January 23, 2020

NRC Staff Recommends Revised Authorized User T&E Rules for Unsealed Materials

On January 17, 2020, the U.S. Nuclear Regulatory Commission (NRC) released highly anticipated staff recommendations to the political leadership of the agency (SECY-20-0005) addressing physician training and experience (T&E) requirements for Authorized Users (AU) of certain nuclear materials.

In the years leading up to SECY-20-0005, all public meetings and comment opportunities provided by the NRC have focused on whether to change AU T&E requirements for therapeutic radiopharmaceuticals under 10 CFR Part 35, Subpart E (“unsealed byproduct material-written directive required”). However, SECY-20-0005 unexpectedly expanded its focus to also include diagnostic uses under Subpart D (“unsealed byproduct material-written directive not required”).

Specifically, the NRC staff recommended a rulemaking for Subparts D and E to eliminate the alternate pathways to board certification. Instead, NRC would establish new board recognition criteria with the stated goal of recognizing additional physician specialty boards. AUs for Subparts D and E would no longer be identified on NRC or Agreement State licenses, and AU T&E documentation would no longer need to be filed with NRC or Agreement States for review. Instead, licensees would be responsible for demonstrating their AUs have appropriate board certifications during inspections. Due to the elimination of alternate pathways in Subparts D and E, young physicians without board certification would be required to work under AU supervision until they are formally board certified (for example, in the 15-month postgraduate gap between a diagnostic radiology residency and board certification).

For reasons unexplained, the NRC staff recommendation excluded Subpart F (“manual brachytherapy”), Subpart G (“sealed sources for diagnosis”) and Subpart H (“Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units”). Subpart K (“Other Medical Uses of Byproduct Material or Radiation from Byproduct Material”), which currently includes Yttrium-90 microsphere brachytherapy, was also excluded from the staff recommendation. Thus, this recommendation would create disparate regulatory paradigms and documentation requirements for AUs of unsealed materials versus sealed sources.

Moving forward, the commissioners (the political leadership of the agency) would need to consider and approve the staff recommendation for a rulemaking. The staff estimated approximately 3.25 years following the commissioners’ decision to proceed — a decision, which could take significant time as well. Following promulgation of a final rule, it is likely that Agreement State regulators would have three years beyond the effective date to adopt compatible regulations.

American College of Radiology® (ACR®) members with questions or feedback about this important issue should contact Michael Peters, ACR director of legislative and regulatory affairs, at (202) 223-1670 or mpeters@acr.org.