April 28, 2023

NRC Requests Comments to Inform Nuclear Medicine Extravasation Rulemaking

The Nuclear Regulatory Commission (NRC) publicly released a request for information (RFI) and preliminary proposed regulatory language to inform the agency’s rulemaking regarding nuclear medicine agent extravasation. The NRC intends to use responses to inform a proposed rule planned for late 2024. A public meeting is planned for May 24, and public comments will be due by July 18.

The release of the RFI is in accordance with the NRC Commissioners’ unanimous vote in December 2022 for a rulemaking to mandate Medical Event reporting under 10 CFR 35.3045 of extravasations that “require medical attention for suspected radiation injury.” The bipartisan decision was made following extensive NRC evaluation of a device company’s controversial petition to necessitate unique measurement methods during all relevant administrations. The Commissioners’ decision stopped short of requiring or promoting any third-party measurement devices or software for compliance, instead focusing on radiation safety significance and outcomes.

The American College of Radiology® (ACR®) is requesting technical feedback from physician and medical physicist members regarding NRC’s questions and preliminary proposed regulatory language. ACR members interested in providing input to relevant ACR leaders and committees can contact Michael Peters, Senior Government Affairs Director.