6 Colo. Code Regs. § 1007-1-3.8
Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-3.8 - Filing An Application for A Specific License3.8.1 Applications for specific licenses shall be filed on a form prescribed by the Department.3.8.2 The Department may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the Department to determine whether the application should be granted or denied or whether a license should be modified or revoked.3.8.3 Each application shall be signed by the applicant or licensee or a person duly authorized to act for and on the applicant's or licensee's behalf.3.8.4 An application for a license may include a request for a license authorizing one or more activities.3.8.5 In the application, the applicant may incorporate by reference information contained in previous applications, statements, or reports filed with the Department provided such references are clear and specific.3.8.6 Applications and documents submitted to the Department may be made available for public inspection except that the Department may withhold any document or part thereof from public inspection pursuant to 24-72-204, CRS.3.8.7 Pre-licensing Construction 3.8.7.1 An application for a license, or to amend or renew an existing license, for (1) source material milling, (2) commercial waste storage, treatment or disposal by incineration, (3) transfer for disposal of wastes from treatment or incineration, (4) commercial waste disposal by land burial or by underground injection, or the (5) conduct of any other activity within the licensing authority of the Department which the Department determines will significantly affect the radiological quality of the human environment, shall be filed with the Department at least nine (9) months prior to the anticipated commencement of construction of the plant or facility in which the activity will be conducted or in accordance with the requirements of Part 18 if applicable, and shall be accompanied by the environmental assessment required by 3.8.8, unless an exemption from the requirement of furnishing such assessment has been obtained from the Department.3.8.7.2 No construction shall be commenced until the license has been issued.3.8.7.3 For the purpose of 3.8.7 the terms "construction" and "commencement of construction", are defined in Part 1, 1.2.3.8.8 Environmental Assessment.3.8.8.1 In the case of an application for a license, or to amend or renew an existing license, for (1) source material milling, (2) commercial waste storage, treatment or disposal by incineration, (3) transfer for disposal of waste from incineration, (4) commercial waste disposal by land burial or by underground injection, or for (5) the conduct of any other activity which will affect the quality of the human environment by reason of exposure to radiation, before "commencement of construction", as defined in 3.8.7.3, of the plant or facility in or at which the activity will be conducted, or in case of a renewal of such a license, the applicant shall submit all information required under these regulations and such other material as the Department may deem necessary. (1) Such information shall include the environmental assessment and other information required by 3.8.8.2 to be submitted to assist the Department in the evaluation of the short-term and long-range environmental impact of the project and activity so that the Department may weigh environmental, economic, technical, and other benefits against environmental costs, while considering available alternatives.(2) In the event that an environmental assessment acceptable to the Department is on file with the Department in regard to the specific licensed activity authorized under an existing license, and upon request of the applicant to amend or renew an existing license or at the initiation of the Department, the Department may grant an exemption of the requirement to submit an additional environmental assessment or require such amendment of the existing environmental assessment as will demonstrate the environmental impact to result from the proposed activity.(3) The request for exemption shall provide the Department with such information as the Department requires of the applicant to demonstrate that no significant environmental impact will result from the licensed activity.3.8.8.2 An environmental assessment shall be required of the applicant and shall contain all information deemed necessary by the Department as required by the Act. (1) Upon receipt of the environmental assessment or any amendment thereto, and of any other documents required, the Department shall determine the necessity to transmit and, if appropriate, shall transmit the same for review and comment to Federal, State, and local agencies having expertise in and jurisdiction over the proposed project and activity.(2) Written comments and reports of reviewing agencies shall be considered by the Department in its decision-making review process on the license application request.(3) If an environmental impact statement (EIS) is required of a Federal agency pursuant to the National Environment Policy Act of 1969 (NEPA) and is provided by such Federal agency, it shall be used by the Department in its decision-making review process on the license application request.(4) The Department shall consider applicable regulations of Federal, State, and local regulatory agencies and permit requirements thereof.3.8.9 Except as provided in 3.8.9.3, 3.8.9.4, and 3.8.9.5, an application for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed source must either: 3.8.9.1 Identify the source or device by manufacturer and model number as registered with the NRC under 10 CFR Part 32.210 or with an Agreement State, or for a source or a device containing radium-226 or accelerator produced radioactive material with an Agreement State under provisions comparable to 10 CFR Part 32.210; or3.8.9.2 Contain the information identified in 3.12.14.3; or3.8.9.3 For sources or devices manufactured before October 23, 2012 that are not registered with the NRC under 10 CFR Part 32.210 or with an Agreement State, and for which the applicant is unable to provide all categories of information specified in 3.12.14.3, the application must include:(1) All available information identified in 3.12.14.3 concerning the source, and, if applicable, the device; and(2) Sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information must include a description of the source or device, a description of radiation safety features, the intended use and associated operating experience, and the results of a recent leak test.3.8.9.4 For sealed sources and devices allowed to be distributed without registration of safety information in accordance with 3.12.14.7(1), the applicant may supply only the manufacturer, model number, and radionuclide and quantity.3.8.9.5 If it is not feasible to identify each sealed source and device individually, the applicant may propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used, in lieu of identifying each sealed source and device.3.8.10 An application from a medical facility, educational institution, or Federal facility to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under Part 7 of these regulations or equivalent Agreement State requirements shall include: 3.8.10.1 A request for authorization for the production of PET radionuclides or evidence of an existing license issued under this Part or Agreement State requirements for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.3.8.10.2 Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in 3.12.10.1(2).3.8.10.3 Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in 3.12.10.2(2).3.8.10.4 Information identified in 3.12.10.1(3) on the PET drugs to be noncommercially transferred to members of its consortium.Colorado Register, Vol 37, No. 14. July 25, 2014, effective 8/14/201438 CR 02, January 25, 2015, effective 2/14/201538 CR 05, March 10, 2015, effective 3/30/201538 CR 12, June 25, 2015, effective 7/15/201538 CR 14, July 25, 2015, effective 8/14/201539 CR 02, January 25, 2016, effective 2/14/201639 CR 16, August 25, 2016, effective 9/14/201639 CR 22, November 25, 2016, effective 12/15/201640 CR 11, June 10, 2017, effective 6/30/201740 CR 20, October 25, 2017, effective 11/14/201742 CR 24, December 25, 2019, effective 1/14/202043 CR 14, July 25, 2020, effective 8/14/202043 CR 18, September 25, 2020, effective 10/15/202044 CR 11, June 10, 2021, effective 7/15/202144 CR 14, July 25, 2021, effective 8/14/202145 CR 22, November 25, 2022, effective 12/15/202246 CR 21, November 10, 2023, effective 12/15/2023