March 05, 2020

ACR Asks NRC to Oppose Revising AU T&E Standards for Unsealed Materials

On Feb. 28, 2020, the American College of Radiology® (ACR®) sent a letter to the leadership of the U.S. Nuclear Regulatory Commission (NRC) advising against revising the training and experience (T&E) requirements for authorized users (AUs) of unsealed radiological materials.

The ACR’s letter was in response to staff recommendations (SECY-20-0005), released in Jan. 2020, which recommended replacing AU T&E specifications from the regulations for diagnostic and therapeutic radiopharmaceuticals with new, as-of-yet-undetermined board recognition criteria. SECY-20-0005 was the accumulation of a multi-year NRC evaluation controversially spurred by lobbying from companies that manufacture or sell therapeutic radiopharmaceuticals. Details were described in the Jan. 23 Advocacy in Action.

The ACR’s letter to the NRC leadership was informed by a multispecialty, multidisciplinary workgroup of the ACR Commission on Government Relations-Federal Regulatory Committee. The workgroup briefly described the following seven major concerns with the NRC staff recommendation:

  1. A lack of trustworthy evidence demonstrating patient access problems caused by the AU T&E regulations — this notion is referenced in SECY-20-0005 as justification for rule changes
  2. Questions about whether the rulemaking would indeed increase patient access to licensed facilities able to provide advanced radiopharmaceutical therapies or if focusing on AUs would fail to accomplish that objective
  3. Tenuous suggestion of a conflict between NRC regulations and NRC policies
  4. As described in the recommendation, the changes would create disparate and conflicting AU authorization, documentation and inspection paradigms for licensed facilities that use both unsealed materials and sealed source modalities
  5. The changes could ignite concerns about state-to-state uniformity and reciprocity processes
  6. Relying on board certification as the only means to obtain AU eligibility could cause potential employability issues for some radiologists in the 15-month gap between physician training and diagnostic radiology board certification (Note: This criticism is specific to diagnostic uses)
  7. A lack of clarity within SECY-20-0005 of what the envisioned “board recognition criteria” would look like and if that paradigm would be as adequately protective for patients and the public as the current AU T&E requirements

As previously reported in Advocacy in Action, the NRC released SECY-20-2005 staff recommendations in January to the political leadership of the agency to address physician T&E for Authorized Users.

Moving forward, the NRC commissioners will consider SECY-20-0005 and determine whether to approve or not approve the agency staff recommendation for a rulemaking. If a rulemaking is approved, it would take several years to come to fruition with many future opportunities for public feedback.

Interested ACR members with questions or concerns should contact Michael Peters, ACR director of legislative and regulatory affairs, at (202) 223-1670 or mpeters@acr.org.