902 KAR 100:052. Broad scope licenses.

 

      RELATES TO: KRS 211.842-211.852, 211.990(4)

      STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844

      NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation prescribes requirements for the issuance of specific licenses of broad scope for radioactive material.

 

      Section 1. Applicability. This administrative regulation establishes requirements for specific licensees to possess, use or transfer radioactive material for licenses of broad scope.

 

      Section 2. Types of Specific Licenses of Broad Scope. (1) A "Type A specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of a chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for any authorized purpose. The quantities specified are usually in the multicurie range.

      (2) A "Type B specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of a chemical or physical form of radioactive material specified in 902 KAR 100:090, relating to broad license quantities, for any authorized purpose. The possession limit for a Type B broad license, if only one (1) radionuclide is possessed, is the quantity specified for that radionuclide in Column I of the table in Section 2 of 902 KAR 100:090. If two (2) or more radionuclides are possessed, 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 the table in Section 2 of 902 KAR 100:090 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 a chemical or physical form of radioactive material specified in 902 KAR 100:090, relating to broad licensed quantities, for any authorized purpose. The possession limit for a Type C broad license, if only one (1) radionuclide is possessed, is the quantity specified for that radionuclide in Column II of the table in Section 2 of 902 KAR 100:090. If two (2) or more radionuclides are possessed, 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 the table in Section 2 of 902 KAR 100:090 for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

 

      Section 3. Requirements for the Issuance of a Type A Specific License of Broad Scope. An application for a Type A specific license of broad scope will be approved if:

      (1) The applicant satisfies the general requirements specified in 902 KAR 100:040;

      (2) The applicant has engaged in a reasonable number of activities involving the use of radioactive material; and

      (3) The applicant has established administrative controls and requirements relating to organization, 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 persons, such as a radiation safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive materials;

      (b) The appointment of a radiation safety officer who is qualified by training and experienced in radiation protection, who is available for advice and assistance on radiological safety matters; and

      (c) The establishment of appropriate administrative procedures to assure control of procurement and use of radioactive material; completion of safety evaluation of proposed uses of radioactive material which take into consideration matters, such as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with this subsection prior to use of the radioactive material.

 

      Section 4. Requirements for the Issuance of a Type B Specific License of Broad Scope. An application for a Type B specific license of broad scope will be approved if:

      (1) The applicant satisfies the general requirements specified in 902 KAR 100:040; and

      (2) The applicant has established administrative controls and provisions relating to organization, management, procedures, recordkeeping, material control and accounting, and management review that are necessary to assure safe operations, including:

      (a) The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, who is available for advice and assistance on radiological safety matters; and

      (b) The establishment of appropriate administrative procedures to assure control of procurement and use of radioactive material; completion of safety evaluations or proposed uses of radioactive materials which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, the operating or handling procedures; and review, approval and recording by the radiation safety officer of safety evaluations of proposed uses prepared in accordance with this subsection prior to use of the radioactive material.

 

      Section 5. Requirements for the Issuance of a Type C Specific License of Broad Scope. An application for a Type C specific license of broad scope shall be approved if:

      (1) The applicant satisfies the general requirements specified in 902 KAR 100:040;

      (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;

      (b) At least forty (40) hours of training and experience in the safe handling of radioactive materials, characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, biological hazards of exposure to radiation appropriate 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.

 

      Section 6. Prohibited Acts and Conditions for Specific Licenses of Broad Scope. (1) Unless otherwise specifically authorized by these administrative regulations, persons licensed under this administrative regulation 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 100,000 curies or more of radioactive material in sealed sources used for irradiation of materials;

      (c) Conduct activities for which a specific license issued by the cabinet under 902 KAR 100:051 or 902 KAR 100:058 is required; or

      (d) Add or cause the addition of radioactive material to a 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 administrative regulation 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 administrative regulation 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 administrative regulation shall be subject to the condition that radioactive material possessed under this license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of Section 5 of this administrative regulation. (6 Ky.R. 219; eff. 12-5-79; Am. 12 Ky.R. 1033; eff. 1-3-86; 18 Ky.R. 1513; eff. 1-10-92.)