a summary of the mammography report written in lay terms within 30 days after the mammographic examination. If assessments are "Suspicious" or "Highly suggestive of malignancy", the facility shall make reasonable attempts to ensure that the results are communicated to the patient as soon as possible.

1. Patients who do not name a health care provider to receive the mammography report shall be sent the report described in subsection (a) of this Section within 30 days, in addition to the written notification of results in lay terms.

2. Each facility that accepts patients who do not have a health care provider shall maintain a system for referring such patients to a health care provider when clinically indicated.

c) Communication of mammography results to health care providers. When the patient has a referring health care provider or the patient has named a health care provider, the facility shall:

1. Provide a written report of the mammography examination, including the items listed in subsection (a) of this Section, to that health care provider as soon as possible, but no later than 30 days after the date of the mammography examination; and

2. If the assessment is "Suspicious" or "Highly suggestive of malignancy," make reasonable attempts to communicate with the health care provider as soon as possible, or if the health care provider is unavailable, to a responsible designee of the health care provider.

d) Recordkeeping. Each facility that performs mammograms:

1. Shall (except as provided in subsection (c)(2) of this Section) maintain mammography films and reports in a permanent medical record of the patient for a period of not less than 5 years, or not less than 10 years if no additional mammograms of the patient are performed at the facility;

2. Shall upon request by, or on behalf of, the patient permanently or temporarily transfer the original mammograms and copies of the patient's reports to a medical institution, or to a physician or health care provider of the patient, or to the patient directly. Any fee charged to the patient for providing the services in this subsection (d) shall not exceed the documented costs associated with this service.

e) Mammographic image identification. Each mammographic image shall have the following information indicated on it in a permanent, legible, and unambiguous manner and placed so as not to obscure anatomic structures:

1. Name of patient and an additional patient identifier.

2. Date of examination.

3. View and laterality. This information shall be placed on the image in a position near the axilla. Standardized codes specified by the accreditation body shall be used to identify view and laterality.

4. Facility name and location. At a minimum, the location shall include the city, state and zip code of the facility.

5. Technologist identification.

6. Cassette/screen identification.

7. Mammography unit identification, if there is more than one unit in the facility.

History

• Source: Amended at 24 Ill. Reg. 18258, effective December 1, 2000

32 Ill. Adm. Code 370.100 Quality Assurance Requirements

Each facility shall establish and maintain a quality assurance program to ensure the safety, reliability, clarity and accuracy of mammography services performed at the facility.

a) Responsible individuals. Responsibility for the quality assurance program and for each of its elements shall be assigned to individuals who are qualified for their assignments and who shall be allowed adequate time to perform these duties.

1. Lead interpreting physician. The facility shall identify a lead interpreting physician who shall have the general responsibility of ensuring that the quality assurance program meets all requirements of this Section and Sections 370.110, 370.120(b) and (c) and 370.130 of this Part. No other individual shall be assigned or shall retain responsibility for quality assurance tasks unless the lead interpreting physician has determined that the individual's qualifications for, and performance of, the assignment are adequate.

2. Interpreting physicians. All interpreting physicians interpreting mammograms for the facility shall:

A) Follow the facility procedures for corrective action when the images they are asked to interpret are of poor quality; and

B) Participate in the facility's medical outcomes audit program.

3. Medical physicist. Each facility shall have the services of a medical physicist available to survey mammography equipment and oversee the equipment-related quality assurance practices of the facility. At a minimum, the medical physicist shall be responsible for performing the surveys and mammography equipment evaluations and providing the facility with the reports described in Section 370.110(i) of this Part.

4. Quality control technologist. Responsibility for all individual tasks within the quality assurance program not assigned to the lead interpreting physician or the medical physicist shall be assigned to a quality control technologist. The tasks are to be performed by the quality control technologist or by other personnel qualified to perform the tasks. When other personnel are utilized for these tasks, the quality control technologist shall ensure that the tasks are completed in such a way as to meet the requirements of Section 370.110 of this Part.

b) Personnel quality assurance records. The lead interpreting physician, quality control technologist and medical physicist shall ensure that records concerning employee qualifications to meet assigned quality assurance tasks, mammography technique and procedures, quality control (including monitoring data, problems detected by analysis of that data, corrective actions and the effectiveness of the corrective actions), safety, and protection are properly maintained and updated. These quality control records shall be kept for each test specified in Section 370.110 of this Part until the next annual inspection has been completed and the Agency has determined that the facility is in compliance with the quality assurance requirements or until the test has been performed two additional times at the required frequency, whichever is longer.

History

• Source: Amended at 29 Ill. Reg. 20963, effective December 16, 2005

32 Ill. Adm. Code 370.110 Equipment Quality Assurance Tests

a) Daily quality control tests. Film processors used to develop mammograms shall be adjusted and maintained to meet the technical development specifications for the mammography film in use. A processor performance test shall be performed on each day that examinations are performed before any clinical films are processed that day. The test shall include an assessment of base plus fog density, mid-density and density difference, using the mammography film used clinically at the facility.

1. The base plus fog density shall be within plus 0.03 of the established operating level.

2. The mid-density shall be within plus or minus 0.15 of the established operating level.

3. The density difference shall be within plus or minus 0.15 of the established operating level.

b) Weekly quality control tests. Facilities with screen-film systems shall perform a phantom image quality evaluation test at least weekly, using the Mammography Image Evaluation Protocol found in Appendix B of this Part.

1. The optical density of the film at the center of an image of the phantom shall be at least 1.20 when exposed under a typical clinical condition.

2. The optical density of the film at the center of the phantom image shall not change by more than plus or minus 0.20 from the established operating level.

3. The mammography system shall be capable of producing images of the mammography phantom in which the following objects are visualized:

A) The three largest masses with thicknesses of 2.0, 1.0 and 0.75 millimeter.

B) The three largest speck groups with diameters of 0.54, 0.40 and 0.32 millimeter.

C) The four largest fibers with thicknesses of 1.56, 1.12, 0.89 and 0.75 millimeter.

4. The density difference between the background of the phantom and an added test object, used to assess image contrast, shall be measured and shall not vary by more than plus or minus 0.05 from the established operating level.

c) Quarterly quality control tests. Facilities with screen-film systems shall perform the following quality control tests at least quarterly:

1. Fixer retention in film. The residual fixer shall be no more than 5 micrograms per square cm.

2. Repeat analysis. If the total repeat or reject rate changes from the previously determined rate by more than 2.0 percent of the total films included in the analysis, the reasons for the change shall be determined. Any corrective actions shall be recorded and the results of these corrective actions shall be assessed.

d) Semiannual quality control tests. Facilities with screen-film systems shall perform the following quality control tests at least semiannually:

1. Darkroom fog. The optical density attributable to darkroom fog shall not exceed 0.05 when a mammography film of the type used in the facility, which has a mid-density of no less than 1.20, is exposed to typical darkroom conditions for 2 minutes while such film is placed on the counter top emulsion side up. If the darkroom has a safelight used for mammography film, it shall be on during this test.

2. Screen-film contact. Testing for screen-film contact shall be conducted using 40 mesh copper screen. All cassettes used in the facility for mammography shall be tested.

3. Compression device performance. The compression device performance shall:

A) Be capable of maintaining a compression force of at least 111 newtons (25 pounds) for at least 15 seconds;

B) Not be capable of exceeding a compression force of more than 209 newtons (47 pounds) when used in an automatic or power drive mode.

e) Annual quality control tests. Facilities with screen-film systems shall perform the following quality control tests at least annually:

1. Automatic exposure control performance.

A) The AEC shall be capable of maintaining film optical density within plus or minus 0.30 of the mean optical density when thickness of a homogeneous material is varied over a range of 2 to 6 cm and the kVp is varied appropriately for such thicknesses over the kVp range used clinically in the facility. If this requirement cannot be met, a technique chart shall be developed showing appropriate techniques (kVp and density control settings) for different breast thicknesses and compositions that shall be used so that optical densities within plus or minus 0.30 of the average under phototimed conditions can be produced.

B) The AEC shall be capable of maintaining film optical density within plus or minus 0.15 of the mean optical density when thickness of a homogeneous material is varied over a range of 2 to 6 cm and the kVp is varied appropriately for such thicknesses over the kVp range used clinically in the facility.

C) The optical density of the film in the center of the phantom image shall not be less than 1.20.

2. Kilovoltage peak accuracy and reproducibility. The kVp shall be accurate within plus or minus 5 percent of the indicated or selected kVp at:

A) The lowest clinical kVp that can be measured by a kVp test device;

B) The most commonly used clinical kVp;

C) The highest available clinical kVp; and

D) At the most commonly used clinical settings of kVp, the coefficient of variation of reproducibility of the kVp shall be equal to or less than 0.02.

3. Focal spot dimensions. Facilities shall evaluate focal spot condition by determining the system resolution. For focal spot dimensions, the measured values of the focal spot length (dimension parallel to the anode cathode axis) and width (dimension perpendicular to the anode-cathode axis) shall be within the tolerance limits specified in this subsection (e)(3).

Focal Spot Tolerance Limit

Nominal Focal

Maximum Measured Dimensions

Spot Size (mm)

Width (mm)

Length (mm)

0.10

0.15

0.15

0.15

0.23

0.23

0.20

0.30

0.30

0.30

0.45

0.65

0.40

0.60

0.85

0.60

0.90

1.30

4. System resolution. Facilities shall evaluate focal spot condition by determining the system resolution as follows:

A) Each x-ray system used for mammography, in combination with the mammography screen-film combination used in the facility, shall provide a minimum resolution of 11 cycles/millimeter (mm) (line-pairs/mm) when a high contrast resolution bar test pattern is oriented with the bars perpendicular to the anode-cathode axis, and a minimum resolution of 13 line-pairs/mm when the bars are parallel to that axis.

B) The bar pattern shall be placed 4.5 cm above the breast support surface, centered with respect to the chest wall edge of the image receptor, and with the edge of the pattern within 1 cm of the chest wall edge of the image receptor.

C) When more than one target material is provided, the measurement shall be made using the appropriate focal spot for each target material.

D) When more than one source-image receptor distance is provided, the test shall be performed at SID most commonly used clinically.

E) Test kVp shall be set at the value used clinically by the facility for a standard breast and shall be performed in the AEC mode, if available. If necessary, a suitable absorber may be placed in the beam to increase exposure times. The screen-film cassette combination used by the facility shall be used to test for this requirement and shall be placed in the normal location used for clinical procedures.

5. Beam quality and half-value layer (HVL). For mammography systems operating at x-ray tube potentials of less than 50 kVp, the HVL in millimeters of aluminum of the useful beam shall be equal to or greater than the product of the measured tube potential in kilivolts multiplied by 0.01. The half-value layer shall be measured with the compression device in the beam and shall be measured at the same tube potential used in Appendix A of this Part, Mammography Dose Measurement Protocol, and Appendix B of this Part, Mammography Phantom Image Evaluation.

AGENCY NOTE: If the measured half-value layer is significantly greater than the specified minimum, image contrast will be reduced and overall image quality will be degraded. For screen-film mammography systems, it is recommended that the HVL not exceed the minimum acceptable HVL by more than 0.1 millimeter of aluminum, as specified in the Mammography Quality Control Manual: Medical Physicist's Section, Revised Edition, 1999.

6. Breast entrance air kerma and AEC reproducibility. The coefficient of variation for both air kerma and mAs shall not exceed 0.05.

7. Dosimetry. The average glandular dose delivered during a single craniocaudal view of a phantom simulating a standard breast shall not exceed 3.0 milligray (mGy) (0.3 rad) per exposure. The dose shall be determined with technique factors and conditions used clinically for a standard breast (see Appendix A of this Part).

8. X-ray field/light field/image receptor/compression paddle alignment.

A) All systems shall have beam-limiting devices that allow the entire chest wall edge of the x-ray field to extend to the chest wall edge of the image receptor and provide means to assure that the x-ray field does not extend beyond any edge of the image receptor by more than 2 percent of the SID.

B) If a light field that passes through the x-ray beam limitation device is provided, it shall be aligned with the x-ray field so that the total of any misalignment of the edges of the light field and the x-ray field along either the length or the width of the visually defined field at the plane of the breast support surface shall not exceed 2 percent of the SID.

C) The chest wall edge of the compression paddle shall not extend beyond the chest wall edge of the image receptor by more than one percent of the SID when tested with the compression paddle placed above the breast support surface at a distance equivalent to standard breast thickness. The shadow of the vertical edge of the compression paddle shall not be visible on the image.

9. Uniformity of screen speed. Uniformity of screen speed of all the cassettes in the facility shall be tested and the difference between the maximum and minimum optical densities shall not exceed 0.30. Screen artifacts shall also be evaluated during this test.

10. System artifacts. System artifacts shall be evaluated with a high-grade, defect-free sheet of homogeneous material large enough to cover the mammography cassette and shall be performed for all cassette sizes used in the facility using a grid appropriate for the cassette size being tested. System artifacts shall also be evaluated for all available focal spot sizes and target filter combinations used clinically.

11. Radiation output.

A) The system shall be capable of producing a minimum output of 4.5 mGy air kerma per second (513 mR per second) when operating at 28 kVp in the standard mammography (moly/moly) mode at any SID where the system is designed to operate and when measured by a detector with its center located 4.5 cm above the breast support surface with the compression paddle in place between the source and the detector. The system, under the same measuring conditions, shall be capable of producing a minimum output of 7.0 mGy air kerma per second (800 mR per second) when operating at 28 kVp in the standard (moly/moly) mammography mode at any SID where the system is designed to operate.

B) The system shall be capable of maintaining the required minimum radiation output averaged over a 3.0 second period.

12. Decompression. If the system is equipped with a provision for automatic decompression after completion of an exposure or interruption of power to the system, the system shall be tested to confirm that it provides:

A) An override capability to allow maintenance of compression;

B) A continuous display of the override status; and

C) A manual emergency compression release that can be activated in the event of power or automatic release failure.

f) Quality control tests-other modalities. For systems with image receptor modalities other than screen-film, the quality assurance program shall be substantially the same as the quality assurance program recommended by the image receptor manufacturer, except that the maximum allowable dose shall not exceed the maximum allowable dose for screen-film systems in subsection (e)(7) of this Section.

g) Mobile units. The facility shall verify that mammography units used to produce mammograms at more than one location meet the requirements in subsections (a) through (f) of this Section. In addition, at each examination location, before any examinations are conducted, mobile mammography systems shall be tested using the mammography phantom image evaluation, or shall meet the following requirements:

1. A medical physicist shall establish a protocol for measurement of the radiation output of the mammography system, including the radiation measuring device to be used, procedures for performing the measurement and the anticipated result of the measurement.

2. Measurements shall be performed using the technique factors that were used for the most recent phantom image evaluation. If a change is made in the technique factors used for the measurements required in this subsection (g)(2), the image quality shall be tested using the mammography phantom image evaluation protocol found in Appendix B of this Part.

AGENCY NOTE: If the phantom image evaluation is performed using a phototimer, the medical physicist may specify appropriate technique factors that approximate those used by the phototimer for the measurements required in this Section.

3. After each relocation of a mobile mammography system, measurements of the radiation output of the machine shall be performed according to the protocol established in this Section.

4. If the radiation output measurement exceeds plus or minus 15 percent of the value established by the medical physicist, the system shall not be used to image human patients until the cause for the variation has been investigated and corrected.

5. Records of radiation output measurements for mobile mammography systems shall be maintained at the location of the mammography system for a period of not less than one inspection cycle.

AGENCY NOTE: The Agency recommends that mobile mammography systems be tested for image quality after each relocation and prior to use on patients, with mammography phantom image evaluation protocol in Appendix B of this Part.

h) Use of test results.

1. After completion of the tests specified in subsections (a) through (g) of this Section, the facility shall compare the test results to the corresponding specified action limits, or for nonscreen-film modalities, to the manufacturer's recommended action limits, or for post-move, preexamination testing of mobile units, to the limits established in the test method used by the facility.

2. If the test results fall outside of the action limits, the source of the problem shall be identified and corrective actions shall be taken:

A) Before any further examinations are performed or any films are processed using the component of the mammography system that failed the test, if the failed test was that described in subsection (a), (b), (d)(1), (d)(2), (d)(3), (e)(7), (f) or (g) of this Section;

B) Within 30 days after the test date for all other tests described in this Section.

i) Surveys.

1. At least once a year, each facility shall undergo a survey by a medical physicist or by an individual under the direct supervision of a medical physicist. At a minimum, this survey shall include the performance of tests to ensure that the facility meets the quality assurance requirements of the annual tests described in subsections (e) and (f) of this Section and the weekly phantom image quality test described in subsection (b) of this Section.

2. Calibration of air kerma measuring instruments. Instruments used by medical physicists in their annual survey to measure the air kerma or air kerma rate from a mammography unit shall be calibrated at least once every 2 years and each time the instrument is repaired. The instrument calibration shall be traceable to a national standard and calibrated with an accuracy of plus or minus 6 percent (95 percent confidence level) in the mammography energy range.

3. The results of all tests conducted by the facility in accordance with subsections (a) through (g) of this Section, as well as written documentation of any corrective actions taken and their results, shall be evaluated for adequacy by the medical physicist performing the survey.

4. The medical physicist shall prepare a survey report that includes a summary of this review and recommendations for necessary improvements.

5. The survey report shall be sent to the facility within 30 days after the date of the survey.

6. The survey report shall be dated and signed by the medical physicist performing or supervising the survey. If the survey was performed entirely or in part by another individual under the direct supervision of the medical physicist, that individual and the part of the survey that individual performed shall also be identified in the survey report.

j) Mammography equipment evaluations. Additional evaluations of mammography units or image processors shall be conducted whenever a new unit or processor is installed, a unit or processor is dissembled and reassembled at the same or a new location, or major components of a mammography unit or processor equipment are changed or repaired. These evaluations shall be used to determine whether the new or changed equipment meets the requirements of applicable standards in this Section and Section 370.80 of this Part. All problems shall be corrected before the new or changed equipment is put into service for examinations or film processing. The mammography equipment evaluation shall be performed by a medical physicist or by an individual under the direct supervision of a medical physicist.

History

• Source: Amended at 33 Ill. Reg. 2224, effective January 23, 2009

32 Ill. Adm. Code 370.120 Additional Administrative Requirements

a) Every operator of a radiation installation at which mammography services are provided shall ensure and have confirmed by each mammography patient that the patient is provided with a pamphlet that is orally reviewed with the patient and that contains the following:

1. How to perform breast self-examination;

2. That early detection of breast cancer is maximized through a combined approach, using monthly breast self-examination, a thorough physical examination performed by a physician, and mammography performed at recommended intervals;

3. That mammography is the most accurate method for making an early detection of breast cancer, however, no diagnostic tool is 100% effective;

4. If the patient is self-referred and does not have a primary care physician, or if the patient is unfamiliar with the breast examination procedures, that the patient has received information regarding public health services where she can obtain a breast examination and instructions. [420 ILCS 40/5(c)]

b) Facility cleanliness.

1. The facility shall establish and implement adequate protocols for maintaining darkroom, screen and view box cleanliness.

2. The facility shall document that all cleaning procedures are performed at the frequencies specified in the protocols.

c) Infection control. Facilities shall establish and comply with a system specifying procedures to be followed by the facility for cleaning and disinfecting mammography equipment after contact with blood or other potentially infectious materials. This system shall specify the methods for documenting facility compliance with the infection control procedures established and shall:

1. Comply with the manufacturer's recommended procedures for the cleaning and disinfection of the mammography equipment used in the facility; or

2. If adequate manufacturer's recommendations are not available, comply with generally accepted guidance on infection control, until such recommendations become available.

d) Mammographic procedure and techniques for mammography of patients with breast implants.

1. Each facility shall have a procedure to inquire whether or not the patient has breast implants prior to the actual mammographic exam.

2. Except where contraindicated, or unless modified by a physician's directions, patients with breast implants undergoing mammography shall have mammographic views to maximize the visualization of breast tissue.

e) Consumer complaint mechanism. Each facility shall:

1. Establish a written and documented system for collecting and resolving consumer complaints;

2. Maintain a record of each serious complaint received by the facility for at least 3 years after the date the complaint was received;

3. Provide the consumer with adequate directions for filing serious complaints with the facility's accreditation body if the facility is unable to resolve a serious complaint to the consumer's satisfaction;

4. Report unresolved serious complaints to the accreditation body in a manner and timeframe specified by the accreditation body.

f) Clinical image quality. Clinical images produced by any certified facility shall continue to comply with the standards for clinical image quality established by that facility's accreditation body.

32 Ill. Adm. Code 370.130 Mammography Medical Outcomes Audit

Each facility shall establish and maintain a mammography medical outcomes audit program to follow up positive mammographic assessments and to correlate pathology results with the interpreting physician's findings. This program shall be designed to ensure the reliability, clarity and accuracy of the interpretation of mammograms.

a) General requirements. Each facility shall establish a system to collect and review outcome data for all mammograms performed, including followup on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician's mammography report. Analysis of these outcome data shall be made individually and collectively for all interpreting physicians at the facility. In addition, any cases of breast cancer among patients imaged at the facility that subsequently become known to the facility shall prompt the facility to initiate followup on surgical and/or pathology results and review of the mammograms taken prior to the diagnosis of a malignancy.

b) Frequency of audit analysis. The facility's first audit analysis shall be initiated no later than 12 months after the date the facility becomes certified. This audit analysis shall be completed within an additional 12 months to permit completion of diagnostic procedures and data collection. Subsequent audit analyses will be conducted at least once every 12 months.

c) Audit interpreting physician. Each facility shall designate at least one interpreting physician to review the medical outcomes audit data at least once every 12 months. This individual shall record the dates of the audit periods and shall be responsible for analyzing results based on this audit. This individual shall also be responsible for documenting the results, notifying other interpreting physicians of their results and the facility aggregate results. If followup actions are taken, the audit interpreting physician shall also be responsible for documenting the nature of the followup.

History

• Source: Amended at 29 Ill. Reg. 20963, effective December 16, 2005

32 Ill. Adm. Code 370.140 Additional Mammography Review and Patient Notification

a) If the Agency believes that mammography quality at a facility has been compromised and may present a serious risk to human health, the facility shall provide clinical images and other relevant information, as specified by the Agency, for review by the accreditation body. This additional mammography review will help the Agency to determine whether the facility is in compliance with this Part and, if not, whether there is a need to notify affected patients, their physicians or the public that the reliability, clarity and accuracy of interpretation of mammograms has been compromised.

b) If the Agency determines that the quality of mammography performed by a facility, whether or not certified under Section 370.50 of this Part, was so inconsistent with the quality standards established in this Part as to present a significant risk to individual or public health, the Agency may require the facility to notify patients who received mammograms at the facility, and their referring physicians, of the deficiencies presenting the risk, the potential harm resulting, appropriate remedial measures and other relevant information as the Agency may require.

History

• Source: Amended at 29 Ill. Reg. 20963, effective December 16, 2005

32 Ill. Adm. Code 370.145 Notification Requirements for Mobile Mammography Facilities Certified by Another Certifying Entity

Mobile mammography facilities that operate in Illinois and are certified under MQSA by the FDA, or another state authorized by FDA to certify mammography facilities under MQSA, shall:

a) Notify the Agency by telephone, facsimile or letter of each date and location of operation of the mobile mammography facility in Illinois prior to conducting such operation.

AGENCY NOTE: Notifications submitted by the mobile mammography facility to the Agency may contain notice of multiple dates and locations of operation by the mobile mammography facility.

b) At all times while operating in Illinois, have the following documentation available for review and inspection by the Agency:

1. A copy of the mammography facility certificate issued by the FDA or another state, showing that the facility is currently certified.

2. A summary of the most recent physics survey of the mammography machine and documentation of any corrective actions recommended by the medical physicist who performed the physics survey.

3. Documentation that personnel meet the qualifications of Section 370.70 of this Part.

History

• Source: Amended at 29 Ill. Reg. 20963, effective December 16, 2005

32 Ill. Adm. Code 370.150 Revocation of Accreditation and Revocation of Accreditation Body Approval

If a facility's accreditation is revoked by an accreditation body, the Agency may conduct an investigation into the reasons for the revocation. Following the investigation, the Agency may act to suspend or revoke the facility's certificate and may take whatever other action or combination of actions will best protect the public health, including requiring the establishment and implementation of a corrective plan of action that will permit the certificate to continue in effect while the facility seeks reaccreditation. A facility whose certificate is suspended or revoked because it has lost its accreditation may not practice mammography.

History

• Source: Amended at 29 Ill. Reg. 20963, effective December 16, 2005

32 Ill. Adm. Code 370.160 Suspension, Revocation or Denial of Certificates

a) The Agency may suspend, revoke or deny a certificate if the Agency finds that the owner, operator or any employee of the facility:

1. Has been guilty of misrepresentation in obtaining the certificate;

2. Has failed to comply with the standards of Sections 370.70, 370.80, 370.90, 370.100, 370.110, 370.120 and 370.130 of this Part;

3. Has failed to comply with reasonable requests of the Agency or the accreditation body for records, information, reports, or materials that the Agency believes are necessary to determine the continued eligibility of the facility for a certificate or continued compliance with the standards of Sections 370.70, 370.80, 370.90, 370.100, 370.110, 370.120, 370.130 and 370.140 of this Part;

4. Has refused a reasonable request of a duly designated FDA inspector, Agency inspector, or accreditation body representative for permission to inspect the facility or the operations and pertinent records of the facility;

5. Has violated or aided and abetted in the violation of any provision of this Part;

6. Has failed to comply with prior sanctions imposed by the Agency; and

7. Has failed to pay any required fees.

b) If, based upon any of the grounds in subsection (a) of this Section, the Agency determines that action to suspend, revoke or deny certification is warranted, the Agency shall notify the owner or operator of a facility and shall provide an opportunity for hearing in accordance with 32 Ill. Adm. Code 200.

c) The Agency may suspend the certificate of a facility before holding a hearing if the Agency determines that:

1. The failure to comply with required standards presents a serious risk to human health;

2. The refusal to permit inspection makes immediate suspension necessary; or

3. There is reason to believe that the violation or aiding and abetting of the violation was intentional or associated with fraud.

d) If the Agency suspends a certificate in accordance with subsection (c) of this Section:

1. The Agency shall provide the facility with an opportunity for a hearing under 32 Ill. Adm. Code 200 not later than 30 days after the effective date of the suspension;

2. The suspension shall remain in effect until the Agency determines that:

A) Allegations of violations or misconduct were not substantiated;

B) Violations of required standards have been corrected to the Agency's satisfaction; or

C) The facility's certificate is revoked in accordance with subsection (e) of this Section.

e) After providing a hearing in accordance with subsection (d)(1) of this Section, the Agency may revoke the facility's certificate if the Agency determines that the facility:

1. Is unwilling or unable to correct violations that were the basis for suspension; or

2. Has engaged in fraudulent activity to obtain or continue certification.

History

• Source: Amended at 29 Ill. Reg. 20963, effective December 16, 2005

32 Ill. Adm. Code 370.165 Failure of Mobile Mammography Facilities Certified by Another Certifying Entity to Meet Requirements

If the Agency has reason to believe that the owner, operator or any employee of a mobile mammography facility certified by another certifying entity:

a) has been guilty of misrepresentation in obtaining the certificate;

b) has failed to comply with the standards of Sections 370.70, 370.80, 370.90, 370.100, 370.110, 370.120 or 370.130 of this Part;

c) has failed to comply with reasonable requests of the Agency for records, information, reports, or materials that the Agency believes are necessary to determine the continued eligibility of the facility for a certificate or continued compliance with the standards of Sections 370.70, 370.80, 370.90, 370.100, 370.110, 370.120, 370.130 or 370.140 of this Part; or

d) has refused a reasonable request of a Agency representative for permission to inspect the facility or the operations and pertinent records of the facility;

the Agency shall notify the certifying entity of the facts and circumstances and may take other actions as may be appropriate under Sections 36, 38 or 40 of the Radiation Protection Act of 1990 [420 ILCS 40/36, 38, and 40].

History

• Source: Amended at 29 Ill. Reg. 20963, effective December 16, 2005

32 Ill. Adm. Code 370.170 Mammography Units Used for Localization or Biopsy Procedures

a) Personnel. The following requirements apply to all personnel involved in localization or biopsy procedures performed with mammography units:

1. The mammography unit shall be operated by or under the direction of a physician licensed under the Medical Practice Act of 1987 [225 ILCS 60].

2. Radiologic technologists operating mammography units for localization or biopsy procedures shall meet the general requirements, mammography requirements and continuing education and experience requirements as specified in Section 370.70(b) of this Part.

3. Medical physicists who perform and provide oversight of quality assurance programs for mammography units used for biopsy procedures shall meet the requirements of Section 370.70(c) of this Part.

b) Equipment. Mammography units used for localization or biopsy procedures shall meet the requirements of Section 370.80 of this Part, except that digital output mammography systems that do not use screen-film image receptors are exempt from the requirements of Section 370.80 of this Part as they relate to screen-film image receptors.

c) Quality assurance. Each facility shall establish and maintain a quality assurance program to ensure the safety, reliability, clarity and accuracy of mammography localization or biopsy procedures performed at the facility.

1. Each facility shall have the services of a medical physicist available to survey mammography equipment and to oversee the equipment-related quality assurance practices of the facility.

2. The quality assurance program shall be in writing and shall have been developed by a medical physicist. The program shall include, but need not be limited to, the following:

A) Specifications of the tests that are to be performed, including instructions to be employed in the performance of those tests; and

B) Specifications of the frequency at which tests are to be performed, the acceptable tolerance for each parameter measured and actions to be taken if tolerances are exceeded.

3. The medical physicist shall conduct a review of the quality assurance program each year. Such review shall include evaluation of the results of quality assurance testing.

d) Each facility shall maintain written records of the radiation dose measurements and quality assurance testing performed, as required in this Section, for inspection by the Agency for a period of at least one year. Such records shall include, but need not be limited to, the following:

1. The date of the test and identification of the person performing the test;

2. Identification of the type of testing that was performed; and

3. Notation of whether the results of the testing were within the parameters established by the medical physicist.

AGENCY NOTE: The Agency recommends that facilities performing interventional mammography seek accreditation through the Stereotactic Breast Biopsy Program of the American College of Radiology.

History

• Source: Amended at 29 Ill. Reg. 20963, effective December 16, 2005

32 Ill. Adm. Code 370.APPENDIX A Mammography Dose Measurement Protocol

The technique factors used for performing a mammography examination shall not permit the mean glandular absorbed dose to exceed the limits specified in Section 370.110(e)(7) of this Part. Radiation measurements shall be performed with an integrating radiation measuring device that is appropriate to the high beam intensity and mammographic kilovoltage peak (kVp) used, and sufficiently sensitive to determine compliance with the criteria specified in Section 370.110(i)(2) of this Part. The instrument shall have been calibrated as specified in Section 370.110(i)(2) of this Part.

The mammography exam dose limits are based on an average compressed breast value of 4.2 centimeters having an average density (i.e., 50 percent adipose and 50 percent glandular).

Perform the following steps to determine the mean glandular dose to a nominal 4.2 centimeter compressed breast:

a) Measure and record the x-ray system's useful beam half-value layer (HVL). (See Section 370.110(e)(5) of this Part.) Any compression device normally in the useful beam during mammography procedures shall be required to be placed between the x-ray tube target and measuring device when determining the HVL. The useful beam shall be collimated to a size encompassing the detector.

AGENCY NOTE: Filters used for the HVL evaluation should be placed as close to the target as practical. The HVL for screen-film mammography should not exceed the minimum acceptable HVL by more than 0.1 millimeter of aluminum equivalent.

b) Determine the glandular dose to entrance exposure factor from the Mammography Dose Evaluation Table (see Table A of this Part) using the appropriate HVL, kVp and x-ray tube target-filter material.

AGENCY NOTE: The kVp of screen-film mammography systems with molybdenum target-filter combinations should be accurately measured to determine the appropriate glandular dose to entrance exposure factor from Table A of this Part.

c) If the equipment has the capability for variable source-image receptor distance, set the craniocaudal source-image receptor distance (SID) for the image receptor system used.

d) Position in the useful beam any compression apparatus normally used.

AGENCY NOTE: Some mammography systems have the capability of providing automatic adjustment of technique factors through feedback from the position of the compression device. On such systems, the compression device should be lowered to a position 4.2 centimeters above the breast support assembly (BSA). The device should then be removed, inverted and replaced to allow placement of the phantom and measuring device on the BSA below the compression device. If the compression device cannot be replaced in an inverted position, the device should be placed in the beam using auxiliary support.

e) Placement of the Radiation Measuring Device

1. For systems equipped with automatic exposure control (AEC):

A) Place a properly loaded film cassette in the cassette holder.

AGENCY NOTE: The loaded cassette is placed in the cassette holder to simulate, as much as is possible, the conditions under which actual patient exposures are made. Following radiation measurements, the film should be discarded and the cassette reloaded with unexposed film.

B) Place a mammography phantom (see the definition for "Phantom" in Section 370.20 of this Part) on the breast support assembly (BSA). Align the phantom so that the edge of the phantom is aligned with the chest wall side of the BSA and the phantom is over the automatic exposure control device(s).

C) Place a radiation measuring device in the useful beam so the center axis of the device is parallel to the breast support assembly (BSA). The geometric center of the measuring device shall be positioned 4.5 centimeters above the BSA, 2.5 centimeters from the chest wall edge of the BSA and immediately adjacent to either side of the mammography phantom.

2. For systems not equipped with AEC, place a radiation measuring device in the useful beam so that the center axis of the device is parallel to the breast support assembly (BSA). The geometric center of the measuring device shall be positioned so that it is centered 4.5 centimeters above the BSA, 2.5 centimeters from the chest wall edge of the BSA and at the center line of the BSA. No part of the device's detector area shall be outside of the useful beam.

f) Collimate the x-ray field to the size normally used and assure that the area covered by the useful beam includes the detector area of the radiation measuring device and the mammography phantom if the equipment is equipped with automatic exposure.

g) Set the appropriate technique factors or automatic exposure controls normally used for a nominal 4.2 centimeter compressed breast.

h) Measure and record the exposure in air with the radiation measuring device.

i) Calculate the mean glandular dose for a 4.2 centimeter compressed breast by multiplying the measured exposure in millicoulombs per kilogram or in roentgens by the glandular dose to entrance exposure factor, which was determined using the procedure described in subsection (b) of this Section.

EXAMPLE: A mammography system is provided with a molybdenum target-filter combination, and the HVL and kVp are determined to be 0.3 and 30, respectively. Therefore, for a 4.2 centimeter compressed breast, the glandular dose to entrance exposure factor from the Mammography Dose Evaluation Table (Table A of this Part) would be 159 mrad. The measured roentgen output determined in subsection (h) of this Appendix is determined to be 1.8 R. Therefore, the mean glandular dose would be 1.8 R multiplied by 159 mrad/R. This results in a mean glandular dose measurement of 286 mrad. As such, the system would be in compliance with Section 370.110(e)(7) of this Part.

32 Ill. Adm. Code 370.APPENDIX B Mammography Phantom Image Evaluation

Mammography phantom image evaluation shall be performed using the procedure below. The evaluation shall be performed weekly as a part of the quality assurance program. The evaluation shall be performed with the mammography phantom specified in Section 370.20 of this Part.

a) Equipment necessary for mammography phantom image evaluation includes a densitometer, the mammography phantom and mammographic cassette and film.

b) Load film in the mammographic cassette according to the manufacturer's instructions.

c) Place the properly loaded cassette in the cassette holder.

d) Place the mammography phantom on the breast support assembly (BSA) so that the edge of the phantom is aligned with the chest wall side of the BSA. Align the phantom so that the masses in the phantom are nearest the chest wall edge of the BSA and the fibers in the phantom are away from the chest wall edge of the BSA. If the mammography machine has the capability of automatic exposure control, place the phantom so that the phantom covers the phototimer sensor.

e) Position the compression device so that it is in contact with the phantom.

f) Select the technique factors used most frequently in the clinical setting for a 4.2 centimeter compressed breast and make an exposure of the phantom.

g) Process the film in the processor used for clinical mammography films.

h) Examine the processed image for areas of non-uniformity of optical density and for the presence of artifacts due to dirt, dust, grid lines or processing.

AGENCY NOTE: If any of the problems noted above are evident on the processed image, the mammography machine film processor and film cassette(s) should be evaluated and the problem corrected. The phantom image evaluation should be repeated after the problem is corrected.

i) Measure and record the optical density of the film near the center of the phantom image. The optical density of the film at the center of the image of the phantom shall be at least 1.20 when exposed under a typical clinical condition.

j) Examine the phantom image and count and record the number of masses visualized. Repeat this procedure for the speck groups and the fibrils and record the number of objects visualized. There are a total of 16 imaging objects (5 masses, 5 speck groups and 6 fibrils) in the phantom. Evaluation criteria for objects visualized in the phantom image are in Section 370.110(b)(3) of this Part. As a minimum, the objects that must be visualized in the phantom image are:

1. The masses that are 0.75 millimeter or larger (a total of 3 masses);

2. The speck groups that are 0.32 millimeter or larger (a total of 3 speck groups);

3. The fibrils that are 0.75 millimeter or larger (a total of 4 fibrils).

AGENCY NOTE: The phantom image should be compared with previous films, including the original phantom image, to determine if subtle changes are occurring from week to week.

32 Ill. Adm. Code 370.TABLE A Mammography Dose Evaluation Table

This Table is used to determine the mean glandular dose in milligrays delivered by 25.8 mC/kg (or millirad) delivered by 1 R in air incident on a 4.2 centimeter thickness compressed breast of average density (50 percent adipose and 50 percent glandular tissue). Values listed are for the first half-value layer (HVL) in millimeters of aluminum (mm Al), for x-ray tube target-filter combinations of molybdenum/molybdenum (Mo/Mo) and tungsten/ aluminum (W/Al). Linear extrapolation or interpolation shall be made for any HVL not listed.

Mean Glandular Dose in milligrays for 25.8 mC/kg (or millirad for 1 R) Entrance Exposure for a 4.2 Centimeter Compressed Breast of Average Density

HVL

Mo/Mo Target-Filter X-Ray Tube Voltage (kVp)

W-A1 Target-

(mm AL)

23

24

25

26

27

28

29

30

31

32

33

Filter Combination

0.23

116

0.24

121

124

0.25

126

129

131

0.26

130

133

135

138

0.27

135

138

140

142

143

0.28

140

142

144

146

147

149

0.29

144

146

148

150

151

153

154

0.30

149

151

153

155

156

157

158

159

170

0.31

154

156

157

159

160

161

162

163

164

175

0.32

158

160

162

163

164

166

167

168

168

170

171

180

0.33

163

165

166

168

169

170

171

173

173

174

175

185

0.34

168

170

171

172

173

174

175

176

177

178

179

190

0.35

174

175

176

177

178

179

180

181

182

183

194

0.36

179

181

182

183

184

185

185

186

187

199

0.37

185

186

187

188

189

190

191

191

204

0.38

190

191

192

193

194

195

195

208

0.39

196

197

198

198

199

200

213

0.40

201

202

203

204

204

217

0.41

206

207

208

208

221

0.42

211

212

212

225

0.43

215

216

230

0.44

220

234

0.45

238

AGENCY NOTE: Adapted from: Mammography Quality Control Manual: Medical Physicist's Section, Revised Edition, 1999.

History

• Source: Amended at 33 Ill. Reg. 2224, effective January 23, 2009

Part 380 Analytical Types of X-Ray Equipment

32 Ill. Adm. Code 380.10 Scope

This Part establishes special requirements for x-ray diffraction units, x-ray spectrographic fluorescence equipment, etc. The provisions of this Part are in addition to, and not in substitution for, other applicable provisions of Agency regulations.

History

• Source: Amended at 33 Ill. Reg. 2240, effective January 23, 2009

32 Ill. Adm. Code 380.20 Definition

"Analytical x-ray machines or equipment" means any machine utilizing x-rays for examination of the microscopic structure, or elemental or chemical composition of materials. This includes all types of x-ray diffraction and spectrographic equipment.

32 Ill. Adm. Code 380.30 Labeling

a) A label bearing the words "Caution – Radiation – This Equipment Produces Radiation When Energized" shall be placed near any switch which energizes a tube.

b) A sign bearing the words "Caution – High Intensity X-Ray Beam", or words having a similar intent, shall be placed in the area immediately adjacent to each tube head. The sign shall be so located that it is clearly visible to any person operating, aligning, or adjusting the unit, or handling or changing a sample.

c) A clearly visible indication of the presence of an x-ray beam shall be provided on or immediately adjacent to each tube head.

d) A clearly visible indication of the status (i.e., open or closed) of each shutter shall be provided.

32 Ill. Adm. Code 380.40 Radiation Exposure Standards

Radiation exposure to individuals, either within the control area or in the environs of the installation, shall be so controlled that the maximum permissible dose equivalent values, as set forth in 32 Ill. Adm. Code 340, are not exceeded.

32 Ill. Adm. Code 380.50 Tests and Inspections

a) Tests and inspections of all safety devices shall be performed at least monthly to insure their proper operation.

b) Surveys and monitoring sufficient to insure that operations are conducted safely shall be provided.

c) Records of tests and inspections, surveys, and monitoring sufficient to show compliance with Agency regulations shall be maintained and kept available for inspection by a representative of the Agency, upon demand.

History

• Source: Amended at 33 Ill. Reg. 2240, effective January 23, 2009

32 Ill. Adm. Code 380.60 Operating Procedures and Instructions

a) Individuals having access to analytical x-ray machines or equipment shall be provided with specific written instructions concerning the radiation hazards, safe working practices, and made aware of the symptoms of an acute localized exposure to radiation. These instructions shall be posted near the controls of the x-ray machine.

b) Medical personnel examining work-connected injuries shall be informed of the possibility of radiation exposure to the worker from the devices regulated in this Part.

c) Operators shall be instructed in the procedures for reporting an actual or suspected radiation overexposure. When it has been determined that an overexposure to an individual has occurred, it shall be reported to the Agency without undue delay.

d) In cases where the primary x-ray beam is not intercepted by the experimental apparatus under all conditions of operation, protective measures shall be provided, such as auxiliary shielding, to avoid exposure to the primary x-ray beam.

e) If, for any reason, it is necessary to temporarily intentionally alter safety devices, such as bypassing interlocks or removing shielding, such action shall be:

1. specified in writing and posted near the x-ray tube housing so that other persons will know the existing status of the machine; and

2. terminated as soon as possible.

f) Whenever possible, an interlocking device that prevents the entry of any portion of an individual body or extremities into the primary beam, or causes the primary beam to be shut off upon entry into its path, shall be provided.

g) Unused tube ports shall be closed in such a fashion that accidental opening is not possible.

History

• Source: Amended at 33 Ill. Reg. 2240, effective January 23, 2009

32 Ill. Adm. Code 380.70 Monitoring

Operators of analytical x-ray equipment shall be provided with finger or wrist radiation monitoring devices as required by 32 Ill. Adm. Code 340.520.

History

• Source: Amended at 33 Ill. Reg. 2240, effective January 23, 2009

Part 390 Particle Accelerators

32 Ill. Adm. Code 390.10 Scope

Except as otherwise specifically provided, this Part applies to all persons who develop, manufacture, receive, possess, use, own or acquire accelerators. These provisions are in addition to, and not in substitution for, other applicable provisions of Agency regulations. See 32 Ill. Adm. Code 360 for applicable regulations concerning particle accelerators for medical therapeutic applications.

History

• Source: Amended at 33 Ill. Reg. 4326, effective March 9, 2009

32 Ill. Adm. Code 390.20 Definitions

As used in this Part:

"Accelerator facility" means the location at which one or more particle accelerators are installed within one building or under one roof and are operated under the same administrative control.

"Particle accelerator" means any device other than an x-ray machine that emits ionizing radiation as a result of the acceleration of charged particles. Examples are cyclotrons, betatrons, electron linear accelerators and potential drop accelerators.

"Qualified expert" means an individual who has demonstrated to the satisfaction of the Agency that he or she possesses the knowledge and training to measure ionizing radiation, to evaluate safety techniques and to advise regarding radiation protection needs. Satisfactory demonstration of knowledge and training should include certification by a nationally recognized credentialing entity in the field of radiation protection.

History

• Source: Amended at 33 Ill. Reg. 4326, effective March 9, 2009

32 Ill. Adm. Code 390.30 Operating Procedures and Instructions

a) Each registrant shall inform individuals working in or frequenting any portion of a restricted area as to the presence of radiation or particle accelerators; instruct those individuals in safety problems associated with those areas and in precautions or procedures to minimize radiation exposure; instruct the individuals in the provisions of Agency regulations for the protection of personnel from exposures to radiation; and advise the individuals of reports of radiation exposure that those individuals may request pursuant to this Part.

b) Each particle accelerator facility shall be under the administrative control of a radiation protection officer or radiation safety committee that will be responsible for the safe operation of the accelerator.

c) Written operating and emergency procedures, as well as specified safety rules, shall be established for each accelerator facility and approved by the radiation protection officer.

d) Personnel who operate or maintain particle accelerators shall be familiar with, and have available a copy of, the written operating and emergency procedures.

e) No individual shall be permitted to operate or maintain an accelerator until the individual has received at least the training specified in Section 390.70.

f) Modification, repairs or preventive maintenance on accelerator components or safety interlocks may be performed only by or under the direct supervision of individuals who have received at least the training specified in Section 390.70.

g) Provisions shall be made at each accelerator control console to display the name of the individual who is authorized to operate the accelerator. Only the individual whose name is displayed may turn on the accelerator or open entrances to high radiation areas.

h) The radiation safety officer shall maintain a current list of all personnel who are qualified to operate or service the particle accelerator.

i) No registrant shall permit a particle accelerator to operate at any time with a safety interlock bypassed, except for necessary testing. Upon circumvention of an interlock, the registrant shall maintain records showing the date and reasons for bypassing the interlock. A sign shall be posted at the personnel entrance door being bypassed and this condition terminated as soon as possible.

j) Additional Requirements. The Agency may, by rule, regulation or order, impose upon any registrant requirements in addition to those established in this Part as it deems appropriate or necessary to minimize danger to public health and safety or property.

History

• Source: Amended at 33 Ill. Reg. 4326, effective March 9, 2009

32 Ill. Adm. Code 390.40 Equipment Controls

a) All meters and controls on the accelerator control console shall be clearly identified and easily discernible. Accelerator control consoles shall be equipped with a keyswitch or other device that will render the console inoperative when the key or device is removed. Only one key shall be available to the operating crew.

b) All entrances into a target room or other high radiation area shall be provided with a minimum of two personnel interlocks.

c) The interlock system shall be designed to prevent restarting of the accelerator without manually resetting the accelerator "ON" switch at the control console after the tripping of a shielding interlock or a power failure. At the time of such an occurrence, the registrant is required to resurvey the radiation area prior to reactivation of the accelerator. Records documenting the circumstances surrounding such occurrences shall be maintained for review by the Agency.

d) A scram or panic button or other emergency power cut-off switch shall be located and easily identifiable in all accessible high radiation areas. A visible and/or audible signal system shall be installed within the protective enclosure that will be activated for a reasonable length of time before the power to the accelerator can be activated.

e) Electrical circuit diagrams of the accelerator and the associated interlock system shall be kept current and on file at each accelerator facility.

f) All safety and warning devices, including interlocks, shall be checked and appropriately serviced each month. A log and written records of these tests shall be kept by the registrant and made available for inspection by the Agency.

History

• Source: Amended at 33 Ill. Reg. 4326, effective March 9, 2009

32 Ill. Adm. Code 390.50 Radiation Monitoring

a) Portable radiation monitoring equipment shall be properly maintained and available at the accelerator facility. An appropriate radiation monitor shall be used for all accelerator target rooms and other high radiation areas. This monitor shall be one or more of the following:

1. An area monitor with an easily observable indicator located near the entrance that warns of radiation levels above a predetermined limit;

2. A personal radiation monitor of the "chirpie" type worn while in the room;

3. A portable survey instrument carried into the room; or

4. A monitor approved by the Agency.

b) No registrant shall permit any individual to enter a restricted area unless the individual wears both:

1. An individual monitoring device, assigned to and worn by only one individual, that is provided and evaluated by a qualified dosimetry processor as described in 32 Ill. Adm. Code 340.510(d); and

2. A direct reading pocket ionization chamber or an electronic dosimeter capable of measuring doses from zero to at least 51.6 microC/kg (200 mR).

History

• Source: Amended at 33 Ill. Reg. 4326, effective March 9, 2009

32 Ill. Adm. Code 390.60 Radiation Surveys

a) The registrant shall maintain sufficient calibrated and operable radiation survey instruments to make physical radiation surveys as required by the Agency. Each radiation survey instrument shall be checked every 3 months and calibrated at intervals not to exceed 1 year. After each instrument servicing, a record shall be maintained of the latest response check or calibration date.

b) Before a new accelerator with its associated components is placed in routine operation, a radiation protection survey shall be made by a qualified expert and a copy of the results submitted to the Agency.

c) The area surrounding a particle accelerator and associated components shall be surveyed at intervals not to exceed 3 months. A record shall be made of the accelerator operating conditions and radiation levels measured at specific control points. These control points must be well defined and reported on at least four consecutive surveys. One of these control points must be at the normal work station of the individual who operates the accelerator. These records shall be made available for inspection by the Agency.

History

• Source: Amended at 33 Ill. Reg. 4326, effective March 9, 2009

32 Ill. Adm. Code 390.70 Personnel Training

a) The registrant shall ensure that all personnel who operate particle accelerators:

1. Receive instruction in the fundamentals of radiation safety including:

A) Characteristics of beta, gamma and x-radiation;

B) Units of radiation dose equivalent (sievert or rem);

C) Hazards of excessive exposure to radiation;

D) Levels of radiation from particle accelerators; and

E) Methods used to limit radiation doses at the specific facility to be operated, including:

i) Shielding;

ii) Interlock system;

iii) Safety rules; and

iv) Radiation monitoring equipment.

2. Receive instruction in the use and care of individual monitoring devices used at the facility.

3. Are knowledgeable of:

A) The location and use of all operating controls;

B) The pertinent requirements of 32 Ill. Adm. Code: Chapter II, Subchapter b; and

C) The registrant's written operating and emergency procedures.

4. Receive at least 1 month of on-the-job training before assuming operational responsibility.

b) All operator's assistants or helpers shall receive the training listed in subsections (a)(1) through (a)(3) above.

History

• Source: Amended at 18 Ill. Reg. 3143, effective February 22, 1994

Part 400 Notices, Instructions and Reports to Workers; Inspections

32 Ill. Adm. Code 400.10 Purpose and Scope

a) This Part 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 those individuals in connection with the Illinois Emergency Management Agency (Agency) inspections of licensees or registrants to ascertain compliance with the provisions of the Radiation Protection Act of 1990 [420 ILCS 40] (the Act) and regulations, orders and licenses issued under that Act regarding radiological working conditions.

b) This Part shall apply to:

1. All persons who receive, possess, use, own or transfer sources of radiation registered with or licensed by the Agency pursuant to 32 Ill. Adm. Code: Chapter II, Subchapters b and d.

2. Inspection and testing of radiation machines and associated operating procedures by the Agency.

3. Inspection of licensed activities by Agency inspectors.

History

• Source: Amended at 33 Ill. Reg. 4333, effective March 9, 2009

32 Ill. Adm. Code 400.110 Posting of Notices to Workers

a) Each licensee or registrant shall post current copies of the following documents:

1. The provisions in this Part and in 32 Ill. Adm. Code 340;

2. The certificate of registration, the license, the license conditions and any documents incorporated into the license by reference and amendments to these documents;

3. The operating procedures applicable to activities under the license or registration; and

4. Any notice of violation involving radiological working conditions, proposed imposition of civil penalty or order issued pursuant to 32 Ill. Adm. Code 310 and any response from the licensee or registrant.

b) If the posting of a document specified in subsection (a)(1), (2) or (3) of this Section is not practicable, the licensee or registrant may post a notice that describes the documents and states where they may be examined.

c) Agency Form KLA.001 "Notice to Employees" shall be posted by each licensee or registrant.

d) Agency documents posted pursuant to subsection (a)(4) of this Section shall be posted within 5 working days after receipt of the documents from the Agency; the licensee's or registrant's response, if any, shall be posted within 5 working days after dispatch from the licensee or registrant. The documents shall remain posted for a minimum of 5 working days or until action correcting the violation has been completed, whichever is later.

e) Documents, notices or forms posted pursuant to this Section shall 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, shall be conspicuous and shall be replaced if defaced or altered.

History

• Source: Amended at 33 Ill. Reg. 4333, effective March 9, 2009

32 Ill. Adm. Code 400.120 Instructions to Workers

a) All individuals working in, or the performance of whose duties requires access to, any portion of a restricted area or who frequent areas where radioactive material is used or stored:

1. Shall be kept informed of the storage, transfer or use of sources of radiation in such portions of the restricted area;

2. Shall be instructed in the health protection problems associated with exposure to radiation or radioactive material, in the risks of radiation exposure to the embryo and fetus, in precautions or procedures to minimize exposure and in the purposes and functions of protective devices employed;

3. Shall be instructed in, and instructed to observe to the extent within the worker's control, the conditions of the license, the provisions of this Part and 32 Ill. Adm. Code: Chapter II, Subchapters b and d for the protection of personnel from exposures to radiation or radioactive material occurring in such areas;

4. Shall be instructed to report promptly to the licensee or registrant any condition that may constitute, lead to or cause a violation of the Act, the conditions of the license, the provisions of this Part or 32 Ill. Adm. Code: Chapter II, Subchapters b and d or unnecessary exposure (i.e., exposure that results when prescribed safety measures are not followed) to radiation or radioactive material;

5. Shall be 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

6. Shall be advised as to the radiation exposure reports that workers are furnished pursuant to Section 400.130.

b) These instructions shall be of sufficient detail to avoid radiological health protection problems and shall be given directly to each worker either in writing or in an orientation course, with the workers signing a statement that they have received the information listed in subsection (a) and understand it. Training shall be provided initially before assigning duties involving radioactive material and following changes in duties or procedures or potential radiation hazards. Refresher training that covers all of the required topics shall be provided at intervals not to exceed 12 months.

History

• Source: Amended at 33 Ill. Reg. 4333, effective March 9, 2009

32 Ill. Adm. Code 400.130 Notifications and Reports to Individuals

a) Notifications and reports provided to individuals in accordance with this Section shall include data and results obtained pursuant to this Part, orders or license conditions as shown in records maintained by the licensee or registrant pursuant to 32 Ill. Adm. Code 340.1160(a) and (d). Each notification and report shall:

1. Be in writing;

2. Include the name of the licensee or registrant, the name of the individual and the individual's social security number;

3. Include the individual's dose information; and

4. Contain the following statement:

"This report is furnished to you under the provisions of the Illinois Emergency Management Agency Regulations for Radiation Protection (32 Ill. Adm. Code 400). You should preserve this report for further reference."

b) Each licensee or registrant shall make dose information available to workers as shown in records maintained by the licensee or registrant under the provisions of 32 Ill. Adm. Code 340.1160. The licensee or registrant shall provide an annual report to each individual monitored under 32 Ill. Adm. Code 340.520 of the dose received in that monitoring year if:

1. The individual's occupational dose exceeds 1 mSv (100 mrem) TEDE or 1 mSv (100 mrem) to any individual organ or tissue; or

2. The individual requests his or her annual dose report.

c) At the request of a worker, each licensee or registrant shall furnish to the worker upon termination of employment a report of the worker's dose. The report shall be furnished within 30 days from the time the request is made, or within 30 days after termination of employment or within 30 days after the individual's dose has been determined by the licensee or registrant, whichever is later. The report shall cover all periods of time in which the worker was required to be monitored pursuant to 32 Ill. Adm. Code 340.520 and shall include the dates and locations of work under the license or registration in which the worker participated.

d) When a licensee or registrant is required pursuant to 32 Ill. Adm. Code 340.1220, 340.1230 or 340.1240 to report to the Agency any dose received by an individual, the licensee or the registrant shall also provide the individual a report of the dose information included in the report to the Agency. The reports shall be transmitted at a time not later than the transmittal to the Agency.

e) At the request of a worker who is terminating employment with the licensee or registrant in work involving radiation dose during the current year, or of a worker who, while employed by another person, is terminating a work assignment involving radiation dose in the licensee's or registrant's facility during the current year, each licensee or registrant shall provide to each such worker, or to the worker's designee, at termination, a written report regarding the radiation dose received by that worker from operations of the licensee or registrant during the current year or fraction of a year, or provide a written estimate of that dose if the finally-determined personnel monitoring results are not available at that time. Estimated doses shall be clearly indicated. If an estimate of dose is provided, the actual radiation dose records shall be provided to the worker when these records become available to the licensee or registrant.

AGENCY NOTE: The reporting requirements of subsections (b), (c) and (e) of this Section apply only to workers who are required to be monitored pursuant to 32 Ill. Adm. Code 340.520.

History

• Source: Amended at 33 Ill. Reg. 4333, effective March 9, 2009

32 Ill. Adm. Code 400.140 Presence of Representatives of Licensees or Registrants and Workers During Inspection

a) Pursuant to Section 400.160 and 32 Ill. Adm. Code 310.50, each licensee or registrant shall afford the Agency at all reasonable times the opportunity to inspect such materials, machines, activities, facilities, premises and records as the Agency determines are necessary to establish compliance with the requirements of the license and the provisions of 32 Ill. Adm. Code: Chapter II, Subchapters b and d. Reasonable times shall be any time the facility is operational. The inspection may be announced or unannounced. Materials licensees shall be inspected at least as frequently as they would have been inspected by the U.S. Nuclear Regulatory Commission (NRC) if the licensees were regulated by the NRC, but no more frequently than once in a calendar quarter. Radiation machines shall be inspected in accordance with Section 25 of the Act. Inspection of licensees and radiation machines may be conducted more frequently than once per calendar quarter if, in the past three years, there has been a condition at the facility that required emergency response; or if the Agency has received a complaint, the investigation of which results in a more frequent inspection; or if the Agency has documented a violation of the Act or Section 400.160 or 32 Ill. Adm. Code 310.50 at the facility and additional inspections are necessary to establish that the violation has been abated.

b) During an inspection, Agency inspectors may consult privately with workers as specified in Section 400.150. The licensee or registrant may accompany Agency inspectors during other phases of an inspection.

c) If, at the time of inspection, an individual has been authorized by the workers to represent them during inspections, the licensee or registrant shall notify the Agency inspectors of that authorization and shall give the workers' representative an opportunity to accompany the inspectors during the inspection of physical working conditions.

d) Each workers' representative shall be routinely engaged in work under control of the licensee or registrant and shall have received instructions as specified in Section 400.120.

e) Different representatives of licensees or registrants and workers may accompany the Agency 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.

f) 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, for example, a consultant to the licensee or registrant or to the workers' representative, shall be afforded the opportunity to accompany Agency inspectors during the inspection of physical working conditions.

g) Notwithstanding the other provisions of this Section, Agency inspectors are authorized to refuse to permit accompaniment by any individual who deliberately interferes with a fair and orderly inspection. With regard to areas containing information classified by an agency of the U.S. Government in the interest of national security, an individual who accompanies an inspector may have access to the classified information only if authorized to do so. With regard to any area containing proprietary information, i.e., trade secrets and commercial or financial information that is privileged or confidential or when disclosure of the information may cause competitive harm, the workers' representative for that area shall be an individual previously authorized by the licensee or registrant to enter that area.

History

• Source: Amended at 33 Ill. Reg. 4333, effective March 9, 2009

32 Ill. Adm. Code 400.150 Consultation with Workers During Inspections

a) Agency inspectors may consult privately with workers concerning matters of occupational radiation protection and other matters related to the activities of the licensee or registrant that bear upon compliance with the conditions of the license or the provisions of this Part or 32 Ill. Adm. Code: Chapter II, Subchapters b and d.

b) During the course of an inspection, or at any other time, any worker may bring privately to the attention of the Agency or its inspectors, either orally or in writing, any past or present condition that the worker has reason to believe may have contributed to or caused any violation of the Act, the provisions of this Part or 32 Ill. Adm. Code: Chapter II, Subchapters b and d or license condition, or any unnecessary exposure (i.e., exposure that results when prescribed safety measures are not followed) of an individual to sources of radiation under the licensee's or registrant's control. Any notice in writing shall comply with the requirements of Section 400.160(a). If a worker seeks an opportunity to speak to an inspector during an Agency inspection, the licensee or registrant shall permit the worker that opportunity.

AGENCY NOTE: The provisions of subsection (b) of this Section shall not be interpreted as authorization to disregard instructions pursuant to Section 400.120.

History

• Source: Amended at 33 Ill. Reg. 4333, effective March 9, 2009

32 Ill. Adm. Code 400.160 Requests by Workers for Inspections

a) Any worker or representative of workers believing that a violation of the Act, the provisions of this Part or 32 Ill. Adm. Code: Chapter II, Subchapters b and d, or license conditions exists or has occurred, or that an unnecessary exposure to radiation or radioactive material has occurred in work under a license or registration with regard to radiological working conditions in which the worker is engaged, may request an inspection by giving notice of the alleged violation to the Agency. The notice shall be in writing, shall set forth the circumstances describing the perceived violation or condition and shall be signed by the worker or representative of the workers. A copy of the notice shall be provided to the licensee or registrant by the Agency no later than at the time of inspection except that, upon the request of the worker giving the notice, the worker's name and the name of individuals referred to in the notice shall not appear in the copy or on any record published, released or made available by the Agency, except for good cause shown, such as when necessary in the course of enforcement actions.

b) If conditions stated on the face of the complaint indicate there is or has been a violation or the possibility of a violation, the Agency shall conduct an inspection as soon as practicable to determine if thealleged violation exists or has occurred. Inspections made pursuant to this Section need not be limited to matters referred to in the complaint.

c) No licensee or registrant shall discharge or in any manner discriminate against any worker because the worker has filed any complaint, or has instituted or caused to be instituted any proceedings under this Part, or has testified or is about to testify in any such proceeding, or because of the exercise by the worker on behalf of himself or herself or others of any option afforded by this Part. Furthermore, each licensee and registrant shall instruct its contractors and subcontractors not to discharge or in any manner discriminate against any worker because the worker has filed any complaint, or has instituted or caused to be instituted any proceedings under this Part, or has testified or is about to testify in any such proceeding, or because of the exercise by the worker on behalf of himself or herself or others any option afforded by this Part. Any worker who believes that he or she has been so discharged or discriminated against may file a complaint with the Agency alleging a violation of this subsection.

History

• Source: Amended at 33 Ill. Reg. 4333, effective March 9, 2009

32 Ill. Adm. Code 400.170 Inspections Not Warranted; Informal Review

a) Review of Determination that No Inspection Is Warranted

1. If the Bureau of Radiation Safety determines, pursuant to Section 400.160, that an inspection is not warranted, the Bureau of Radiation Safety shall notify the complainant in writing within 60 days after receipt of the complaint. The complainant may obtain review of the determination by submitting a written statement of position with the Agency. The Agency shall provide the licensee or registrant with a copy of the statement by certified mail, excluding, at the request of the complainant, the name of the complainant. The licensee or registrant may submit an opposing written statement of position with the Agency. The Agency shall provide the complainant with a copy of the statement by certified mail.

2. Upon the request of the complainant or the licensee or registrant, the Agency shall hold an informal conference in which the complainant and the licensee or registrant may orally present their views. If a conference is requested by the complainant, the presence of the licensee or registrant at the conference shall be subject to the concurrence of the complainant. If the conference is requested by the licensee or registrant, the presence or disclosure of the identity of the complainant shall be made only pursuant to written authorization from the complainant. After considering all written and oral views presented, the Agency shall affirm, modify or reverse the determination of the Office of Radiation Safety and furnish the complainant and the licensee or registrant a written notification of the decision and the reason for that decision.

b) If the Agency determines that an inspection is not warranted because the requirements of Section 400.160(a) have not been met, the complainant shall be notified in writing, within 30 days after receipt of the complaint, of the determination. The determination shall be without prejudice to the filing of a new complaint meeting the requirements of Section 400.160(a).

History

• Source: Amended at 33 Ill. Reg. 4333, effective March 9, 2009

Part 401 Accrediting Persons in the Practice of Medical Radiation Technology

32 Ill. Adm. Code 401.10 Policy and Scope

a) This Part establishes educational standards and an accreditation program applicable to persons who apply ionizing radiation to human beings. Specifically, this Part provides:

1. Minimum standards of preparatory education and experience for persons who apply ionizing radiation to human beings in the disciplines of medical radiography, nuclear medicine technology, radiation therapy technology and chiropractic radiography.

2. Examination requirements for certain categories of accreditation.

3. Continuing education requirements for renewal of accreditation.

b) This Part shall apply to any person who applies ionizing radiation to human beings for diagnostic, therapeutic or human research purposes in this State or who otherwise engages in the practice of medical radiation technology in this State unless specifically exempted by the Act or under Section 401.30. This Part shall also apply to persons who are not appropriately licensed under other statutes or regulations and who supervise students for purposes of instructing them while applying ionizing radiation to human beings.

History

• Source: Amended at 44 Ill. Reg. 2488, effective January 22, 2020

32 Ill. Adm. Code 401.20 Definitions

As used in this Part, the following definitions shall apply:

"Accreditation" – The process by which the Agency grants permission to persons meeting the requirements of the Act and the Agency's rules and regulations to engage in the practice of administering radiation to human beings. [420 ILCS 40/4]

"ACRRT" − American Chiropractic Registry of Radiologic Technologists, 52 W Colfax Street, Palatine, Illinois 60067-5048, Phone (847) 705-1178, website: www.acrrt.com.

"Act" – The Radiation Protection Act of 1990 [420 ILCS 40].

"Agency" − The Illinois Emergency Management Agency.

"Applies Ionizing Radiation" or "Administers Radiation" – The acts of using ionizing radiation for diagnostic or therapeutic purposes. Specifically included are those tasks that have a direct impact on the radiation burden of the patient, which if performed improperly would result in the re-administration of radiation.

"Approved Program" – A formal education program in the respective discipline of radiography, nuclear medicine technology or radiation therapy that is accredited by one or more of the following:

Joint Review Committee on Education in Radiologic Technology

Joint Review Committee on Educational Programs in Nuclear Medicine Technology

Regional Accrediting Agencies

Conjoint Accreditation Services of the Canadian Medical Association

Australian Institute of Radiography

Medical Radiation Practice Board of Australia

National faith related accrediting agencies

National accrediting agencies.

"ARRT" − The American Registry of Radiologic Technologists, 1255 Northland Drive, St. Paul MN 55120-1155, Phone (651) 687-0048, website: www.arrt.org.

"Authorized User" − A licensed practitioner who is identified as an authorized user on a license or equivalent permit issued by the Agency, Nuclear Regulatory Commission or Agreement State that is authorized to permit the medical use of radioactive material.

"Bone Densitometry" − The science and art of applying x-radiation to human beings for determination of site specific bone density.

"CBRPA" − Certification Board for Radiology Practitioner Assistants, P.O. Box 469, Plaistow NH 03865, Phone (603) 421-2020, website: www.cbrpa.org.

"Chiropractic Radiographer" – A person other than a licensed practitioner who performs medical radiation procedures and applies x-radiation to the human body for diagnostic evaluation of skeletal anatomy, while under the general supervision of a licensed chiropractor.

"Chiropractic Radiography" – The science and art of applying x-radiation to human beings for diagnostic purposes in Chiropractic.

"Continuing Education Activity" − A learning activity that is planned, organized and administered to enhance the professional knowledge and skills underlying professional performance that a technologist uses to provide services for patients, the public or the medical profession. In order to qualify as continuing education, the activity must be planned, be organized and provide sufficient depth and scope of a subject area.

"Continuing Education Credit" or "CE Credit" − Unit of measurement for continuing education activities. One continuing education credit is awarded for one contact hour (50 minutes). Activities longer than one hour are assigned whole or partial credits based on the 50-minute hour. Educational activities of 30-49 minutes of duration will be awarded one-half of one CE credit. Activities that last less than 30 minutes will receive no credit.

"CT" or "Computed Tomography" – The production of a tomogram by the acquisition and computer processing of x-ray transmission data.

"Director" – The Director of the Illinois Emergency Management Agency.

"Ionizing Radiation" – Gamma rays, and x-rays, alpha and beta particles, high speed electrons, neutrons, protons, and other nuclear particles; but not sound or radio waves, or visible, infrared or ultraviolet light.

"In vitro" – Isolated from the living organism.

"In vivo" – Occurring within the living organism.

