Nuclear Regulatory Commission (NRC) staff has revealed plans to submit recommendations to the agency’s commissioners on training and experience (T&E) requirements for authorized users (AUs) of unsealed material requiring a written directive (as specified in 10 CFR 35.390).
The timeline and plans were discussed as part of the fall business meeting of the NRC Advisory Committee on the Medical Uses of Isotopes (ACMUI). The recommendations are scheduled to be submitted to NRC commissioners in December.
The future NRC staff recommendations on AU T&E will inform the commissioners’ decision on whether to pursue regulatory changes to more easily enable clinicians without radiation expertise to supervise the handling and use in cancer care of therapeutic quantities of unsealed radioactive materials. Unsealed materials requiring a written directive are generally far more expensive and carry a higher radiation risk than materials used in medical imaging.
The ongoing effort to reevaluate AU T&E for therapeutic and theranostic radiopharmaceuticals was instigated by years of lobbying from companies that either manufacture or prepare the expensive radiopharmaceuticals in question. Proponents of weakened requirements have historically been unsuccessful in generating enough momentum to execute the change, including via a 2006 petition for rulemaking (PRM‐35‐19) that was ultimately denied by the NRC in 2007.
Many serious concerns are associated with deregulating or weakening AU T&E requirements, as outlined in comment submissions from various professional organizations. Among others, these groups include:
- The American College of Radiology
- American Medical Association
- American Society for Radiation Oncology
- Society for Nuclear Medicine and Molecular Imaging
- American Osteopathic College of Radiology
- American College of Radiation Oncology
- American Association of Physicists in Medicine
- Health Physics Society
- Organization of Agreement States
- Conference of Radiation Control Program Directors
Medical community experts have argued that there is no supportable justification for weakening T&E requirements that have long been integrated into physician training programs and have served public health and safety well for approximately two decades.
There are concerns that instead of increasing patient access via the creation of new NRC and Agreement State licenses, the approaches under consideration would serve to internally disrupt licensed health care facilities, physician training programs, quality/safety accreditation programs and radiation protection programs and regulatory agencies (including NRC).
Most importantly, experts are concerned about the negative impact of weakened AU T&E on patient and public safety, quality in the use of therapeutic quantities of radioactive materials and the ability of radiation programs and regulators to adequately monitor and investigate medical events and trends that may occur under supervision and use by insufficiently trained individuals.
The concepts and draft approaches that will be described in the NRC staff paper are under review by the ACMUI and representatives of the Agreement State programs. After review, NRC staff will revise the recommendations and select a preferred approach for the commissioners’ consideration.
Nearly all professional organizations representing the relevant physician, physicist and regulator communities support the proven protections afforded by the current AU T&E criteria under 10 CFR 35.390.