Specific Licenses for Irradiators

The Agency will approve an application for a specific license for the use of licensed material in an irradiator if the applicant meets the requirements contained in 105 CMR 120.633. (A) The applicant shall satisfy the general requirements specified in 105 CMR 120.100 and the requirements contained in 105 CMR 120.620. (B) The application must 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, safety, and emergency procedures; and (5) Minimum training and experience of personnel who may provide training. (C) The application must include an outline of the written operating, safety, and emergency procedures listed in 105 CMR 120.673 that describes the radiation safety aspects of the procedures. (D) The application must 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 must specify who, within the management structure, has the authority to stop unsafe operations. The application must also describe the training and experience required for the position of radiation safety officer. (E) The application must include a description of the access control systems required by 105 CMR 120.643, the radiation monitors required by 105 CMR 120.649, the method of detecting leaking sources required by 105 CMR 120.679, including the sensitivity of the method, and a diagram of the facility that shows the locations of all required interlocks and radiation monitors. (F) 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 must include the: (1) instruments to be used; (2) methods of performing the analysis; and, (3) pertinent experience of the individual who analyzes the samples. (G) If licensee 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 must be done by an organization specifically authorized by the Agency, the Commission, an Agreement State, or a Licensing State to load or unload irradiator sources. (H) The applicant shall describe the inspection and maintenance checks, including the frequency of the checks required by 105 CMR 120.681.