"Licensed Practitioner" – A person licensed to practice a treatment of human ailments by virtue of the Medical Practice Act of 1987 [225 ILCS 60], the Illinois Dental Practice Act [225 ILCS 25], or the Podiatric Medical Practice Act of 1987 [225 ILCS 100], who may use radiation for therapeutic, diagnostic or other medical purposes within the limits of the individual's licensure.

"Limited Diagnostic Radiographer" – A person, other than a licensed practitioner, who, while under the general supervision of a licensed practitioner, applies x-radiation for diagnostic purposes. Radiographic procedures are limited to one or more of the following anatomical regions: chest, extremities, skull/sinus or spine. However, a limited diagnostic radiographer may not perform any radiographic exam for a portable x-ray service provider.

AGENCY NOTE: Specific radiographic examinations appropriate to each type of limited radiography accreditation may be found in Appendix A.

"Medical Radiation Technology" – The science and art of performing medical radiation procedures involving the application of ionizing radiation to human beings for diagnostic and therapeutic purposes.

"Medical Radiographer" – A person, other than a licensed practitioner, who, while under general supervision of a licensed practitioner, applies x-radiation to any part of the human body and who, in conjunction with radiation studies, may administer contrast agents and related drugs for diagnostic purposes.

"Medical Radiography" – The science and art of applying x-radiation to human beings for diagnostic purposes.

"NMTCB" − Nuclear Medicine Technology Certification Board, 3558 Habersham At Northlake, Building I, Tucker GA 30084-4009, Phone (404) 315-1739, website: www.nmtcb.org.

"Nuclear Medicine Advanced Associate" − A person, other than a licensed practitioner, who, as a nuclear medicine technologist with advanced training and certifications, performs a variety of activities under the direct, general or personal supervision of a licensed practitioner, who is also an authorized user of radioactive materials, in the areas of patient care, patient management, clinical imagine and invasive or therapeutic procedures. A Nuclear Medicine Advanced Associate may not make diagnoses or prescribe medications or therapies.

"Nuclear Medicine Technologist" – A person, other than a licensed practitioner, who administers radiopharmaceuticals and related drugs to human beings for diagnostic purposes, performs in vivo and in vitro detection and measurement of radioactivity and administers radiopharmaceuticals to human beings for therapeutic purposes. A nuclear medicine technologist may perform such procedures only while under the general supervision of a licensed practitioner who is licensed to possess and use radioactive materials.

"Nuclear Medicine Technology" – The science and art of in vivo and in vitro detection and measurement of radioactivity and the administration of radiopharmaceuticals to human beings for diagnostic and therapeutic purposes.

"PET" or "Positron Emission Tomography" − A nuclear medicine imaging technique that produces a three-dimensional image of functional processes in the body by detecting pairs of gamma rays emitted indirectly by a positron-emitting radionuclide.

"Portable X-Ray Service Provider" − A registrant who, under a physician's authorization, provides diagnostic x-ray procedures with hand-held or mobile radiographic equipment in a patient's place of residence.

"Radiation Therapist" – A person, other than a licensed practitioner, who performs procedures and applies ionizing radiation emitted from x-ray machines, particle accelerators, or sealed radioactive sources to human beings for therapeutic purposes while under the general supervision of a licensed practitioner who is licensed, as required, to possess and use radioactive materials.

"Radiation Therapy Technology" – The science and art of applying ionizing radiation emitted from x-ray machines, particle accelerators and sealed radioactive sources to human beings for therapeutic purposes.

"Radiologist Assistant" − A person, other than a licensed practitioner, who, as a medical radiographer with advanced-level training and certification, performs a variety of activities under the direct, general or personal supervision of a radiologist, certified by the American Board of Radiology or the American Osteopathic Board of Radiology, in the areas of patient care, patient management, clinical imaging and interventional procedures. The Radiologist Assistant may not interpret images, make diagnoses or prescribe medications or therapies.

"Recognized Continuing Education Evaluation Mechanism" or "RCEEM" − A mechanism for evaluating the content, quality and integrity of an educational activity. The evaluation shall include a review of educational objectives, content selection, faculty qualifications, and educational methods and materials. Among the requirements for qualification as an RCEEM, an organization shall be national in scope, non-profit, radiology based and willing to evaluate the CE activity developed by any technologist within a given discipline. Organizations with current RCEEM status may be found at https://www.arrt.org/partners/rceems.

"SPECT" or "Single Photon Emission Computed Tomography" – A nuclear medicine tomographic imaging technique using gamma rays.

"Supervision" – Responsibility for, and control of, quality, radiation safety and protection, and technical aspects of the application of ionizing radiation to human beings for diagnostic and/or therapeutic purposes. For purposes of this Part, supervision shall consist of one of the following:

Personal − The required individual must be in attendance in the room during the performance of the procedure.

Direct − The required individual must be present in at least an adjacent area and immediately available to furnish assistance and direction throughout the performance of the procedure.

General − The procedure is furnished under the overall direction and control of a licensed practitioner whose presence is not required during the performance of the procedure.

History

• Source: Amended at 44 Ill. Reg. 2488, effective January 22, 2020

32 Ill. Adm. Code 401.30 Exemptions

a) Nothing in the Act or this Part shall be construed to limit or affect in any respect, the practice of persons properly licensed under other statutes or regulations with respect to their professions.

b) The Agency shall, upon application therefor or upon its own initiative, grant such exemptions or exceptions from the requirements of this Part as it determines are authorized by law and will not result in a hazard to public health and safety.

c) Exemptions shall include:

1. A student enrolled in an approved program applicable to his/her profession who, as a part of his/her course of study, applies ionizing radiation to human beings while under the direct supervision of a licensed practitioner or medical radiation technologist who holds active status accreditation.

2. A person registered with the Agency as a student-in-training in limited diagnostic radiography pursuant to Section 401.90 who, as a student, applies ionizing radiation to human beings while under the personal supervision of a licensed practitioner or an accredited medical, chiropractic, or appropriately qualified limited diagnostic radiographer. The procedures performed shall be limited to the procedures listed in Appendix A and applicable to the particular status condition of limited diagnostic radiography for which the student is registered. This exemption shall only apply to individuals who are registered with the Agency and shall only apply for 16 months.

3. A person licensed to practice a treatment of human ailments by virtue of the Medical Practice Act of 1987, the Illinois Dental Practice Act, or the Podiatric Medical Practice Act of 1987.

4. A person employed as a dental assistant who performs dental radiography for a licensed dentist.

5. A technician, nurse or other assistant who performs radiography under the general supervision of a person licensed under the Podiatric Medical Practice Act of 1987.

6. A person who holds Conditional Accreditation Type II issued in accordance with Section 401.100(a) during such time as that person is under the personal supervision of a licensed practitioner or medical radiation technologist who holds active status accreditation for purposes of being instructed in the use of equipment and/or procedures other than those for which the person is currently accredited. This exemption is specific to the facility at which the accreditation is valid.

7. A nurse, technician, or other assistant who, under the general supervision of a person licensed under the Medical Practice Act of 1987, administers radiation to human beings, but only when such administration is performed on employees of a business at a medical facility owned and operated by that business.

8. A nurse, technician, or other assistant who, under the general supervision of a person licensed under the Medical Practice Act of 1987, performs bone densitometry.

9. An accredited nuclear medicine technologist who performs CT radiographic exams as part of a PET/CT or SPECT/CT combination exam.

10. An accredited nuclear medicine technologist or radiation therapist who, certified in CT by the ARRT or NMTCB, performs CT radiographic exams.

History

• Source: Amended at 44 Ill. Reg. 2488, effective January 22, 2020

32 Ill. Adm. Code 401.40 Application for Accreditation (repealed)

History

• Source: Repealed at 44 Ill. Reg. 2488, effective January 22, 2020

32 Ill. Adm. Code 401.50 Categories of Accreditation

The Agency shall accredit persons in the practice of Medical Radiation Technology in one or more of these specific categories:

a) Medical Radiography;

b) Nuclear Medicine Technology;

c) Radiation Therapy Technology;

d) Chiropractic Radiography;

e) Limited Diagnostic Radiography;

f) Radiologist Assistant; and

g) Nuclear Medicine Advanced Associate.

History

• Source: Amended at 37 Ill. Reg. 14008, effective August 22, 2013

32 Ill. Adm. Code 401.60 Examination Requirements (repealed)

History

• Source: Repealed at 31 Ill. Reg. 11622, effective July 26, 2007

32 Ill. Adm. Code 401.70 Examination Requirements

a) Persons who seek active or limited accreditation in medical radiation technology shall pass the appropriate examination as specified in subsection (b).

b) Examinations appropriate to category of accreditation are as follows:

1. Medical Radiography

The American Registry of Radiologic Technologists (R) (ARRT)

2. Nuclear Medicine Technology

A) The American Registry of Radiologic Technologists (N) (ARRT)

B) The Nuclear Medicine Technology Certification Board (NMTCB)

3. Radiation Therapy Technology

The American Registry of Radiologic Technologists (T) (ARRT)

4. Chiropractic Radiography

American Chiropractic Registry of Radiologic Technologists (ACRRT), provided that the examination was administered after June 30, 1984

5. Radiologist Assistant

A) The American Registry of Radiologic Technologists (RRA) (ARRT)

B) Certification Board for Radiology Practitioner Assistants (RPA) (CBRPA)

6. Nuclear Medicine Advanced Associate

The Nuclear Medicine Technologist Certification Board (NMAA) (NMTCB)

7. Limited Diagnostic Radiography

The American Registry of Radiologic Technologists (ARRT) Examination for the Limited Scope of Practice in Radiography

A) The exam will cover general radiography topics and, depending on the type of limited radiography sought, specific questions related to radiography of the chest, extremities, skull/sinus or spine.

B) Applicants shall follow all rules established by ARRT for the examination, including ARRT's right to bar applicants from the exam for misconduct or irregular behavior.

C) All exams shall be scheduled through the Agency.

D) The passing score shall be 65 percent for any combination

of sections of the exam.

History

• Source: Amended at 44 Ill. Reg. 2488, effective January 22, 2020

32 Ill. Adm. Code 401.80 Approved Program (repealed)

History

• Source: Repealed at 31 Ill. Reg. 11622, effective July 26, 2007

32 Ill. Adm. Code 401.90 Student-in-Training in Limited Diagnostic Radiography

a) A Student-in-Training in Limited Diagnostic Radiography shall be registered with the Agency on forms provided by the Agency.

b) A Student-in-Training in Limited Diagnostic Radiography shall not begin application of ionizing radiation to humans prior to the Agency's approval of the student's proposed training as identified through the Student-in-Training registration process.

c) A Student-in-Training in Limited Diagnostic Radiography may only perform those procedures listed in Appendix A that are applicable to the particular type of limited diagnostic radiography for which the student is registered, but only while under the personal supervision of a licensed practitioner or an accredited medical, chiropractic, or appropriately qualified limited diagnostic radiographer.

d) Students shall register for the examination to become accredited on a form prescribed by the Agency and shall pay the fee in accordance with Section 401.130(b).

e) Students shall not perform radiographic procedures beyond the 16 month registration period.

History

• Source: Amended at 44 Ill. Reg. 2488, effective January 22, 2020

32 Ill. Adm. Code 401.100 Application and Issuance of Accreditation

a) Any person applying to the Agency for initial accreditation or renewal of accreditation shall submit the appropriate application and pay the appropriate application fee in accordance with Section 401.130.

b) The Agency shall issue and recognize the following types of accreditation:

1. Active Status Accreditation for persons who have passed an examination as indicated in Section 401.70(b).

A) A Radiologist Assistant shall also submit a letter of agreement/delegation from a radiologist certified by the American Board of Radiology or the American Osteopathic Board of Radiology. An example letter may be found in Appendix D.

B) A Nuclear Medicine Advanced Associate shall also submit a letter of agreement/delegation from a licensed practitioner who is also an authorized user. An example letter may be found in Appendix E.

2. Temporary accreditation for persons who have completed an approved program in medical radiography, nuclear medicine technology or radiation therapy technology and are eligible for the examination specified in Section 401.70(b). Temporary Accreditation shall convey the same rights as the Active Status Accreditation for which the individual is awaiting examination.

3. Conditional Accreditation Type I for persons in a category of medical radiation technology upon determining that community hardship exists. When making a determination of the existence of community hardship, the Agency will consult with State, county or local health departments and will evaluate the availability of alternative radiology services and trained personnel.

4. Conditional Accreditation Type II. The Agency will not issue Conditional Accreditation Type II after September 7, 1990. However, Conditional Accreditation Type II issued on or before September 7, 1990, is renewable in accordance with Section 401.140.

5. Limited Diagnostic Radiography Accreditation for persons who have passed examinations as indicated in Section 401.70(b)(7).

c) All persons who have received accreditation from the Agency shall notify the Agency of any permanent or temporary change in their designated mailing address and of any change in name within 30 days after that change. Failure of the accredited individual to notify the Agency of any change shall not be considered a valid cause for delaying any subsequent administrative proceeding involving the particular accredited individual nor excuse the accredited individual from complying with any other legal obligations from the laws and rules administered by the Agency.

d) The duration of issuance of Active Status, Temporary, Conditional Type I, Conditional Type II or Limited Diagnostic Radiography Accreditation shall be 2 years. Temporary accreditation is nonrenewable.

e) The expiration date of a renewed accreditation that has been renewed on or before the expiration of the previous accreditation shall be 2 years from the expiration date of the previous accreditation. For renewal of accreditation that has lapsed, the expiration shall be 2 years from the last day of the month in which the application for renewal is processed.

History

• Source: Amended at 44 Ill. Reg. 2488, effective January 22, 2020

32 Ill. Adm. Code 401.110 Duration of Accreditation (repealed)

History

• Source: Repealed at 31 Ill. Reg. 11622, effective July 26, 2007

32 Ill. Adm. Code 401.120 Suspension, Revocation and Denial of Accreditation

a) The Agency may act to suspend or revoke an individual's accreditation, or refuse to issue or renew accreditation, for any one or a combination of the following causes:

1. Knowingly causing a material misstatement or misrepresentation to be made in the application for initial accreditation or renewal of accreditation if such misstatement or misrepresentation would impair the Agency's ability to assess and evaluate the applicant's qualifications for accreditation under this Part;

2. Knowingly making a false material statement to an Agency employee during the course of official Agency business;

3. Willfully evading the statute or regulations pertaining to accreditation, or willfully aiding another person in evading the statute or regulations pertaining to accreditation;

4. Performing procedures under or representing as valid to any person either a certificate of accreditation not issued by the Agency, or a certificate of accreditation containing on its face unauthorized alterations or changes that are inconsistent with Agency records regarding the issuance of that certificate;

5. Having been convicted of a crime that is a felony under the laws of this State or conviction of a felony in a federal court, unless the individual demonstrates to the Agency that he/she has been sufficiently rehabilitated to warrant the public trust (see subsection (b));

6. Exhibiting significant or repeated incompetence in the performance of professional duties;

7. Having a physical or mental illness or disability that results in the individual's inability to perform professional duties with reasonable judgment, skill and safety;

8. Continuing to practice medical radiation technology when knowingly having a potentially serious disease, such as those listed in 77 Ill. Adm. Code 690.100, which could be transmitted to patients;

9. Having an actual or potential inability to practice radiologic technology with reasonable skill and safety on patients or other individuals due to use of alcohol, narcotics or stimulants;

10. Having had a similar credential by another state or the District of Columbia suspended or revoked if the grounds for that suspension or revocation are the same as or equivalent to one or more grounds for suspension or revocation set forth in this Section;

11. Failing to meet child support orders as provided in 5 ILCS 100/10-65. The action will be based solely upon the certification of delinquency made by the Department of Healthcare and Family Services, Division of Child Support Enforcement, or its successor agency, or the certification of violation made by the court. Further process, hearing or redetermination of the delinquency or violation by the Agency shall not be required (see 5 ILCS 100/10-65(c));

12. Failing to pay a fee or civil penalty properly assessed by the Agency;

13. Failing to respond to an audit request by the Agency for documentation of continuing education;

14. Applying ionizing radiation to a human being when not operating in each particular case under the direction of a duly licensed practitioner or to any person or part of the human body other than specified in the law under which the practitioner is licensed;

15. Interpreting a diagnostic image for a physician, a patient, the patient's family or the public;

16. Performing in a way that deviates from accepted professional conduct; and

17. Engaging in conduct with a patient or another individual that is sexual, in any verbal behavior that is sexually demeaning to a patient, or in sexual exploitation of a patient or former patient. This applies to any unwanted sexual behavior, verbal or otherwise.

b) Applicant Convictions

1. The Agency shall not consider the following criminal history records in connection with an application for accreditation:

A) Juvenile adjudications of delinquent minors as defined in Section 5-105 of the Juvenile Court Act of 1987, subject to the restrictions set forth in Section 5-130 of the Juvenile Court Act of 1987 [705 ILCS 405];

B) Law enforcement records, court records, and conviction records of an individual who was 17 years old at the time of the offense and before January 1, 2014, unless the nature of the offense required the individual to be tried as an adult;

C) Records of arrest not followed by a conviction;

D) Convictions overturned by a higher court; or

E) Convictions or arrests that have been sealed or expunged.

2. The Agency, upon a finding that an applicant for accreditation was convicted of a felony, shall consider any evidence of rehabilitation and mitigating factors contained in the applicant's record, including any of the following factors and evidence, to determine if the conviction will impair the ability of the applicant to engage in the position for which accreditation is sought:

A) The lack of direct relation of the offense for which the applicant was previously convicted to the duties, functions and responsibilities of the position for which a license is sought;

B) Whether 5 years since a felony conviction, or 3 years since release from confinement for the conviction, whichever is later, have passed without a subsequent conviction;

C) If the applicant was previously licensed or employed in this State or other states or jurisdictions, then the lack of prior misconduct arising from or related to the licensed position or position of employment;

D) The age of the person at the time of the criminal offense;

E) Successful completion of sentence and, for applicants serving a term of parole or probation, a progress report provided by the applicant's probation or parole officer that documents the applicant's compliance with conditions of supervision;

F) Evidence of the applicant's present fitness and professional

character;

G) Evidence of rehabilitation or rehabilitative effort during or after incarceration, or during or after a term of supervision, including, but not limited to, a certificate of good conduct under Section 5-5.5-25 of the Unified Code of Corrections or a certificate of relief from disabilities under Section 5-5.5-10 of the Unified Code of Corrections; and

H) Any other mitigating factors that contribute to the person's potential and current ability to perform the duties and responsibilities of the position for which accreditation is sought.

3. If the Agency refuses to issue accreditation to an applicant, then the Agency shall notify the applicant of the denial in writing, with the following included in the notice of denial:

A) A statement about the decision to refuse to grant the accreditation;

B) A list of the convictions that the Agency determined will impair the applicant's ability to engage in the position for which accreditation is sought;

C) A list of convictions that formed the sole or partial basis for the refusal to issue accreditation; and

D) A summary of the appeal process or the earliest the applicant may reapply for accreditation, whichever is applicable.

c) If, based upon any of the grounds in subsection (a), the Agency determines that action to suspend or revoke accreditation, or refusal to issue or renew accreditation, is warranted, the Agency shall notify the individual and shall provide an opportunity for a hearing in accordance with 32 Ill. Adm. Code 200. An opportunity for a hearing shall be provided before the Agency takes action to suspend or revoke an individual's accreditation unless the Agency finds that an immediate suspension of accreditation is required to protect against immediate danger to the public health or safety (see 420 ILCS 40/38), in which case the Agency shall suspend an individual's accreditation pending a hearing.

d) If the Agency finds that removal or refusal to issue or renew accreditation is warranted, the usual action shall be a suspension or denial of accreditation for up to one year. The term of suspension or denial may be reduced by the Director, based upon evidence presented, if the conditions leading to the Preliminary Order for Suspension can be cured in less than one year. In the case of frequent child support arrearages, the Agency may also impose conditions, restrictions or disciplinary action upon the accreditation. However, if the Agency finds that the causes are of a serious or continuous nature, such as past actions that posed an immediate threat to public health or safety, deficiencies that cannot be cured within one year or frequent child support arrearages, the Agency shall revoke the individual's accreditation or deny the application.

e) When an individual's accreditation is suspended or revoked, the individual shall surrender his/her credential to the Agency until the termination of the suspension period or until reissuance of the accreditation.

f) An individual whose accreditation has been revoked may seek reinstatement of accreditation by submitting to the Agency an application with the appropriate fee. The application may be filed one year or more after the beginning of the revocation period.

History

• Source: Amended at 44 Ill. Reg. 2488, effective January 22, 2020

32 Ill. Adm. Code 401.130 Fees

a) The fees for initial or renewal of accreditation in all categories − Active, Conditional, Temporary or Limited Status shall be $120 per application.

b) The examination fee for Limited Diagnostic Radiography Accreditation shall be $140 for the categories of Chest, Extremities, Spine, Skull and Sinuses, or any combination thereof. The fee amount is set by ARRT to cover the costs of providing the examination. The required fee shall be paid by:

1. Cashier's check or money order made payable to ARRT (personal and business checks will not be accepted). The Agency will submit the payment to ARRT; or

2. Credit card. Instructions for paying by credit card will be provided by the Agency upon receipt of the application. Failure to pay after instructions are provided will delay scheduling of the examination.

c) The appropriate fees are to accompany the application when filing with the Agency, except as provided in subsection (b)(2). All fees under this Section are nonrefundable and nontransferable. An application is filed on the date that it is received and stamped by the Agency.

History

• Source: Amended at 44 Ill. Reg. 2488, effective January 22, 2020

32 Ill. Adm. Code 401.140 Renewal of Accreditation

a) Prerequisites

1. An individual shall make application for renewal of accreditation on or before the expiration date of the accreditation. Accreditation shall lapse if not renewed within this time period and an individual may not legally perform medical radiation technology without valid accreditation, or without the expressed approval of the Agency during the time an application is pending. The approval shall be limited to the applicant who meets all requirements for accreditation and requires additional time for the filing of continuing education records, or is undergoing an Agency audit of continuing education records.

2. Each applicant shall submit a complete and legible application with the fee for renewal of accreditation in accordance with Section 401.130. Submission of a complete application for renewal on or before the expiration date of the accreditation shall hold the prior accreditation valid until the Agency acts to grant or deny renewal of accreditation. The Agency will grant or deny renewal of accreditation within 90 days after receipt of application for renewal or the expiration date of the current accreditation, whichever is later.

3. For those individuals who have Conditional Accreditation Type II that was issued on or before September 7, 1990, issuance of the renewal is contingent upon submission of a written Statement of Assurance that the individual is competent to apply ionizing radiation to human beings. The Statement of Assurance submitted to the Agency shall specify the nature of the equipment and procedures the individual is competent to utilize. The Statement of Assurance shall be on file or a new Statement shall be provided by a licensed practitioner under whose general supervision the individual is employed or has been employed. Conditional accreditation issued pursuant to this Section shall be specific to the procedures and equipment indicated in the Statement of Assurance. Renewal shall be for a two-year period.

b) Continuing Education Requirements

All applicants for renewal of accreditation shall have participated in an approved program that includes the amount of continuing education as indicated in subsection (b)(1):

1. The required effort in continuing education credits for each category of medical radiation technology is as follows:

A)

Medical Radiology

24 CE credits

B)

Nuclear Medicine Technology

24 CE credits

C)

Radiation Therapy Technology

24 CE credits

D)

Chiropractic Radiology

24 CE credits

E)

Limited Diagnostic Radiography

12 CE credits

F)

Radiologist Assistant

50 CE credits

G)

Nuclear Medicine Advanced

Associate

48 CE credits

2. The options for meeting the CE requirements are:

A) A continuing education activity approved by the Agency. Relevant CE activities will be approved if submitted 30 days in advance, with appropriate documentation consisting of:

i) The Agency's CE approved request form;

ii) Course Outline;

iii) Course Objectives; and

iv) Instructor's curriculum vitae.

B) Category A Activities – A continuing education activity that meets one of the following criteria:

i) Activities approved by an RCEEM.

ii) Approved academic courses offered by a post-secondary educational institution that are relevant to the radiologic sciences and/or patient care. Courses in the biologic sciences, physical sciences, communication (verbal and written), mathematics, computers, management or education methodology are considered relevant. Credit will be awarded at the rate of 12 CE credits for each academic quarter or 16 CE credits for each academic semester credit.

iii) Advanced Life Support, or Instructor or Instructor Trainer CPR certification through the Heart Association or the Red Cross will be awarded 6 CE credits.

AGENCY NOTE: Illinois is currently approved as meeting ARRT CE criteria. As such, technologists accredited by the Agency may count all Agency approved CE activities as Category A.

3. Individual courses may be applicable to more than one category of accreditation.

4. All technologists accredited by the Agency are required to maintain proof of participation in CE activities. This proof may be in the form of a certificate or an itemized list from an ARRT approved record keeping mechanism. All documentation shall include:

A) Name of participant;

B) Dates of attendance;

C) Title and content of the activity;

D) Number of contact hours for the activity;

E) Name of the sponsor;

F) Signature of the instructor or an authorized representative of the sponsor issuing the documentation; and

G) A reference number if the activity has been approved by an RCEEM or the Agency.

5. Technologists seeking renewal will be required to attest that they have acquired the required number of CE credits. Within 30 days after receipt of this attestation, the Agency may perform an audit in which the individual will be asked to provide copies of documentation of CE. Failure to respond to the Agency's audit request and/or failure to provide acceptable documentation may result in a refusal to renew accreditation as provided in Section 401.120(a)(13).

6. Technologists who are registered with ARRT, NMTCB, or CBRPA and who are in compliance with CE requirements or on CE probation at the time of renewal with the Agency will be considered in compliance with the CE requirements of this Part.

c) Nonrenewal of Accreditation

1. The Agency shall not renew an individual's accreditation if he/she fails to present satisfactory evidence that he/she possesses the necessary qualifications for accreditation, and that he/she has participated in an approved continuing education program in accordance with this Part.

2. If the Agency does not find satisfactory evidence that the individual meets these requirements, the Agency shall, within 90 days after receipt of the application for renewal of accreditation or the expiration date of the current accreditation, whichever is later, send the individual a Notice of Intent Not to Renew Accreditation. This notice shall include the areas of deficiency and the individual's rights as set forth in this Section.

3. The individual, at any time while an application is pending, may submit additional information to the Agency in order to establish that the identified areas of deficiency have been met or corrected.

4. If the applicant does not provide additional information to the Agency within the time frame specified in the Notice of Intent Not to Renew Accreditation, the Agency shall issue a Notice of Accreditation Denied.

5. An individual's current credential shall be invalid as of the date of his/her receipt of a Notice of Accreditation Denied pursuant to subsection (c)(4). After the Agency has sent the Notice of Accreditation Denied, the individual may request a hearing within 30 days in accordance with 32 Ill. Adm. Code 200.70.

6. If an individual's accreditation is not renewed, he/she shall have the right at any time to submit an application for renewal of accreditation. The application shall be reviewed and processed in accordance with the requirements of this Section, except that an individual may not legally apply ionizing radiation to human beings until and unless the Agency has acted to grant the application for renewal of accreditation.

History

• Source: Amended at 44 Ill. Reg. 2488, effective January 22, 2020

32 Ill. Adm. Code 401.150 Reciprocity (repealed)

History

• Source: Repealed at 31 Ill. Reg. 11622, effective July 26, 2007

32 Ill. Adm. Code 401.160 Additional Requirements for Radiographers Performing Mammography (repealed)

History

• Source: Repealed at 31 Ill. Reg. 11622, effective July 26, 2007

32 Ill. Adm. Code 401.170 Civil Penalties

a) The Agency shall assess civil penalties, in accordance with subsections (c) and (d), against any person who performs, and against the operator of the radiation installation where a person performs, medical radiation procedures without valid accreditation, unless the person performing the medical radiation procedures is specifically exempt from the accreditation requirements as specified in Section 401.30.

b) Prior to assessing civil penalties, the Agency shall confirm the violation of the accreditation requirements by:

1. Observation of the violation;

2. Obtaining records, documents or other physical evidence;

3. Obtaining statements from either the employer or the employee that confirm the existence of the violation; or

4. Obtaining statements from third parties, e.g., patients or co-workers, that corroborate the allegation that a violation has occurred.

c) Civil penalties shall be assessed against persons who perform medical radiation procedures without valid accreditation as follows:

1. First violation by an individual who is fully qualified for accreditation but has failed to apply for initial, or renewal of, accreditation at the time the violation is discovered:

A)

In violation 30 days or less

$100

B)

In violation 31 through 90 days

$150

C)

In violation greater than 90 days

$250

2. First violation by a person who is not qualified for accreditation at the time the violation is discovered is $500.

3. Second and subsequent violations by an individual, whether qualified or not, shall be assessed civil penalties using the factors set out in 32 Ill. Adm. Code 310.81(c). The Agency may assess a civil penalty not to exceed $10,000 per violation for each day the violation continues.

4. Any violation involving presentation of falsified accreditation certificates or any other documents used to meet accreditation qualifications may be assessed civil penalties using the factors set out in 32 Ill. Adm. Code 310.81(c). The Agency may assess a civil penalty not to exceed $10,000 per violation for each day the violation continues.

d) Civil penalties shall be assessed against the operators of a radiation installation where an individual performs medical radiation procedures without valid accreditation as follows:

1. First violation by an operator shall be double the fine assessed against the individual performing radiography without accreditation.

2. Second and subsequent violations by an operator shall be assessed a civil penalty using the factors set out in 32 Ill. Adm. Code 310.81(c). The Agency may assess a civil penalty not to exceed $10,000 per violation for each day the violation continues.

e) The Agency may commence administrative proceedings for the assessment and collection of civil penalties by sending a Notice of Violation. The Notice shall give the individual/operator of a radiation installation an opportunity to pay the penalty without further action from the Agency.

f) Failure of an individual/operator of a radiation installation to abate an accreditation violation or to pay the civil penalty as directed shall cause the Agency to issue a Preliminary Order and Notice of Opportunity for Hearing as provided in 32 Ill. Adm. Code 200.60.

History

• Source: Amended at 44 Ill. Reg. 2488, effective January 22, 2020

32 Ill. Adm. Code 401.APPENDIX A Limited Diagnostic Radiography Procedures by Type of Limited Accreditation

a) Limited Diagnostic Radiography – Chest

• Chest: Routine P.A. and Lateral

• Chest: Lateral Decubitus, Apical Lordotic, Obliques

• Ribs

b) Limited Diagnostic Radiography – Extremities

• Fingers

• Hand

• Wrist

• Forearm

• Elbow

• Humerus

• Shoulder

• Clavicle

• Scapula

• Toes

• Foot

• Ankle

• Lower leg

• Knee

• Patella

• Femur

• Hip/Pelvis

c) Limited Diagnostic Radiography – Spine

• Cervical Spine

• Thoracic Spine

• Lumbar Spine

• Lumbosacral Spine

• Sacroiliac Joints

• Sacrum

• Coccyx

• Pelvis

d) Limited Diagnostic Radiography – Skull and Sinuses

• Skull

• Paranasal Sinuses

• Mandible

• Facial bones

History

• Source: Amended at 31 Ill. Reg. 11622, effective July 26, 2007

32 Ill. Adm. Code 401.APPENDIX B Example Topics Directly Related to Radiologic Sciences (repealed)

History

• Source: Repealed at 31 Ill. Reg. 11622, effective July 26, 2007

32 Ill. Adm. Code 401.APPENDIX C Minimum Training Requirements for Radiographers Performing Mammography (repealed)

History

• Source: Repealed at 31 Ill. Reg. 11622, effective July 26, 2007

32 Ill. Adm. Code 401.APPENDIX D Example Letter of Agreement for Radiologist Assistant

Technologist Accreditation Program

Illinois Emergency Management Agency

1035 Outer Park Dr.

Springfield IL 62704

Re: (Name of Applicant)

To whom it may concern:

This letter is to serve as acknowledgement that (Name of Applicant) will be employed by (Name of Radiology Group or Facility) under my supervision. (Name of Applicant) will, as a radiologist assistant, perform a variety of activities in the areas of patient care, patient management, clinical imaging and interventional procedures. It is also recognized that (he/she) may not interpret images, make diagnosis or prescribe medications or therapies.

I am a radiologist, licensed by the State of Illinois as a physician, and certified by the American Board of Radiology or the American Osteopathic Board of Radiology (select the appropriate Board).

Sincerely,

Physician's Name (Typed)

History

• Source: Added at 37 Ill. Reg. 14008, effective August 22, 2013

32 Ill. Adm. Code 401.APPENDIX E Example Letter of Agreement for Nuclear Medicine Advanced Associate

Technologist Accreditation Program

Illinois Emergency Management Agency

1035 Outer Park Dr.

Springfield IL 62704

Re: (Name of Applicant)

To whom it may concern:

This letter is to serve as acknowledgement that (Name of Applicant) will be employed by (Name of Radiology Group or Facility) under my supervision. (Name of Applicant) will, as a nuclear medicine advanced associate, perform a variety of activities in the areas of patient care, patient management, clinical imaging and interventional procedures. It is also recognized that (he/she) may not interpret images, make diagnosis or prescribe medications or therapies.

I am a physician, licensed by the State of Illinois, whose name appears as an authorized user on Radioactive Materials License (License Number) issued by the Illinois Emergency Management Agency.

Sincerely,

Physician's Name (Typed)

History

• Source: Added at 37 Ill. Reg. 14008, effective August 22, 2013

Part 405 Certification of Individuals to Perform Industrial Radiography

32 Ill. Adm. Code 405.10 Purpose and Scope

a) This Part establishes a program to certify persons to perform industrial radiography. Specifically, this Part provides:

1. Minimum standards for training and experience for persons who perform industrial radiography;

2. Application and examination requirements for certification and recertification;

3. Standards for the recognition of certification by other parties;

4. Provisions for the suspension or revocation of certification; and

5. Civil penalties.

b) This Part applies to any person who performs industrial radiography in this State. For purposes of this Part, industrial radiography does not include radiography performed with Lixiscopes or cabinet x-ray systems, nor does it include computed tomography or computer-based digital radiography in which the useful beam of radiation is collimated to detectors.

32 Ill. Adm. Code 405.20 Definitions

As used in this Part, the following definitions shall apply:

"Act" means the Radiation Protection Act of 1990 [420 ILCS 40].

"Agency" means the Illinois Emergency Management Agency.

"Approved Training Program" means a program that the Agency has determined is adequate to prepare individuals to meet the training requirements prescribed in Appendix A.

"Cabinet x-ray system" means an x-ray system with the x-ray tube installed in an enclosure which, independent of existing architectural structures except the floor on which it may be placed, is intended to contain at least that portion of a material being irradiated, provide radiation attenuation and exclude personnel from its interior during generation of x radiation. Included are all x-ray systems designed primarily for the inspection of carry-on baggage at airline, railroad, bus terminals and similar facilities. An x-ray tube used within a shielded part of a building or x-ray equipment that may temporarily or occasionally incorporate portable shielding is not considered a cabinet x-ray system.

"Certification" means the authorization by the Illinois Emergency Management Agency of an individual to perform industrial radiography in Illinois.

"Certified Industrial Radiographer" means an individual who has met prescribed training and experience requirements and has passed an approved examination and is authorized by the Agency, pursuant to Section 405.90(a), to perform industrial radiography.

"Certified Industrial Radiographer Trainee" means an individual who is authorized by the Agency, pursuant to Section 405.90(b), to be instructed in industrial radiography and who may perform industrial radiography while under the personal supervision of a Certified Industrial Radiographer.

AGENCY NOTE: Instruction in industrial radiography for trainees certified by the Agency includes on-the-job and field experience.

"Director" means the Director of the Illinois Emergency Management Agency.

"Industrial Radiography" means the process used to perform the examination of the macroscopic structure of materials by non-destructive methods using radioactive materials or radiation machines. For purposes of this Part, industrial radiography does not include radiography performed with Lixiscopes or cabinet x-ray systems, nor does it include computed tomography or computer-based digital radiography in which the useful beam of radiation is collimated to detectors.

"Industrial Radiography − Radiation Machines" means the process of performing industrial radiography using radiation producing machines.

"Industrial Radiography − Radioactive Materials" means the process of performing industrial radiography using radioactive materials.

"Lixiscope" means a portable light-intensified imaging device using a sealed source.

"Personal supervision" means supervision provided by a Certified Industrial Radiographer who is physically present at the immediate site where sources of radiation and associated equipment are being used, visually evaluating the performance of the Certified Industrial Radiographer Trainee and in such proximity that immediate assistance can be given if required.

"Radiographic exposure device" means any instrument containing a sealed source fastened or contained therein, in which the sealed source or shielding thereof may be moved, or otherwise changed, from a shielded to unshielded position for purposes of making a radiographic exposure.

History

• Source: Amended at 32 Ill. Reg. 13161, effective July 24, 2008

32 Ill. Adm. Code 405.30 Application for Certification

a) Any individual applying to the Agency for certification to perform industrial radiography shall:

1. Submit a complete and legible application on a form prescribed by the Agency;

2. Pay the appropriate non-refundable application fee in accordance with Section 405.110;

3. Meet the examination requirements set forth in Section 405.50 or satisfy the requirements for certification based on reciprocity as set forth in Section 405.120; and

4. Provide evidence that the requirements for the given category and class for which certification is sought have been met.

b) The appropriate fee shall accompany the application when filing with the Agency. An application shall be deemed filed on the date that it is received by the Agency or on the date that it is postmarked by the United States Postal Service or equivalent.

c) The Agency shall refuse to issue or renew certification to any individual if the Agency has evidence that the applicant is delinquent in the repayment of an educational loan guaranteed by the Illinois Student Assistance Commission, as set forth in 20 ILCS 3310/80.

d) The Agency shall refuse to issue or renew certification to any individual, after an opportunity for a hearing, if the Agency has evidence that the applicant is delinquent in the payment of child support orders, pursuant to the provisions and procedures set forth in 5 ILCS 100/10-65. Further process, hearing, or redetermination of the delinquency or violation by the Agency shall not be required if the refusal is based solely upon the certification of delinquency made by the Illinois Department of Healthcare and Family Services (or successor agency) or the certification of violation made by the court. The Agency may issue or renew a certification if the applicant has arranged for payment of past and current child support obligations in a manner satisfactory to the Illinois Department of Healthcare and Family Services (or successor agency). The Agency may also impose conditions, restrictions or disciplinary action upon the certification.

History

• Source: Amended at 32 Ill. Reg. 13161, effective July 24, 2008

32 Ill. Adm. Code 405.40 Categories of Certification

a) The Agency shall certify individuals to perform industrial radiography in one or more of the following categories:

1. Certified Industrial Radiographer; or

2. Certified Industrial Radiographer Trainee.

b) Each certification issued shall include a class endorsement for the type of industrial radiography authorized. Such class endorsements are limited to:

1. Radioactive Materials;

2. Radiation Machines; or

3. Radioactive Materials and Radiation Machines.

History

• Source: Amended at 32 Ill. Reg. 13161, effective July 24, 2008

32 Ill. Adm. Code 405.50 Examination Requirements

a) An individual who seeks certification or renewal of certification as a Certified Industrial Radiographer shall have passed, within 12 months prior to application for certification, a written examination appropriate to the category and class of certification sought in accordance with Section 405.60.

b) Application for examination or re-examination shall be on forms prescribed by the Agency and shall include the appropriate fee specified by Section 405.110. Examination fees are non-refundable.

c) Examinees shall present photographic identification (e.g., drivers license) at the time of examination.

History

• Source: Amended at 32 Ill. Reg. 13161, effective July 24, 2008

32 Ill. Adm. Code 405.60 Examinations

a) The Agency shall administer examinations in each class of industrial radiography as specified in Section 405.40(b) at such times and places as the Agency determines necessary.

1. The examination shall be available through the Conference of Radiation Control Program Directors, Inc.

2. The passing score shall be 70 percent.

3. A candidate who fails an examination may apply for re-examination in accordance with Section 405.50.

b) The Agency shall accept or utilize alternative examinations provided that the examinations are found acceptable by the U.S. Nuclear Regulatory Commission or the Conference of Radiation Control Program Directors, Inc.

History

• Source: Amended at 32 Ill. Reg. 13161, effective July 24, 2008

32 Ill. Adm. Code 405.70 Approved Training Program

Industrial radiographer training programs shall be approved by the Agency. The Agency shall recognize other programs approved by another state or jurisdiction provided that such programs consist of standards and procedures that are the same or comparable to the standards and procedures established by the Radiation Protection Act of 1990 and this Part. The Agency shall base its approval on information provided by the training program that shall include:

a) Curriculum information sufficient to assure inclusion of subjects referenced in Appendix A;

b) Copies of test questions and answers and other evaluation tools and criteria used to demonstrate a participant's comprehension of subject matter in Appendix A; and

c) Resumes of instructors.

History

• Source: Amended at 32 Ill. Reg. 13161, effective July 24, 2008

32 Ill. Adm. Code 405.80 Experience Requirements for Certification

Applicants for certification to perform industrial radiography shall have a minimum of experience appropriate to each category and class of industrial radiography as follows:

a) Certified Industrial Radiographer

Radioactive Materials................................................

200 hrs

Radiation Machines...................................................

120 hrs

Both Radioactive Materials and Radiation................

320 hrs

Machines of which not less than 200 hours shall be with radioactive materials and not less than 120 hours shall be with radiation machines.

b) Certified Industrial Radiographer Trainee. No prior experience required.

History

• Source: Amended at 26 Ill. Reg. 3483, effective February 25, 2002

32 Ill. Adm. Code 405.90 Requirements for Issuance of Certification

The Agency shall certify in a category and class of industrial radiography any individual who has satisfied the following requirements:

a) Certified Industrial Radiographer

1. Submitted an application for certification on a form prescribed by the Agency;

2. Submitted the application fee specified in Section 405.110(a);

3. Passed an examination as required by Section 405.50(a) or satisfies the requirements for certification based on reciprocity as set forth in Section 405.120; and

4. Completed the required hours of experience in industrial radiography as specified in Section 405.80 or satisfies the requirements for certification based on reciprocity as set forth in Section 405.120.

b) Certified Industrial Radiographer Trainee

1. Submitted an application for certification on a form prescribed by the Agency;

2. Submitted the application fee specified in Section 405.110(a); and

3. Submitted documentation of successful completion of an approved training program as specified in Section 405.70 or satisfies the requirements for certification based on reciprocity as set forth in Section 405.120.

AGENCY NOTE: Training includes didactic study incorporating those topics included in Appendix A. Training does not include on-the-job experience.

History

• Source: Amended at 32 Ill. Reg. 13161, effective July 24, 2008

32 Ill. Adm. Code 405.100 Duration of Certification

The duration of certification issued by the Agency shall be:

a)

Certified Industrial Radiographer..........................

5 years

b)

Certified Industrial Radiographer Trainee.............

2 years

History

• Source: Amended at 32 Ill. Reg. 13161, effective July 24, 2008

32 Ill. Adm. Code 405.110 Fees

a) The application fees for examination or certification are non-refundable and are as follows:

Each application for examination by the Agency...........................

$150

Each application for certification

A)

Certified Industrial Radiographer........................................

$125

B)

Certified Industrial Radiographer Trainee...........................

$125

b) The appropriate fees shall accompany the application when filing with the Agency.

History

• Source: Amended at 37 Ill. Reg. 20235, effective December 9, 2013

32 Ill. Adm. Code 405.120 Reciprocity

a) The Agency may issue certification to an applicant who has been certified in another state or jurisdiction, or by the American Society of Nondestructive Testing (ASNT), provided that:

1. The applicant holds a valid certification in the appropriate category and class issued by another state or jurisdiction or by the ASNT;

2. The standards and procedures for the certification issued by the state, jurisdiction or ASNT are the same or comparable to the certification standards established by or pursuant to the Radiation Protection Act of 1990 and this Part;

3. The applicant presents a legible copy of the certification document issued by the other state or jurisdiction, or by the ASNT, to the Agency; and

4. The applicant submits the application fee in accordance with Section 405.110(a).

b) Individuals who are certified by reciprocity shall either:

1. Maintain the certification upon which the reciprocal certification was issued; or

2. Satisfy the requirements of Section 405.90 prior to the expiration of the certification upon which reciprocal certification was issued.

c) Enforcement actions by the Agency, another agreement state or the Nuclear Regulatory Commission, or sanctions by an independent certifying entity may be considered when the Agency reviews a request for reciprocal recognition from a certified radiographer.

d) The Agency may refuse to issue or renew a certification under this Section for any one or a combination of the causes in Section 405.140.

History

• Source: Amended at 37 Ill. Reg. 20235, effective December 9, 2013

32 Ill. Adm. Code 405.130 Requirements for Renewal of Certification

a) Prerequisites

1. An individual shall submit an application for renewal of certification on or before the expiration date of certification. An individual may not perform industrial radiography without valid certification or without the written approval of the Agency during such time as an application may be pending.

2. Each applicant shall submit a complete and legible application with the fee for renewal of certification in accordance with Section 405.110(a)(2)(A).

b) Re-examination. Applicants for renewal of certification shall meet the requirements of Section 405.50(a).

c) Certification as a Certified Industrial Radiographer Trainee is non-renewable and will not be re-issued for any other type of industrial radiography.

History

• Source: Amended at 32 Ill. Reg. 13161, effective July 24, 2008

32 Ill. Adm. Code 405.140 Suspension, Revocation and Denial of Certification

a) The Agency may act to suspend or revoke an individual's certification or refuse to issue or renew certification, for any one or a combination of the following causes:

1. Knowingly causing a material misstatement or misrepresentation to be made in the application for initial certification or renewal of certification if such misstatement or misrepresentation would impair the Agency's ability to assess and evaluate the applicant's qualifications for certification pursuant to this Part;

2. Knowingly making a false material statement to an Agency employee during the course of official Agency business;

3. Knowingly falsifying records of employees when such falsification would impair the Agency's ability to assess and evaluate the applicant's qualifications for certification pursuant to this Part;

4. Willfully evading the statute or regulations pertaining to certification, or willfully aiding another person in evading such statute or regulations pertaining to certification;

5. Performing procedures under, or representing as valid to any person, a certification issued by the Agency containing on its face unauthorized alterations or changes that are inconsistent with Agency records regarding the issuance of that certification;

6. Performing procedures under, or representing as valid to any person, a credential not issued by the Agency to prove certification in Illinois;

7. Having been convicted of a crime which is a felony under the laws of this State or conviction of a felony in a federal court, unless the individual demonstrates to the Agency that he/she has been sufficiently rehabilitated to warrant the public trust;

8. Exhibiting significant or repeated incompetence in the performance of industrial radiography duties;

9. Having a physical or mental illness or disability that results in the individual's inability to perform industrial radiography duties with reasonable judgment, skill and safety;

10. Performing industrial radiography in such a manner that requirements of 32 Ill. Adm. Code 350 are violated resulting in a threat to health and safety of the individual, other workers or the public;

11. Having an actual or potential inability to perform industrial radiography duties with reasonable judgment, skill and safety due to the use of alcohol, narcotics or stimulants;

12. Having had a similar certification suspended or revoked if the grounds for that suspension or revocation are the same or equivalent to one or more grounds for suspension or revocation as set forth in this subsection (a);

13. Failure to maintain the out-of-state certification upon which certification by reciprocity was issued;

14. Failure to repay educational loans guaranteed by the Illinois Student Assistance Commission, as provided in 20 ILCS 3310/80;

15. Failure to meet child support orders, as provided in 5 ILCS 100/10-65; and

16. Failure to pay a fee or civil penalty properly assessed by the Agency.

b) If, based upon any of the grounds in subsection (a) of this Section, the Agency determines that action to suspend or revoke certification, or refusal to issue or renew certification, is warranted, the Agency shall notify the individual and shall provide an opportunity for a hearing in accordance with 32 Ill. Adm. Code 200. An opportunity for a hearing shall be provided before the Agency takes action to suspend or revoke an individual's certification unless the Agency finds that an immediate suspension of certification is required to protect against immediate danger to the public health or safety (see 420 ILCS 40/38), in which case the Agency shall suspend an individual's certification pending a hearing. The Agency shall revoke or suspend, or shall refuse to issue or renew certification under subsection (a)(15) of this Section based solely upon the certification of delinquency made by the Illinois Department of Healthcare and Family Services (or successor agency) or the certification of violation made by the court. Further process, hearing, or redetermination of the delinquency or violation by the Agency shall not be required. The Agency may issue or renew a certification if the individual has arranged for payment of past and current child support obligations in a manner satisfactory to the Illinois Department of Healthcare and Family Services (or successor agency) or the court. The Agency may impose conditions, restrictions, or disciplinary action upon that certification. [5 ILCS 100/10-65(c)]

c) If the Agency finds that removal or refusal to issue or renew certification is warranted, the usual action shall be a suspension or denial of certification for up to one year. The term of suspension may be reduced by the Director, based upon evidence presented, if the conditions leading to the Preliminary Order for Suspension can be cured in less than one year. However, if the Agency finds that the causes are of a serious or continuous nature, such as past actions which posed an immediate threat to occupational or public health or safety, deficiencies that cannot be cured within one year or frequent child support arrearages, the Agency shall revoke the individual's certification or deny the application.

d) When an individual's certification is suspended or revoked, the individual shall surrender his/her certification document to the Agency until the termination of the suspension period or until reissuance of the certification.

e) An individual whose certification has been revoked may seek reinstatement of certification by filing with the Agency a petition for reinstatement. The petition may be filed one year or more after the beginning of the revocation period. The individual shall be afforded a hearing in accordance with 32 Ill. Adm. Code 200 and shall bear the burden of proof of establishing that the certification should be reinstated due to rehabilitation or other just cause.

History

• Source: Amended at 32 Ill. Reg. 13161, effective July 24, 2008

32 Ill. Adm. Code 405.150 Civil Penalties

a) The Agency shall assess civil penalties, in accordance with subsection (c) of this Section, against any individual who performs industrial radiography without valid certification.

AGENCY NOTE: Licensees and registrants that allow individuals who are not certified to perform industrial radiography are also subject to civil penalties. These penalties are assessed pursuant to 32 Ill. Adm. Code 310.

b) Prior to assessing civil penalties, the Agency shall confirm the violation of the certification requirements by:

1. Observation of the violation;

2. Obtaining records, documents or other physical evidence;

3. Obtaining statements from either the employer or the employee which confirm the existence of the violation; or

4. Obtaining statements from third parties (e.g., co-workers) that corroborate the allegation that a violation has occurred.

c) Civil penalties shall be assessed against individuals who perform industrial radiography without certification (i.e., uncertified radiographer) as follows:

1. First violation by an uncertified individual − $250.

2. Second violation by an uncertified individual − $500.

3. Third and subsequent violation by an uncertified individual − $1,000 for each violation.

d) The Agency may commence administrative proceedings for the assessment and collection of civil penalties by sending a Notice of Violation. The Notice shall give the individual an opportunity to pay the penalty without further action from the Agency.

e) Failure of an individual to abate a certification violation or to pay the civil penalty as directed may cause the Agency to issue a Preliminary Order and Notice of Opportunity for Hearing as provided in 32 Ill. Adm. Code 200.

History

• Source: Amended at 32 Ill. Reg. 13161, effective July 24, 2008

32 Ill. Adm. Code 405.APPENDIX A Minimum Training Requirements for Industrial Radiography Applicable to Radioactive Materials and Radiation Machines

a) Fundamentals of Radiation Safety

1. Characteristics of radiation

2. Units of radiation dose and quantity of radioactivity

3. Significance of radiation dose

A) Radiation protection standards

B) Biological effects of radiation

4. Levels of radiation from sources of radiation

5. Methods of controlling radiation dose

A) Working time

B) Working distances

C) Shielding

b) Radiation Detection Instrumentation to be Used

1. Use of radiation survey instruments

A) Operation

B) Calibration

C) Limitations

2. Survey techniques

3. Use of personnel monitoring equipment

A) Film badges

B) Thermoluminescent dosimeters (TLDs) or optically stimulated luminescence dosimeters (OSLs)

C) Pocket dosimeters

D) Alarm ratemeter

c) The Requirements of Pertinent Federal and State Regulations

d) Written Operating and Emergency Procedures

e) Case Histories of Radiation Accidents

f) Radiography Equipment to be Used

1. For Industrial Radiography Using Radioactive Material

A) Remote handling equipment

B) Radiographic exposure devices and sealed sources

C) Storage containers

D) Inspection, maintenance, operation and control of radiography equipment

E) Demonstration of competency to safely perform radiographic procedures using a simulated source of radioactive material

2. For Industrial Radiography Using Radiation Machines

A) Remote exposure equipment

B) Radiation machine exposure equipment

C) Inspection, maintenance, operation and control of radiography equipment

D) Demonstration of competency to safely perform radiographic procedures using a simulated source of radiation

History

• Source: Amended at 26 Ill. Reg. 3483, effective February 25, 2002

Part 410 Registration Requirements for Diagnostic Imaging Specialists and Therapeutic Radiological Physicists

32 Ill. Adm. Code 410.10 Policy and Scope

This Part implements the provisions of the Radiation Protection Act of 1990 [420 ILCS 40] regarding approval and registration of individuals responsible for implementing a comprehensive radiation protection program for Class D facilities as defined in 32 Ill. Adm. Code 320. Specifically this Part:

a) Establishes standards and procedures the Agency will apply for approving individuals as diagnostic imaging specialists and/or therapeutic radiological physicists; and

b) Establishes standards and procedures to be applied by the Agency when withdrawing its approval of a diagnostic imaging specialist and/or therapeutic radiological physicist.

History

• Source: Amended at 33 Ill. Reg. 2245, effective January 23, 2009

32 Ill. Adm. Code 410.20 Education/Experience Requirements for Diagnostic Imaging Specialists and Therapeutic Radiological Physicists

a) Diagnostic imaging specialists and therapeutic radiological physicists responsible for implementing comprehensive radiation protection programs shall be approved by the Agency in accordance with Section 410.30 of this Part.

b) Diagnostic Imaging Specialist. Individuals seeking approval as a diagnostic imaging specialist must possess the knowledge, training and experience to apply principles of radiological physics to diagnostic x-ray applications. Individuals seeking such approval shall meet any one of the criteria set forth in this subsection (b).

Education and/or Certification

Experience

Certification by the American Board of Radiology, American Board of Medical Physics or Canadian College of Medical Physics, in radiological physics or diagnostic radiological physics

and

experience included in certification.

Certification by the American Board of Health Physics, by the College, or one of the Boards listed in subsection (b)(1) of this Section, in Therapeutic radiological physics

and

6 months of experience in diagnostic x-ray, which shall include quality assurance and survey experience.

Doctorate (Ph. D.) or Master's (MS/MA) degree in health physics, medical radiological physics or physics

and

1 year of applied x-ray radiation protection experience of which 6 months shall include quality assurance and survey experience in diagnostic x-ray.

Bachelor's (BS/BA) degree in health physics, medical radiological physics or physics

and

2 years of applied x-ray radiation protection experience of which 6 months shall include quality assurance and survey experience in diagnostic x-ray.

Mater's (MS/MA) or Bachelor's (BS/BA) degree in physical or life science, mathematics, or other equivalent degree as determined by the Department

and

3 years of applied x-ray radiation protection experience of which 1 year shall include quality assurance and survey experience in diagnostic x-ray.

AGENCY NOTE: A degree that is not readily identifiable as meeting the requirements of this Part may be referred to the State Board of Higher Education for a determination of the degree classification.

c) Therapeutic Radiological Physicist. Individuals seeking approval as a therapeutic radiological physicist must possess the knowledge, training and experience to measure ionizing radiation, evaluate safety techniques, advise regarding radiation protection needs and apply the principles of radiological physics to clinical radiation therapy. To meet these criteria, a therapeutic radiological physicist shall meet either of the criteria set forth in this subsection (c).

Education and/or

Certification

Experience

Certification by the American Board of Radiology, the American Board of Medical Physics or Canadian College of Medical Physics, in therapeutic radiological physics, roentgen ray and gamma ray physics, x-ray and radium physics, or radiological physics

and

experience included in certification.

Doctorate (Ph.D.) or Master's (MS/MA) degree in physics, biophysics, radiological physics or health physics

and

1 year of full-time training in radiological physics and also 1 year of full-time work experience under the supervision of a therapeutic radiological physicist at a medical institution.

d) To meet the work experience requirements of subsection (c)(2) of this Section, the individual shall have performed the tasks specified in 32 Ill. Adm. Code 360.120(c), (d) and (e) under the supervision of an individual meeting the requirements of subsection (c) of this Section during the year of work experience.

e) An individual previously holding a designation as a diagnostic imaging specialist and/or a therapeutic radiological physicist, and previously approved by the former Illinois Department of Nuclear Safety as a qualified inspector, shall remain approved as a diagnostic imaging specialist and/or therapeutic radiological physicist, unless approval is removed for cause pursuant to this Part.

History

• Source: Amended at 33 Ill. Reg. 2245, effective January 23, 2009

32 Ill. Adm. Code 410.30 Approval of Application and Application/Registration Fees

a) An applicant for approval by the Agency as a diagnostic imaging specialist and/or therapeutic radiological physicist shall submit a complete and legible application on a form prescribed and furnished by the Agency. Each applicant shall pay an application fee of $200 that will serve as a registration fee for the remainder of the calendar year. The application fee is non-refundable.

b) Upon initial application to the Agency, and as a condition for approval as a diagnostic imaging specialist and/or a therapeutic radiological physicist, an applicant shall submit verification of access to instruments that will enable the individual to perform measurements and tests in accordance with Agency standards.

c) The Agency shall provide written notification to the applicant concerning the status of the application within 4 weeks after receipt of the application and required fee. If approval is granted, the applicant shall receive a "Notice of Approval" and the individual's name and address shall be entered in the record of persons approved as diagnostic imaging specialists and/or as therapeutic radiological physicists.

d) Individuals approved by the Agency as diagnostic imaging specialists and/or as therapeutic radiological physicists shall continue to remain approved unless approval is removed for cause pursuant to this Part.

e) All approved diagnostic imaging specialists and/or therapeutic radiological physicists shall pay an annual non-refundable registration fee of $150. The fee shall be due and payable within 60 days after the date of billing. Failure to remit the appropriate registration fee after 60 days shall cause the Agency to remove the individual's name from the record specified in subsection (c) of this Section. If an individual's name is removed from this record, the Agency shall not accept radiation machine evaluations or the establishment and oversight of equipment-related quality assurance practices performed on or after the date the individual's name was removed.

f) If an individual's name has been removed from the record of approved diagnostic imaging specialists and/or therapeutic radiological physicists due solely to nonpayment of the fee prescribed in this Section, that individual's name shall be reinstated automatically upon payment of and receipt by the Agency of the prescribed fee.

g) If the registration of a diagnostic imaging specialist or therapeutic radiological physicist has been revoked pursuant to Section 410.35 of this Part, the Agency shall consider the petition for reinstatement and the reasons for revocation before approving a new application.

History

• Source: Amended at 33 Ill. Reg. 2245, effective January 23, 2009

32 Ill. Adm. Code 410.35 Suspension and Revocation of Registration as an Approved Diagnostic Imaging Specialist or a Therapeutic Radiological Physicist

a) The Agency may act to suspend or revoke an individual's registration as an approved diagnostic imaging specialist and/or therapeutic radiological physicist and remove the individual's name from the record of approval for any one or a combination of the following causes:

1. Making a material misstatement or misrepresentation in the application for approval as a diagnostic imaging specialist and/or a therapeutic radiological physicist if such misstatement or misrepresentation would impair the Agency's ability to assess and evaluate the applicant's qualifications for approval under this Part;

2. Evading or violating the Radiation Protection Act of 1990 or an Agency regulation or order, or aiding another person in evading or violating a statute, regulation or order;

3. Exhibiting significant or repeated incompetence in the performance of evaluations of radiation machines or the establishment and oversight of equipment-related quality assurance practices;

4. Providing to the Agency, or to a Class D registrant, false or misleading information in any of the records required by 32 Ill. Adm. Code 320.70;

5. Providing to the Agency, or to a Class D registrant, under his/her diagnostic imaging specialist and/or therapeutic radiological physicist identification number or signature, a radiation machine evaluation report that he or she did not personally perform;

6. Failing to pay a civil penalty assessed by the Agency;

7. Failing to repay an educational loan guaranteed by the Illinois Student Assistance Commission as provided in 20 ILCS 3310/80; or

8. Failing to meet child support orders as provided in 5 ILCS 100/10-65.

b) The Agency may revoke the registration of an individual as an approved diagnostic imaging specialist and/or therapeutic radiological physicist for repetitive activities initially resulting in suspension.

c) If, based upon any of the grounds stated in subsection (a), the Agency determines that action is necessary to suspend or revoke the registration of an approved diagnostic imaging specialist and/or therapeutic radiological physicist and to remove the individual's name from the record of approved individuals, the Agency shall first notify the individual of the reason for its action and the proposed length of a suspension or revocation and shall provide an opportunity for a hearing in accordance with 32 Ill. Adm. Code 200. An opportunity for a hearing shall be provided before the Agency takes final action to suspend or revoke an individual's registration.

d) An individual whose registration has been suspended shall be reinstated upon completion of the duration of the suspension period.

e) An individual whose registration has been revoked for reasons other than non-payment of fees shall have his/her name removed from the record. The individual may seek reinstatement to the record by filing a petition for reinstatement and a new application with the Agency. The petition and application for reinstatement may only be accepted for consideration by the Agency after the specified revocation period has ended. The individual shall be afforded a hearing in accordance with 32 Ill. Adm. Code 200 if the reinstatement petition and application are denied.

f) Any of the causes for suspension or revocation specified in subsections (a)(1) through (5) of this Section may also be used as the grounds for the assessment of civil penalties pursuant to Section 36 of the Radiation Protection Act of 1990.

History

• Source: Amended at 33 Ill. Reg. 2245, effective January 23, 2009

32 Ill. Adm. Code 410.40 Radiation Installations and Classifications (repealed)

History

• Source: Repealed at 23 Ill. Reg. 14501, effective January 1, 2000

32 Ill. Adm. Code 410.50 Inspection Procedures (repealed)

History

• Source: Repealed at 23 Ill. Reg. 14501, effective January 1, 2000

32 Ill. Adm. Code 410.60 Choice of Type of Inspector and Inspection Schedule (repealed)

History

• Source: Repealed at 23 Ill. Reg. 14501, effective January 1, 2000

32 Ill. Adm. Code 410.65 Inspection Fees (repealed)

History

• Source: Repealed at 23 Ill. Reg. 14501, effective January 1, 2000

32 Ill. Adm. Code 410.70 Separate Installation (repealed)

History

• Source: Repealed at 23 Ill. Reg. 14501, effective January 1, 2000

32 Ill. Adm. Code 410.80 Change in Operator (repealed)

History

• Source: Repealed at 23 Ill. Reg. 14501, effective January 1, 2000

32 Ill. Adm. Code 410.ILLUSTRATION A New Facility Filing Anniversary Date (class C Facility Used as an Example) (repealed)

History

• Source: Repealed at 17 Ill. Reg. 17953 effective October 4, 1993

32 Ill. Adm. Code 410.ILLUSTRATION B Existing Facility Filing Anniversary Date (class B Facility Used as an Example) (repealed)

History

• Source: Repealed at 17 Ill. Reg. 17953, effective October 4, 1993

Part 422 Regulations for Radon Service Providers

32 Ill. Adm. Code 422.10 Purpose and Scope

a) This Part establishes licensing requirements for individuals who perform services to measure the presence of radon or radon progeny, and individuals who perform mitigation services to reduce the concentration of radon or radon progeny.

b) The Part also establishes licensing requirements for laboratories that perform analysis of radon and radon progeny detection or measurement devices.

c) Nothing in the Radon Industry Licensing Act [420 ILCS 44] or this Part shall be construed to limit or affect in any respect the practice of persons properly licensed under other statutes or regulations with respect to their professions.

32 Ill. Adm. Code 422.15 Incorporations by Reference

a) All rules, standards and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified in the reference and do not include any later amendments or editions. Copies of these rules, standards and guidelines that have been incorporated by reference are available for public inspection and copying at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois.

b) In addition, copies of ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories Compliance may be obtained through the American National Standards Institute (ANSI), 1430 Broadway, New York, New York 10018 and directly from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. Copies of ISO/IEC 17025 can also be obtained from the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield , Illinois 62704.

History

• Source: Added at 29 Ill. Reg. 3212, effective February 22, 2005

32 Ill. Adm. Code 422.20 Definitions

As used in this Part:

"Act" means the Radon Industry Licensing Act [420 ILCS 44].

"Active Mitigation System", also known as "Active Soil Depressurization" or "ASD", means a family of radon mitigation systems involving mechanically driven soil depressurization, including sub-slab depressurization (SSD), drain tile depressurization (DTD), block wall depressurization (BWD), and sub-membrane depressurization (SMD). [420 ILCS 52]

"Agency" means the Illinois Emergency Management Agency (IEMA).

"Altering" means to change or modify a building or building design, or to revise, rather than repair, a mitigation system or mitigation system design.

"As Low As Is Reasonably Achievable" or "ALARA" means making every reasonable effort to maintain exposures to radiation as far below the dose limits in 32 Ill. Adm. Code: Chapter II, Subchapters b and d 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 the state of technology, the economics of improvements in relation to benefits to the public health and safety and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest.

"Backdrafting" means a condition where the normal movement of combustion products up a flue, resulting from the buoyant forces on the hot gases, is reversed, so that the combustion products can enter the house. Backdrafting of combustion appliances (such as fireplaces and furnaces) can occur when depressurization in the house overwhelms the buoyant force on the hot gases. Backdrafting can also be caused by high air pressures or blockage at the chimney or flue termination.

"Backer Rod" means a semi-rigid foam material resembling a rope of various diameters used to fill around pipes, etc., and to assist in making a sealed penetration. For example, where a pipe is inserted through a concrete slab, a length of backer rod is jammed into the opening around the pipe. Caulking is then applied to the space above the backer rod and between the outside of the pipe and the slab opening. The purpose of the backer rod is to hold the semi-fluid caulk in place until it sets or hardens. It is most important that a sealant only adhere to the 2 sides of the joint and not the base of the joint (third side). Adhesion to all 3 sides will prevent the sealant from elongating properly and will cause sealant failure.

"Batch" means a group of passive detectors manufactured by the same entity at the same time.

"Block Wall Depressurization" means a radon mitigation technique that depressurizes the void network within a block wall foundation by drawing air from inside the wall and venting it to the outside.

"Client" means any person who contracts for measurement or mitigation services.

"Combination Foundations" means buildings constructed with more than one foundation type, e.g., basement/crawlspace or basement/slab-on-grade.

"Commercial Building" means a type of building that is designed for commercial use, but not limited to office buildings, warehouses, retail facilities, schools, recreational facilities, assisted living facilities and buildings that combine these uses.

"Communication Test" means a diagnostic test designed to qualitatively measure the ability of a suction field and air flow to extend through the material beneath a concrete slab floor and thus evaluate the potential effectiveness of a sub-slab depressurization system. This qualitative test is commonly conducted by applying suction on a centrally located hole drilled through the concrete slab and simultaneously observing the movement of smoke downward into small holes drilled in the slab at locations separated from the central suction hole. (See also Pressure Field Extension.)

"Continuing Education Credits" or "CE Credits" means those continuing education credits received for documented successful completion of Agency-approved CE courses or for instructing an approved CE course.

"Crawlspace" means a foundation type with an open area beneath the livable space of a dwelling that typically has either a concrete slab or earthen floor. The crawlspace can have an open height of a few inches to several feet. The crawlspace may or may not be ventilated to the outdoors.

"Crawlspace Depressurization" means a radon control technique designed to achieve lower air pressure in the crawlspace relative to indoor air pressure by use of a fan-powered vent drawing air from within the crawlspace. (See also Mechanically Ventilated Crawlspace System.)

"Diagnostic Tests" means procedures used to identify or characterize conditions within buildings that may contribute to radon entry or elevated radon levels or may provide information regarding the performance of a mitigation system.

"Drain Tile Depressurization" or "DTD" means a type of active soil depressurization system where the suction point piping attaches to a drain tile or is located in the gas-permeable material near the drain tile. The drain tile may be inside or outside the footings of the building.

"Drain Tile Loop" means a continuous length of drain tile or perforated pipe extending around all or part of the internal or external perimeter of a basement or crawlspace footing.

"Dwelling" means a single family home or a single unit within a multiple family complex.

"Eave" means the border of a roof that overhangs any wall.

