Draft Interim Staff Guidance: Guidance for the Implementation of Training and Experience Requirements

Draft Interim Staff Guidance: Guidance for the Implementation of Training and Experience Requirements

Dates

Submit comments by November 4, 2024. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.

Supplementary Information

I. Obtaining Information and Submitting Comments

A. Obtaining Information

Please refer to Docket ID NRC-2024-0143 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2024-0143.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select "Begin Web-based ADAMS Search." For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email to [email protected]. The draft ISG, NMSS-ISG-03, "Guidance for the Implementation of 10 CFR part 35 Training and Experience Requirements," is available in ADAMS under Accession No. ML24200A183.

• NRC's PDR: The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to [email protected] or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.

B. Submitting Comments

The NRC encourages electronic comment submission through the Federal rulemaking website ( https://www.regulations.gov ). Please include Docket ID NRC-2024-0143 in your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

II. Discussion

The NRC is issuing this draft ISG to clarify the roles and responsibilities of individuals subject to T&E requirements in part 35 of title 10 of the Code of Federal Regulations (10 CFR), "Medical Use of Byproduct Material" and to explain how individuals can fulfill these requirements. To do so, the draft ISG outlines applicable regulatory requirements, consolidates and clarifies existing guidance, and provides insight into the NRC staff's evaluation of applications or license amendment requests seeking to add authorized individuals to a license. If finalized, this ISG is intended for use by licensees and applicants that are seeking to add authorized individuals to their license. Authorized individuals include authorized users, radiation safety officers, associate radiation safety officers, authorized nuclear pharmacists, authorized medical physicists, and ophthalmic physicists. Further, if finalized, this ISG can be used by NRC staff and Agreement State regulators when evaluating applications and license amendment requests.

The draft ISG does not contain new expectations or requirements for implementing the T&E requirements. Rather, it consolidates the guidance previously contained in various sources into a streamlined format to improve clarity and accessibility. In the Staff Requirements Memorandum for SECY-20-0005, "Staff Requirements-SECY-20-0005-Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material (10 CFR part 35)," dated January 27, 2022 (ADAMS Accession No. ML22027A519), the Commission directed the staff to develop implementation guidance to clarify expectations on how individuals fulfill T&E requirements and clarify the roles and responsibilities of persons subject to the T&E requirements. This draft ISG supplements NUREG-1556, "Consolidated Guidance About Materials Licenses," Volume 9, Revision 3, "Program-Specific Guidance About Medical Use Licenses, Final Report," issued September 2019 (ADAMS Accession No. ML19256C219), which contains guidance on medical T&E criteria. NUREG-1556 is updated periodically, concurrent with regulatory changes. However, given the types of questions that the NRC and Agreement States routinely receive about T&E requirements, the NRC staff has determined that supplemental guidance would benefit individuals applying for authorized individual status, until the next update to NUREG-1556, Volume 9, Revision 3.

The staff is also issuing for public comment a draft regulatory analysis for this ISG (ADAMS Accession No. ML24205A116).