NRC Proposes Major Changes to Medical Use Regulations

The U.S. Nuclear Regulatory Commission (NRC) proposed significant changes to its medical use licensing regulations in 10 CFR Part 35 and plans to accept public comments for 45 days following publication in the Federal Register (see NPRM and FAQ). The proposed rule is part of a broader series of rulemakings and other activities the NRC says will advance Executive Order 14300 implementation, agency modernization, and burden reduction.

Among the proposed revisions, licensed facilities would no longer need license amendments to add Authorized Users (AUs) for diagnostic nuclear medicine uses under certain sections of Part 35. Instead, licensees would verify and document physician qualifications internally, with NRC or Agreement State oversight occurring primarily through inspections. The NRC also proposes changes to expand AU-eligibility for certain foreign-trained physicians who are licensed to practice medicine in the U.S. if they meet the corresponding training and experience requirements. Additionally, the NRC proposes assorted revisions and clarifications to training and experience criteria, continuing education/experience requirements and translatability of requirements across uses, and supervision levels for certain administrations.

Beyond the burden reduction focus, the NRC also proposed revisions related to licensing and oversight of certain mature “emerging medical technologies (EMTs)”—these changes have been discussed by the agency and its medical stakeholders for many years. Specifically, the proposed rule would codify regulatory frameworks for certain EMTs currently licensed through guidance (i.e., by reference via 10 CFR 35.1000), including Y-90 microspheres and rubidium-82 generators. ACR^® previously filed comments on the regulatory basis underlying the proposed changes in 2023.

ACR seeks input from interested members to help inform future comments. If you have feedback or questions, contact Michael Peters, Senior Director, Government Affairs.