Section 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 5 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 5 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).

 

(Source:  Amended at 46 Ill. Reg. 866, effective December 21, 2021)