"Electret Ion Chamber" or "Electret" means an electrostatically charged piece – usually a disk – of Teflon, called an electret, located inside an electrically conducting plastic chamber of a known air volume. The electret serves as a source of high voltage needed for the chamber to operate as an ion chamber. It also serves as a sensor for the measurement of ionization in air. The ions produced inside the sensitive volume of the chamber are collected by the electret causing a depleted charge. The measurement of the depleted charge during the exposure period is a measure of integrated ionization during the measurement period. The electret charge is read before and after the exposure using a specially built non-contact electret voltage reader.

"Footprint" means each foundation type in direct contact with soil or other material.

"Foundation Type" means basement, crawlspace, slab-on-grade or any other construction technique approved by local building code.

"Government Entity" means the State, a State agency, a political subdivision, or any entity of local government.

"HVAC" means heating, ventilation and air conditioning.

"Home Environment Measurement" means a short term or long term measurement of radon in a single family home, duplex or condominium.

"Individual" means any human being.

"Interfere" means to adversely or potentially adversely impact the successful completion of an indoor radon measurement by changing the radon or radon progeny concentrations or altering the performance of measurement equipment or an indoor radon mitigation system installation or operation. [420 ILCS 44/15]

"Laboratory" means any organization that analyzes or calibrates radon or radon progeny measurement devices or detectors.

"Laboratory Analysis" means the act of analyzing the radon or radon progeny concentrations with passive devices, or the act of calibrating radon or radon progeny measurement devices, or the act of exposing radon or radon progeny devices to known concentrations of radon or radon progeny as a compensated service. [420 ILCS 44/15]

"Living Area" means any area in a building that is, or could be, adapted for human habitation whether the area is located in a basement, over a crawlspace, or situated on a slab-on-grade.

"Long Term Measurement" means measurements lasting 91 days or more; closed building conditions are not required, but are recommended. Long term measurements are not time-sensitive and, therefore, real estate testing options do not apply.

"Measurement" means any radon or radon progeny tests, laboratory analysis, or exposure in a known radon or radon progeny environment, as in a radon chamber.

"Mechanically Ventilated Crawlspace System" means a radon control technique designed to increase ventilation within a crawlspace, achieve higher air pressure in the crawlspace relative to air pressure in the soil beneath the crawlspace, or achieve lower air pressure in the crawlspace relative to air pressure in the living spaces, by use of a fan. (See also Crawlspace Depressurization.)

"Mitigation" means the act of repairing or altering a building or building design for the purpose in whole or in part of reducing the concentration of radon in the indoor atmosphere. [420 ILCS 44/15]

"Mitigation System" means any system or steps designed to reduce radon concentrations in the indoor air of a building.

"Multi-Family Building" means a building, 3 stories or less, designed to house more than 4 families in separate units that do not have a common HVAC system for multiple units.

"New Residential Construction" means any original construction of a single-family home or a dwelling containing 2 or fewer apartments, condominiums, or town houses. [420 ILCS 52]

"NIST" means the United States Department of Commerce, Technology Administration, National Institute of Standards and Technology (formerly National Bureau of Standards).

"Passive Monitor" means a measurement tool that does not require external power or batteries to operate, such as charcoal detectors or alpha track detectors.

"Passive New Construction Pipe" or "PNC" means a pipe installed in new construction that relies solely on the convective flow of air upward for soil gas depressurization and may consist of multiple pipes routed through conditioned space from below the foundation to above the roof. [420 ILCS 52]

"Performance Audit" means an examination of a program, function or operation or of the management systems, procedures and records of a radon contractor to assess whether the entity is complying with the Radon Industry Licensing Act [420 ILCS 44], this Part and its Quality Assurance Program.

"Perimeter Channel Drain" means a system for collecting water in a basement by means of a large gap or channel between the concrete floor and the wall. Collected water may flow to aggregate beneath the slot ("French Drain") or to a sump where it can be drained or pumped away.

"Person" means an entity including, but not limited to, an individual, company, corporation, firm, group, association, partnership, joint venture, trust, or government agency or subdivision. [420 ILCS 44/15]

"Picocurie Per Liter" or "pCi/L" means 2.2 disintegrations per minute of radioactive material per liter of air.

"Pressure Field Extension" means the distance that a pressure change is induced in the sub-slab area, measured from a single or multiple suction points. (See also Communication Test.)

"QAP" means Quality Assurance Program.

"Radon" means a gaseous radioactive decay product of uranium or thorium. [420 ILCS 44/15]

"Radon Chamber" means a facility in which radon measurement devices or detectors are exposed to known radon concentrations.

"Radon Contractor" or "Contractor" means a person licensed to perform radon or radon progeny mitigation or to perform measurements of radon or radon progeny in an indoor atmosphere. [420 ILCS 44/15]

"Radon Progeny" means any combination of the radioactive decay products of radon. [420 ILCS 44/15]

"Radon Resistant Construction" means the installation of passive new construction pipe during new residential construction. [420 ILCS 52]

"Radon Service Provider" means a radon contractor, laboratory, or person who performs laboratory analysis.

"Real Estate Testing" means short-term measurements that may be requested by a party not residing in the dwelling and that are performed in, or as a result of, or in expectation of, a real estate transaction and are time-limited due to this transaction.

"Re-Entrainment" means the unintended re-entry into a building of radon that is being exhausted from the vent of a radon mitigation system.

"Renewal" means issuance of a license that is expiring, has expired or has been previously terminated.

"Research" means Agency-approved scientific investigation by testing and/or mitigating for radon or radon progeny.

"Residential Building Code" means an ordinance, resolution or law that establishes standards applicable to new residential construction. [420 ILCS 52]

"Residential Building Contractor" means any individual, corporation or partnership that constructs new residential buildings. [420 ILCS 52]

"Residential Real Estate Measurement" means a measurement of radon in a single family home, duplex or condominium involved in a real estate transaction. Based on the time sensitive nature of real estate transactions, only short term measurements are appropriate and specific protocols are required.

"School Screening Measurement" means a measurement of radon performed by school district staff in accordance with the School Code [105 ILCS 5].

"Sealing and Caulking" means to plug and make tight to reduce the passage of gas. Sealing and caulking enhances radon reduction techniques; however, sealing and caulking alone has not been shown to lower radon levels significantly or consistently.

"Short Term Measurement" means measurements conducted for at least 48 hours and up to 90 days; closed building conditions are required for measurements lasting seven days or less and recommended throughout.

"Soil Gas" means the gas mixture present in soil that may contain radon.

"Soil Gas Retarder" means a continuous membrane of 6 mil (3 mil cross-laminated) polyethylene or equivalent flexible material used to retard the flow of soil gases into a building.

"Stack Effect" means the overall upward movement of air inside a building that results from heated air rising and escaping through openings in the building envelope, thus causing indoor air pressure in the lower portions of a building to be lower than the pressure in the soil beneath or surrounding the building foundation.

"Subfloor" means a concrete slab and other approved permanent floor system that directly contacts the ground and is within the walls of the living spaces of the building.

"Sub-Membrane Depressurization" or "SMD" means a radon control technique designed to achieve lower air pressure in the space under a soil gas retarder membrane laid on the crawlspace floor and sealed, relative to air pressure in the crawlspace, by use of a vent or fan-powered vent drawing air from beneath the membrane.

"Sub-Slab Depressurization (Active)" or "SSD (Active)" means a radon control technique designed to achieve lower sub-slab pressure relative to indoor air pressure by use of a fan-powered vent drawing air from beneath the concrete slab.

"Sub-Slab Depressurization (Passive)" or "SSD (Passive)" means a radon control technique designed to achieve lower sub-slab air pressure relative to indoor air pressure by use of a vent pipe (without a fan) routed through the conditioned space of a building and connecting the sub-slab area to the outdoor air. This system relies primarily on the convective flow of warmed air upward in the vent to draw air from beneath the concrete slab.

"Suitable for Occupancy" means a structural area in a home currently lived in or an area not currently used for occupancy, such as a basement, that an occupant or homeowner could use for living space without renovations. This includes an unfinished basement that could be used regularly as, for example, a recreation room, playroom, exercise room or workshop.

"USEPA" means the United States Environmental Protection Agency.

"Working Level" or "WL" means any combination of short-lived radon progeny in 1 liter of air that will result in the ultimate emission of 1.3 x 105 MeV of potential alpha particle energy. The short-lived radon progeny for radon-222 are: polonium-218, lead-214, bismuth-214 and polonium-214.

"Working Level Month" or "WLM" means a unit of exposure used to express the accumulated human exposure to radon decay products. It is calculated by multiplying the average working level to which a person has been exposed by the number of hours exposed and dividing the product by 170.

History

• Source: Amended at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.30 Exemptions from Requirements for a License

The Agency may, upon application or upon its own initiative, grant such exemptions or exceptions from the requirements of this Part as it determines are authorized by law and will not result in a hazard to public health and safety. The following persons are exempt from the licensing requirements of this Part:

a) A person performing radon measurements or mitigation on a dwelling in which the person resides.

b) A person temporarily practicing in Illinois who possesses a license granted by another state's regulatory authority that is recognized by this State under principles of mutual reciprocity.

c) Retail stores that only sell or distribute radon sampling devices but are not engaged in a relationship with the client for other services such as home inspection or representation as in a real estate transaction and that do not perform laboratory analysis, measurement or mitigation services.

d) Persons who do not perform radon measurements or mitigation, but who are employed for the purpose of disseminating beneficial information to the public for agencies that the USEPA considers to be partners in providing accurate radon information to the public, such as educational institutions, the American Lung Association, the National Safety Council, and the National Association of City and County Governments and State and local public health officials who disseminate radon measurement devices to the public.

e) A person performing diagnostic tests for the purpose of assessing site decontamination in accordance with a radioactive materials license granted by the Agency. Diagnostic tests shall not be used as a basis for a decision to, or not to, mitigate the radon level within a building.

f) Employees of the Agency performing measurements or mitigations as part of their official duties.

g) A residential building contractor or his or her subcontractor that installs radon resistant construction.

AGENCY NOTE: Only a radon contractor may install a radon vent fan or upgrade a passive new construction pipe to an active mitigation system.

h) School district employees performing radon screening measurements in accordance with the exemptions outlined in Sections 10-20.48 and 34-18.39 of the School Code [105 ILCS 5/10-20.48 and 34-18.39].

History

• Source: Amended at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.40 Categories of Licenses

a) The following types of licenses are issued by the Agency to individuals:

1. Radon Measurement Professional license;

2. Radon Measurement Technician license;

3. Radon Mitigation Professional license; and

4. Radon Mitigation Technician license.

b) The Agency also issues licenses to persons performing radon-related laboratory analysis.

History

• Source: Amended at 29 Ill. Reg. 3212, effective February 22, 2005

32 Ill. Adm. Code 422.45 Form, Location and Retention of Records

a) Each record required by this Part and other applicable Parts of Title 32 shall be legible throughout the specific retention period. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of reproducing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate and complete records during the required retention period. Records such as letters, drawings and specifications shall include all pertinent information, stamps, initials and signatures. Adequate safeguards against tampering with and loss of records shall be maintained throughout the retention period, even if the license expires or is terminated.

b) Each professional licensee shall maintain the records required by this Part and, at the request of the Agency, make his or her records required in accordance with this Part, and himself or herself, available during normal business hours, in the offices of the Agency, for a performance audit of the license.

c) At the time of application for a license or renewal, the applicant shall specify, for Agency approval, a location where records required by this Part and other applicable Parts of Title 32 Ill. Adm. Code shall be maintained for inspection by the Agency. This location shall be in Illinois or within 50 miles of the Illinois border and at the location where the licensed professional who ensures the Quality Assurance Program is implemented is located.

d) Records required by this Part or other Parts of Title 32, including but not limited to records of radon measurements, mitigations, Quality Assurance Programs, calibration measurements, equipment repairs and worker protection plans, shall be retained by the licensee for at least 5 years or the length of time of any warranty or guarantees, whichever is longer.

History

• Source: Amended at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.50 Application for Licenses

a) Any person applying to the Agency for a new license or a renewal of a license to perform radon-related measurement, mitigation or laboratory analysis services shall:

1. Submit a complete and legible application form;

2. Pay the appropriate non-refundable fee prescribed in Section 422.100; and

3. Meet the licensing requirements, as applicable, and as set forth in Section 422.60.

b) Any person who anticipates conducting radon-related measurement, mitigation, or laboratory analysis services shall receive the license prior to providing such services in Illinois.

c) The Agency may at any time after the filing of the original application, and before the expiration or termination of the license, require further statements in order to enable the Agency to determine whether the application should be granted or denied or whether an existing license should be modified or revoked.

d) An application for renewal of a license shall be submitted at least 30 days prior to the expiration date of the license. An application shall be deemed filed on the date that it is received by the Agency. A radon service provider shall not provide radon services after the expiration date of a license.

e) The application for renewal shall demonstrate successful completion of continuing education requirements as specified in Section 422.80, as applicable, satisfactory inspection or audit results, submittal of a complete and accurate application form for renewal and the payment of the appropriate fee as specified in Section 422.100.

History

• Source: Amended at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.60 Requirements for Issuance or Renewal of Licenses

a) The Agency shall issue a Radon Measurement Professional license to any individual who fulfills the following requirements:

1. Is at least 18 years of age.

2. Provides evidence of relevant work experience and education that meets any one of the following criteria:

A) Documented work history approved by the Agency demonstrating completion of 50 radon measurements; or

B) No experience. A new license performance audit will be performed by the Agency.

3. Provides proof of successful completion of the USEPA Radon Measurement Operators Course, or an equivalent indoor radon and radon progeny measurement course approved by the Agency.

4. Has successfully completed a USEPA Radon Measurement Examination, or an equivalent examination approved by the Agency.

5. Submits a complete and accurate application form prescribed by the Agency that includes, but is not limited to:

A) Home address;

B) Home phone number;

C) Work address;

D) Work phone number;

E) Email address;

F) A description of all types of indoor radon measurements performed and any other related services offered;

G) A description of all measurement devices the applicant or licensee plans to use;

H) A worker protection program description acceptable to the Agency that includes, but is not limited to, methods to reduce or minimize the radon or radon progeny exposures in the work area; and

I) A Quality Assurance Program description acceptable to the Agency that includes, but is not limited to:

i) A policy statement committing to provide quality work;

ii) A description of management and structure of the organization;

iii) A listing of personnel, their qualifications and training;

iv) Procedures for procurement of items and services;

v) Procedures for maintaining documents and records;

vi) A description of relevant computer hardware and software;

vii) A planning process for radon and radon progeny services;

viii) Procedures for calibration and testing of instruments;

ix) A corrective action program; and

x) Standard operating procedures.

6. Submits standard operating procedures for the performance of radon or radon progeny measurements in each of the following categories for which they offer services: home, multi-family building, or school and commercial building measurements.

AGENCY NOTE: The Agency recommends using the "ANSI/AARST Standard: Protocol for Conducting Radon and Radon Decay Product Measurements in Multifamily Buildings" in preparing multi-family building standard operating procedures.

7. For an individual requesting renewal evidence of meeting the continuing education requirements in Section 422.80.

b) The Agency shall issue a Radon Measurement Technician license to any individual authorizing work under the general supervision of a Radon Measurement Professional licensee, if the applicant meets the following requirements:

1. Is at least 18 years of age.

2. Provides proof of successful completion of the USEPA Radon Measurement Operators Course, or an equivalent indoor radon and radon Progeny measurement course approved by the Agency.

3. Has successfully completed a USEPA Radon Measurement Examination, or an equivalent examination approved by the Agency.

4. Submits a complete and accurate application form prescribed by the Agency that includes, but is not limited to:

A) Home address;

B) Home phone number;

C) Work address;

D) Work phone number; and

E) Email address.

5. For an individual requesting renewal, evidence of meeting the continuing education requirements in Section 422.80.

c) The Agency shall issue a Radon Mitigation Professional license to any individual who fulfills the following requirements:

1. Is at least 18 years of age.

2. Provides evidence of relevant work experience and education that meets any of the following criteria:

A) At least 4 years of design and construction of buildings, or associated heating, ventilation and air conditioning (HVAC), or closely related activities approved by the Agency;

B) Documented work history approved by the Agency demonstrating completion of 50 radon mitigation installations; or

C) No experience. A new license performance audit will be performed by the Agency.

3. Provides proof of successful completion of the USEPA Radon Mitigation Course, or an equivalent indoor radon and radon progeny mitigation course approved by the Agency.

4. Has successfully completed a USEPA Radon Mitigation Examination, or an equivalent mitigation examination approved by the Agency.

5. Submits a complete and accurate application form prescribed by the Agency that includes, but is not limited to:

A) Home address;

B) Home phone number;

C) Work address;

D) Work phone number;

E) Email address;

F) A description of all diagnostic tests that may be performed to determine the mitigation strategy and any other radon related services offered;

G) A description of all mitigation system designs or strategies offered. Materials and design controls shall be included in the professional licensees' Quality Assurance Program description;

H) A worker protection program description acceptable to the Agency, to be followed when performing mitigation installations, that includes, but is not limited to, methods to reduce or minimize the radon or radon progeny concentrations in the work area;

I) A Quality Assurance Program description acceptable to the Agency that includes, but is not limited to:

i) A policy statement committing to provide quality work;

ii) A description of management and structure of the organization;

iii) A listing of personnel, their qualifications and training;

iv) Procedures for procurement of items and services;

v) Procedures for maintaining documents and records;

vi) A description of relevant computer hardware and software;

vii) A planning process for radon and radon progeny services;

viii) Procedures for calibration and testing of instruments;

ix) A corrective action program; and

x) Standard operating procedures.

6. Provides proof of insurance as specified in Section 422.70(q).

7. Submits standard operating procedures for the performance of mitigations in each of the following categories for which they offer services: home, multi-family building, or school and commercial building mitigations.

8. For an individual requesting renewal, evidence of meeting the continuing education requirements in Section 422.80.

d) The Agency shall issue a Radon Mitigation Technician license to any individual authorizing work under the general supervision of a Radon Mitigation Professional licensee, if the applicant meets the following requirements:

1. Is at least 18 years of age.

2. Provides proof of successful completion of the USEPA Radon Mitigation Operators Course, or an equivalent indoor radon and radon progeny mitigation course approved by the Agency.

3. Has successfully completed a USEPA Radon Mitigation Examination, or an equivalent examination approved by the Agency.

4. Submits a complete and accurate application form prescribed by the Agency that includes, but is not limited to:

A) Home address;

B) Home phone number;

C) Work address;

D) Work phone number; and

E) Email address.

5. For an individual requesting renewal, evidence of meeting the continuing education requirements in Section 422.80.

e) The Agency shall issue a Laboratory Analysis license to any person who submits a complete and accurate application form prescribed by the Agency that includes:

1. The name of one individual who is responsible for the laboratory radon analytical activities;

2. A description of all measurement devices used and services offered; and

3. Documentation of a Quality Assurance Program that meets one of the following:

A) A quality assurance program description consistent with ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories Compliance published June 29, 2005, exclusive of subsequent amendments or editions; or

B) Is successfully enrolled in an independent third party accreditation/certification program consistent with national laboratory accreditation and certification standards, or an equivalent program approved by the Agency, for the devices listed in subsection (e)(2).

History

• Source: Amended at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.65 Terminating a License

a) Any person licensed by the Agency may cease licensed activities and terminate his or her license at any time.

b) The licensee desiring to terminate his or her license shall submit to the Agency, within 15 days after ceasing to provide licensed services, the following information:

1. A request in writing stating the last date of any licensed activity.

2. The original license document.

3. The location where records will be maintained in compliance with Section 422.45.

c) The licensee shall allow the Agency to perform an audit that was scheduled before the licensee submitted a request to terminate the license.

AGENCY NOTE: Failure to pay the annual fee DOES NOT automatically terminate an Illinois radon license. The Agency must be notified in writing if a license is to be terminated.

History

• Source: Added at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.70 Conditions of Licenses

a) Any person licensed by the Agency to perform radon measurement shall perform in accordance with the measurement protocol provided in Section 422.130 as applicable to the measurement type performed and the devices used.

b) Any person licensed by the Agency to perform radon measurements shall use devices approved by USEPA, prior to the retirement of the USEPA Radon Proficiency Program, or the Agency to measure radon and radon progeny.

c) No unlicensed individual shall perform radon measurement or mitigation activities without the direct on-site supervision of a licensed individual.

d) Within 45 days after providing radon measurements, the individual providing the service shall report the results in picocuries per liter (pCi/L) to the occupant, the owner of the building, his/her representatives or the client.

e) Licensees shall comply with 32 Ill. Adm. Code 340. This means that the radiation exposure shall not exceed 30 pCi/L or 0.3 WL, based on continuous workplace exposure for 40 hr/week, 52 weeks per year and shall not exceed 4 working level months (WLM) over a 12 month period, using an equilibrium ratio of 50 percent to convert radon exposure to WLM.

f) Records of radon measurements, mitigations, Quality Assurance Programs, calibration measurements, equipment repairs and worker protection plans shall be retained by the licensee for a least 5 years or the length of time of any warranty or guarantees, whichever is longer.

g) No person shall interfere with, or cause another to interfere with, the successful completion of a radon measurement or the installation or operation of a radon mitigation.

h) The radon laboratory licensee shall notify the Agency in writing within 5 working days when it loses or replaces the individual named pursuant to Section 422.60(e)(1).

i) A licensee shall return the original license document to the Agency within 15 days after ceasing to provide licensed services, unless the license has expired.

j) Mitigators who are also licensed to perform measurements shall not perform radon measurements before or after the installation of a mitigation system at the same address as the mitigation installation, unless a measurement has been made by another independent person in accordance with this Part.

k) Licensees shall inform the Agency of changes in biographical information, such as addresses and telephone numbers within 10 days after the change is effective.

l) Substantive changes to license application representations require an amendment to the license and Agency approval. Licensees shall request amendments to documents at least 30 days prior to the effective date of the desired revision.

m) The licensee shall comply with all the applicable provisions of this Part.

n) The licensee shall comply with the Agency-approved Quality Assurance Program.

o) Professional licensees shall be located in Illinois or within 50 miles of the Illinois border. Professional licensees shall provide general supervision of technician licensees working under their Quality Assurance Program.

p) Radon contractors or residential building contractors installing research or innovative radon techniques or otherwise deviating from the standards in this Part shall notify the Agency in writing. Approval from the Agency in writing must be received prior to the commencement of work. When the research is conducted, a performance standard shall be applied, for example, post-mitigation radon levels shall be below USEPA's action level (4.0 pCi/L). Written notification to the Agency shall include:

1. Written acknowledgement signed by the client stating that the client understands the reasons the contractor plans to deviate from the standards of this Part;

2. The technical bases for the measurement or mitigation technique and description of the functional accomplishments that will be achieved; and

3. The identity of the client and the address of the building, including the zip code.

q) A Radon Mitigation Professional engaged in the business of radon mitigation shall obtain and maintain in full force and effect during the operation of the business public liability and property damage insurance that meets the requirements of the Home Repair and Remodeling Act [815 ILCS 513]. The licensee or applicant for a license shall provide proof of this insurance to the Agency annually. Illinois Radon Mitigation System tags will not be issued without valid proof of insurance.

History

• Source: Amended at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.75 State Radon License Exam

a) Any person applying to the Agency to take the measurement or mitigation Radon License Exam shall:

1. Submit a complete and legible application form;

2. Provide proof of successful completion of the USEPA Radon Measurement Operators Course, or an equivalent indoor radon and radon progeny measurement course approved by the Agency.

b) No person shall take the Radon License Exam more than once in any 28 day period.

c) Persons who have a physical or mental disability that requires reasonable accommodation in accordance with the Americans With Disabilities Act (42 USC 101 et seq.) shall, in addition to subsection (a):

1. Submit a complete and legible application form 30 days prior to the exam date;

2. Provide a physician's statement of the disability that includes a list of accommodations that are needed to take the exam.

History

• Source: Added at 33 Ill. Reg. 14479, effective October 9, 2009

32 Ill. Adm. Code 422.80 Continuing Education Requirements

All applicants for renewal of individual licenses shall provide evidence of having participated in an Agency-approved program of continuing education as indicated in this Section:

a) The required continuing education per year for categories of licenses issued pursuant to this Part is as follows:

Radon Measurement Professional

6 credits

Radon Measurement Technician

6 credits

Radon Mitigation Professional

6 credits

Radon Mitigation Technician

6 credits

AGENCY NOTE: An individual who is licensed for both Measurement and Mitigation needs 6 credits per year for each license (i.e., 12 credits per year).

b) Continuing education (CE) credits may be obtained via participation in courses or teaching approved courses.

c) Licensed individuals shall receive CE credits for an approved radon course only once during a 5 year interval.

d) The basis for a unit of continuing education credit shall be the contact hour (50 minutes) of lecture. Activity other than lecture shall be submitted to the Agency for evaluation in accordance with Section 422.85.

e) Licensees shall submit required documentation for CE as part of the application for renewal.

f) CE credit shall be given for courses approved by the Agency in accordance with the procedures specified in Section 422.85.

g) For courses not approved by the Agency, a licensee may submit the information required by Section 422.85 to the Agency for approval. The documentation shall be submitted at least 180 days prior to license expiration.

History

• Source: Amended at 33 Ill. Reg. 14479, effective October 9, 2009

32 Ill. Adm. Code 422.85 Agency Approval of Radon Courses

a) Persons offering continuing education for a licensed individual may apply for approval by submitting to the Agency, 90 days prior to the start of the course, the following:

1. A completed application on a form prescribed by the Agency that shall include, but not be limited to, the following information:

A) Name, business address, telephone number, fax number and e-mail address of the person providing the training;

B) Type of course and title; and

C) Total hours of supervised instruction within the course;

2. Copies of the syllabus and all training materials to be used in the training course;

3. Pertinent biographical information or credentials of all individuals instructing the training course participants; and

4. Criteria for course approval upon which successful completion of the course by participants will be judged pursuant to subsection (e) of this Section.

AGENCY NOTE: Operators of training courses shall submit a separate application for each course, but if a single course will provide instruction for more than one type of licensed individual, only one application is required.

b) To maintain approval of a training course, the course operator shall do all of the following:

1. Issue a certificate of completion to each individual who successfully completes the course;

2. Submit to the Agency a list of all individuals who successfully completed the course within 30 days after completion of the course. The list shall include name, business address, telephone number and radon license number;

3. Request, in writing, the Agency's approval of any changes that would render the information contained in the application for approval inaccurate; and

4. For a revised course, submit within 30 days before first teaching the revised course, an informational copy of the complete revised course, whether or not the revisions render the information contained in the application for approval inaccurate.

c) The Agency may refuse to issue an approval and may revoke or suspend an approval issued pursuant to this Part if the operator of the course fails to meet the criteria specified in subsection (a) or (b) of this Section or if the course is not updated to incorporate new information pertinent to licensed activities.

d) Approval of a training course shall be valid until the course is revised.

e) Criteria for CE Course Approval

1. General Format for Course Approval

A) Opening pages/introduction of the course shall include the following:

i) Name of the sponsor/course provider.

ii) Name of the course developer, if different than the sponsor/provider.

iii) Name/title of the course. The title shall be the same as approved by the Agency.

iv) Course description.

v) Course objectives.

vi) Other references or source materials required for the course (e.g., textbook).

vii) Course instructions shall include the following statements:

• "In order to receive CE credit, you shall first complete the course content. When completed, go to the last page of the course to access the post-test."

• "Submit the completed answers to determine if you have passed the post-test assessment. You must obtain a score of at least 70% to receive the CE credit. You will have no more than 3 attempts to successfully complete the post-test."

viii) CE credits: Number of CE credits awarded for successful completion of the course.

ix) Approving organization statement: "Approved by Illinois Emergency Management Agency, Radon Program" and the course number.

x) Statement about seeking CE credit for repeating a course: "This course may be available in multiple formats or from different sponsors. The Illinois Emergency Management Agency, Radon Program, does not allow CE courses such as Internet courses, home study programs or directed reading to be repeated for CE credit in the same 5 year period."

AGENCY NOTE: The Illinois Emergency Management Agency, Radon Program, will approve CE credits for courses that have similar content. However, the credits cannot be for the same course completed from different formats. For example, two different courses on Radiation Protection would be acceptable. Two courses, one on CD and one as a home study, with the same content would not be acceptable.

xi) Statement concerning a course awarded multiple CE course numbers. Depending on the situation, a course may be awarded credit through multiple evaluation programs for use by different credentialing organizations. Different course numbers are then awarded to the same course. In such situations, each course number and the approving authority for each course number shall be listed.

xii) CE sponsor contact information shall be provided for participants who have questions regarding the CE course.

B) Additional Requirements for an Online CE Course

i) Hardware and software requirements for the course.

ii) Access options (for example, dial-up, broadband, cable, DSL).

2. Agency Approval for Number of CE Credits

A) Evaluation of Content

i) For an original approval, the course title shall match the title that was submitted on the CE credit application form.

ii) For renewal applications, the title shall match the title approved by the Agency.

iii) The content shall support the stated objectives.

iv) The content shall be current and accurate.

v) The content shall provide sufficient depth and scope of the subject matter.

vi) Content taken from other copyrighted materials shall be appropriately identified as such and referenced.

vii) Documentation of appropriate permissions for use of reprinted materials shall be clearly referenced.

viii) All supporting materials (e.g., images, photos, diagrams, charts, tables and text) shall be legible and labeled correctly.

ix) Acronyms shall be spelled out with the first use or a glossary of terms shall be provided.

x) Credit requested to be awarded for the course shall be determined by the length of time it takes to complete the course. Time utilized to complete the post-test may be considered part of learning the course information.

xi) The CE application materials shall include a description of the grading and documentation process. A copy of the certificate to be awarded and the post-test, with correct answers indicated, shall be included.

xii) CE sponsors for courses that were developed by others (i.e., individuals or organizations) shall indicate the following information on the application for the CE credit: The name of the individual or organization that developed the course and an affirmation statement that the developer of the course has granted the CE sponsor permission to use and distribute the course.

xiii) For all formats of any course and at all sites, the Agency shall be provided with access (i.e., user ID and password) in order to evaluate the course in the manner that it is being presented. For electronic courses, access shall be provided prior to the course being made available for use by customers.

3. Assessment (Post-Test)

A) Possible Uses for the Post-Test

i) Post-Test Used to Assess Participation. Multiple choice questions shall be provided to help determine if a person has participated in the course. Answers do not need to be provided to the participant.

ii) Post-Test Used as a Learning Tool. Multiple choice questions shall be provided to help determine a level of learning. If a question is answered incorrectly, detailed information is provided to explain the questions and answers.

B) Format Evaluation

i) Post-tests shall have a minimum number of questions based upon the number of CE credits requested to be awarded to the course (i.e., 5 questions for each credit hour).

ii) When submitted for evaluation, the correct answers to the post-test questions shall be referenced (with paragraph and page numbers) in the content of the course.

iii) Additionally, for online courses:

• The participant shall not be able to go directly to the post-test from the introductory page without at least "paging" or "scrolling" through the content. (This may be accomplished by requiring the participant to page through the content before reaching the post-test. For example, do not place access to the post-test at the beginning of the course.)

• The CE course content may be printed for review; however, the post-test shall not be available to print.

• If the sponsor is using a test item, all questions and answers that a participant might see shall be provided to the Agency for review.

C) Scoring

i) A maximum of three attempts to pass the post-course assessment is allowed. No CE credit will be awarded if there are three failed attempts. (See subsection (e)(1)(A)(viii) of this Section.)

ii) If a participant fails to score at least 70% on the post-test, the number of incorrect answers or the percent correct may be provided, but the individual questions answered incorrectly shall not be identified. Post-test question security shall be maintained.

4. Certificates of Participation

A) Certificate Format

i) Certificates shall contain the participant name, course, date completed, credits earned, approving organization (i.e., IEMA, Radon Program), reference number, sponsor name and/or logo and signature of the sponsor or its authorized representative. (The same certificate information is required for all formats of a course, i.e., Internet, print, live, etc.)

ii) The certificate shall reflect the "date of completion" as the date the sponsor received the completed post-test.

iii) All post-tests received shall be date/time stamped (or date collected and recorded) for verification purposes.

B) Certificate Distribution

i) The certificate shall be awarded only after successful completion of the course.

ii) The participant shall not be able to alter the information for the on-line certificate in any way before printing.

iii) Duplicate on-line certificates may be made available by the CE sponsor for re-printing.

History

• Source: Amended at 33 Ill. Reg. 14479, effective October 9, 2009

32 Ill. Adm. Code 422.90 Renewal of Licenses

a) Licenses shall be renewed in accordance with Section 422.60.

b) All applicants seeking renewal shall complete the continuing education requirements in Section 422.80 except when the license has been expired or terminated, the person may take the appropriate qualification course and Radon Licensing Exam as an alternative to the required CE.

History

• Source: Amended at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.100 Fees

a) The annual fee in all categories shall be as follows:

Radon Measurement Professional license – Individual

$500

Radon Measurement Technician license – Individual

$250

Radon Mitigation Professional license – Individual

$500

Radon Mitigation Technician license – Individual

$250

Laboratory Analysis

$500

b) An individual license application fee of $125 shall accompany a new application when filed with the Agency. A laboratory application fee of $500 shall accompany a new application when filed with the Agency.

c) All fees assessed in accordance with this Section are non-refundable.

d) The appropriate fees shall be paid within 60 days after the date on the statement issued by the Agency.

e) The fee for an Illinois Mitigation System Tag shall be $50. Only Radon Mitigation Professionals shall purchase Illinois Mitigation System Tags from the Agency. Illinois Mitigation System Tags shall be purchased in amounts not less than 5 per transaction.

f) Effective January 1, 2014, an application fee of $125 shall accompany an application for the State Radon License Exam.

History

• Source: Amended at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.110 Reports to the Agency

a) All individuals licensed to perform radon measurements and former licensees shall submit to the Agency the following information of all radon and radon progeny measurements individually on an annual basis by a method prescribed by the Agency. The file submitted to the Agency shall be an ASCII, comma delimited file.

1. Address, city, state, zip code.

2. Start date and time the measurement began.

3. End date and time the measurement was completed.

4. Location where test was performed (i.e., basement, crawlspace, slab, other).

5. Room use (i.e., living, family, bedroom).

6. Whether a PNC or ASD radon reduction system is currently in use and, if the system is ASD, include the mitigation tag number for systems installed after November 1, 2009.

7. Result of the measurements taken in pCi/L.

8. The type of test performed (i.e., duplicate, simultaneous).

9. Device used (i.e., AC, AT, CR, LS, ES, etc.).

10. Serial number of the device used.

11. The lab used or manufacturer of the device.

12. The permanent vents at this location (i.e., crawlspace, fireplace, fresh air intake).

13. Status of the permanent vents during the test (i.e., open, closed).

14. An indication of whether the test was valid.

15. Brief description of why the test was invalid.

b) All individuals licensed to perform radon mitigations and former licensees shall submit to the Agency the following information of all radon and radon progeny mitigations individually on an annual basis by a method prescribed by the Agency. The file submitted to the Agency shall be an ASCII, comma delimited file.

1. Address, city, state and zip code where mitigation was conducted.

2. Date mitigation system was installed.

3. Indication of whether an active soil depressurization system was installed.

4. Indication of whether radon resistant new construction techniques were used.

5. The Illinois Mitigation System Tag number issued by IEMA installed on the system.

c) All individuals licensed to perform laboratory analysis who report results to home occupants, owners or their representative shall submit to the Agency the following information of all complete radon and radon progeny measurements on an annual basis by a method prescribed by the Agency. The files submitted to the Agency shall be an ASCII, comma delimited file.

1. Address, city, state, zip code.

2. Start date and time the measurement began.

3. End date and time the measurement was completed.

4. Result of the measurements taken in pCi/L.

5. Device used (i.e., AC, AT, CR, LS, ES, etc.).

6. Serial number of the device used.

7. The lab used or manufacturer of the device.

AGENCY NOTE: In general, this type of file can be generated by most spreadsheet and database software. Instructions for the specific information and formatting are available from the Agency or on the Agency website.

d) All licensees shall report apparent non-compliances with either the Radon Industry Licensing Act or this Part to the professional licensee upon discovery; then to the Agency in writing within 45 days upon discovery unless appropriate corrective action has been performed within 30 days after discovery.

History

• Source: Amended at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.120 Disciplinary Action by the Agency

a) The Agency may refuse to issue or to renew, or may suspend or revoke, a person's license, or take other disciplinary action as the Agency may deem proper, including fines not to exceed $1,000 for each violation, with regard to any license for any one or a combination of the following causes or those listed in Section 45 of the Radon Industry Licensing Act [420 ILCS 44/45]:

1. Knowingly causing a material misstatement or misrepresentation to be made in the application for a license, if such misstatement or misrepresentation would impair the Agency's ability to assess and evaluate the applicant's qualifications for a license pursuant to this Part, such as a misstatement or misrepresentation regarding training or experience;

2. Willfully evading the statute or regulations pertaining to a license, or willfully aiding another person in evading the statute or regulations pertaining to a license;

3. Having been convicted in any state of a crime that is a felony under the laws of this State or having been convicted of a felony in a federal court, unless such individual demonstrates to the Agency that he/she has been sufficiently rehabilitated to warrant the public trust;

4. Misrepresenting the capabilities of a device for detecting and measuring radon or radon progeny or misrepresenting the results of a test to detect or measure radon or radon progeny;

5. Gross and willful overcharging for professional services, including filing false statements for collection of fees or moneys for which services are not rendered;

6. A person knowingly makes a false material statement to an Agency employee during the course of official Agency business;

7. Failure to make records available for audit or inspection at all reasonable times, such as during usual business hours;

8. Failing, within 60 days, to provide information in response to a written request made by the Agency that has been sent by mail to the licensee's last known address [420 ILCS 44/45(g)];

9. Failure to file a return or to pay the tax, penalty or interest shown in a filed return, or to pay any final assessment of tax, penalty, or interest, as required by a tax Act administered by the Department of Revenue, until such time as the requirements of any such tax Act are satisfied [420 ILCS 44/45(q)];

10. Failing to repay an education loan guaranteed by the Illinois Student Assistance Commission as provided in Section 80 of the Nuclear Safety Law of 2004 [20 ILCS 3310/80]; or

11. Failing to meet child support orders as required in Section 10-65 of the Illinois Administrative Procedure Act [5 ILCS 100/10-65]. The action will based solely upon the certification of delinquency made by the Department of Healthcare and Family Services, Division of Child Support Enforcement, or the certification of violation made by the court. Further process, hearing or redetermination of the delinquency or violation by the Agency shall not be required (see IAPA Section 10-65(c)).

b) If, based upon any of the grounds in subsection (a) of this Section or Section 45

of the Radon Industry Licensing Act, disciplinary action is initiated, the Agency shall notify the person and shall provide an opportunity for a hearing in accordance with 32 Ill. Adm. Code 200. An opportunity for a hearing shall be provided before the Agency takes action to suspend or revoke a person's license, unless the Agency has evidence of imminent danger as provided in subsection (d) of this Section.

c) If the Agency finds that removal or refusal to issue or renew accreditation is warranted, the usual action shall be a suspension or denial of licensure for up to one year. The term of suspension or denial may be reduced by the Director, based upon evidence presented, if the conditions leading to the Preliminary Order for Suspension can be cured in less than 1 year. However, if the Agency finds that the causes are of a serious or continuous nature, such as past actions that posed an immediate threat to public health or safety, deficiencies that cannot be cured within one year or frequent child support arrearages, the Agency shall revoke the person's license or deny the application.

d) The Director may summarily suspend the license of a licensee without a hearing, simultaneously with the institution of proceedings for a hearing, if the Director finds that evidence in his or her possession indicates that continuation of the contractor in practice would constitute an imminent danger to the public. If the Director summarily suspends a license without a hearing, a hearing by the Agency shall be held within 30 days after the suspension has occurred and shall be concluded without appreciable delay. [420 ILCS 44/50] The hearing shall be held in accordance with 32 Ill. Adm. Code 200.

e) When a person's license is suspended or revoked, the person shall surrender the license to the Agency and cease licensed activities.

f) A person whose license has been revoked may seek reinstatement of the license by filing with the Agency a petition for reinstatement. Petitions may be filed one year or more after the beginning of the revocation period. The person shall be afforded a hearing in accordance with 32 Ill. Adm. Code 200 and shall bear the burden of proof of establishing that the license should be reinstated due to rehabilitation or other just cause.

g) A person who violates any provisions of this Part shall be guilty of a business offense and shall be assessed a penalty in accordance with Section 35 of the Act.

History

• Source: Amended at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.130 Measurement Protocol

a) Measurement Location

1. Short-term or long-term measurements shall be made, at the same time, in each lowest structural area suitable for occupancy. For example, a split-level building with a basement, a slab-on-grade room and a room over crawlspace shall have measurements made in each of the foundation types: the basement, a slab-on-grade room and a room over the crawlspace.

A) Measurements shall be made in rooms that can be regularly occupied by individuals, such as family rooms, living rooms, dens, playrooms and bedrooms.

B) Charcoal canisters of any type shall not be placed in bathrooms, kitchens, laundry rooms, spa rooms or other areas of high humidity.

C) When the area of the home being tested is over 2000 square feet, an additional test location is required for each 2000 square feet of the area being tested.

D) Measurement devices shall be placed in the general breathing zone and shall be:

i) Undisturbed during the measurement period;

ii) At least 3 feet from exterior doors, windows to the outside, or ventilation ducts;

iii) Out of the direct flow of air from the ventilation duct;

iv) At least 1 foot from exterior walls;

v) 20 inches to 6 feet from the floor;

vi) At least 4 inches away from other objects horizontally or vertically above the detector;

vii) At least 4 feet from heat, fireplaces and furnaces, out of direct sunlight, etc.;

viii) At least 7 feet from sump pits.

E) Measurement devices may be suspended in the general breathing zone and, if suspended, shall be 20 inches to 6 feet above the floor and at least 1 foot below the ceiling.

F) Measurements made in closets, cupboards, sumps, crawlspaces or nooks within the foundation shall not be used as a representative measurement and shall not be the basis for a decision to, or not to, mitigate the radon level within a building.

b) Measurements

1. A short-term measurement shall range in duration from 48 hours to 90 days, depending upon the measurement device used. Unoccupied homes shall be tested with the HVAC system set and operating throughout the measurement interval in the normal range, such as 72 degrees F plus or minus 5 degrees F.

A) Short-term measurements shall be made under closed-building conditions. In measurements lasting more than seven days and less than 90 days, closed-house conditions shall be maintained as much as possible while the measurement is in progress.

B) Closed building conditions shall begin at least 12 hours prior to the beginning of the measurement period for measurements lasting less than 96 hours.

C) The following conditions shall be complied with during closed-building conditions:

i) Operation of permanently installed HVAC systems shall continue during closed-building conditions. Radon Measurement licensees shall inform the resident in writing that operation of dryers, range hoods, bathroom fans and other mechanical systems that draw air out of the building may adversely affect the measurement results.

ii) In buildings having permanently installed radon mitigation systems, the mitigation system shall be functioning during the measurement interval.

iii) Air conditioning systems that recycle interior air may be operated during closed-building conditions.

iv) All windows shall be kept closed. Individuals licensed in accordance with the Home Inspector License Act [225 ILCS 441] may momentarily open and reclose windows when performing an inspection, after informing the measurement licensee of the inspection.

v) All external doors shall be closed except for normal entry and exit. Structural openings due to disrepair or structural defects shall be repaired to correct their condition prior to initiation of closed-building conditions. All exterior windows and doors shall be inspected by a Radon Measurement Professional licensee or Radon Measurement Technician at the placement and retrieval of the detectors and the result of the inspection documented for the measurement file.

vi) Whole-house fans shall not be operated. Portable window fans shall be removed from the window or sealed in place. Window air conditioning units shall only be operated in a recirculating mode. If the building contains an air handling system, the air handling system shall not be set for continuous operation unless the air handling equipment is specifically used for radon control and is so labeled.

vii) Fireplaces or combustion appliances, except water heaters and cooking appliances, shall not be operated unless they are the primary sources of heat for the building.

viii) Ceiling fans, portable dehumidifiers, portable humidifiers, portable air filters and window air conditioners shall not be operated within 20 feet of the detector.

D) Short-term measurements of less than 96 hours shall not be conducted during severe storms or periods of sustained high winds (30 miles per hour or more). Radon Measurement licensees shall check and document local weather forecasts prior to placing short-term measurement devices when the measurement period is less than 96 hours.

AGENCY NOTE: The National Weather Service defines a severe storm as a storm that generates winds of 58 mph and/or ¾-inch diameter hail and that may produce tornadoes – not necessarily in that order.

E) The Radon Measurement licensee shall document that instructions describing closed-building conditions in subsection (b)(1) were provided for the person who controls the building in accordance with subsections (d)(1) and (2).

2. The Radon Measurement licensee shall advise the resident in accordance with Appendix A.

3. Follow-up measurements shall be conducted in the same location as the initial measurement, provided the initial measurement was performed in accordance with acceptable measurement placement protocol.

4. The results of both initial and follow-up measurements and the average of duplicate measurements shall be reported. The average shall be considered appropriate as the basis for determining the need for mitigation.

c) Options for Real Estate Testing

1. Option 1: Simultaneous Testing

A) Simultaneous testing shall be comprised of a minimum of 2 indoor radon measurements conducted simultaneously with similar measurement devices (see Appendix C).

B) Simultaneous tests shall be:

i) Co-located and spaced 4 to 5 inches apart;

ii) Exposed for the same measurement period; and

iii) Produce results in the same units (pCi/L or WL).

C) The results of both measurements and the average of the simultaneous measurements shall be reported and shall be considered appropriate as the basis for determining the need for mitigation.

D) Simultaneous measurement results that are both less than 4.0 pCi/L shall agree with a Relative Percent Difference (RPD) of less than 67 percent. RPD is the difference between the 2 results divided by the average of the 2 results times 100. If the RPD is greater than 67 percent, the Radon Measurement Professional licensee shall investigate, document and correct the sources of the error.

E) When one of the measurements is equal to or greater than 4.0 pCi/L and one is less than 4.0 pCi/L, and the higher result is greater than twice the lower result, the client shall be informed of the large discrepancy and the simultaneous measurements repeated at no added cost to the client.

F) Simultaneous measurement results that are both equal to or greater than 4.0 pCi/L shall agree with a RPD of less than 36 percent. If the RPD is greater than 36 percent, the Radon Measurement Professional licensee shall investigate, document and correct the sources of the error.

G) The precision of simultaneous measurements shall be monitored and recorded in the quality assurance records. The analysis of data from simultaneous measurements shall be plotted on range control charts. If the precision estimated by the user is not within the precision expected of the measurement method, the cause of the problem shall be investigated and corrective action taken in accordance with the licensee's Agency-approved quality program.

2. Option 2: Continuous Monitor Testing

A) This option requires an active continuous monitor that has the capability to integrate and record a new result at least hourly. Shorter integration periods and more frequent data logging afford greater ability to detect unusual variations in radon or radon progeny concentrations.

B) The minimum test measurement period shall be 48 hours. The first 4 hours of data from a continuous monitor may be discarded or incorporated into the result using system correction factors. There shall be at least 44 contiguous hours of usable data to produce a valid average.

i) The "backing out" of data (i.e., removal of portions imbedded in the 44 contiguous hours of monitoring) shall invalidate the measurement.

ii) The periodic results shall be averaged to produce a result that is reported to the client.

3. Additional Requirement for Real Estate Option Testing

A) Real Estate Option tests shall be conducted in accordance with subsections (a)(1) and (b)(1).

B) The measurement exposure time shall be a minimum of 48 hours.

C) Measurement licensees shall establish controls consistent with the devices used in their measurements to prevent interference and document those controls in accordance with subsection (l)(1).

d) Non-Interference Agreement

1. The buyer, seller, occupant, real estate professional or other individual in control of the property shall sign a non-interference agreement indicating an understanding of the testing conditions, the penalties for interference with an in-progress radon measurement, and that any test interference that is detected will be documented in the report and will invalidate the measurement results.

2. If such an agreement cannot be or will not be signed by the buyer, seller, occupant, real estate professional or other individual in control of the property, the Radon Measurement licensee shall document on the agreement why the signature was not obtained. The agreement shall be retained for inspection by the Agency.

e) Radon Measurement In Progress Notification. The licensee shall post at every building entry and in a conspicuous location a Radon Measurement In Progress Notification. The Notice shall be posted upon initiation of a radon measurement. A copy of a Radon Measurement In Progress Notice is provided in Appendix D.

f) Multi-Family Building Measurements. Professional licensees shall submit standard operating procedures for the performance of multi-family building measurements.

AGENCY NOTE: This subsection does not apply to measurements in an individual condominium unit.

1. Initial measurements shall be short-term measurements of at least 48 hours to 90 days, depending on the device used, and shall be made in regularly occupied rooms in contact with the soil, whether the contact is slab-on-grade, a basement, a berm, a room above a crawlspace or any combination.

A) Regularly occupied rooms include bedrooms, offices, dens, family rooms, work areas and play rooms.

B) A minimum of one detector shall be placed per every 2000 square feet of open floor area.

2. Regularly occupied rooms shall be tested simultaneously.

A) The licensee shall ensure that each occupant/resident is provided information regarding necessary test conditions.

B) The licensee shall perform and document a surveillance of the building to determine the rooms needing testing prior to placement.

3. Follow-up Measurements

A) Follow-up measurements shall be performed in every room with a short-term, initial measurement result of 4.0 pCi/L or greater, unless measurements are during a real estate transaction. Refer to Appendix A.

B) If performing measurements in accordance with subsection (c), Options for Real Estate Testing, follow-up measurements are not required. Refer to Appendix B.

4. During both initial and follow-up measurements, the HVAC system shall be operated normally. An understanding of the design, operation and maintenance of a building's HVAC system and how it influences indoor air conditions is essential for understanding, managing and developing a measurement strategy in multi-family buildings. If the units of a building have a common HVAC system, the building shall be tested by a licensee licensed to perform measurements in commercial buildings.

5. The Radon Measurement Professional licensee shall recommend in writing to the multi-family building management, owners or representatives that a decision to mitigate be based on Appendix A or Appendix B, as applicable.

6. Multi-family building measurements shall be performed in accordance with subsections (a) through (e) and (h) through (n).

A) A Device Placement Log and Floor Plan shall be finalized for each multi-family building in which radon or radon progeny measurements are made.

B) All measurements devices, including duplicate measures and blanks, shall be noted on the Device Placement Log and by serial number.

7. Requirements for Specific Multi-Family Building Designs

A) Slab-on-Grade Design. Measure a regularly-occupied room in each unit in contact with the ground.

B) Crawlspace Design. Measure a regularly-occupied room directly in each unit above an enclosed crawlspace.

C) Basement Design. In addition to measuring a regularly-occupied basement room in each unit, measure a regularly-occupied room in each unit above the basement that has at least one wall with substantial contact with the ground.

g) School and Commercial Building Measurements. Professional licensees shall submit standard operating procedures for the performance of school and commercial building measurements.

1. Initial measurements shall be short-term measurements of at least 48 hours to 90 days, depending on the device used, and shall be made in all frequently occupied rooms in contact with the soil, whether the contact is slab-on-grade, a basement, berm, a room above a crawlspace or any combination.

A) Frequently occupied rooms include classrooms, offices, conference rooms, gymnasiums, auditoriums, cafeterias and break rooms.

B) Testing need not be conducted in infrequently used areas such as storage rooms, stairwells, restrooms, utility closets, elevator shafts or hallways.

C) A minimum of one detector shall be placed per every 2000 square feet of open floor area.

D) Schools and commercial buildings shall only be tested for radon during periods when the HVAC system is operating as it does normally when the buildings are occupied, even if the testing occurs when school is not in session or during long holidays.

2. All frequently occupied rooms shall be tested simultaneously.

A) The licensee shall ensure that the teacher or frequent adult user of the room being tested is aware of the detector.

B) The licensee shall perform and document a surveillance of the building to determine the rooms needing testing prior to placement.

C) The measurement professional shall review any School Screening Measurements available and may accept those measurements as valid in determining any additional appropriate testing strategies.

3. Follow-up measurements shall be performed in every room with a short-term, initial measurement result of 4.0 pCi/L or greater. Refer to Appendix A.

4. During both initial and follow-up measurements, the HVAC system shall be operated normally.

5. The Radon Measurement Professional licensee shall recommend in writing to the school or commercial building management, owners or representatives that a decision to mitigate not be based on initial measurement results.

6. School and commercial building measurements shall be performed in accordance with subsections (a) and (b).

A) School and commercial building measurements of less than 96 hours duration shall be performed under closed-building conditions as described in subsection (b)(1).

B) Duplicate measurements shall be performed and shall represent 10 percent of all the detectors deployed, or a maximum of 50 detectors, whichever is less, within the building.

C) Blank measurements shall be performed and shall represent 5 percent of all the detectors deployed, or a maximum of 25 detectors, whichever is less, within the building.

D) Licensees using passive monitors shall conduct spiked measurements at the rate required in Section 422.140(a)(2)(B)(ii).

E) A Device Placement Log and Floor Plan shall be finalized for each school or commercial building in which radon or radon progeny measurements are made. All measurement devices, including duplicate measures and blanks, shall be noted on the Device Placement Log and Floor Plan by serial number.

7. Requirements for Specific School and Commercial Building Designs

A) Slab-on-Grade Design. Measure all frequently-occupied rooms in contact with the ground.

B) Open-Plan or Pod Design. If sections of a pod have moveable walls that can physically separate them from other sections, measure each section separately. If moveable walls are absent or inoperable, measure the pod as one room placing detectors every 2000 square feet.

C) Crawlspace Design. Measure all rooms directly above an enclosed crawlspace.

D) Basement Design. In addition to measuring all frequently-occupied basement rooms, measure all frequently occupied rooms above the basement that have at least one wall with substantial contact with the ground.

8. The on-site presence of the Licensed Radon Measurement Professional providing supervision is required for all radon measurement activities at schools and commercial buildings.

h) New Construction Testing Conditions

1. Newly constructed buildings shall not be tested for radon or radon progeny unless the installation of the following items is completed:

A) All insulation;

B) All exterior doors with associated hardware shall be installed prior to testing;

C) All windows;

D) All fireplaces and fireplace dampers;

E) All heating, air conditioning, and plumbing appliances;

F) All ceiling covers;

G) All interior trim and coverings for the exterior walls;

H) All exterior siding, weatherproofing and caulking;

I) All interior and exterior structural components; and

J) Any interior or exterior work that may adversely affect the measurement validity.

2. Unoccupied homes shall be tested with the HVAC system set and operating in the normal range, such as 72 degrees F plus or minus 5 degrees F.

i) Post-Mitigation Testing

1. Post-mitigation measurements shall not be conducted if temporary radon reduction measures are in use.

2. Post-mitigation measurements shall be conducted to determine a system's effectiveness after a permanent radon reduction system has been fully operational for at least 24 hours but not later than 30 days following completion and activation of a mitigation system. The mitigation system shall be operated normally and continuously during the entire measurement period.

3. Post-mitigation measurements shall be conducted in accordance with subsections (a), (b) and (c).

j) Temporary Radon Reduction Measures

1. Temporary radon reduction measures include:

A) The introduction of unconditioned air into the building; or

B) Closure of normally accessible areas of the building; or

C) Lowering the thermostat below its normal use range, such as 72 degrees F plus or minus 5 degrees F.

2. Any of the conditions listed in subsection (k) of this Section shall invalidate measurement results. The Radon Measurement licensee shall not conduct a measurement until the conditions have been corrected. The Radon Measurement licensee shall inform the client and other parties involved in a real estate transaction that these conditions invalidate the measurement results.

3. Any improper radon reduction efforts that may affect the measurement results identified prior to, during, or after initial, follow-up, real estate option or post-mitigation measurements shall invalidate the measurement results. The Radon Measurement licensee shall not conduct a measurement until the improper conditions have been corrected.

4. Post-mitigation measurements shall not be conducted if any improper radon reduction efforts that may affect the measurement results are identified.

k) When Radon Measurements Shall Not Be Made

1. Short-term radon measurements of less than 96 hours shall not be conducted during severe storms or periods of sustained high winds (30 miles per hour or more). Radon Measurement licensees shall check and document local weather forecasts prior to placing short-term measurement devices when the measurement period is less than 96 hours.

AGENCY NOTE: The National Weather Service defines a severe storm as a storm that generates winds of 58 mph, and/or ¾-inch diameter hail and that may produce tornadoes – not necessarily in that order.

2. Radon measurements of any duration shall not be made during renovation of a building, especially renovations involving structural changes, or during renovations of the HVAC systems or any change that disturbs the normal airflow of the building.

AGENCY NOTE: When renovations are planned, radon measurements should be made prior to renovations and immediately upon the completion of renovations.

l) Quality Assurance for Radon Measurements.

1. Radon Measurement licensees shall abide by the Quality Assurance Program described in Section 422.60(a)(5)(I).

2. Measurements not performed in accordance with subsections (a), (b) and (c) shall be considered inappropriate for the purpose of determining the need for mitigation or the effectiveness of a mitigation service.

m) Measurement Documentation

1. Radon Measurement Professional licensees shall ensure that sufficient information on each measurement is recorded in a permanent record to allow for future data comparisons, interpretations and reporting to clients.

2. Radon Measurement Professional licensees shall keep the following information in a measurement record that shall be maintained for inspection for a minimum of 5 years. Additional method-specific documentation is outlined in Section 422.140.

A) A complete copy of the measurement report.

B) A description of any non-interference controls used and copies of non-interference agreements completed in accordance with subsection (d); and

C) A record of any quality control measures associated with the test, such as the results of simultaneous measurements, diagnostic measurements, duplicate measurements and calculations associated with the measurement.

n) Measurement Results

1. Measurement results shall be reported in the units that the device measures.

2. Any measurement results based on radon gas shall be reported to no more than one decimal place, e.g., 4.3 pCi/L.

3. All valid individual measurement results shall be reported.

4. When using continuous radon monitors, hourly readings shall be included.

5. Measurements made in separate locations shall not be averaged.

6. The average of collocated measurement devices shall be reported, as well as the individual results. Standard mathematical rules shall be followed; i.e., if the average of two measurements produces a result of 3.95 pCi/L, the result shall be reported as 4.0 pCi/L.

7. Any quality control measurements shall be reported as such.

o) Measurement Reports

1. Radon Measurement Professional licensees shall return radon measurement results to the occupant, the owner of the building, his/her representatives or the client within 45 days after retrieving exposed devices. As a minimum, the measurement report shall contain:

A) Measurement results reported in accordance with subsection (n).

B) The exact start and stop dates and times of the measurement period.

C) The address of the building measured, including the zip code.

D) A description of the measurement device used, its manufacturer, model or type, and serial numbers or other unique device identification numbers.

E) The names and Illinois radon license numbers of the licensees placing and retrieving the devices.

F) The name and Illinois license number of the laboratory analyzing the device, if applicable.

G) A statement describing recommendations concerning retesting or mitigation provided to the occupant, the owner of the building, his/her representatives or the client in accordance with Appendix A or B, as appropriate.

H) A statement of whether a mitigation system was observed in the building during placement or retrieval. The statement shall indicate whether the system is PNC or ASD. If the system is ASD, the statement shall indicate whether the mitigation system is operating and the mitigation tag number for systems installed after November 1, 2009.

I) A statement describing any observed tampering, interference or deviations from the required measurement conditions.

J) A description of the condition of any permanent vents that allow outdoor air into the building, such as crawlspace vents or combustion air supply to combustive appliances.

K) A description of any severe weather conditions.

L) The exact locations of all measurement devices deployed and any information that would allow for future data comparisons and interpretations. Licensees shall provide the exact locations by one of the following methods:

i) A scale diagram of the footprint of the building identifying the windows and doors, finished and unfinished areas, room use, furnaces, hot water heaters, dryers, combustion appliances, crawlspace vents, fireplaces, mitigation systems, floor drains and foundation types, indicating the front of the home and any other pertinent information that may affect the measurement.

ii) A copy of Appendix E for each foundation type measured.

2. Laboratories receiving an exposed device that has been delivered for analysis shall return results to the client within 45 days. At a minimum, the measurement report shall contain:

A) Measurement results reported in accordance with subsection (n).

B) The exact start and stop dates of the measurement period.

C) The address of the building measured, including the zip code.

D) A description of the measurement device used, its manufacturer, model or type, and serial numbers or other unique device identification numbers.

E) The name and Illinois license number of the laboratory analyzing the device.

p) Devices Placed by Clients. Radon licensees shall provide the client with the following:

1. For licensees providing measurement devices to clients, sufficient detectors to ensure that testing is performed consistent with this Part.

2. The Agency's address and telephone number.

3. Devices that will be placed by the client shall be accompanied by instructions on how to use the device. These instructions shall be consistent with this Section and include specific information on the minimum and maximum length of time that the device shall be exposed.

History

• Source: Amended at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.140 Device Protocol

a) Quality Assurance

1. Professional licensees providing measurement services using radon and radon product measurement devices shall establish and maintain a Quality Assurance Program (QAP). These programs shall include written procedures for attaining quality assurance objectives and a system for recording and monitoring the results of the quality assurance measurements for each device used. The QAP shall include the maintenance of control charts and related statistical data.

2. The objective of quality assurance is to ensure that data are scientifically sound and of known precision and accuracy. This subsection (a)(2) discusses the 6 general categories of quality control measurements. Specific guidance is provided for each method in the relevant protocol.

A) Calibration Measurements. Calibration measurements are samples collected or measurements made in a known radon environment, such as a radon chamber. Instruments providing immediate results, such as continuous working level and radon monitors, shall be operated in a radon chamber to establish individual instrument calibration factors.

i) Calibration measurements must be conducted to determine and verify the conversion factors used to derive the concentration results. These factors are determined normally for a range of concentrations and exposure times, and for a range of other exposure and/or analysis conditions pertinent to the particular device.

ii) Determination of these calibration factors is a necessary part of the laboratory analysis and is the responsibility of the laboratory. These calibration measurement procedures, including the frequency of tests and the number of devices to be tested, shall be specified in the QAP maintained by manufacturers and analysis laboratories.

iii) Licensees providing measurements with active devices are required to recalibrate their instruments at least once every 12 months.

B) Known Exposure Measurements (Spikes). Known exposure measurements or spiked samples consist of detectors that have been exposed to known concentrations in a radon chamber. These detectors, such as charcoal canisters, alpha track detectors and electret ion chambers, are labeled and submitted to the laboratory in the same manner as ordinary samples to preclude special processing.

i) Suppliers and analysis laboratories shall provide for the blind introduction of spiked samples into their measurement processes and the monitoring of the results in their QAP.

ii) Licensees using passive monitors shall conduct spiked measurements (i.e., exposure in a radon chamber where the environmental radon level is controlled) to aid the Agency in verifying the accuracy of the entire measurement system. The licensee shall conduct 3 spiked measurements per 100 measurements, with a minimum of 3 spiked measurements per year. For example, a licensee conducting only 70 measurements in a year must conduct at least 3 spiked measurements. A licensee conducting 500 measurements during a one-year period must conduct at least 15 spiked measurements (3 per each 100). No more than 6 spiked measurements will be required to be taken within any single month. For example, a licensee performing more than 200 measurements in one month is not required to perform more than 6 spiked measurements that month. Licensees are encouraged to take their spiked measurements from multiple batches when possible and to take more than the minimally required spiked measurements at their discretion. Devices shall be exposed in a radon chamber at a minimum of 3 different radon concentrations, such as approximately 4.0, 10-30 and 30-100 pCi/L.

iii) Spikes shall be labeled in the same manner as field detectors to ensure identical processing. The results of analyses of detectors exposed to known radon concentrations shall be monitored and recorded. Any significant deviation from the known concentration to which they were exposed shall be investigated and corrective action taken.

C) Background Measurements. Background measurements are required both for continuous monitors and for passive detectors requiring laboratory analysis.

i) Licensees using continuous monitors shall perform sufficient instrument background measurements to establish a reliable instrument background and to act as a check on instrument operation.

AGENCY NOTE: Calibration laboratories routinely perform background measurements of continuous monitors during the calibration of instruments.

ii) Passive detectors requiring laboratory analysis require one type of background measurement made in the laboratory and another in the field.

iii) Laboratories shall measure the background of a statistically significant number of unexposed detectors from each batch or lot to establish the laboratory background for the batch and the entire measurement system. This laboratory blank value is subtracted (by the laboratory) from the field sample results reported to the user, and shall be made available to the users for quality assurance purposes.

iv) Laboratories performing these measurements shall calculate the lower limit of detection (LLD) for their measurement systems. This LLD is based on the detector and analysis system's background and can restrict the ability of some measurement systems to measure low concentrations.

v) Licensees using passive detectors shall employ field controls (called blanks) equal to approximately 5 percent of the detectors that are deployed, or 25 each month, whichever is smaller.

vi) These controls shall be set aside from each detector shipment, kept sealed and in a low radon environment, labeled in the same manner as the field samples to preclude special processing, and returned to the analysis laboratory along with each shipment. These field blanks measure the background exposure that may accumulate during shipment and storage. The results shall be monitored and recorded.

vii) The recommended action to be taken if the concentrations measured by one or more of the field blanks is significantly greater than the LLD is dependent upon the type of detector and is discussed in the protocol for each method.

D) Duplicate Measurements. Duplicate measurements provide a check on the precision of the measurement result and allow the user to make an estimate of the relative precision. Large precision errors may be caused by detector manufacture or improper data transcription or handling by suppliers, laboratories, or technicians performing placements. Precision error can be an important component of the overall error; therefore, licensees performing measurements shall monitor precision.

i) Duplicate measurements shall be side-by-side measurements made in at least 10 percent of the total number of measurement locations, or 50 each month, whichever is smaller. The locations selected for duplicate measurement shall be distributed systematically throughout the entire population of samples.

ii) The precision of duplicate measurements shall be monitored and recorded in the quality assurance records. The analysis of data from duplicates shall be plotted on range control charts. If the precision estimated by the user is not within the precision expected of the measurement method, the cause of the problem shall be investigated.

iii) Detectors shall be treated identically in every respect. They shall be shipped, stored, opened, installed, removed and processed together, and not identified as duplicates to the processing laboratory.

E) Routine Instrument Performance Checks. Proper functioning of analysis equipment and operator usage require that the equipment and measurement system be subject to routine checks. Regular monitoring of equipment and operators is vital to ensure consistently accurate results. Performance checks include the frequent use of an instrument check source. Components of the device (such as a pump, battery or electronics) shall be checked regularly and the results noted in a record. Each user shall develop methods for regularly monitoring (preferably daily with use) their measurement system and for recording and reviewing results.

F) Cross-checks. Professional licensees using active monitors shall check their monitors for bias on a regular basis. Ideally, such measurements are made in a radon chamber. Exposure in a radon chamber is required during calibration. It can be difficult to expose active monitors more often than once every 12 months. It is important to more frequently assess the continued satisfactory operation of the instrument response and to ensure damage from shipping has not occurred prior to an instrument being placed into service after calibration. Cross-checks shall be performed prior to placing an instrument being returned to service after calibration and at 6 months (plus or minus a month) after calibration. The following conditions shall be met:

i) Where feasible, a cross-check shall begin with an instrument background measurement.

ii) The cross-check measurement shall be made in an environment that has been chosen for its stability and radon concentration that is above the lower limit of detection.

iii) Cross-checks shall be side-by-side measurements.

iv) One of the instruments shall have been calibrated within the last 45 days.

v) A measurement of at least 48 hours duration shall be conducted.

vi) The bias of cross-check measurements shall be monitored and recorded in the quality assurance records. If the bias estimated by the user is not within the bias expected of the measurement, the cause of the problem shall be investigated and corrective action taken in accordance with the licensee's Agency-approved QAP.

b) Protocol for using continuous radon monitors (CRs) to measure indoor radon concentrations

1. Refer to Section 422.130 for a list of general conditions that shall be met and standard information that shall be documented.

2. When performing a radon measurement, the CR shall be programmed to run continuously, recording periodically (hourly or more frequently) the radon concentration for at least 48 hours. Longer measurements may be required per the continuous monitor type and the radon level being measured.

3. If the first 4 hours of data from a 48-hour measurement are discarded because data are produced prior to the establishment of equilibrium conditions in the test device, the remaining hours of data shall be averaged and shall be sufficient to represent a 2-day measurement.

4. Every CR shall be calibrated in a radon chamber, approved by the Agency, before being placed into service, and after any repairs or modifications that could affect the calibration. Subsequent recalibrations and background checks shall be performed at least once every 12 months. Each scintillation cell requires an individual calibration factor.

5. Background measurements shall be performed after every 1,000 hours of operation of scintillation cell-type CRs and whenever any type of CR is calibrated. The background shall be checked by purging the monitor with clean, aged air or nitrogen in accordance with the manufacturer's instructions. In addition, the background count rate shall be monitored in accordance with the manufacturer's instruction.

