Safety Evaluation Report Related to SHINE Medical Technologies, Inc. Construction Permit Application for a Medical Radioisotope Production Facility — Docket Number 50-608(NUREG-2189)
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Manuscript Completed: October 2015
Date Published: August 2016
Office of Nuclear Reactor Regulation
U.S. Nuclear Regulatory Commission
Washington, DC 20555-0001
This safety evaluation report (SER) documents the U.S Nuclear Regulatory Commission (NRC) staff's technical review of the construction permit application submitted by SHINE Medical Technologies, Inc. (SHINE or the applicant) for a medical radioisotope production facility to be located in Janesville, Wisconsin. The proposed facility would comprise an irradiation facility (IF) and radioisotope production facility (RPF) for the irradiation and processing of special nuclear material to produce medical radioisotopes, such as molybdenum-99. The IF would consist of eight subcritical operating assemblies (or irradiation units [IUs]), which would each be licensed as utilization facilities as defined in Title 10 of the Code of Federal Regulations (10 CFR) 50.2, "Definitions." The RPF would consist of three hot cell structures, licensed collectively as a production facility, as defined in 10 CFR 50.2. In this SER, the IF and RPF are collectively referred to as the SHINE facility.
The staff’s environmental review of the SHINE construction permit application is documented in NUREG-2183, "Final Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility." A record of decision will be published at a future date concerning the proposed issuance of the construction permit.
This SER presents the results of the staff’s review of the SHINE construction permit application, as supplemented by the applicant's responses to requests for additional information (RAIs), and as updated on August 27, 2015.
The NRC's Advisory Committee on Reactor Safeguards (ACRS) independently reviewed those aspects of the application that concern safety and provided the results of its review to the Commission in a report dated October 15, 2015. Appendix D, "Report by the Advisory Committee on Reactor Safeguards," to this SER includes a copy of the report by the ACRS on the SHINE construction permit application.
Based upon the review documented in the SER, the staff finds that the preliminary design and analysis of the SHINE IF and RPF, including the principal design criteria; design bases; information relative to materials of construction, general arrangement, and approximate dimensions; and preliminary analysis and evaluation of the design and performance of structures, systems, and components (SSCs) of the facility, as described in the SHINE preliminary safety analysis report, and as supplemented by responses to RAIs: (1) provides reasonable assurance that the final design will conform to the design basis; (2) includes an adequate margin of safety; (3) SSCs adequately provide for the prevention of accidents and the mitigation of consequences of accidents; and (4) meets applicable regulatory requirements as well as NRC guidance. Therefore, the staff recommends that the Commission make the necessary findings with respect to the safety of the construction permit in accordance with 10 CFR 50.35, "Issuance of construction permits"; 50.40, “Common standards”; and 50.50, "Issuance of licenses and construction permits."
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