September 27, 2018

NRC Addresses 35.390 T&E and Y-90 Guidance Controversies

The U.S. Nuclear Regulatory Commission (NRC) discussed its plans to address controversial topics — including radiopharmaceutical therapy Authorized User (AU) training and experience (T&E) requirements for clinicians without NRC-recognized board certification, and separately proposed changes to the Yttrium-90 (Y-90) microsphere brachytherapy licensing guidance — at the Advisory Committee on the Medical Uses of Isotopes (ACMUI) business meeting on Sept. 20–21, 2018.

The ACMUI is NRC’s federal advisory committee comprised primarily of independent medical professionals from various disciplines, including diagnostic radiology, radiation oncology, nuclear medicine and medical physics.

T&E for AUs of Unsealed Radiopharmaceuticals Requiring a Written Directive

The NRC has worked throughout 2018 to evaluate the feasibility of establishing less comprehensive T&E requirements for certain referring clinicians to more easily obtain AU eligibility for specific therapeutic radiopharmaceuticals — the concept is referred to as “limited AU” status. The background of this controversial agency effort was documented in the September 1, 2018, ACR Advocacy in Action eNews.

A recently released NRC staff paper essentially states that the limited AU concept would be technically feasible, but more data and stakeholder feedback would be needed before proceeding with any regulatory changes. In July 2018, the American College of Radiology (ACR) provided verbal testimony that expressed its opposition to the concept of a nominally trained, “limited AU.” In Aug. 2018, the ACR sent a letter to the five politically-appointed NRC commissioners arguing against the presumptions from industry lobbyists that informed the agency’s momentum.

At the September 2018 meeting, ACMUI members and NRC staff provided new information about the issue, including plans to solicit comments from the public on key questions, convene a public hearing and collecting additional data to determine if there would be any real basis for regulatory changes. After an estimated period of 12-to-14 months, the NRC intends to decide whether to proceed with a rulemaking.

Y-90 Microsphere Brachytherapy — 10th Revision to the Licensing Guidance

In February 2018, the ACR submitted comments opposing the NRC’s proposed elimination of an alternative to AU-supervised patient cases in the work experience requirements for Y-90 microsphere brachytherapy. The alternative approach is intended to allow interventional radiologists the flexibility to complete the AU work experience requirements with manufacturer-provided simulated cases followed by manufacturer-supervised patient cases.

The NRC has always intended to eventually normalize the regulatory requirements for Y-90 microsphere brachytherapy, which is currently handled as a new and emerging modality in 10 CFR 35.1000. It allows the agency to oversee its use via licensing guidance (as opposed to via regulation) and to gradually revise that guidance over time. Y-90 microspheres are also technically sealed sources, but are handled in practice more like unsealed materials, putting the modality in misalignment with NRC’s paradigm in the normal subparts of 10 CFR Part 35.

The ACR argued that the NRC should maintain the current flexibility until more data is gathered about the size and distribution of the Y-90 AU population and its ability to provide ample replacement T&E opportunities, particularly for interventional radiologists. The ACR also recommended the addition of prescriptive work experience requirements for manufacturer-contracted physician proctors on the requisite patient cases.

At the September 2018 meeting, NRC staff also discussed that its workgroup, comprised of both NRC and Agreement State representatives, is reviewing public comments and preparing changes as part of its role in updating the agency’s Y-90 microsphere brachytherapy licensing guidance. The final iteration of the 10th guidance revision will be provided to ACMUI for review this winter. There are no immediate plans to release the revision again for wider public comment unless there are significant modifications from the draft version.

For more information, contact Michael Peters, the ACR’s director of legislative and regulatory affairs at mpeters@acr.org.