In 2019, my colleagues and I reported on the activities of the ACR Commission on Government Relations’ Federal Regulatory Committee Workgroup, tasked with responding to an evaluation by the Nuclear Regulatory Commission (NRC) of the authorized user training and experience (AU T&E) requirements for certain therapeutic radiopharmaceuticals.1 The workgroup had developed comment submissions in consultation with like-minded stakeholder organizations and met with NRC staff and commissioners in support of the College’s position. This article will update readers on more recent activities.
On Jan. 17, 2020, the NRC released staff recommendations (SECY-20-0005, Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material) to the agency’s commissioners, following a multi-year evaluation of the AU T&E requirements. The evaluation was spurred by advocacy from drug manufacturers and affiliated individuals seeking reduced AU T&E requirements for their products. In the public meetings and comment opportunities leading up to SECY-20-0005, the discourse focused exclusively on the AU T&E requirements in 10 CFR 35.390 for certain unsealed material requiring a written directive (i.e., radiopharmaceutical therapies). However, SECY-20-0005 unexpectedly expanded the focus to also include most diagnostic uses of unsealed material under §35.190 and §35.290 — as well as other therapeutic uses of radiopharmaceuticals involving sodium iodide I–131 (§35.392 and §35.394) and parenteral administrations of unsealed material requiring a written directive (§35.396).2
Specifically, SECY-20-0005 recommended eliminating AU T&E requirements for diagnostic and therapeutic uses of unsealed materials. Physicians would only be AU-eligible if they have NRC-recognized board certification. While board certification is currently the primary pathway to AU eligibility, SECY-20-0005 recommended the creation of new board recognition criteria intended to be more inclusive of non-radiological subspecialty boards. AUs of unsealed materials would no longer be identified on NRC or agreement state licenses, and AU T&E documentation would no longer be filed with NRC or agreement state agencies for review. Instead, licensed facilities would be responsible for demonstrating their affiliated AUs have appropriate board certifications during NRC or agreement state inspections. For reasons unexplained in SECY-20-0005, all medical uses that involve sealed sources — such as manual brachytherapy and radiation therapy modalities — would be excluded from the recommended changes and, hence, multi-modality licensees would need to comply with disparate physician authorization, documentation, and inspection paradigms.3
Moving forward, the commissioners will need to consider SECY-20-0005 and approve or reject the NRC staff recommendations. Any subsequent rulemaking activities would likely take the NRC years to complete and several years longer for agreement states to adopt compatible regulations.
In cooperation with like-minded stakeholders, the workgroup will continue its outreach to the NRC to promote policies that protect public safety and quality of care and will continue to inform ACR members of its activities. As has been stated previously, unfettered patient access to diagnostic and therapeutic agents by current AUs is critical to support of the Workgroup’s activities.