Rulemaking: Reporting Nuclear Medicine Injection Extravasations as Medical Events
In May 2020, the U.S. Nuclear Regulatory Commission (NRC) received a petition for rulemaking requesting that the NRC amend 10 CFR Part 35, “Medical Use of Byproduct Material,” to require medical event reporting of certain radiopharmaceutical extravasations. The NRC reviewed the petition and conducted an independent evaluation of whether radiopharmaceutical extravasations should be reported as medical events, considering input from the Advisory Committee on the Medical Uses of Isotopes (ACMUI), Agreement States, and external stakeholders, as well as published literature on extravasations. In May 2022, the NRC staff issued a rulemaking plan in SECY-22-0043, Petition for Rulemaking and Rulemaking Plan on Reporting Nuclear Medicine Injection Extravasations as Medical Events, which recommended amending 10 CFR Part 35 to include the reporting of certain nuclear medicine injection extravasations as medical events. On December 12, 2022, the Commission issued a Staff Requirements Memorandum (SRM) for this plan. In the SRM, the Commission approved the staff’s recommended Option 3, to initiate a rulemaking that would amend Part 35 to report nuclear medicine injection extravasations that require medical attention for suspected radiation injury as reportable medical events.
The staff has begun rulemaking activities. More information about the NRC’s rulemaking process can be found at the NRC Rulemaking Process Webpage. The NRC staff will use this page and email announcements via the Medical List Server to provide updates on the extravasations reporting rulemaking, including the schedule for the rulemaking, as they become available.
On December 30, 2022, the NRC published a notice in the Federal Register announcing the staff’s intent to initiate the rulemaking. On April 19, 2023, the NRC published another Federal Register notice requesting input on the issues that should be considered in the development of the rule. The notice announces a 90-day public comment period on a request for information related to this rulemaking, and section IV of the notice poses questions for public feedback. The NRC is also requesting comments on preliminary proposed rule language.
The NRC plans to hold a public meeting on May 24, 2023, from 1:00 p.m. to 4:00 p.m. ET and will publish a notice with the meeting link and agenda on the NRC’s public meeting website at least 10 calendar days before the meeting. The meeting information will also be posted in the table below as it becomes available.
In addition to obtaining feedback in the form of public comments, the NRC staff will coordinate with the Advisory Committee on the Medical Uses of Isotopes (ACMUI) in an open and transparent manner. The ACMUI meeting minutes, as well as information on how to participate in these meetings, are maintained on the NRC public website to ensure availability to the medical community and the public. Public teleconference summaries and reports of the ACMUI’s Subcommittee on Extravasation will be included in the table below as they become available.
Any links in the tables below to non-NRC servers and websites are provided solely as a reference for the convenience of users. NRC cannot guarantee the authenticity of documents or the validity of information obtained at these non-NRC websites. See our Site Disclaimer for more information.
On July 18, 2023, the NRC published a notice in the Federal Register announcing the extension of the public comment period by 45 days. This extension was granted on the request of the Organization of Agreement States Board to allow more time for members of the public to submit their comments. The comment period now ends on September 1, 2023.
The following table summarizes key milestones in the schedule for this rulemaking, with links to the related documents.
|Lucerno Dynamics submits petition for rulemaking to amend 10 CFR 35.3045
|May 18, 2020
|Staff develops assessment of petition and rulemaking plan, described in SECY-22-0043, "Petition for Rulemaking and Rulemaking Plan on Reporting Nuclear Medicine Injection Extravasations as Medical Events"
|May 9, 2022
|Commission issues staff requirements memorandum (SRM) SRM-SECY-22-0043
|December 12, 2022
|Federal Register notice announcing intent to initiate rulemaking
|December 30, 2022
|87 FR 80474
|Federal Register notice requesting input to inform the NRC staff’s rulemaking process; 90-day comment period begins
|April 19, 2023
|88 FR 24130
|Federal Register notice extending the public comment period by 45 days
|July 18, 2023
|88 FR 45824
|Proposed Rule and draft Implementation Guidance
|Final Rule and Implementation Guidance