United States Nuclear Regulatory Commission - Protecting People and the Environment
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Medical Radioisotope Irradiation and Processing Facilities

In support of the national initiative to establish a domestic supply of molybdenum-99 (Mo-99), the U.S. Nuclear Regulatory Commission (NRC) is prepared to receive license applications for medical radioisotope facilities. The NRC will review all applications in accordance with the agency's mission to protect public health and safety, promote the common defense and security, and protect the environment.

What We Regulate

Potential and current applicants have proposed a variety of technologies to produce Mo-99, including accelerator-driven subcritical operating assemblies, non-power reactors, and hot cell structures. In most cases, these facilities will feature multiple technologies co-located on a single site to prepare or manufacture targets, irradiate targets, and process targets for Mo-99 extraction. Given this diversity in technology, the licensing process for these facilities could vary based on the chosen production method. As of July 2016, the NRC has received construction permit applications for non-power production and utilization facilities from SHINE Medical Technologies, Inc. and Northwest Medical Isotopes, LLC supporting commercial Mo-99 production.

The NRC has also issued a license amendment to Oregon State University and materials licenses to Niowave, Inc. supporting proof-of-concept demonstrations of Mo-99 production.

Other technologies (e.g., those involving the irradiation of enriched Mo-98 or Mo-100 targets) may be regulated by Agreement States.

How We Regulate

While licensing processes are technology-dependent, the commercial proposals for non-power production and utilization facilities require both a construction permit and operating license under 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities" prior to operation. Possession and use of special nuclear material, including the manufacturing of low enriched uranium targets, requires licensing under 10 CFR Part 70, "Domestic Licensing of Special Nuclear Material." The production of byproduct material, such as Mo-99, is licensed under 10 CFR Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material." Environmental considerations are addressed using the requirements of 10 CFR Part 51, "Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions."

To assist in the preparation and review of construction permit and operating license applications, the NRC developed interim staff guidance (Part 1 and Part 2) that augments the standard review plan for nonpower reactor licensing (NUREG-1537 , "Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors") to address the unique licensing considerations of medical radioisotope irradiation and processing facilities.

For more information on the NRC's licensing processes, see the How We Regulate page.

Facility-Specific Information

Page Last Reviewed/Updated Monday, July 25, 2016