July 19, 2018

ACR Requests Data for NRC Evaluation of Therapy T&E Requirements

On July 16, the American College of Radiology (ACR) provided comments to the Nuclear Regulatory Commission (NRC) Advisory Committee on the Medical Uses of Isotopes (ACMUI) during its teleconference to discuss NRC’s draft staff evaluation of the requirements for different categories of therapeutic radiopharmaceuticals under 10 CFR 35 Subpart E.

The discussion emphasized 10 CFR 35.390, “training for use of unsealed byproduct material for which a written directive is required,” which has been criticized by certain manufacturers who perceive training and experience (T&E) requirements for those without NRC-recognized board certification to be unduly restrictive and creating radiopharmaceutical therapy access issues. The ACMUI call served as an open session for feedback on its July 5 recommendations regarding the NRC staff’s draft evaluation paper.

In verbal comments, Paul E. Wallner, MD, chair of ACR’s workgroup on NRC training and experience regulations, urged the NRC to work with state regulators and broad-scope licensees to collect comprehensive data on authorized users (AU) to determine if there is indeed an access problem before proceeding with any regulatory changes. Wallner also recommended that NRC and ACMUI extensively engage the medical stakeholder community.

“Forward movement on this topic seems to be predicated on the presumption that the 700-hour training and experience requirement in 35.390 is no longer appropriate, particularly for individuals without NRC-recognized board certification,” he said. “Before there is any serious movement toward modifying T&E content or hours, there should be a fact-driven assessment of the external criticisms regarding 35.390.”

The NRC staff will finalize and submit its evaluation paper to the NRC commissioners on August 31. Any rulemaking or additional information-gathering activities would likely occur after the commissioners review the staff paper. The ACMUI is undergoing a separate activity to develop advice for NRC staff regarding alternative pathway requirements for potential users who lack NRC-recognized board certification. However, the NRC is not required to follow its federal advisory committee’s recommendations.

Meanwhile, the NRC’s long-awaited final rule to update various aspects of its medical use regulations was published in the Federal Register on July 16. This effort has been ongoing for over a decade, with most of the subtopics recommended in previous years by ACMUI and national professional societies. Examples of covered issues include medical event definition improvements for permanent implant brachytherapy, grandfathering provisions for certain individuals (Ritenour petition), elimination of preceptor attestation requirements for NRC-recognized board-certified individuals, molybdenum contamination measurement, reporting of failed technetium and rubidium generators, Associate Radiation Safety Officer designation on licenses and more.