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 review 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, hot cell structures, and target fabrication facilities. 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. The NRC issued construction permits for non-power production and utilization facilities to SHINE Medical Technologies, LLC (SHINE) and Northwest Medical Isotopes, LLC in February 2016 and May 2018, respectively supporting commercial Mo-99 production.
In 2019, the NRC began the review of the SHINE operating license application and inspection of the construction of the SHINE Medical Isotope Production Facility. Other prospective applicants interested in submitting initial license applications for medical radioisotope facilities include Eden Radioisotopes and Atomic Alchemy.
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."
The NRC staff inspects each facility periodically to ensure licensees safely conduct regulated activities. The NRC currently maintains a construction inspection program for medical radioisotope facilities. Inspection programs for construction of medical radioisotope facilities include all construction-related activities including design, procurement, fabrication, construction, pre-operational testing, quality, and operational readiness activities.
The NRC Inspection Manual Chapter 2550 contains the guidance which the NRC uses to administer the construction inspection program for Non-Power Production and Utilization Facilities (NPUFs).
For information on Inspection Procedures 69020, 69021, and 69022, see our complete collection of Inspection Procedures.
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.
1. Interim Staff Guidance Augmenting NUREG-1537, Part 1, For Application to Heterogeneous and Homogeneous Non-Power Reactors and Radioisotope Production Facilities
2. Interim Staff Guidance Augmenting NUREG-1537, Part 2, For Application to Heterogeneous and Homogeneous Non-Power Reactors and Radioisotope Production Facilities
For more information on the NRC's licensing processes, see the How We Regulate page.
Page Last Reviewed/Updated Thursday, August 27, 2020