6. Licensees providing measurement services with CR devices shall perform duplicate measurements. The performance and analysis of duplicates shall be completed in accordance with subsection (a)(2)(D).

7. Pumps and flow meters shall be checked before and after each measurement in accordance with the manufacturer's instruction.

8. Licensees providing measurement services with CR devices shall perform cross-checks. The performance and analysis of cross-checks shall be completed in accordance with subsection (a)(2)(F).

c) Protocol for using alpha track (AT) detectors to measure indoor radon concentrations

1. Refer to Section 422.130 for a list of general conditions that shall be met and standard information that shall be documented.

2. The laboratory background level for each batch of ATs shall be established by each laboratory licensed by the Agency. Laboratories shall measure the background of a statistically significant number of unexposed ATs that have been processed according to the licensee's Quality Assurance Program implementing/operating procedures.

3. Every AT laboratory system shall be calibrated in a radon chamber at least once every 12 months. Determination of a calibration factor requires exposures of ATs to a known radon concentration in a radon chamber. These calibration exposures shall be used to obtain or verify the conversion factor between net tracks per unit area and radon concentration.

A) ATs shall be exposed in a radon chamber at a minimum of 3 different radon concentrations such as approximately 4.0, 10-30 and 30-100 pCi/L or exposure levels similar to those found in the tested buildings.

B) Expose a minimum of 10 detectors at each radon concentration of the chamber.

C) A calibration factor shall be determined for each batch or sheet of detector material received from the supplier. Alternatively, calibration factors may be established for several sheets, and these factors extended to detectors from sheets exhibiting similar sensitivities (within pre-established tolerance limits).

D) Analysis instruments shall be checked at least daily for operability prior to operation. Analysis instruments do not need to be checked on days not used.

4. Licensees providing measurement services with AT devices shall perform known exposure measurements (spikes). The performance and analysis of spikes shall be completed in accordance with subsection (a)(2)(B).

5. Licensees providing measurement services with AT devices shall perform duplicate measurements. The performance and analysis of duplicates shall be completed in accordance with subsection (a)(2)(D).

6. Licensees providing measurement services with AT devices shall perform background measurements. The performance of background measurements shall be completed in accordance with subsection (a)(2)(C).

A) The results shall be monitored and recorded. If one or a few field blanks have concentrations significantly greater than the LLD established by the supplier, it may indicate defective packaging or handling and the licensee shall investigate the cause. If the average value from the field control devices (field blanks) is significantly greater than the LLD established by the supplier, this average value shall be subtracted from the individual values reported for the other devices in the exposure group.

B) It may be advisable to use 3 sets of detectors (pre-exposure, field and post-exposure background) in order to allow the most thorough and complete evaluation of radon levels. For example, one group of detectors (pre-exposure detectors) may be earmarked for background measurement and returned for processing immediately after the other detectors are deployed. The results from these detectors determine if the number of tracks acquired before deployment is significant and should be subtracted from the gross result. The second set of background detectors (post-exposure background detectors) are obtained just before the field monitors are to be collected and are opened and kept in the same location as the returning field monitors for the same duration, and returned with them. Finally, this "post-exposure background" is subtracted from the field results, if found to be significant. In general, a value of 1 pCi/L or greater for any blank AT indicates a significant level that should be investigated and potentially subtracted from the field AT results.

d) Protocol for using electret ion chamber radon (ES or EL) detectors to measure indoor radon concentration.

1. Refer to Section 422.130 for a list of general conditions that shall be met and standard information that shall be documented.

2. Every short-term and long-term electret system and the electret reader(s) shall be calibrated in a radon chamber, approved by the Agency. Initial calibration for the system is provided by the manufacturer. Subsequent recalibrations shall be performed at least once every 12 months. Determination of calibration factors for short-term or long-term detectors requires exposure of detectors to known concentrations of radon-222 in a radon exposure chamber. Since short-term and long-term electret detector systems are also sensitive to gamma radiation, a gamma exposure rate measurement in the test chamber is also required annually.

3. The following is provided to manufacturers and suppliers of ES or EL services as minimum requirements in determining the calibration factor:

A) Detectors shall be exposed in a radon chamber at a minimum of 3 different radon concentrations, such as approximately 4.0, 10-30 and 30-100 pCi/L, or exposure levels similar to those found in the tested buildings.

B) Expose a minimum of 10 detectors at each radon concentration of the chamber.

C) Ensure a period of exposure sufficient to allow the detector to achieve equilibrium with the radon chamber atmosphere.

4. Licensees providing measurement services with ES or EL devices shall perform known exposure measurements (spikes). The performance and analysis of spikes shall be completed in accordance with subsection (a)(2)(B).

5. Licensees providing measurement services with ES or EL devices shall perform duplicate measurements. The performance and analysis of duplicates shall be completed in accordance with subsection (a)(2)(D).

6. Licensees providing measurement services with short-term or long-term electrets shall set aside a minimum of 5 percent of the electrets or 10, whichever number is smaller, from each shipment and evaluate them for voltage drift. The electrets shall be kept covered with protective caps in a low radon environment and analyzed for voltage drift over a time period similar to the time period used for those deployed in measurements. Any voltage loss found in the control electrets of more than one volt per week over a 3-week test period for short-term electrets, or one volt per month over a 3-month period for long-term electrets, shall be investigated.

7. Proper operation of the surface voltmeter shall be monitored following the manufacturer's procedures for zeroing the voltmeter and analyzing a reference electret. These checks shall be conducted at least once a week while the voltmeter is in use.

8. All Laboratory Analysis licensees providing recharging services of short-term or long-term electrets shall only provide those services for devices they manufacture or for devices for which they have written authorization from the manufacturer.

e) Protocol for using activated charcoal adsorption (AC) devices to measure indoor radon concentrations

1. Refer to Section 422.130 for a list of general conditions that shall be met and standard information that shall be documented.

2. Every activated charcoal adsorption system shall be calibrated in a radon chamber at least once every 12 months. Determination of calibration factors for ACs requires exposure of the detectors to known concentrations of radon-222 in a radon chamber. The calibration factors depend on the exposure time and may also depend on the amount of water adsorbed by the charcoal container during exposure. Calibration factors shall be determined for each AC measurement system (container type, amount of charcoal, gamma detector type, etc.).

3. Licensees providing measurement services with AC devices shall perform known exposure measurements (spikes). The performance and analysis of spikes shall be completed in accordance with subsection (a)(2)(B).

4. Licensees providing measurement services with AC devices shall perform duplicate measurements. The performance and analysis of duplicates shall be completed in accordance with subsection (a)(2)(D).

5. Laboratory Control Detectors. The laboratory background level for each batch of ACs shall be established by each laboratory or supplier. Suppliers shall measure the background of a statistically significant number of unexposed detectors that have been processed according to their standard operating procedures (laboratory blanks). The analysis laboratory or supplier calculates the net readings, that are used to calculate the reported sample radon concentrations, by subtracting the laboratory blank values from the results obtained from the field detectors.

6. Licensees providing measurement services with AC devices shall perform background measurements. The performance of background measurements shall be completed in accordance with subsection (a)(2)(C).

A) One or a few of the field blanks have concentrations significantly greater than LLD established by the supplier may indicate defective devices or poor procedures and the licensee shall investigate the cause.

B) If most of the field blanks have concentrations significantly greater than the LLD, the average value of the field blanks shall be subtracted from the reported field detector concentrations and the supplier notified of a possible problem.

7. Counting equipment shall be subject to daily operability checks by counting an instrument check source and determining whether the reference source is constant to within established limits (2 standard deviations). Daily operability checks do not need to be performed on days the instrument is not used. The characteristics of the check source (geometry, type of radiation emitted, etc.) shall be similar to those of the samples analyzed. The count rate of the check sources shall be high enough to yield good counting statistics in a short time (for example, 1000 to 10,000 counts per minute) to provide a maximum random uncertainty of 5 percent.

f) Protocol for using charcoal liquid scintillation (LS) devices to measure indoor radon concentrations

1. Refer to Section 422.130 for a list of general conditions that shall be met and standard information that shall be documented.

2. Every LS laboratory system shall be calibrated in a radon chamber at least once every 12 months. Determination of calibration factors for LS devices requires exposure of calibration devices to known concentrations of radon-222 in a radon chamber at carefully measured radon concentrations. The calibration factors depend on the exposure time and may also depend on the amount of water adsorbed by the device during exposure. Calibration factors shall be determined for a range of different exposure times and, as appropriate, humidities.

3. Licensees providing measurement services with LS devices shall perform known exposure measurements (spikes). The performance and analysis of spikes shall be completed in accordance with subsection (a)(2)(B).

4. Licensees providing measurements services with LS devices shall perform duplicate measurements. The performance and analysis of duplicates shall be completed in accordance with subsection (a)(2)(D).

5. Laboratory Control Devices. The laboratory background level for each batch of LS devices shall be established by each laboratory or supplier. Suppliers shall measure the background of a statistically significant number of unexposed LS devices that have been processed according to their standard operating procedures (laboratory blanks). The analysis laboratory or supplier calculates the net readings that are used to calculate the reported sample radon concentrations, by subtracting the laboratory blank values from the results obtained from the field detectors.

6. Licensees providing measurement services with LS devices shall perform background measurements. The performance of background measurements shall be completed in accordance with subsection (a)(2)(C).

A) One or a few of the field blanks have concentrations significantly greater than the LLD established by the supplier may indicate defective devices or poor procedures and the licensee shall investigate the cause.

B) If most of the field blanks have concentrations significantly greater than the LLD, the average value of the field blanks shall be subtracted from the reported field detector concentrations and the supplier notified of a possible problem.

7. Counting equipment shall be subject to daily operability checks by counting an instrument check source and determining whether the reference source is constant to within established limits (2 standard deviations). Daily operability checks do not need to be performed on days the instrument is not used. The characteristics of the check source (geometry, type of radiation emitted, etc.) shall be similar to those of the samples analyzed. The count rate of the check sources shall be high enough to yield good counting statistics in a short time (for example, 1000 to 10,000 counts per minute) to provide a maximum random uncertainty of 5 percent.

g) Protocol for using continuous working level (CW) monitors to measure indoor radon progeny concentrations

1. Radon Decay Product measurements may be appropriate under certain conditions in large buildings, but are not currently routinely performed by licensees or recommended by the American Association of Radon Scientists and Technologists. The Agency does not recommend their use for home environment or residential real estate measurements. Licensees interested in using CWs for measurement purposes shall submit Standard Operating Procedures, consistent with this Part, specific to the model and design of the CW instrument to the Agency for approval.

2. Conditions and information in Section 422.130 shall be met.

3. Any measurement result based on radon progeny shall be reported to no more than 3 decimal places, e.g., 0.033 working level (WL).

4. The integrated average WL over the measurement period shall be reported as the measurement result.

5. When performing a radon measurement, the CW shall be programmed to run continuously, recording the periodic WL and, when possible, the total integrated average WL. The longer the operating time, the smaller the uncertainty associated with using the measurement result to estimate a longer-term average concentration.

6. Working level values shall be converted to pCi/L and both shall be reported to the client. The conversions from WL to pCi/L shall be presented and explained clearly in the report to the client. A statement shall be included in the measurement report that this approximate conversion is based on a 40 percent equilibrium ratio. In addition, the report shall state that this equilibrium ratio is typical, but that any indoor environment may have a different and varying relationship between radon and radon progeny.

7. Every continuous WL monitor shall be calibrated in a radon chamber, approved by the Agency, before being placed into service and after any repairs or modifications that could affect the calibration. Subsequent recalibrations shall be performed at least once every 12 months.

8. Background measurements shall be performed after every 168 hours of operation and whenever the unit is calibrated. The CW shall be purged with clean, aged air or nitrogen in accordance with the manufacturer's instructions. In addition, the background count rate may be monitored more frequently by operating the CW in a low radon concentration.

9. Measurement licensees providing measurement services with CW devices shall perform duplicate measurements. The performance and analysis of duplicates shall be completed in accordance with subsection (a)(2)(D).

10. Pumps and flow meters shall be checked before and after each measurement in accordance with the manufacturer's instruction to ensure accuracy of volume measurements. This may be performed using a dry-gas meter or other flow measurement device of traceable accuracy.

11. Licensees providing measurement services with CW devices shall perform cross-checks. The performance and analysis of cross-checks shall be completed in accordance with subsection (a)(2)(F).

History

• Source: Amended at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.150 Mitigation Standard for Existing Housing

a) The Mitigation Standard (MS) includes requirements for installation of radon remediation systems and provides a basis for evaluating the quality of such installations. It provides the basis against which in-progress or completed inspections will be evaluated.

b) Radon Mitigation Professional licensees shall be responsible for all radon mitigation systems installed by their firm or its subcontractors to ensure compliance with the requirements of this Mitigation Standard.

c) Limitations

1. Where discrepancies exist between provisions of the MS and municipal codes, the municipal codes shall take precedence, except that the municipal codes shall not take precedence with regard to alterations that may adversely impact the radon reduction functions for which such systems were originally designed and may adversely impact public health and safety regarding exposure to a radioactive element.

2. Compliance with the MS does not guarantee reduction of indoor radon concentrations to any specific level.

3. When altering a mitigation system, it shall be upgraded to the requirements of this Section. Altering radon mitigation systems does not include activities such as replacing worn out equipment or providing new filters, while leaving the remainder of the system unchanged. When maintenance is performed by a licensee on a mitigation system that does not comply with this Part, the client shall be notified in writing that the mitigation system does not comply with the mitigation standards of this Part. In addition, the professional licensee shall provide a written estimate of the upgrades needed and the cost to bring the system into compliance.

d) Quality Assurance. Radon Mitigation licensees shall follow the procedures specified in the Quality Assurance Program as required by Section 422.60(c)(5)(D).

e) General Practices. The following general practices are required for all contacts between Radon Mitigation licensees and clients.

1. In the initial contact with a client, the licensee shall review any available results from previous radon measurements to assist in developing an appropriate mitigation strategy. If the radon measurement was not performed in accordance with this Part, the client shall be advised that a retest is recommended.

2. The licensee shall inform the client of or provide to the client, Illinois specific documents, approved by the Agency, that discuss interpretation of indoor radon test results and the health risk associated with the radon level found in the building. These documents are available from the Agency and are on the Agency web site.

3. The licensee shall inform the client in writing, at the time a proposal for the installation of a radon reduction system is offered, of any sealants, caulks, or bonding chemicals containing volatile solvents and of the need to ventilate work areas during and after the use of such materials. The licensee shall provide ventilation as recommended by the manufacturer of the material used if existing ventilation does not meet the recommendations of the manufacturer of the material used.

f) Building Investigation

1. The licensee shall conduct a thorough visual inspection of the building prior to initiating any radon mitigation work. The results of the inspection shall be recorded in detail on a drawing of the floor plan. The licensee shall identify and describe any specific building characteristics and configurations, such as large cracks in slabs, exposed earth in crawlspaces, open stairways to basements, or air ducts under the slab of any foundation, and operational conditions, such as continuously running HVAC systems, or operability of windows, that may affect the design, installation, and effectiveness of radon mitigation systems.

A) As part of this inspection, the licensee shall request from the client any available information on the building, such as construction specifications, pictures, drawings, etc., that might be valuable in determining the radon mitigation strategy.

B) A floor-plan drawing shall be finalized from preliminary inspection sketches and shall include illustration of the building foundation, the location of all walls, drain fixtures, HVAC systems and radon entry points, results of any diagnostic testing, the layout of any radon mitigation system piping, and the location of any vent fan and system warning devices.

C) The finalized drawing shall be an auditable part of the mitigation file and shall be available to the occupant, the owner of the building, his/her representatives or the client, upon request.

2. The licensee shall conduct diagnostic tests to assist in identifying and verifying radon entry points and shall document the results of these tests in writing. Such tests may include radon grab sampling, continuous radon monitoring, and the use of smoke sticks.

3. If a contractor has concerns about backdrafting potential at a particular site, the contractor shall recommend that a qualified person inspect the natural draft combustion appliances and venting systems for compliance with local codes and regulations. The contractor shall recommend that the building owner bring into compliance any combustion appliance or venting system found to be non-complying.

4. Licensees shall not install a fan-powered radon reduction system in any building wherein confirmed spillage from any natural combustion appliance occurs, until the licensee has confirmed that the problem has been corrected by the client.

5. Licensees shall conduct a communication test prior to completing a proposal for the installation of a radon reduction system in any building where the characteristics of the sub-slab material are unknown to the licensee. The results of the communication test shall be documented in writing or on a drawing of the building floor plan.

g) Systems Design

1. All radon mitigation systems shall be designed and installed as permanent, integral additions to a building, except in accordance with subsection (e)(3).

2. All radon mitigation systems shall be designed to avoid the creation of other health, safety, or environmental hazards to building occupants, such as backdrafting of natural draft combustion appliances.

3. The main run of vent pipe, from primary suction point to exhaust, shall be a minimum 3 inches in diameter to avoid excessive flow noise inside the pipe and noise when the exhaust jet is released.

4. All radon mitigation systems and their components shall be designed to comply with the laws, ordinances, codes, and regulations of relevant jurisdictional authorities, including applicable mechanical, electrical, building, plumbing, energy and fire prevention codes.

5. All radon mitigation systems shall be designed to reduce a radon concentration in each area within the footprint of the building as low as reasonably achievable (ALARA).

6. As installed, the mitigation system shall operate at a reasonable noise level.

h) Systems Installation

1. General Requirements

A) All components of radon mitigation systems shall also be in compliance with the applicable mechanical, electrical, building, plumbing, energy and fire prevention codes, standards, and regulations of local jurisdiction.

B) Where portions of structural framing material must be removed to accommodate radon vent pipes, material removed shall be no greater than that permitted for plumbing installations by applicable building or plumbing codes.

C) Where radon mitigation system installation requires pipes or ducts to penetrate a firewall or other fire resistance rated wall, floor or ceiling penetrations shall be protected in accordance with applicable building, mechanical, fire and electrical codes.

AGENCY NOTE: An example of a protected penetration would be the installation of a fire collar on a vent pipe penetrating a ceiling.

D) Sump pits shall not be used as the primary suction point for mitigation systems, unless in accordance with subsection (h)(7).

2. Radon resistant construction is required of new one- and two-family building construction. Active mitigation systems installed in new construction must be performed by a licensed mitigation professional or technician.

3. Radon Vent Pipe Installation

A) All joints and connections in radon mitigation systems using plastic vent pipes shall be permanently sealed with adhesives as specified by the manufacturer of the pipe material used, with 2 exceptions:

i) If secondary suction points are installed in sump pits, the system shall be designed with removable or flexible couplings to facilitate removal of the sump pit cover and for sump pump maintenance; and

ii) To facilitate maintenance and future replacement, radon vent fans shall 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.

B) All joints and connections in radon mitigation systems using a 3-inch by 4-inch metal downspout on the exterior of a building shall be permanently sealed with appropriate sealants.

C) Vent stack discharge points shall be directed vertically with no obstruction in the discharge except for a rodent screen of wire mesh no smaller than ¼ inch. The rodent screen or wire mesh shall be installed in a manner that allows for easy removal for cleaning. Rain caps shall not be installed on the discharge.

D) Radon vent pipes shall be fastened to the structure of the building with hangers, strapping, or other supports that will permanently secure the vent material. Existing plumbing pipes, ducts, or mechanical equipment shall not be used to support or secure a radon vent pipe.

E) Radon vent pipes shall be supported as follows:

i) Supports for radon vent pipes shall be installed at least every 6 feet on non-vertical runs.

ii) Vertical runs shall be secured either above or below the points of penetration through floors, ceilings and roofs.

iii) Vertical runs shall be secured at least every 8 feet on runs that do not penetrate floors, ceilings or roofs.

F) To prevent blockage of air flow into the bottom of radon vent pipes, these pipes shall be supported or secured in a permanent manner that prevents their downward movement to the bottom of suction pits or sump pits, or into the soil beneath an aggregate layer under a slab.

G) Radon vent pipes shall be installed in a configuration that ensures that any rain water or condensation within the pipes drains downward into the ground beneath the slab or soil gas retarder membrane.

H) Radon vent pipes shall not block access to any areas requiring maintenance or inspection. Radon vents shall not be installed in front of or interfere with any light, opening, door, window or equipment access area required by code.

I) When a radon mitigation system is designed to draw soil gas from a perimeter drain tile loop (internal or external) that discharges water through a drain line to daylight or a soakaway, a one-way flow valve, water trap, or other control device shall be installed if diagnostic testing indicates that outside air is entering the system.

4. Vent Stack Discharge Point. The discharge from vent stack pipes of active soil depressurization systems shall prevent re-entrainment of radon, prevent vent stack blockage due to heavy snowfall and prevent the direct exposure of individuals outside of buildings to high levels of radon by meeting all the following requirements:

A) Above the highest eave of the roof and as close to the roof ridge line as possible, unless an attached garage may be used for vent stack pipe discharge and all the following additional conditions are met:

i) The vent stack point penetrates the highest point on the roof that maximizes distance from people using the house, yard, patio, deck, etc.;

ii) There are no windows in the direct line of sight from the vent stack point;

iii) The vent stack point penetrates the farthest point on the roof that maximizes distance from the nearest opening (such as windows, doors, etc.) into the house and garage that is less than 2 feet below the exhaust point; and

iv) The reason for routing through an attached garage shall be documented and maintained for inspection by the Agency;

B) 10 feet or more above ground level;

C) 10 feet or more from any window, door or other opening into conditioned spaces of the structure that is less than 2 feet below the exhaust point. The 10 feet may be measured either directly between the 2 points or be the sum of measurements made around intervening obstacles;

D) 10 feet or more from any opening into an adjacent building;

E) For vent stack pipes that penetrate the roof, at least 12 inches above the surface of the roof; and

F) For vent stack pipes attached to or penetrating the sides of buildings, vertical and at least 12 inches above the edge of the roof and in a position to prevent blockage from snow or other materials and from being filled with water from the roof or an overflowing gutter.

5. Radon Vent Fan Installation

A) Vent fans used in radon mitigation systems shall be designed or otherwise sealed to reduce the potential for leakage of soil gas from the fan housing.

B) Radon vent fans used in active soil depressurization systems shall be installed in attics, in garages that are not beneath conditioned spaces, or on the exterior of the building. Radon vent fans shall not be installed below ground nor in the conditioned (heated/cooled) space of a building, nor in any basement, crawlspace, or other interior location directly beneath the conditioned spaces of a building.

C) Radon vent fans shall be installed in a configuration that avoids condensation buildup in the fan housing. Fans shall be installed in vertical runs of the vent pipe.

D) Radon vent fans shall be mounted and secured in a manner that minimizes transfer of vibration to the structural framing of the building.

E) Radon vent fans shall be to mounted to the vent pipe with removable couplings or flexible connections to facilitate fan removal for repair or replacement.

F) The intakes of fans used in crawlspace pressurization, or in pressurizing the building itself, shall be screened or filtered to prevent ingestion of debris or personal injury. Screens or filters shall be removable to permit cleaning or replacement and the building occupant and owner shall be informed of the need to periodically replace or clean such screens and filters. This information shall be included in documentation provided to the client.

G) Vent fans shall originate from a manufacturer that lists radon mitigation as one of the fan's intended uses.

6. Suction Pit Requirement for Sub-Slab Depressurization (SSD) Systems.

Materials shall be excavated from the area immediately below the slab penetration point of SSD system vent pipes to provide optimum pressure field extension.

7. Sump Pit Requirements

A) Sump pits shall not be used as the primary suction point for mitigation systems except in accordance with subsection (h)(7)(J).

B) Sump pits that require a sump pump shall have a submersible sump pump installed, except in areas where the water table is near the surface causing flooding of the basement or interfering with the effectiveness of the mitigation system. (See subsection (h)(7)(D).)

C) When the sump pit is used as a secondary suction point, a submersible pump shall be installed in the sump pit.

D) In areas where the water table is near the surface, causing flooding of the basement or interfering with the effectiveness of the mitigation system, pedestal pumps with a higher pumping capacity may be installed in accordance with all the following conditions:

i) The pump is installed in accordance with the manufacturer's instructions.

ii) The sump lid can be sealed air tight with the exception of the tiny opening necessary to permit free operation of the pedestal pump's float.

iii) The design does not create noise, through the float opening, that is objectionable to the client.

E) Sump pits that permit entry of soil gas or that would allow conditioned air to be drawn into a mitigation system shall be covered and sealed to prevent such entry.

F) The covers on sumps that previously provided protection or relief from surface water collection shall be fitted with a water or mechanically trapped drain. Water traps shall be fitted with an automatic supply of priming water.

G) Sump pit covers shall be made of durable plastic or clear polycarbonate and be designed to permit air-tight sealing.

H) Sump pit covers shall be designed to support the weight of a 155-pound individual standing on the cover.

I) To permit easy removal for sump pump servicing, the sump pit cover shall be sealed using silicone or other non-permanent type caulking materials or an air-tight gasket.

J) When the basement of the home being mitigated has radiant heat lines installed in or below the floor, the sump pit may be used as the primary suction point. The radon vent shall include provisions for the removal of the sump lid for maintenance of the sump pump.

8. Sealing Requirements

A) Openings around radon vent pipe penetrations of the slab, the foundation walls, or the crawlspace soil gas retarder membrane shall be cleaned, prepared and sealed in a permanent, air-tight manner using compatible caulks or other sealants.

B) Openings around other utility penetrations of the slab, walls or soil gas retarder shall also be sealed. Cracks in slabs and other small openings around penetrations of the slab and foundation walls shall be cleaned, prepared and sealed in a permanent air-tight manner using caulks or other sealants designed for such application.

C) Where a Block Wall Depressurization (BWD) system is used to mitigate radon, openings in the tops of the block walls and all accessible openings or cracks in the interior surfaces of the block walls shall be cleaned, prepared and sealed with caulks or other sealants designed for such application.

D) When sealing holes for plumbing rough-in or other large openings in slabs and foundation walls that are below the ground surface, non-shrink mortar, grouts, expanding foam, or other sealants designed for such application shall be used.

E) Openings or cracks that are determined to be inaccessible or beyond the ability of the licensee to seal shall be disclosed to the client and included in the documentation.

F) Openings, perimeter channel drains or cracks that exist where the slab meets the foundation wall (floor-wall joint), shall be sealed with urethane caulk or other sealants designed for such application. When the opening or channel is greater than ½ inch in width, a foam backer rod shall be inserted in the channel before application of the sealant. This sealing technique shall be done in a manner that retains the channel feature as a water control system. Other openings or cracks in slabs or at expansion or control joints should also be sealed.

G) When installing baseboard type suction systems, all seams and joints in the baseboard material shall be joined and sealed using materials recommended by the manufacturer of the baseboard system. Baseboards shall be secured to walls and floors with adhesives designed and recommended for such installations. If a baseboard system is installed on a block wall foundation, the tops of the block walls shall be closed and sealed.

9. Soil Gas Retarder Requirements

A) A soil gas retarder membrane shall be installed in basement or crawlspace areas without a concrete floor.

B) Plastic sheeting installed in crawlspaces or basements as soil gas retarders shall be a minimum of 6 mil (3 mil cross-laminated) polyethylene or equivalent flexible material. Heavier gauge sheeting shall be used when crawlspaces or basements are used for storage or frequent entry is required for maintenance of utilities.

C) Any seams in soil gas retarder membranes shall be overlapped at least 12 inches and sealed in a permanent air tight manner using compatible glues. The membrane shall also be sealed around interior piers and to the inside of exterior walls with furring strips and sealant or in accordance with specific procedures approved by the Agency.

D) Access doors required by local building codes shall be fitted with air tight gaskets and a means of positive closure, but shall not be permanently sealed. In cases where both the basement and the adjacent crawlspace areas are being mitigated with active SSD and SMD systems, sealing of the openings between those areas is not required.

E) Crawlspace depressurization without the use of a soil gas retarder membrane shall only be used when the crawlspace is inaccessible. When crawlspace depressurization is used for radon mitigation, openings and cracks in floors above the crawlspace that would permit conditioned air to pass out of the living spaces of the building, shall be identified, closed and sealed. Sealing of openings around hydronic heat or steam pipe penetrations shall be done using non-combustible materials.

F) Drain tile depressurization in a crawlspace shall only be installed under the following conditions:

i) In conjunction with a sub-membrane depressurization system; or

ii) Suction can be obtained beneath the soil gas retarder.

10. Electrical Requirements

A) All electrical components of radon mitigation systems shall conform to provisions of the National Electrical Code and any additional local regulations.

B) Wiring shall not be located in or chased through the radon vent piping or any heating or cooling ductwork.

C) Any plugged cord used to supply power to a radon vent fan shall be no longer than 6 feet in length.

D) No plugged cord shall penetrate a wall or be concealed within a wall.

E) Radon mitigation fans installed on the exterior of buildings shall be hard-wired into an electrical circuit. Electrical disconnects shall be installed within line of sight and within 4 feet of the fan. Exteriorly, plugged fans shall be used only inside of weather-proofed fan housings or weather-proofed chases.

F) If the rated electricity requirements of a radon mitigation system fan exceeds 50 percent 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 percent of the circuit's rated capacity, a separate, dedicated circuit shall be installed to power the fan.

G) An electrical disconnect switch or circuit breaker shall be installed in radon mitigation system fan circuits to permit deactivation of the fan for maintenance or repair. Disconnect switches are not required with plugged fans.

11. Drain Installation Requirements

A) If drains discharge directly into soil beneath the slab or through solid pipe to a soakaway, the licensee shall install a drain that meets local building codes.

B) If condensate drains from air conditioning units terminate beneath the floor slab, the licensee shall install a trap in the drain that provides a minimum 6-inch standing water seal depth, reroute the drain directly into a trapped floor drain, or reconnect the drain to a condensate pump.

C) Perimeter (channel or French) drains shall be sealed with backer rods and urethane or comparable sealants in a manner that will retain the channel feature as a water control system.

D) When a sump pit is the only system in a basement for protection or relief from excess surface water and a cover is installed on the sump for radon control, the cover shall be recessed and fitted with a trapped drain meeting the requirements of subsection (h)(7).

12. HVAC Installation Requirements

A) Modifications to an existing HVAC system that are proposed to mitigate elevated levels of radon should be reviewed and approved by the original designer of the installed HVAC system or by a licensed mechanical contractor.

B) Foundation vents, installed specifically to reduce indoor radon levels by increasing the natural ventilation of a crawlspace, shall be non-closeable. In areas subject to sub-freezing conditions, the existing location of water supply and distribution pipes in the crawlspace, and the need to insulate or apply heat tape to those pipes, shall be considered when selecting locations for installing foundation vents.

C) Heat Recovery Ventilation (HRV) systems shall not be installed in rooms that contain friable asbestos.

D) In HRV installations, supply and exhaust ports in the interior shall be located a minimum of 12 feet apart. The exterior supply and exhaust ports shall be positioned to avoid blockage by snow or leaves and be a minimum of 10 feet apart.

E) Contractors installing HRV systems shall verify that the incoming and outgoing airflow is balanced to ensure that the system does not create a negative pressure within the building. Contractors shall inform their client, the occupant and the owner that periodic filter replacement and inlet grill cleaning are necessary to maintain a balanced airflow. Information on filter replacement and inlet grill cleaning shall be provided to their client, the occupant and the owner and shall be included in the documentation.

F) Both internal and external intake and exhaust vents in HRV systems shall be covered with wire mesh or screening to prevent entry of animals or debris or injury to occupants.

13. Materials

A) As a minimum, all plastic vent pipes in mitigation systems shall be smooth-walled Schedule 40 PVC.

B) Piping routed exteriorly shall be rated against deterioration from ultra-violet radiation from the sun.

C) Exteriorly, Schedule 40 PVC or 3-inch by 4-inch metal downspout shall be used as the vent pipe.

D) Vent pipe fittings in a mitigation system shall be of the same material as the vent pipes except as noted in subsection (h)(3)(A).

E) Cleaning solvents and adhesives used to join plastic pipes and fittings shall be as recommended by manufacturers for use with the type of pipe material used in the mitigation system.

F) When sealing holes for plumbing rough-in or other large openings in slabs and foundation walls that are below the ground surface, non-shrink mortar, grouts, expanding foam or other sealants designed for such application shall be used.

G) Penetrations of sump covers to accommodate electrical wiring, water ejection pipes, or radon vent pipes shall be designed to permit air-tight sealing around penetrations, using caulk or grommets.

H) Plastic sheeting installed in crawlspaces or basements as soil gas retarders shall be a minimum of 6 mil (3 mil cross-laminated) polyethylene or equivalent flexible material. Heavier gauge sheeting shall be used when crawlspaces or basements are used for storage or frequent entry is required for maintenance of utilities.

I) Any wood that comes into direct contact with the soil or concrete and is used in attaching soil gas retarder membranes to crawlspace walls or piers shall be pressure treated or naturally resistant to decay and termites.

J) When transitioning from one material or shape to another, an adapter specifically designed for the transition shall be used.

K) Drain tile or perforated pipe may be installed under soil gas retarders for the purpose of depressurization and to allow condensation to drain back to the soil.

L) The juncture of each radon vent pipe with the roof line shall be made water tight by an approved flashing. Radon vent pipes discharge large quantities of water vapor that will freeze at the discharge point; therefore, lead vent flashings or any other flashing or cap that would impede the exhaust from the radon vent are prohibited from use.

14. Monitors and Labeling

A) All active soil depressurization systems shall include a mitigation system monitor to indicate fan operation system performance or warn of fan failure.

B) Electrical radon mitigation system monitors (whether visual or audible) shall be installed on non-switched circuits and be designed to reset automatically when power is restored after service or power supply failure. Battery operated monitoring devices shall not be used unless they are equipped with a low-power warning feature.

C) Mechanical radon mitigation system monitors, such as manometer type pressure gauges, shall be clearly marked to indicate the range or zone of pressure readings that existed when the system was initially activated.

D) An Illinois Mitigation System Tag shall be placed on the vent pipe next to the mitigation system monitor. This label shall be purchased from the Agency and include the following information: "Radon Reduction System"; the installer's name, phone number and the Illinois license number; the date of installation; and an advisory that the building should be tested for radon at least every 2 years.

E) All exposed and visible interior radon mitigation system vent pipe sections shall be identified with at least one label on each floor level that reads "Radon Reduction System".

F) Fans mounted outdoors and exterior vent pipe shall be identified with a label that reads "Radon Reduction System" in a weatherproof manner.

G) Sump pits that are depressurized by the mitigation system or covered to minimize radon entry shall be identified with a label that reads "Radon Reduction System – Removal of this cover may result in failure of the Radon Reduction System. Consult (installer's name and phone number) before removing this cover and for instructions on the correct procedure for replacing it."

H) Circuit breakers controlling the circuits on which the radon vent fan and system failure warning devices operate shall be labeled "Radon Reduction System".

15. Post Installation Checklist

A) Upon completion of the installation of any radon mitigation system, the licensee shall complete the following steps, and document them on an installation check sheet that shall be signed and dated by a mitigation licensee and shall become auditable evidence.

i) Re-examine and verify the integrity of the fan mounting seals and all joints in the interior vent piping.

ii) Verify suctions or flows in the system piping or ducting to assure that the system is operating as designed.

iii) Advise the client that retesting the building at least every 2 years or if the building undergoes significant alteration is recommended.

iv) Request a copy of the report of any post-mitigation testing conducted by the client or by a Radon Measurement licensee.

B) Radon Mitigation licensees shall inform the client in writing that post-mitigation testing should be conducted no sooner than 24 hours nor later than 30 days following completion and activation of the mitigation system and that the test may be conducted by an independent Radon Measurement licensee or by the resident of the dwelling.

16. Post-Mitigation Testing

A) Evaluate the effectiveness of the mitigation system using an approved measurement device to assure the system is performing as designed.

B) Post-mitigation tests shall be performed in accordance with the applicable requirements of Section 422.130.

17. Contracts and Documentation

A) No mitigation activity shall be undertaken before a proposal for the work is accepted by the client, as evidenced by the client's signature and date on the proposal. A proposal for the installation of any radon mitigation system shall include as a minimum:

i) The Radon Mitigation Professional licensee's Illinois license number;

ii) A statement describing the planned scope of the work and an estimated completion date;

iii) A statement describing any known hazards associated with chemicals used in or as part of the installation;

iv) A statement indicating compliance with and implementation of the mitigation standards described in this Section;

v) A description of any system maintenance that the client, the occupant, or the building owner would be required to perform;

vi) A firm price of the installation cost and an estimate of the annual operating costs of the system; and

AGENCY NOTE: The firm price may include stepped approaches.

vii) A statement that the system is guaranteed to reduce and maintain the average radon concentration to less than 4.0 pCi/L and the conditions thereof; or a statement explaining that there is no guarantee and the reasons why there is no guarantee.

B) Licensees shall maintain the following records for 5 years or for the period of any warranty or guarantees, whichever is longer, and shall make the following records available to the homeowner upon request and documentation of home ownership:

i) Copies of the building investigation summary and floor plan sketch;

ii) The finalized drawing that includes illustration of the building foundation, the location of all walls, drain fixtures, HVAC systems and radon entry points, results of any diagnostic testing, the layout of any radon mitigation system piping, and the location of any vent fan and system warning devices;

iii) Pre- and post-mitigation radon test data;

iv) Copies of contracts and warranties;

v) A description of the mitigation system installed and its basic operating principles;

vi) A description of any deviations from the MS and applicable regulations of this Part;

vii) A description of the proper operating procedures of any mechanical or electrical systems installed, including manufacturer's operation and maintenance instructions and warranties;

viii) The proposal, contract, and warranties or guarantees made to the client, and any other documentation important to the mitigation system installed; and

ix) The address of the building mitigated, including the zip code, the mitigation system type, the mitigation date, whether radon resistant new construction techniques were used, and the Illinois Mitigation System Tag number.

C) Licensees shall, upon completion of the mitigation project, provide clients with an information package that includes:

i) A list of appropriate actions for clients to take if the system failure warning device indicates system degradation or failure; and

ii) The name, telephone number, and license number of the professional licensee and the phone number of the Agency's Radon Program.

History

• Source: Amended at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.160 Mitigation Standard for New Residential Construction

a) General Practices. This Section contains the requirements for new construction in Illinois in accordance with the Radon Resistant Construction Act [420 ILCS 52]. The following required construction methods are intended to resist radon entry and prepare the building for post-construction radon mitigation, if necessary. These techniques are required in all areas of Illinois.

b) Subfloor Preparation. A layer of gas-permeable material shall be placed under all concrete slabs and other floor systems that directly contact the ground and are within the walls of the living spaces of the buildings, to facilitate future installation of a sub-slab depressurization system, if needed. The gas permeable layer shall consist of one of the following:

1. A uniform layer of clean aggregate, a minimum of 4 inches (102 mm) thick. The aggregate shall consist of material that will pass through a 2 inch (51 mm) sieve and be retained by a ¼ inch (6.4 mm) sieve; or

2. A uniform layer of sand (native or fill), a minimum of 4 inches (102 mm) thick, overlain by a layer or strips of geo-textile drainage matting designed to allow the lateral flow of soil gases. The geotextile matting shall have a cross-sectional area of not less than 12 square inches (77 sq. cm) and shall be placed, at a minimum, along the entire inside perimeter of the foundation at a distance of 12 to 18 inches (30 to 46 cm) distance from the foundation wall to the edge of the drainage matting. Deviation from the 12 to 18 inches (30 to 46 cm) distance to the foundation wall shall be allowed to avoid obstacles such as plumbing and other utilities; or

3. Other materials, systems or floor designs with demonstrated capability to permit depressurization across the entire subfloor area.

c) Soil Gas Retarder. A minimum 6-mil (0.15 mm) (or 3-mil (0.075 mm) cross‑laminate) polyethylene or equivalent flexible sheeting material shall be placed on top of the gas permeable layer prior to casting the slab or placing the floor assembly to serve as a soil gas retarder by bridging any cracks that develop in the slab or floor assembly and to prevent concrete from entering the void spaces in the aggregate base material. The sheeting shall cover the entire floor area with separate sections of sheeting lapped at least 12 inches (305 mm). The sheeting shall fit closely around any pipe, wire or other penetrations of the material. All punctures or tears in the material shall be sealed or covered with additional sheeting.

d) Entry Routes. Potential radon entry routes shall be closed in accordance with the following:

1. Floor openings around bathtubs, showers, water closets, pipes, wires or other objects that penetrate concrete slabs or other floor assemblies shall be filled with a polyurethane caulk or equivalent sealant applied in accordance with the manufacturer's recommendations.

2. All concrete control joints, isolation joints, construction joints and any other joints in concrete slabs or between slabs and foundation walls shall be sealed with a polyurethane caulk. Gaps and joints shall be cleared of loose material and filled with polyurethane caulk applied in accordance with the manufacturer's recommendations.

3. Condensate drains shall be trapped or routed through non-perforated pipe to daylight.

4. Sump pits open to soil or serving as the termination point for subslab or exterior drain tile loops shall be covered with a gasketed or otherwise sealed lid. Sump pits shall not be used as a primary suction point in a sub-slab depressurization system. Sumps used as a floor drain shall have a lid equipped with a trapped inlet.

5. Hollow block masonry foundation walls shall be constructed with either a continuous course of solid masonry, one course of masonry grouted solid, or a solid concrete beam at or above finished ground surface to prevent passage of air from the interior of the wall into the living space. Where a brick veneer or other masonry ledge is installed, the course immediately below that ledge shall be sealed. Joints, cracks or other openings around all penetrations of both exterior and interior surfaces of masonry block or wood foundation walls below the ground surface shall be filled with polyurethane caulk or equivalent sealant. Penetrations of concrete walls shall be filled.

6. The exterior surfaces of concrete and masonry block walls below the ground surface shall be damp-proofed in accordance with Section R406 of the 2012 International Residential Code for One- and Two-Family Dwellings (copyrighted 2011 by the International Code Council, Inc.; incorporated by reference in accordance with Section 422.15).

7. Air-handling units shall be sealed to prevent air from being drawn into the unit. Units with gasketed seams or units that are otherwise sealed by the manufacturer to prevent leakage are exempted from this requirement.

8. Underground and crawlspace duct systems shall be sealed in accordance with Section M1601.4.1 of the 2012 International Residential Code for One- and Two-Family Dwellings (copyrighted 2011 by the International Code Council, Inc.; incorporated by reference in accordance with Section 422.15).

9. Openings around all penetrations through floors above crawlspaces shall be caulked or otherwise filled to prevent air leakage.

10. Access doors and other openings or penetrations into crawlspaces shall be closed, gasketed or otherwise sealed to prevent air leakage.

e) Passive Sub-membrane Depressurization (SMD) System. In buildings with crawlspace foundations or earthen floors, the following components of a passive SMD system shall be installed during construction.

1. Crawlspaces shall be provided with vents to the exterior of the building in accordance with Section R408 of the 2012 International Residential Code for One- and Two‑Family Dwellings.

2. The soil in crawlspaces shall be covered with a continuous layer of minimum 6-mil (0.15 mm) polyethylene soil gas retarder. The ground cover shall be lapped a minimum of 12 inches (305 mm) at joints and shall extend to all foundation walls enclosing the crawlspace area.

3. Any seams in soil gas retarder membranes shall be overlapped at least 12 inches and sealed in a permanent air tight manner using compatible glues. The membrane shall also be sealed around interior piers and to the inside of exterior walls with furring strips and compatible glues or in accordance with specific procedures submitted by radon contractors as part of their license application and approved by the Agency.

4. A plumbing tee or other approved connection fitted with not less than 5 feet (105 m) of perforated pipe extending from each horizontal opening of the tee shall be inserted horizontally beneath the sheeting and connected to a 3- or 4-inch diameter (76 mm or 102 mm) fitting with a vertical vent pipe installed through the sheeting. The vent pipe shall be extended up through the building floors, terminate at least 12 inches (305 mm) above the penetration in the highest roof in a location at least 2 feet (609.6 mm) above any window or other opening into the conditioned spaces of the building and 10 feet (3048 mm) from any window or other opening in adjoining or adjacent buildings.

f) Passive Sub-slab Depressurization (SSD) System. Buildings with a basement, crawlspace or slab-on grade concrete floor in contact with the earth or grade shall have the following components of a passive SSD system that shall be installed during construction.

1. A minimum 3-inch diameter (76 mm) Schedule 40 PVC shall be embedded vertically into the sub-slab aggregate or other permeable material before the slab is cased.

A) A plumbing tee or other approved connection fitted with not less than 5 feet (105 m) of perforated pipe extending from each horizontal opening of the tee shall be inserted horizontally within the sub-slab permeable material to ensure that the pipe opening remains within the sub-slab. Alternatively, the 3-inch (76 mm) pipe shall be inserted directly into an interior perimeter drain tile loop. The vent pipe shall be extended up through the building floors, terminate at least 12 inches (305 mm) above the highest roof in a location of at least 2 feet (609.6 mm) above any window or other opening into the conditioned spaces of the building and 10 feet (3048 mm) from any window or other opening in adjoining or adjacent buildings; or

B) A penetration into the sub-slab permeable material may be cored through sub-slab after the slab is cased. A minimum 3-inch diameter (76 mm) Schedule 40 PVD shall be embedded vertically into the sub-slab aggregate or other permeable material and extended up through the building floors, terminate at least 12 inches (305 mm) above the penetration in the highest roof in a location at least 2 feet (609.6 mm) above any window or other opening into the conditioned spaces of the building and 10 feet (3048 mm) from any window or other opening in adjoining or adjacent buildings.

2. In buildings where interior footings or other barriers separate the sub-slab aggregate or other gas-permeable material, each area shall be fitted with an individual vent pipe. Vent pipes shall connect to a single vent that shall terminate at least 12 inches (305 mm) above the penetration in the highest roof in a location at least 2 feet (609.6 mm) above any window or other opening into the conditioned spaces of the building and 10 feet (3048 mm) from any window or other opening in adjoining or adjacent buildings.

g) All components of the radon vent pipe system shall be installed to provide positive drainage to the ground beneath the slab or soil gas retarder.

h) Radon vent pipes shall be accessible for fan installation through an attic or other area outside and above the habitable space. The radon vent pipe need not be accessible in an attic space when an approved roof-top electrical supply is provided for future use.

i) All exposed and visible interior radon vent pipes shall be conspicuously identified with at least one label on each floor and in accessible attics. The label shall read "Radon Reduction System".

j) Combination basement/crawlspace or slab-on-grade/crawlspace foundations shall have separate radon vent pipes installed in each type of foundation area or be connected with a continuous drain tile loop. Vent pipes shall connect to a single vent that shall terminate at least 12 inches (305 mm) above the highest roof in a location at least 2 feet (609.6 mm) above any window or other opening into the conditioned spaces of the building and 10 feet (3048 mm) from any window or other opening in adjoining or adjacent buildings.

k) Joints in air ducts and plenum spaces shall meet the requirements of Section M1601 of the 2012 International Residential Code for One- and Two-Family Dwellings (copyrighted 2011 by the International Code Council, Inc.; incorporated by reference pursuant to Section 422.15). Thermal envelope air infiltration requirements shall comply with the energy conservation provisions in Chapter 11 of the 2012 International Residential Code for One- and Two-Family Dwellings (copyrighted 2011 by the International Code Council, Inc.; incorporated by reference pursuant to Section 422.15). Firestopping shall be in conformance with the most recent general building code enacted by the appropriate local government or meet the requirements contained in Section R302.11 of the 2012 International Residential Code for One- and Two-Family Dwellings (copyrighted 2011 by the International Code Council, Inc.; incorporated by reference pursuant to Section 422.15).

l) To provide for future installation of an active SMD or SSD system, an electrical circuit terminated to a single outlet in an accessible approved box shall be installed during construction in the attic in the anticipated location of vent pipe fans.

m) To provide for future installation of an active SSD, the piping length in the attic of the building shall have a minimum height of 3 feet to allow for the anticipated installation of a radon mitigation fan in the vent pipe.

n) The juncture of each radon vent pipe with the roof line shall be made water tight by an approved flashing. Lead vent flashings or any other flashing or cap that would impede the exhaust from the radon vent are prohibited from use.

History

• Source: Added at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.APPENDIX A Recommended Testing Strategy for Home Environment Measurements (buildings Not Involved in a Real Estate Transaction)

The first step is to perform a short-term measurement* in the lowest structural areas**.

Perform Short-Term Test

If the result is less than 4pCi/L

If the result is 4pCi/L or more, but less than 8 pCi/L

If the result is 8 pCi/L or more

No further action is required. Retest in 2 years or if any renovations or additions are made to the building.

Perform an additional

short-term test.

For a better understanding of your year-round average perform a long-term test.

Perform an additional short-term test.

For a better understanding of your year-round average perform a

long-term test.

If the average of the 2 tests is less than 4 pCi/L

If the average of the 2 tests is 4 pCi/L or more

If the result is less than 4 pCi/L

If the result is 4 pCi/L or more

If the 2nd result is less than 4 pCi/L

If the 2nd result is 4 pCi/L or more

No further action is required. Retest in 2 years or if any renovations or additions are made to the building.

Fix the home.

No further action is required. Retest in 2 years or if any renovations or additions are made to the building.

Fix the home.

Perform a long-term test.

Fix the home.

• Short-term tests may last between 2 and 90 days, most last between 2 and 7 days. Examples of short-term detectors used in home environment testing include: activated charcoal canisters, liquid scintillation vials, electret chambers and continuous monitors. Examples of long-term detectors used in home environment testing include: alpha track detectors and electret chambers.

** Conduct a short-term test in each of the lowest structural areas suitable for occupancy in the home. For example, if the home is a split-level building with one or more foundation types: test in the basement, in a room over the crawlspace and in a slab-on-grade room. In accordance with this protocol, measurement licensees are required to test in each of the foundation types.

History

• Source: Amended at 37 Ill. Reg. 20240, effective December 9, 2013

32 Ill. Adm. Code 422.APPENDIX B Recommended Testing Strategy for Measurements in Buildings Involved in Real Estate Transactions

The first step is to perform a short-term measurement* in the lowest structural areas**.

Perform a Short-Term Test

The minimum length of a short-term test shall be 48 hours.

There are 2 methods that may be used for short-term testing during a Real Estate transaction.

(1) Simultaneous Tests – Two short-term tests set side by side conducted simultaneously.

(2) Continuous Monitor Testing – A Continuous Monitor that measures in hourly increments.

If the result is less than 4.0 pCi/L

If the result is 4.0 pCi/L or more

No further action is required. Retest in two years or if any renovations or additions are made to the building.

Fix the home.

• Short-term tests may last between 2 and 90 days, most last between 2 and 7 days. Tests between seven and 90 days are usually impractical for real estate transactions but are fine for homeowners assessing their own radon situation. Examples of short-term detectors used in home environment testing include: activated charcoal canisters, charcoal liquid scintillation vials, electret chambers and continuous monitors.

** Conduct a short-term test in each of the lowest structural areas suitable for occupancy in the home. For example, if the home is a split-level building with one or more foundation types: test in the basement, in a room over the crawlspace and in a slab-on-grade room. In accordance with this protocol, measurement professionals are required to test in each of the foundation types.

History

• Source: Amended at 33 Ill. Reg. 14479, effective October 9, 2009

32 Ill. Adm. Code 422.APPENDIX C Radon and Radon Decay Product Measurement Method Categories

A

(pCi/L)

B

(WL)

AC

Activated charcoal adsorption integrating

AT

Alpha track detection

CW

Continuous working level monitor

LS

Charcoal liquid scintillation

CR

Continuous radon monitor

EL

Electret ion chamber; long-term

ES

Electret ion chamber; short-term

History

• Source: Amended at 33 Ill. Reg. 14479, effective October 9, 2009

32 Ill. Adm. Code 422.APPENDIX D Sample Notice

Radon Measurement in Progress

THIS NOTICE IS POSTED IN ACCORDANCE WITH TITLE 32, CHAPTER II, SUBCHAPTER b: RADIATION PROTECTION, MEASUREMENT PROTOCOL, SECTION 422.130(e).

Tampering with a radon or radon progeny measurement is prohibited

by law and may result in civil penalties.

Removal of this Notice, except by the Radon Measurement Professional licensee named below, is considered tampering.

Radon Measurement Professional licensee:

License No.:

Company:

Telephone No(s).:

History

• Source: Amended at 29 Ill. Reg. 3212, effective February 22, 2005

32 Ill. Adm. Code 422.APPENDIX E Diagram of Room Worksheet for Radon Measurements

This worksheet may be used in accordance with Section 422.130(o)(1)(L)(ii). Complete all areas of the worksheet and include a separate worksheet for each foundation type measured. A copy of each worksheet shall be retained as a permanent record and included as part of a measurement report in accordance with Section 422.130(o).

Placement of Measurement Devices

Short-term or long-term measurements shall be made in each lowest structural area suitable for occupancy. For example, a split-level building with a basement, a slab-on-grade room and a room over crawlspace shall have measurements made in each of the foundation types: the basement, a slab-on-grade room and a room over the crawlspace.

Measurement devices shall (check all that apply):

Be made in rooms that can be regularly occupied, such as family rooms, living rooms, dens, playrooms and bedrooms.

If charcoal canisters, not be placed in bathrooms, kitchens, laundry rooms, spa rooms or other areas of high humidity.

Be undisturbed during the measurement period.

Be at least 3 feet from doors, windows to the outside, or ventilation ducts and out of the direct flow of air from the ventilation duct.

Be at least 1 foot from exterior walls.

Be 20 inches to 6 feet from the floor.

Be at least 4 inches away from other objects horizontally or vertically above the detector.

Be at least 4 feet from heat, fireplaces and furnaces, out of direct sunlight, etc.

Diagram of Room Measured The following information shall be included:

1. All windows and doors. Annotate exterior walls and the direction of north or the front of the building.

2. Factors that may affect the measurement, including but not limited to crawlspace vents, fireplaces, combustive appliances, floor drains, furnaces, dryers, water heaters and mitigation systems.

3. Include measurements (to the nearest inch) from the testing device to two separate walls.

4. Current room use (ex.: family room, bedroom, unfinished basement, playroom).

5. Address:

6. Device Serial Number

History

• Source: Added at 33 Ill. Reg. 14479, effective October 9, 2009

Subchapter c Nuclear Facility Safety

Part 501 Compensation of Local Governments for Emergency Planning and Participation in Nuclear Emergency Response Exercises

32 Ill. Adm. Code 501.10 Purpose and Scope

The purpose is to establish the policies and procedures necessary to compensate grantees for costs associated with implementation of Section 4 of the Illinois Nuclear Safety Preparedness Act (the Act) [420 ILCS 5]. The policies and procedures contained in this Part are intended to further the following objectives:

a) to encourage grantees to prepare to deal with the effects of nuclear accidents;

b) to reduce the encumbrance of public funds obligated by grantees in implementation of the Act by establishment of a system of compensation, whereby grant monies are paid to the grantee in advance of actual expenditures, when possible; and

c) to provide guidance to grantees and Agency staff in determining necessary activities and expenses payable pursuant to the Act.

History

• Source: Amended at 33 Ill. Reg. 9110, effective June 11, 2009

32 Ill. Adm. Code 501.20 Definitions

"Agency" means the Illinois Emergency Management Agency.

"Authorized Expenses" means the actual expenditures of public funds by a grantee attributable to implementation of the Act as determined necessary by the Illinois Emergency Management Agency .

"Claim" means the forms used by grantee to document expenditures.

"Drill" means the test or trial of a particular emergency preparedness system, function or operation, such as communications.

"Employee" means an individual actually paid wages or allowances by a grantee for work performed on a full-time, part-time or intermittent basis.

"Exercise" means the testing of emergency response plans for nuclear facilities, including, but not limited to, the biennial testing and evaluation of off-site radiological emergency response plans and preparedness in support of nuclear generating stations, as required by the U.S. Nuclear Regulatory Commission, 10 CFR 50, appendix E, current as of January 1, 1996.

"Grantee" means a local governmental entity receiving a grant.

"Local Government" means a political subdivision below the State Government level, such as a county, municipality, township, village or district, with authority to expend public funds.

"Volunteer" means an individual paid an allowance, set forth by grantee resolution, for work performed on an intermittent basis.

History

• Source: Amended at 33 Ill. Reg. 9110, effective June 11, 2009

32 Ill. Adm. Code 501.30 Incorporations by Reference

All rules, standards and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified in the reference and do not include any later amendments or editions. Copies of these rules, standards and guidelines that have been incorporated by reference are available for public inspection at the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois.

History

• Source: Amended at 33 Ill. Reg. 9110, effective June 11, 2009

32 Ill. Adm. Code 501.40 Policies and Procedures

a) The Agency shall provide compensation to grantees from fees collected pursuant to Section 4 of the Act.

b) The Agency shall provide grants to grantees for expenses relating to implementation of emergency preparedness activities conducted to deal with the possibility of nuclear accidents at nuclear power stations.

c) All grants made under this Part providing for payment of funds in advance of anticipated expenditures shall be made in accordance with a grant agreement to be executed by both the Agency and the head of the local governmental entity to whom the grant is awarded.

d) The Illinois Emergency Management Agency, Division of Nuclear Safety, shall be responsible for implementation and shall be the point of contact for grantees relative to the provisions contained in this Part.

History

• Source: Amended at 45 Ill. Reg. 9941, effective July 26, 2021

32 Ill. Adm. Code 501.50 Determination of Grant Awards

a) The base amount of each grant, excluding special requirement and request amounts, shall be based on the grantee's recurring costs plus the grantee's expected participation in activities during the grant period (e.g., training and biennial exercises).

b) Special requirement amounts shall be based on a grantee's preparation for or participation in an exercise or drill required outside of the biennial exercise cycle. Such requests shall be made to the Agency in writing and will be subject to approval based upon available funds. Amounts disbursed and approved by the Agency as special requirements will not be considered in calculating future base grant awards.

c) Special request amounts shall be based on requirements identified by a grantee for specialty items to enhance the capability to implement nuclear emergency response plans. Examples of specialty items, include, but are not limited to, radios, computers, furniture or conference and training course fees. The requests shall be made to the Agency in writing and will be subject to approval based upon available funds. Amounts disbursed and approved by the Agency as special requests will not be considered in calculating future base grant awards.

d) Special requirements and special requests approved by the Agency after the initial disbursement of the grant funds shall be incorporated into an amendment to the grant agreement, if necessary, before disbursement of the additional grant funds.

History

• Source: Amended at 33 Ill. Reg. 9110, effective June 11, 2009

32 Ill. Adm. Code 501.60 Procedures for Awarding Future Grants

a) Participating applicants shall submit to the Agency by March 15 of each year a grant application for the purpose of determining the amount of the grant award. The grant application shall be submitted on forms provided by the Agency. The application shall be signed by the head of the local government organization. Failure to meet the grant application submittal deadline may result in denial of the application if funds are no longer available due to allocation to other grants.

b) Special request and special requirement applications may be submitted any time throughout the year.

c) Local governmental applicants who have not participated in the local compensation program may be eligible to receive grant funds pursuant to Section 501.90 and subject to Agency approval based upon available funds. Applicants shall contact the Agency for the necessary application forms.

History

• Source: Amended at 33 Ill. Reg. 9110, effective June 11, 2009

32 Ill. Adm. Code 501.70 Contents of Grant Agreement and Disbursement of Grant Funds

a) The Agency shall execute a grant agreement with each grantee to whom a grant is awarded. The grant agreement shall specify the parties to the grant, the term of the grant, the amount of the grant, method of payment of the grant funds, permissible uses of the grant funds, that documentation of expenditures be maintained by the grantee, that the Agency may audit records required to be maintained to verify that grant monies were used for permissible uses under the grant and, if not, will be recovered pursuant to the Illinois Grant Funds Recovery Act [30 ILCS 705] or offset as indicated in subsection (b), and that the grant agreement shall cease if funds for the grant are not appropriated by the General Assembly, and any other standard provisions required by the Comptroller to be included in grant agreements entered into by the State.

b) The Agency may offset a grantee's award with unexpended funds from the previous year if the offset will aid the State and grantee in preparedness efforts relative to this Part. The offset shall be clearly documented by the Agency in order to identify the approved purpose and use for the unexpended funds.

c) Failure to comply with conditions of the grant agreement, this Part, or other IEMA regulations may result in actions taken to recover grant funds pursuant to the Illinois Grant Funds Recovery Act or offset in accordance with subsection (b).

d) On July 1 of each year, or as soon thereafter as is practicable, the Agency shall disburse to the grantee the grant amount determined by the Agency for that fiscal year.

AGENCY NOTE: It is the Agency's intent that grant funds will be disbursed on July 1 of each year. However, such disbursement might be delayed for reasons beyond the Agency's control (e.g., failure of the General Assembly to make appropriations before July 1).

History

• Source: Amended at 47 Ill. Reg. 15909, effective October 26, 2023

32 Ill. Adm. Code 501.80 Claims, Audit, Expenditure Record Requirements and Grant Fund Recovery Procedures

a) Grantees shall submit signed claim forms and a copy of the related receipts that verify expenditures of grant funds to the Agency for review by mail or as directed by the Agency. Submittals can be directed to the contact below:

IEMA

Attention: REP Grants

1035 Outer Park Drive

Springfield, IL 62704

1. Claims are due as follows:

A) County grantee claim forms are due on a quarterly basis in accordance with the following schedule:

1st Quarter (July-September): due October 31

2nd Quarter (October-December): due January 31

3rd Quarter (January-March): due April 30

4th Quarter (April-June): due July 31

B) Claims from grantees from political subdivisions other than counties are due on a biannual basis in accordance with the following schedule:

1st and 2nd Quarter (July-December): due January 31

3rd and 4th Quarter (January-June): due July 31

C) Grantees who receive a grant for a special request or special requirement only shall submit the claim based on the quarter when the expenditure was made.

2. After claims are received and reviewed by the Agency to ensure that expenditures are in accordance with approved spending plans, receipt of the claim and results of the review will be confirmed by return correspondence to the grantee.

3. Failure to meet the claim submittal deadlines outlined in this Section may result in denial of the claim and may jeopardize future grant awards.

b) Participating grantees shall maintain, in separate files, documentation of expenditures under the grant that is readily accessible during an Agency audit for a minimum of 5 years. The documentation shall be on forms provided by the Agency.

c) The Agency shall have the right to audit and obtain copies of the books, records, and any other recorded information of the grantee related to grantee expenses for which grantee received compensation under this Part.

d) If, through an Agency audit, the Agency finds that the grantee has misspent or improperly held any grant funds, the Agency shall have the right of recovery of the grant funds in accordance with the provisions and procedures of the Illinois Grant Funds Recovery Act. The Agency may also offset a future award with the previous year's unexpended funds in accordance with Section 501.70(b).

e) The Agency shall inform the grantee on whether future disbursements of the grant award are subject to adjustment in accordance with the provisions and procedures of the Illinois Grant Funds Recovery Act or Section 501.70(b).

History

• Source: Amended at 47 Ill. Reg. 15909, effective October 26, 2023

32 Ill. Adm. Code 501.90 Determination of Permissible Uses of Grant Funds

a) The following categories are used by the Agency staff as a guide in determining necessary activities and authorized expenses payable under this Part. These categories are designed to achieve equality among known prospective grantees while taking into account the limitations imposed by the availability of appropriated funds.

b) Necessary Activities:

1. Plan development and maintenance.

2. Preparation for and participation in training.

3. Preparation for and participation in exercises and drills.

4. Maintenance of a specific capability to implement nuclear emergency response plans.

c) Authorized Expenses:

1. Personnel Services

A) Wages, plus fringe benefits, actually paid to employees of the grantee for participation in necessary activities as described in subsection (b) of this Section.

B) Compensation shall be based on hourly rates for the number of hours of actual participation in necessary activities as described in subsection (b) of this Section. For personnel not normally paid at an hourly rate, an hourly rate shall be determined by dividing the periodic salary or contract amount by the number of hours required to be worked (or if there is no such requirement, the hours typically worked) within the period.

C) Compensation for volunteers of the grantee shall be a set hourly rate documented by local government resolution. The rate per hour shall not exceed the usual and customary amount paid to volunteers assisting the grantee in local government emergency preparedness functions.

2. Travel

A) Travel allowances actually paid to grantee employees or volunteers for travel performed in connection with their participation in necessary activities as described in subsection (b) of this Section.

B) Compensation for transportation, lodging, and per diem or meal expenses shall not exceed the rate in the State of Illinois Travel Regulations, 80 Ill. Adm. Code 3000, in effect at the time the expenditure was incurred, unless a grantee ordinance, rule or regulation applicable to all employees of the grantee specifies a higher rate.

3. Equipment Use

A) Costs actually paid, incurred or obligated for grantee owned or leased equipment used during or in connection with a necessary activity as specified in subsection (b) of this Section.

B) Compensation for equipment use shall not exceed the current State of Illinois rate. Current rates can be found in the FEMA Schedule of Equipment Rates. Expenses for use of motorized equipment shall be fully documented. Documentation shall include the date of use, type of equipment, entity that used the equipment, miles or hours that the equipment was in use, and cost per mile for equipment use.

4. Telecommunications

A) Emergency Operations Center (EOC) telecommunications costs include installation, service and maintenance charges for those telecommunication lines, circuits and equipment used to maintain the capability to implement nuclear emergency response plans.

B) Monthly usage charges for EOC to include telecommunication lines and the circuit usage charges relating exclusively to maintaining the capability to implement nuclear emergency response plans.

5. Miscellaneous expenses include maintenance agreements, office supplies, postage or similar expenses related to maintaining the capability to implement nuclear emergency response plans.

History

• Source: Amended at 33 Ill. Reg. 9110, effective June 11, 2009

32 Ill. Adm. Code 501.APPENDIX A Wording of the Block Grant Agreement (repealed)

History

• Source: Repealed at 33 Ill. Reg. 9110, effective June 11, 2009

Part 504 Status Signals for Nuclear Power Reactors

32 Ill. Adm. Code 504.10 Policy and Scope

a) The Illinois Emergency Management Agency (Agency) has the responsibility under State law to acquire from each nuclear power reactor in the State all system status signals which initiate Emergency Action Level Declarations, actuate accident mitigation and provide mitigation verification, including indications of operating power levels.

b) Signals shall be provided by each owner in a manner that assures availability to the Agency during all modes of reactor operation (including defueled conditions) as well as throughout accidents and subsequent recovery operations.

c) This Part provides the criteria and requirements under which each owner of a nuclear power reactor shall transmit to the Agency a System Status Signals Catalogue for the reactor via a Reactor Data Link (RDL).

d) This Part shall apply to all owners. For any nuclear power reactor for which no License to Operate has been issued by the United States Nuclear Regulatory Commission on the effective date of this Part, a System Status Signals Catalogue shall be transmitted by the owner to the Agency prior to commencing initial fuel load.

e) For any nuclear power reactor providing an RDL, the owner shall continue to transmit a System Status Signals Catalogue after the License to Operate is no longer maintained and until such time that all fuel is removed from the site or until the owner no longer possesses the capability to supply such data.

History

• Source: Amended at 33 Ill. Reg. 2254, effective January 23, 2009

32 Ill. Adm. Code 504.20 Definitions

As used in this Part, the following definitions will apply:

"Agency" means the Illinois Emergency Management Agency.

"Communication Link" means the network connection between the Agency supplied communication hardware on the owner's premises to the Agency's headquarters in Springfield, Illinois.

"Owner" means the owner and operator of the nuclear power reactor.

"Point" means the system parameter being monitored.

"RDL" means the Reactor Data Link for a reactor. The RDL includes the entire system by which the owner provides and the Agency receives a System Status Signals Catalogue at the Agency's headquarters in Springfield, Illinois.

"RDL outage" means any breakdown in the RDL that prevents the normal continuous data transmission of the System Status Signals Catalogue to the Agency's headquarters in Springfield, Illinois.

"Reactor" means a nuclear power reactor.

"Station Catalogue" means the complete and inclusive list of all computer monitored points available for transmission from a nuclear power station from which the System Status Signals Catalogue for each reactor is chosen.

"Station Computer" means the computer or computers that collect and transfer data to the Agency's communication hardware.

"System Status Signals Catalogue" means the points selected by the Agency from the Station Catalogue to be transmitted over the Communications Link. A System Status Signals Catalogue is selected for each reactor.

History

• Source: Amended at 42 Ill. Reg. 10418, effective May 31, 2018

32 Ill. Adm. Code 504.30 Protocol for Data Transmissions

Communications protocol, data representation and data transmission frequency for the System Status Signals Catalogue shall be established and/or changed by mutual consent of the Agency and the owner subject to the condition that the owner shall provide signals to the Agency in a manner and at a frequency that allows the Agency to incorporate the signals into and augment the Agency's remote effluent monitoring system.

