The Nuclear Regulatory Commission is Seeking Your Input on its Evaluation of Training and Experience for Authorized Users

The U.S. Nuclear Regulatory Commission (NRC) is evaluating its regulations for training and experience (T&E) required for a physician to become an authorized user for medical uses under Subpart E, "Unsealed Byproduct Material—Written Directive Required," of Title 10 of the Code of Federal Regulations (10 CFR) Part 35, "Medical Use of Byproduct Material."

On October 29, 2018, the NRC published a series of questions on T&E in the Federal Register, the daily journal of the Federal government that contains government agency rules, proposed rules, and public notices. With the publication of these questions, the NRC opened a three-month public comment period seeking feedback on whether there is a need to change its T&E regulations under Subpart E of 10 CFR Part 35.

The T&E requirements in Subpart E of 10 CFR Part 35 provide three ways that a physician can currently be authorized to administer unsealed byproduct materials or radiopharmaceuticals requiring a written directive:

1. A physician can be certified by a medical specialty board, whose certification process is recognized by the NRC or an Agreement State.
2. A physician can complete a structured educational program and supervised work experience under an alternate pathway. The 700 hours required for authorization under this alternate pathway consists of a minimum of 200 hours of classroom and laboratory training and 500 hours of supervised work experience.
3. A physician can be authorized if previously identified as an authorized user on an NRC or Agreement State license or permit (i.e., grandfathered).

The NRC staff is considering whether another pathway should be created or if the alternate pathway should be revised. Specifically, the staff is evaluating: (1) whether it makes sense to establish tailored T&E requirements for different categories of radiopharmaceuticals; (2) how those categories should be determined (such as by risks posed by groups of radionuclides or by delivery method); (3) what the appropriate T&E requirements would be for each category; and (4) whether those requirements should be based on hours of training and experience, or focused more on competency.

The NRC encourages all individuals and organizations interested in the T&E evaluation to read the Federal Register notice and submit written comments on the notice using the Federal rulemaking website. On Regulations.gov, search for Docket Number NRC-2018-0230. The deadline for submitting comments is January 29, 2019.

The NRC is also holding four public meetings where it will accept oral comments. The meetings will be accessible for remote participation and are scheduled for January 10 and January 22, 2019. The NRC's public meeting page has participation details. Contact Sarah Lopas, Project Manager in the NRC's Office of Nuclear Material Safety and Safeguards, for questions about the T&E evaluation: Sarah.Lopas@nrc.gov and (301) 415-6360.