ML24358A266

Industry Comments to Inform the Nrc’S White Paper on Nth-of-a-Kind Micro-Reactor Licensing and Deployment Considerations

ML24358A266
Person / Time
Site:	99902028, Nuclear Energy Institute
Issue date:	12/20/2024
From:	Klein S Nuclear Energy Institute
To:	Jeremy Bowen Office of Nuclear Reactor Regulation, Document Control Desk
References
Download: ML24358A266 (1)

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Spencer Klein Senior Project Manager, New Nuclear Phone: 865.466.9248 Email: spk@nei.org December 20, 2024 Mr. Jeremy Bowen Director, Division of Advanced Reactors and Non-Power Production and Utilization Facilities Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

Subject:

Industry Comments to Inform the NRCs White Paper on Nth-of-a-Kind Micro-Reactor Licensing and Deployment Considerations Project Number: 689

Dear Mr. Bowen,

The Nuclear Energy Institute (NEI)1 and its members are providing the attached comments and recommendations to inform the NRCs draft white paper on Nth-of-a-Kind Micro-Reactor Licensing and Deployment Considerations that will maintain safety and provide a more effective and efficient approach to address the unique considerations of advanced reactors. These recommendations are focused on attaining the regulatory efficiency and agility required for large-scale micro-reactor deployment, but many could be applied to larger advanced (light-water and non-light water) reactors. The next generation of nuclear reactors bring with them very different manufacturing, construction, and operational models, coupled with vastly different business models that require adaptation of the regulatory processes that have developed to date.

NEI appreciates the considerable amount of work that the NRC has done to address the variety of advanced reactor technologies and various intended applications of these technologies, and we appreciate the NRCs continued progress to establish alternative approaches for advanced reactors in a broad range of topical areas, including the work that has been done previously with a consideration of micro-reactors and manufacturing licenses that has also established a foundation for many of the topics addressed in this paper.

1 The Nuclear Energy Institute (NEI) is responsible for establishing unified policy on behalf of its members relating to matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEIs members include entities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect and engineering firms, fuel cycle facilities, nuclear materials licensees, and other organizations involved in the nuclear energy industry.

Mr. Jeremy Bowen December 20, 2024 Page 2 Nuclear Energy Institute In parallel with the NRCs efforts in this area, NEI provided the Proposal Paper for the Regulation of Rapid High-Volume Deployable Reactors in Remote Applications (RHDRA) to the NRC on July 31, 2024.2 The goal of that paper was to provide insight into the technology characteristics, concepts of deployment and operations, and concepts for alternative regulatory approaches that the industry has been discussing.

As discussed in that paper, many substantive changes are needed to create processes and alternative regulatory approaches to enable business models that would meet the business case requirements identified for oil and gas applications and could also enable business models for other industries that are hard to decarbonize and/or have market characteristics that are similar. The market potential for nuclear energy in markets that would utilize this type of business model could be in the multiple 1,000s of operating reactors by 2050. Therefore, safely and efficiently enabling these business models is important to meeting the U.S. needs for more nuclear energy to achieve our climate, energy, environmental, economic, and national security goals.

NEI is excited to see that the NRC staff has completed a comprehensive review of the RHDRA proposal paper and provided a response, dated December 9, 2024, that expresses agreement with the high-level concepts outlined in the RHDRA proposal paper and indicates that no fundamental gaps have been identified with the NRCs ongoing and planned activities that would deter implementation of the planned business models associated with microreactor deployment. Further, it is great to see in the staffs response that the NRC supports the NEI position that the strategies and guidance being developed to support microreactor deployment may be applied in a graded manner to other advanced reactor designs.

While the NRCs paper and the list of completed, current, or planned initiatives regarding microreactors provided in the NRCs response to NEIs RHDRA proposal paper generally align with NEIs proposed approaches and address the topics outlined in NEIs RHDRA proposal paper, there are some differences in the details of the NRCs paper and the identified initiatives that can result in significantly different outcomes. The attachment to this letter provides more detailed comments on the paper, and NEI welcomes additional engagement with the staff on the topics and details presented in the RDHRA paper.

NEI recommends that the NRC:

1. In parallel with Commission policy decision on the NOAK White Paper topics, consider the details of the NEI RHDRA proposals in the included topic areas discussed in the attachment to this letter, as staff positions and guidance are developed.

2. Establish a roadmap (project plan) of the NRC plans to address the full scope of RHDRA topic areas in future efforts, papers and guidance, including how the NRC will integrate various sources of direction affecting prospective regulation for these technologies, such as SECY-24-0008, the ADVANCE Act and Commission direction in Part 53.

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Mr. Jeremy Bowen December 20, 2024 Page 3 Nuclear Energy Institute

3. In alignment with the NRC response to the NEI RHDRA paper, pursue engagement with stakeholders to develop the full set of topical areas. This should take the form of a series of public workshops to productively engage all stakeholders in discussing these topic areas in more detail that would begin in early 2025 and continue until any associated rulemakings and guidance development are finalized. As these ideas are relatively new, cover a broad set of topics, and many need near-term clarification to enable new uses of advanced reactors, the benefits of a series of workshops would be to foster mutual understanding and transparency among all stakeholders, and to produce more timely and well-considered approaches that are effective and efficient for all advanced reactors, and address the unique aspects of NEIs RHDRA proposal and the concepts in the NRCs draft white paper, to enable new business models. Although the NRC and NEI have been working on these topics for several years, the NRC has not instated more detailed stakeholder engagement that would lead to convergence of NRC and stakeholder understanding of the topics that would result in more complete proposed alternative approaches.

