August 23, 2023

ACR Recommends Against NRC Proposals for Patient Releasability Determinations

The American College of Radiology® (ACR®) filed comments with the U.S. Nuclear Regulatory Commission (NRC) Aug. 20, advising against NRC’s proposed guidance update, “Regulatory Guide (RG) 8.39 Revision 2, Release of Patients Administered Radioactive Materials.” The document informs licensee compliance with NRC regulations enabling nuclear medicine and radiation oncology care to be provided on an outpatient basis if the total effective dose equivalent (TEDE) to any other individual from exposure to the released individual is not likely to exceed 5 mSv/0.5 rem.

The NRC’s proposed revision to RG 8.39 would increase the conservatism and calculational complexity for licensees of certain releases of patients (e.g., following I-131 therapies). However, studies of family member exposures to I-131 therapy patients, including those conducted by the National Laboratories, have consistently demonstrated that NRC’s release requirements and guidance already conservatively protect the public.

The ACR noted that many of the nearly 5,000 licensed facilities currently offering I-131 therapies in the U.S. would not have the capability to follow the proposed releasability determination methodologies detailed in NRC’s draft guidance. Therefore, it would unintentionally restrict where patients can access these therapies. ACR advised instead that NRC guidance incorporate existing U.S. standards and compliance resources.

If you would like more information or have questions, contact Michael Peters, ACR Senior Government Affairs Director.