NRC Vetoes T&E Changes; Approves ⁸²Rb and Emerging Tech Modernization

In a public meeting held on January 28, Nuclear Regulatory Commission (NRC) commissioners voted to disapprove staff recommendations to change training and experience (T&E) requirements for Authorized Users (AUs) of radiopharmaceuticals. The proposed changes had been the source of comment and protest from major professional societies and their members. In 2020, NRC staff formally recommended that the commission pursue regulatory changes to the T&E requirements, moving to board certification as the sole factor for determining and obtaining AU status and modifying NRC criteria to allow for additional medical specialty board diplomates (beyond nuclear medicine and radiation oncology) to qualify as AUs. In voting down this proposal, one commissioner noted that the proposed changes had suggested “that the current training and experience framework could be viewed as encroaching on the practice of medicine. I disagree. Ensuring that AUs meet training and experience requirements necessary for radiological safety does not insert NRC into the actual practice of medicine. The broad support among medical organizations for NRC’s licensing role makes it clear that the medical community does not view the current framework as encroaching on the practice of medicine.”

SNMMI was among the groups that opposed T&E changes and submitted comments in multiple formats to the NRC. In 2020, Vasken Dilsizian, MD, then SNMMI President, testified before the Commission during a public hearing. He noted that expansion of medical specialty training requirements was not within the purview of the NRC. Moreover, Nuclear Medicine, Radiation Oncology, and Diagnostic Radiology with 16-mo Nuclear Medicine/Nuclear Radiology (NM/NR) pathways are the only Accreditation Council for Graduate Medical Education (ACGME)–approved training programs with specific goals and objectives pertaining to administration of radioactive material, and such training must be completed under supervision of board-certified physicians trained in this area.

Feedback from stakeholders was considered by the commissioners in making their decision. Another commissioner stated in his final review: “Many stakeholders offer persuasive arguments that the current T&E framework is working effectively to ensure radiological safety and is not resulting in a shortage of authorized users to administer radiopharmaceuticals.” In a February 4 statement, SNMMI praised the NRC for this decision.

Current pathways for obtaining AU status remain:

• Certification by a medical specialty board (e.g., the American Board of Nuclear Medicine) recognized by the NRC or an Agreement State;

• Completion of 200 hours of classroom training and 500 hours of supervised work experience in an ACGME-accredited program (Nuclear Medicine, Diagnostic Radiology with a 16-month NM/NR pathway, or Radiation Oncology); and

• Previous identification as an AU on an NRC or Agreement State license or permit.

• © 2022 by the Society of Nuclear Medicine and Molecular Imaging.