We appreciate the NRCs effort in developing this draft white paper and encourage your consideration of all stakeholder comments prior to finalizing the white paper. We trust that you will find these comments useful and informative as you finalize the white paper, and we look forward to future engagement on these important matters.

If you have any questions or comments about the content of this letter or the attached responses and comments, please contact me at spk@nei.org.

Sincerely, Spencer Klein Senior Project Manager, New Nuclear

Attachment:

Industry Comments to Inform the NRCs White Paper on Nth-of-a-Kind Micro-Reactor Licensing and Deployment Considerations c:

Mr. Greg Bowman, NRC Mr. Jonathan Grieves, NRC Mr. Mike Wentzel, NRC Mr. Duke Kennedy, NRC NRC Document Control Desk

ATTACHMENT Industry Comments to Inform the NRCs White Paper on Nth-of-a-King Micro-Reactor Licensing and Deployment Considerations NRC has already taken several important steps toward enabling advanced manufacturing and construction. In SECY-18-0060, the NRC's Executive Director for Operations (EDO) indicated that to efficiently and effectively regulate new technologies, the NRC staff should engage early with ongoing industry research; develop codes and standards that support the use of new materials and manufacturing methods NEI appreciates the NRCs continued progress to establish alternative approaches for advanced reactors in many topical areas, including the specific consideration of micro-reactors. The NRCs topics and alternative approaches in the paper generally align with industry priorities and needs for regulatory clarity and alternative approaches that are more effective and efficient for these technologies. We appreciate the NRCs rapid development in these areas. While the approaches described in the paper generally hit on the topics of priority and address technology considerations, there are a number of areas where industry believes more work and enhancements are needed.

Additionally, we agree with the NRC statement that the applicability of the paper is not constrained to a defined power level but rather are dependent upon the characteristics of the design and licensing strategy that enable the alternative approaches discussed. Similarly, many concepts are not limited solely to micro-reactors, and not all alternatives are dependent upon achieving the full suite of characteristics the NRC has described as pertaining to micro-reactors. For example, the amount of site-specific information will depend on the extent to which the applicant has decided to address design and site considerations in the ML, DC or SDA. Also, it depends somewhat separately from the extent to which the design is independent of site conditions. Therefore, the paper should more explicitly acknowledge that there is nothing inherent in many of the proposed approaches which preclude them from being used by technologies other than micro-reactors (e.g., LWR SMRs and grid-scale non-LWRs).

Comments on Preliminary White Paper - Nth-of-a-Kind Micro-Reactor Licensing and Deployment Considerations The white paper includes a limited scope of topics related to NOAK licensing, and makes reference to other NRC papers, e.g., SECY 24-008, that contain other issues related to NOAK licensing. The NEI related paper on RHDRA includes 31 topic areas to address that were determined to be necessary to provide regulatory clarity on alternative approaches for NOAK licensing, deployment and operations for near-term end users interested in these technologies. While it is understandable that the NRC would include a limited number of topics in each paper, there is a need for the NRC to identify their plans for addressing all of the relevant topics, including identifying the full scope of topics (as known today) that will be addressed, the timing for addressing those topics, including according to phases, e.g., identification, workshops with stakeholders, draft alternative approaches, and rulemaking and/or guidance development.

A lack of clarity on whether, and when, the NRC plans to address additional topics creates regulatory uncertainty to industry and customers that are attempting to develop business plans for use of these technologies and that need to know the NRCs plans to develop alternative approaches in order to inform the timing and scale of investments. For example, the NRC identified Construction Inspection as a topic,

Attachment Page 2 but it is not clear whether the NRC will at some point also consider Operations Inspections, which is often a more significant consideration for business planning.

Legislative and Regulatory Considerations The NRC paper states that it proposes alternative approaches that do not require legislative changes.

However, the paper does not discuss whether legislative changes were considered that would enable other more effective and efficient alternatives for NOAK licensing. The NRC should discuss the potential legislative changes that were considered, and if none were considered, the NRC should perform an evaluation of statutory requirements to determine whether legislative changes could enable more effective and efficient NOAK licensing. For example, in the NEI RHDRA paper, several potential legislative changes were identified, and for one topic a legislative change (elimination of the mandatory uncontested hearing) was proposed as the preferred option, which corresponds to legislation that has been introduced into Congress. The NRC is permitted to perform such an evaluation of potential legislative changes, and including such a discussion would enable Congress to better understand the potential improvements they could enable.

Licensing Strategy for NOAK Micro-Reactors The success of the NOAK licensing will depend on ensuring that only the minimum and sufficient level of information necessary for the NRC to make their reasonable assurance safety and environmental decisions are included in Phase 1 and Phase 2 applications. Further, the Phase 2 applications should focus on confirmation that the conditions in Phase 1 are met, which also depends upon a clear and concise set of conditions established in Phase 1 that will provide reasonable assurance that the site conforms to and is bounded by prior NRC safety and environmental decisions. The outcome of these additional components of NOAK licensing will be streamlined Phase 2 applications, which are more helpful in establishing an effective and efficient NOAK licensing process that is transparent to the public. While the NRC proposed automation of processing information will likely speed up the licensing process, efforts to right-size the information and scope of reviews will provide much larger benefits to improving the process and will minimize the extent to which automated information processes are relied upon. Further, the NRC should discuss how the optimized licensing strategies proposed for DCs and MLs, as discussed in the NRCs paper, can be utilized by SDAs and S-COLs.

