ML24205A116
| ML24205A116 | |
| Person / Time | |
|---|---|
| Issue date: | 08/21/2024 |
| From: | Cindy Flannery NRC/NMSS/DMSST |
| To: | |
| References | |
| NMSS-ISG-03 | |
| Download: ML24205A116 (1) | |
Text
1 REGULATORY ANALYSIS DRAFT INTERIM STAFF GUIDANCE (NMSS-ISG-03)
GUIDANCE FOR THE IMPLEMENTATION OF 10 CFR PART 35 TRAINING AND EXPERIENCE REQUIREMENTS (New Interim Staff Guidance) 1.
Statement of the Problem The U.S. Nuclear Regulatory Commission (NRC) is considering issuing a new interim staff guidance (ISG) for use by licensees or applicants who are seeking to add individuals to their license as authorized individuals. These include authorized users, radiation safety officers, associate radiation safety officers, authorized nuclear pharmacists, authorized medical physicists, or ophthalmic physicists.
The training and experience (T&E) requirements have evolved over the years in response to changes in medical practice, and to ensure that access to patient care is not affected by changes in the medical arena. In the Staff Requirements Memorandum for SECY200005, Staff RequirementsSECY-20-0005Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material (10 CFR Part 35), dated January 27, 2022 (Agencywide Documents Access and Management System Accession No. ML22027A519), the Commission directed the staff to develop implementation guidance to clarify the roles and responsibilities of individuals subject to T&E requirements and to clarify how individuals will fulfill these requirements. NUREG-1556, Consolidated Guidance About Materials Licenses, Volume 9, Revision 3, Program-Specific Guidance About Medical Use Licenses, Final Report, issued September 2019 (ML19256C219), contains most of the guidance on medical T&E criteria. This NUREG is updated periodically, concurrent with regulatory changes. Additional guidance can also be found throughout a variety of NRC documents and resources, such as NUREG-1516, Management of Radioactive Material Safety Programs at Medical Facilities, issued May 1997; the NRCs Medical Uses Licensee Toolkit website; and rulemaking documents.
Due to ongoing rulemakings for Title 10 of the Code of Federal Regulations (10 CFR) Part 35, Medical Use of Byproduct Material, and because some of the T&E requirements could change in the near future, the staff is preparing the T&E implementation guidance as an ISG. Given the types of questions that the NRC and Agreement State staffs routinely receive about T&E requirements, the NRC staff has determined that supplemental guidance would benefit individuals applying for authorized individual status in the interim until the next rulemaking, and that the ISG should address the following in response to the Commissions direction:
expectations for individuals who are subject to the T&E requirements (e.g., supervision) training, including equivalency of hours, recentness of training, and vendor-and device-specific training preceptors and their role in T&E requirements multiple authorizations (e.g., authorized users or authorized medical physicists who can also serve as radiation safety officers)
2 completion of NRC Form 313A series and supporting documentation Once the NRC is closer to promulgating these medical rulemakings the NRC staff will decide on the best vehicle to transmit the guidance (e.g., include as part of existing licensing guidance in NUREG-1556, Volume 9, or issue as a standalone guidance document).
2.
Objective The ISG points applicants and licensees to regulatory requirements, consolidates and clarifies existing guidance, and provides additional guidance for the NRC staff and Agreement State regulators to use when evaluating applications or license amendment requests seeking to add authorized individuals to their license. It clarifies the roles and responsibilities of individuals subject to T&E requirements, and outlines the information needed to demonstrate the necessary T&E for individuals being listed on the license. Additionally, the ISG details ways that these individuals can fulfill the T&E requirements.
The ISG does not contain new expectations in implementing the T&E requirements. Rather, it consolidates the guidance previously contained in various sources into a streamlined format to improve clarity and accessibility.
3.
Alternative Approaches This section analyzes the two alternatives that the NRC considered for development of the ISG on implementing the T&E requirements in 10 CFR Part 35: (1) do not issue the ISG, and (2) issue the ISG.
Alternative 1: Do not issue the ISG Under this alternative, the NRC would not develop guidance for implementing the T&E requirements in 10 CFR Part 35. This alternative is considered the no action alternative and provides a baseline condition from which any other alternatives will be assessed. This alternative would result in no new direct costs to the NRC, the Agreement States, or the industry.
This alternative would continue to provide reasonable assurance that public health and safety would be adequately protected since the 10 CFR Part 35 T&E regulations are well established, and guidance is available on how to complete a license application or an amendment request to approve individuals as authorized individuals on a license. However, under this alternative, the NRC would not be providing licensees, applicants, Agreement State regulators, or the NRC staff with more detailed and streamlined guidance regarding the process for adding authorized individuals to licenses. Furthermore, the NRC would not be providing clarification of the roles and responsibilities of individuals subject to T&E requirements or how individuals fulfill the T&E requirements. This may lead to continued inconsistencies and inefficiencies in the approval of T&E of proposed authorized individuals and could result in continued submission of insufficient information and documentation by licensees and applicants who are seeking to add authorized individuals to their license.
Alternative 2: Issue the ISG Under this alternative, the NRC would develop guidance for implementing the T&E requirements in 10 CFR Part 35. This alternative would improve efficiency and would ensure the NRCs
3 implementation guidance on 10 CFR Part 35 T&E requirements relies on the best available information and practices.
The impact to the NRC would be the costs associated with preparing and issuing the ISG, responding to Agreement State and public comments, and holding a public meeting. The value of the ISG would be that more concise and streamlined guidance would be available for applicants and licensees seeking to add authorized users to their licenses and permits. Having more streamlined guidance should assist applicants and licensees with developing their submittals to the NRC and Agreement State regulators. Because the ISG will clarify expectations and point applicants and licensees to the applicable regulations, it should lead to higher quality applications and license amendment requests. Therefore, the ISG should enhance the efficiency of reviews and reduce the need for NRC or Agreement State requests for additional information (RAIs). Ultimately, the increased efficiency in Agency reviews could lead to lower operational costs for the NRC and Agreement States and could produce cost savings for applicants and licensees.
Conclusion Based on this regulatory analysis, the NRC staff concludes that issuing an ISG (Alternative 2) is warranted because it results in:
clearer and more concise guidance to applicants and licensees, fewer regulatory questions from applicants and licensees regarding T&E requirements and therefore fewer requests for additional information from the NRC and Agreement
- States, averted costs for industry, the NRC, and the Agreement States, due to the increased clarity and efficiency, and numerous qualitative and substantive benefits to requests for adding individuals as authorized individual to a medical-use license.
ML24200A068; ML24205A116 OFFICE NMSS/MSST/SLPB NMSS/MSST/MSEB R-III/DNMS/MLB NMSS/MSST/MSEB NAME CFlannery KTapp BParker FTran for CEinberg DATE Jul 18, 2024 Jul 26, 2024 Jul 26, 2024 Jul 26, 2024 OFFICE ADM/DRMA ADM/DRMA OGC/NLO NMSS/MSST NAME THerrera JDougherty TJones KWilliams DATE Jul 26, 2024 Aug 7, 2024 Aug 13, 2024 Aug 16, 2024