History

• Source: Amended at 33 Ill. Reg. 2254, effective January 23, 2009

32 Ill. Adm. Code 504.40 Equipment

a) The Agency shall provide communication hardware to the owner and shall establish a Communication Link. All Agency owned equipment shall be maintained by the Agency.

b) Agency personnel and agents shall have access to all Agency equipment located at the nuclear station site, subject to any security requirements imposed by law, regulation, or normal security practices of the owner, including Fitness-For-Duty requirements.

c) The owner shall provide and maintain necessary hardware and software at its reactor site to communicate via the Agency supplied communication hardware.

History

• Source: Amended at 42 Ill. Reg. 10418, effective May 31, 2018

32 Ill. Adm. Code 504.50 Updating Station Catalogues and System Status Signals Catalogue

a) For each point included in the Station Catalogue, the Station Catalogue shall contain, as a minimum, the name of the point; a description of each parameter (point) measured, sensed or calculated; the units of measure for analog points; the state indication for digital points, e.g., open or closed, on or off; and the type of point, e.g., analog or digital.

b) The owner shall provide the Agency an updated Station Catalogue for each nuclear power station at six month intervals. In the event that the Station Catalogue remained unchanged, the owner shall notify the Agency that no changes were made, in lieu of providing an updated Station Catalogue. The Agency may lengthen the Station Catalogue submission interval at any time.

c) Within 14 calendar days after receipt of an updated Station Catalogue, the Agency shall provide the owner with notice of any changes to the System Status Signals Catalogue.

d) The Agency shall select points for the System Status Signals Catalogue from the updated Station Catalogue using the following criteria:

1. those points by which the off-site radiological consequences can be determined;

2. those points by which challenges to, and failures of, the clad, the primary boundary, and the containment structures can be determined;

3. those points by which short and long-term decay heat removal capabilities can be determined; or

4. those points by which on and off-site station electrical power status can be determined.

History

• Source: Amended at 42 Ill. Reg. 10418, effective May 31, 2018

32 Ill. Adm. Code 504.60 Implementation of System Status Signals Catalogue

Except as provided in this Section, the owner shall coordinate the transmission of a new System Status Signals Catalogue no later than 14 calendar days after receiving the notice provided for in Section 504.50(d). If the owner determines that it cannot transmit the new System Status Signals Catalogue in the 14 calendar day period, the owner shall, prior to the expiration of the 14 calendar day goal, apply in writing to the Agency for an extension of time to transmit the new System Status Signals Catalogue.

a) A written request to extend the time for implementation shall include an estimate of the amount of time needed by the owner to begin transmitting the new System Status Signals Catalogue and the reasons why the additional time is needed for implementation.

b) Timely submittal to the Agency of a written request described in subsection (a) will result in an automatic 14 day extension of the time for implementation by the owner.

History

• Source: Amended at 33 Ill. Reg. 2254, effective January 23, 2009

32 Ill. Adm. Code 504.70 Availability

a) Each owner shall transmit a System Status Signals Catalogue for each reactor over a Communications Link continuously 24 hours a day during all modes of reactor operation (including defueled conditions) as well as throughout accident and subsequent recovery operations, except during planned station computer and RDL system outages or unplanned station computer and RDL system outages beyond the control of the owner. The owner shall establish measures to assure that unplanned RDL system outages are promptly identified and corrected and that the root cause of the RDL outage is determined and corrective action taken to preclude repetition when appropriate.

b) In the event of an RDL outage, or station computer outage, the owner, when required by the Agency, shall establish a point of technical contact with the Agency to communicate reactor status information until the RDL is restored.

c) In the event of a planned or unplanned station computer outage, data transmission to the Agency shall be restored as soon as possible after the station computer's return to service.

d) The Agency's access to the System Status Signals Catalogue shall not be intentionally degraded by the owner's computer usage unless that usage is necessary to protect public health and safety as required under the Nuclear Regulatory Commission license, and the degradation of access cannot be avoided.

History

• Source: Amended at 42 Ill. Reg. 10418, effective May 31, 2018

Part 505 Safe Operation of Nuclear Facility Boilers and Pressure Vessels

32 Ill. Adm. Code 505.10 Scope

This Part shall apply to all boilers and pressure vessels contained within or upon or in connection with nuclear facilities within this State except as provided in Section 505.50 and elsewhere in this Part. This Part sets forth standards for the safe and proper design, construction, installation, inspection, inservice examination and testing, repair and alteration of boilers and pressure vessels which are consistent with ASME Boiler and Pressure Vessel Code and National Board Inspection Code requirements as adopted and enforced by the Nuclear Regulatory Commission (NRC). This Part provides for the registration of boilers and pressure vessels. This Part also provides for the issuance of Inspection Certificates for nuclear power systems and non-ISI boilers and pressure vessels to document that such power systems, boilers and pressure vessels comply with this Part.

32 Ill. Adm. Code 505.20 Policy

a) Pursuant to the Boiler and Pressure Vessel Safety Act and the Nuclear Safety Law of 2004, the Agency has sole jurisdiction over all boilers and pressure vessels contained within or upon or in connection with any nuclear facility within this State and has the same powers and duties as the State Fire Marshal and the Board of Boiler and Pressure Vessel Rules with regard to those boilers and pressure vessels notwithstanding any other provision to the contrary.

b) It is the intent of the Agency that the boiler and pressure vessel safety program be implemented in a manner consistent with the State role provided for in the ASME Code and National Board Inspection Code. The Agency intends to review Inservice Inspection Plans, reports and other documentation, as provided in this Part, to determine, in coordination and cooperation with the NRC, compliance with the ASME Code, National Board Inspection Code and other applicable codes and standards incorporated by reference in Section 505.40.

c) This Part is not intended to be, in any way, inconsistent with the applicable regulations, rules and requirements of the NRC. If a requirement of this Part as applied in any situation is or would be inconsistent with the regulations, rules and requirements of the NRC, the requirements of this Part shall not be applied. In addition, if the application of any requirement of this Part could affect the safety or the operation of the nuclear facility, as determined by the NRC, the Agency shall apply the requirements only with the prior concurrence of the NRC, as provided for in Section 505.86.

History

• Source: Amended at 45 Ill. Reg. 686, effective December 23, 2020

32 Ill. Adm. Code 505.30 Definitions

The following definitions shall apply to this Part:

"Act" means the Boiler and Pressure Vessel Safety Act [430 ILCS 75].

"Agency" means the Illinois Emergency Management Agency and Office of Homeland Security.

"Alteration" means a change to a boiler or pressure vessel made necessary by, or resulting in, a change in design requirements. Non-physical changes such as rerating of a boiler or pressure vessel shall be considered an alteration. The addition of nozzles smaller than a reinforced opening size shall not be considered an alteration.

"ANSI" means the American National Standards Institute, 1180 Avenue of Americas, 10th Floor, New York NY 10036.

"Appurtenance" means an item attached to a stamped component that has work performed on it requiring verification by an Authorized Inspector.

"ASME" means the American Society of Mechanical Engineers, Two Park Avenue, New York NY 10016-5990.

"ASME Code" means the American Society of Mechanical Engineers Boiler and Pressure Vessel Code with addenda thereof made, approved and adopted by the Council of the Society and adopted and incorporated by the Agency in Section 505.40. Copies of the ASME Code may be obtained from the American Society of Mechanical Engineers.

"ASME Code Case" or "Code Case" means a document published by ASME to clarify the intent of the ASME Code or to provide alternative requirements to those specifically indicated in the ASME Code due to special circumstances or for the use of new technology.

"Authorized Inspection Agency" means one of the following organizations:

A department or division established by a jurisdiction that has adopted one or more Sections of the ASME Code and whose inspectors hold valid commissions issued by the National Board of Boiler and Pressure Vessel Inspectors. In Illinois, the Division of Boiler and Pressure Vessel Safety of the Office of the State Fire Marshal (OSFM) is the jurisdiction, except for the City of Chicago; or

An insurance company that has been licensed or registered by the appropriate authority in the State of Illinois to write boiler and pressure vessel insurance in the State of Illinois; or

A company in the business of providing third party inspection services that has recognition from the State of Illinois to perform inspection and design reviews for boilers and pressure vessels; or

An owner of boilers or pressure vessels who maintains a regularly established inspection department, whose organization and inspection procedures meet the requirements established by OSFM.

"Authorized Inspector" means an individual who is employed by an authorized inspection agency and meets the requirements of Section 505.180.

"Boiler" means a closed vessel used to heat water or other liquids or to generate steam or other vapors under pressure or vacuum by the application of heat resulting from the combustion of fuels, electricity, atomic energy or waste gases.

"Power boiler" means a boiler in which steam or other vapor is generated at a pressure of more than 15 psig and includes water boilers operating at pressures exceeding 160 psig or temperatures exceeding 250º F at or near the boiler outlet.

"High pressure, high-temperature water boiler" means a water boiler operating at pressures exceeding 160 psig or temperatures exceeding 250º F at or near the boiler outlet.

"Heating boiler" means a steam heating boiler operated at pressures not exceeding 15 psig, or a hot water heating boiler operated at pressures not exceeding 160 psig or temperatures not exceeding 250º F at or near the boiler outlet.

"Hot water supply boiler" means a boiler (including fired storage water heater) furnishing hot water to be used externally to itself at pressures not exceeding 160 psig or temperatures not exceeding 250º F at or near the boiler outlet.

"Certificate inspection" means an inspection, the report of which is used by the Agency as justification for issuing, withholding or revoking the Inspection Certificate.

"Condemned" means any boiler or pressure vessel, including related appurtenances, that has been inspected and declared unsafe, or disqualified by legal requirements, by the Agency.

"Design pressure" means the pressure used in the design of a boiler or pressure vessel for the purpose of determining the minimum permissible thickness or physical characteristics (e.g., material properties) of different parts of the vessel, in accordance with design standards of the ASME Code.

"Director" means the Director of the Illinois Emergency Management Agency and Office of Homeland Security.

"External inspection" means as complete an examination as can reasonably be made of the external surfaces of a boiler or pressure vessel. This examination shall be made while it is in operation, if possible.

"Inoperative" means a boiler, pressure vessel or attached appurtenance that is no longer capable of functioning within its design requirements. The inability of support equipment to operate does not cause a boiler or pressure vessel to be considered inoperative.

"Inservice inspection interval" means the period of time during which inservice examinations and system pressure tests are performed, as defined by the owner in accordance with ASME Code Section XI.

"Inservice inspection period" means a subdivision of the inservice inspection interval, as defined by the owner in accordance with ASME Code Section XI.

"Inservice Inspection Plan" means the documents prepared by the owner in accordance with paragraph IWA-2420 of the edition and addenda of Section XI approved by the NRC for use by the plant (10 year plan).

"Inspection" means examination and evaluation of documents and hardware by an Authorized Inspector to determine conformance of an item or an activity to the requirements of this Part.

"Inspection Certificate" means a certification issued by the Agency for the operation of a non-ISI boiler or pressure vessel or nuclear power system.

"Internal inspection" means as complete an examination as can reasonably be made of the internal surfaces of a boiler or pressure vessel while it is shut down and manhole plates, handhole plates or other inspection opening closures are removed as required by the Authorized Inspector.

"ISI boiler or pressure vessel" means any boiler or pressure vessel, including related appurtenances, that is in the owner's Inservice Inspection Plan.

"Maintenance" means routine activities conducted on an item that are performed and controlled in accordance with the owner's procedures, including minor restorative actions, that are not otherwise classified as a repair, replacement or alteration.

"Maximum Allowable Working Pressure" or "MAWP" means the maximum gauge pressure permissible (in accordance with the design requirements) at the top of a vessel in its operating position at the design temperature. This pressure is the least of those calculated for every element of the vessel using nominal thickness exclusive of allowances for corrosion and thickness required for loadings other than pressure. It is the basis for the pressure setting of the pressure relieving devices (e.g., pressure relief valves) protecting the vessel. The design pressure may be used in place of the maximum allowable working pressure in all cases for which calculations are not made to determine the value of the maximum allowable working pressure.

"National Board" means the National Board of Boiler and Pressure Vessel Inspectors, 1055 Crupper Avenue, Columbus OH 43229.

"National Board Inspection Code" means the National Board Inspection Code published by the National Board and adopted and incorporated by the Agency in Section 505.40. Copies may be obtained from the National Board.

"NFPA" means the National Fire Protection Association, 1 Batterymarch Park, Quincy MA 02169-7471.

"Non-ISI boiler or pressure vessel" means any boiler or pressure vessel, including related appurtenances, that is not in the owner's Inservice Inspection Plan.

"Non-standard boiler or pressure vessel" means any boiler or pressure vessel, including related appurtenances, that does not bear the Certification Mark with appropriate designator.

"NRC" means the United States Nuclear Regulatory Commission or any agency that succeeds to its function in the licensing of nuclear power reactors or facilities, or facilities for spent nuclear fuel.

"Nuclear facility" means a nuclear power station. There may be one or more nuclear power systems at a nuclear power station.

"Nuclear power system" means all ISI boilers and pressure vessels in a unit, including their appurtenances, at a nuclear facility that are inspected in accordance with an Inservice Inspection Plan. Such components are generally associated with systems that serve the purpose of producing and controlling the output of thermal energy from nuclear fuel and associated systems essential to the function and overall safety of the nuclear power system.

"OSFM" means the Illinois Office of the State Fire Marshal.

"Outage" means temporary suspension of operation of a component or system to conduct actions such as maintenance, forced repairs or testing of equipment.

"Owner" means any organization, person, firm or corporation legally responsible for the safe operation of any boiler or pressure vessel at a nuclear facility within the State.

"PSIG" means pounds per square inch gauge and is a measure of pressure.

"Pressure relief valve" means a safety valve, relief valve or safety relief valve.

"Pressure vessel" means an enclosed vessel in which pressure is obtained from an external source, or by applying heat from an indirect source or from a direct source other than boilers as defined in this Section. Reactor containments are not considered pressure vessels.

"Quality Assurance Program" means a controlled system of planned and systematic actions required to provide adequate confidence that the items designed and constructed are in accordance with the rules of the ASME Code Section III; or all the planned and systematic actions necessary to provide adequate confidence that a structure, system or component will perform satisfactorily in service in accordance with Appendix B of 10 CFR 50, as applicable.

"Refueling outage" means temporary suspension of power production of the nuclear power system to conduct actions, including refueling the reactor. Refueling outages normally occur approximately every 2 years.

"Reinstalled" means any boiler or pressure vessel, including related appurtenances, removed from its original setting and reinstalled at the same location or at a new location within the State of Illinois without change of ownership.

"Relief valve" means an automatic pressure relieving device, actuated by the static pressure upstream of the valve, that opens further with the increase in pressure over the opening pressure. It is used primarily for liquid service.

"Repair" means the process of restoring a nonconforming item by welding or brazing so that existing design requirements are met.

"Report of Inspection" means a report prepared by an Authorized Inspector that documents that a non-ISI boiler or pressure vessel meets the requirements of this Part for installation and periodic inspection.

"Reportable event" means any accident that either causes a boiler or pressure vessel to become inoperative due to damage from an explosion, catastrophic event or failure due to material condition, of either itself or an attached appurtenance, or results in death or bodily injury to a person.

"Rerated" or "Rerating" means alteration.

"Safety relief valve" means an automatic pressure actuated relieving device suitable for use as a safety or relief valve, depending on application.

"Safety valve" means an automatic pressure relieving device actuated by the static pressure upstream of the valve and characterized by full opening pop action. It is primarily used for gas or vapor service.

"State Special" means a boiler or pressure vessel, including related appurtenances, of special construction that may not be constructed in accordance with the ASME Code. See Sections 505.170, 505.1700 and 505.2700 for the procedures for granting a State Special.

"Technical specifications" means part of the Updated or Final Safety Analysis Report and Operating License issued by the NRC that designates safety limits, limiting safety system settings, limiting conditions for operation and surveillance requirements for the safe operation of the nuclear facility.

"Updated or Final Safety Analysis Report" means a report required by the NRC in accordance with 10 CFR 50.34.

"Welding" means a group of processes in which coalescence is produced by heating with an arc or arcs, with or without the application of pressure and with or without the use of filler metal.

History

• Source: Amended at 50 Ill. Reg. 3902, effective February 23, 2026

32 Ill. Adm. Code 505.40 Standards Incorporated by Reference

The Agency hereby adopts and incorporates by reference the following codes and standards.

a) The Boiler and Pressure Vessel Code of the American Society of Mechanical Engineers with addenda thereto made. Those sections of the ASME Code listed in this Section are incorporated into the regulations of the Agency.

1. ASME Boiler and Pressure Vessel Code, 1952 Edition including all addenda and editions through the 2025 edition, for the following:

A) Section I, Rules for Construction of Power Boilers;

B) Section II, Materials

Part A − Ferrous Material Specifications

Part B − Nonferrous Material Specifications

Part C − Specifications for Welding Rods, Electrodes and Filler Metals

Part D – Properties (Customary and Metric);

C) Section III, Rules for Construction of Nuclear Facility Components

Subsection NCA – General Requirements for Division 1 and Division 2

Appendices

Division 2 − Code for Concrete Containments

Division 3 − Containment Systems and Transport Packaging's for Spent Nuclear Fuel and High-Level Radioactive Material

Division 4 – Fusion Energy Devices

Division 5 − High Temperature Reactors;

D) Section IV, Rules for Construction of Heating Boilers;

E) Section V, Nondestructive Examination;

F) Section VI, Recommended Rules for the Care and Operation of Heating Boilers;

G) Section VII, Recommended Guidelines for the Care of Power Boilers;

H) Section VIII, Rules for Construction of Pressure Vessels

Division 1

Division 2 − Alternative Rules

Division 3 − Alternative Rules for Construction of High Pressure Vessels;

I) Section IX, Welding, Brazing, and Fusing Qualifications;

J) Section X, Fiber-Reinforced Plastic Pressure Vessels;

K) Section XII, Rules for Construction and Continued Service of Transport Tanks;

L) Section XIII, Rules for Overpressure Protection.

2. ASME Boiler and Pressure Vessel Code, editions and addenda referenced in 10 CFR 50.55a, including all limitations and modifications contained therein, for the following:

A) Section III, Rules for Construction of Nuclear Facility Components, Division 1; and

B) Section XI, Rules for Inservice Inspection of Nuclear Power Plant Components, Division 1 − Rules for Inspection and Testing of Components of Light-Water-Cooled Plants.

AGENCY NOTE: The Agency will review programs at specific plants on the basis of the edition and addenda of Sections III and XI approved by the NRC for the specific plant.

b) The National Board Inspection Code, 2025 edition, published by the National Board, except that "jurisdiction" shall be read as "Agency".

c) ASME CSD-1, 2024 edition, Controls and Safety Devices for Automatically Fired Boilers

d) NFPA 85, 2023 edition, Boiler and Combustion Systems Hazards Code.

e) ANSI/ASME N626, Qualification and Duties of Authorized Nuclear Inspection Agencies and Personnel, 1974 Edition including all addenda and editions through the N626b-1992 addendum. The Agency also adopts the successor standard to this standard, ASME QAI-1, Qualification for Authorized Inspection, 1995 edition, including all addenda and editions through the 2025 edition.

f) For documents included in subsections (a) through (e), the Agency is incorporating only those editions and addenda indicated. The Agency is not incorporating any subsequent edition or addendum to these documents. All documents are available for public review, by appointment, at the Agency's offices, 1035 Outer Park Drive, Springfield, Illinois.

History

• Source: Amended at 50 Ill. Reg. 3902, effective February 23, 2026

Chapter II Illinois Emergency Management Agency and Office of Homeland Security

Subchapter c Nuclear Facility Safety

Part 505 Safe Operation of Nuclear Facility Boilers and Pressure Vessels

32 Ill. Adm. Code 505.50 Exemptions

The following exemptions to requirements in this Part shall be permitted, except as defined in this Section or as otherwise provided in this Part. The exemptions provided in subsections (a)(1), (2), (3) and (4) shall not be permitted for ISI boilers and pressure vessels.

a) Except as provided in Section 505.70, the following boilers and pressure vessels shall be exempt from the requirements of this Part:

1. Those classes of pressure vessels not within the scope of ASME Code Section VIII, Division I as defined in the introduction under paragraph U-1.

2. Boilers and pressure vessels which have either a Limiting Condition for Operation (LCO) or a surveillance requirement in the plant's technical specifications.

3. Pressure vessels that do not exceed:

A) A volume of 15 cubic feet and 250 psig when not located in a place of public assembly; or

B) A volume of 5 cubic feet and 250 psig when located in a place of public assembly; or

C) A volume of 1½ cubic feet and 600 psig.

4. Water conditioning equipment used for removing minerals, chemicals, or organic or inorganic particulate from water by means other than application of heat, e.g., water softeners, water filters, dealkalizers and demineralizers, provided the following conditions are met:

A) The temperature of such vessels is maintained below 212° F;

B) No heat is applied to the water after being placed into such vessels; and

C) No heat is applied either directly or indirectly to such vessels.

5. Hot water supply boilers that are directly fired with oil, gas or electricity, provided none of the following limitations are exceeded:

A) Heat input of 200,000 BTU/hr.; or

B) Water temperature of 200º F; or

C) Nominal water containing capacity of 120 gallons.

6. Coil type hot water boilers in which the water can flash into steam when released directly to the atmosphere through a manually operated nozzle, provided the following conditions are met:

A) There is no drum, headers or other steam spaces;

B) No steam is generated within the coil;

C) Outside diameter of tubing does not exceed 1 inch;

D) Pipe size does not exceed ¾ inch;

E) Water capacity of the unit does not exceed 6 U. S. gallons; and

F) Water temperature does not exceed 350º F.

7. ISI pressure vessels that have a surveillance requirement in the plant technical specifications or are continuously monitored or are routinely subjected to examinations and tests (e.g., visual examinations and pressure tests), other than those required in this Part but that are determined by the Agency to give an assurance of structural integrity at least equal to that provided by the examinations and test required by this Part.

8. Other boilers and pressure vessels listed under Section 5(a) of the Act.

b) Boilers and pressure vessels listed under Section 5(b) of the Act shall be subject to the requirements of this Part (e.g., design, construction and registration), except for those requirements pertaining to inspection, Inspection Certificates and penalties for operating without a valid Inspection Certificate.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

32 Ill. Adm. Code 505.60 Access to Facilities and Documents

Upon prior notice and subject to requirements contained in the Memorandum of Understanding, Subagreement No. 2, between the Agency and the NRC, effective May 15, 1990, representatives of the Agency or an Authorized Inspector may enter upon any privately or publicly owned property in this State where a boiler or pressure vessel, including related appurtenances, or a part thereof is being designed, constructed, installed or used within or upon or in connection with a nuclear facility in this State to ascertain whether such boiler or pressure vessel or part thereof is designed, constructed, installed and inspected in accordance with the standards of this Part. In addition to the documents required by this Part, owners shall make available to the Agency additional documents as the Agency determines are required to verify ASME Code and National Board Inspection Code compliance in accordance with this Part. These documents may include, but need not be limited to, such documents as a Quality Assurance Program in effect at the nuclear facility meeting the requirements of the ASME Code, or the details of flaw evaluations. The requirements of this Section are subject to the limitations of Section 505.20(c).

AGENCY NOTE: Documentation required to be made available under this Section shall be relevant to a determination of compliance with this Part.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

32 Ill. Adm. Code 505.70 Notification of Failures

a) Any owner, which includes any person, firm, partnership, corporation or government entity, that knowingly fails to notify the Agency within 24 hours, or the next business day, after a reportable event, or after any bodily injury or death to any person caused by a reportable event, is guilty of a Class B misdemeanor, if a natural person, or a business offense punishable by a fine of not less than $501 and not more than $10,000, if a corporation or government agency.

b) In the case of a reportable event, the owner of the affected boiler or pressure vessel may take whatever measures it determines in its sole discretion are necessary to give emergency assistance to injured persons or to alleviate any threat to the public health and safety.

c) In the case of a reportable event, the owner may not move, disturb or repair the affected boiler or pressure vessel until the Agency has been given the opportunity to examine the boiler or pressure vessel within 12 hours after the reportable event, except that the owner may initiate an investigation, including the gathering of material for samples and the taking of any ancillary action necessary for such sample gathering, where the owner either determines that such activities will not substantially interfere with the Agency's subsequent examination or provides a record of the initial circumstances sufficient to provide the Agency with an accurate report of the condition that was obtained before the owner initiated its activities.

d) The requirements of this Section shall apply to any boiler or pressure vessel, including those exempt under Section 505.50.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

32 Ill. Adm. Code 505.80 Administrative Review and Hearings - Inspection Certificates

This Section shall apply to all actions by the Agency for noncompliance with this Part that potentially could impact upon the issuance, suspension or revocation of an Inspection Certificate required by this Part.

a) When in any instance an Agency review reveals that an owner may not be in compliance with one or more requirements of this Part, the Agency will notify the owner in writing of those facts and circumstances known to the Agency that give rise to the inference that the owner is not in compliance. If the facts and circumstances giving rise to the inference involve only boilers and pressure vessels that the NRC has determined are not within NRC's jurisdictional authority, subsection (c) shall apply and subsection (b) shall not apply. If the facts and circumstances giving rise to the inference involve any other boiler, pressure vessel or nuclear power system, subsection (b) shall apply and subsection (c) shall not apply.

b) Simultaneously with the notification provided for in subsection (a), the Agency will notify the NRC in writing of those facts and circumstances known to the Agency that give rise to the inference that the owner is not in compliance. If the owner fails to demonstrate to the Agency that the owner is in compliance within 10 days after the notification, the Agency shall provide to the NRC a written request, pursuant to 10 CFR 2.200, that the NRC take appropriate action, e.g., pursuant to 10 CFR 2.206. The request will specify the NRC action or actions that the Agency is requesting.

c) If the owner fails to demonstrate to the Agency that the owner is in compliance within 10 days after the notification provided for in subsection (a), the Agency shall issue a Preliminary Order and Notice of Opportunity for Hearing in accordance with 32 Ill. Adm. Code 200.

1. If, after the hearing, the Director finds that the owner or organization was in compliance with the requirements of this Part, the Director shall issue to the owner an Order of Compliance or issue such other order as appropriate.

2. If, after the hearing or default, the Director finds that the owner is not in compliance with the requirements of this Part, the Director will render a final decision which may include denying an application for, or suspending or revoking, an affected Inspection Certificate.

d) All final administrative decisions of the Director under this Part shall be subject to the Administrative Review Law [735 ILCS 5/Art. III].

History

• Source: Amended at 45 Ill. Reg. 686, effective December 23, 2020

32 Ill. Adm. Code 505.82 Administrative Review and Hearings - Authorized Inspection Agency

This Section shall apply to any action by the Agency to deny an application for, or to suspend or revoke, Agency recognition of an Authorized Inspection Agency.

a) An owner or organization aggrieved by the Agency's action pursuant to Section 505.190(b) or (d) may within 15 days submit a written request for a hearing to the Agency, which shall thereafter hold an adjudicatory hearing in accordance with 32 Ill. Adm. Code 200.

1. If, after the hearing, the Director finds that the owner or organization was in compliance with the requirements of this Part, the Director shall issue an order directing that recognition be extended to the organization.

2. If, after the hearing or default, the Director finds that the owner or organization is not in compliance with the requirements of this Part, the Director will render a final decision which may include denying the application for recognition.

b) All final administrative decisions of the Director under this Part shall be subject to the Administrative Review Law.

History

• Source: Amended at 41 Ill. Reg. 645, effective January 4, 2017

32 Ill. Adm. Code 505.84 Administrative Review and Hearings - Special Permits

This Section shall apply to any action by the Agency to deny an application for, or to suspend or revoke, a special permit for construction of a non-ASME Code boiler or pressure vessel pursuant to Section 505.2700.

a) An owner aggrieved by an Agency denial pursuant to Section 505.2700(c)(5), (d)(5) and (e)(5) or Agency action pursuant to Section 505.2700(c)(4), (d)(5) and (e)(5) may within 15 days submit a written request for a hearing to the Agency, which shall thereafter hold an adjudicatory hearing in accordance with 32 Ill. Adm. Code 200.

1. If, after the hearing, the Director finds that the owner was in compliance with the requirements of this Part or that the affected non-ASME boiler or pressure vessel meets the criteria of Section 505.2700(c), the Director shall issue an order directing that the Special Permit be issued to the owner or organization.

2. If, after the hearing or default, the Director finds that the owner is not in compliance with the requirements of this Part, the Director will render a final decision which may include denying the application for, or suspending or revoking, a Special Permit.

b) All final administrative decisions of the Director under this Part shall be subject to the Administrative Review Law.

History

• Source: Amended at 41 Ill. Reg. 645, effective January 4, 2017

32 Ill. Adm. Code 505.86 Actions Pending Before the United States Nuclear Regulatory Commission

Whenever any person brings an action before the NRC pursuant to 10 CFR 2.200 alleging that an Agency application of a requirement of this Part could affect the safety or the operation of a nuclear facility, the Agency shall not apply or enforce the requirement until such time as the NRC concurs in the application or enforcement or until the NRC otherwise finds and notifies the Agency that the application of the requirement could not affect the safety or the operation of the nuclear facility.

History

• Source: Amended at 45 Ill. Reg. 686, effective December 23, 2020

32 Ill. Adm. Code 505.90 Address and Telephone Number for Notifications and Inquiries

Written reports or communications concerning or required by this Part shall be addressed to:

Illinois Emergency Management Agency and Office of Homeland Security

ATTN: Nuclear Facility Inspection

1301 Knotts Street

Springfield, IL 62703

The Agency may be reached by telephone at (217) 782-2700 or for 24-hour response at (217) 782-7860.

History

• Source: Amended at 50 Ill. Reg. 3902, effective February 23, 2026

Chapter II Illinois Emergency Management Agency and Office of Homeland Security

Subchapter c Nuclear Facility Safety

Part 505 Safe Operation of Nuclear Facility Boilers and Pressure Vessels

32 Ill. Adm. Code 505.100 Standards for Design, Construction, Operation and Inspection (general)

Please refer to Section 505.1000 of this Part for ISI boilers and pressure vessels and Section 505.2000 of this Part for non-ISI boilers and pressure vessels.

History

• Source: Amended at 23 Ill. Reg. 13089, effective October 6, 1999

32 Ill. Adm. Code 505.110 Registration Requirements (general)

a) The requirements of this Section are subject to the limitations of Section 505.20(c).

b) The owner of a nuclear facility shall register with the Agency all boilers and pressure vessels contained within or upon or in connection with the nuclear facility unless exempt under Section 505.50(a). For each boiler and pressure vessel installed after February 7, 1994 that has not been registered with the Agency, the owner shall register the boiler or pressure vessel prior to its operation in accordance with this Section and either Section 505.1100 or 505.2100, as applicable.

c) Manufacturer's Data Reports shall be filed by the owner with the Agency for new installation and reinstallation of boilers and pressure vessels at nuclear facilities, unless otherwise exempted by Section 505.50(a). If a boiler or pressure vessel is of special design or will not bear the ASME Certification Mark with appropriate designator, the owner shall additionally comply with the requirements of Sections 505.170 and 505.1700 or Section 505.2700 for non-ASME Code ISI or non-ISI boilers and pressure vessels, respectively.

AGENCY NOTE: Data Reports as used in this subsection (c) refers to those documents completed as required by the construction code applicable to the boiler or pressure vessel.

d) Each boiler or pressure vessel subject to the Act shall be identified by a serial number of the State of Illinois. If a State serial number has not already been assigned, a number will be assigned and applied by the Authorized Inspector. Additionally, the ASME Code Certification Mark with appropriate designator shall be kept free of paint and lagging so that it will be plainly visible and easily read by the Authorized Inspector.

e) The State serial number on boilers shall not be less than 5/16" in height and shall be preceded by the letters "ILL" and the letter "B", which also shall be not less than 5/16" in height. The State serial number on unfired pressure vessels shall be not less than 5/16" in height and shall be preceded by the letters "ILL" and the letter "U", which also shall be not less than 5/16" in height. The Authorized Inspector shall make certain that the correct Illinois State serial number is affixed to the boiler or pressure vessel.

f) The requirements of subsections (d) and (e) for the physical application of the State serial number may be waived if a system to identify the boiler or pressure vessel with the assigned State serial number has been established and the system of identification is acceptable to the Agency. An alternative system for the identification of boilers and pressure vessels with assigned State serial numbers shall be acceptable to the Agency if the alternative system readily and unambiguously allows the Agency and Authorized Inspector to track the inspection status of the boilers and pressure vessels using the State serial numbers. Acceptable alternative systems of identification may include, but are not limited to, the use of cross-reference lists between assigned State serial numbers and any of the following: National Board serial numbers; manufacturers' names and serial numbers; or plant equipment identification numbers as shown on controlled plant system identification drawings provided to the Agency.

g) A Certificate Inspection shall be made of all used or second-hand boilers or pressure vessels prior to operation at a nuclear facility in this State. In a case where a boiler or pressure vessel is moved and reinstalled the fittings and appliances shall be upgraded to comply with the rules for new installations.

History

• Source: Amended at 41 Ill. Reg. 645, effective January 4, 2017

32 Ill. Adm. Code 505.120 Inspection Certificates (general)

a) Inspection Certificates for nuclear power systems shall be issued in accordance with Section 505.1200. Inspection Certificates for non-ISI boilers and pressure vessels shall be issued in accordance with Section 505.2200. Both nuclear power systems and non-ISI boilers and pressure vessels and their Inspection Certificates shall be subject to the provisions of subsections (b) and (c).

b) Owners shall keep the Inspection Certificate in an accessible location.

c) Boilers and pressure vessels that change classification (i.e., to or from ISI or non-ISI) as a result of additions to or deletions from the Inservice Inspection Plan shall be subject to the registration and submittal requirements of the new classification. To reduce the administrative burden on the owner, the owner need only inform the Agency of all previous submittals made on behalf of existing registration that the owner intends to apply to the new classification.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

32 Ill. Adm. Code 505.130 Operation Requirements (general)

a) The requirements of this Section are subject to the limitations of Section 505.20(c).

b) Any person, firm, partnership or corporation violating any of the provisions shall be subject to the penalties provided in the Act.

c) An Inspection Certificate may be suspended by the Agency if an ISI or non-ISI boiler or pressure vessel or nuclear power system is in operation but not in compliance with this Part.

d) An Inspection Certificate may be suspended by the Agency if an ISI or non-ISI boiler or pressure vessel or nuclear power system is being operated in an unsafe condition.

e) If the owner of any boiler or pressure vessel or nuclear power system required to be inspected refuses to allow an inspection to be made, the Agency shall take action to suspend the Inspection Certificate under Section 505.80 until the owner complies with the requirements.

f) For any boiler or pressure vessel that has been inspected and declared unsafe by an Authorized Inspector, the Authorized Inspector shall notify the Agency of his or her intention to condemn the boiler or pressure vessel. The Agency shall act in accordance with subsection (g) for such ISI or non-ISI boilers or pressure vessels.

g) Upon being notified under the provisions of subsection (f), the Agency shall take action concerning the affected Inspection Certificate in accordance with Section 505.80.

h) Subject to the limitations of Sections 505.20(c), 505.80 and 505.86, the owner who causes a non-ISI boiler or pressure vessel or nuclear power system to be operated without a valid Inspection Certificate shall be subject to the penalty as provided in the Act.

i) Removal of Safety Appliances.

1. No person, except under the direction of an Authorized Inspector, shall attempt to remove or shall do any work upon safety appliances required by this Part while a boiler or pressure vessel is in operation. If any of these appliances are repaired during an outage of a boiler or pressure vessel, they shall be reinstalled and in proper working order before the object is again placed in service.

2. No person shall in any manner load the safety valve or valves to maintain a working pressure in excess of that stated on the Inspection Certificate.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

32 Ill. Adm. Code 505.140 Inspection Requirements (general)

a) The requirements of this Section are subject to the limitations of Section 505.20(c).

b) If, upon inspection and notification by an Authorized Inspector, a boiler or pressure vessel at a nuclear facility is found to be in such condition that it is unsafe to operate, the Agency, subject to the limitations of Section 505.20(c), shall act to suspend the Inspection Certificate in accordance with Section 505.80.

c) Owners shall assure that examinations and tests are conducted in accordance with the methods and frequencies established by this Part.

d) In addition to the reporting frequencies specified in this Part, the owner shall report to the Agency within 72 hours when, on the basis of observation or objective information, the owner has reason to believe that an ISI or non-ISI boiler or pressure vessel or nuclear power system does not meet the standards of this Part.

e) Inspections shall be conducted by Authorized Inspectors.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

32 Ill. Adm. Code 505.150 Repairs and Alterations (general)

Please refer to Section 505.1500 of this Part for ISI boilers and pressure vessels and Section 505.2500 of this Part for non-ISI boilers and pressure vessels.

History

• Source: Amended at 23 Ill. Reg. 13089, effective October 6, 1999

32 Ill. Adm. Code 505.160 Code Case Applications (general)

The owner may, at its discretion, elect to use an ASME Code Case to design, construct, examine, test, repair or alter a boiler or pressure vessel. The owner shall notify the Agency of all intentions to use a Code Case and the extent and nature of the use of the Code Case for the particular application.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

32 Ill. Adm. Code 505.170 Use of Alternative Standards for Construction, Inspection and Repair (general)

a) The Agency may issue special permits for boilers and pressure vessels at nuclear facilities that for some reason were not constructed in accordance with the applicable ASME Code Section, or for some reason cannot be inspected or repaired in accordance with this Part. The Agency shall issue special permits in accordance with Section 505.1700 or Section 505.2700, as applicable.

b) Owners may request the Agency to issue a special permit for a boiler or pressure vessel not constructed in accordance with the applicable ASME Code Section.

c) For boilers and pressure vessels using alternative standards for construction, upon completion of construction and installation, the owner shall register the non-ASME Code boiler or pressure vessel with the Agency. The owner shall demonstrate compliance with the provisions of the special permit. The owner shall meet the applicable registration requirements for either ISI boilers and pressure vessels in Sections 505.1100 and 505.1200 or non-ISI boilers and pressure vessels in Sections 505.2100 and 505.2200.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

32 Ill. Adm. Code 505.180 Authorized Inspectors (general)

a) ISI and non-ISI boilers and pressure vessels at nuclear facilities within the State shall be inspected by Authorized Inspectors.

b) If an Authorized Inspector finds that the boiler or pressure vessel or any of its appurtenances are in an unsafe condition, the Authorized Inspector shall immediately notify the Agency and submit a report of the defects.

c) The requirements of this Section are subject to the limitations of Section 505.20(c).

d) Authorized Inspectors shall perform all duties required of them under the ASME Code or the National Board Inspection Code, as applicable. Authorized Inspectors shall notify the Agency within 7 days if they have knowledge of a nuclear power system or an ISI or non-ISI boiler or pressure vessel that:

1. is being operated without a valid Inspection Certificate;

2. is being operated at a pressure that exceeds indicated pressure on the Inspection Certificate; or

3. otherwise deviates from the requirements of this Part.

e) Authorized Inspectors inspecting ISI boilers or pressure vessels or nuclear power systems shall meet the requirements of Section 505.1800.

f) Authorized Inspectors inspecting non-ISI boilers and pressure vessels shall meet the requirements of Section 505.2800.

History

• Source: Amended at 41 Ill. Reg. 645, effective January 4, 2017

32 Ill. Adm. Code 505.190 Authorized Inspection Agencies (general)

a) An organization that wishes to provide ASME Code or National Board Inspection Code inspection services at a nuclear facility shall be recognized as an Authorized Inspection Agency by the Agency in accordance with subsection (b) prior to providing ASME Code or National Board Inspection Code inspection services at a nuclear facility. Such an organization shall submit the following to the Agency:

1. A written request for recognition as an Authorized Inspection Agency;

2. A list of the names of Authorized Inspectors employed; and

3. A written description of the types of inspections that the organization will perform and the ASME Code Sections/National Board Inspection Code for which it will conduct inspection activities.

AGENCY NOTE: An Authorized Inspection Agency already recognized by the Agency does not need to resubmit the documents specified in this subsection (a).

b) The Agency shall, within 90 days after receipt of an organization's request submitted pursuant to this Section, recognize the organization as an Authorized Inspection Agency upon determining that it has demonstrated in the request that it meets all qualification, duty and other requirements in those ASME Code Sections/National Board Inspection Code for which it wishes to provide inspection services. If it is determined that an organization's request submitted pursuant to this Section does not meet the requirements of this Section, the Agency shall take action under Section 505.82.

AGENCY NOTE: Qualification, duty and other requirements for organizations in subsections (a) and (b) shall be in accordance with the latest edition and addenda of the ASME Code/National Board Inspection Code referenced in Section 505.40.

c) OSFM is exempt from all the requirements of this Section.

d) If the Agency determines that an Authorized Inspection Agency is not qualified, the Agency shall act to suspend or revoke its recognition of the Authorized Inspection Agency under Section 505.82.

AGENCY NOTE: Applicable ASME Code Sections/National Board Inspection Code as used in this Section means those under which the Authorized Inspection Agency is performing inspection activities. Agency reviews will determine whether the organization meets all requirements for Authorized Inspection Agencies as found in the most recent edition and addenda of the ASME Code or National Board Inspection Code, as applicable, referenced in Section 505.40.

e) Within 30 days following each inspection required by this Part, the Authorized Inspection Agency shall submit an accurate report of the results of the inspection to the Agency in accordance with this Part.

History

• Source: Amended at 41 Ill. Reg. 645, effective January 4, 2017

32 Ill. Adm. Code 505.1000 Standards for Design, Construction, Operation and Inspection

ISI boilers and pressure vessels, including related appurtenances, except those exempt under Section 505.50(a) of this Part, installed or operated within or upon or in connection with a nuclear facility in Illinois shall be designed, constructed, installed, stamped, examined, tested, repaired, altered and inspected in accordance with Sections III and XI of the ASME Code or with other codes and standards as reflected in the facility's Operating License, Final Safety Analysis Report, technical specifications or other licensing documents as required or approved by the NRC.

History

• Source: Amended at 23 Ill. Reg. 13089, effective October 6, 1999

32 Ill. Adm. Code 505.1100 Registration Requirements

For registration of each ISI boiler and pressure vessel, except those exempt under Section 505.50(a), the owner shall submit the following to the Agency. If the submittal applies to a collection of ISI boilers and pressure vessels, the owner shall submit the documentation once for the ISI boilers and pressure vessels included in the submittal. If it is determined that any of the documents have previously been submitted to the Agency, the owner does not have to resubmit them.

a) A controlled copy of the Inservice Inspection Plans for the nuclear power system;

b) Cross-references to the State serial numbers, and National Board serial numbers if available, for all ISI boilers and pressure vessels in the Inservice Inspection Plan;

c) A preservice inspection summary report for the nuclear power system;

d) For boilers and pressure vessels covered by this Section, owners shall meet the requirements of Section 505.110.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

32 Ill. Adm. Code 505.1200 Inspection Certificates

This Section is not intended to be, in any way, inconsistent with the applicable regulations, rules and requirements of the NRC. If a requirement of this Section as applied in any situation is or would be inconsistent with the regulations, rules and requirements of the NRC, the requirements of this Section shall not be applied. The Agency will take action in regard to an Inspection Certificate only in accordance with Section 505.80. The Agency shall issue Inspection Certificates for nuclear power systems in accordance with this Section if the reports, programs and plans required to be submitted by this Section, Sections 505.110 and 505.1100 are submitted in accordance with the frequencies and standards specified in those Sections and are in compliance with this Part.

a) Owners of nuclear power systems shall not operate those nuclear power systems without a valid Inspection Certificate issued by the Agency. The Agency shall issue one Inspection Certificate for each nuclear power system at a nuclear facility. Unless suspended by the Agency, the Inspection Certificate shall remain valid through the 6-month period following the end of the inservice inspection period for which the certificate was issued, or as otherwise permitted by this Part.

b) Owners of nuclear power systems not yet in operation shall, prior to operation of the nuclear power systems, have a valid Inspection Certificate issued by the Agency for the nuclear power systems. The Agency shall issue the initial Inspection Certificates for the first inservice inspection period based on an Agency determination that the submittal requirements of Section 505.1100 are met.

c) An Inspection Certificate shall be issued for each nuclear power system at the nuclear facility for the succeeding inservice inspection period when the Agency determines that:

1. The examinations and tests required by the Inservice Inspection Plan during the preceding inservice inspection period were completed; and

2. All related submittal requirements of this Part are met.

AGENCY NOTE: In order to determine whether the examinations and tests required by the Inservice Inspection Plan during the preceding inspection period were performed and completed, the Agency will review the submittals required by this Section against the Inservice Inspection Plan and the applicable edition and addenda of the ASME Code Section XI. The review and determination will be made separately for each nuclear power system. During this review the Agency shall accept requests for relief from ASME Code Section XI requirements that have been approved by the NRC.

d) The inservice inspection interval for the nuclear power system may be extended or reduced as permitted by the applicable Code edition and addenda or that has been approved by the NRC. The owner shall notify the Agency in writing of any such change in the inservice inspection interval. The Agency may issue a new Inspection Certificate, or may adjust the term of the Inspection Certificate in effect for the applicable inservice inspection period.

e) When the owner discovers that an ISI boiler or pressure vessel is not in compliance with this Part, the owner shall take measures to bring the ISI boiler or pressure vessel into compliance. Those measures may include, but are not limited to, repair or replacement of the ISI boiler or pressure vessel in accordance with Section 505.1500. In such cases, the owner shall notify the Agency in accordance with Section 505.140. The owner shall submit information concerning the details of the noncompliance and the measures taken to bring the noncomplying ISI boiler or pressure vessel into compliance to the Agency within 90 days following the completion of the corrective measures. Any replacement ISI boiler or pressure vessel shall meet the requirements of this Part for new boilers and pressure vessels and shall be registered by the owner with the Agency in accordance with Section 505.1100. The Agency shall review the information submitted regarding the noncompliance and the corrective measures taken and may issue a revised Inspection Certificate to reflect any change in nuclear power system composition.

f) The owner shall submit the following:

1. In addition to the information submitted under Section 505.1100, the owner shall submit to the Agency within 90 days after completing a refueling outage:

A) The inservice inspection summary report required by ASME Code Section XI;

B) The Owner's Data Report, form NIS-1, required by ASME Code Section XI or an equivalent form;

C) The Owner's Report for Repairs or Replacements, form NIS-2 of Section XI or an equivalent form, if required by the applicable Code Edition and Addenda or Code Case used, for all repairs and replacements performed since the last inservice inspection; and

D) Deviations from the Inservice Inspection Plan implemented during inservice inspections that impact upon compliance with this Part.

2. The owner shall submit the Inservice Inspection Plan for the next inservice inspection interval to the Agency prior to the end of each inservice inspection interval.

g) The Agency shall take action under Section 505.80 if the Agency finds that:

1. The submittals in subsection (f) have not been made or are incomplete; or

2. The examinations and tests required by the owner's Inservice Inspection Plan have not been performed or are incomplete; or

3. The owner has not met the requirements of subsection (e); or

4. The nuclear power system is not being inspected in accordance with this Part.

h) In addition to the requirements of this Section, owners shall meet the requirements of Section 505.120.

History

• Source: Amended at 41 Ill. Reg. 645, effective January 4, 2017

32 Ill. Adm. Code 505.1300 Operation Requirements

ISI boilers and pressure vessels shall meet the requirements of Section 505.130 of this Part.

History

• Source: Amended at 23 Ill. Reg. 13089, effective October 6, 1999

32 Ill. Adm. Code 505.1400 Inspection Requirements

ISI boilers and pressure vessels shall meet the requirements of Section 505.140 of this Part.

History

• Source: Amended at 23 Ill. Reg. 13089, effective October 6, 1999

32 Ill. Adm. Code 505.1500 Repairs

Repairs of ISI boilers and pressure vessels and pressure relief valves associated with ISI boilers and pressure vessels, except boilers and pressure vessels and those pressure relief valves associated with boilers and pressure vessels that are exempt under Section 505.50(a) of this Part, shall be made in accordance with this Section.

a) ISI boilers and pressure vessels shall be repaired in accordance with the applicable repair and replacement requirements of Section XI of the ASME Code or other codes and standards as reflected in the facility's Operating License, Final Safety Analysis Report, technical specifications or other licensing documents as required or approved by the NRC.

b) Pressure relief valves associated with ISI boilers and pressure vessels shall be repaired in accordance with the applicable repair and replacement requirements of Section XI of the ASME Code or other codes and standards as reflected in the facility's Operating License, Final Safety Analysis Report, technical specifications or other licensing documents as required or approved by the NRC.

History

• Source: Amended at 23 Ill. Reg. 13089, effective October 6, 1999

32 Ill. Adm. Code 505.1600 Code Case Applications

a) Approval to use an ASME Code Case for ISI boilers and pressure vessels is vested in the NRC. The Agency shall accept all ASME Code Cases approved for use by the NRC.

b) Owners shall meet the notification requirements of Section 505.160 in all cases involving the use of Code Cases for ISI boilers or pressure vessels.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

32 Ill. Adm. Code 505.1700 Use of Alternative Standards for Construction, Inspection and Repair

a) Approval to permit an owner to use alternative standards for construction, inspection or repair of an ISI boiler or pressure vessel is vested in the NRC. The Agency shall accept alternative construction, inspection or repair standards that have been accepted by the NRC.

b) Owners shall meet the requirements of Section 505.170 in all cases involving use of alternative standards for ISI boilers or pressure vessels.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

32 Ill. Adm. Code 505.1800 Authorized Inspectors

In order to perform the duties of an Authorized Inspector for ISI boilers and pressure vessels or nuclear power systems at nuclear facilities within the State, the individual shall, in addition to the requirements of Section 505.180, possess a current Inservice Commission (IS) and one of the following specialized qualifications, referred to as endorsements, issued by the National Board:

a) Authorized Nuclear Inservice Inspector (I); or

b) Authorized Nuclear Inservice Inspector Supervisor (NSI).

History

• Source: Amended at 45 Ill. Reg. 686, effective December 23, 2020

32 Ill. Adm. Code 505.1900 Authorized Inspection Agencies

a) Organizations seeking to provide inspection services to the requirements of ASME Code Section III, Section XI or both, shall be subject to the requirements of this Section and Section 505.190.

b) The request for recognition submitted in Section 505.190(a) shall also contain documentation demonstrating that the organization meets the ASME Code and ASME/ANSI N626 or ASME QAI-1 qualifications for Authorized Inspection Agencies for the scope of inspection activities, including the possession of a valid ASME Certificate of Accreditation.

c) The Agency shall act in accordance with Section 505.190(b) on all requests for recognition submitted in accordance with this Part.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

32 Ill. Adm. Code 505.2000 Standards for Design, Construction, Operation and Inspection

Non-ISI boilers and pressure vessels, including related appurtenances, except those exempt under Section 505.50(a), operated within or upon or in connection with a nuclear facility in Illinois, shall be designed, constructed, installed, examined, tested, repaired, altered and inspected as required by this Section, except in those cases in which NRC has jurisdiction, as determined by NRC. When NRC has jurisdiction, the codes and standards reflected in the facility's Operating License, Final Safety Analysis Report, technical specifications or other licensing documents as required or approved by the NRC shall apply. For non-ISI boilers and pressure vessels over which NRC has no jurisdiction, as determined by NRC, the standards required by this Part apply. If the NRC determines that NRC has jurisdiction, but has not established standards, the Agency may propose to NRC that these or other standards be applied to such boilers and pressure vessels in nuclear power plants in Illinois.

a) All new, existing and reinstalled non-ISI boilers, including related appurtenances, shall be designed, constructed, installed, examined, tested, repaired and altered in accordance with the ASME Code or National Board Inspection Code, as applicable, and inspected in accordance with this Part. Where a non-ISI boiler is moved and reinstalled, the fittings and appliances of that boiler shall comply with this Part.

b) All non-ISI pressure vessels installed and placed in operation after December 31, 1976 and all reinstalled non-ISI pressure vessels, including related appurtenances, shall be designed, constructed, installed, tested, examined, repaired and altered in accordance with the ASME Code or National Board Inspection Code, as applicable, and inspected in accordance with this Part. Where a non-ISI pressure vessel is moved and reinstalled, the fittings and appliances of that pressure vessel shall comply with this Part.

c) Non-ISI pressure vessels and related appurtenances installed and placed in operation at nuclear facilities on or before December 31, 1976 shall be inspected in accordance with this Part and designed, constructed, installed, tested, repaired and altered, in accordance with the following requirements.

1. The MAWP for standard pressure vessels shall be determined in accordance with the applicable provisions of the ASME Code under which they were constructed and stamped.

2. MAWP for Non-standard Pressure Vessels

A) The MAWP of a non-standard pressure vessel subject to internal pressure shall be determined by the strength of the weakest course computed from the thickness of the plate, the tensile strength of the plate, the efficiency of the longitudinal joint, the inside diameter of the course and the factor of safety set by this Part, as follows:

TS x t x E

=

MAWP, in psig

R x FS

where:

TS

=

ultimate tensile strength of shell plate, in psi. When the tensile strength of steel plate is not known, it shall be taken as 55,000 psi for temperature not exceeding 650° F.

t

=

minimum thickness of shell plate of weakest course, in inches.

E

=

efficiency of longitudinal joint, depending upon construction. Use the following values (in percents):

For Fusion-Welded and Brazed Joints:

Single lap welded........................................ 40

Double lap welded....................................... 60

Single butt welded....................................... 60

Double butt welded..................................... 75

Forge welded............................................... 70

Brazed steel................................................. 80

For riveted joints − calculate riveted joint efficiency in accordance with rules given in Section I, Part PR, of the 1971 ASME Code.

R

=

inside radius for weakest shell course, in inches, provided the thickness does not exceed 10 percent of the radius. If the thickness is over 10 percent of the radius, the outer radius shall be used.

FS

=

factor of safety permitted shall be a minimum of 5.0.

B) The MAWP for cylindrical non-standard pressure vessels subject to external or collapsing pressure shall be determined by the rules in Par. UG-27 and UG-28 of the ASME Code Section VIII.

C) The minimum factor of safety may be increased when deemed necessary by the Authorized Inspector to assure the operation of the vessel within safe limits. The condition of the vessel and the particular service to which it is subject will be determining factors.

D) The MAWP permitted for formed heads under pressure shall be determined by using the appropriate formulas from UG-32 or UG-33 of the ASME Code Section VIII and the tensile strength and efficiencies given in this Section.

d) All non-ISI boilers and pressure vessels, including related appurtenances, shall be inspected in accordance with the National Board Inspection Code and this subsection (d). The following general requirements shall apply to all non-ISI boilers and pressure vessels.

1. The owner shall prepare each boiler and pressure vessel for internal inspection in accordance with the National Board Inspection Code. The Authorized Inspector should not enter any boiler or pressure vessel before he or she is satisfied that all necessary safety precautions of the National Board Inspection Code have been taken, including testing the boiler or pressure vessel atmosphere for oxygen and toxic, flammable and inert gases.

2. The owner shall prepare for and apply the hydrostatic test, whenever necessary, on a date agreeable to the owner and the Authorized Inspector.

e) All cases not specifically covered by this Part shall be treated as new installations. Existing non-ISI boilers and pressure vessels shall be governed by current ASME Code and National Board Inspection Code requirements or the requirements of the ASME Code in effect at the time of construction.

History

• Source: Amended at 41 Ill. Reg. 645, effective January 4, 2017

32 Ill. Adm. Code 505.2100 Registration Requirements

For registration of each non-ISI boiler or pressure vessel, except those exempt under Section 505.50(a), the owner shall submit the following to the Agency. If the submittal applies to a collection of non-ISI boilers and pressure vessels, the owner shall submit the documentation once for the non-ISI boilers and pressure vessels included in the submittal.

a) For each non-ISI boiler and pressure vessel not already registered with the Agency, the owner shall submit any manufacturer's Data Reports related to the construction, repair, replacement or alteration of the non-ISI boiler or pressure vessel and its appurtenances.

AGENCY NOTE: Data Reports as used in this subsection (a) refers to those documents completed as required by the construction code applicable to the non-ISI boiler or pressure vessel.

b) For boilers and pressure vessels covered by this Section, owners shall meet the requirements of Section 505.110.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

32 Ill. Adm. Code 505.2200 Inspection Certificates

This Section is not intended to be, in any way, inconsistent with the applicable regulations, rules and requirements of the NRC. If a requirement of this Section as applied in any situation is or would be inconsistent with the regulations, rules and requirements of the NRC, the requirements of this Section shall not be applied. The Agency will take action in regard to an Inspection Certificate only in accordance with Section 505.80. The Agency shall issue Inspection Certificates for non-ISI boilers and pressure vessels in accordance with this Section if the reports, inspection criteria and plans required to be submitted by and identified in Sections 505.110 and 505.2100 and this Section are submitted in accordance with the frequencies specified in those Sections and are in compliance with this Part.

a) The Agency shall issue one Inspection Certificate to each non-ISI boiler and pressure vessel for a term equal to the frequency of inspection of the non-ISI boiler or pressure vessel. The frequency and type of inspection for each non-ISI boiler and pressure vessel shall be as follows:

1. Power boilers, high pressure water boilers and high temperature water boilers shall be inspected annually, which shall be an internal inspection where conditions permit. The boilers shall also be inspected externally annually while under representative operating conditions, if possible.

2. Low pressure steam boilers, hot water heating boilers and hot water supply boilers shall be inspected every 2 years. The inspection shall be internal and external, where conditions permit. An external inspection shall be conducted under representative operating conditions at the request of the Authorized Inspector.

3. Pressure vessels subject to internal corrosion shall be inspected in accordance with subsection (a)(3)(A), unless the Agency approves an alternative under subsection (a)(3)(B).

A) Pressure vessels shall be inspected every 3 years. The inspection shall be internal and external where conditions permit.

B) Alternatively, for each pressure vessel that can be inspected only during refueling outages, the owner may develop an inspection plan for the remaining life of the pressure vessel. The plan shall provide that an inspection of each pressure vessel will occur prior to the completion of every 2 consecutive refueling outages, but in no case more than 5 years after the last inspection of the pressure vessel. The owner may include in the plan contingency options for conducting inspections during unplanned or extended refueling outages, provided the required frequency of inspection is met. The bases for the inspection plan may include, but is not necessarily limited to, alternative examinations and tests planned and performed, past performance of this and similar pressure vessels, status of the pressure vessel in the plant's maintenance program, the environment and contents of the pressure vessel, vessel use, service condition (operating or not) of the pressure vessel relative to operation of the plant, corrosive environment where the pressure vessel is installed, risks, methods of inspection, ALARA (as defined in 32 Ill. Adm. Code 310) considerations, trade-offs and relevant engineering data. This plan shall be submitted to the Agency for approval.

4. Pressure vessels not subject to internal corrosion shall be inspected in accordance with subsection (a)(4)(A) or (B) as applicable, unless the Agency approves an alternative under subsection (a)(4)(C):

A) Vessels containing incompressible fluids (e.g., water) shall be inspected externally every 5 years.

B) Vessels containing compressible fluids (e.g., air steam), or a combination of compressible and incompressible fluids, shall be inspected externally every 3 years.

C) Alternatively, the owner may develop an inspection plan for the vessel for its remaining life based upon refueling outages. This plan shall be submitted to the Agency for approval. The basis for such an inspection plan may include alternative examinations and tests planned and performed, past performance of the pressure vessel and similar pressure vessels, status of the pressure vessel in the plant's maintenance program, the environment and contents of the pressure vessel and relevant engineering data.

AGENCY NOTE: External inspection may be waived by the Agency due to inaccessibility of the equipment, based on the owner's detailed assessment of documentation and performance data verifying vessel integrity.

5. Inspection of flame safeguard equipment shall be to the standards of Section 505.40(c) and will be in conjunction with the regular inspection of boilers.

6. A grace period of 2 months beyond the period specified in subsection (a)(1) or (2), may elapse between internal inspections of the boiler while it is not under pressure and the external inspection of the boiler while it is under pressure.

b) The Agency shall issue an initial Inspection Certificate for a non-ISI boiler or pressure vessel in accordance with this subsection (b). Owners of a non-ISI boiler or pressure vessel not yet in operation shall, prior to operation of the boiler or pressure vessel, have a valid Inspection Certificate issued by the Agency. Application for an Inspection Certificate shall be in accordance with subsection (f) except that the owner shall submit the documents listed in subsection (f)(2) at least 90 days prior to operating the boiler or pressure vessel.

c) For other than initial issuance of an Inspection Certificate in accordance with subsection (b), the Agency shall issue an Inspection Certificate for each non-ISI boiler or pressure vessel at the nuclear facility in accordance with this Section when the Agency determines that:

1. The inspections required under subsection (a) were applied to the non-ISI boiler or pressure vessel, were completed and the condition of the non-ISI boiler or pressure vessel is such that an Inspection Certificate may be issued in accordance with subsection (d);

2. The Report of Inspection or similar report form was completed for the non-ISI boiler or pressure vessel and was submitted to the Agency in accordance with subsection (f)(2); and

3. If applicable, all submittals in subsections (e) and (f)(2)(B) are met.

d) The Agency shall issue the Inspection Certificate within 90 days following receipt of the Report of Inspection on the non-ISI boiler or pressure vessel, or shall observe the procedures of subsection (g). The latter shall occur either within 90 days following receipt of the Report of Inspection or within 10 days following the expiration date of the Inspection Certificate.

e) The Inspection Certificate issued for the non-ISI boiler or pressure vessel as established by this Section may be extended for a maximum of 1 year.

1. For all pressure vessels and for boilers, other than power boilers, high pressure water boilers and high temperature water boilers, the owner shall request permission from the Agency to extend the term of the Inspection Certificate prior to implementing the extension. The Agency shall review a request for extension and permit the extension when the extension does not increase the risk to the health and safety of the public and personnel.

2. For power boilers, high pressure water boilers and high temperature water boilers, the Agency may extend, for a time not exceeding 1 year, the time within which the power boiler is required to be internally inspected, subject to the following conditions and qualifications:

A) The analysis and treatment of feedwater for the power boilers shall be under the supervision of a person qualified in the field of water chemistry.

B) The analysis and treatment of the boiler feedwater shall be for the purpose of controlling and limiting serious deteriorating, crusting and sludge that affect the safety of the boiler.

C) The owner of the boilers shall maintain, for examination by the Authorized Inspector, accurate records of chemical and physical laboratory analyses of samples of the boiler water taken at regular intervals of not more than 24 hours operation and of the treatment applied. These records shall specify dates and times of analyses, by whom analyzed, and the treatment applied at that time, and shall be certified by the responsible authority. These records will adequately show the conditions of the water and any constituents or characteristics that are capable of producing corrosion or other deterioration of the boiler or its parts.

D) Application for extension shall be in writing setting forth facts establishing compliance with the foregoing conditions and qualifications and shall be accompanied by the report of external inspection.

f) For each non-ISI boiler or pressure vessel, the owner shall submit the following:

1. The information required by Section 505.2100;

2. On or before the expiration date of the Inspection Certificate issued to the non-ISI boiler or pressure vessel:

A) The completed Report of Inspection or similar report form documenting that the inspections were performed in accordance with the inspection criteria and frequency requirements of subsection (a) and Section 505.2000.

B) All Code Data Reports and all other information related to the repair, replacement or alteration of the non-ISI boiler or pressure vessel or its appurtenances performed since the last Certificate Inspection.

g) The Agency shall take action under Section 505.80 if the Agency finds that:

1. The submittals and notifications required by subsections (e) and (f) have not been made or are incomplete; or

2. The inspections required by this Section have not been performed or are incomplete; or

3. A change to the inspection frequency applied to the non-ISI boiler or pressure vessel is not in accordance with subsection (e); or

4. The non-ISI boiler or pressure vessel was insured and the insurance has been canceled or has otherwise become ineffective.

h) In addition to the requirements of this Section, owners shall meet the requirements of Section 505.120.

i) Notwithstanding any other provision of this Section, an Inspection Certificate shall remain valid beyond the expiration date noted on the certificate until the boiler or pressure vessel is reinspected by the Authorized Inspector or until the certificate is suspended by the Agency, provided that the owner of the boiler or pressure vessel makes it available for inspection at reasonable times.

History

• Source: Amended at 41 Ill. Reg. 645, effective January 4, 2017

32 Ill. Adm. Code 505.2300 Operation Requirements

Non-ISI boilers and pressure vessels shall meet the requirements of Section 505.130 of this Part.

History

• Source: Amended at 23 Ill. Reg. 13089, effective October 6, 1999

32 Ill. Adm. Code 505.2400 Inspection Requirements

a) If, upon an external inspection, there is evidence of a leak or crack, enough of the covering of the non-ISI boiler or pressure vessel shall be removed so that the Authorized Inspector may determine the condition of the non-ISI boiler or pressure vessel. If removing the covering could create a situation which could affect the operability or safety of the vessel, the limitations of Section 505.20(c) of this Part shall apply.

b) Owners shall permanently maintain inspection reports and supporting documents throughout the lifetime of the equipment.

c) In addition to the requirements of this Section, owners shall meet the requirements of Section 505.140.

History

• Source: Amended at 45 Ill. Reg. 686, effective December 23, 2020

32 Ill. Adm. Code 505.2500 Repairs and Alterations

Repairs and alterations of non-ISI boilers and pressure vessels, and repairs of pressure relief valves associated with non-ISI boilers and pressure vessels, except boilers and pressure vessels and those pressure relief valves associated with boilers and pressure vessels that are exempt under Section 505.50(a), shall be made in accordance with this Section. The requirements of this Section are subject to the limitations of Section 505.20(c).

a) Non-ISI boilers and pressure vessels that are repaired or altered shall be repaired or altered in accordance with the National Board Inspection Code or this subsection (a). The requirements of this subsection (a) are limited to welded repairs and welded and non-welded alterations of non-ISI boilers and pressure vessels. When requirements for a repair or alteration are not given, it is intended that, subject to approval of the Authorized Inspector, details of design and construction, insofar as practical, will be consistent with the ASME Code for boilers and pressure vessels constructed to the ASME Code, or the code to which the item was originally constructed for boilers and pressure vessels not constructed to the ASME Code or the repair or alteration rules of the National Board Inspection Code.

1. All non-ISI boilers and pressure vessels covered by the Act that are repaired shall be repaired by one of the following organizations:

A) An owner and those organizations under contract to the owner, provided that:

i) the repairs are made in accordance with a Quality Assurance Program that meets the requirements of 10 CFR 50 Appendix B and has been approved by the NRC;

ii) all portions of the owner's 10 CFR 50 Appendix B Quality Assurance Program, referenced in subsection (a)(1)(A)(i), that are applicable to a repair activity are applied to the repair; and

iii) the owner notifies the Agency of its intention to apply 10 CFR 50 Appendix B Quality Assurance Program, referenced in subsection (a)(1)(A)(i), to the repair of boilers and pressure vessels. This notification only needs to be given once for all repairs of boilers and pressure vessels performed under the owner's 10 CFR 50 Appendix B Quality Assurance Program at the nuclear facility.

AGENCY NOTE: The application of the owner's 10 CFR 50 Appendix B Quality Assurance Program, referenced in subsections (a)(1)(A)(i), (ii) and (iii), is subject to review by the Authorized Inspector.

B) An organization in possession of a valid "R" Certificate of Authorization issued by the National Board.

C) An organization authorized by the Division of Boiler and Pressure Vessel Safety, Office of the State Fire Marshal, to repair boilers and pressure vessels.

2. Repairs shall be initiated only after they have been authorized by the Authorized Inspector who has reviewed and accepted the weld procedures, welders and welding operators' qualifications and repair methods. The Authorized Inspector may give prior approval for repairs of a routine nature. In every case the Authorized Inspector shall be advised of each repair under prior agreement.

3. All non-ISI boilers and pressure vessels covered by the Act that are altered shall be altered by one of the following organizations:

A) An owner and those organizations under contract to the owner, provided that:

i) the alterations are made in accordance with a Quality Assurance Program that meets the requirements of 10 CFR 50 Appendix B and has been approved by the NRC;

ii) all portions of the owner's 10 CFR 50 Appendix B Quality Assurance Program, referenced in subsection (a)(3)(A)(i), that are applicable to an alteration activity are applied to the alteration; and

iii) the owner notifies the Agency of its intention to apply 10 CFR 50 Appendix B Quality Assurance Program, referenced in subsection (a)(3)(A)(i), to the alteration of boilers and pressure vessels. This notification only needs to be given once for all alterations of boilers and pressure vessels performed under the owner's 10 CFR 50 Appendix B Quality Assurance Program at the nuclear facility.