Licensing Timelines The business models for microreactors are dependent on timeliness in meeting deployment needs of their customers. Its unclear if the efficiency opportunities identified by the NRC will, on their own, result in application reviews that meet industry objectives for timeliness. The optimized NRC licensing timelines for NOAK licensing do not achieve the business conditions for deployment of 180 days or less as identified by potential customers. The NRCs licensing timelines, as currently described in the preliminary white paper, range from 206 to 566 days for Part 50, and 211 to 511 days for Part 52, as measured from submission of the application to issuance of the license/authorization to load fuel. In contrast, the NEI RHDRA paper identified that the NRC would need to accomplish this scope of work within 150 days, and identified alternative approaches that are similar to the NRCs proposal that could achieve those timelines. The

Attachment Page 3 biggest difference between the NEI and NRC proposal is that NEI proposed that some licensing activities be performed in parallel, i.e., in Part 50 review and issue the CP and OL at the same time, and in Part 52 review and issue the COL and 103.g at the same time. The NRC today can issue the CP and OL in parallel and has a process to do it, while the NRC would need to create a new process to issue the COL and 103.g in parallel. The NRC should discuss these alternatives for parallel licensing actions, CP/OL and COL/103.g, including what can be done today and what would require changes (guidance, rulemaking, legislation) to enable them in the future. This may be sufficient to enable the NRC to achieve licensing timelines from application acceptance to approval for operations/fuel load that are consistent with the 150 days needed to enable the business model of 180 days for deployment.

The NRC timelines discussed in the paper focus solely on the NRC actions from application submittal to issuance of the operating license/authorization to load fuel. While application preparation time is highly dependent on both the NRCs requirements for application content and the ability of the applicant itself to execute efficiently, the NRC regulatory framework affects schedule on other parts of the deployment timeline, specifically in the area of site characterization to inform an applicants submittal. While site characterization is identified in Enclosure 3, and the NRCs proposal for more standardized content of application in Enclosure 2 through the use of an online portal is a good step in creating the conditions to enable the business models previously discussed, the NRC should identify the timelines that the requirements and guidance impose, and consider how the alternative approaches address the needs for the business requirements to fully realize the business model of 180 days for deployment. The NRC should include the timeline for applicant site characterization and identify how the alternative approach can achieve a 30 day or less site characterization process, i.e., how the NRC can enable all pre-application actions to be completed in 30 days or less from site identification to application submittal.

Options for Standardization of Operational Programs and Alternative Environmental Reviews Standardization of Operational Programs Based on NEIs preliminary review, the NRCs recommended Option 2 in the paper for the Standardization of Operational Programs where an applicant would have the option to provide proposed measures to satisfy operational requirements or complete operational programs as part of a DC or ML application appears to most effective and efficient. Operational Programs - NEI recommends the NRC pursue Option O2 to allow the NRC to develop an approach for applicants that is optional, for obtaining NRC approval and finality on operational programs as part of the DC or ML. The NEI RHDRA paper also identified the expanded use of topical reports to enable NRC approval of operational programs prior to the identification of a specific site as another option.

Alternative Environmental Reviews In looking at the proposed approaches to streamlining Environmental Reviews - NEI recommends the NRC pursue a multi-option phased approach that begins with design-specific GEIS Option 2a in parallel with General Permits in Option 3, followed by Option 4 for categorical exclusions. In developing Option 2a, the NRC also should consider using regional or area-wide GEISs, to address environmental conditions and potential impacts within larger geographical areas in which many NOAK micro-reactors may be rapidly

Attachment Page 4 deployed, in addition to the design-specific GEIS related to the design conditions. In developing Option 4, the NRC should develop technology-inclusive categorical exclusions that minimize the need for repetition of work for each design that can meet the relevant performance-based acceptance criteria (e.g., land use, water use). Thus, as noted in the draft white paper, using this performance-based approach, the NRC staff would assess whether such new categorical exclusions could be applied more broadly to other micro-reactors, such that it may be possible to develop categorical exclusions that apply to entire classes of micro-reactors. This could further increase efficiency by reducing the number of design-specific rulemakings needed to implement new categorical exclusions. Finally, the NRC should pursue options that enable the conclusion of consultations with Federal, State and Tribes to be done generically and minimize or even eliminate application specific consultations.

Stakeholder Engagement It seems reasonable to NEI that the NRC provides a discussion of how stakeholder input has been incorporated into the paper. As previously noted, NEI submitted a paper on Rapid High-Volume Deployable Reactors to the NRC that addresses the topic areas included in the NRCs paper and is an industry proposal for addressing Section 208 of the ADVANCE Act. While the NRC discusses that the paper addresses the considerations of the ADVANCE Act it does not mention the NEI paper or discuss how the proposed alternatives were incorporated into the NRCs proposed alternatives. As discussed in many detailed comments, the NRCs lack of addressing NEI and other stakeholder input results in an incomplete paper and consideration of the topics. To ensure that the NRC adequately addresses stakeholder input, the NRC should hold a series of workshops to ensure detailed stakeholder engagement and discussion is obtained and use that to inform a future revision to the paper. NEI would prefer that the NRC includes a commitment in the paper to hold those workshops in parallel with Commission policy decision on the NOAK White Paper topics.

Comments on Enclosure 1 - Standardization of Operational Programs for Nth-of-a-Kind Micro-Reactors At a high level, there is more work that needs to be done to address opportunities for efficiency across many of the operational programs discussed in the NRCs paper. The NRC seems to be relying on traditional program requirements, while handling deviations through pre-application meetings. NEI would welcome an NRC workshop with stakeholders to discuss Operational Programs and transformational approaches that industry is considering.

