February 4, 2022
The Nuclear Regulatory Commission (NRC) recently voted on training and experience requirements (T&E) for Authorized Users (AUs) and disapproved their staff’s recommendations. SNMMI strongly supports this long-awaited decision.
In 2020, NRC staff recommended that the Commission pursue regulatory changes to the T&E requirements for radiopharmaceuticals, moving to using solely board certification for determining and obtaining AU status. Specifically, NRC staff indicated they planned to modify the board certification criteria to allow for additional medical specialty boards, beyond nuclear medicine and radiation oncology, to qualify for meeting the T&E requirements. In practice, this would necessitate weakening the already robust, yet flexible, board recognition criteria.
SNMMI opposed T&E changes and requested that the Commission maintain the status quo in their comments in 2019. Additionally, then-President Vasken Dilsizian, MD, testified in front of the Commission during its public briefing on January 28, 2020. He echoed the thoughts of SNMMI and other medical societies. Specifically:
Since 2021, SNMMI, along with other medical societies, has met with House and Senate Appropriations Committee staffers and submitted language favoring maintaining the status quo in Appropriations Committee reports.
Feedback from stakeholders was clearly considered by the Commission. Commissioner Jeffery Baran stated, "Many stakeholders offer persuasive arguments that the current training and experience framework is working effectively to ensure radiological safety and is not resulting in a shortage of authorized users to administer radiopharmaceuticals."
Current pathways for obtaining AU status are:
SNMMI applauds NRC for this critical decision.