On Nov. 18, 2020, the Nuclear Regulatory Commission (NRC) Advisory Committee on the Medical Uses of Isotopes (ACMUI) convened its annual briefing with the five politically-appointed NRC Commissioners. The ACMUI is the agency’s federal advisory committee of external medical experts representing diagnostic radiology, nuclear medicine, radiation oncology and medical physics, among others.
The discussions focused on ACMUI recommendations for two highly controversial topics under current NRC consideration. First, agency staff recommendations to modify authorized user (AU) training and experience requirements for diagnostic and therapeutic uses of unsealed radiological materials to enable referring providers to supervise radiopharmaceutical therapies without meeting current radiation safety requirements (SECY-20-0005). Second, a petition for rulemaking filed by the manufacturer of an injection site monitor product to require quantification and reporting of certain nuclear medicine extravasations as medical events (PRM-35-22).
The ACMUI previously recommended against the NRC staff recommendation on AU training and experience. The ACMUI similarly noted opposition to generally regulating extravasation as a reportable medical event, although the committee has not yet made recommendations specific to the manufacturer’s current petition for rulemaking.
The American College of Radiology® (ACR®) has provided formal input to NRC on multiple occasions over the past few years regarding the AU training and experience topic. SECY-20-0005 has been under NRC Commissioners’ consideration since Jan. 2020.
The public comment period is open until Nov. 30 on the extravasation petition, and members with an interest in PRM-35-22 are encouraged to review the Federal Register notice and provide specific responses to NRC’s questions via regulations.gov. The NRC is also convening a public workshop about the petition on Dec. 8, from 2–4pm ET.
ACR members with questions about either issue can contact Michael Peters, ACR Director of Legislative and Regulatory Affairs, at firstname.lastname@example.org.