Inservice Inspection, Inservice Testing, and Preservice Inspection and Testing and Motor-Operated Valve Programs The NRC states in its NOAK Strategy that Current regulations for a DC or ML do not require a detailed description of these inspection and testing programs. However, the regulations do not preclude an applicant from providing that information for a DC or ML. Depending on the COL application, some site-specific information may be required to be verified during the COL stage. It is not clear to industry regarding the distinction between regulatory requirements and regulatory expectations. While citing

Attachment Page 5 current regulations not requiring detailed descriptions of the inspection programs, the Strategy states that submittal is not precluded, and certain details may be required.

Most of the codes, standards and regulations being referenced in the NRCs paper were developed and geared for LWR designs, much different than what would is expected for micro-reactors with passive design safety features. The NRC should consider adjusting their approach and not impose many of these requirements and standards that were developed and applicable to LWR and likely impart impractical or unnecessary inspections, tests or qualifications for little to no safety benefit.

Reactor Vessel Material Surveillance Program NEI agrees with the approach being taken by the NRC to address Reactor Vessel Material Surveillance Programs. The proposed NOAK Strategy recognizes the well-understood operating parameters and the material properties of interest in an LWR. The Strategy recognizes that non-LWRs will have present different material, chemistry and operating parameters than LWRs. The Strategy provides an approach to develop a standard surveillance program that reflects specific materials and materials properties, fabrication and operating parameters unique to the non-LWR design.

Quality Assurance, Maintenance Rule, and Reliability Assurance Programs It does not appear that the NRC staff considered the potential need for alternative approaches for micro-reactors using the LMP approach.The scope of the maintenance Rule (MRule) under 10 CFR 50.65 is not appropriate for micro-reactors following LMP. In line with the MRule scoping suggested in Table 4-1 of NEI 18-04 and the language in Proposed Part 53, the MRule scope should be limited to safety-significant SSCs. There is a case to be made that LMP+QAPD+special treatment selection including C&S and inspections testing + Mrule + Tech Specs covers the full scope of RAP.

The NOAK Strategy recognizes the regulatory requirement that a QA program description be submitted per application. The Strategy points to the 10 CFR Part 50 Appendix B requirements. NRC points out the importance of clear delineation of responsibilities, ownership, persons, organizations and duties. It does not, however, specify NQA-1 as the only acceptable quality program. NEI encourages NRC to be open to consider the validity and efficacy of other commercial quality programs, with additional controls and requirements as warranted, to meet the QAPD requirements.

Radiation Protection Program (Including Minimization of Contamination)

It appears that there may be a need for the use of Design Acceptance Criteria for radiation shielding that should be considered such that reactor designers may consider using updated standards for shielding design calculations. The use of updated standards for shielding design calculations, and their underlying methodologies may potentially require exemptions from existing NRC regulations (e.g., 10 CFR Part 20).

For designs that justify the use of updated standards, it should be ensured that NOAK designs do not need to submit additional exemption requests for approval of these updated standards.

Attachment Page 6 For example, in RG 1.206 Rev. 1, it is noted that the use of DAC is appropriate for certain design areas.

Although no recent DCs have used DAC for radiation protection, previous DCs have used DAC for radiation protection. RG 1.206 Rev. 1 goes on to note that the NRC has allowed the use of DAC when applicants justified certain conditions, such as completing the final design was impractical because of the unavailability of sufficient as-built or as-procured information for things such as radiation shielding.

Non-licensed Plant Staff Training, Reactor Operator Training, and Requalification Programs NEI is pleased to see the staffs reference to NEI 06-13A as an appropriate option for addressing training programs included in the white paper. The staff should consider revising the NOAK Strategy to clarify whether a single training exemption request for the FOAK can subsequently be applied without prior approval to future NOAK reactors operated by the same entity, if not then rulemaking should be considered to allow that to happen or this is a no value burden to licensees for something that will ultimately be approved.

The NRC has appropriately provided an example of an exemption for the 18-months prior to operation of a training program being established, however, rulemaking to prevent having to submit multiple exemptions for a fleet of microreactors at numerous sites should be taken into consideration, or a strategy for generically approving the first exemption for future NOAK reactors owned and operated by a single entity.

From the text in the white paper, it is unclear to NEI whether the staff would only expect a single exemption that would be applicable to future NOAK reactors.

Technical Specifications DANU-ISG-2022-08, Risk-Informed Technical Specifications (ML23277A146) references existing guidance in RG 1.174 and RG 1.177 which depend on the risk metrics of CDF and LERF, while noting that

. Advanced reactor applicants should use other risk metrics, such as those described in NEI 18-04, for determining completion times. While the risk metrics in NEI 18-04 are acceptable to the NRC as endorsed in RG 1.233, they require a level 3 PRA which is computationally burdensome. EPRI has developed a paper on AR risk metrics that would be technology-inclusive but does not require level 3 PRA. NRC should work with industry to develop alternative risk metrics, derived from the Quantitative Health Objectives (QHOs), that are appropriate for microreactors. This is a project NEI intends to pursue in 2025, and industry looks forward to future engagement with the NRC on this important technical topic.

Security NEI agrees with the NRCs conclusion that it should be possible for an applicant to reference applicable portions of a security program approved at the DC or ML level. To enable this approach, the NRC should issue new and updated guidance to address the gaps in DC and ML application guidance related to security, as noted by the staff.

We believe that pointing a microreactor applicant to NEI 03-12, Template for the Security Plan, Training and Qualification Plan, Safeguards Contingency Plan, [and Independent Spent Fuel Storage Installation Security Program] is not an effective solution since the material in that document was developed for

Attachment Page 7 compliance with 10 CFR 73.55 as implemented by large LWR facilities. Finally, we appreciate the staffs willingness to consider standardized security using geographic bounding conditions that applicants would need to meet in order to utilize a standardized security plan template (i.e., the content of a security application would need to be based on a geographic model).

Cyber Security The NRC NOAK paper recognizes the Cybersecurity Program is designed for the protection of digital computer and communication systems and networks. This program must comply with the performance objectives to establish, maintain, and implement a program in accordance with the regulation.

The desired outcome is a cybersecurity program scoped to ensure that only systems that perform or rely on functions that can contribute to the consequences stated in the regulation are assessed and protected.

A security by design approach, as well as adequately independent (diverse) methods to fulfill the safety and security functions, may also resolve or mitigate additional security issues. Documentation of the design basis elements and physical protection system features are needed to justify why a cyber-attack does not result in unacceptable consequences as described in the regulation.

A security by design approach may also resolve or mitigate additional security issues. Documentation of the design basis elements and physical protection system features are needed to justify why a cyber-attack does not result in unacceptable consequences as described in the regulation.

The use of a graded approach for the acceptance criteria, based upon different levels of potential off-site consequences (such as doses) or other basis (such as source term or thermal power), would be appropriate. Small off-site doses are expected to be achieved using passive and inherent systems, simplicity in design, and other features that result in higher safety margins and lower risks.

These levels (graded approach) provide a graded approach for determining the level of cyber protections commensurate with potential consequences. Based on the information available (DG-5075), the requirements focus on protecting from a Cyber-Enabled Accident Scenario and a Cyber-Enabled Physical Scenario. This tiered approach seeks to ensure that only systems that perform or rely on functions that can contribute to the consequences stated in the regulation are assessed and protected. It is possible that some sites plant design basis and physical protection systems are sufficient to prevent the potential consequences from a cyber-attack. Licensees will need to develop scenarios to analyze an adversarys access to attack pathways that allow for the compromise of plant functions.

An alternative regulatory approach is needed that provides flexibility (i.e., levels of requirements) in protecting the integrity of automatic/autonomous operations, remotely monitored data and remote operations/control related to the performance of plant functions and human actions that protect the public health and safety, and to protect sensitive plant data that could be used as a security threat against the reactor.

Access Authorization/Fitness for Duty

Attachment Page 8 The NRC NOAK paper recognizes the Access Authorization and Fitness for Duty (AA/FFD) programs are designed to provide assurance that personnel meet high standards of trustworthiness and reliability, by providing assurance that personnel are fit to perform nuclear duties safely and completely free from impaired conditions. The integrity of AA/FFD programs directly contributes to viable insider threat mitigation initiatives and supports an effective safety program. Operator reactor staffing and the concept of operations applicable to the design will help determine the AA/FFD program requirements. The current regulatory framework for Access Authorization (10 CFR 73.56) and Fitness for Duty (10 CFR Part 26) establishes the criteria for each program. An alternative regulatory framework would create an AA/FFD program that enables the two options of concept of operations: 1) as low as a single person on-site, and 2) no on-site staffing, operations from a remote center and field technicians that visits site periodically.

Access Authorization The evolving landscape of advanced reactor technology requires a regulatory framework that is both robust and adaptable to emerging innovations. Current methodologies, while effective for traditional reactors, may not fully address the unique opportunities presented by advanced reactors. Thus, an alternative approach to access authorization that is performance-based and graded is needed for advanced reactors. The alternative approach should establish the acceptance criteria that must be met and the corresponding requirements for features and functions that must be implemented. The alternative approach should include guidance to provide clarity for applicants.

AA requirements for advanced reactors must provide reasonable assurance that individuals are trustworthy and reliable include the following: background investigation, verification of true-identity, employment evaluation, unemployment, education, military service, credit history evaluation, character reputation evaluation, FBI criminal history, behavior observation, self-reporting.

One challenge noted is the maintenance and execution of an effective behavior observation program.

Limited staffing and site configuration could present challenges in maintaining viable behavior observations. In a full operating 10 CFR 73.56 framework, there are requirements for training in behavior observation.

For the proposed approach, personnel should have some level of training in observing concerning or aberrant behaviors, including insider threats. The frequency or level of training for advanced reactors should be less stringent than the 10 CFR 73.56 program requirements based on their lesser offsite dose consequences. Furthermore, the alternative approach should consider alternative methods of observing behavior, such as greater reliance on technology (e.g., biometrics, facial recognition or AI pattern recognition) and a less frequent interactions (e.g., limited to shift turnover or virtual meetings) rather than on direct constant human to human interactions. Human interaction should be applied whenever plausible and reasonable.

As mentioned, program elements include background investigation, psychological screening, fingerprinting, and fitness for duty (drug screening). Behavior observation is a hallmark program that supports safety and security programs in assuring that aberrant behavior is observed, documented, and reported. The current 10 CFR 73.56 operating program requires formal annual review from supervisors.

Attachment Page 9 An annual review may not be necessary for the proposed approach for advanced reactors, as personnel are expected to report aberrant behaviors immediately. Additionally, the current AA programs require annual fitness for duty training followed by an exam (continued AA is predicated on completing training).

However, there are considerations for training a population of personnel on what specific behaviors to look for and the frequency could be varied depending on the needs of the organization.

Initial background investigations are required under both Part 53 and 10 CFR 73.56. The elements of the background investigation are ostensibly the same, however, once an individual exceeds 30 days unobserved from the Behavior Observation program, the individual must be processed as a reinstatement for reissuance of the clearance. For advanced reactors and in consideration for sites that are isolated, modifying the requirement to longer than 30 days based on the applicants concept of operations or eliminating the requirement may be appropriate. The reduced burden of reduced reinstatements would provide relief to the site administrators. Additionally, a random-pre-access drug/alcohol screen could be implemented providing assurance that personnel can never know whether a drug/alcohol screen will be conducted. The employee should sign a program document stipulating there have been no arrests, drug/alcohol activity etc. during the time outside Behavior Observation, and if signed untruthfully, could result in termination.

Some type of reinvestigation will be necessary. Currently 10 CFR 73.56 requires reinvestigations every three years with a psychological component every five years for personnel designated as critical for large light water reactors. Increases in reinvestigation periodicity may be suitable, as noted in Part 37 programs, given the limited ability for workers to affect plant safety and security.

Fitness For Duty As mentioned above, an alternative approach that is performance-based and graded is needed for advanced reactors to fully address the unique opportunities presented by advanced reactors. For Fitness for Duty requirements, the alternative approach should establish the acceptance criteria that must be met and the corresponding requirements for features and functions that must be implemented. The alternative approach should include guidance to provide clarity for applicants. It would be appropriate that these FFD requirements for advanced reactors provide reasonable assurance that individuals are trustworthy and will perform their tasks in a reliable manner, are not under the influence of any substance, legal or illegal, that may impair their ability to perform their duties, and are not mentally or physically impaired from any cause that can adversely affect their ability to safely and competently perform their duties.

It would be appropriate for Fitness for Duty requirements to require conditions for testing such as Pre-Access, Random, For Cause, Post-Event, Follow-Up. A modified program that considers reducing the random testing population based on the level of detected abuse may be a reasonable approach. The population could be adjusted annually based on current metrics and trends.

Given the size, location, and reduced numbers of personnel associated with micro reactor operation, maintaining a viable pool for random testing could be problematic. A consortium could offer a viable solution to maintaining an FFD pool. A consortium is a group of organizations grouped together for the purpose of creating a random drug and alcohol testing pool to meet the regulatory requirements. Small

Attachment Page 10 companies could realize savings in time and money by contracting with a consortium to handle their random pool. Third-party administrators (as referred to in DOT regulation) can manage a part of or all of a consortiums drug and alcohol testing program, which often includes testing records. They perform agreed upon tasks to assist employers in implementing their drug and alcohol testing programs efficiently.

Consortiums are routinely used in the Department of Transportation and have been successful. The consortium third party administrator and on-site Designated Employee representative would work in concert to ensure regulatory standards are met.

Varied FFD testing devices and materials should also be considered. Oral fluid testing allows for portable transport, easy administration, and meets the same screening standards as urine collection. A program should also consider other options, such as rapid testing with kits that can determine the presence of a drug metabolite within minutes. An individual detected with this mechanism could be referred for full specimen collection at the programs request. Additional consideration will be needed into how and who administers the testing since many of these sites may be remote.

The alternative approach should be based upon the duties that workers perform that could impact the safety or security of the plant. It is expected that RHDRAs will have greatly reduced potential for workers to impact the safety and security of the plant.

The alternative approach should consider alternative methods of testing, such as greater reliance on technology (e.g., biometrics, facial recognition or AI pattern recognition or self-serve scanning/testing devices) to verify the identity of the individual and that the test specimen is from that individual. Use of such technology could be more easily implemented in operational models where there are not constantly two individuals together, with one being an administrator of the FFD program testing. Such approach could consider notification methods for random unannounced testing, with appropriate response time for use of the self-serve testing machines, and a response time from the FFD program administrators to respond if a test indicates the personnel needs to be removed from duty. Additionally, technology also offers options for scanning for alcohol detection through the skin and swab devices that can detect the presence of drugs by swabbing exterior surfaces.

Emergency Planning & EPZ Sizing NEI agrees with the proposed approach to emergency preparedness (EP) programs described in of the NRCs white paper. This includes support for the position that many aspects of a micro-reactor EP program could be reviewed in a DC or ML application and allowing approved portions of an emergency plan to be incorporated into a license application but remain part of the EP operational program. NEI also strongly supports the staffs intent to consider approval of an EPZ size at the DC or ML stage and permit the use of analysis bounding assumptions for site-specific factors like meteorology and consequences of event scenarios like seismic and security events. Finally, we are aligned on the need for a bounding safety analysis and hazard analysis to account for the radiological risks and hazards associated with any additional reactors desired in a NOAK application for a site.

Comments on Enclosure 2 - Environmental Reviews for Nth-of-a-Kind Micro-Reactors

Attachment Page 11 NEI strongly supports the NRCs proposed multi-option time-phased approach to micro-reactor licensing that begins with design-specific GEIS Option 2a (Design-Specific Generic Environmental Impact Statement) in parallel with Option E3 (Generic Micro-Reactor Online Portal with a Streamlined NEPA Process), followed by Option E4 (Design-Specific Categorical Exclusions). This approach is generally consistent with the recommendations set forth in Appendix 1 to NEIs RHDRA Proposal Paper. As the staff notes, implementation of Option E2a along with the parallel development of Option E3 would allow for flexibility of design changes and the necessary data collection and time requirement for deployment of Option E4. NEI agrees that the staff should assess whether new design-specific categorical exclusions also could be applied more broadly to other micro-reactors. As noted in NEIs RHDRA Proposal Paper, the staff also should consider possible use of an area or region-wide EIS/EA (or supplemental EIS/EA) where an applicant seeks to rapidly deploy large numbers (e.g., hundreds or more) of micro-reactors within a broad region (e.g., the Permian Basin).

NEI strongly supports the NRC staffs plan to make use of bounding assumptions in the form of plant parameter envelopes (PPE) and site parameter envelopes (SPE), and to tier from the New Reactor GEIS that the NRC has issued for public comment. These methods are consistent with NEPA requirements, related legal principles, and longstanding NRC regulatory practice, as well as the need for performance-based, technology-inclusive approaches to the licensing of new reactors.

We commend the NRC for examining the environmental review streamlining practices of other federal and state environmental or engineering agencies, as documented in the 2024 PNNL report cited in Enclosure

2. We believe the NRC can and should make use of each of the listed practices. As summarized on page 12 of Enclosure 2, these practices include using programmatic environmental NEPA documentation as a tiering tool and environmental checklists to confirm the applicability to the programmatic reviews; using CATEXs where appropriate; working with other consulting agencies to establish criteria to eliminate the need for repetitive formal consultations; allowing some portion of the NEPA and/or consultation process to conducted by the applicant; and using web portals or online databases/tools to streamline application submittals and facilitate communication with other agencies and consulting parties.

In this regard, NEI believes the NRC staffs proposed use of an Environmental Review Portal, Generic Micro-Reactor EA Template, and checklists could substantially expedite the agencys NEPA review process for NOAK micro-reactors. Consistent with rapid efficient repeatable licensing (ReLic) process described in NEIs RHDRA Proposal Paper, use of these tools would help ensure that NRC site-specific reviews of NOAK micro-reactors (and other RHDRA) become largely confirmatory in nature, with the staff verifying that the proposed facility and site meet or are bounded by the relevant values and assumptions in the PPE and SPE that support the generic findings made by the NRC in its prior NEPA analyses (e.g., the NR GEIS or Desing-Specific GEISs). As the staff notes, development of a portal to support environmental reviews could potentially support the NRCs response to the Congressional direction in Section 506(b)(2)(K) of the ADVANCE Act. Additionally, NEI notes that use of such a portal appears to be consistent with the intent of Section 110 (E-NEPA) of NEPA, as added by the FRA of 2023, in which Congress directed the CEQ to study and report on the potential for online and digital technologies to address delays in reviews and improve public accessibility and transparency under NEPA.

Attachment Page 12 The NRC Staffs preliminary white paper on NOAK licensing for micro-reactors acknowledges the FRA amendments to NEPA. The staff notes that it will fully implement the FRA in accordance with the Commissions direction on SECY-24-0046, Implementation of the Fiscal Responsibility Act of 2023 National Environmental Policy Act Amendments (ML24078A013). It further states that it will continue to seek efficiencies in the implementation of the current processes and would extend those efficiencies to reviews for micro-reactors. NEI strongly supports these NRC efforts, however, we recommend that the NRC staff similarly acknowledge and leverage, to the extent practicable, the agencys ongoing efforts to implement Section 506 (Modernization of nuclear reactor environmental reviews) of the ADVANCE Act.

There are considerable synergies between the actions that the NRC staff is taking, or has proposed to take, in response to the FRA and Section 506 of the ADVANCE Act, and the various options for streamlining environmental reviews for NOAK micro-reactors described in Enclosure 2 the NRC staffs white paper. Section 506 directs the NRC to submit a report to Congress within 180 days that describes the NRCs efforts to facilitate efficient, timely, and predictable environmental reviews of nuclear reactor license applications. Notably, Section 506 identifies numerous potential means for achieving this objective, including the expanded use of categorical exclusions, environmental assessments, and generic environmental impact statements. This directive is consistent with, and reinforces the need for, the staffs proposed use of GEISs (i.e., the NR GEIS, Design-Specific GEISs, and Generic Micro-Reactor GEIS),

EAs where possible, and CATEXs for micro-reactors.

Consistent with NEI recommendations in Appendix 1 to its RHDRA Proposal Paper, applicants and the NRC should make full use of the guidance contained in COL-ISG-029, Environmental Considerations Associated with Micro-reactors (Oct. 2020) (ML20252A076), which provides strategies for appropriately scaling micro-reactor environmental reviews commensurate with their expected smaller impacts. Among other things, COL-ISG-029 provides resource area-specific guidance.

The NRC staffs preliminary white paper also should discuss the potential role of mitigation measures to avoid or reduce potential environmental impacts that are greater than small to acceptable levels, consistent with recommendations set forth in NEIs Sept. 6, 2024, letter (ML24250A193) to the NRC regarding ADVANCE Act Section 506 implementation. In several places, the staffs paper mentions the possibility of extraordinary circumstances or special circumstances but does mention the concomitant possibility of mitigation of those circumstances through best management practices or other mitigation measures. Consistent with NEI's recommendations in its RHDRA Proposal Paper, Sept. 6 letter, and Sept.

20 letter (ML24264A112) on the NRCs proposed CATEX rule, we encourage the staff to expand its use of mitigated findings of no significant impact (FONSIs) and mitigated categorical exclusions, where necessary and appropriate. ADVANCE Act Section 506 specifically directs the NRC to consider expanded use of mitigated FONSIs. Additionally, COL-ISG-029 discusses the role that mitigation measures may play in reducing potential environmental impacts, and current CEQ regulations permit the use of mitigated CATEXs.

NEI also strongly supports the NRCs ongoing efforts to identify and implement means to expedite interagency consultations required under various federal statutes, including the ESA, NHPA, CWA, and CZMA. As the staff notes, such consultations have previously delayed the completion of the NRCs NEPA review in some cases. Importantly, Section 506(b)(2)(F) of the ADVANCE Act directs the NRC to explore

Attachment Page 13 opportunities to streamline formal and informal consultations and coordination with other Federal, State, and local governmental permitting agencies during environmental reviews of applications. In a related vein, new NEPA Section 107 (42 USC 4336a) directs each federal lead agency to develop a schedule, in consultation with each cooperating agency, the applicant, and other relevant entities, for completing any environmental review, permit, or authorization required to carry out the proposed agency action, and to ensure that any schedule deviations are appropriately addressed. To those ends, in addition to the approaches described in the preliminary white paper, we encourage the staff to consider the consultation-related recommendations contained in Appendix 1 to NEIs RHDRA Proposal Paper and its Sept. 6, 2024, letter to NRC regarding ADVANCE Act Section 506 implementation, as well as the NRC staffs own recommendations in SECY-24-0046.

Comments on Enclosure 3 - Technical, Licensing, and Policy Considerations for Nth-of-a-Kind Micro-Reactors Grading the Level of Site Characterization Based on our review, a graded approach to site characterization appears to be an efficient and effective approach. However, to further build on the approach outlined in the paper, the NRC graded approach matrix should allow reduced characterization when either the EAB dose margin or the Site parameter margin is high, they should not require traditional characterization. If the NRC believes that a high/low requires more characterization than high/med or med/med, then a new category of significantly reduced should be created for those, so that the high/low can be categorized as reduced, and the high/high can still be categorized as minimal.

NEIs RHDRA proposal included additional details on approaches to implement a more effective and efficient site characterization for advanced reactors that the NRC should consider. For seismic characterization, the NRC should permit the use of the USGS National Seismic Hazard Model (NSHM). Further, the NRC should include other characterization topics, such as an option to use NOAA or other reliable data to satisfy meteorological data requirements, in lieu of site data collection. The NRC should also discuss whether Population is a siting criterion to be addressed together with engineering topics, or whether the NRC plans to address Population siting separately in a future paper.

Lasty, NEI recommends that the NRC implement the guidance included Sec. 401 of the Advance Act where we see overlap between the site characterization aspects of the NRCs paper and the ADVANCE Act guidance to consider "standard materials that are in compliance with existing codes and standards".

Specifically, the NRC should develop an option for the use of ASCE 7 or IBC, which can rely on commercial means of site characterization, as opposed to ASCE 43, which relies on SSHAC.

Deployment Site Emergency Preparedness NEI supports the staffs intent to develop an ISG for the review of applications under 10 CFR 50.160 and identify additional ways to implement efficiencies within RG 1.242. As experience is gained in the review of applications, additional risk-informed guidance and strategies specific to the application of 10 CFR 50.160 could be needed. Depending upon several factors, NEI may be able develop the necessary guidance and

Attachment Page 14 strategies and submit them to the NRC for review and endorsement. We also appreciate the staffs interest in developing bounding-type approaches to the approval of standardized to emergency plans and EPZ analyses and encourage the pursuit of research needed to support this goal.

Deployment Site Security The NRC should be prepared to identify and develop additional guidance that would enable standardized approaches to security and efficient review of applications. Experience from application reviews, possibly coupled with research efforts such as consequence assessments, could provide the information necessary to support a bounding type of approach to the approval of security plans. In addition, it was not clear to us why the requirement in 10 CFR 100.21(f) was identified as a challenge to the NOAK strategy described in the paper.

The staff also points to use of 10 CFR 73.5, Specific Exemptions and 10 CFR 73.55(r), Alternative Measures, as ways to achieve goals concerning physical security, but notes that Barring exigent circumstances, either process can take a year or longer to complete.

While acknowledging that Design standardization at the DC or ML stage could enable the deployment of micro-reactors of a common design with a streamlined NRC review and approval of operational programs (i.e., targeted to site-specific features) at the CP/OL or COL stage, the staff cite NEI 03-12 as a template that applicants could use for a standard security plan which was developed for compliance with all aspects of 10 CFR 73.55 by large LWRs, and is excessive for micro-reactors.

NEIs RHDRA proposal included additional details on approaches to implement a more effective and efficient site security for advanced reactors that the NRC should consider.

Streamlined Licensing Process As discussed on page 3 of this attachment, the NRCs proposal for streamlining licensing processes appears to be effective and efficient. However, there is additional work that can be done to create the conditions for rapid license application development that should be considered prior to the finalization of the proposed approaches. NRC timelines in the paper focus solely on the NRC actions from application submittal to issuance of the operating license/authorization to load fuel. That said, there are schedule requirements that the NRC regulatory framework imposes on other parts of the deployment timeline, specifically in the area of site characterization that should be considered. Further, it would seem to make sense that the approaches being considered in the NRCs paper for NOAK licensing could be developed/considered now for the licensing of FOAK deployments, where possible, and should be stated as such.

Construction Inspection NEI looks forward to reviewing the NRCs ARCOP paper that is expected to be issued to the commission in December 2024.