Section 410IAC5-3-12. 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 such licenses.^10/

                                ^10/ 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 licenses are set forth below:

(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 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 any chemical or physical form of radioactive material specified in Schedule D, 410 IAC 5-3-29, 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 Schedule D, 410 IAC 5-3-29, Column I. If two or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Schedule D, 410 IAC 5-3-29, Column I, 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 Schedule D, 410 IAC 5-3-29, 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 Schedule D, 410 IAC 5-3-29, Column II. If two or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide determine the ratio of the quantity possessed to the applicable quantity specified in Schedule D, 410 IAC 5-3-29, Column II, 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 410 IAC 5-3-10;

(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 provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:

(i) The establishment of a radiation safety committee composed of such persons as a radiation safety officer, a representative of management and persons trained and experienced in the safe use of radioactive material;

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

(iii) The establishment of appropriate administrative procedures to assure:

(A) Control of procurement and use of radioactive material;

(B) Completion of safety evaluations of proposed uses of radiactive [sic.] material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

(C) Review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with 410 IAC 5-3-12(b)(3)(iii)(B) prior to use of the radioactive material.

                                (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 410 IAC 5-3-10; and

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

(i) 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, and

(ii) The establishment of appropriate administrative procedures to assure:

(A) Control of procurement and use of radioactive material,

(B) Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

(C) Review, approval, and recording by the radiation safety officer of safety evaluations of proposed uses prepared in accordance with 410 IAC 5-3-12(c)(2)(ii)(B) 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 410 IAC 5-3-10;

(2) The applicant submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received:

(i) A college degree at the bachelor level, or equivalent training experience, in the physical or biological sciences or in engineering, and

(ii) 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 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, record keeping, 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 410 IAC 5-3-12 shall not:

(i) Conduct tracer studies in the environment involving direct release of radioactive material;

(ii) 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;

(iii) Conduct activities for which a specific license issued by the board under 410 IAC 5-3-11, 410 IAC 5-3-13 or 410 IAC 5-3-12.5 is required; or

(iv) Add or cause the addition of radioactive material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being.

(2) Each Type A specific license of broad scope issued under 410 IAC 5-3-12 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 410 IAC 5-3-12 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 410 IAC 5-3-12 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 410 IAC 5-3-12(d).

(Indiana State Department of Health; Rule HRH-2,PT C,Sec C.27; filed May 26, 1978, 3:30 pm: 1 IR 152; filed Feb 29, 1984, 10:10 am: 7 IR 861; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFA)