ML25042A010

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1-08-2025 Part 53 Proposed Rule Public Meeting Summary
ML25042A010
Person / Time
Issue date: 01/24/2025
From: Robert Beall, Nicole Fields
NRC/NMSS/DREFS/RRPB
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References
NRC-2019-0062, RIN 3150-AK31, 10 CFR Part 53
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1 ML25042A010 U.S. Nuclear Regulatory Commission Public Meeting Summary January 24, 2025

Title:

Public Meeting to Discuss the Part 53 Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors Rulemaking - Proposed Rule Meeting Identifier: 20241511 Date of Meeting: January 8, 2025 Location: Virtual Meeting - Webinar (via Microsoft Teams)

Type of Meeting: Information Meeting with a Question and Answer Session Purpose of Meeting:

The U.S. Nuclear Regulatory Commission (NRC) staff hosted a public meeting on January 8, 2025, to explain the staffs regulatory approach to proposing a risk-informed, technology-inclusive regulatory framework and to promote an understanding of the proposed rule. This meeting focused primarily on the topic of testing fueled manufactured reactors in the manufacturing facility and other technical topics of interest raised by stakeholders during the public meeting from Nov. 19-21, 2024, on the Part 53 proposed rule.

General Details:

In response to direction from the Nuclear Energy Innovation and Modernization Act (NEIMA)

(Public Law 115-439), the NRC is proposing to amend its regulations to create a voluntary, performance-based alternative regulatory framework for licensing future commercial nuclear plants. The new alternative requirements and implementing guidance would adopt technology-inclusive approaches and use risk-informed and performance-based techniques to ensure an equivalent level of safety to that of operating commercial nuclear plants while providing flexibility for licensing and regulating a variety of technologies and designs for commercial nuclear reactors.

The proposed Part 53 rule was published in the Federal Register on October 31, 2024 (89 FR 86918). The comment period closes on February 28, 2025.

Along with the publication of the proposed rule, the NRC publicly released a draft white paper, Subpart H - Licenses, Certifications, and Approvals; DRAFT Section 53.1480 -

Combined license supporting testing of manufactured reactors (Agencywide Documents Access and Management System (ADAMS) Accession No. ML24344A037) to support interactions with stakeholders on testing fueled manufactured reactors in the factory.

The meeting consisted of NRC staff presentations on testing fueled manufactured reactors at the manufacturing facility, the relationship between Parts 50 and 52 and Part 53, consensus codes and standards in Part 53, guidance documents for Part 53, and specific requests for comment related to the ADVANCE Act contained in the proposed Part 53 rule.

There was also a question and answer session where the public was invited to pose questions to the staff to get any needed clarifications on the proposed rule package. The meeting was attended by approximately 200 people participating through webinar or in person at NRC headquarters (see Appendix A, Attendees at January 8, 2025 Public Meeting on Part 53 Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors Rulemaking - Proposed Rule).

2 ML25042A010 Summary of Presentations:

Nicole Fields of the NRC staff opened the meeting and introduced herself as the meeting facilitator and backup project manager for the proposed rulemaking. Ms. Fields also introduced Robert Beall of the NRC staff as the primary project manager for the Part 53 rulemaking and another meeting facilitator. Ms. Fields described the purpose of the meeting (to discuss the proposed rule to inform the public comment process) and introduced Michael Wentzel of the NRC staff to provide opening remarks. Mr. Wentzel thanked participants for their attendance and encouraged participants to provide specific comments on the proposed rule, including any specific regulatory language recommendations, before the close of the comment period in February 2025.

Ms. Fields provided an overview of the meeting logistics and agenda, provided links to the proposed rule and associated documents, and encouraged participants to read the proposed rule. Ms. Fields stated that no comments would be accepted, and no formal responses or regulatory decisions would be made, during the public meeting. Ms. Fields then introduced and turned the meeting over to Bill Reckley of the NRC staff.

After each section of the staff presentations described below, the staff paused for questions from stakeholders; stakeholder feedback is summarized together in the Public Feedback and Questions section of this summary.

Mr. Reckley discussed the direction received from the Commission in the Staff Requirements Memorandum (SRM)-SECY-23-0021, Staff Requirements - SECY-23-0021

- Proposed Rule: Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors (RIN 3150-AK31) regarding factory testing of fueled manufactured reactors and the staffs approach to addressing that direction, including publication of a question in the Federal Register notice, development of a white paper, discussion in this public meeting, and consideration of public comments received on the proposed rule. Mr. Reckley highlighted that in addition to questions regarding provisions for testing for and limitations on operation of fueled manufactured reactors, the NRC is seeking input on appropriate regulations for the manufacturing facility and licensing mechanisms.

Mr. Reckley then discussed the white paper which contained draft preliminary rule language on a conceptual combined license for testing of manufactured reactors (COL-TMR),

beginning with the Commission findings on operating states and Question 7 in the Federal Register notice regarding categorization of a fueled manufactured reactor as a utilization facility. Mr. Reckley discussed the basic approach considered in the white paper, including efforts to limit the introduction of byproduct material, and the consideration of various regulations and licenses.

After a short break, Mr. Reckley continued his discussion of the white paper, focusing on selected examples regarding conceptual technical requirements and licensing construct. Mr.

Reckley discussed limits to power levels and inventory, licensing-basis events, impacts to downstream activities, and possible alternative requirements such as for staffing. Mr.

Reckley also discussed the applicability of the COL-TMR to the manufacturing facility and manufactured reactor, updates to the inspections, tests, analyses, and acceptance criteria (ITAAC) schedule and notifications, and conforming changes to Part 53 that would be necessary if the concepts from the white paper were adopted in the Part 53 final rule.

Nanette Valliere of the NRC staff then discussed considerations for transitioning from a Part 50 or 52 license to a Part 53 license, including topics for stakeholders to consider when formulating comments.

3 ML25042A010 After a break for lunch, Mr. Reckley discussed the application of consensus codes and standards to non-safety-related but safety-significant structures, systems, and components (NSRSS SSCs). Ms. Valliere and Marty Stutzke of the NRC staff discussed guidance related to Part 53, including guidance issued for public comment with the proposed rule, existing guidance to be updated with or after the final rule, and other guidance development activities. Mr. Reckley then transitioned to discussing the Accelerating Deployment of Versatile, Advanced Nuclear for Clean Energy Act of 2024 (ADVANCE Act) and introduced Michael King of the NRC staff who further discussed the ADVANCE Act, including providing the link for stakeholders to contact NRC staff about the ADVANCE Act. Mr. Reckley then discussed specific request for comment included in the Federal Register notice related to the ADVANCE Act. Mr. Reckley then provided an overview of the change evaluation criteria contained in § 53.1550 compared to NEI 22-05, Technology Inclusive Risk Informed Change Evaluation (TIRICE) Guidance for the Evaluation of Changes to Facilities Utilizing NEI 18-04 and NEI 21-07. As of this meeting, NEI 22-05 had not been endorsed by the NRC.

After a short break, Ms. Fields indicated that the final session of the public meeting was allotted for questions from the public on any aspect of the Part 53 proposed rule. The staff then took questions from the public.

Public Feedback and Questions:

Following each presentation, meeting attendees were given the opportunity to ask questions. Several members of the public raised questions related to the proposed rule language. Members of the public also asked questions throughout each presentation. In several instances when members of the public provided feedback on the proposed rule, the NRC staff encouraged them to submit their comments formally through regulations.gov.

Below is a high-level summary of the questions that were asked and the staffs responses.

Testing of Fueled Manufactured Reactors and White Paper on COL-TMR A stakeholder asked why Option 1b discussed in SECY-24-0008, Micro-Reactor Licensing and Deployment Considerations: Fuel Loading and Operational Testing at a Factory (ML23207A250) is not being pursued. The staff responded that the NRC developed the white paper for one approach to licensing for testing fueled manufactured reactors but will consider additional approaches proposed in public comments. The staff clarified that Option 1b concerning a factory-fabricated module with features to preclude criticality is addressed in the Part 53 proposed rulemaking. The stakeholder further questioned what kind of license is appropriate for the testing of a fueled micro-reactor, starting with whether it is a utilization facility or when the facility is in operation. The staff clarified that under an approach described in a 1970 Atomic Energy Commission proposed rule (35 FR 16687; October 28, 1970) that was not ultimately finalized, a reactor could be loaded with fuel and not be considered in operation under a Part 50 construction permit but would still be considered a utilization facility. The staff added that the white paper approach aligns with the Commissions findings as proposed that a fueled manufactured reactor is a utilization facility not in operation.

A stakeholder asked whether the language in the proposed rule deliberately departs from endorsed American Nuclear Society standards, international standards, and decades of practice regarding the double contingency principle. The staff responded that the referenced standards are for facilities outside of reactor areas, and that the two mechanisms proposed in § 53.620(d) keep a fueled manufactured reactor sub-critical, in line with General Design Criterion 26.

4 ML25042A010 A stakeholder asked if an evaluation of the pros and cons of categorizing the manufactured reactor as a utilization facility is available in some public format. The staff responded that there is some discussion in SECY-24-0008.

A stakeholder asked whether the NRC is working on an accompanying guidance document regarding the requirement for two independent security mechanisms. The staff responded that the NRC is not actively working on guidance for this topic, but that the NRC welcomes comments on whether guidance is needed for this issue.

Regarding the two independent physical mechanisms, a stakeholder said that the wording used by the NRC in the proposed § 53.620(d)(1)(i) (i.e., at least two independent physical mechanisms in place, each of which is sufficient to prevent criticality assuming optimum neutron moderation and neutron reflection conditions) is different than the language used in Section 4.2.2, Double-contingency principle, of ANSI/ANS-8.1-2014, Nuclear Criticality Safety In Operations With Fissionable Material Outside Reactors (i.e., Process designs should incorporate sufficient factors of safety to require at least two unlikely, independent, and concurrent changes in process conditions before a criticality accident is possible.). The stakeholder said that this is required to meet the ANS-8.1 process analysis requirement, and that ANSI/ANS-8.1-2014 is endorsed by the NRC in Revision 3 to RG 3.71, Nuclear Criticality Safety Standards for Nuclear Materials Outside Reactor Cores (ML18169A258). The stakeholder said that in Part 53 the NRC should use the double-contingency principle as stated in ANSI/ANS-8.1-2014. The staff responded that the referenced standard is for facilities that are not reactors, and that the two independent mechanisms as proposed in § 53.620 to keep a fueled manufactured reactor sub-critical are in line with General Design Criterion (GDC) 26 in 10 CFR Part 50, Appendix A.

A stakeholder asked what types of testing regimes were considered (e.g., sub-critical testing, neutron multiplication testing) and if comments on this topic would be helpful.

The staff responded that the approach in the white paper includes those tests limited to approaches to criticality and that comments on this topic are welcomed. The staff added that the Atomic Energy Act, as amended (AEA), establishes certain legal requirements regarding licensing for operators and that there are limits to who can operate in testing environments. The staff discussed that while zero-power physics testing might be possible under the white paper proposal, it would put the facility into operation and would require a combined license and associated requirements. The staff also stated that the white paper does not explore the possibility that the fueled manufactured reactor is not a utilization facility when actually undergoing testing.

A stakeholder asked to what degree controls for a fueled manufactured reactor could be similar to those used for existing critical assemblies in non-power reactors and whether a comparison and contrasting of controls for the two devices could be considered. The staff responded that the NRC welcomes public comments on requirements imposed on the facilities with critical assemblies and how they might relate to testing of fueled manufactured reactors.

A stakeholder asked whether a process is needed to establish common ground on foundational issues, such as when a fueled manufactured reactor is considered a utilization facility or when the reactor is in operation, before developing specific rule language. The staff responded that the NRC has several options for addressing this topic, including deferring this matter and having additional stakeholder engagements as part of a future rulemaking.

A stakeholder asked whether the white paper will be posted as an official document available for comment. The staff responded that the white paper supports the Part 53

5 ML25042A010 proposed rule. Any comments on the paper should be provided as a response to the related question in the Federal Register notice and will be addressed in the NRCs Response to Comments document as part of the final Part 53 rule. The staff added that comments submitted to the rulemaking docket on the white paper should be relevant to the response to the specific request for comment on this topic found in Section VI of the Part 53 proposed rule Federal Register notice.

A stakeholder asked whether comments on the § 53.1480 proposed regulatory language should be provided in response to NRCs request for public comment. The staff responded that the white paper structure or content can be referenced when preparing public comments on the Part 53 proposed rule, but requested that comments which do not agree with the white paper approach describe alternative approaches rather than provide detailed feedback on the paper itself. The staff added that fully formed proposals or points of consideration, including how proposals may interface with Sections 185 and 189 of the AEA, would be very helpful for the NRC.

Relationships between Parts 50 and 52 and the ProposedPart 53 A stakeholder asked whether the only changes necessary to the Part 53 rule language to achieve cross-part licensing would be removing references to Part 53 and in this part statements. The staff responded that it is more involved than that. For example, there are certain requirements for the technical content of applications that refer to specific Part 53 safety requirements that would not be met by, for example, a construction permit under Part 50. The stakeholder added that X-energy published a topical report on principal design criteria (PDC), which the stakeholder believes shows that applicants can meet the functional design criteria under Part 53 in the same way they would meet PDC under Parts 50 and 52. The staff further stated that an applicant under Part 50 using Advanced Reactor Content Of Application (ARCAP) and/or Technology Inclusive Content of Application Project (TICAP) guidance would likely be able to more easily transition to Part 53 than a non-Licensing Modernization Project (LMP) applicant.

A stakeholder asked whether an applicant leveraging portions of Part 50 and demonstrating that they meet the PDC would automatically be considered low risk within the Part 53 framework. The staff stated that it would be considered acceptable risk, as low risk is subjective.

Consensus Codes and Standards - Application to NSRSS SSCs A stakeholder asked about language in § 53.440 that stated design features must be designed using consensus codes and standards that have been endorsed, specifically inquiring whether the intent of this language was for the consensus codes and standards used to be endorsed prior to the submittal of an application, asserting the wording implies that is the case. The staff stated that the intent was that they could also be accepted during the review of the application.

A stakeholder asked whether the staff intends to revise every existing RG endorsing consensus codes and standards to include acceptability for Part 53. The staff noted they would discuss this during the guidance discussion later on in the meeting, noting that some of the guidance documents the stakeholder listed as examples are included in the staffs plans to revise guidance.

A stakeholder stated the rule text in § 53.440(c) and (d) states materials used for NSRSS SSCs must be qualified, which is a higher standard than current requirements, and asked if the intent was for that standard to apply to everything under § 53.440. The staff responded, noting there are typically differences between what would constitute

6 ML25042A010 qualified for safety-related and NSRSS SSCs (e.g., seismically qualified vs. seismically rugged).

Section VI, Specific Requests for Comments - Recent Legislation (ADVANCE Act)

A stakeholder stated that there could be significant overlap between comments on the ADVANCE Act and Part 53, and asked whether stakeholders can trust that the respective NRC teams will collaborate and share comments received in one area if they comments are relevant to the other area. The staff stated the Part 53 team will do their best to share relevant comments with the ADVANCE Act team and vice versa, but noted that comments submitted directly on the ADVANCE Act site will not be official comments on the Part 53 proposed rule and will also not have a written response issued by the ADVANCE Act team. The staff encouraged stakeholders to submit comments on the Part 53 proposed rule if they are relevant to both the ADVANCE Act and Part 53. The staff also stated that there are meetings being held on different ADVANCE Act topics and urged interested stakeholders to attend.

Guidance Documents for Part 53 A stakeholder asked whether DG-1443, Comprehensive Risk Metrics and Associated Risk Performance Objectives for Commercial Nuclear Plants would be applicable to light-water-reactors (LWRs). The staff responded that it is meant to be technology-inclusive guidance, so it would address both LWRs and non-LWRs. The stakeholder asked if it would also address probabilistic risk assessment (PRA) acceptability for LWRs. The staff responded that it does not, but that topic will be addressed within the forthcoming content of application guidance. The stakeholder then stated that it may be necessary to update RG 1.200, Acceptability of Probabilistic Risk Assessment Results for Risk-Informed Activities for PRA acceptability for LWRs.

A stakeholder stated that the deadline for public comments on Part 53 is not aligned with the proposed guidance development, noting it will be hard to provide comments on some topics (e.g., comprehensive risk metrics) without having the guidance detailing what they would entail under the Part 53 rule. The staff responded that there were timing issues that prevented certain guidance from being issued along with the proposed rule. The staff added they tried to address comprehensive risk metrics in the preamble to the Federal Register notice and noted that quantitative health objectives are one existing method to meet the proposed requirements.

A stakeholder asked about the long-term strategy for guidance development, particularly noting that while interim staff guidance (ISG) may be helpful for initial applicants, it would be more helpful for the future to have technology-inclusive application-agnostic guidance, such as a revision to NUREG-0711, Human Factors Engineering Program Review Model. The stakeholder asked if there would be a set of Part 53 guidance that is limited in scope, or if the intent is to have a more inclusive set of guidance that can be used by any applicant. The staff responded that for the initial rollout of Part 53, the staff had to select which guidance was crucial to develop first, but there will be a whole suite of guidance eventually. The staff added that specifically for DRO-ISG-2023-02, the decision was made to augment NUREG-1791 because the underlying framework is already technology-inclusive. The stakeholder added that their comments would address confusion regarding wording in the ISG, and the staff urged stakeholders to submit comments if any aspect of the guidance is not clear.

7 ML25042A010 Additional Requested Topics and Opportunities for Questions on the Part 53 Proposed Rule A stakeholder asked if proposed § 53.1550(a)(2)(iii) would prohibit licensees from changing a comprehensive risk metric without NRC approval. The stakeholder also stated that this paragraph is not the only area of the rule where fundamental safety criteria are explicitly detailed, but the NRC did not require approval for changes in other parts of the rule. The stakeholder added that if the intent is to address changes to the values of metric, a threshold to define what constitutes a change would be needed. The staff responded that it is accurate that licensees would need NRC approval for changes to their comprehensive risk metrics. The staff noted that the Commission instructed that metrics should not be changed without prior NRC approval in SRM-SECY-23-0021.

A stakeholder asked if the NRC had considered licensing reactors in a rapid deployment model through a service provider license approach. The stakeholder said that there was precedent for this in the NRC staff option in SECY-23-0055, Options for Licensing Emerging Technologies Used for Remediation of Mine Waste (ML23121A271), in the staffs consideration of options for licensing emerging technologies used for remediation of mine waste under Part 40. The staff responded that the topic of licensing reactors independent of a site been raised in the context of microreactors but they are not aware of any action within the Advanced Reactor Policy Branch or the Division of Advanced Reactors and Non-Power Production and Utilization Facilities (DANU) specifically looking at developing such an approach for nuclear reactors. Additionally, the referenced SECY paper has possible limitations, specifically in that it concerns source material, and the staff stated it was not clear how that might be applicable to the requirements for utilization or production facilities under the AEA, such as siting considerations. In any case, the staff stated that the development of such an approach is outside the scope of the Part 53 rulemaking.

o The stakeholder asked where these siting requirements might be located (if not in Part 53), and asked if there is any recognition that a plant parameter envelope of assumptions about the site might be an alternative to actual designation of the site.

The staff responded that siting requirements are contained in the AEA, in 10 CFR Part 100, and, for Part 53, the proposed siting requirements are in Subpart D. The staff added that there is always comparison and confirmation that the site fits the design. The staff said that this can be minimized, but a license is always associated with a site.

A stakeholder stated that §§ 53.220(b) and 53.450 appear to have a different definition of metrics that create an appropriate level of safety, and § 53.220, which includes comprehensive risk metrics refers to § 53.450. The stakeholder asked if a separate regulatory finding was required for each of these metrics. The staff responded that the analysis done under § 53.450 would include performance objectives associated with comprehensive risk metrics satisfied from § 52.220(b). In § 53.450, there are also separate evaluation criteria for each licensing-basis event (LBE). Therefore, two analyses would be requiredwhether the licensee meets the performance objective under § 53.220(b) and whether individual LBEs meet evaluation criteria under § 53.450.

A stakeholder stated that the criteria in § 53.800(a)(1)-(5) requires that the design must provide for a layered defense-in-depth approach not dependent on a single barrier for accredited human action, and it appears that there is no time-bound aspect. The stakeholder asked if this is the intent of the regulation. The staff responded that there is a content of applications regulatory guide for Part 53 under development that covers material on human factors engineering and operations that is not included in other regulatory guides that have been released. The staff said that, regarding this specific context, their intent is not endless layers of defense in depth that must be accounted for

8 ML25042A010 without reliance on human action. Rather, the intent was that, for each safety function, at least a single layer of defense in depth that is not dependent on human performance would be accounted for.

o A stakeholder asked if one layer of defense in depth refers to each safety function, or if a sufficiently robust fuel form could be the one layer of defense in depth that is not dependent on operator action. The staff responded that the intent of the rule is to not be too prescriptive, and that they do not want to point to a single barrier. The staff said that it is tough to envision a modern plant design with only one barrier.

o The staff further added that § 53.440(g) and (h) were included for long-term cooling and the ability to make the reactor sub-critical. The staff noted that licensing-basis events, as theyre analyzed and used for identification of safety functions and referenced in § 53.800, might enter an equilibrium state, and those provisions in

§ 53.440 recognize some later action that might be needed to shut down the unit and make it sub-critical. The staff asked participants to think about those requirements and how they fit into the various stages of an event and recovery from an event as they are developing comments.

Closing:

After the staff took questions from the public, Ms. Fields closed the meeting and encouraged all participants to submit comments on the proposed rule by the deadline on February 28, 2025.

Action Items/Next Steps:

This concluded the public meeting to discuss the Part 53 Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors Rulemaking proposed rule.

Related Documents:

ML24366A056 - 01/08/2025 Public Meeting to Discuss the Part 53 Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors Rulemaking Proposed Rule ML25003A060 - January 8, 2025 - NRC Staff Presentation Slides Public Meeting -

Proposed Rule 10 CFR Part 53 Risk-Informed, Technology-Inclusive Regulatory Framework For Commercial Nuclear Plants"