AGENCY NOTE: The application of the owner's 10 CFR 50 Appendix B Quality Assurance Program, referenced in subsections (a)(3)(A)(i), (ii) and (iii), is subject to review by the Authorized Inspector.

B) An organization in possession of a valid "R" Certificate of Authorization issued by the National Board, provided the alterations are within the scope of that authorization.

4. Alterations shall be initiated only after they have been authorized by the Authorized Inspector who has reviewed and accepted the alteration methods and calculations. If considered necessary, the Authorized Inspector shall make an inspection of the object before granting authorization.

5. Reports documenting repairs and alterations shall be sent to the Agency in addition to the distribution required by the National Board Inspection Code.

6. Documentation of repairs and alterations shall be in accordance with the National Board Inspection Code, except that, in lieu of a form R-1 or R-2, an alternative form containing equivalent information may be used. All alternative forms shall be signed by the Authorized Inspector. All alternative forms shall be approved by the Agency prior to use. The Authorized Inspector shall determine whether the completion of the form R-1, R-2, or an alternative form is required for routine repairs.

7. Repairs and alterations shall be accepted by either an Authorized Inspector employed by the Authorized Inspection Agency responsible for the boiler or pressure vessel or by an Authorized Inspector employed by the Authorized Inspection Agency of record for the organization making the repair or alteration. It shall be the responsibility of the organization making the repair or alteration to coordinate the acceptance inspection of the repair or alteration.

8. For pressure parts, the rules of Part 3, Section 3 of the National Board Inspection Code shall apply.

9. Pressure Testing

A) The Authorized Inspector may require a pressure test after completing a repair to a boiler or pressure vessel when in the Authorized Inspector's judgment one should be conducted.

B) A pressure test in accordance with the National Board Inspection Code shall be applied to the boiler or pressure vessel on the completion of an alteration.

10. For repair methods, the rules of Part 3 of the National Board Inspection Code shall apply.

11. Alteration methods shall comply with the general requirements of this subsection (a), and with the appropriate ASME Code Section or Part 3 of the National Board Inspection Code, as applicable, including any service restrictions.

12. Major replacement of pressure parts, including drums and shells, that are fabricated by welding and for which a Manufacturers Data Report is required by the applicable ASME Code Section shall be fabricated by a manufacturer having an ASME Certificate of Authorization and the appropriate Certification Mark with appropriate designator. The item shall be inspected, stamped with the applicable Certification Mark with appropriate designator and the word "PART", and reported on the appropriate Manufacturers Partial Data Report.

13. When a repair or alteration requires removal of that part of a non-ISI boiler or pressure vessel containing the Code stamping, the Authorized Inspector shall, subject to the approval of the Agency, witness the making of a facsimile of the stamping, the obliteration of the old stamping and the transfer of the stamping to the new part. When the stamping is on a nameplate, the Authorized Inspector is to witness the transfer of the nameplate to the new part. The Certification Mark with appropriate designator is not to be restamped.

14. For rerating, the rules of this subsection (a) and Part 3 of the National Board Inspection Code shall apply. Additionally, the following shall apply:

A) All requirements in Part 3 of the National Board Inspection Code and this subsection (a) shall be met to the satisfaction of the Authorized Inspection Agency at the location of the installation.

B) Revised calculations verifying the new service conditions shall be required from the original manufacturer or, when the calculations cannot be obtained from this source, they may be prepared by an engineer in accordance with Part 3 of the National Board Inspection Code.

C) The boiler or pressure vessel shall be pressure tested for the rerated condition as required by subsection (a)(9)(B).

15. Nameplates and Stamping for Repair and Alteration

A) The rules of Part 3, Section 5 of the National Board Inspection Code shall apply. The exceptions and clarifications of this subsection (a)(15) shall also apply.

B) For owners that act as the repair organization under the provisions of subsection (a)(1)(A) for repairs or under subsection (a)(3)(A) for alterations who are not in possession of a valid "R" Certificate of Authorization issued by the National Board, the requirements for nameplates and stamping in Part 3, Section 5 of the National Board Inspection Code shall not apply. All other requirements shall be met.

b) Pressure relief valves associated with non-ISI boilers and pressure vessels shall be repaired in accordance with the National Board Inspection Code or with this subsection (b).

1. All pressure relief valves covered by this subsection (b) that are repaired shall be repaired by one of the following organizations:

A) An owner and those organizations under contract to the owner, provided that:

i) the repairs are made in accordance with a Quality Assurance Program that meets the requirements of 10 CFR 50 Appendix B and has been approved by the NRC;

ii) all portions of the owner's 10 CFR 50 Appendix B Quality Assurance Program, referenced in subsection (b)(1)(A)(i), that are applicable to a repair activity are applied to the repair; and

iii) the owner notifies the Agency of its intention to apply 10 CFR 50 Appendix B Quality Assurance Program, referenced in subsection (b)(1)(A)(i), to the repair of these pressure relief valves. This notification only needs to be given once for all repairs of pressure relief valves performed under the owner's 10 CFR 50 Appendix B Quality Assurance Program at the nuclear facility.

AGENCY NOTE: The application of the owner's 10 CFR 50 Appendix B Quality Assurance Program, referenced in subsections (b)(1)(A)(i), (ii) and (iii), is subject to review by the Authorized Inspector.

B) The manufacturer of the valve who is in possession of a valid ASME "V", "NV" or "UV" Certificate of Authorization, provided repairs are within the scope of the organization's Certificate of Authorization and are performed under the organization's Quality Control System or Quality Assurance System, as applicable.

C) An organization in possession of a valid "VR" Certificate of Authorization issued by the National Board, provided repairs are within the scope of the organization's Certificate of Authorization and are performed under the organization's Quality Control System.

D) An organization in possession of a valid Certificate of Authorization issued by the Division of Boiler and Pressure Vessel Safety, Office of the State Fire Marshal, to repair pressure relief valves provided repairs are within the scope of the organization's Certificate of Authorization and performed under the organization's accepted Quality Control System.

2. Repair of a pressure relief valve is considered to be the replacement or machining of any critical part, lapping of seat and disc or any other operation that may affect the flow passage, capacity, function or pressure retaining integrity. Disassembly and reassembly or adjustments that affect the pressure relief valve function are not considered a repair, but a test confirming the valve's set pressure shall be performed. The initial installation, testing and adjustments of a new pressure relief valve on a non-ISI boiler or pressure vessel are not considered a repair.

3. Nameplates and Stamping

A) The rules of Part 4, Section 4 of the National Board Inspection Code shall apply. The exceptions and clarifications of this subsection (b)(3) shall also apply.

B) Individuals authorized by the Division of Boiler and Pressure Vessel Safety, Office of the State Fire Marshal, who are properly trained and qualified employees of the owner may make adjustments to the set pressure provided the adjusted settings and the date of the adjustment are recorded on a metal tag secured to the seal wire. All external adjustments shall be resealed showing the identification of the organization making the adjustments.

C) For owners that act as the valve repair organization under the provisions of subsection (b)(1)(A) who are not in possession of a valid "VR" Certificate of Authorization issued by the National Board, the requirements for stamping and nameplates in Part 4, Section 4 of the National Board Inspection Code shall not apply. All other requirements shall be met.

4. Performance Testing

A) The rules of Part 4, Section 4 of the National Board Inspection Code shall apply, regardless of whether the "VR" stamp will be or has been applied. The exceptions and clarifications of this subsection (b)(4) shall also apply.

B) For owners that act as the valve repair organization under the provisions of subsection (b)(1)(A) who are not in possession of a valid "VR" Certificate of Authorization issued by the National Board, performance testing equipment qualified by the owner under Part 4, Section 4 of the National Board Inspection Code shall be done by the owner. The Authorized Inspector shall witness the qualification of test equipment and review the documentation of the qualification.

5. Organizations that repair pressure relief valves under subsections (b)(1)(B) through (b)(1)(D) may perform field repairs in accordance with the following requirements.

A) Qualified technicians in the employ of the repair organization perform the repairs.

B) Procedures that address field repairs are contained in the Quality Control System or Quality Assurance System, as applicable, and are maintained.

C) All functions affecting the quality of the repaired pressure relief valves are controlled from the location for which the appropriate authorization was issued.

D) Periodic audits of work carried out in the field are made by quality control personnel of the repair organization to ensure that the requirements of the Quality Control System or Quality Assurance System, as applicable, are met. This audit may include witnessing the test of the field repaired pressure relief valve.

History

• Source: Amended at 50 Ill. Reg. 3902, effective February 23, 2026

Chapter II Illinois Emergency Management Agency and Office of Homeland Security

Subchapter c Nuclear Facility Safety

Part 505 Safe Operation of Nuclear Facility Boilers and Pressure Vessels

32 Ill. Adm. Code 505.2600 Code Case Applications

a) The Agency shall act on requests to use ASME Code Cases within 30 days after their receipt. The Agency shall approve the use of a Code Case if that use is directly applicable to and consistent with the uses authorized by the ASME Code Case.

b) The Agency shall automatically approve the use of Code Cases to non-ISI boilers or pressure vessels in all cases in which the use is approved by the NRC and referenced in the nuclear facility's Updated or Final Safety Analysis Report, technical specifications or other licensing documents. The Agency shall not approve use of Code Cases when the use is disapproved by the NRC.

c) ASME Code Cases approved by the Agency for a particular situation rather than for generic use shall be used only for that situation.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

32 Ill. Adm. Code 505.2700 Use of Alternative Standards for Construction, Inspection and Repair

a) For all non-ISI boilers and pressure vessels, the Agency shall determine the acceptability of the alternative standards in accordance with this Section.

b) The Agency shall automatically accept alternative standards that have been accepted by the NRC and referenced in the nuclear facility's Updated or Final Safety Analysis Report, technical specifications or other licensing documents.

c) For boilers and pressure vessels, other than those covered by subsection (b), installed subsequent to February 7, 1994 to be constructed to alternative standards other than the ASME Code standards referenced in Section 505.40, the owner may request the Agency to issue a permit for the installation of a boiler or pressure vessel not constructed in accordance with the applicable ASME Code.

1. The owner shall submit the documentation described in this Section to the Agency and obtain a special installation permit.

2. The owner shall specify the reasons why the boiler or pressure vessel cannot be constructed in accordance with ASME Code standards. The owner shall also supply the following information to the Agency for review and consideration of requests for a special installation permit:

A) Full details of design and construction showing equivalency to and departures from the ASME Code, including blueprints and material showing details of the construction;

B) Data relating to the physical and chemical properties of all materials used in construction;

C) Calculations showing how the MAWP was derived;

D) An authentic test record for all non-ASME Code materials used in construction; and

E) Other data as the owner deems relevant or as the Agency may request in order to establish that the boiler or pressure vessel will be capable of operating as safely as one built to ASME Code standards.

3. The Agency may issue special installation permits to a class of boilers or pressure vessels meeting the criteria listed in subsection (c)(2) when it deems that the public interest would be best served by application of the class of boilers or pressure vessels rather than individual case-by-case determination.

4. The Agency may, as a condition to issuance of a special installation permit, require the installation of safety features or prescribed operating procedures for boilers or pressure vessels. The Agency will use relevant safety data in determining the need for installation of safety features or operating features.

5. If the Agency denies a request for a special permit, the owner may request a hearing pursuant to Section 505.84.

d) For boilers and pressure vessels, other than those covered by subsection (b), to be inspected to standards other than those specified in this Part, the owner shall request the use of alternative standards.

1. The owner shall submit the documentation described in this Section to the Agency and obtain permission to use the alternative standards.

2. The owner shall specify the reasons why the boiler or pressure vessel cannot be inspected in accordance with this Part.

3. The Agency may approve the use of alternative standards for inspection for a class of boilers or pressure vessels when it deems that the public interest would be best served by application of the class of boilers or pressure vessels rather than individual case-by-case determination.

4. The Agency may, as a condition of approval of the use of alternative standards for inspection, require the installation of safety features or prescribed operating procedures for boilers or pressure vessels. The Agency will use relevant safety data in determining the need for installation of safety features or operating features.

5. If the Agency denies a request for the use of alternative standards for inspection, the owner may request a hearing pursuant to Section 505.84.

e) For boilers and pressure vessels, other than those covered by subsection (b), to be repaired to standards other than those specified in this Part, the owner shall request the use of alternative standards.

1. The owner shall submit the documentation described in this Section to the Agency and obtain permission to use the alternative standards.

2. The owner shall specify the reasons why the boiler or pressure vessel cannot be repaired in accordance with this Part.

3. The Agency may approve the use of alternative standards for repair for a class of boilers or pressure vessels when it deems that the public interest would be best served by application of the alternative standards to the class of boilers or pressure vessels rather than individual case-by-case determination.

4. The Agency may, as a condition of approval of the use of alternative standards for repair, require the installation of safety features or prescribed operating procedures for boilers or pressure vessels, require monitoring the integrity of the alternative repair, or approve the alternative repair on a temporary basis. The Agency will use relevant safety data in determining the need for installing safety features or operating features, monitoring the integrity of the alternative repair, or approving the alternative repair on a temporary basis.

5. If the Agency denies a request for the use of alternative standards for repair, the owner may request a hearing pursuant to Section 505.84.

f) Owners shall meet the requirements of Section 505.170 in all cases involving use of alternative standards for non-ISI boilers or pressure vessels.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

32 Ill. Adm. Code 505.2800 Authorized Inspectors

In order to perform the duties of an Authorized Inspector for non-ISI boilers and pressure vessels at nuclear facilities within the State, an individual shall, in addition to the requirements of Section 505.180, possess either a current Inservice Commission (IS) issued by the National Board or a commission as an inspector of boilers and pressure vessels issued by OSFM.

History

• Source: Amended at 41 Ill. Reg. 645, effective January 4, 2017

32 Ill. Adm. Code 505.2900 Authorized Inspection Agencies

a) Authorized Inspection Agencies that are insuring a non-ISI boiler or pressure vessel shall immediately notify the Agency when the insurance is canceled, not renewed, suspended or otherwise made ineffective because of unsafe conditions.

b) Organizations seeking to provide inspection services to the requirements of the National Board Inspection Code or the ASME Code, except for Section III and Section XI, shall be subject to the requirements of Section 505.190.

c) The request for recognition submitted in Section 505.190(a) shall also contain documentation demonstrating that the organization meets the ASME Code or the National Board Inspection Code requirements for Authorized Inspection Agencies, if any, for the scope of inspection activities.

d) Organizations that are providing inspection services at nuclear facilities may be reviewed by the Agency. The reviews shall be for the purpose of verifying that the organization is in compliance with applicable ASME Code Sections or National Board Inspection Code, as applicable, including qualification and duty requirements for Authorized Inspection Agencies contained in those codes.

e) An organization that is recognized by the Agency under Section 505.190(b) as an Authorized Inspection Agency may be reviewed by the Agency either prior or subsequent to recognition. The reviews shall be for the purpose of verifying that the organization is in compliance with applicable ASME Code Sections or National Board Inspection Code, as applicable, including qualification and duty requirements for Authorized Inspection Agencies contained in those codes.

f) The Agency shall give 15 days written notice before any reviews are performed under this Section. Reviews shall be performed at the locations where control of Authorized Inspectors occurs or at the organization's home office.

History

• Source: Amended at 33 Ill. Reg. 4345, effective March 9, 2009

Subchapter b Radiation Protection

Part 601 Licensing Requirements for a Low-Level Radioactive Waste Disposal Facility

32 Ill. Adm. Code 601.10 Purpose and Scope

a) This Part establishes procedures, criteria, performance objectives, and terms and conditions upon which the Illinois Emergency Management Agency – Division of Nuclear Safety (Agency) issues licenses for a low-level radioactive waste disposal facility. Disposal of waste by an individual licensee is set forth in 32 Ill. Adm. Code 340. The requirements of this Part are in addition to, and not in substitution for, the requirements of 32 Ill. Adm. Code Chapter II, Subchapters b and d.

b) This Part does not apply to disposal of licensed material as provided for in 32 Ill. Adm. Code 340.

c) This Part is intended to reflect the best available management technologies which are economically reasonable, technologically feasible, and environmentally sound for the disposal of low-level radioactive waste, as required by Section 6 of the Illinois Low-Level Radioactive Waste Management Act [420 ILCS 20/6].

d) The use of shallow land burial of low-level radioactive waste at a disposal facility is prohibited.

32 Ill. Adm. Code 601.15 Incorporations by Reference

All rules, standards and guidelines of agencies of the United States or nationally recognized organizations or associations that are incorporated by reference in this Part are incorporated as of the date specified. All references to 10 CFR are incorporated as of July 1, 2009, unless otherwise specified in this Part, and do not include any later amendments or editions. Copies of rules, standards and guidelines that have been incorporated by reference are available for public inspection at the Illinois Emergency Management Agency – Division of Nuclear Safety, 1035 Outer Park Drive, Springfield, Illinois.

32 Ill. Adm. Code 601.20 Definitions

As used in this Part, the following definitions apply:

"Accepted engineering principles and practices" means those engineering principles and practices that are used by engineers when fulfilling their requirements and duties consistent with the specific requirements of this Part and as certified by a Professional Engineer licensed under the Professional Engineering Practice Act [225 ILCS 325].

"Active maintenance" means activity needed during the institutional control period to provide reasonable assurance that the performance objectives in Section 601.30 are met. Active maintenance includes ongoing activities such as the pumping and treatment of water from a disposal unit and one-time measures such as replacement of a disposal unit cover. Active maintenance does not include minor custodial care such as repair of fences, repair or replacement of monitoring equipment, revegetation, minor additions to soil cover, minor repair of disposal unit covers, and general disposal site upkeep such as mowing grass.

"As low as is reasonably achievable" or "ALARA" means making every reasonable effort to maintain exposures to radiation as far below the dose limits in 32 Ill. Adm. Code: Chapter II, Subchapters b and d 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 the state of technology, the economics of improvements in relation to benefits to the public health and safety and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest.

"Buffer zone" means a portion of the disposal site that is controlled by the licensee and that lies under the disposal units and between the disposal units and the boundary of the site.

"Chelating agent" means amine polycarboxylic acids, hydroxycarboxylic acids, glucinic acid and polycarboxylic acids.

"Commence construction" means any clearing of land, excavation or other substantial action that would adversely affect the environment of a disposal facility. The term does not mean disposal site exploration, necessary roads for disposal site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the disposal site or the protection of the environment.

"Disposal" means the isolation of waste from the biosphere in a permanent facility designed for that purpose [420 ILCS 20/3(f)].

"Disposal facility" or "facility" means a parcel of land, together with buildings, structures, equipment and improvements on or appurtenant to the land, that is used or is being developed for the disposal of low-level radioactive waste.

"Disposal site" means that portion of a disposal facility that is used for disposal of waste. It consists of disposal units and a buffer zone.

"Disposal unit" means a discrete portion of the disposal site into which waste is placed for disposal.

"Engineered barrier" means a man-made structure or device that is intended to improve the disposal facility's ability to meet the performance objectives in this Part.

"Inadvertent intruder" means a person who might occupy the disposal site after the institutional control period and engage in normal activities, such as agriculture, dwelling construction, or other pursuits in which an individual might be unknowingly exposed to radiation from the waste.

"Institutional control period" means the period of time after the termination of the license during which the State implements an institutional control program based upon the institutional control plan to protect public health and safety and the environment.

"Intruder barrier" means a sufficient depth of cover over the waste that inhibits contact with waste and helps to ensure that radiation exposures to an inadvertent intruder will meet the performance objectives set forth in this Part, or engineered structures that provide equivalent protection to the inadvertent intruder.

"Low-level radioactive waste" or "waste" means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel or byproduct material as defined in Section 11e(2) of the federal Atomic Energy Act of 1954 (42 USC 2014) [420 ILCS 20/3(k)].

"Monitoring" means observing and making measurements to provide data to evaluate the performance and characteristics of the disposal facility.

"Post-closure care" means the continued monitoring of the regional disposal facility after closure for the purposes of detecting a need for maintenance, ensuring environmental safety, and determining compliance with applicable licensure and regulatory requirements, and includes undertaking any remedial actions necessary to protect public health and the environment from radioactive releases from the facility [420 ILCS 20/3(n)].

"Release" means any spilling, leaking, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, dumping or disposing into the environment of low-level radioactive waste [420 ILCS 20/3(p)].

"Remedial action" means those actions taken in the event of a release or threatened release of low-level radioactive waste into the environment, to prevent or minimize the release of the waste so that it does not migrate to cause substantial danger to present or future public health or welfare or the environment. The term includes, but is not limited to, actions at the location of the release such as storage, confinement, perimeter protection using dikes, trenches or ditches, clay cover, neutralization, cleanup of released low-level radioactive wastes, recycling or reuse, dredging or excavations, repair or replacement of leaking containers, collection of leachate and runoff, provision of alternative water supplies and any monitoring reasonably required to assure that these actions protect human health and the environment. [420 ILCS 20/3(q)]

"Shallow land burial" means a land disposal facility in which radioactive waste is disposed of in or within the upper 30 meters of the earth's surface. However, this definition shall not include an enclosed, engineered, structurally re-enforced and solidified bunker that extends below the earth's surface. [420 ILCS 20/3(r)]

"Site closure and stabilization" means those actions that are taken upon completion of operations that prepare the disposal site for institutional control and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

32 Ill. Adm. Code 601.30 Performance Objectives

Disposal facilities shall be sited, designed, constructed, operated, closed and controlled after closure to provide reasonable assurance that:

a) Concentrations of radioactive material that may be released to the general environment in groundwater, surface water, air, soil, plants or animals do not result in an annual dose exceeding an equivalent of 0.25 mSv (25 mrem) to the whole body, 0.75 mSv (75 mrem) to the thyroid, and 0.25 mSv (25 mrem) to any other organ of any member of the public. The licensee shall assume initiatives necessary to maintain releases of radioactivity in effluents to the general environment as low as is reasonably achievable.

b) Operations at the disposal facility are conducted in compliance with the standards for radiation protection set out in 32 Ill. Adm. Code 340, except for releases of radioactivity in effluents from the disposal facility, which shall be governed by subsection (a). The licensee shall assume initiatives necessary to maintain radiation exposures as low as is reasonably achievable.

c) The disposal facility protects any individual inadvertently intruding into the disposal site and occupying the site at any time after the institutional control period.

d) Following closure, the disposal site achieves long-term stability and eliminates, to the extent practicable, the need for active maintenance.

32 Ill. Adm. Code 601.40 License Required

a) Each applicant shall file an application with the Agency pursuant to 32 Ill. Adm. Code 330.240 and obtain a license as provided in this Part before commencing construction of a disposal facility.

b) Prior to submitting a license application, the applicant shall have conducted a monitoring program to obtain basic environmental data on the site characteristics. The applicant shall obtain information about the ecology, meteorology, climate, hydrology, geology, geochemistry and seismology of the disposal site. For those characteristics that are subject to seasonal variation, data must cover at least a 12 month period. The monitoring program shall be conducted under a quality assurance program.

c) No person may receive, possess and dispose of waste at a disposal facility unless authorized by a license issued by the Agency pursuant to this Part and 32 Ill. Adm. Code 330.

32 Ill. Adm. Code 601.50 Content of an Application

An application for a license to commence construction of, or to operate, a disposal facility shall be filed in accordance with 32 Ill. Adm. Code 330.240. Each application shall meet the general requirements set forth in 32 Ill. Adm. Code 330.250 and the additional general, technical, institutional and financial requirements specified in this Part. General information to be included in an application is described in Subpart A. Information specific to design, construction and operation is described in Subpart B. Information regarding site closure and license termination is described in Subpart C.

32 Ill. Adm. Code 601.60 Application Information - General

The license application shall include, but not be limited to, the following information:

a) Identity of the applicant, including:

1. If the applicant is a partnership, the name and address of each partner and the principal location where the partnership does business;

2. If the applicant is a corporation or an unincorporated association:

A) the state where it is incorporated or organized and the principal location where it does business; and

B) the names and addresses of its directors and principal officers;

3. If the applicant is a limited liability company:

A) the state where it is organized and the principal location where it does business; and

B) the names and addresses of its members and managers;

b) The organizational structure of the applicant, both offsite and onsite, including a description of lines of authority and assignments of responsibilities, whether in the form of administrative directives, contract provisions, or otherwise;

c) A description of the applicant's quality assurance program;

d) The technical qualifications and experience of the applicant;

e) The technical qualifications, including training and experience, of personnel;

f) A description of the applicant's personnel training program;

g) A description of:

1. The location of the proposed disposal site;

2. The general character of the proposed handling, storage, treatment and disposal activities;

3. The wastes to be received, possessed and disposed of, including, but not limited to, a description of the waste types, classifications and physical forms; the types, volumes and quantities of containers; an identification and estimate of the radionuclides contained in the various waste types, including concentration and total activity; and identification of stabilization media and chelating agents;

4. Plans for use of the disposal facility for purposes other than disposal of radioactive wastes; and

5. The proposed facilities and equipment;

h) Proposed schedules for construction, receipt of waste, and first emplacement of waste at the proposed disposal facility.

32 Ill. Adm. Code 601.70 Application Information – Land Ownership

a) Identity of Owner. Disposal of radioactive waste in a facility licensed under this Part may be permitted only on land owned in fee simple absolute by the State.

b) Where the proposed disposal site is on land not owned by the State, the applicant shall submit evidence that arrangements have been made for assumption of ownership in fee simple absolute by the State before the Agency issues a license.

32 Ill. Adm. Code 601.80 Application Information – Financial

The applicant shall demonstrate that it either possesses the necessary funds, or has reasonable assurance of obtaining the necessary funds, to cover the estimated costs of conducting all activities over the planned operating life of the project, including costs of construction, operation, closure, post-closure and institutional control.

a) Operation. The applicant shall post a performance bond with the Department or show evidence of liability insurance or other means of establishing financial responsibility in an amount sufficient to adequately provide for any necessary remedial actions or liabilities that might be incurred by the operation of the disposal facility during the operating period and during a reasonable period of post-closure care [420 ILCS 20/6(b)].

AGENCY NOTE: This may include costs associated with failure of the operator or failure to fulfill terms of the contract and costs associated with transferring operation and ownership. The italicized text is a direct quotation from the Illinois Low-Level Radioactive Waste Management Act, which has not been updated to reflect Illinois Executive Order 2003-12, effective July 1, 2003, which transferred the responsibilities of the Illinois Department of Nuclear Safety to the Agency. In this case, the Department means the Illinois Emergency Management Agency.

b) Closure and Post-Closure.

1. In addition to complying with the requirements of 32 Ill. Adm. Code 326, the applicant shall provide assurances that sufficient funds will be available to carry out disposal facility closure and post-closure. These assurances shall be based on Agency-approved cost estimates reflecting the Agency-approved plan for disposal facility closure and post-closure. The applicant's cost estimates must take into account total costs that would be incurred if an independent contractor were hired to perform the closure and post-closure work. The assurances shall establish that there will be sufficient funds for:

A) Decontamination or dismantlement of disposal facility structures; and

B) Closure and post-closure of the disposal facility so that, following termination of the license and transfer of custody of the disposal site to the State, the need for active maintenance is eliminated to the extent possible.

2. Liability under the financial assurance mechanism shall remain in effect until the license has been terminated.

c) Institutional Control Period Funding.

1. Prior to the issuance of the license, the applicant shall provide for Agency approval a copy of a binding arrangement, such as a lease or contract, between the applicant and the State that ensures that sufficient funds will be collected and available to cover the costs of monitoring and projected maintenance during the institutional control period.

2. The binding arrangement will be reviewed periodically by the Agency to ensure that changes in inflation, technology and disposal facility operations are reflected in the arrangements. Subsequent changes to the binding arrangement shall be submitted to the Agency for approval.

32 Ill. Adm. Code 601.90 Application Information – Closure, Post-Closure and Institutional Control Plans

a) Closure Plan. The application for a facility license shall contain a closure plan, which shall be consistent with the performance objectives of this Part, and shall include, but need not be limited to, the following:

1. A procedure for disposal of all waste and contaminated equipment remaining at the facility at the time of closure, removal of structures and equipment, and installation of permanent monuments or markers warning against intrusion;

2. An estimate of the funds needed to close the facility and provisions for assuring the availability of those funds;

3. A description of how the facility closure will satisfy the performance objectives of this Part;

4. A description of the permissible uses of the facility and buffer zone following closure; and

5. A description of the monitoring systems to be implemented during the closure, post-closure and institutional control periods.

b) Post-Closure Plan. The application for a facility license must contain a post-closure plan under which the licensee will observe, monitor and carry out necessary maintenance and repairs at the disposal facility for a period of 10 years after facility closure. The plan shall be consistent with the performance objectives of this Part and shall include, but need not be limited to:

1. A procedure for evaluating the performance of both engineered and natural barriers to radionuclide release or migration at the disposal site;

2. A procedure for monitoring the air, soil, surface water and groundwater at the disposal site;

3. A procedure for confirming that the disposal site will meet the long term performance objectives and requirements of this Part;

4. A procedure for identifying potential failure to meet the performance objectives or requirements of this Part;

5. A procedure for correcting any condition that would result in failure to meet the performance objectives of this Part; and

6. An estimate of the funds needed to implement the plan and provisions for assuring the availability of those funds.

c) Institutional Control Plan. The application must contain an institutional control plan for the long term care, maintenance and monitoring of the disposal site. The plan shall describe the activities to be taken by the site owner following the 10 year post-closure period, as described in subsection (b), and after transfer of title and custody and termination of the facility license. The plan shall be consistent with the performance objectives of this Part and shall include, but need not be limited to, the following:

1. A procedure for monitoring the air, soil, surface and groundwater at the disposal site; and

2. An estimate of the costs necessary to carry out the institutional control plan for a period of 300 years and provisions for assuring the availability of those funds.

32 Ill. Adm. Code 601.100 Application Information – Technical

The license application shall include, but not be limited to, the following technical information:

a) A description of the natural and demographic disposal site characteristics as determined by disposal site selection and characterization activities. The description shall include geologic, geotechnical, hydrologic, meteorologic, climatologic and biotic features of the disposal site and vicinity.

b) A description of the pre-operational monitoring program and the associated quality assurance plan, and results of the pre-operational monitoring program specified in Section 601.40(b).

c) An environmental report required by 32 Ill. Adm. Code 330.250(b).

d) A description of the design basis natural events or phenomena and their relationship to the principal design criteria.

e) A description of the principal design criteria and their relationship to the performance objectives described in Section 601.30.

f) A description of the design features of the disposal facility and the disposal units. The description shall include design features related to infiltration of water; integrity of covers for disposal units; structural stability of filling material, wastes and covers; contact of wastes with standing water; disposal site drainage; disposal site closure and stabilization; elimination, to the extent possible, of long-term disposal site maintenance; inadvertent intrusion; occupational exposures; disposal site monitoring; and adequacy of the size of the buffer zone for monitoring and potential mitigative measures.

g) Analyses of pathways evaluated in demonstrating protection of the general population from releases of radioactivity shall include air, soil, groundwater, surface water, plant uptake and exhumation by burrowing animals. The analyses shall clearly identify and differentiate between the roles performed by the natural disposal site characteristics and design features in isolating and segregating the wastes. The analyses must clearly demonstrate that there is reasonable assurance that the exposures to humans from the release of radioactivity will not exceed the limits set forth in Section 601.30(a).

h) A description of the environmental monitoring program required by Section 601.240 to be followed during construction, operation, closure and post-closure that includes, but is not limited to, the frequency, type and method of analysis to provide data to evaluate potential health and environmental impacts, and the plan for taking corrective measures if migration of radionuclides is indicated.

i) A description of codes and standards that the applicant has applied to the design and that will apply to construction of the disposal facilities. The standards shall meet local, State and national building code standards.

j) A description of the construction and general operation of the disposal facility. The description shall include, as a minimum, the methods of construction of disposal units, waste emplacement, the procedures for and areas of waste segregation, types of intruder barriers, onsite traffic and drainage systems, survey control program, methods and areas of waste storage, and methods to control surface water and groundwater access to the wastes. The description shall also include a description of the methods to be employed in the handling and disposal of wastes containing chelating agents or other nonradiological substances that might affect meeting the performance objectives of this Part.

k) A description of the quality assurance program applied during the determination of natural disposal site characteristics and during the design, construction and operation of the disposal facility.

l) Analyses of the long-term stability of the disposal site and the need for active maintenance after closure shall be based upon analyses of active natural processes such as erosion, seismic activity, mass wasting, slope failure, settlement of wastes and backfill, infiltration through covers over disposal areas and adjacent soils, and surface drainage of the disposal site. The analyses must provide reasonable assurance that there will not be a need for active maintenance of the disposal site following closure.

m) An identification of the known natural resources at the disposal site whose exploitation could result in inadvertent intrusion into the low-level radioactive wastes.

n) A description of the radiation safety program for control and monitoring of radioactive effluents to ensure compliance with this Part and for occupational radiation exposure to ensure compliance with the requirements of 32 Ill. Adm. Code 340 and to control contamination. Both routine operations and accidents shall be addressed. The program description shall include procedures, instrumentation, facilities and equipment.

o) Analyses of the protection of individuals during operations, including assessments of expected exposures due to routine operations and potential accidents during handling, storage, treatment and disposal of waste. The analyses must provide reasonable assurance that exposures will be controlled to meet the requirements of 32 Ill. Adm. Code 340.

p) A description of the administrative and operating procedures that the applicant will apply to control activities at the facility.

q) A description of the contingency plan required by Section 601.260.

r) A description of the electronic recordkeeping system required in Section 601.140.

32 Ill. Adm. Code 601.110 Issuance of a License

The Agency shall review license applications filed in accordance with Section 601.50. If the Department determines that the license should be issued, the Department shall publish in the State newspaper a notice of intent to issue the license. Objections to issuance of the license may be filed within 90 days after publication of the notice. Upon receipt of objections, the Director shall appoint a hearing officer who shall conduct an adjudicatory hearing on the objections. The burden of proof at the hearing shall be on the person filing the objections. Upon completion of the hearing, the hearing officer shall recommend to the Director whether the license should be issued. The decision of the Director to issue or deny the license may be appealed under Section 18 of the Illinois Low-Level Radioactive Waste Management Act [420 ILCS 20/10.3(c)].

AGENCY NOTE: The italicized text is a direct quotation from the Illinois Low-Level Radioactive Waste Management Act, which has not been updated to reflect Illinois Executive Order 2003-12, effective July 1, 2003. In this case, the Department means the Illinois Emergency Management Agency.

32 Ill. Adm. Code 601.120 Conditions of Licenses

a) A license issued under this Part, or any right under that license, may not be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, unless the Agency finds, after securing full information, that the transfer is in accordance with the provisions of the Radiation Protection Act of 1990 [420 ILCS 40], the Illinois Low-Level Radioactive Waste Management Act [420 ILCS 20] and this Part and gives its consent in writing in the form of a license amendment.

b) The licensee shall not receive waste until the licensee has received written notification from the Agency that the Agency has inspected the disposal facility and has found it to be in conformance with the description, design and construction described in the application for a license.

c) Failure to renew the license shall not relieve the licensee of responsibility for carrying out site closure and post-closure, and obtaining a license amendment terminating the license.

d) The terms and conditions of the license are subject to amendment, revision or modification, by reason of amendments to, or by reason of rules, regulations and orders issued in accordance with, the terms of the Radiation Protection Act of 1990 and the Illinois Low-Level Radioactive Waste Management Act.

e) The Agency shall, upon request or on its own initiative, authorize provisions other than those set forth in this Part for the classification and characteristics of waste, disposal of waste, or design and operation of a disposal facility on a specific basis only if the Agency establishes that performance objectives of this Part will be met.

32 Ill. Adm. Code 601.130 Application for Renewal

a) An application for renewal must be filed at least 90 days prior to license expiration. Applications for renewal of a license must be filed in accordance with 32 Ill. Adm. Code 330.240 and this Part.

b) In any case in which a licensee has filed an application in proper form for renewal of a license, the license does not expire until the Agency has taken final action on the application for renewal.

32 Ill. Adm. Code 601.140 Recordkeeping Requirements

a) The licensee shall maintain any records and make any reports in connection with the licensed activities as are required by the conditions of the license, this Part or 32 Ill. Adm. Code 340.

b) Records required by this Part or by license conditions shall be maintained until the termination of the license or as specified by a license condition. If a retention period is not otherwise specified, these records shall be maintained and transferred to the officials specified in subsection (e) as a condition of license termination, unless the Agency authorizes their disposition because of inaccuracies or obsolescence.

c) Records that must be maintained pursuant to this Part may be the original or a reproduced copy or microfilm if the reproduced copy or microfilm is capable of producing a copy that is clear and legible at the end of the required retention period. Records may also be stored in electronic media with the capability for reproducing legible, accurate and complete records during the required retention period. Records such as letters, drawings or specifications shall include all pertinent information such as stamps, initials and signatures. The licensee shall maintain safeguards against tampering with and loss of records.

AGENCY NOTE: Safeguards may include such actions as storing a duplicate copy in an offsite location and maintaining suitable software for viewing computer images.

d) If there is a conflict between this Part and other Agency Parts or a license condition pertaining to the retention period for the same type of record, the longest retention period specified takes precedence.

e) Following receipt and acceptance of a shipment of radioactive waste, the licensee shall:

1. Record the date that the shipment is received at the low-level radioactive waste disposal facility, the date of disposal of the waste, a traceable shipment manifest number, a description of any engineered barrier or structural overpack provided for disposal of the waste, the location of disposal at the disposal site, the containment integrity of the waste disposal containers received, any discrepancies between materials listed on the manifest and those received, the volume of any pallets, bracing or other shipping or onsite generated materials that are contaminated and are disposed of as contaminated or suspect materials, and any evidence of leaking or damaged disposal containers or radiation or contamination levels in excess of limits specified in regulations of the U.S. Department of Transportation and the Agency (see 32 Ill. Adm. Code 341);

2. Describe any repackaging operations of any of the disposal containers included in the shipment, plus any other information required by the Agency as a license condition.

f) The licensee shall store, or have stored, manifest and other information pertaining to receipt and disposal of radioactive waste in an electronic recordkeeping system that includes:

1. Information required under 32 Ill. Adm. Code 340.1060, with the exception of shipper and carrier telephone numbers and shipper and consignee certifications; and

2. Information required under subsection (e).

g) Notwithstanding subsections (a) through (f), copies of records of the location and the quantity of radioactive wastes contained in the disposal site shall be transferred to the Agency, or other agency designated by the Agency, at the time of license termination.

32 Ill. Adm. Code 601.200 Disposal Site Suitability Requirements

The following minimum characteristics shall be used in determining a site acceptable for disposal of low-level radioactive waste:

a) The primary emphasis in disposal site suitability is isolation of waste and disposal site features that ensure that the long-term performance objectives are met.

b) The disposal site shall be capable of being characterized, modeled, analyzed and monitored.

c) Within the region where the facility is to be located, a disposal site shall be selected so that projected population growth and future developments are not likely to affect the ability of the disposal facility to meet the performance objectives of this Part.

d) Areas shall be avoided having known natural resources that, if exploited, would result in failure to meet the performance objectives of this Part.

e) The disposal site shall be generally well drained and free of areas of standing water or flooding or frequent ponding. Waste disposal shall not take place in a regulatory flood plain, as provided in the rules of the Illinois Department of Natural Resources (see 17 Ill. Adm. Code 3706).

f) Upstream drainage areas shall be minimized to decrease the amount of runoff that could erode or inundate waste disposal units.

g) The disposal site shall provide sufficient depth to the water table that groundwater intrusion, perennial or otherwise, into the waste will not occur.

h) Areas shall be avoided where tectonic processes such as faulting, folding, seismic activity or vulcanism occur with such frequency and to such an extent that they would affect the ability of the disposal site to meet the performance objectives of this Part or would preclude defensible modeling and prediction of long-term impacts.

i) Areas shall be avoided where surface geologic processes such as mass wasting, erosion, slumping, landsliding or weathering occur with such frequency and to such an extent that they would affect the ability of the disposal site to meet the performance objectives of this Part, or would preclude defensible modeling and prediction of long-term impacts.

j) The disposal site must not be located where nearby facilities or activities could adversely impact the ability of the site to meet the performance objectives of this Part or significantly mask the environmental monitoring program.

32 Ill. Adm. Code 601.210 Disposal Facility Design and Construction

The disposal facility shall be designed and constructed, based on accepted engineering principles and practices, to further the following:

a) The design and construction of the disposal facility shall utilize the best available technology that is economically reasonable, technologically feasible and environmentally sound for the receipt, handling and disposal of waste.

b) The design of the disposal facility shall be compatible with the expected waste characteristics, methods of operation and proposed methods of handling, closure and stabilization and shall demonstrate that the requirements of this Part will be met.

c) Buildings shall be designed, constructed and maintained in accordance with all applicable codes and standards. In the event that two or more building codes or standards conflict or apply, the most stringent shall be met.

d) The disposal facility shall be designed to minimize, to the extent practicable, the contact of water with waste following receipt and prior to disposal.

32 Ill. Adm. Code 601.220 Disposal Site Design and Construction

The disposal site shall be designed and constructed, based on accepted engineering principles and practices, to further the following:

a) Site design features shall be directed toward long-term isolation and avoidance of the need for continuing active maintenance after site closure.

b) Site design and operation shall be compatible with the closure and post-closure plans and lead to disposal site closure that provides reasonable assurance that the performance objectives will be met.

c) The disposal site shall be designed to complement and improve, where appropriate, the ability of the disposal site's natural characteristics to assure that the performance objectives will be met.

d) Surface features shall direct surface water drainage away from disposal units at velocities and gradients that will not result in erosion that will require active maintenance in the future.

e) The site design shall allow closure in a manner that isolates the wastes and waste constituents and that requires only minor custodial care to assure long-term performance.

f) The site shall be designed and constructed to allow remedial action, if necessary. Achievement of this objective shall not be accomplished by compromising, or in any way lessening, the ability of the site to satisfy the performance objectives and requirements of this Part.

g) The site shall be designed to accept waste for disposal for a period of at least 50 years. The site shall be designed to accommodate waste generated during the decommissioning of nuclear power stations in Illinois.

32 Ill. Adm. Code 601.230 Disposal Unit Design and Construction

a) Disposal units shall be designed and constructed, based on accepted engineering principles and practices, to:

1. Minimize, to the extent practicable, the contact of standing water with waste during disposal and the contact of percolating or standing water with wastes after disposal.

2. Be compatible with the expected waste characteristics, methods of operation, and proposed methods of closure and stabilization.

3. Withstand all natural phenomena, such as precipitation, earthquakes and tornadoes, that are expected to occur for 500 years.

4. Incorporate multiple engineered safety features, such as, but not limited to, placing a cover over disposal units, using backfill that adds structural strength and reinforcing units with manufactured materials that provide structural support, prevent the release of waste and waste constituents and prevent inadvertent intrusion.

5. Incorporate design elements that will allow operation of the units in such a manner that the amount of waste on site that is not yet permanently disposed of, as well as the time that waste is held on site prior to disposal, will be minimized.

6. Accommodate waste that cannot be packaged in standard containers, e.g., reactor components, contaminated steel.

7. Maintain their structural integrity regardless of the physical form of the waste.

8. Allow characterization, modeling, analysis and evaluation of the unit's ability to contain waste.

b) Disposal unit covers shall be designed to minimize water infiltration to the extent practicable, to direct percolating or surface water away from the disposed waste, and to resist degradation by surface geologic processes and biotic activity.

c) Disposal unit design shall not incorporate the use of shallow land burial or underground injection wells and shall provide for the use of above-ground units or other designs to provide greater and safer confinement of low-level radioactive waste.

d) Disposal units made of manufactured materials shall be designed and constructed, using accepted engineering principles and practices, to ensure that the tensile stress in the manufactured materials never exceeds the level that will cause the materials to fail.

e) Disposal units shall be constructed of materials that will not interact with each other, any surrounding earth, backfill, cover material or base grade material in such a manner as to compromise the ability of the materials to perform their intended function.

f) If intruder barriers are required by Section 601.250(b), disposal units shall be designed and constructed with intruder barriers designed to last at least 500 years.

32 Ill. Adm. Code 601.240 Environmental Monitoring

a) During construction, operation, closure and post-closure, the licensee shall maintain an environmental monitoring program. Measurements and observations shall be made and recorded to provide data to evaluate the potential health and environmental impacts during the construction and operation of the facility and to enable the evaluation of long-term effects and the need for mitigative measures. The monitoring system shall be capable of providing early warning of releases of radionuclides from the disposal unit before they leave the site boundary.

b) The licensee shall have plans for taking corrective measures if the environmental monitoring program detects migration of radionuclides, which would indicate that the performance objectives may not be met.

32 Ill. Adm. Code 601.250 Technical Requirements - Facility Operation

a) Wastes designated as Class A pursuant to 32 Ill. Adm. Code 340.1052(b) shall be segregated from other wastes by placement in disposal units that are sufficiently separated from disposal units for the other waste classes so that any interaction between Class A wastes and other wastes will not result in failure to meet the performance objectives of this Part. This segregation is not necessary for Class A wastes if they meet the stability requirements in 32 Ill. Adm. Code 340.1055(b).

b) Wastes designated as Class C pursuant to 32 Ill. Adm. Code 340.1052(b) shall be disposed of so that the waste is protected by a barrier of a minimum of 5 meters between the top of the Class C waste and the top surface of the cover, or with intruder barriers that are designed to protect against an inadvertent intrusion for at least 500 years.

c) Except as allowed by the Agency in Section 601.120(e), only waste classified as Class A, B or C shall be acceptable for disposal.

d) Wastes shall be emplaced in a manner that maintains the package integrity during emplacement and minimizes the void spaces between packages to ensure structural stability.

e) The boundaries and locations of each disposal unit shall be accurately located and mapped by means of a land survey. Disposal units shall be marked in such a way that the boundaries of each unit can be easily defined. Three permanent survey marker control points, referenced to United States Geological Survey (USGS) or National Geodetic Survey (NGS) survey control stations, shall be established on the site to facilitate surveys. The USGS or NGS control stations shall provide horizontal and vertical controls as checked against USGS or NGS record files.

f) A buffer zone of land shall be maintained between disposed waste and the disposal site boundary. The buffer zone shall be of adequate dimensions to carry out environmental monitoring activities and take mitigative measures if needed.

g) Closure and stabilization measures set forth in the approved site closure plan shall be carried out as each disposal unit is filled and enclosed.

h) Active waste disposal operations shall not have an adverse effect on completed closure and stabilization measures.

i) Only wastes containing or contaminated with radioactive materials shall be disposed of at the disposal site.

32 Ill. Adm. Code 601.260 Contingency Plan and Emergency Procedures

a) The licensee shall develop and implement a contingency plan for responding to risks to human health and the environment from fires, explosions or any unplanned release, sudden or gradual, of waste or waste constituents to air, soil, surface water and groundwater. The plan shall address response actions to be taken in the event there is a temporary inability to dispose of wastes at the facility (e.g., because the facility has been closed temporarily) or the facility is permanently closed.

b) Notwithstanding the requirements of 32 Ill. Adm. Code 330.250(e)(2), the licensee shall meet all contingency plan requirements specified in 32 Ill. Adm. Code 330.290, in addition to other additional requirements specified in this Section.

c) The provisions of the contingency plan shall be carried out immediately whenever there is a fire, explosion, release of waste or waste constituents to the environment, or an unscheduled closure of the facility, either temporary or permanent.

d) The plan shall contain provisions for conducting on-site drills prior to initial receipt of waste for disposal.

32 Ill. Adm. Code 601.270 Reporting Requirements

a) Unmanifested Waste Report. The licensee shall notify the Agency immediately of any waste received at the facility that is unaccompanied by a proper manifest.

b) Accident Report. The licensee shall provide a written report to the Agency within 7 days after any event resulting in either a release of radioactive material from a disposal unit or a radiation dose to any person outside the facility in excess of the limits specified in Section 601.30 for releases and 32 Ill. Adm. Code 340.310 for exposures. The report shall include:

1. A description of the events causing the releases or exposures;

2. A description of the release, resulting exposures and impacts;

3. A description of the remedial action taken; and

4. A description of actions that will be taken to prevent such events from occurring in the future.

c) Annual Report. By the end of the first calendar quarter of each year, the licensee shall submit an annual report to the Agency summarizing facility operations for the preceding year. A copy of the report shall be available for public inspection. This report shall contain, but need not be limited to, the following:

1. A summary of the sources, volumes, Curie content and types of low-level radioactive waste received at the facility in the previous year and an inventory of the total volume and Curie content of wastes disposed of at the facility since it commenced operation;

2. Specification of the quantity of each of the principal radionuclides released to unrestricted areas in liquid and in airborne effluents during the preceding year;

3. A description of any incidents or accidents in which radioactive materials were released, or occupational exposures in excess of the limits set by 32 Ill. Adm. Code 340 occurred;

4. A description of the environmental and personnel monitoring programs and the results of those programs;

5. The results of the testing and evaluation of disposal unit design and construction, and recommendations;

6. A description of the status and adequacy of plans for closure and post-closure of the facility, specifying and considering information learned as a result of the testing and monitoring program and other facility operations during the previous year; and

7. An accounting of the fees collected by the facility operator for deposit by the Agency into the Low-Level Radioactive Waste Facility Closure, Post-Closure Care and Compensation Fund established by 420 ILCS 20/14. The accounting shall be performed using generally accepted accounting principles.

32 Ill. Adm. Code 601.280 Tests at Waste Disposal Facilities

The licensee shall perform, or permit the Agency to perform, any tests the Agency deems appropriate or necessary for the administration of the requirements in this Part, including, but not limited to, tests of:

a) Wastes and facilities used for the receipt, storage, treatment, handling and disposal of radioactive wastes;

b) Radiation detection and monitoring instruments; and

c) Other equipment and devices used in connection with the receipt, possession, handling, treatment, storage or disposal of waste.

32 Ill. Adm. Code 601.300 Closure Application

a) An application to amend the license for closure shall include a final revision and specific details of the disposal facility final closure plan that had been included as part of the license application submitted under Section 601.90. The application shall include, but not be limited to, the following:

1. Any additional geologic, hydrologic or other data pertinent to the long-term containment of emplaced wastes obtained during the operational period.

2. The results of tests, experiments or any other analyses relating to filling material or excavated areas, closure and sealing, waste migration and interaction with emplacement media, or any other tests, experiments or analysis pertinent to the long-term containment of emplaced waste within the disposal site.

3. Any proposed revision of plans for:

A) Decontamination and/or dismantlement of buildings, structures, equipments and improvements;

B) Backfilling of excavated areas; or

C) Site closure and stabilization.

4. Any new information regarding the environmental impact of closure activities and long-term performance of the disposal site.

b) Upon review and consideration of an application to amend the license for closure, the Agency shall issue an amendment authorizing closure if the licensee provides reasonable assurance that the long-term performance objectives of this Part will be met.

32 Ill. Adm. Code 601.310 Closure – Technical Requirements

a) The licensee shall close the facility at the end of its operating lifetime.

b) Not more than 2 years nor less than one year prior to anticipated facility closure, the licensee shall submit an application to the Agency in accordance with Section 601.300(a) for a license amendment to close the facility.

c) Upon granting of the license amendment, the licensee shall close the facility in accordance with the closure plan and the license conditions imposed.

d) Within 6 months after completing facility closure, the licensee shall certify in writing to the Agency that the facility has been closed in accordance with the requirements of this Part.

32 Ill. Adm. Code 601.320 Emergency Closure

a) Upon finding that immediate closure of the facility is necessary to avoid an imminent threat to the public health or safety or to the environment, the Director of the Agency shall issue an emergency closure order to the licensee. An emergency closure order may be issued by the Director in the event of either:

1. A finding of non-compliance with any applicable regulation of the Agency or provision of the license, if the non-compliance is determined by the Director to pose a risk of a release of radioactive material beyond the site boundary in excess of any applicable limit imposed by 32 Ill. Adm. Code 340; or

2. A finding that continued operation of the facility represents a significant and immediate threat to the public health or safety, as evidenced by a violation of any provision of the Radiation Protection Act of 1990, the Low-Level Radioactive Waste Management Act or any rule, regulation or order promulgated under these Acts, and that requires immediate action to protect the public welfare.

b) Upon receipt of a written order requiring immediate closure, the licensee shall immediately take the following actions:

1. Implement the contingency plan required by Section 601.260;

2. Notify all persons holding a site use permit or similar evidence of permission to use the facility; and

3. Notify the Central Midwest Interstate Low-Level Radioactive Waste Commission.

32 Ill. Adm. Code 601.330 Post-Closure Observation and Maintenance

The licensee shall observe, monitor, carry out maintenance and repairs, and maintain security at the disposal site for a minimum period of 10 years following site closure and until the license is terminated by the Agency. The licensee shall maintain a monitoring system based on past monitoring performance and the closure and stabilization of the disposal site. The monitoring system must be capable of providing early warning of releases of radionuclides from disposal units before they leave the site boundary. A longer time period for post-closure observation and maintenance may be required as part of the site closure plan, based upon site-specific conditions.

32 Ill. Adm. Code 601.340 Termination of License and Site Transfer

a) Following the period of post-closure care specified in Section 601.330, the licensee shall submit a report to the Agency regarding the projected long term performance of the disposal site and shall apply for an amendment to terminate the license and transfer the title and custody of the facility to the State.

b) This application will be reviewed in accordance with the provisions of this Part and 32 Ill. Adm. Code 330.

c) A license will be terminated only if the Agency finds that:

1. The requirements of 32 Ill. Adm. Code 330 and this Part have been met;

2. The closure of the disposal facility has been made in conformance with the licensee's closure plan, as amended and approved as part of the license;

3. The performance objectives of this Part are met;

4. Any additional requirements resulting from new information developed during the post-closure period have been met and permanent monuments or markers warning against intrusion have been installed;

5. The licensee has met all contractual requirements;

6. Facility records and any funds held by the licensee for the institutional control plan have been transferred to the State;

7. The post-closure monitoring program is operational for implementation by the State agency that will assume responsibility for institutional control of the disposal site; and

8. The State agency that will assume responsibility for institutional control of the disposal site is prepared to assume responsibility and ensure that the institutional control requirements found necessary under Section 601.90 will be met.

AGENCY NOTE: The State will implement the institutional control plan, that will physically control access to the disposal site following transfer of control of the disposal site from the licensee and termination of the license. The institutional control program shall include, but not be limited to, carrying out an environmental monitoring program at the disposal site, periodic surveillance, minor custodial care, other requirements as determined by the State, and administration of funds to cover the costs for these activities. Under 10 CFR 61.59, controls may not be relied upon for more than 100 years following transfer of control of the disposal site by the licensee. It is the Agency's intention that controls will remain as long as they are necessary to protect the public health and safety and the environment.

Subchapter d Low Level Radioactive Waste/Transportation

Part 605 Standards for Selection of Contractors

32 Ill. Adm. Code 605.10 Scope

This Part sets out the standards the Illinois Emergency Management Agency (Agency) will use when selecting a contractor for the design, development, construction, operation and closure of the low-level radioactive waste disposal facility envisioned by the Illinois Low-Level Radioactive Waste Management Act. (Act) [420 ILCS 20]. The Agency will issue a Request for Proposals for the project. It is the intent of the Agency that the project will be awarded to the proposer whose proposal, based on the standards of this Part, will result in a low-level radioactive waste disposal facility that furthers the interests of the State of Illinois, as stated in Section 2 of the Act. Illinois is a member of the Central Midwest Interstate Low-Level Radioactive Waste Compact and has been designated as the host state for a regional low-level radioactive waste disposal facility. Therefore, when selecting the proposal that will suit Illinois' needs, the Agency will also evaluate the proposal with respect to implementation of policies and recommendations adopted by the Central Midwest Interstate Low-Level Radioactive Waste Compact Commission, to the extent that those policies and recommendations are not inconsistent with Illinois standards expressed by the Act and 32 Ill. Adm. Code 340, 341, 400 and 601.

History

• Source: Amended at 37 Ill. Reg. 12414, effective July 19, 2013

32 Ill. Adm. Code 605.20 Number of Contractors; Use of Subcontractors

a) The Agency shall initiate contract negotiations with the single proposer or joint venture that has submitted the overall contract proposal that best conforms to the standards specified in this Part. However, if, based on the criteria stated in this Part, the Agency determines that none of the proposals submitted will serve the interests of the State of Illinois, as stated in Section 2 of the Act, the Agency shall not be required to accept any of the proposals. A time limit of one hundred and eighty (180) days has been established as the allowable negotiation period. If the negotiations are not completed within this period, the Agency may extend the negotiation period with the selected proposer. Furthermore, if a contract cannot be negotiated with the first proposer selected, the Agency may either initiate contract negotiations with another proposer or reissue the Request for Proposals. The Agency reserves the right to terminate negotiations prior to the end of the negotiation period or extend the negotiations.

b) When evaluating proposals, the Agency shall consider the proposed use of subcontractors and consultants. Specifically, the Agency shall determine, based on the criteria set out in this Part, whether the proposed use of subcontractors and consultants will further the interests of the State of Illinois, as stated in Section 2 of the Act. The Agency shall not select any proposal that calls for the subcontracting of facility operation. Subcontractors will be evaluated against the same standards as contractors, but only to the extent that the standards apply to the specific responsibilities assigned to the subcontractor as set out in the proposal.

History

• Source: Amended at 37 Ill. Reg. 12414, effective July 19, 2013

32 Ill. Adm. Code 605.30 Financial Integrity

a) The proposer who is selected to be contractor shall establish that it has the financial resources necessary to design, develop, construct, operate and close the low-level radioactive waste disposal facility. In addition, the proposer must have resources sufficient to meet the contractor's obligations regarding closure and post-closure (32 Ill. Adm. Code 601). Further, because it is likely that the low-level waste disposal facility will receive mixed waste (i.e., waste that has both radioactive and hazardous components), when evaluating the financial integrity of the proposers, the Agency shall establish whether the firm is capable of meeting the financial requirements of 35 Ill. Adm. Code 724. Specifically, the Agency shall negotiate a contract only with a proposer that is capable of meeting either of the following two financial tests:

1. Test One: The proposer must have:

A) Two of the following three ratios:

i) a ratio of total liabilities to net worth less than 2.0;

ii) a ratio of the sum of net income plus depreciation, depletion and amortization to total liabilities greater than 0.1;

iii) a ratio of current assets to current liabilities greater than 1.5; and

B) Net working capital and tangible net worth each at least six times the sum of the closure and post-closure costs estimates contained in the proposal; and

C) Tangible net worth of at least $10 million; and

D) Assets in the United States amounting to at least 90 percent of its total assets or at least six times the sum of the closure and post-closure estimates contained in the proposal.

2. Test Two: The proposer must have:

A) A current rating for its most recent bond issuance of AAA, AA, A or BBB as issued by Standard and Poor or Aaa, Aa, A or Baa as issued by Moody; and

B) Tangible net worth at least six times the sum of the closure and post-closure cost estimates contained in the proposal; and

C) Tangible net worth of at least $10 million; and

D) Assets located in the United States amounting to at least 90 percent of its total assets or at least six times the sum of the closure and post-closure cost estimates contained in the proposal.

b) When evaluating whether a proposer is capable of satisfying the financial requirements of 32 Ill. Adm. Code 601, the Agency shall consider:

1. The proposer's current assets and liabilities;

2. The proposer's short-term and long-term debt;

3. The proposer's credit rating;

4. The most recent Form 10K and all Form 10Qs since the last 10K that the proposer (or if more than one firm is proposing, all proposers) has filed with the United States Securities and Exchange Commission;

5. If proposer has not filed a Form 10K with the United States Securities and Exchange Commission, audited financial statements for the past three fiscal years and quarterly financial reports for the past two years;

6. Court decisions, decrees or agreements that have been issued or that are pending and that could adversely affect the financial well-being of the company;

7. Whether the proposer has ever initiated bankruptcy proceedings, either voluntary or involuntary, as well as the time and performance of the proposer since the proceedings; and

8. Any additional information provided by proposer.

c) When determining whether a proposer is capable of satisfying the financial requirements of 32 Ill. Adm. Code 601, the Agency shall apply the accounting standards of the Financial Accounting Standards Board (FASB) (see www.fasb.org).

History

• Source: Amended at 37 Ill. Reg. 12414, effective July 19, 2013

32 Ill. Adm. Code 605.40 Experience of the Firm; Performance History Requirements

a) The Agency shall select as contractor a proposer who has demonstrated an ability to design, develop, construct, operate and close a low-level radioactive waste disposal facility that incorporates the best available management technologies that are economically reasonable, technologically feasible and environmentally sound. When evaluating whether a proposer has demonstrated this ability, the Agency shall evaluate the proposer's experience developing and operating a low-level radioactive waste storage, treatment or disposal facility. If a proposer does not have experience in both the development and operation of a low-level radioactive waste disposal facility, the Agency shall evaluate the proposer's experience as either a low-level radioactive waste disposal facility developer or as a disposal facility operator, or the proposer's experience in radioactive materials management, hazardous materials management, nuclear fuel cycle facility design, construction, or operation, or other related experience presented by the proposer.

b) The proposer shall provide a complete performance history of its activities as described in subsection (a). When evaluating the proposer's experience, the Agency shall consider for each project:

1. general information about the project, including:

A) the facility and its location;

B) the capacity of the facility;

C) the actual performance of the facility;

D) the type of storage, treatment or disposal method used;

E) the proposer's role in the project (i.e., design, construction, operation);

F) project initiation and completion dates;

G) current facility status and, if closed, the reason for closure;

H) the proposer's client;

I) current facility manager business address and phone;

2. the complexity and scope of the previous project, such as, but not limited to, the previous projects' budget, duration, staffing and regulatory complexity;

3. the success of the project, i.e., whether the proposer met the objectives of the project in a timely manner, without exceeding anticipated costs and in a manner consistent with regulatory requirements, as well as whether the client was satisified with the proposer's performance;

4. whether the proposer has ever forfeited a performance bond or neglected to fulfill contract responsibilities;

5. whether the proposer has ever initiated or defended litigation arising from the activities, as described in the performance history, as well as the nature and outcome of the litigation;

6. the proposer's history with respect to licensing and regulatory compliance, including any record of safety violations or other compliance problems; and

7. any other information provided by the proposer.

History

• Source: Amended at 37 Ill. Reg. 12414, effective July 19, 2013

32 Ill. Adm. Code 605.50 Management Qualifications of the Firm

The Agency shall select as a contractor a proposer who possesses and will apply the project management resources, procedures, and expertise necessary to assure that the low-level radioactive waste disposal facility will be designed, developed, constructed, operated and closed according to the schedule contained in the proposal. To evaluate whether a proposer meets the requisite management qualifications, the Agency will review the proposed system of management and cost and quality control, the proposer's record of experience and expertise in managing projects of similar magnitude and scope, the proposed project schedules and resources dedicated to accomplishment of each task, the proposed system of quality control checks, financial controls, cost accounting procedures, and efficient use of time and personnel, by evaluating such things as the proposer's schedule of completion against statutory deadlines and also by examining the proposer's estimated costs. The Agency will also review the organizational chart submitted by the proposer, which shall identify the key management positions in the project, the responsibilities assigned to each position, the chain of responsibility in the project management team, and the procedures that would be used to assure accountability and control of all phases of the project. In addition, the Agency shall consider any other information provided by the proposer.

History

• Source: Amended at 37 Ill. Reg. 12414, effective July 19, 2013

32 Ill. Adm. Code 605.60 Qualifications of the Employees of the Firm

a) Because the contractor and its subcontractors will be responsible for performing a variety of activities, as set forth in this Part and 32 Ill. Adm. Code 601, ranging from designing a facility to negotiating plans for impact assistance with local governments, when selecting a contractor to design, develop, construct, operate and close a low-level radioactive waste disposal facility, the Agency will only select a proposer that has or will obtain a qualified staff that will be assigned to the project and that meets the requirements of this Section. The employee qualifications listed in this Section are minimum requirements for the contractor and must be met collectively by the contractor's staff; the qualifications need not be met by a single individual.

1. Project Manager

A) The contractor selected shall have an identified individual (or individuals) who will act as Project Manager for the designing, development, construction, operation and closure of the low-level radioactive waste disposal facility.

B) The Project Manager will be required to work with the Agency to ensure that the project is proceeding in accordance with the provisions of the contract and in accordance with the requirements of the Act.

C) The Project Manager will also be responsible for organizing, managing and coordinating the staff of both the contractor and the subcontractors. To assure that the Project Manager is capable of fulfilling these responsibilities, the Project Manager must have previous managerial experience on a project of similar magnitude and complexity (i.e., project of similar budget, duration, staffing, and regulatory complexity). The Project Manager must have been manager of a project that involved supervision of at least 30 professional (engineering or other technical) employees. Additionally, the Project Manager must be familiar with federal, State and local requirements applicable to radioactive or hazardous waste disposal, or with radioactive materials licensing. The Project Manager's familiarity with these regulatory requirements shall have been obtained through involvement on previous projects.

2. Senior Project Engineer. The Senior Project Engineer will be responsible for approving all engineering plans, designs, drawings, reports, specifications and other engineering documents on behalf of the contractor. Therefore, the Senior Project Engineer shall:

A) Be a Professional Engineer licensed in Illinois by the Department of Financial and Professional Regulation in accordance with the Illinois Professional Engineering Practice Act of 1989 [225 ILCS 325] or be a Professional Engineer licensed in another state and be eligible for reciprocal licensure within six months; and

B) Have been a senior engineer on at least two other engineering projects of similar complexity and magnitude as the proposed project (i.e., project of similar budget, duration, staffing and regulatory complexity). Preference will be given to proposers who designate as a senior engineer an individual who has worked on a project for the design, development, or remediation of a radioactive waste disposal facility.

3. Mechanical Engineer. If the proposer's plan requires the services of a mechanical engineer, the mechanical engineer shall:

A) Be a Professional Engineer licensed in Illinois by the Department of Financial and Professional Regulation in accordance with the Professional Engineering Practice Act of 1989 [225 ILCS 325] or be a Professional Engineer licensed in another state and be eligible for reciprocal licensure within six months; or

B) Have a degree in mechanical engineering and at least five years experience as a mechanical engineer.

4. Geotechnical or Civil Engineer. The geotechnical or civil engineer shall:

A) Be a Professional Engineer licensed in Illinois by the Department of Financial and Professional Regulation in accordance with the Professional Engineering Practice Act of 1989 [225 ILCS 325] or be a Registered Professional Engineer licensed in another state and be eligible for reciprocal licensure within six months; or

B) Have a degree in geotechnical or civil engineering and at least five years experience as a geotechnical or civil engineer.

5. Structural Engineer. The Structural Engineer will be responsible for designing structural components of the facility. To be able to accomplish this task, the structural engineer will have to be knowledgeable in reinforced concrete design and construction. At a minimum, the individual identified to perform these responsibilities shall:

A) Be a Structural Engineer licensed in Illinois by the Department of Financial and Professional Regulation in accordance with the Structural Engineering Practice Act of 1989 [225 ILCS 340] or be a Structural Engineer licensed in another state and be eligible for reciprocal licensure within six months; and

B) Shall have at least 10 years of experience in reinforced concrete design and construction.

6. Geohydrologist. The proposer selected as contractor shall have a geohydrologist knowledgeable in geologic interpretation and hydraulic transport of contaminants through soil or other porous material. The geohydrologist shall either:

A) Hold a Master's Degree in geology or hydrogeology and have at least five years experience as a hydrogeologist; or

B) Hold a Bachelor's degree in geology and have at least eight years of experience as hydrogeologist.

7. Environmental Scientist. The proposer selected as contractor shall have an environmental scientist who:

A) Holds an advanced degree (Ph.D., M.A. or M.S.) in Environmental Science or related natural or physical science; and

B) Has at least five years experience in evaluation and mitigation of environmental impacts.

8. Health Physicists

A) During the design, development and planning of operation of a low-level radioactive waste disposal facility, the full time services of a health physicist will be required to establish compliance with the requirements of 32 Ill. Adm. Code 310, 330, 341, 400 and 601. The health physicist will be responsible for developing and implementing an environmental monitoring plan, preparing an emergency response plan, and assisting the contractor in the design and development of a disposal facility that incorporates the best available management technologies that are economically reasonable, technologically feasible and environmentally sound. In order to assure that the health physicist available to the contractor is competent to fulfill these responsibilities, the contractor selected must have a health physicist whose services will be dedicated to the project and who meets one of the following:

i) Is certified by the American Board of Health Physics, 1313 Dolley Madison Blvd., Suite 402, McLean VA 22101, in accordance with that organization's standards for certification in effect in November 2011. A copy of these standards is available from the Agency;

ii) Holds a Doctorate (Ph.D.) in health physics, medical radiological physics or physics, and has at least three years of applied radiation protection experience; or

iii) Holds a Master's (M.S., M.A.) degree in health physics or physics and has at least five years of applied radiation protection experience.

