October 14, 2016

NRC Continues Review for Part 35 Regulatory Update

The long-anticipated final rule updating Nuclear Regulatory Commission (NRC) medical use regulations (largely enumerated under 10 CFR Part 35) remains under review by the Commission — the last internal step before Office of Management and Budget (OMB) review and publication.

The rule would revise various aspects of NRC’s regulations, including:
  • Updates to training and experience requirements for authorized users, medical physicists, radiation safety officers (RSOs) and nuclear pharmacists; 
  • Changes to the definition of reportable “medical events” in permanent implant brachytherapy; 
  • Implementation of the ACR-supported petition to recognize the qualifications of board certified medical physicists and RSOs not specifically named on a license; and 
  • Many other items that have been vetted or requested by medical stakeholders in the years since Part 35 implementation in the early 2000s. 
The rulemaking, which has been in the works since 2005, has been held up under significant political pressure while NRC Commissioners consider a recent request from the radiopharmaceutical industry to substantially decrease training and experience hours for authorized users of alpha and beta-emitters who do not have NRC-recognized board certification. Industry supporters believe that increasing the number of authorized users (AUs) will boost utilization of alpha- and beta-emitters like Zevalin® and Xofigo®. The NRC Advisory Committee on the Medical Uses of Isotopes (ACMUI) found insufficient scientific evidence of an AU shortage or that any such shortage is causing the perceived underutilization versus other factors.

Last week at the fall ACMUI business meeting, clinical oncologists who spoke in support of the industry request indicated that these therapies are not preferred because their residents are not trained for them and because oncologists prefer to maintain direct control over treatments instead of referring their patients to other specialists for therapy.

In response to the industry request, which is specific to alpha- and beta-emitters, the NRC ACMUI intends to revisit all training and experience requirements in the NRC’s medical use regulations over the next several years. In the meantime, the American College of Radiology, American Society for Radiation Oncology, Society of Nuclear Medicine and Molecular Imaging and others in the medical community are requesting that the final rule currently under Commission review advance as quickly as possible to address the more thoroughly vetted needs of the medical community.