Earlier this year, leaders of the U.S. Nuclear Regulatory Commission (NRC) voted to maintain the highest level of training and experience criteria for physicians serving as “authorized users” (AUs) at facilities licensed to medically use unsealed radiological materials. The decision defeated a staff-level proposal to modify the AU criteria to more easily enable non-radiological specialists to handle radioactive materials without adequate expertise. The proposal was opposed by the ACR and other medical stakeholders who believe that AUs must have specialized training in radiation safety, physics, biology, and clinical implications to perform their duties. The ACR applauds the NRC for this important decision, which prioritizes radiation safety by ensuring the continued expertise of physicians responsible for the medical use of radiological materials.
The Bulletin recently talked with two experts close to the controversial issue and decision — a culmination of years of public meetings, comment requests, agency papers, and other NRC activities relying on extensive input from the ACR and other stakeholders in radiology, radiation oncology, nuclear medicine, and medical physics. Paul E. Wallner, DO, FACR, chair of the ACR Federal Regulatory Committee (FRC), and Ralph P. Lieto, MS, FACR, chair of the ACR Nuclear Medicine and Molecular Imaging Committee on Government Relations, served on a multidisciplinary task force charged with ensuring radiation expertise by those supervising the use of radiological materials.
Why is it important to ensure that AUs have radiation expertise?
WALLNER: There is no evidence of current shortage of available AUs, and their numbers are increasing. Even alpha- and beta-emitting radiopharmaceuticals have the potential for real and “perceived” damage. Any event, regardless of danger (i.e., low levels, low doses, short-lived agents, etc.) is perceived by the public to be frightening. Many of the currently available or pipeline agents (new agents being studied and for likely approval in the next one to three years) have mixed radiation emissions that often include a gamma component — increasing the risks of misuse and mishandling.
LIETO: AUs are totally responsible for their own authorized activities and the participation of the individuals who use radionuclides for which the AUs are authorized. The NRC’s “supervision rule” (10 CFR 35.27) designates the AU responsible for instruction and regulatory compliance for all activities of their authorized uses — receipt, use, administration, and disposal. This supervision responsibility underscores the importance of adequate training and experience to assure compliance, especially with therapeutic radionuclides.
What could an alternative outcome to the NRC vote have meant for patients?
WALLNER: Vendors who submitted the petition wanted individuals with minimal training in radiation biology and safety, such as internists, medical oncologists, and urologists, to be able to serve as AUs for alpha- and beta-emitting agents. If the vendor-proposed outcome had been adopted by the NRC, healthcare providers with no training or limited training and experience related to the use of specified radiopharmaceuticals would have been permitted to prescribe and administer alpha- and beta-emitting agents.
LIETO: The proposed alternative would have created divergent regulatory standards and documentation requirements for AUs of unsealed radionuclides versus sealed sources. It would not have maintained consistent standards of patient safety or quality of care. The alternative would have significantly increased the administrative burden on licensees in assessing, documenting, and managing training and education activities.
How did the ACR’s advocacy efforts around this issue help radiologists, patients, and regulators in terms of radiation safety policy?
WALLNER: Members of the FRC, working with ACR staff, testified before the Advisory Committee for Medical Use of Isotopes (ACMUI) during open hearings, provided peer-reviewed literature and workforce documentation, and met with NRC staff and commissioners.
LIETO: With input from the ACR’s commissions and government relations staff, the FRC provided written comments on draft rulemaking, regulatory guides, and oral remarks at open public sessions to assist in decision-making around AUs and patient safety related to the use of radiopharmaceuticals.
The ACR’s advocacy efforts educate federal appointees, regulatory and legislative staff, provide written statements based on input from ACR members, and maintain current communications with ACR leadership and members on relevant governmental issues. These efforts provide critical support to ACR members in their work to advocate for quality care and patient and worker safety in radiological imaging and therapy.