B) Operation. During the operation of the low-level radioactive waste disposal facility, health physicists will be needed to conduct personnel monitoring, perform environmental monitoring, inspect packages received for disposal, and perform the responsibilities of a Radiation Safety Officer. In order to assure that the health physicists available to the contractor are capable of performing duties necessary to establish compliance with the requirements of 32 Ill. Adm. Code 340 and 601, the contractor selected must have health physicists whose services will be dedicated, i.e., a full-time employee on site, to the operation of the low-level radioactive waste disposal facility. In addition, the health physicists must either:

i) Be certified by the American Board of Health Physics, 1313 Dolley Madison Blvd, Suite 402, McLean VA 22101, in accordance with that organization's standards for certification in effect in November 2011. A copy of these standards is available from the Agency;

ii) Hold a Doctorate (Ph.D.) in health physics, physics or natural or physical science and have at least three years of applied radiation protection experience;

iii) Hold a Master's (M.S., M.A.) degree in health physics, physics or natural or physical science and have at least five years of applied radiation protection experience; or

iv) Hold a Bachelor's (B.S., B.A.) degree in health physics, physics, or natural or physical science and have at least eight years of applied radiation protection experience.

9. Radiochemist. The contractor will be required to operate an onsite radiochemistry laboratory. This laboratory will be used to analyze incoming radioactive materials, as well as samples obtained in the process of environmental monitoring. The radiochemist will be responsible for managing this laboratory and performing chemical analyses. In order to ensure that the contractor will be able to fulfill its obligation to provide radiochemistry support services, the proposer selected must have a radiochemist who:

A) Holds an advanced degree (Ph.D., M.A., M.S.) in radiochemistry or chemistry; and

B) Has at least five years experience working in a radiochemistry laboratory.

10. Community Liaison. The community liaison will be responsible for involving all segments of the public in the decision making surrounding the development, operation, closure and post-closure phases of the facility and will also be responsible for establishing a long-term local citizens' advisory group. To ensure that the community liaison is capable of fulfilling these responsibilities, the proposer selected must have a community liaison who will be assigned to this project and who either has:

A) An advanced degree (Ph.D., M.S., M.A.) in public administration or a related field, e.g., public affairs, or technology and public policy, and a minimum of three years experience in conducting public participation programs, particularly those involving the siting of locally controversial land uses, such as prisons or landfills; or

B) A Bachelor's degree (B.A., B.S.) in public administration or a related field and a minimum of five years experience in conducting public participation programs, particularly those involving the siting of locally controversial land uses.

11. Support Services

A) Comptroller – The contractor shall dedicate to the project the full-time services of a comptroller experienced in managing projects of similar budget size and complexity of the proposed project. The comptroller shall hold a degree in accounting and shall have at least five years experience.

B) Information Management Services Staff. The contractor will be responsible for developing and maintaining computerized record keeping systems that track generators, container contents, shippers, dates, certifications, treatments, package characteristics, special disposal requirements and location of containers in disposal units. These computerized record keeping systems must be compatible with the Agency's systems. To ensure that the contractor is capable of fulfilling this responsibility, the proposer shall have an information management specialist who has training in the development and maintenance of computer systems. The information management specialist shall hold a Bachelor's or graduate level degree in computer science or information management and shall have at least three years of computer programming experience.

b) The Agency shall evaluate the qualifications of any other project staff identified by the proposer in its proposal. When determining whether the staff is qualified to perform the responsibilities identified in the proposal, the Agency will evaluate staff qualifications as characterized by the proposer in the proposal. In addition, the Agency will evaluate the qualifications specified by the proposer for positions that have been identified but not yet filled in order to determine whether the proposer anticipates filling vacant positions with individuals competent to perform assigned tasks. The Agency also will evaluate the proposer's procedures for hiring qualified replacements when the identified staff leaves the employ of the proposer.

History

• Source: Amended at 37 Ill. Reg. 12414, effective July 19, 2013

32 Ill. Adm. Code 605.70 Socioeconomic Merit of Proposal

The proposer who is selected to be contractor for the design, development, construction, operation and closure of the low-level radioactive waste disposal facility will be required to develop a plan that, if executed, would assure that the community hosting a low-level radioactive waste disposal facility would realize benefits. In order to ensure that the contractor selected is capable of developing such a plan, the Agency will evaluate the proposed plan for identifying and addressing local concerns, providing public information and a forum for public involvement, and designing and negotiating programs for incentives and compensation to the host community.

a) Public Information Plan. The Agency shall evaluate the proposer's public information plan by establishing whether the plan contains the following:

1. A program for explaining both the potential risks and benefits associated with low-level radioactive waste disposal and the proposer's approach for minimizing the risks;

2. A method for effectively identifying all interested or potentially affected parties; and

3. A plan for development and distribution of sufficient, accurate, and understandable informational materials to permit and encourage public participation in the site development process.

b) Local Involvement Plan. The Agency shall evaluate the local involvement plan to establish that the proposer selected as contractor is capable of and willing to ascertain and respond to the matters of particular concern to each county or municipality that has been selected as a potential host community. When evaluating the adequacy of local involvement plans, the Agency will review:

1. The proposer's plan for:

A) Guaranteeing the property value of land contiguous to the facility;

B) Establishing or encouraging compatible economic or other activities in the vicinity of the facility;

C) Preserving the local revenue attributable to property taxes on the land that will be used for the facility;

D) Preparing an economic and community development plan;

E) Providing local residents with appropriate training and jobs at the facility;

F) Procuring goods and services locally;

G) Assuring procedures for local oversight of and participation in facility operation and development, including independent or cooperative monitoring and access to information regarding facility operations;

H) Assuring that third party liability and remedial action funds are available to meet reasonably foreseeable contingencies as described in the plan required under Section 605.80(b)(5);

I) Guaranteeing that the selling price of local produce is not adversely affected due to the presence of the disposal facility;

J) Enhancing the human and natural environment in the vicinity of the facility by establishing recreational facilities, wildlife preserves, natural areas or similar land uses;

K) Employing permanent and seasonal workers in professional, clerical, skilled or semi-skilled positions, with employment efforts directed at hiring local residents;

L) Soliciting input from local officials regarding concerns associated with hosting the disposal facility; and

M) Accommodating other requests and responding to other concerns that may be raised by the counties and municipalities where the alternative sites will be located.

2. The proposer's plan for addressing technical matters of local concern, including the following:

A) Facility design;

B) Facility construction schedules, plans and procedures;

C) Facility operating procedures;

D) Monitoring systems and procedures;

E) Emergency, remedial action and closure plans;

F) Long-term care and maintenance plans;

G) Control and routing of transport of low-level radioactive waste to the facility; and

H) Solicitation of input from local officials regarding technical and procedural concerns associated with design, construction, operation, monitoring and closing a low-level radioactive waste disposal facility.

History

• Source: Amended at 37 Ill. Reg. 12414, effective July 19, 2013

32 Ill. Adm. Code 605.80 Method of Disposal

The Agency shall select as a contractor a proposer who is capable of designing, constructing, operating, and closing a low-level radioactive waste disposal facility that does not incorporate the use of shallow land burial or deep well injection and that will further the objective of providing for the management of these wastes in the safest manner possible and in a manner that creates the least risk to human health and the environment of Illinois [420 ILCS 20/2(b)]. For purposes of this Section, shallow land burial has the same definition ascribed in Section 3 of the Act. The Agency will establish whether a proposer is capable of designing such a facility by evaluating a reference facility design submitted by the proposer as part of its proposal. The reference facility design shall briefly and concisely describe for consideration by the Agency the proposer's concept of the best available technology that is economically reasonable, technologically feasible, and environmentally sound for the disposal of low-level radioactive waste. The reference facility design shall include schematic drawings and narrative descriptions only in sufficient detail to permit an evaluation by the Agency of the technical merit of the design and the knowledge and expertise of the proposer. The reference facility design shall specifically address the role and performance of the engineered features in enhancing long-term isolation, monitoring, retrievability or remedial action and minimizing exposure to personnel. Reference facility designs shall be evaluated according to the following criteria:

a) Disposal Facility Design

1. To determine whether the proposer has demonstrated an ability to meet the design constraints of 32 Ill. Adm. Code 601 and the Act, the Agency will request each proposer to submit a reference facility design.

2. To make this determination, the Agency will then evaluate the reference design to determine whether the proposer has applied the following criteria:

A) Incorporation of multiple engineered features to provide structural integrity, prevent release of material from engineered containment, and provide radiation shielding;

B) Incorporation of design elements that reduce the amount of waste on site and not permanently disposed of and that minimize the time waste is held on site prior to disposal;

C) Promotion of worker safety, including minimization of worker radiation dose to as low as is reasonably achievable;

D) Disposal capacity sufficient to accommodate the anticipated waste volume;

E) Ability of the facility to accommodate waste that is of unusual volume or shape;

F) Ability of the facility to accommodate mixed waste (i.e., waste that has both radioactive and chemically hazardous components); and

G) Flexibility to accommodate waste streams and volumes not currently identified.

b) Operating Plan. When evaluating the proposer's operating plan, the Agency will evaluate the adequacy of the proposer's procedures for:

1. Inspection of packages;

2. Treatment of wastes for disposal;

3. Personnel monitoring;

4. Environmental monitoring, specifically monitoring of air, groundwater, and soil;

5. Contingency planning;

6. Maintaining records of the source and type of waste received for disposal; and

7. Continual in situ testing of the design and construction of disposal units, research and development of improved methods of disposal, and application of those methods.

c) Closure Plan. The Agency will evaluate the adequacy of the proposer's plan for satisfying the closure requirements of 32 Ill. Adm. Code 601.

History

• Source: Amended at 37 Ill. Reg. 12414, effective July 19, 2013

32 Ill. Adm. Code 605.90 Procedures for Soliciting Proposals

a) The Agency shall issue a Request for Proposals for contractors to design, develop, construct, operate and close a low-level radioactive waste disposal facility.

b) The deadline for receiving proposals shall be no earlier than 60 days from the date that the proposal announcement is first published in the official state newspaper.

c) All proposals received by the Agency by the submission date set forth in the Request for Proposals will be catalogued and distributed by the Agency for review and evaluation. All proposals will then be reviewed by the Agency, Agency staff, and such experts outside the Agency as may be needed. Following the receipt of proposals, the Agency will review all proposals with respect to completeness and conformance with the instructions and requirements specifically indicated in the Request for Proposals. Proposals that are deemed incomplete or non-conforming with instructions and requirements of the Request for Proposals may not be given further evaluation. The Agency reserves the right to reject any or all proposals and to waive any irregularity, variance, or informality, whether technical or substantive in nature. All proposals will be equally evaluated with respect to the completeness of the data provided, the support for the performance claims made, and the criteria established for evaluation in the Request for Proposals according to the Act and related rules (32 Ill. Adm. Code 601).

d) The Agency shall reject, without consideration of the merits, any proposal that is not accompanied by an acceptable ($1,000,000) proposal guaranty. The proposal guaranty is acceptable if it is in any of the following forms:

1. A certified check, drawn on a solvent commercial bank or trust company to the order of the Illinois Emergency Management Agency;

2. A bank check, drawn on a solvent commercial bank or trust company, to the order of the Illinois Emergency Management Agency;

3. An irrevocable letter of credit issued by a solvent commercial bank or trust company; or

4. A bond executed by a corporate surety company authorized to do business in the State of Illinois.

e) All proposal guaranties shall:

1. Be valid for at least 180 days from the proposal submission date;

2. Be extended at the Agency's request for an additional period, up to 365 days, without cost to the Agency. The Agency would request that proposal guarantees be extended if either:

A) No proposer was selected as a contractor within the 180 day period; or

B) A proposer was selected, but contract negotiations were not completed within the 180 day period.

3. Be returned, within five business days after execution of a contract for the design, development, construction, operation and closure of the low-level radioactive waste disposal facility.

f) Failure of a successful proposer to execute the contract as proposed in the response to the Request for Proposals and file acceptable bonds within 45 days after the contract has been mailed to the proposer shall be just cause for cancellation of the award and the forfeiture of the proposal guaranty that shall become the property of the Agency, not as a penalty, but in liquidation of the damages sustained. If the contract is not executed by the Agency within 30 days following receipt from the proposer of the executed contracts and bonds, the proposer shall have the right to withdraw the proposal without penalty.

History

• Source: Amended at 37 Ill. Reg. 12414, effective July 19, 2013

32 Ill. Adm. Code 605.100 Waiver of Requirements

The Agency shall waive any requirement if the specific objective the requirement is intended to achieve has been met or exceeded by an alternative that does not fulfill the requirement itself.

History

• Source: Amended at 37 Ill. Reg. 12414, effective July 19, 2013

32 Ill. Adm. Code 605.110 Verification of Statements; Material False Statements

a) When evaluating proposals, the Agency may request and consider the advice and knowledge of others, such as representatives of local government, other State agencies and technical consultants, in order to verify the validity of statements made in the proposal and to evaluate the proposer's efforts to satisfy the standards.

b) The Agency shall not select as contractor any proposer who submits a proposal that contains material false statements or material omissions. A false statement or omission is material if it prevents the Agency from making an informed and accurate assessment of the proposer's ability to meet the criteria.

History

• Source: Amended at 37 Ill. Reg. 12414, effective July 19, 2013

32 Ill. Adm. Code 605.120 Performance Guaranty

The successful proposer, at the time of the execution of the contract, shall deposit with the Agency a performance guaranty in a form acceptable to the Agency for the full amount of the contract. The performance guaranty shall be acceptable to the Agency if it is of a type listed in Section 605.90(c). At the contractor's request, the amount of the performance guarantee shall be reevaluated and adjusted to reflect the costs of performing remaining contract obligations, upon the submission of application, the granting of licensing, the completion of construction, and the acceptance of waste for disposal. Guaranty amounts will be forfeited by the contractor if the contractor fails to perform its obligations as specified in the terms of the contract. Any guaranty amounts not forfeited before the first disposal module shall be released by the Agency upon closure of the first disposal module.

History

• Source: Amended at 37 Ill. Reg. 12414, effective July 19, 2013

Part 609 Access to Facilities for Treatment, Storage, or Disposal of Low-Level Radioactive Waste

32 Ill. Adm. Code 609.10 Purpose and Applicability

a) This Part establishes one of the systems for the regulation of the use of facilities in the State of Illinois to:

1. Collect, store, treat or dispose of low-level radioactive waste;

2. Maintain a data base as to the location of all such waste in the State of Illinois; and

3. Implement some of the requirements, prohibitions and mandates of the Compact, the Radioactive Waste Compact Enforcement Act [45 ILCS 141], the Radioactive Waste Tracking and Permitting Act [420 ILCS 37] and the Illinois Low-Level Radioactive Waste Management Act [420 ILCS 20].

b) This Part establishes a system for monitoring and tracking shipments of low-level radioactive waste into, out of or within the State of Illinois for the purpose of tracking the points of origin of the shipments, as transported to the places of destination of the shipments.

c) This Part establishes an enforcement and verification system directed to the movements of low-level radioactive waste into, out of or within the State of Illinois.

d) This Part applies to any generator, broker, owner or operator of any treatment or disposal facility, or to any person who sends low-level radioactive waste into, within or out of the State of Illinois.

e) This Part does not apply to:

1. Shipments of low-level radioactive waste that are sent or transported through the State of Illinois but do not originate in the State of Illinois and are not accepted for treatment, storage, collection or disposal at a location in the State of Illinois;

2. Naturally occurring radioactive materials, unless required to be licensed by the Agency;

3. Radioactive materials exempt from licensing by the Agency based upon regulatory or statutory determinations; and

4. Radioactive materials authorized for disposal under 32 Ill. Adm. Code 340.1030 and 340.1050.

f) This Part does not relieve any person from compliance with any other state, Commission or Federal requirements, including transport or licensing requirements, pertaining to the packaging, transportation, disposal, storage or delivery of low-level radioactive materials or wastes.

g) This Part does not relieve any person from compliance with any order, directive or rule of the Central Midwest Interstate Low-Level Radioactive Waste Commission, pursuant to its authority under the provisions of the Central Midwest Radioactive Waste Compact Act [45 ILCS 140].

History

• Source: Amended at 38 Ill. Reg. 12088, effective May 29, 2014

32 Ill. Adm. Code 609.20 Definitions

Except when otherwise indicated, or when the context clearly requires a different definition, the following terms shall have the following meanings for purposes of this Part.

"Acceptance" means taking possession of waste. Waste is not "accepted" for purposes of this Part if it is delivered to a facility, and the owner or operator of the facility refuses to take possession and promptly so informs both the person sending the waste and the Agency of the refusal.

"Agency" means the Illinois Emergency Management Agency.

"Broker" means any person who takes possession of low-level radioactive waste for purposes of consolidation and shipment. [420 ILCS 20/3]

"Carrier" means a person who transports low-level radioactive waste into, out of or within the State of Illinois.

"Commission" means the Central Midwest Interstate Low-Level Radioactive Waste Commission.

"Compact" means the Central Midwest Interstate Low-Level Radioactive Waste Compact.

"Consolidated Waste" means waste from more than one generator that has been consolidated into a single shipment of waste. However, separate containers of waste would not be classified as "consolidated waste".

"Dispose" or "Disposal" means the isolation of waste from the biosphere in a permanent facility designed for that purpose. [45 ILCS 141/15]

"Electronic Data Transmission" or "EDT" means files that are comprised of a variety of record types, which are used based on the type and source of the shipment of low-level radioactive waste (original shipment versus a consolidated shipment, in or out-of-state shipment, etc.). These files are ASCII files with comma delimited records.

"Facility" means a parcel of land or site, together with the structures, equipment and improvements on or appurtenant to the land or site, that is used or is being developed by the owners or operators for the generation, collection, treatment, storage or disposal of low-level radioactive waste. [45 ILCS 141/15]

"Generator" means any person who produces or possesses low-level radioactive waste in the course of or incident to manufacturing, power generation, processing, medical diagnosis and treatment, research, education or other activity. [420 ILCS 20/3]

"Low-Level Radioactive Waste" or "LLRW" or "Waste" means radioactive waste not classified as:

high-level radioactive waste,

transuranic waste,

spent nuclear fuel, or

by-product material as defined in Section 11e(2) of the Atomic Energy Act (42 USC 2021).

This definition shall apply notwithstanding any declaration by the federal government or any state that any radioactive material is exempt from any regulatory control. [45 ILCS 141/15]

"Permit" means the license authority issued by the Agency upon application which authorizes the person identified by that number to either send waste to a facility for treatment, storage, consolidation or disposal or to receive waste at a facility for treatment, storage, consolidation or disposal.

"Person" means any individual, corporation, business enterprise or other legal entity, public or private and any legal successor, representative, agent or agency of that individual, corporation, business enterprise or legal entity. [45 ILCS 141/15]

"Region" means the geographical area of the State of Illinois and the Commonwealth of Kentucky. [45 ILCS 141/15]

"Regional Facility" means any facility as defined in the Radioactive Waste Compact Enforcement Act that is located in Illinois and established by Illinois pursuant to designation of Illinois as a host state by the Commission.

"Shipper" means a person, whether located within or outside of the Region that offers waste for transportation into, within or out of the State of Illinois.

"Storage" means the temporary holding of radioactive material for treatment or disposal. [45 ILCS 141/15]

"Transaction Reference Number" means a number issued by the Agency under this Part that acknowledges the shipper's submittal of, and the Agency's acceptance as complete of, shipment specific information required under this Part.

"Transport" means the movement of waste into, within or out of the State of Illinois.

"Treatment" means any method, technique or process, including storage for radioactive decay, designed to change the physical, chemical, or biological characteristics of the radioactive material in order to render the radioactive material safe for transport or management, amenable to recovery, convertible to another usable material, or reduced in volume. [45 ILCS 141/15]

History

• Source: Amended at 38 Ill. Reg. 12088, effective May 29, 2014

32 Ill. Adm. Code 609.30 Prohibited Activities

a) Unless the shipment of the waste is authorized by the Central Midwest Interstate Low-Level Radioactive Waste Commission, no person shall:

1. Send waste from any point located outside of the State of Illinois to any facility located within the State of Illinois, regardless of its origin.

2. Accept at any facility in the State of Illinois any waste from outside the Region, regardless of origin.

3. Deposit at any Regional Facility in the State of Illinois any waste that is owned or generated by the United States Department of Energy, owned or generated by the United States Navy as a result of decommissioning of vessels of the United States Navy, or owned or generated as the result of any research, development, testing or production of any atomic weapon.

4. Accept at any Regional Facility in the State of Illinois any waste that is owned or generated by the United States Department of Energy, owned or generated by the United States Navy as a result of decommissioning of vessels of the United States Navy, or owned or generated as the result of any research, development, testing or production of any atomic weapon.

5. Send any waste from the State of Illinois outside the State of Illinois, other than waste that is owned or generated by the United States Department of Energy, owned or generated by the United States Navy as a result of decommissioning of vessels of the United States Navy, or owned or generated as the result of any research, development, testing or production of any atomic weapon.

6. Dispose of any waste in the State of Illinois other than at a regional disposal facility.

b) No person shall send to any facility in Illinois or accept at any facility in Illinois any waste that has as its place of origin the disposal facility located at Maxey Flats, Kentucky.

c) No generator, broker, facility or other person shall send any waste into, out of or within the State of Illinois or accept any waste without complying with the requirements of this Part, including all Agency notification requirements.

History

• Source: Amended at 38 Ill. Reg. 12088, effective May 29, 2014

32 Ill. Adm. Code 609.40 Permit Requirements and Application Procedures

Each person who ships waste into, out of or within the State of Illinois or accepts waste shall apply to the Agency for a Permit.

a) A person applying for a Permit shall submit the application to the Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois 62704. The person shall provide to the Agency at the time of the application the following information in writing, on paper bearing the name, current address and current telephone number of the person making the application and signed in ink by a person authorized to make the application:

1. The name of a contact person for the applicant and the current address and phone number of that contact person if different from that of the applicant.

2. The radioactive materials license number currently issued to the applicant and the name of the entity issuing the license.

3. The name and location of the applicant's facility that would be recorded under any assigned Permit.

b) A person shall be eligible to receive a Permit only if the person is:

1. A generator or broker registered by the Agency under Section 4 of the Low-Level Radioactive Waste Management Act;

2. A facility licensed by the Agency under Section 8 of the Low-Level Radioactive Waste Management Act;

3. A generator, broker, treatment facility or other person located outside of the State of Illinois. The out-of-state entity must be a party to an agreement with the Compact that is in effect on the date of the Permit application, or as otherwise authorized by the Commission. The agreement with the Compact must provide that waste from the unaffiliated state or regional compact is currently permitted to be treated, stored or disposed of at a facility in the Region and that the Commission has not revoked the permission granted to that person, state or regional compact allowing these shipments;

4. A generator, broker, treatment facility or other person located outside of the State of Illinois that is allowed to send waste for treatment or storage in Illinois, pursuant to an agreement entered into by the Commission;

5. A generator, broker, treatment facility or other person located outside of the State of Illinois that is allowed to send waste for disposal in Illinois, pursuant to an agreement entered into by the Commission and approved by law in Illinois;

6. A generator, broker, treatment facility or other person located in the Commonwealth of Kentucky; or

7. A generator that is an agency of the United States government that is located in the Region.

c) A generator applying for a Permit must certify to the Agency in the written application for the Permit that it will make lawful and suitable arrangements for the final disposition of the waste, or that it will retrieve and reclaim physical possession of such waste in the event final disposition or storage has not been arranged.

d) Within 14 calendar days from the receipt by the Agency of the application, the Agency will issue, in writing, a Permit to an eligible applicant whose application complies with all of the relevant requirements of this Section. Denial by the Agency of any application within this same time period shall also be in writing, citing the reason for the action.

History

• Source: Amended at 38 Ill. Reg. 12088, effective May 29, 2014

32 Ill. Adm. Code 609.50 Waste Shipment Tracking Process

a) Each person sending a shipment of waste into, within or out of the State of Illinois shall provide the Agency with an EDT file formatted and containing the information prescribed in Appendix A at the time of the shipment. All EDT file submittals shall be made in a manner that allows the Agency to incorporate the transmission into the Agency's electronic data base. Waste brokers may provide the EDT file on behalf of the generator.

b) All instate receiving facilities that store waste for decay in storage shall report to the Agency the placement of waste into decay in storage according to the procedures outlined in Appendix A. The receiving facilities shall also report to the Agency when the containers are removed from the decay in storage inventory utilizing the procedures identified in Appendix A.

c) All instate receiving facilities that process waste in a manner that no waste, either direct or residual, is attributable back to the shipper shall report those affected containers according to the procedures identified in Appendix A.

d) Each person needing to correct information previously provided to the Agency pursuant to this Section shall provide those corrections to the Agency in writing addressed to the Supervisor, Low-Level Radioactive Waste Management and Decommissioning Unit, Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois 62704 or at ema.LLRWTRACK@illinois.gov.

History

• Source: Amended at 38 Ill. Reg. 12088, effective May 29, 2014

32 Ill. Adm. Code 609.60 Standards for Issuance of Transaction Reference Number

a) Based upon transmitted information required by Section 609.50, the Agency shall issue a Transaction Reference Number upon determining that the:

1. Applicant has complied with the requirements of this Part;

2. Activity undertaken is not prohibited by any provision of the Compact, the Radioactive Waste Compact Enforcement Act or this Part;

3. Activity has received approval from the Commission, if so required under the provisions of the Compact; and

4. Information reporting requirements of this Part have been met.

b) The Agency shall issue the Transaction Reference Number to the shipper within 7 days after the receipt of information.

History

• Source: Amended at 38 Ill. Reg. 12088, effective May 29, 2014

32 Ill. Adm. Code 609.65 Transaction Reference Number and Waste Shipment Tracking Process (repealed)

History

• Source: Repealed at 24 Ill. Reg. 18191, effective December 1, 2000

32 Ill. Adm. Code 609.70 Suspension, Revocation or Voluntary Termination of Permits

a) The Agency may revoke or suspend any Permit issued under this Part, for any reason, including but not limited to any of the following conditions:

1. The individual to whom the Permit was issued is determined by the Agency to no longer be alive or to have been adjudged legally incompetent.

2. The person to whom the Permit was issued, if other than an individual, is determined by the Agency to no longer be legally in existence.

3. Any person eligible for a Permit pursuant to Section 609.40(b)(1) is no longer registered by the Agency under Section 4 of the Low-Level Radioactive Waste Management Act.

4. Any person eligible for a Permit pursuant to Section 609.40(b)(2) is no longer licensed by the Agency under Section 8 of the Low-Level Radioactive Waste Management Act.

5. The person is no longer eligible for a permit under Section 609.40(b)(3), (4) or (5).

6. Falsification of any information in an application for a Permit.

7. Failure to notify the Agency of any change in the information previously provided to the Agency in an application for a Permit.

8. If the Commission has revoked the permission granted to such person under any compact region or unaffiliated state agreements to treat, store or dispose of waste at a facility in the Region.

9. For any violation of the Radioactive Waste Compact Enforcement Act or for violation of any condition imposed by any approval or interstate agreement of the Commission.

b) The Agency shall notify the Commission of any suspension, emergency suspension or revocation of a Permit. In addition, all alleged violations that could affect the retention, classification or validity of a Permit shall be reported to the Commission by the Agency. The notification shall be in writing, on a quarterly basis, including all reported and alleged violations, as well as the particular instances in which the Agency concluded that official action under this Part was either not merited or not necessary.

c) Any pending action by the Agency to suspend or revoke a Permit shall be initiated by written notice to the Permit holder or applicant, specifying the reasons for that action and the right to a hearing on the determination of the Agency, pursuant to the terms of the Illinois Administrative Procedure Act [5 ILCS 100/Art. 10]. No suspension or revocation shall take effect prior to the issuance of a final order from the administrative hearing proceeding, except as outlined in subsection (d).

d) The Agency may also issue a preliminary Summary Suspension Order against any person holding a particular Permit who is also subject to a pending administrative hearing that could result in the revocation or suspension of the same Permit, provided that:

1. The Agency finds that the public interest, safety or welfare requires immediate action; and

2. Specific, factual reasons for the emergency action are also included in the Agency's written "Notice of Hearing", advising the Permit holder of the pending administrative proceeding.

AGENCY NOTE: Any subsequent hearing proceedings shall be promptly instituted and determined.

e) A party to whom a Permit has been issued may voluntarily terminate the Permit by mailing to the Agency written notice that the particular authorization is being voluntarily terminated. The termination shall be effective upon receipt by the Agency of the notice. The notice shall set forth the name and address of the person to whom the Permit was issued.

f) No person shall voluntarily terminate a Permit if the person to whom the Permit has been issued has offered a shipment of waste for transportation into, within or out of the State of Illinois and that shipment of waste has not either been returned to the shipper or been accepted at a facility properly authorized to dispose of that shipment of waste.

History

• Source: Amended at 38 Ill. Reg. 12088, effective May 29, 2014

32 Ill. Adm. Code 609.80 Penalties

a) The Agency may impose a civil penalty on any person who sends, receives or accepts waste in violation of any provision of this Part or the Radioactive Waste Compact Enforcement Act.

b) Civil penalties imposed under this Part shall not exceed $100,000 per occurrence. For a continuing violation, the Agency may consider each day in which the violation continues as a separate occurrence.

c) In determining the amount of a civil penalty imposed under this Part, the Agency will consider the following:

1. Whether the violation was the result of willful, reckless or negligent conduct.

2. The previous history of compliance with the provisions of the Radioactive Waste Compact Enforcement Act and this Part.

3. Whether the violation was voluntarily reported to the Agency.

4. The amount and type of the radioactive material involved.

5. Whether mitigative actions were taken.

6. The recommendations, if any, of the Commission.

d) The Agency will notify the Commission when it initiates a civil penalty action and request the Commission's recommendations, if any, as to the civil penalty the Agency seeks to impose. The Agency shall also notify the Commission of any imposition of a civil penalty by the Agency.

e) Imposition of a civil penalty shall be by written order, specifying the reasons for and amount of the penalty. The order shall include a notice of the right to an administrative appeal and hearing, in accordance with the provisions of Section 609.100. The order shall be served either personally or by registered or certified mail. Notice of the order shall be effective as of the date of personal service or receipt of the mailed notice.

f) Unless the right of administrative appeal and hearing, provided in Section 609.100, is exercised, any civil penalty imposed shall be payable within 60 days after the effective date of notice of imposition of the penalty.

g) The Agency will inform the Attorney General and the Commission of any failure to pay any civil penalty imposed under this Part. Any person who refuses to pay a civil penalty assessed under this Part shall be liable in an amount not to exceed 4 times the amount of the penalty not paid.

h) Section 30(d) of the Radioactive Waste Compact Enforcement Act provides a criminal penalty for any person who intentionally violates Section 20(a)(1), (a)(2), (a)(3), (a)(4) or (a)(6) of that Act. If the Agency becomes aware of a possible intentional violation of those Sections of the Act, the Agency shall make a report to the Attorney General or State's Attorney for criminal prosecution of the offender.

History

• Source: Amended at 38 Ill. Reg. 12088, effective May 29, 2014

32 Ill. Adm. Code 609.90 Exemptions

a) Any person may apply to the Agency for an exemption from the requirements of this Part.

b) A request for an exemption shall be in writing and shall state with particularity the reasons why granting an exemption would be consistent with the provisions of this Part and the Compact. A copy of the request shall be filed with the Commission.

c) Exemptions shall only be granted by the Agency upon an express finding by the Agency that granting the exemption would be consistent with the provisions of this Part and the Compact. In making those determinations, the Agency shall consider the recommendations, if any, of the Commission.

d) Exemptions granted under this Part may be limited in scope or duration, or may be conditional, providing that the limits or conditions are consistent with the Compact.

e) Any exemption granted under this Part shall not be in conflict with any provision of the Illinois Low-Level Radioactive Waste Management Act, the Radioactive Waste Tracking and Permitting Act, the Central Midwest Interstate Low-Level Radioactive Waste Compact Act, the Radioactive Waste Compact Enforcement Act, or the federal Low-Level Radioactive Waste Policy Amendment Act of 1985 (42 USC 2021b et seq.).

f) The Agency shall provide the Commission with written notice of any exemption granted pursuant to this Part.

History

• Source: Amended at 38 Ill. Reg. 12088, effective May 29, 2014

32 Ill. Adm. Code 609.100 Administrative Appeal and Hearing

a) Any person may petition the Agency for reconsideration of any:

1. Denial by the Agency to issue a Permit to that person;

2. Summary suspension of a Permit issued to that person; or

3. Civil penalty imposed on that person.

b) The petition shall be made in writing, shall be directed to the Chief, Bureau of Radiation Safety, Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield, Illinois, 62704, and shall state concisely and with particularity the reasons for the petition. The Agency shall provide a copy of the petition to the Commission.

c) Any person petitioning the Agency for reconsideration has the right to a hearing before the Agency. The request for a hearing shall be filed with the petition. Petitions shall be filed within 30 calendar days after notice of the:

1. Denial of a Permit;

2. Summary suspension of a Permit; or

3. Imposition of a civil penalty.

d) Failure of a petitioner to comply with the requirements of this Part with respect to petitions for reconsideration or requests for a hearing shall be grounds for denial of the petitioner's request.

e) All hearings under this Part, as well as administrative hearings ordered by the Agency that could result in the revocation or suspension of a previously issued Permit to a person, shall be governed by the procedures set forth in the Illinois Administrative Procedure Act [5 ILCS 100/Art. 10] and in 32 Ill. Adm. Code 200. The Agency shall provide notice of these hearings to the Commission.

History

• Source: Amended at 38 Ill. Reg. 12088, effective May 29, 2014

32 Ill. Adm. Code 609.APPENDIX A Electronic Data Transmission

Section 609.TABLE A-1 Detailed listing of data elements

TABLE A-1

Record Type "MO1"

Record Type "MO2"

Record Type "MO3"

Record Type

(REC_TYPE)

Record Type

(REC_TYPE)

Record Type

(REC_TYPE)

Manifest Number

(MANIF_NUM)

Manifest Number

(MANIF_NUM)

Manifest Number

(MANIF_NUM)

Consignor's Permit

(CNSGNOR_ID)

Consignor's Permit

(CNSGNOR_ID)

Consignor's Permit

(CNSGNOR_ID)

Consignee's Permit

(CNSGNEE_ID)

Consignee's Permit

(CNSGNEE_ID)

Consignee's Permit

(CNSGNEE_ID)

Total Container Count

(TOT_CNTRS)

Total Container Count

(TOT_CNTRS)

Total Container Count

(TOT_CNTRS)

Total Activity

(TOT_ACTVY)

Total Activity

(TOT_ACTVY)

Total Activity

(TOT_ACTVY)

Activity Unit of measure

(ACTVY_MEAS)

Activity Unit of measure

(ACTVY_MEAS)

Activity Unit of measure

(ACTVY_MEAS)

Total volume

(TOT_VOLUME)

Total volume

(TOT_VOLUME)

Total volume

(TOT_VOLUME)

Volume unit of measure

(VOL_MEAS)

Volume unit of measure

(VOL_MEAS)

Volume unit of measure

(VOL_MEAS)

Total weight

(TOT_WEIGHT)

Total weight

(TOT_WEIGHT)

Total weight

(TOT_WEIGHT)

Actual ship date

(ACT_SHIP)

Actual ship date

(ACT_SHIP)

Actual ship date

(ACT_SHIP)

EPA manifest number

(EPA_MANIF)

EPA manifest number

(EPA_MANIF)

EPA manifest number

(EPA_MANIF)

Total source material weight

(TOT_SRC_WT)

Total source material weight

(TOT_SRC_WT)

Total source material weight

(TOT_SRC_WT)

Total special nuclear material weight

(TOT_SNM_WT)

Total special nuclear material weight

(TOT_SNM_WT)

Total special nuclear material weight

(TOT_SNM_WT)

Total H-3 activity

(H3_ACT)

Total H-3 activity

(H3_ACT)

Total H-3 activity

(H3_ACT)

Total TC-99 activity

(TC99_ACT)

Total TC-99 activity

(TC99_ACT)

Total TC-99 activity

(TC99_ACT)

Total I-129 activity

(I129_ACT)

Total I-129 activity

(I129_ACT)

Total I-129 activity

(I129_ACT)

Total C-14 activity

(C14_ACT)

Total C-14 activity

(C14_ACT)

Total C-14 activity

(C14_ACT)

Exclusive use indicator

(EXCLUS_USE)

Exclusive use indicator

(EXCLUS_USE)

Exclusive use indicator

(EXCLUS_USE)

Carrier Code

(CARRIER_CODE)

Carrier Code

(CARRIER_CODE)

Carrier Code

(CARRIER_CODE)

Carrier Name

(CARRIER_NAME)

Carrier Name

(CARRIER_NAME)

Carrier Name

(CARRIER_NAME)

Carrier Address 1

(CARRIER_ADDR1)

Carrier Address 1

(CARRIER_ADDR1)

Carrier Address 1

(CARRIER_ADDR1)

Carrier Address 2

(CARRIER_ADDR2)

Carrier Address 2

(CARRIER_ADDR2)

Carrier Address 2

(CARRIER_ADDR2)

Carrier City

(CARRIER_CITY)

Carrier City

(CARRIER_CITY)

Carrier City

(CARRIER_CITY)

Carrier State

(CARRIER_STATE)

Carrier State

(CARRIER_STATE)

Carrier State

(CARRIER_STATE)

Carrier Zip

(CARRIER_ZIP)

Carrier Zip

(CARRIER_ZIP)

Carrier Zip

(CARRIER_ZIP)

Carrier Zip4

(CARRIER_ZIP4)

Carrier Zip4

(CARRIER_ZIP4)

Carrier Zip4

(CARRIER_ZIP4)

Carrier Contact

(CARRIER_CONTACT)

Carrier Contact

(CARRIER_CONTACT)

Carrier Contact

(CARRIER_CONTACT)

Carrier Contact Phone

(CARRIER_PHONE)

Carrier Contact Phone

(CARRIER_PHONE)

Carrier Contact Phone

(CARRIER_PHONE)

TABLE A-1 (continued)

Record Type "CO2"

Record Type "CO4"

Record Type "CO5"

Record Type

(REC_TYPE)

Record Type

(REC_TYPE)

Record Type

(REC_TYPE)

Consignor's Permit

(CNSGNOR_ID)

Holding facility permit

(PERMIT_NUM)

Consignor's Permit

(CNSGNOR_ID)

Manifest Number

(MANIF_NUM)

Consignor's Permit

(CNSGNOR_ID)

Manifest Number

(MANIF_NUM)

Container Number

(CNTR_NUM)

Manifest Number

(MANIF_NUM)

Container Number

(CNTR_NUM)

Container volume

(CNTR_VOL)

Container Number

(CNTR_NUM)

Container Volume

(CNTR_VOL)

Volume Unit of Measure

(VOL_MEAS)

Volume Unit of Measure

(VOL_MEAS)

Container type

(CNTR_TYPE)

Container type

(CNTR_TYPE)

Container activity

(CNTR_ACTVY)

Container activity

(CNTR_ACTVY)

Activity units of measure

(ACTVY_MEAS)

Activity units of measure

(ACTVY_MEAS)

Container Alpha

(CNTR_ALPHA)

Container Alpha

(CNTR_ALPHA)

Alpha less than indicator

(ALPHA_SIGN)

Alpha less than indicator

(ALPHA_SIGN)

Container Beta

(CNTR_BETA)

Container Beta

(CNTR_BETA)

Beta less than indicator

(BETA_SIGN)

Beta less than indicator

(BETA_SIGN)

Container disposition

(CNTR_DISP)

Container disposition

(CNTR_DISP)

Over pack indicator

(OP_FLAG)

Over pack indicator

(OP_FLAG)

Surface radiation

(SURF_RADIA)

Surface radiation

(SURF_RADIA)

Surface radiation units

(RAD_MEAS)

Surface radiation units

(RAD_MEAS)

Rad less than indicator

(RAD_SIGN)

Rad less than indicator

(RAD_SIGN)

DOT Label

(DOT_LABEL)

DOT Label

(DOT_LABEL)

Container weight

(CNTR_WGT)

Container weight

(CNTR_WGT)

DOT UN ID number

(DOT_UN_ID)

DOT UN ID number

(DOT_UN_ID)

Transport Index

(TRANS_INDEX)

Transport index

(TRANS_INDX)

Cert. of Compliance

(CERT_NUM)

Cert. of compliance

(CERT_NUM)

TABLE A-1 (continued)

Record Type "WO1"

Record Type

(REC_TYPE)

Consignor's Permit

(CNSGNOR_ID)

Manifest Number

(MANIF_NUM)

Container Number

(CNTR_NUM)

Waste Type

(WASTE_TYPE)

Waste activity

(WST_ACTVY)

Activity units of measure

(ACTVY_MEAS)

Waste Classification

(WASTE_CLAS)

Waste volume

(WASTE_VOL)

Volume unit of measure

(VOL_MEAS)

Waste code

(WASTE_CODE)

Physical form

(PHYS_FORM)

SSS media

(SSS_MEDIA)

SSS vendor

(SSS_VENDOR)

SSS brand

(SSS_BRAND)

Chelating agent 1

(CHE_AGENT1)

% of chelating agent 1

(CHE_PCT1)

Chelating agent 2

(CHE_AGENT2)

% of chelating agent 2

(CHE_PCT2)

LSA/SCO indicator

(LSA_SCO)

TABLE A-1 (continued)

Record Type "I05"

Record Type

(REC_TYPE)

Consignor's Permit

(CNSGNOR_ID)

Manifest Number

(MANIF_NUM)

Container Number

(CNTR_NUM)

Waste Type

(WASTE_TYPE)

Radionuclide

(RADIONUCL)

Radionuclide activity

(NUCL_ACTVY)

Activity units of measure

(ACTVY_MEAS)

Activity less than indicator

(ACTVY_SIGN)

Radionuclide percentage

(RADIO_PCT)

% less than indicator

(PCT_SIGN)

Special nuclear material grams

(SNM_GRAMS)

Chemical form

(CHEM_FORM)

TABLE A-1 (continued)

Record Type "PO1"

Record Type

(REC_TYPE)

Consignor's Permit

(CNSNOR_ID)

Manifest Number

(MANIF_NUM)

Container Number

(CNTR_NUM)

Previous Consignor's Permit

(PREV_CNSNR)

Previous manifest number

(PREV_MANF)

Previous container number

(PREV_CNTR)

Consolidated volume

(COMB_VOL

% of previous container

(PREV_PCT)

History

• Source: Amended at 38 Ill. Reg. 12088, effective May 29, 2014

32 Ill. Adm. Code 609.APPENDIX A Electronic Data Transmission

Section 609.TABLE A-2 Data element definitions

TABLE A-2

NAME

DEFINITION

FIELD SIZE

DECIMAL PLACES

FIELD TYPE

FIELD FORMAT

USAGE CODE

CODE DESCRIPTION

ACT_SHIP

The actual shipment date of a LLRW shipment.

8

0

Numeric (Date)

YYYYMMDD

N/A

N/A

ACTVY_MEAS

The units used to measure activity (Curies or Millicuries, Microcuries, Becquerels, Terrabecquerels, Gigabecquerels, Megabecquerels, Kilobecquerels)

1

0

Alpha-Numeric

X

C

Curies

M

Millicuries

U

Microcuries

B

Becquerels

T

Terrabecquerels

G

Gigabecquerels

E

Megabecquerels

K

Kilobecquerels

ACTVY _ SIGN

Indicates whether the activity number is a less than value.

1

0

Alpha-Numeric

X

<

Activity value is less than number shown.

(blank)

Alpha amount is the number shown.

ALPHA_SIGN

Indicates whether the Container Alpha (CNTR_ALPHA) number is a less than value

1

0

Alpha-Numeric

X

<

Alpha amount is the number shown.

(blank)

Alpha amount is the number shown.

BETA_SIGN

Indicates whether the Container Beta (CNTR_BETA) number is a less than value.

1

0

Alpha-Numeric

X

<

Beta amount less than number shown.

(blank)

Beta amount is the number shown.

C14_ACT

The total activity of C-14 within a LLRW shipment. Unit of measure is the manifest record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

CARRIER_CD

Carrier Code

2

Alpha-Numeric

X(2)

N/A

N/A

CARRIER_NAME

Carrier Name

50

Alpha-Numeric

X(50)

N/A

N/A

CARRIER_ADDR1

Carrier Address 1

50

Alpha-Numeric

X(50)

N/A

N/A

CARRIER_ADDR2

Carrier Address 2

50

Alpha-Numeric

X(50)

N/A

N/A

CARRIER_CITY

Carrier City

50

Alpha-Numeric

X(50)

N/A

N/A

CARRIER_STATE

Carrier State

2

Alpha-Numeric

X(2)

N/A

N/A

CARRIER_ZIP

Carrier Zip Code

5

Alpha-Numeric

X(5)

N/A

N/A

CARRIER_ZIP4

Carrier ZIP Suffix

4

Alpha-Numeric

X(4)

N/A

N/A

CARRIER_

CONTACT

Carrier Contact

50

Alpha-Numeric

X(50)

N/A

N/A

CARRIER_PHONE

Carrier Phone

20

Alpha-Numeric

X(20)

N/A

N/A

CERT_NUM

An NRC or host state certificate of compliance number. Refers to a specific container type, i.e., High Integrity Container.

16

0

Alpha-Numeric

X(16)

N/A

N/A

CHE_AGENT1

The primary chelating agent used in a LLRW waste type.

16

0

Alpha-Numeric

X(16)

N/A

N/A

CHE_AGENT2

The secondary chelating agent used in a LLRW waste type.

16

0

Alpha-Numeric

X(16)

N/A

N/A

CHE_PCT1

The percentage of the primary chelating agent by weight of waste.

5

2

Numeric

999.99

N/A

N/A

CHE_PCT2

The percentage of the secondary chelating agent by weight of waste.

5

2

Numeric

999.99

N/A

N/A

CHEM_FORM

A description of the chemical form of a specific radionuclide within a container.

25

0

Alpha-Numeric

X(25)

N/A

N/A

CNSGNEE_ID

The Tracking System Permit number assigned to the receiving facility of a LLRW shipment.

6

0

Alpha-Numeric

XX9999

Positions 1-2: State abbreviation

Positions 3-6: Sequential number for permits in that state.

CNSGNOR_ID

The Tracking System Permit number assigned to the sending facility of a LLRW shipment.

6

0

Alpha-Numeric

XX9999

Positions 1-2: State abbreviation

Positions 3-6: Sequential number for permits in that state.

CNTR_ACTVY

The total activity of all waste within a LLRW container. Units of measure are indicated by the record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

CNTR_ALPHA

The surface contamination of a LLRW container in alpha disintegrations per minute: (dpm)/100 cm2.

5

0

Numeric

99999

N/A

N/A

CNTR_BETA

The surface contamination of a container in beta disintegrations per minute: (dpm)/100 cm2.

5

0

Numeric

99999

N/A

N/A

CNTR_NUM

The unique identification number assigned to each LLRW container within a shipment.

16

0

Alpha- Numeric

X(16)

N/A

N/A

CNTR_TYPE

A code identifying the container type of a LLRW container.

3

0

Alpha- Numeric

XXX

BUW

Bulk unpackaged waste

CTL

Concrete tank or liner

DMZ

Demineralizer

FBB

Fiberboard box

FBD

Fiber drum

FTL

Fiberglass tank

GCY

Gas cylinder

HIC

High integrity container

MBC

Metal box or crate

MDP

Metal drum or pail

MTL

Metal tank or liner

OTH

Other

PDP

Plastic drum or pail

PLT

Pallet

PTL

Polyethylene tank

SLC

Sealand container

UNP

Unpacked components

WBC

Wooden box or crate

CNTR_VOL

The total volume (outside dimension) of a LLRW container, in cubic feet.

7

2

Numeric

99999.99

N/A

N/A

CNTR_WGT

The total weight of a LLRW container, including the contents, in pounds.

5

0

Numeric

99999

N/A

N/A

COMB_VOL

The post-consolidation volume of a container.

7

2

Numeric

99999.99

N/A

N/A

DOT_LABEL

The USDOT label which applies to a LLRW container.

1

0

Numeric

9

0

Empty

1

White-I

2

Yellow-II

3

Yellow-III

4

Oxidizer

5

Spontaneously combustible

6

Corrosive

7

N/A

DOT_UN_ID

The identification number for the proper shipping name of a LLRW container.

6

0

Alpha-Numeric

XXXXXX

UN1219

Isopropanol or Isopropyl alcohol

UN1280

Propylene oxide

UN1325

Flammable solids, organic, n.o.s.

UN1595

Dimethyl sulfate

UN1671

Phenol, solid

UN1987

Alcohols, n.o.s.

UN1993

Flammable liquid, n.o.s.

UN2029

Hydrazine, anhydrous

UN2908

Radioactive material, excepted package − emptying packaging

UN2909

Radioactive material, excepted package − articles manufactured from natural uranium or depleted uranium or thorium

UN2910

Radioactive material, excepted package – empty package

UN2911

Radioactive material, excepted package – instruments or articles

UN2912

Radioactive material, low specific activity (LSA-I) non- fissile or fissile-excepted

UN2913

Radioactive material, surface contaminated object (SCO-I or SCO-II) non- fissile or fissile-excepted

UN2915

Radioactive material, Type A package non-special form, non-fissile or fissile-excepted

UN2916

Radioactive

material, Type B (U) package non-fissile or fissile-excepted

UN2917

Radioactive material, Type B (M) package non-fissile or fissile-excepted

UN2919

Radioactive material, transported under special arrangement, non-fissile or fissile-excepted

UN2924

Flammable liquids, corrosive, n.o.s.

UN2928

Toxic solids, corrosive, organic, n.o.s.

UN2977

Radioactive material, uranium hexafluoride, fissile

UN2978

Radioactive material, uranium hexafluoride, non-fissile or fissile-excepted

UN3071

Mercaptans, liquid, toxic, flammable, n.o.s. or Mercaptan mixtures, liquid, toxic, flammable, n.o.s., flash point not less than 23 degrees

UN3077

Environmentally hazardous substances, solid, n.o.s.

UN3084

Corrosive solids, oxidizing, n.o.s.

UN3224

Self-reactive solid type C

UN3265

Corrosive liquid, acidic, organic, n.o.s.

UN3286

Flammable liquid, toxic, corrosive, n.o.s.

UN3321

Radioactive material, low specific activity (LSA-II) non- fissile or fissile-excepted

UN3322

Radioactive material, low specific activity (LSA-III) non- fissile or fissile- excepted

UN3327

Radioactive material, Type A package, fissile non-special form

UN3328

Radioactive material, Type B (U) package, fissile

UN3329

Radioactive material, Type B (M) package, fissile

UN3331

Radioactive material, transported under special arrangement, fissile

UN3332

Radioactive material, Type A package, special form non-fissile or fissile-excepted

UN3333

Radioactive material, Type A package, special form, fissile

UN3399

Organometallic substance, liquid, water-reactive, flammable

UN3439

Nitriles, toxic, solid, n.o.s.

UNEXMT

Exempt packaging

EPA_MANIF

The EPA manifest number assigned to a LLRW shipment which has EPA regulated waste.

12

0

Alpha- Numeric

X(12)

N/A

N/A

EXCLUS_USE

A flag indicating whether a LLRW shipment is an exclusive use shipment, i.e., a shipment which cannot be opened after shipment except by the consignee.

1

0

Alpha- Numeric

X

T

True

F

False

Y

Yes

N

No

H3_ACT

The total activity of H-3 within a LLRW shipment. Unit of measure is indicated by record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

I129_ACT

The total activity of I-129 within a LLRW shipment. Unit of measure is indicated by record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

LSA_SCO

The group notation for a shipment of Low Specific Activity material or Surface Contaminated Objects.

4

0

Alpha-Numeric

XXXX

LSA1

Low Specific Activity − I

LSA2

Low Specific Activity − II

LSA3

Low Specific Activity − III

SCO1

Surface Contaminated Objects − I

SCO2

Surface Contaminated Objects − II

N/A

N/A

MANIF_NUM

The unique number assigned to a LLRW shipment by the sending or receiving facility

13

0

Alpha- Numeric

X(13)

N/A

N/A

NUCL_ACTVY

The activity level for a specific radionuclide within a given LLRW container. Units of measure indicated by the record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

OP_FLAG

A logical flag indicating whether a LLRW container requires disposal in an approved structural overpack.

1

0

Alpha- Numeric

X

T

True

F

False

Y

Yes

N

No

PCT_SIGN

Indicates whether the radionuclide percentage (RADIO_PCT) number is a less than value.

1

0

Alpha- Numeric

X

<

Percent amount is less than the number given.

(blank)

Percent amount is the number given.

PERMIT_NUM

The Tracking System permit number assigned to the holding facility of a LLRW container.

6

0

Alpha- Numeric

XX9999

N/A

Positions 1-2: State abbreviation.

Positions 3-6: Sequential number for permits in that state.

PHYS_FORM

A code indicating the physical form of LLRW within the container.

1

0

Alpha- Numeric

X

G

Gas

L

Liquid

S

Solid

PREV_CNSNR

The Tracking System permit number assigned to the facility sending a LLRW shipment for depleting.

6

0

Alpha- Numeric

XX9999

Positions 1-2: State abbreviation.

Positions 3-6: Sequential number for permits in that state.

PREV_CNTR

The previous unique identification number of a container which has been consolidated into the current container.

16

0

Alpha- Numeric

X(16)

N/A

N/A

PREV_MANF

The manifest number assigned to the shipment in which the previous container (PREV_CNTR) was received.

10

0

Alpha- Numeric

X(10)

N/A

N/A

PREV_PCT

The percentage of the consolidated container (PREV_CNTR) that has been consolidated into the current container.

3

0

Numeric

999

N/A

N/A

RAD_MEAS

A code indicating the units used to measure the radiation level of a LLRW container (SURF_RADIA).

1

0

Alpha-Numeric

X

M

R

Millirems per hour (mR/hr)

Rems per hour (R/hr)

RAD_SIGN

Indicates whether the radiation level of a LLRW container (SURF_RADIA) is less than the value given.

1

0

Alpha-Numeric

X

<

Radiation level less than number given.

(blank)

Radiation level is the number given.

RADIO_PCT

The percentage of a radionuclide within a LLRW container with respect to all radionuclides within the container.

6

3

Numeric

999.999

N/A

N/A

RADIONUCL

The abbreviated atomic name of a radionuclide within a LLRW container.

8

0

Alpha-Numeric

XXXXXXXX

N/A

Any valid radionuclide atomic symbol with atomic weight (C12 scale), e.g. C14, TC99, or CA40.

REC_TYPE

The EDT record type of the current record.

3

0

Alpha-Numeric

X99

M01

Original manifest record

M02

Consolidated manifest record

M03

Out of state consolidated manifest record

C02

Consolidated container record

C04

Container removed from inventory record

C05

Original container record

W01

Waste Type record

I05

Radionuclide record

P01

Consolidated container pointer record

SNM_GRAMS

The weight of a specific radionuclide of special nuclear material (U-233, U-235) in grams.

10

7

Numeric

999.9999999

N/A

N/A

SSS_BRAND

The brand name of a particular stabilization, sorbent, or solidification media (SSS_MEDIA) within a LLRW waste type.

15

0

Alpha-Numeric

X(15)

N/A

N/A

SSS_MEDIA

A code identifying the particular stabilization, sorbent or solidification media (SSS_MEDIA) within a LLRW waste type.

3

0

Numeric

999

60

Speedi Dri

61

Celetom

62

Floor Dry/Superfine

63

Hi Dri

64

Safe T Sorb

65

Safe N Dri

66

Florco

67

Florco X

68

Solid A Sorb

69

Chemsil 30

70

Chemsil 50

71

Chemsil 3030

72

Dicaperl HP200

73

Dicaperl HP500

74

Petroset

75

Petroset II

76

Aquaset

77

Aquaset II

89

Other Sorbent

90

Cement

91

Concrete

(Encapsulation)

92

Bitumen

93

Vinyl Chloride

94

Vinyl Ester Styrene

99

Other solidification

100

None Required

SSS_VENDOR

The vendor of a particular stabilization, sorbent, solidification media (SSS_MEDIA) within a LLRW waste type.

15

0

Alpha-Numeric

X(15)

N/A

N/A

SURF_RADIA

The radiation level measure on contact with a LLRW container. Units of measure indicated by the record's RAD_MEAS value.

8

2

Numeric

999999.99

N/A

N/A

TC99_ACT

The total activity of TC-99 within a LLRW shipment. Units of measure indicated by the record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

TOT_ACTVY

The total activity of all containers in a LLRW shipment. Units of measure indicated by the record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

TOT_CNTRS

The total number of containers in a LLRW shipment.

6

0

Numeric

999999

N/A

N/A

TOT_SNM_WT

The total weight of all radionuclides of special nuclear material within a LLRW shipment, measured in grams.

10

7

Numeric

999.9999999

N/A

N/A

TOT_SRC_WT

The total weight of source material on a LLRW shipment, in pounds.

9

2

Numeric

9999999.99

N/A

N/A

TOT_VOLUME

The total volume of all containers in a LLRW shipment, in cubic feet.

10

2

Numeric

99999999.00

N/A

N/A

TOT_WEIGHT

The total weight of all containers in a LLRW shipment, in pounds.

10

0

Numeric

9999999999

N/A

N/A

TRANS_INDX

The transportation index for a package label on a LLRW container.

10

0

Alpha-Numeric

X(10)

N/A

N/A

VOL_MEAS

The volume unit of measure.

1

0

Alpha-Numeric

X

F

Cubic Feet

M

Cubic Meters

WASTE_CLAS

The waste classification of a LLRW waste type.

2

0

Alpha-Numeric

XX

AS

Class A stable

AU

Class A unstable

B

Class B

C

Class C

C

Greater than Class C

WASTE_CODE

A code indicating whether the waste in a waste type has been collected or processed.

1

0

Alpha-Numeric

X

C

Collected

P

Processed

D

De-

commissioned

(blank)

Neither

WASTE_TYPE

A code indicating the specific type of waste type.

2

0

Alpha-Numeric

XX

20

Charcoal

21

Incinerator ash

22

Soil

23

Gas

24

Oil

25

Aqueous liquid

26

Filter media

27

Mechanical filter

28

EPA Hazardous

29

Demolition rubble

30

Cation ion-exchange media

31

Anion ion-exchange media

32

Mixed bed ion-exchange media

33

Contaminated equipment

34

Organic liquid (except oil)

35

Glassware or lab ware

36

Sealed source/device

37

Paint or plating

38

Evaporator bottoms, sludges, concentrates

39

Compactible trash

40

Non-compactible trash

41

Animal carcasses

42

Biological material (except animal caracasses)

43

Activated material

44

Mixed waste

59

Other

WASTE_VOL

The volume of the specific waste type (WASTE_TYPE) within a LLRW container, in cubic feet.

7

2

Numeric

99999.99

N/A

N/A

WSTE_ACTVY

The total activity of all radionuclides within a waste type. Units are indicated by the record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

History

• Source: Amended at 38 Ill. Reg. 12088, effective May 29, 2014

32 Ill. Adm. Code 609.APPENDIX A Electronic Data Transmission

Any person required under Section 609.50(b), (c), (d) or (e) to report shipment information to the Agency shall prepare an Electronic Data Transmission (EDT) file for submittal to the Agency. This EDT file contains the pertinent information regarding the shipment in general (consignee, consignor, etc.) and the waste in detail (waste type, volume, activity, isotopes, etc.). The files shall be submitted to the Agency in electronic format via email to the address ema.LLRWTRACK@illinois.gov.

A) EDT FILE RECORD TYPE DESCRIPTION

a) The information regarding the shipment of low-level radioactive waste (LLRW) contained in the EDT file is provided using the five different types of records. Each record type focuses on a specific aspect of the shipment. The record types are as follows:

1. The "M" (Manifest) record contains the summary information about the waste shipment. This information is summary level information that is normally contained on the shipping papers prepared to accompany the shipment.

2. The "C" (Container) record contains information about the waste container. This information details for each container comprised in the shipment the contents of that container.

3. The "W" (Waste Type) record contains information about the waste types in the container. Detailed information regarding the waste form contained in each container is provided using the "W" record.

4. The "I" (Isotope) record contains information about the isotopes contained in each waste type in each container. Each specific isotope contained in each waste type reported in each container is identified, along with the associated activity information.

5. The "P" (Pointer) record contains cross-reference information about each original container that has been consolidated into the current container. This record is used by a broker or processor to identify which original containers are currently packaged in a consolidated container. The use of the "P" record prevent the unnecessary report of information already contained in the Agency data base.

b) The record types described in paragraph (A)(a) of this Appendix are further subdivided based on the specific reporting requirements for the various shipment scenarios. These specific record types include:

1. "M01" − This record type indicates that the record contains summary information about an original LLRW shipment. This record type shall always be followed by one or more container ("C05") records.

2. "M02" − This record type indicates that the record contains summary information about a consolidated LLRW shipment. This record type shall always be used when all information on the containers being consolidated has already been reported to and verified by the Agency, and shall always be followed by one or more container ("C02") records.

3. "M03" − This record type indicates that the record contains summary information about a consolidated LLRW shipment originating out of the State of Illinois. This record type shall always be accompanied by at least one original shipment ("M01") record, and followed by one or more container ("C02") records.

4. "C02" − This record type indicates that the record contains information about a specific container in a consolidated LLRW shipment. This record type is used in conjunction with the "M02" record types, and shall always be followed by one or more consolidated container ("P01") records. There shall be one "C02" record for each container in the shipment.

5. "C04" − This record type indicates that the record contains information about a container that has been depleted (stored for decay to background, incinerated with no residue attributed to the generator or shipper, or ownership transferred from the generator to the receiving entity). It is not used in conjunction with any other record. There shall be one "C04" record for each depleted container reported.

6. "C05" − This record type indicates that the record contains information about a specific container in an original LLRW shipment. This record type is used in conjunction with the "M01" record type, and shall always be followed by one or more waste type ("W01") records. There shall be one "C05" record for each container in the shipment.

7. "P01" − This record type indicates that the record contains information about a container that has been consolidated. This record type is used in conjunction with the "C02" record type. There is one "P01" record for each previous container consolidated in the current container.

8. "W01" − This record type indicates that the record contains information about a specific waste type within an original container. This record type is used in conjunction with the "C05" record type, and shall always be followed by one or more isotope "I05" records. There is one "W01" record for each waste type in the container.

9. "I05" − This record type indicates that the record contains information about a specific isotope within a waste type within an original container. This record type is used in conjunction with the "W01" record type. There shall be one "I05" record for each isotope in each waste type present in the container.

c) A detailed listing of the data elements that comprise these various record types is shown on Table A-1 of this Part. Table A-2 of this Part provides the data element definitions as well as the field size, type and format, and usage codes.

B) SHIPMENT SCENARIOS AND EDT FILE FORMAT REQUIREMENTS

a) For purpose of defining the EDT file format requirements, the various transaction scenarios can be combined into the following groupings:

1. Original shipment (both in-state and out-of-state).

2. Consolidated or continuing shipment by an Illinois shipper or a consolidated or continuing shipment of Illinois generated LLRW to a facility in Illinois by an out-of-state shipper.

3. Consolidated or Continuing Shipment by an out-of-state shipper of out-of-state generated LLRW to a facility located in Illinois.

4. Report of depleted containers.

b) Original shipments are prepared and sent by the generator of the LLRW. Consolidated or continuing shipments are those shipments sent from a broker, collector, processor or storer of LLRW.

c) The following defines the record type requirements for the shipment scenarios listed in this paragraph B.

1. Original shipment (both in-region and out-of-region)

Each EDT file for an original shipment of LLRW sent into, out of, or within the State of Illinois shall contain a "M01" record. There shall be a "C05" record for each container of LLRW present in the shipment, followed by a "W01" record for each waste type present in the container, followed by an "I05" record for each isotope present in each waste type.

2. Consolidated or continuing shipment by an Illinois shipper or a consolidated or continuing shipment of Illinois generated LLRW to a facility in Illinois by an out-of-state shipper. Each EDT file for a consolidated or continuing shipment of Illinois generated LLRW shall contain a "M02" record. There shall be a "C02" record for each container of consolidated or continuing LLRW present in the shipment, followed by a "P01" record for each previous container present in the consolidated or continuing container.

3. Consolidated or continuing shipment by an out-of-state shipper of out-of-state generated LLRW to a facility located in Illinois:

A) Since the Tracking System will have no record of the out-of-state generated LLRW received by an out-of-state facility, the out-of-state facility needs to report those records for the LLRW it ships into Illinois. This is accomplished by providing information comparable to that provided for an original shipment as part of the EDT file for the shipment into Illinois.

B) For each incoming shipment of LLRW to the out-of-state facility of out-of-state generated LLRW represented on the shipment to an Illinois facility, there will be a "M01" record followed by a "C05" record for each original container of LLRW present in the shipment, followed by a "W01" record for each waste type present in the container, followed by an "I05" record for each isotope present in each waste type. For the consolidated or continuing shipment by an out-of-state shipper of out-of-state generated LLRW to an Illinois facility there will be a "M03" record followed by a "C02" record for each container of consolidated or continuing LLRW present in the shipment, followed by a "P01" record for each previous container present in the consolidated or continuing container.

4. Report of Depleted Containers

Illinois facilities that deplete LLRW need to report those depleted containers to the Agency in order for that waste to be removed from the tracking system. For purposes of the tracking system, LLRW is depleted when it has been stored for decay, incinerated with no residue attributed back to the original generator, or otherwise had the ownership of the waste transferred (as in the melting of contaminated metal into usable shielding blocks). The facilities report the depleted containers to the Agency using an EDT file composed of one "C04" record for each container depleted.

History

• Source: Amended at 38 Ill. Reg. 12088, effective May 29, 2014

Chapter II Illinois Emergency Management Agency

Subchapter d Low Level Radioactive Waste/Transportation

Part 609 Access to Facilities for Treatment, Storage, or Disposal of Low-Level Radioactive Waste

32 Ill. Adm. Code 609.TABLE A-2 Data Element Definitions

TABLE A-2

NAME

DEFINITION

FIELD SIZE

DECIMAL PLACES

FIELD TYPE

FIELD FORMAT

USAGE CODE

CODE DESCRIPTION

ACT_SHIP

The actual shipment date of a LLRW shipment.

8

0

Numeric (Date)

YYYYMMDD

N/A

N/A

ACTVY_MEAS

The units used to measure activity (Curies or Millicuries, Microcuries, Becquerels, Terrabecquerels, Gigabecquerels, Megabecquerels, Kilobecquerels)

1

0

Alpha-Numeric

X

C

Curies

M

Millicuries

U

Microcuries

B

Becquerels

T

Terrabecquerels

G

Gigabecquerels

E

Megabecquerels

K

Kilobecquerels

ACTVY _ SIGN

Indicates whether the activity number is a less than value.

1

0

Alpha-Numeric

X

<

Activity value is less than number shown.

(blank)

Alpha amount is the number shown.

ALPHA_SIGN

Indicates whether the Container Alpha (CNTR_ALPHA) number is a less than value

1

0

Alpha-Numeric

X

<

Alpha amount is the number shown.

(blank)

Alpha amount is the number shown.

BETA_SIGN

Indicates whether the Container Beta (CNTR_BETA) number is a less than value.

1

0

Alpha-Numeric

X

<

Beta amount less than number shown.

(blank)

Beta amount is the number shown.

C14_ACT

The total activity of C-14 within a LLRW shipment. Unit of measure is the manifest record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

CARRIER_CD

Carrier Code

2

Alpha-Numeric

X(2)

N/A

N/A

CARRIER_NAME

Carrier Name

50

Alpha-Numeric

X(50)

N/A

N/A

CARRIER_ADDR1

Carrier Address 1

50

Alpha-Numeric

X(50)

N/A

N/A

CARRIER_ADDR2

Carrier Address 2

50

Alpha-Numeric

X(50)

N/A

N/A

CARRIER_CITY

Carrier City

50

Alpha-Numeric

X(50)

N/A

N/A

CARRIER_STATE

Carrier State

2

Alpha-Numeric

X(2)

N/A

N/A

CARRIER_ZIP

Carrier Zip Code

5

Alpha-Numeric

X(5)

N/A

N/A

CARRIER_ZIP4

Carrier ZIP Suffix

4

Alpha-Numeric

X(4)

N/A

N/A

CARRIER_

CONTACT

Carrier Contact

50

Alpha-Numeric

X(50)

N/A

N/A

CARRIER_PHONE

Carrier Phone

20

Alpha-Numeric

X(20)

N/A

N/A

CERT_NUM

An NRC or host state certificate of compliance number. Refers to a specific container type, i.e., High Integrity Container.

