Safety Evaluation Report: Northwest Medical Isotopes, LLC Construction Permit Application for a Radioisotope Production Facility (NUREG-2229)

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Publication Information

Manuscript Completed: May 2018
Date Published: May 2020

Office of Nuclear Regulatory Regulation
U.S. Nuclear Regulatory Commission
Washington, DC 20555-0001

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This safety evaluation report (SER) documents the results of the safety review conducted by the U.S. Nuclear Regulatory Commission (NRC) staff (the staff) on the Northwest Medical Isotopes, LLC (NWMI or the applicant) application to obtain a construction permit for a production facility (NWMI production facility or facility) under Title 10 of the Code of Federal Regulations (10 CFR) Part 50, "Domestic Licensing of Production and Utilization Facilities," to be constructed in Columbia, Missouri. Subject to 10 CFR Part 50, the proposed production facility would receive irradiated special nuclear material (SNM), and process the SNM to produce the medical radioisotope molybdenum-99. The production facility would be part of a larger facility, which the staff refers to as the radioisotope production facility (RPF), and which would also include target fabrication activities conducted under 10 CFR Part 70, "Domestic Licensing of Special Nuclear Material." Although the staff reviewed NWMI's entire application, including information related to the 10 CFR Part 70 activities, to understand the interfaces between the 10 CFR Part 50 and 10 CFR Part 70 portions of the RPF, the staff findings in this SER are limited to those required for licensing a production facility under 10 CFR Part 50.

This SER presents the results of the staff's review of the NWMI construction permit application as updated on September 8, 2017, and as supplemented by the applicant's responses to requests for additional information (RAIs).

The staff's environmental review of the NWMI construction permit application is documented in NUREG-2209, "Environmental Impact Statement for the Construction Permit for the Northwest Medical Isotopes Radioisotope Production Facility."

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 November 6, 2017. Appendix D, "Report by the Advisory Committee on Reactor Safeguards," to this SER includes a copy of the report by the ACRS on the NWMI construction permit application.

Based upon the review documented in the SER, the staff finds that the preliminary design and analysis of the NWMI production facility, 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 NWMI preliminary safety analysis report, 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) demonstrates that SSCs adequately provide for the prevention of accidents and the mitigation of consequences of accidents; and (4) meets applicable regulatory requirements as well as applicable 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."

The Commission issued its Memorandum and Order, CLI–18–06, documenting its final decision on the mandatory hearing held on January 23, 2018. The Commission's final decision authorized the issuance of the construction permit for the NWMI medical radioisotope production facility, contingent upon the inclusion of a revised safety permit condition. In May 2018, the staff updated the permit condition in Section 2.4.5 and Appendix A.1 of this SER to reflect the Commission's final decision. The staff also reformatted the permit condition related to the criticality accident alarm system in Section 6.4.5 of this SER for clarity.

Page Last Reviewed/Updated Tuesday, March 09, 2021