16

0

Alpha-Numeric

X(16)

N/A

N/A

CHE_AGENT1

The primary chelating agent used in a LLRW waste type.

16

0

Alpha-Numeric

X(16)

N/A

N/A

CHE_AGENT2

The secondary chelating agent used in a LLRW waste type.

16

0

Alpha-Numeric

X(16)

N/A

N/A

CHE_PCT1

The percentage of the primary chelating agent by weight of waste.

5

2

Numeric

999.99

N/A

N/A

CHE_PCT2

The percentage of the secondary chelating agent by weight of waste.

5

2

Numeric

999.99

N/A

N/A

CHEM_FORM

A description of the chemical form of a specific radionuclide within a container.

25

0

Alpha-Numeric

X(25)

N/A

N/A

CNSGNEE_ID

The Tracking System Permit number assigned to the receiving facility of a LLRW shipment.

6

0

Alpha-Numeric

XX9999

Positions 1-2: State abbreviation

Positions 3-6: Sequential number for permits in that state.

CNSGNOR_ID

The Tracking System Permit number assigned to the sending facility of a LLRW shipment.

6

0

Alpha-Numeric

XX9999

Positions 1-2: State abbreviation

Positions 3-6: Sequential number for permits in that state.

CNTR_ACTVY

The total activity of all waste within a LLRW container. Units of measure are indicated by the record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

CNTR_ALPHA

The surface contamination of a LLRW container in alpha disintegrations per minute: (dpm)/100 cm2.

5

0

Numeric

99999

N/A

N/A

CNTR_BETA

The surface contamination of a container in beta disintegrations per minute: (dpm)/100 cm2.

5

0

Numeric

99999

N/A

N/A

CNTR_NUM

The unique identification number assigned to each LLRW container within a shipment.

16

0

Alpha- Numeric

X(16)

N/A

N/A

CNTR_TYPE

A code identifying the container type of a LLRW container.

3

0

Alpha- Numeric

XXX

BUW

Bulk unpackaged waste

CTL

Concrete tank or liner

DMZ

Demineralizer

FBB

Fiberboard box

FBD

Fiber drum

FTL

Fiberglass tank

GCY

Gas cylinder

HIC

High integrity container

MBC

Metal box or crate

MDP

Metal drum or pail

MTL

Metal tank or liner

OTH

Other

PDP

Plastic drum or pail

PLT

Pallet

PTL

Polyethylene tank

SLC

Sealand container

UNP

Unpacked components

WBC

Wooden box or crate

CNTR_VOL

The total volume (outside dimension) of a LLRW container, in cubic feet.

7

2

Numeric

99999.99

N/A

N/A

CNTR_WGT

The total weight of a LLRW container, including the contents, in pounds.

5

0

Numeric

99999

N/A

N/A

COMB_VOL

The post-consolidation volume of a container.

7

2

Numeric

99999.99

N/A

N/A

DOT_LABEL

The USDOT label which applies to a LLRW container.

1

0

Numeric

9

0

Empty

1

White-I

2

Yellow-II

3

Yellow-III

4

Oxidizer

5

Spontaneously combustible

6

Corrosive

7

N/A

DOT_UN_ID

The identification number for the proper shipping name of a LLRW container.

6

0

Alpha-Numeric

XXXXXX

UN1219

Isopropanol or Isopropyl alcohol

UN1280

Propylene oxide

UN1325

Flammable solids, organic, n.o.s.

UN1595

Dimethyl sulfate

UN1671

Phenol, solid

UN1987

Alcohols, n.o.s.

UN1993

Flammable liquid, n.o.s.

UN2029

Hydrazine, anhydrous

UN2908

Radioactive material, excepted package − emptying packaging

UN2909

Radioactive material, excepted package − articles manufactured from natural uranium or depleted uranium or thorium

UN2910

Radioactive material, excepted package – empty package

UN2911

Radioactive material, excepted package – instruments or articles

UN2912

Radioactive material, low specific activity (LSA-I) non- fissile or fissile-excepted

UN2913

Radioactive material, surface contaminated object (SCO-I or SCO-II) non- fissile or fissile-excepted

UN2915

Radioactive material, Type A package non-special form, non-fissile or fissile-excepted

UN2916

Radioactive

material, Type B (U) package non-fissile or fissile-excepted

UN2917

Radioactive material, Type B (M) package non-fissile or fissile-excepted

UN2919

Radioactive material, transported under special arrangement, non-fissile or fissile-excepted

UN2924

Flammable liquids, corrosive, n.o.s.

UN2928

Toxic solids, corrosive, organic, n.o.s.

UN2977

Radioactive material, uranium hexafluoride, fissile

UN2978

Radioactive material, uranium hexafluoride, non-fissile or fissile-excepted

UN3071

Mercaptans, liquid, toxic, flammable, n.o.s. or Mercaptan mixtures, liquid, toxic, flammable, n.o.s., flash point not less than 23 degrees

UN3077

Environmentally hazardous substances, solid, n.o.s.

UN3084

Corrosive solids, oxidizing, n.o.s.

UN3224

Self-reactive solid type C

UN3265

Corrosive liquid, acidic, organic, n.o.s.

UN3286

Flammable liquid, toxic, corrosive, n.o.s.

UN3321

Radioactive material, low specific activity (LSA-II) non- fissile or fissile-excepted

UN3322

Radioactive material, low specific activity (LSA-III) non- fissile or fissile- excepted

UN3327

Radioactive material, Type A package, fissile non-special form

UN3328

Radioactive material, Type B (U) package, fissile

UN3329

Radioactive material, Type B (M) package, fissile

UN3331

Radioactive material, transported under special arrangement, fissile

UN3332

Radioactive material, Type A package, special form non-fissile or fissile-excepted

UN3333

Radioactive material, Type A package, special form, fissile

UN3399

Organometallic substance, liquid, water-reactive, flammable

UN3439

Nitriles, toxic, solid, n.o.s.

UNEXMT

Exempt packaging

EPA_MANIF

The EPA manifest number assigned to a LLRW shipment which has EPA regulated waste.

12

0

Alpha- Numeric

X(12)

N/A

N/A

EXCLUS_USE

A flag indicating whether a LLRW shipment is an exclusive use shipment, i.e., a shipment which cannot be opened after shipment except by the consignee.

1

0

Alpha- Numeric

X

T

True

F

False

Y

Yes

N

No

H3_ACT

The total activity of H-3 within a LLRW shipment. Unit of measure is indicated by record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

I129_ACT

The total activity of I-129 within a LLRW shipment. Unit of measure is indicated by record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

LSA_SCO

The group notation for a shipment of Low Specific Activity material or Surface Contaminated Objects.

4

0

Alpha-Numeric

XXXX

LSA1

Low Specific Activity − I

LSA2

Low Specific Activity − II

LSA3

Low Specific Activity − III

SCO1

Surface Contaminated Objects − I

SCO2

Surface Contaminated Objects − II

N/A

N/A

MANIF_NUM

The unique number assigned to a LLRW shipment by the sending or receiving facility

13

0

Alpha- Numeric

X(13)

N/A

N/A

NUCL_ACTVY

The activity level for a specific radionuclide within a given LLRW container. Units of measure indicated by the record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

OP_FLAG

A logical flag indicating whether a LLRW container requires disposal in an approved structural overpack.

1

0

Alpha- Numeric

X

T

True

F

False

Y

Yes

N

No

PCT_SIGN

Indicates whether the radionuclide percentage (RADIO_PCT) number is a less than value.

1

0

Alpha- Numeric

X

<

Percent amount is less than the number given.

(blank)

Percent amount is the number given.

PERMIT_NUM

The Tracking System permit number assigned to the holding facility of a LLRW container.

6

0

Alpha- Numeric

XX9999

N/A

Positions 1-2: State abbreviation.

Positions 3-6: Sequential number for permits in that state.

PHYS_FORM

A code indicating the physical form of LLRW within the container.

1

0

Alpha- Numeric

X

G

Gas

L

Liquid

S

Solid

PREV_CNSNR

The Tracking System permit number assigned to the facility sending a LLRW shipment for depleting.

6

0

Alpha- Numeric

XX9999

Positions 1-2: State abbreviation.

Positions 3-6: Sequential number for permits in that state.

PREV_CNTR

The previous unique identification number of a container which has been consolidated into the current container.

16

0

Alpha- Numeric

X(16)

N/A

N/A

PREV_MANF

The manifest number assigned to the shipment in which the previous container (PREV_CNTR) was received.

10

0

Alpha- Numeric

X(10)

N/A

N/A

PREV_PCT

The percentage of the consolidated container (PREV_CNTR) that has been consolidated into the current container.

3

0

Numeric

999

N/A

N/A

RAD_MEAS

A code indicating the units used to measure the radiation level of a LLRW container (SURF_RADIA).

1

0

Alpha-Numeric

X

M

R

Millirems per hour (mR/hr)

Rems per hour (R/hr)

RAD_SIGN

Indicates whether the radiation level of a LLRW container (SURF_RADIA) is less than the value given.

1

0

Alpha-Numeric

X

<

Radiation level less than number given.

(blank)

Radiation level is the number given.

RADIO_PCT

The percentage of a radionuclide within a LLRW container with respect to all radionuclides within the container.

6

3

Numeric

999.999

N/A

N/A

RADIONUCL

The abbreviated atomic name of a radionuclide within a LLRW container.

8

0

Alpha-Numeric

XXXXXXXX

N/A

Any valid radionuclide atomic symbol with atomic weight (C12 scale), e.g. C14, TC99, or CA40.

REC_TYPE

The EDT record type of the current record.

3

0

Alpha-Numeric

X99

M01

Original manifest record

M02

Consolidated manifest record

M03

Out of state consolidated manifest record

C02

Consolidated container record

C04

Container removed from inventory record

C05

Original container record

W01

Waste Type record

I05

Radionuclide record

P01

Consolidated container pointer record

SNM_GRAMS

The weight of a specific radionuclide of special nuclear material (U-233, U-235) in grams.

10

7

Numeric

999.9999999

N/A

N/A

SSS_BRAND

The brand name of a particular stabilization, sorbent, or solidification media (SSS_MEDIA) within a LLRW waste type.

15

0

Alpha-Numeric

X(15)

N/A

N/A

SSS_MEDIA

A code identifying the particular stabilization, sorbent or solidification media (SSS_MEDIA) within a LLRW waste type.

3

0

Numeric

999

60

Speedi Dri

61

Celetom

62

Floor Dry/Superfine

63

Hi Dri

64

Safe T Sorb

65

Safe N Dri

66

Florco

67

Florco X

68

Solid A Sorb

69

Chemsil 30

70

Chemsil 50

71

Chemsil 3030

72

Dicaperl HP200

73

Dicaperl HP500

74

Petroset

75

Petroset II

76

Aquaset

77

Aquaset II

89

Other Sorbent

90

Cement

91

Concrete

(Encapsulation)

92

Bitumen

93

Vinyl Chloride

94

Vinyl Ester Styrene

99

Other solidification

100

None Required

SSS_VENDOR

The vendor of a particular stabilization, sorbent, solidification media (SSS_MEDIA) within a LLRW waste type.

15

0

Alpha-Numeric

X(15)

N/A

N/A

SURF_RADIA

The radiation level measure on contact with a LLRW container. Units of measure indicated by the record's RAD_MEAS value.

8

2

Numeric

999999.99

N/A

N/A

TC99_ACT

The total activity of TC-99 within a LLRW shipment. Units of measure indicated by the record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

TOT_ACTVY

The total activity of all containers in a LLRW shipment. Units of measure indicated by the record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

TOT_CNTRS

The total number of containers in a LLRW shipment.

6

0

Numeric

999999

N/A

N/A

TOT_SNM_WT

The total weight of all radionuclides of special nuclear material within a LLRW shipment, measured in grams.

10

7

Numeric

999.9999999

N/A

N/A

TOT_SRC_WT

The total weight of source material on a LLRW shipment, in pounds.

9

2

Numeric

9999999.99

N/A

N/A

TOT_VOLUME

The total volume of all containers in a LLRW shipment, in cubic feet.

10

2

Numeric

99999999.00

N/A

N/A

TOT_WEIGHT

The total weight of all containers in a LLRW shipment, in pounds.

10

0

Numeric

9999999999

N/A

N/A

TRANS_INDX

The transportation index for a package label on a LLRW container.

10

0

Alpha-Numeric

X(10)

N/A

N/A

VOL_MEAS

The volume unit of measure.

1

0

Alpha-Numeric

X

F

Cubic Feet

M

Cubic Meters

WASTE_CLAS

The waste classification of a LLRW waste type.

2

0

Alpha-Numeric

XX

AS

Class A stable

AU

Class A unstable

B

Class B

C

Class C

C

Greater than Class C

WASTE_CODE

A code indicating whether the waste in a waste type has been collected or processed.

1

0

Alpha-Numeric

X

C

Collected

P

Processed

D

De-

commissioned

(blank)

Neither

WASTE_TYPE

A code indicating the specific type of waste type.

2

0

Alpha-Numeric

XX

20

Charcoal

21

Incinerator ash

22

Soil

23

Gas

24

Oil

25

Aqueous liquid

26

Filter media

27

Mechanical filter

28

EPA Hazardous

29

Demolition rubble

30

Cation ion-exchange media

31

Anion ion-exchange media

32

Mixed bed ion-exchange media

33

Contaminated equipment

34

Organic liquid (except oil)

35

Glassware or lab ware

36

Sealed source/device

37

Paint or plating

38

Evaporator bottoms, sludges, concentrates

39

Compactible trash

40

Non-compactible trash

41

Animal carcasses

42

Biological material (except animal caracasses)

43

Activated material

44

Mixed waste

59

Other

WASTE_VOL

The volume of the specific waste type (WASTE_TYPE) within a LLRW container, in cubic feet.

7

2

Numeric

99999.99

N/A

N/A

WSTE_ACTVY

The total activity of all radionuclides within a waste type. Units are indicated by the record's ACTVY_MEAS value.

24

10

Scientific

9.9999E99

N/A

N/A

History

• Source: Amended at 38 Ill. Reg. 12088, effective May 29, 2014

32 Ill. Adm. Code 609.TABLE A-1 Detailed Listing of Data Elements

TABLE A-1

Record Type "MO1"

Record Type "MO2"

Record Type "MO3"

Record Type

(REC_TYPE)

Record Type

(REC_TYPE)

Record Type

(REC_TYPE)

Manifest Number

(MANIF_NUM)

Manifest Number

(MANIF_NUM)

Manifest Number

(MANIF_NUM)

Consignor's Permit

(CNSGNOR_ID)

Consignor's Permit

(CNSGNOR_ID)

Consignor's Permit

(CNSGNOR_ID)

Consignee's Permit

(CNSGNEE_ID)

Consignee's Permit

(CNSGNEE_ID)

Consignee's Permit

(CNSGNEE_ID)

Total Container Count

(TOT_CNTRS)

Total Container Count

(TOT_CNTRS)

Total Container Count

(TOT_CNTRS)

Total Activity

(TOT_ACTVY)

Total Activity

(TOT_ACTVY)

Total Activity

(TOT_ACTVY)

Activity Unit of measure

(ACTVY_MEAS)

Activity Unit of measure

(ACTVY_MEAS)

Activity Unit of measure

(ACTVY_MEAS)

Total volume

(TOT_VOLUME)

Total volume

(TOT_VOLUME)

Total volume

(TOT_VOLUME)

Volume unit of measure

(VOL_MEAS)

Volume unit of measure

(VOL_MEAS)

Volume unit of measure

(VOL_MEAS)

Total weight

(TOT_WEIGHT)

Total weight

(TOT_WEIGHT)

Total weight

(TOT_WEIGHT)

Actual ship date

(ACT_SHIP)

Actual ship date

(ACT_SHIP)

Actual ship date

(ACT_SHIP)

EPA manifest number

(EPA_MANIF)

EPA manifest number

(EPA_MANIF)

EPA manifest number

(EPA_MANIF)

Total source material weight

(TOT_SRC_WT)

Total source material weight

(TOT_SRC_WT)

Total source material weight

(TOT_SRC_WT)

Total special nuclear material weight

(TOT_SNM_WT)

Total special nuclear material weight

(TOT_SNM_WT)

Total special nuclear material weight

(TOT_SNM_WT)

Total H-3 activity

(H3_ACT)

Total H-3 activity

(H3_ACT)

Total H-3 activity

(H3_ACT)

Total TC-99 activity

(TC99_ACT)

Total TC-99 activity

(TC99_ACT)

Total TC-99 activity

(TC99_ACT)

Total I-129 activity

(I129_ACT)

Total I-129 activity

(I129_ACT)

Total I-129 activity

(I129_ACT)

Total C-14 activity

(C14_ACT)

Total C-14 activity

(C14_ACT)

Total C-14 activity

(C14_ACT)

Exclusive use indicator

(EXCLUS_USE)

Exclusive use indicator

(EXCLUS_USE)

Exclusive use indicator

(EXCLUS_USE)

Carrier Code

(CARRIER_CODE)

Carrier Code

(CARRIER_CODE)

Carrier Code

(CARRIER_CODE)

Carrier Name

(CARRIER_NAME)

Carrier Name

(CARRIER_NAME)

Carrier Name

(CARRIER_NAME)

Carrier Address 1

(CARRIER_ADDR1)

Carrier Address 1

(CARRIER_ADDR1)

Carrier Address 1

(CARRIER_ADDR1)

Carrier Address 2

(CARRIER_ADDR2)

Carrier Address 2

(CARRIER_ADDR2)

Carrier Address 2

(CARRIER_ADDR2)

Carrier City

(CARRIER_CITY)

Carrier City

(CARRIER_CITY)

Carrier City

(CARRIER_CITY)

Carrier State

(CARRIER_STATE)

Carrier State

(CARRIER_STATE)

Carrier State

(CARRIER_STATE)

Carrier Zip

(CARRIER_ZIP)

Carrier Zip

(CARRIER_ZIP)

Carrier Zip

(CARRIER_ZIP)

Carrier Zip4

(CARRIER_ZIP4)

Carrier Zip4

(CARRIER_ZIP4)

Carrier Zip4

(CARRIER_ZIP4)

Carrier Contact

(CARRIER_CONTACT)

Carrier Contact

(CARRIER_CONTACT)

Carrier Contact

(CARRIER_CONTACT)

Carrier Contact Phone

(CARRIER_PHONE)

Carrier Contact Phone

(CARRIER_PHONE)

Carrier Contact Phone

(CARRIER_PHONE)

TABLE A-1 (continued)

Record Type "CO2"

Record Type "CO4"

Record Type "CO5"

Record Type

(REC_TYPE)

Record Type

(REC_TYPE)

Record Type

(REC_TYPE)

Consignor's Permit

(CNSGNOR_ID)

Holding facility permit

(PERMIT_NUM)

Consignor's Permit

(CNSGNOR_ID)

Manifest Number

(MANIF_NUM)

Consignor's Permit

(CNSGNOR_ID)

Manifest Number

(MANIF_NUM)

Container Number

(CNTR_NUM)

Manifest Number

(MANIF_NUM)

Container Number

(CNTR_NUM)

Container volume

(CNTR_VOL)

Container Number

(CNTR_NUM)

Container Volume

(CNTR_VOL)

Volume Unit of Measure

(VOL_MEAS)

Volume Unit of Measure

(VOL_MEAS)

Container type

(CNTR_TYPE)

Container type

(CNTR_TYPE)

Container activity

(CNTR_ACTVY)

Container activity

(CNTR_ACTVY)

Activity units of measure

(ACTVY_MEAS)

Activity units of measure

(ACTVY_MEAS)

Container Alpha

(CNTR_ALPHA)

Container Alpha

(CNTR_ALPHA)

Alpha less than indicator

(ALPHA_SIGN)

Alpha less than indicator

(ALPHA_SIGN)

Container Beta

(CNTR_BETA)

Container Beta

(CNTR_BETA)

Beta less than indicator

(BETA_SIGN)

Beta less than indicator

(BETA_SIGN)

Container disposition

(CNTR_DISP)

Container disposition

(CNTR_DISP)

Over pack indicator

(OP_FLAG)

Over pack indicator

(OP_FLAG)

Surface radiation

(SURF_RADIA)

Surface radiation

(SURF_RADIA)

Surface radiation units

(RAD_MEAS)

Surface radiation units

(RAD_MEAS)

Rad less than indicator

(RAD_SIGN)

Rad less than indicator

(RAD_SIGN)

DOT Label

(DOT_LABEL)

DOT Label

(DOT_LABEL)

Container weight

(CNTR_WGT)

Container weight

(CNTR_WGT)

DOT UN ID number

(DOT_UN_ID)

DOT UN ID number

(DOT_UN_ID)

Transport Index

(TRANS_INDEX)

Transport index

(TRANS_INDX)

Cert. of Compliance

(CERT_NUM)

Cert. of compliance

(CERT_NUM)

TABLE A-1 (continued)

Record Type "WO1"

Record Type

(REC_TYPE)

Consignor's Permit

(CNSGNOR_ID)

Manifest Number

(MANIF_NUM)

Container Number

(CNTR_NUM)

Waste Type

(WASTE_TYPE)

Waste activity

(WST_ACTVY)

Activity units of measure

(ACTVY_MEAS)

Waste Classification

(WASTE_CLAS)

Waste volume

(WASTE_VOL)

Volume unit of measure

(VOL_MEAS)

Waste code

(WASTE_CODE)

Physical form

(PHYS_FORM)

SSS media

(SSS_MEDIA)

SSS vendor

(SSS_VENDOR)

SSS brand

(SSS_BRAND)

Chelating agent 1

(CHE_AGENT1)

% of chelating agent 1

(CHE_PCT1)

Chelating agent 2

(CHE_AGENT2)

% of chelating agent 2

(CHE_PCT2)

LSA/SCO indicator

(LSA_SCO)

TABLE A-1 (continued)

Record Type "I05"

Record Type

(REC_TYPE)

Consignor's Permit

(CNSGNOR_ID)

Manifest Number

(MANIF_NUM)

Container Number

(CNTR_NUM)

Waste Type

(WASTE_TYPE)

Radionuclide

(RADIONUCL)

Radionuclide activity

(NUCL_ACTVY)

Activity units of measure

(ACTVY_MEAS)

Activity less than indicator

(ACTVY_SIGN)

Radionuclide percentage

(RADIO_PCT)

% less than indicator

(PCT_SIGN)

Special nuclear material grams

(SNM_GRAMS)

Chemical form

(CHEM_FORM)

TABLE A-1 (continued)

Record Type "PO1"

Record Type

(REC_TYPE)

Consignor's Permit

(CNSNOR_ID)

Manifest Number

(MANIF_NUM)

Container Number

(CNTR_NUM)

Previous Consignor's Permit

(PREV_CNSNR)

Previous manifest number

(PREV_MANF)

Previous container number

(PREV_CNTR)

Consolidated volume

(COMB_VOL

% of previous container

(PREV_PCT)

History

• Source: Amended at 38 Ill. Reg. 12088, effective May 29, 2014

Chapter II Illinois Emergency Management Agency and Office of Homeland Security

Subchapter d Low Level Radioactive Waste/Transportation

Part 620 Registration of Low-Level Radioactive Waste Generators

32 Ill. Adm. Code 620.10 Definitions

As used in this Part, the following definitions shall apply:

"Act" means the Illinois Low-Level Radioactive Waste Management Act [420 ILCS 20].

"Agency" means the Illinois Emergency Management Agency.

"Broker" means any person who takes possession of low-level radioactive waste solely for purposes of consolidation and shipment.

"Disposal" means the isolation of waste from the biosphere in a permanent facility designed for that purpose.

"Generator" means any person who produces or possesses low-level radioactive waste in the course of or incident to manufacturing, power generation, processing, medical diagnosis and treatment, research, education or other activity.

"Low-Level Radioactive Waste" or "Waste" means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel or byproduct material as defined in section 11e(2) of the Atomic Energy Act of 1954 (42 USC 2014).

"Person" means an individual, corporation, business enterprise or other legal entity either public or private and any legal successor, representative, agent or agency of that individual, corporation, business enterprise, or legal entity.

"Storage" means the holding of waste for treatment or disposal for a period

of 24 hours or more.

"Treatment" means any method, technique or process, including storage for radioactive decay, designed to change the physical, chemical or biological characteristics or composition of any waste in order to render the waste safer for transport, storage or disposal, amenable to recovery, convertible to another usable material or reduced in volume. (Section 3 of the Act)

History

• Source: Amended at 37 Ill. Reg. 12438, effective July 19, 2013

32 Ill. Adm. Code 620.20 Generator Registration

All generators shall register with the Agency within 60 days after commencement of producing or possessing any quantity of low-level radioactive waste in Illinois. Registration shall be on a form developed by the Agency and shall include:

a) name, address, officers and contact information for the generator;

b) radioactive materials license numbers and issuing agency;

c) the types and amounts of wastes produced or possessed and to be produced or possessed; and (Section 4(a) of the Act)

d) a description of the activities that produce low-level radioactive waste.

History

• Source: Amended at 37 Ill. Reg. 12438, effective July 19, 2013

32 Ill. Adm. Code 620.25 Broker Registration

All brokers shall register within 60 days after taking possession of any low-level radioactive waste. Registration shall be on a form developed by the Agency and shall include:

a) the name, address, officers and contact information for the broker;

b) the radioactive materials license numbers and issuing agency;

c) the types and amounts of waste possessed or to be possessed by the broker; and (Section 4(a) of the Act)

d) a description of activities conducted by the broker.

History

• Source: Amended at 37 Ill. Reg. 12438, effective July 19, 2013

32 Ill. Adm. Code 620.30 Filing of Annual Report by Generators

Each generator who has generated any low level waste during a given calendar year shall file an annual report with the Agency. The annual report shall be submitted by February 1. This report shall be on a form developed by the Agency and shall include:

a) the name, address and contact information for the generator;

b) the types and amounts of waste produced or possessed during the prior calendar year;

c) the types and amounts of waste expected to be produced or possessed in the future;

d) waste stored during the prior calendar year, including types and amounts;

e) waste shipped during the prior calendar year, including types, amounts and destination;

f) methods used to manage these wastes;

g) technological feasibility, economic reasonableness and environmental soundness of alternative treatment, storage and disposal methods.

History

• Source: Amended at 37 Ill. Reg. 12438, effective July 19, 2013

32 Ill. Adm. Code 620.35 Filing of Annual Reports by Brokers

Each broker who has taken possession of any low-level radioactive waste generated in Illinois during a given calendar year shall file an annual report with the Agency. The annual report shall be submitted by February 1. This report shall be on a form developed by the Agency or by electronic means that are compatible with the Agency's computer capabilities. The report shall include:

a) the name, address and contact information for the broker.

b) for waste shipped to disposal sites outside Illinois during the prior year, the disposal manifest information kept pursuant to 32 Ill. Adm. Code 340.1180. The original generator name and address and waste volume for each generator must be given for each shipment.

c) for waste permanently disposed of in Illinois during the prior year, in addition to the manifest information described in subsection (b), the types, amounts, dates disposed of and disposal methods.

d) for each shipment of waste received, the name and address of the generator from whom the waste was received and the volume and type of waste received.

e) for waste shipped for storage or treatment, the name and address of the entity to whom the waste is shipped and the volume and type of waste shipped.

History

• Source: Amended at 37 Ill. Reg. 12438, effective July 19, 2013

32 Ill. Adm. Code 620.40 Payment of Fees for Waste Storage

a) Generators that have stored any quantity of waste for shipment at a later date shall pay a fee to the Agency annually. The fee shall be in the amount of $3 per cubic foot of all waste stored for shipment.

b) The fee shall be calculated and invoiced by the Agency based on the Annual Survey submitted by the generator that identifies the types and amounts of waste stored during that period. Generators shall be responsible for reporting and paying all fees due and owing in accordance with this Section, except as provided in Sections 620.60 and 620.70.

History

• Source: Amended at 37 Ill. Reg. 12438, effective July 19, 2013

32 Ill. Adm. Code 620.50 Payment of Fees for Waste Shipped

a) Generators that have shipped any quantity of waste for storage, disposal or treatment shall pay a fee to the Agency annually. The fee shall be in the amount of $3 per cubic foot for waste that has been shipped, except that no fee shall be assessed if a fee has already been paid to the Agency for storage of that waste in accordance with Section 620.40.

b) The fee shall be calculated and invoiced by the Agency based on the Annual Survey submitted by the generator that identifies the types and amount of waste shipped during that period. Generators shall be responsible for reporting and paying all fees due and owing in accordance with this Section, except as provided in Sections 620.60 and 620.70.

History

• Source: Amended at 37 Ill. Reg. 12438, effective July 19, 2013

32 Ill. Adm. Code 620.60 Payment of Fees – Small Generators

Any generator of low-level radioactive waste that was not subject to fees in the amount of at least $50 for waste stored and shipped during a given calendar year in accordance with Sections 620.40 and 620.50 shall pay a fee in the amount of $50 for that calendar year to the Agency. The fee shall be payable when invoiced by the Agency.

History

• Source: Amended at 37 Ill. Reg. 12438, effective July 19, 2013

32 Ill. Adm. Code 620.70 Payment of Fees – Nuclear Power Reactors

In lieu of the fees specified in Sections 620.40, 620.50 and 620.60, the owner of any nuclear power reactor in Illinois for which an operating license has been issued by the Nuclear Regulatory Commission shall be required to pay an annual fee of $30,000 per operating reactor for the treatment, storage and disposal of low-level radioactive waste. Such fees shall be due and payable on July 1 of each year.

History

• Source: Amended at 37 Ill. Reg. 12438, effective July 19, 2013

32 Ill. Adm. Code 620.80 Non-Compliance with Registration and Filing of Reports

If any person fails or refuses to register with the Agency, to file required reports with the Agency, or to pay the required fees, the Agency shall notify the person by registered mail that he or she has (30) days to respond, after which the Agency may refer the case to the Attorney General. Any person failing to pay the fees shall be liable to a civil penalty not to exceed four times the amount of the fees not paid. (Section 17(b) of the Act)

History

• Source: Amended at 37 Ill. Reg. 12438, effective July 19, 2013

32 Ill. Adm. Code 620.90 Deposit of Fees (repealed)

History

• Source: Repealed at 37 Ill. Reg. 12438, effective July 19, 2013

Part 622 Handling and Disposal of Water Treatment Residuals

32 Ill. Adm. Code 622.10 Purpose and Scope

This Part establishes requirements for the possession and disposal of water treatment residuals including requirements for worker protection and training. This Part applies to all entities that produce or possess water treatment residuals.

32 Ill. Adm. Code 622.20 Definitions

The following terms found in this Part have the definitions set forth in this Section:

"Agency" means the Illinois Emergency Management Agency and Office of Homeland Security.

"As low as is reasonably achievable" or "ALARA" means making every reasonable effort to maintain exposures to radiation as far below the dose limits of Sections 622.30 and 622.40 as is practical, consistent with the purpose for which the registered activity is undertaken, taking into account the state of technology and the economics of improvements in relation to the state of technology, the economics of improvements in relation to benefits to public health and safety and other societal and socioeconomic considerations, and to the use of nuclear energy and licensed or registered sources of radiation in the public interest.

"Combined Radium" means the sum of the results of the analysis for radium-226 and the analysis for radium-228.

"Curie" or "Ci" is as defined in 32 Ill. Adm. Code 310.20.

"Dry weight basis" is as defined in 32 Ill. Adm. Code 310.20.

"Groundwater" means underground water which occurs within the saturated zone and geologic materials where the fluid pressure in the pore space is equal to or greater than atmospheric pressure. [415 ILCS 5/3.210]

"IEPA" means the Illinois Environmental Protection Agency.

"Low-level radioactive waste" means the definition contained in Section 3 of the Low Level Radioactive Waste Management Act [420 ILCS 20].

"Naturally occurring radioactive material" or "NORM" means materials that are undisturbed as a result of human activities and that contain any of the primordial radionuclides or radioactive elements as they occur in nature, such as radium, uranium, thorium, potassium, and their radioactive decay products. NORM does not include accelerator-produced, byproduct, source, or special nuclear material.

"Occupied" means any frequently occupied areas, including but not limited to offices, conference rooms, and breakrooms, as well as restricted areas when entered by workers. "Occupied" does not include infrequently used areas such as storage rooms, stairwells, restrooms, utility closets, elevator shafts, or hallways unless posted as a restricted area.

"Picocurie" or "pCi" means the quantity of radioactive material producing 2.22 nuclear transformations per minute.

"Person" means any individual, corporation, partnership, 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 foregoing, other than the United States Nuclear Regulatory Commission, or any successor thereto, and other than federal government agencies licensed by the United States Nuclear Regulatory Commission, or any successor thereto. "Person" also includes a federal entity (and its contractors) if the federal entity agrees to be regulated by the State or as otherwise allowed under federal law. [420 ILCS 40/4(e)]

"Publicly regulated treatment works" means private companies that the Illinois Commerce Commission regulates as public utilities engaged in the disposal of domestic and industrial wastes.

"Publicly owned treatment works" or "POTW" is as defined in Subpart A of 35 Ill. Adm. Code 310.

"Registrant" means persons who, due to the nature of the water treatment residuals they produce or possess, have additional regulatory requirements under this Part.

"Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sv).

"Sludge" means any solid, semisolid, or liquid waste generated from a municipal, commercial, or industrial wastewater treatment plant, water supply treatment plant, or air pollution control facility or any other such waste having similar characteristics and effects. [415 ILCS 5/3.465]

"Technologically enhanced naturally occurring radioactive material" or "TENORM" means naturally occurring radioactive material whose radionuclide concentrations are increased by or as a result of past or present human practices. TENORM does not include background radiation or the natural radioactivity of rocks or soils. TENORM does not include "source material" and "by-product material" as both are defined in the Atomic Energy Act of 1954 (42 U.S.C. 2011 et seq.), as amended, and relevant regulations implemented by the NRC.

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

"Treatment" means, for purposes of water treatment residuals only, any process that changes the physical, chemical, microbiological, or radiological properties of water, is under the control of the supplier, and is not a point-of-use treatment device or a point-of-entry treatment device as defined in 35 Ill. Adm. Code 611.101. Treatment includes, but is not limited to, aeration, coagulation, sedimentation, filtration, activated carbon treatment, disinfection, and fluoridation.

"USEPA" means the United States Environmental Protection Agency.

"Wastewater" means sewage, industrial waste, or other waste, or any combination of these, whether treated or untreated, plus any admixed land runoff.

"Wastewater treatment facility" means a treatment works owned by a municipality, sanitary district, county, or State agency that treats domestic and industrial wastes collected by a publicly owned or regulated sewer system. For the purposes of this Part, "wastewater treatment facility" encompasses both publicly owned treatment works and publicly regulated treatment works.

"Water treatment facility" means a plant or facility whose primary function is to treat raw water and to produce potable water for distribution, together with all the other real and personal property reasonably necessary to collect, treat, or distribute the water.

"Water treatment residuals" or "WRS" means biosolids, sludge, filter media, anthracite, scales, or other solids, either alone or as a component of liquid mixtures or solutions, that are technologically enhanced in combined radium concentration (radium-226, radium-228 or associated progeny) as a result of the treatment of water or sewage containing naturally occurring radium from groundwater.

"Working level" or "WL" means any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3 x 105 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

radon-220: polonium-216, lead-212, bismuth-212 and polonium-212.

"Working level month" or "WLM" means an exposure to 1 working level (WL) for 170 hours. (2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month.)

32 Ill. Adm. Code 622.30 Persons in Possession of Water Treatment Residuals

a) The following persons shall register with the Agency within 60 days of producing or possessing water treatment residuals:

1. Water treatment facilities permitted by the IEPA that treat groundwater with a treatment technology identified in subsections (a)(2)(B).

AGENCY NOTE: Persons who possess groundwater wells only as an emergency or backup source (i.e., a primary source of purchased or surface water) do not meet the registration requirements in subsection (a)(1) or (a)(2).

2. Water treatment facilities permitted by IEPA whose groundwater sources and utilized treatment technologies are identified in subsections (a)(2)(A) and (B):

A) Table 1. Aquifers designated to contribute elevated concentrations of radium to groundwater:

i) Cambrian

ii) Ordovician

iii) Devonian

iv) Silurian

v) Any other aquifer that gives rise to a maximum contaminant level for combined radium as specified in 35 Ill. Adm. Code 611.330.

B) Table 2. Treatment Technologies Capable of Concentrating Radium:

i) Ion exchange

ii) Reverse osmosis

iii) Lime softening

iv) Green sand filtration

v) Co-precipitation with Barium sulfate

vi) Electrodialysis/electrodialysis reversal

vii) Pre-formed hydrous manganese oxide filtration

viii) Activated alumina

ix) Enhanced coagulation filtration

x) Any other treatment technology that increases the combined radium concentration in the media or resulting water treatment residuals beyond that which is naturally present.

3. Wastewater treatment facilities permitted by IEPA and receiving treatment process backwash from a water treatment facility described in subsection (a)(2).

4. IEPA-permitted municipal solid waste landfills if the water treatment residuals generated by a registrant identified in subsections (a)(1), (a)(2), or (a)(3) are disposed of in those landfills;

5. Land applicators permitted by IEPA who apply water treatment residuals generated by a registrant identified in subsections (a)(2) or (a)(3); and

6. Any other person that the Agency determines is required to register.

b) Registrants in compliance with Section 622.30 who elect to dispose of water treatment residuals at a licensed low-level radioactive waste disposal facility will be exempted by the addition of Section 622.30(m).

c) Registrants may dispose or repurpose water treatment residuals under the provisions of this subsection (c) and the requirements of Title 35 of the Illinois Administrative Code, Subtitles C and G, as implemented by IEPA:

1. If the concentration of combined radium in the water treatment residuals is greater than 3.1 pCi/g and less than or equal to 100 pCi/g (dry weight basis), water treatment residuals may be:

AGENCY NOTE: Water treatment residuals with a combined radium concentration less than or equal to 3.1 pCi/g (dry weight basis) are not subject to the disposal requirements in this Section. However, registrants must maintain records of the combined radium concentration and the location where the material was disposed of.

A) Disposed at a facility authorized to receive such material under any federal or State solid or hazardous waste laws provided:

i) Combined radium concentration in pCi/g (dry weight basis) has been determined by a laboratory meeting the accreditation requirements in subsection (e)(1) with methods approved by the USEPA in Title 40 of the Code of Federal Regulations or by a screening method approved by the Agency in accordance with subsections (c)(1)(A)(ii);

ii) A registrant may apply to the Agency for approval to use a screening method instead of laboratory analysis to determine the combined radium concentration of water treatment residuals. Each application shall include: a description of the water treatment residuals being screened, including the physical and chemical properties of the material; a description of the proposed screening method including instruments or equipment to be used, calculations performed, and procedures for how a representative combined radium concentration can be obtained; and analyses and procedures to ensure that doses are maintained ALARA and within the dose limits in this Section;

iii) Water treatment residuals transported in compliance with the Illinois Vehicle Code [625 ILCS 5/15-109];

iv) Water treatment residuals that are easily dispersible are packaged or stabilized to prevent dispersion during transportation and/or landfill placement;

v) There is at least 10 feet of non-contaminated overburden between the water treatment residuals and grade level (at the time of landfill closure); and

B) Used for soil conditioning purposes on agricultural cropland (e.g., corn, soybeans) provided:

i) Land application is performed in accordance with and under the authorization of a current IEPA land application permit;

ii) Water treatment residuals are transported in compliance with the Illinois Vehicle Code [625 ILCS 5/15-109] covered during transportation;

iii) The combined radium concentration of the water treatment residuals (in pCi/g, dry weight basis) has been determined by a laboratory meeting the accreditation standards in subsection (e)(1) with methods approved by the USEPA in Title 40 of the Code of Federal Regulations or by a screening method approved by the Agency in accordance with subsection (c)(1)(B)(iv);

iv) A registrant may apply to the Agency for approval to use a screening method instead of laboratory analysis to determine the combined radium concentration of water treatment residuals. Each application shall include: a description of the water treatment residuals being screened, including the physical and chemical properties of the material; a description of the proposed screening method including instruments or equipment to be used, calculations performed, and procedures for how a representative combined radium concentration can be obtained; and analyses and procedures to ensure that doses are maintained ALARA and within the dose limits in Section 622.30.

v) Water treatment residuals shall be incorporated in accordance with the registrant’s land application permit. All water treatment residuals applied to land for soil conditioning purposes under this subsection (c)(1)(B)(v) shall be mixed with soil such that the limits specified in items (vi) and (viii) are not exceeded;

vi) The concentration of combined radium in the water treatment residuals and the application rate is such that, after the water treatment residuals are mixed with soil, the cumulative increase of the combined radium concentration in the soil does not exceed 1.0 pCi/g (compliance with this Section shall be calculated as an addition of 1778 microcuries per acre, dry weight basis);

vii) This increased limit applies to the sum of all land applications of water treatment residuals on a specific tax parcel of land;

viii) At no time shall the application of water treatment residuals result in the combined radium concentration in the soil exceeding 3.1 pCi/g (the mean natural background as determined by the Agency of 2.1 pCi/g and the soil concentration increase limit of 1.0 pCi/g due to water treatment residuals application);

ix) The landowner or an authorized agent of the landowner must acknowledge awareness that water treatment residuals are being applied to the land (this acknowledgement must be updated as landownership changes). The acknowledgement shall contain, at a minimum, the language provided in 622.APPENDIX A;

x) Before using a parcel of land for the application of water treatment residuals for the first time, the registrant must determine the combined radium concentration in the soil;

xi) Soil sample collection shall be conducted to be representative of the entire water treatment residual application site at a depth of 12 inches and may be submitted for analysis as a single composite sample;

xii) Land receiving application of water treatment residuals shall not be used for the cultivation of tobacco; and

xiii) When calculating the increase in combined radium concentration, a soil density value of 90 pounds/cubic foot and a mixing depth of 1 foot shall be used unless the registrant is utilizing site-specific soil density values. Corrections to the cumulative increase of combined radium may be adjusted for the decay of radium-228.

C) Disposed by release into sanitary sewerage.

D) Disposed using an alternative method approved by the Agency before disposal, under 32 Ill. Adm. Code 340.1020.

2. If the concentration of combined radium in the water treatment residuals is greater than 100 pCi/g (dry weight basis) and less than or equal to 200 pCi/g (dry weight basis), water treatment residuals may be disposed of:

A) Using an alternative method approved by the Agency before disposal, under 32 Ill. Adm. Code 340.1020;

B) In an IEPA-permitted facility authorized to receive such material. Disposals shall:

i) Be reviewed and approved by the Agency in advance.

ii) Comply with all requirements in subsection (c)(1)(A).

C) By release into sanitary sewerage.

D) At a facility authorized to dispose of such material under any federal or State solid or hazardous waste laws as long as the registrant ensures compliance with 32 Ill. Adm. Code 340.1060, as applicable.

d) Registrants identified in subsection (a)(2), which requires workers, contractors, or other persons to come into contact with water treatment residuals during routine and maintenance work shall sample the residuals and receive results before the next scheduled service, or as soon as practicable for emergency work, to determine compliance under this Section and Section 622.40 and to identify potential worker exposure concerns.

e) All analysis of water treatment residuals shall be conducted:

1. By a laboratory certified to perform radiological analysis by the U.S. Environmental Protection Agency, the International Organization of Standardization (ISO 17025- general requirements for the competence of testing and calibration laboratories), or the National Environmental Laboratory Accreditation Conference (NELAC). The combined radium concentration will be determined by a method approved by the Agency.

2. At a frequency specified in the registrant’s IEPA land application permit. If an IEPA permit does not specify a radium sampling frequency, or for landfill or alternative disposals approved by the Agency, sample frequency shall be no less than one representative sample per year.

3. Utilizing a sampling methodology that ensures analyses are representative of the water treatment residuals being disposed of or repurposed. The registrant shall:

A) Utilize applicable guidance, such as EPA SW-846, American Water Works Association B100, or USEPA’s RCRA Waste Sampling Guidance, where procedures for representative sampling are absent (i.e., those for disposal of water treatment resins or filters);

B) To the extent practicable, collect samples before removing the water treatment residuals from the treatment system; and

C) Ensure composite samples comply with the following requirements:

i) Sub-samples comprising a composite shall be drawn from homogenous waste (i.e., process waste that has been shown to be homogenous);

ii) If homogeneity cannot be confirmed, then a representative composite sample comprised of six sub-samples shall be taken to determine the average concentration;

iii) No single measurement used to calculate an average shall exceed five times the exemption criteria (i.e., 1000 pCi/g); and

iv) Each waste container is considered a separate waste volume (i.e., two waste volumes cannot be averaged).

f) Nothing in this Section relieves the registrant from complying with all other applicable federal, State and local government regulations governing toxic or hazardous properties of water treatment residuals that are disposed of or repurposed under this Section.

g) No person producing or possessing water treatment residuals shall cause violations of the requirements of Title 35 of the Illinois Administrative Code, Subtitles C and G, as implemented by the IEPA.

h) The total effective dose equivalent to workers or individual members of the public from the registrant’s operation shall not exceed 1 millisievert (0.1 rem) in any year, exclusive of the dose contribution from:

1. Background radiation;

2. Any medical administration the individual has received;

3. Exposure to individuals administered radioactive material and released in accordance with 32 Ill. Adm. Code 335;

4. Voluntary participation in medical research programs;

5. A radioactive material licensee's disposal of radioactive material into sanitary sewerage under 32 Ill. Adm. Code 340.1030; and

6. Radon and its progeny.

i) Registrants shall limit radon exposure to workers.

1. Registrants identified in subsections (a)(1), (a)(2), and (a)(3) shall conduct radon measurements in accordance with 32 Ill. Adm. Code 422 by [date certain], and at least once every five calendar years following the initial testing.

A) Measurements shall be conducted immediately before exchanging of exhausted filter media, or if the media is not scheduled to be exchanged during the measurement window, as close to the end of the measurement window as practical to allow for maximum loading of radium onto the filter media.

B) Radon concentrations shall be retested following the guidance outlined above within a year of any of the following circumstances occurring:

i) A new addition is constructed or alterations for building reconfiguration or rehabilitation occur;

ii) A ground contact area not previously tested is occupied;

iii) Treatment technologies capable of concentrating radium are newly installed or altered. Altering treatment technologies does not include activities such as replacing worn-out equipment or filter media while leaving the remainder of the system unchanged;

iv) A facility begins receiving treatment process backwash from a new (additional) water treatment facility or alterations are made to the treatment technologies at existing facilities that supply treatment process backwash. Alterations to treatment technologies do not include activities such as replacing worn-out equipment or filter media while leaving the remainder of the system unchanged;

v) The use of a new or different primary water source drawn from an aquifer designated to contribute elevated concentrations of radium to groundwater;

vi) Heating or cooling systems are altered with changes to air distribution or pressure relationships;

vii) Ventilation is altered by extensive weatherization, changes to mechanical systems, or comparable procedures;

viii) Alterations or renovations resulting in sizable openings are made to the facility’s foundation, or flooring or natural settlement occurs causing major cracks to develop; or

ix) An installed mitigation system is altered or repaired.

AGENCY NOTE: Agency recommends radon mitigation when radon concentrations in routinely occupied areas are found to be greater than 4.0 pCi/L, and recommends considering mitigation for concentrations between 2.0 and 4.0 pCi/L.

2. Registrants shall ensure that worker exposure from radon within all occupied areas does not exceed 30 pCi/L or 0.3 WL, based on continuous workplace exposure for 40 hours per week, 52 weeks per year, and shall not exceed 4 WLM over a 12-month period, using an equilibrium ratio of 50 percent to convert radon exposure to WLM.

j) Persons producing or possessing water treatment residuals shall not cause contamination of any area exceeding the values specified in Appendix A of 32 Ill. Adm. Code 340.

k) For fixed facilities, registrants shall comply with 32 Ill. Adm. Code 340.920(e) and post each area, tank, basin, or room in which an amount of material exceeding ten times the quantity of radium-226 and radium-228 specified in Appendix C to 10 CFR 20, effective January 1, 2004, is used or stored with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION RADIOACTIVE MATERIALS" or "DANGER RADIOACTIVE MATERIALS". Areas visible to the public may be posted within the confines of the barrier (fencing, hatch, etc.) but must remain visible to workers entering the restricted area;

AGENCY NOTE: The referenced value is 1.0 microcurie. This equates to 5 kg at 200 pCi/g.

l) Registrants shall comply with 32 Ill. Adm. Code 310.60 through 310.90, the Radon Industry Licensing Act [420 ILCS 44] and 32 Ill. Adm. Code 422.

m) Registrants in compliance with Section 622.30 are exempt from the requirements of 32 Ill. Adm. Code 340.1060(e).

32 Ill. Adm. Code 622.40 Worker Protection and Disposal Requirements for Water Treatment Residuals Greater Than 200 Pci/G

a) This Section only applies to persons producing or possessing water treatment residuals with concentrations of combined radium greater than 200 pCi/g (dry weight basis).

b) Persons producing or in possession of water treatment residuals identified in subsection (a) shall:

1. Register with the Agency within 60 days of becoming subject to subsection (a) in a format specified by the Agency;

2. Limit Dose to Workers and Members of the Public. Registrants shall conduct operations so that:

A) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with 32 Ill. Adm. Code 335, does not exceed 0.02 millisievert (0.002 rem) in any single hour.

B) Before allowing a worker or a member of the public to enter a restricted area, instructions are given on radiation hazards and protective measures to that individual. These instructions must comply with subsection (b)(11).

C) Persons entering restricted areas or performing work in contact with water treatment residuals identified in subsection (a) are supplied with appropriate personal protective equipment (PPE). PPE shall include, at a minimum, protective barriers to prevent inadvertent ingestion or inhalation of airborne particles of radioactive material as well as to limit the spread of contamination from the work area.

D) Procedures are in place to ensure doses to workers are kept as low as reasonably achievable and in compliance with this Part. Emergency work that results in work duties or exposures outside the scope of TENORM awareness training provided for workers as outlined in Section 622.50(a) shall be reported to the Agency within 45 days. The report shall include proposed revisions to the registrant’s training agenda or operating procedures necessary to maintain compliance with this Part.

AGENCY NOTE: Calculation of doses for compliance with this subsection may be based upon calibrated radiation meter survey data and worker occupancy times, or work area monitoring, rather than an individual worker dosimetry program.

3. Employ institutional and engineered controls to limit exposure of water treatment residuals to personnel and the environment.

A) If, during the course of operation, noncompliance with the limits specified in subsection (b)(2) is discovered, the registrant shall submit alternative procedures to the Agency within 45 days after discovery.

B) Continued inability to comply with the protective limits specified in subsection (b)(2) may result in the Agency requiring the registrant to comply with the specific license requirements in 32 Ill. Adm. Code 330 and additional training required for workers.

4. Afford the Agency, at all reasonable times, the opportunity to inspect sources of radiation and the premises and facilities in which those sources of radiation are used or stored, and records maintained under this Section.

5. Perform radiation surveys to demonstrate compliance with this Section. Surveys shall be done to evaluate:

A) Gamma radiation exposure rate in all occupied areas, at a minimum, of once per year;

B) Gamma radiation exposure rate in restricted areas before, during, and after work requiring entry; and

C) Potential contamination of workers and the work area immediately following work in restricted areas.

6. Ensure use of calibrated radiation detection instruments. Instruments and equipment used for quantitative radiation measurements (e.g., exposure rate and contamination monitoring) shall be calibrated at intervals not to exceed 12 months for the radiation measured. To satisfy this requirement, the registrant shall:

A) Post a legible note on the instrument showing the date of calibration; and

B) Ensure that instrument calibrations are performed by persons specifically licensed by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State to perform such calibrations.

7. Provide notices and instructions to workers.

A) Each registrant shall post, in conspicuous places easily visible to workers, current copies of the following documents:

i) This Part;

ii) Agency Form KLA.001 “Notice to Employees”;

iii) The operating procedures applicable to activities under the registration;

iv) Any notice of violation or administrative order involving radiological working conditions and any response from the registrant; and

v) All radiological surveys, analytical media analysis results, and radon testing results.

B) If the posting of a document specified in subsection (b)(7)(A) is not practicable, the registrant may post a notice summarizing the documents and the location where the documents may be examined.

C) The registrant shall post Agency notices of violation or administrative orders involving radiological working conditions, along with any responses from the registrant, within 5 working days after receipt of the notice or order. The registrant's response, if any, shall be posted within 5 working days after the registrant sends it to the Agency. The documents shall remain posted for a at least 5 working days or until action correcting the violation has been completed, whichever is later.

D) All individuals whose job duties do not require entry into restricted areas or contact with material identified in subsection (a) shall be provided instruction which includes, at a minimum, the material identified in Section 622.50(a), (b), and (c). The initial instruction and annual refreshers must last at least one hour.

E) All individuals working in, or the performance of whose duties requires access to any portion of a restricted area or who frequent areas where radioactive material is used or stored shall be instructed, at a minimum, in all content described in Section 622.50.

F) The registrant shall maintain records of initial and annual employee training for five years after the date of the training.

8. Shall identify a responsible individual with sufficient knowledge and authority to prevent unsafe practices, approve radiation safety-related issues and communicate promptly to an appropriate level of management. The designated official shall be responsible for ensuring the requirements specified in this Part are adequately implemented.

c) Any person who receives, possesses, uses, or transfers water treatment residuals with concentrations of combined radium greater than 200 pCi/g (dry weight basis), and is not otherwise a registrant under Section 622.30 (including, but not limited to, vendors, contractors, service providers, consultants, low-level radioactive waste brokers, or persons performing decommissioning work) shall obtain a radioactive material license 32 Ill. Adm. Code 330.

AGENCY NOTE: The requirement to obtain a license does not apply to the transportation of water treatment residuals. However, persons transporting water treatment residuals must comply with all other applicable federal, State and local government regulations.

d) The registrant shall notify the Agency before removing material identified in subsection (a) from the facility for disposal, treatment, or transport. Such notification shall include the location, quantity, proposed dates, and proposed method for disposal.

AGENCY NOTE: For the purposes of this subsection, "disposal, treatment, or transport" does not apply to discharge to a sanitary sewer.

1. Unless specifically authorized by a radioactive material license or elsewhere in this Section, registrants are not authorized to transport material identified in subsection (a) outside the site where the registrant is authorized to produce and possess the material.

2. Before releasing, repurposing, or repair of equipment (piping, pumps, tanks, etc.) that has been contaminated with material identified in subsection (a), the registrant shall remove or provide for the removal of such contaminants and ensure that:

A) The equipment is decontaminated to the lowest practicable level before release. Unless the Agency specifies another value, the values specified in Appendix A of 32 Ill. Adm. Code 340 shall serve as guidelines for this purpose.

B) The total amount of contamination does not exceed the quantities listed in Appendix C to 10 CFR 20.

AGENCY NOTE: Notification to the Agency is not required when transport is incidental to shipment for analytical services.

e) Registrants may dispose of material by:

1. Disposal by Release into Sanitary Sewerage. A registrant may discharge material into the sanitary sewer if each of the following conditions is satisfied:

A) The registrant provides information on the nature of the discharge to the water treatment facility and receives written authorization from that facility before discharge;

B) Wastewater treatment facilities receiving discharges authorized this subsection are registered and in compliance with the provisions of Section 622.30; and

AGENCY NOTE: Discharges of material identified in subsection (a) to a wastewater treatment facility will require that facility to register under Section 622.30 due to the unquantified impact the material will have on the facility's water treatment residuals. Receiving wastewater treatment plants may have local pretreatment standards restricting such discharges.

C) The total quantity of material identified in subsection (a) that the registrant releases into the sanitary sewer in a year does not exceed 1.0 Ci.

2. An alternative disposal method may be used if the Agency reviews and approves it beforehand under 32 Ill. Adm. Code 340.1020; or

3. The material may be disposed of at a facility authorized to dispose of such material in accordance with any federal or State solid or hazardous waste laws as long as the following conditions are satisfied:

A) Packaging, decommissioning, preparation of manifests, and shipment of material is performed by persons with a specific radioactive material license from the Agency, authorized Agreement State or the NRC to perform such work; and

B) The registrant ensures compliance with 32 Ill. Adm. Code 340.1060, as applicable.

f) Persons producing or possessing water treatment residuals shall not cause contamination of any area exceeding the values specified in Appendix A of 32 Ill. Adm. Code 340.

32 Ill. Adm. Code 622.50 Tenorm Awareness Training for Registrants

a) For those registrants identified in Section 622.40, TENORM awareness training (1-2 hours at a minimum) shall be included as part of the facility’s health and safety training program and conducted before starting of any job duties associated with a radiological hazard.

b) TENORM Awareness Training shall contain, at a minimum, policies and procedures for each facility, including the management policy to maintain all personnel exposure as low as reasonably achievable. Additionally, workers shall be:

1. Kept informed of the storage, transfer, or use of sources of radiation and the identity of restricted areas;

2. Instructed, at appropriate levels of detail, in the health protection problems associated with exposure to radiation or radioactive material, in the risks of radiation exposure to the embryo and fetus, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;

3. Instructed in, and instructed to observe to the extent within the worker's control, the requirements in Section 622.40 for the protection of personnel from exposure to radiation or radioactive material;

4. Instructed to report promptly to the licensee or registrant any condition that may constitute, lead to, or cause a violation of the Radiation Protection Act of 1990 [420 ILCS 40], the requirements of Section 622.40 or unnecessary exposure (i.e., exposure that results when prescribed safety measures are not followed) to radiation or radioactive material;

5. Advised of the mechanisms in place to ensure workers' exposures within the limits established in Sections 622.30(i)(2) and 622.40(b)(2).

c) These instructions shall be of sufficient detail to avoid radiological hazards and shall be given directly to each worker either in writing or in an orientation course, with the workers signing a statement that they have received the information listed in subsection (b) and understand it. Refresher training that covers all of the required topics shall be provided at intervals not to exceed 12 months.

d) In addition to TENORM Awareness Training, training for workers whose job duties may involve entering restricted areas or contact with material identified in Section 622.40(a) shall include the following:

1. Fundamentals of Radiation Safety:

A) Introduction to NORM and TENORM;

B) Characteristics of alpha, beta, and gamma radiation;

C) Units of radiation dose and quantity of radioactivity associated with TENORM;

D) Hazards of exposure to different kinds of radiation;

E) Levels of radiation from TENORM sources of radiation;

F) Methods of controlling radiation dose through time, distance and shielding, ventilation, decontamination, and source reduction to reduce doses as low as practicable; and

G) Methods of avoiding intake or exposure to radiation through the use of personal protective equipment, proper working procedures, and decontamination.

2. Radiation Detection Instruments, including:

A) Use, operation, and limitations of radiation survey instruments for alpha, beta and gamma radiation;

B) Survey techniques, including ambient and frisking methods;

C) Surveying and sampling for NORM and TENORM; and

D) Monitoring equipment and action levels for radon.

3. Proper Use of Personnel Protective Equipment (PPE), including:

A) Different types of PPE;

B) Donning of PPE;

C) Removal of PPE;

D) Decontamination techniques; and

E) Use of respiratory protection equipment and radon mitigation as needed.

4. Identification of areas requiring posting and labeling, including identification of known and potential TENORM-containing areas. This includes pumps and piping where mineral scale accumulates; lagoons, flocculation tanks, and sedimentation tanks where residual sludge accumulates; filters, pumping stations, and storage tanks where scales and sludge accumulate; facilities where filter backwash, brines, or other contaminated water accumulates; facilities that are enclosed (radon); and residuals processing or handling areas.

5. Containerization, storage, and disposal of TENORM wastes.

6. Requirements of pertinent federal and State of Illinois regulations.

7. Topics and discussions of assigned activities during normal and abnormal situations involving exposure to TENORM that can reasonably be expected to occur during work activities.

e) Recommended Training for Instructors. Instructors of TENORM courses should have adequate and commensurate experience in field operations associated with TENORM activities at water and wastewater facilities. The field experience work needs to include sufficient time in radiation protection and the use of radiation detection equipment.

32 Ill. Adm. Code 622.60 General Variance

A variance is a temporary exemption from this Part, that the Agency may grant with or without conditions for a period of up to five years upon the presentation of adequate proof by the petitioner that compliance with a requirement would impose an undue hardship. A person filing a petition for a variance shall provide the information in subsections (a) through (h) to the Agency. If the petitioner believes that any of the required information does not apply to the specific variance requested, the petitioner shall include an explanation.

AGENCY NOTE: The filing of a petition for a variance does not stay enforcement of a requirement of this Part.

a) A statement describing the requirement from which the petitioner seeks a variance. The statement must include the citation to that requirement;

b) A complete and concise description of the nature of the petitioner's activity that is the subject of the proposed variance, including:

1. Location of, and area affected by, the petitioner's activity;

2. Location of points of disposal or repurposing, and, as applicable, the identification of the receiving waterway or land;

3. Identification of any prior variance issued to the petitioner and, if known, the petitioner's predecessors, concerning similar relief;

4. An explanation of other permits or licenses held by any other federal, state, or local agency that is affected by this variance request;

5. Nature and amount of the materials used in the process or activity for which the petitioner seeks a variance, and a full description of the particular process or activity in which the materials are used;

6. Description of the relevant measures to mitigate the accumulation of TENORM already in use; and

7. Nature and amount of disposal, discharges, or releases of the material in question currently generated by the petitioner's activity.

c) A description of the efforts that would be necessary for the petitioner to achieve immediate compliance with the requirement at issue. All possible compliance alternatives, with the corresponding costs for each alternative, shall be identified. The description of compliance alternatives shall include the availability of alternate methods of compliance, the extent that the methods were studied, and the comparative factors leading to the selection of the proposed alternative for compliance. The description of the costs of immediate compliance should include the overall capital costs and the annualized capital and operating costs, if applicable;

d) Facts setting forth the reasons the petitioner believes immediate compliance with the requirement would impose an arbitrary or unreasonable hardship;

e) A detailed description of the compliance plan, including:

1. Discussion of the proposed equipment or proposed alternative measures to mitigate TENORM accumulation to be undertaken to achieve full compliance with the requirement;

2. Schedule for the implementation of all phases of the proposed alternative compliance measures from initiation of design to program completion; and

3. The estimated costs involved for each phase and the total cost to achieve compliance.

f) A description of the environmental impact of the petitioner's activity, including:

1. Nature and amount of disposals, discharges, or releases of the material in question if the Agency grants the requested variance, compared to that identified in subsection (b)(7);

2. Quantitative demonstration that actions undertaken during the period of variance will not result in any individual members of the public receiving more than 1 millisievert (0.1 rem) TEDE annually (excluding the contribution from radon) from all licensed or registered sources of radiation, including water treatment residuals; and

3. A statement of the measures to be undertaken during the period of the variance to minimize the impact of the discharge of contaminants on human, plant, and animal life in the affected area, including the numerical interim discharge limitations that can be achieved during the period of the variance.

g) A proposed beginning and ending date for the variance. If the petitioner requests that the term of the variance begin on any date other than the date on which the Agency takes final action on the petition, a detailed explanation and justification for the alternative beginning date; and

h) Any other information the Agency deems necessary.

32 Ill. Adm. Code 622.70 Maintenance of Records & Inspections

a) Maintain records. Each registrant shall maintain records showing compliance with this Part for five years. Records may be stored in electronic media with the capability to produce legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications shall include all pertinent information such as stamps, initials, and signatures.

1. Each registrant with a combined radium concentration greater than 3.1 pCi/g (dry weight basis) shall maintain records of the following:

A) Registrants who dispose of water treatment residuals in an IEPA-permitted municipal solid waste landfill or a facility authorized to dispose of that material in accordance with any federal or State solid or hazardous waste laws:

i) Quantity of water treatment residuals disposed of;

ii) Concentration of combined radium in pCi/g (dry weight basis) contained in the water treatment residuals;

iii) Dates the water treatment residuals were disposed of in a landfill;

iv) Name and location of the landfill receiving the water treatment residuals; and

v) Any additional records showing compliance with this Part requested by the Agency.

B) Registrants who land apply water treatment residuals:

i) Tax parcel identification number of lands utilized for application of water treatment residuals;

ii) County, township, section, and range in which the tax parcel lies;

iii) Tillable acres for the tax parcel;

iv) A signed landowner acknowledgement form for the tax parcel;

v) Total dry tons of water treatment residuals applied to the tax parcel;

vi) For each application, the concentration of radium-226 and radium-228 in pCi/g (dry weight basis) contained in the water treatment residuals;

vii) Dates the water treatment residuals were land applied;

viii) The cumulative increase and total combined radium concentration in the soil for each tax parcel having received application of water treatment residuals; and

ix) Any additional records showing compliance with this Part requested by the Agency.

2. Registrants identified in Section 622.40 who dispose of residuals via release into sanitary sewerage shall maintain documentation demonstrating that the total quantity of material released in a year does not exceed 1.0 Ci.

3. Registrants who dispose or repurpose water treatment residuals approved by the Agency under 32 Ill. Adm. Code 340.1020 shall maintain documentation in accordance with this Section.

4. All Registrants shall maintain documentation pertaining to radon measurements.

b) Registrants shall make records available for Agency inspection in accordance with Section 27 of the Radiation Protection Act of 1990 [420 ILCS 40/27]. In addition, the registrant shall afford the Agency, at all reasonable times, an opportunity to inspect sources of radiation, and the premises and facilities in which those sources of radiation are used or stored, and records maintained under this Section.

c) Registrants shall post or make available to employees all records of radiation survey measurements, water treatment residuals analysis results, and radon measurements.

32 Ill. Adm. Code 622.80 Noncompliance and Reporting of Incidents

a) Each registrant shall report to the Agency any noncompliance with this Part within 30 days after the noncompliance is discovered.

b) Each registrant shall, within 30 days of discovery of the event, report to the Agency each event involving loss of control of water treatment residuals possessed by the registrant that may have caused, or threatens to cause, an unplanned contamination event outside of a restricted area exceeding the values specified in Appendix A of 32 Ill. Adm. Code 340.

AGENCY NOTE: Reports can be made to EMA.RadiumResiduals@illinois.gov or the 24-hour IEMA-OHS Communications Center (217-782-7860).

c) Persons found to have caused or contributed to violations of the requirements of this Part may be required to:

1. Remediate under the Agency's rules in Title 32 of the Illinois Administrative Code;

2. Reimburse for remediation efforts initiated on the person's behalf under 32 Ill. Adm. Code 310; and

3. Obtain a radioactive material license in accordance with 32 Ill. Adm. Code 330.

32 Ill. Adm. Code 622.90 Notifications to the Agency

All notifications to the Agency concerning the requirements of this Part shall be sent to EMA.RadiumResiduals@illinois.gov.

32 Ill. Adm. Code 622.APPENDIX A Landowner Acknowledgement Form

At a minimum, the following language shall be included in the landowner acknowledgement form required in Section 622.30(c)(1)(B)(ix). Failure to include this language and to have the landowner sign and date shall invalidate the acknowledgement.

The Illinois Environmental Protection Agency, as well as the U.S. Environmental Protection Agency, requires the water treatment residuals you are receiving to be monitored for trace metals, organic and inorganic chemicals, and pathogens. In addition, the Illinois Emergency Management Agency and Office of Homeland Security (IEMA-OHS) requires the monitoring of radium under 32 Ill. Adm. Code 622 (Part 622). Radium is naturally present in soil and groundwater. When removed from water and land-applied, these water treatment residuals could elevate the radium content in the soil above natural levels.

IEMA-OHS, as the regulatory agency for ionizing radiation, requires that land-applied water treatment residuals be monitored for radium, including the cumulative amount of radium, deposited on agricultural fields. Fields that approach the regulatory limit of 3.1 pCi/g are required to utilize alternative sources of fertilizer (i.e., water treatment residuals without elevated radium from water). The additional monitoring and land application provisions of Part 622 ensure that the public is protected from significant health, environmental, and agricultural impacts.

This form serves as an acknowledgement of awareness by the landowner, or authorized agent of the landowner, that biosolids applied to fields for beneficial nutrient purposes contain radium. For further information, you may contact IEMA-OHS at EMA.RadiumResiduals@illinois.gov.

I hereby acknowledge my awareness of the above conditions resulting from application of treatment residuals to my property.

SIGNATURE OF LANDOWNER OR LANDOWNER'S DESIGNEE

PRINTED NAME

DATE