Text

HI-2240423, Rev. 6, SMR-300 Regulatory Engagement Plan
	ML25272A265
Person / Time
Site:	99902049
Issue date:	09/29/2025
From:	Haneman M; Holtec, SMR
To:	; Office of Nuclear Reactor Regulation
Shared Package
ML25272A263	List: ML25272A264; ML25272A265;
References
	HI-2240423, Rev. 6
	Download: ML25272A265 (1)
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SMR, LLC 8002 Sponsoring Company Project No.

Company Record Number HI-2240423 6

Revision No.

29 Sep 2025 Issue Date Record Type Report Copyright Proprietary Classification Nuclear Quality Class A Holtec International Company Record

Title:

SMR-300 Regulatory Engagement Plan Prepared by:

Reviewed by:

Approved by:

Export Control Status Export Control restrictions do not apply to this record.

Proprietary Classification This record does not contain confidential or Proprietary Information. Holtec International reserves all copyrights.

Signature histories are provided here for reference only. Company electronic signature records are traceable via the provided Verification QR Code and are available for review within the secure records management system. A valid Verification QR Code and the presence of this covering page indicates this record has been approved and accepted.

M.Haneman, 29 Sep 2025 C.Shurtleff, 29 Sep 2025 P.Lashley, 29 Sep 2025 No Export Control Applicability Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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Revision Log Revision Description of Changes 0

Initial issue under new report and project numbers.

1 Quarterly revision to update planned and completed meetings and reports.

Various editorial changes and revision of meeting plans to better align with typical practice.

2 Quarterly revision to updated planned and completed preapplication engagements and updated topical report and application timelines.

3 Quarterly revision to updated planned and completed preapplication engagements and updated topical report and application timelines.

4 Quarterly revision to updated planned and completed preapplication engagements and updated topical report and application timelines. Revised Holtec contact information.

5 Quarterly revision to updated planned and completed preapplication engagements and updated topical report and application timelines. Moved previously completed pre-application engagement topics from Table 4-1 to Appendix A.

6 Quarterly revision to update planned and completed preapplication engagements and topical report timelines. Revised Holtec contact information.

Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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Executive Summary The purpose of this Regulatory Engagement Plan (REP) is to guide interactions and enhance communication between Holtec International (Holtec) and the Nuclear Regulatory Commission (NRC) during the pre-application activities that support the development of a construction permit application (CPA) as part of a two-step license approach under Title 10 of the Code of Federal Regulations (CFR) Part 50, Domestic licensing of production and utilization facilities. The objective of these pre-application interactions is to ensure an acceptable future application and to address areas of potential licensing risk early in the licensing process.

Section 4.0 articulates the topics where Holtec intends to proceed with pre-licensing engagement. This REP is intended as a living document and will be updated as additional topics for engagement are identified.

Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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Table of Contents 1.0 Introduction.................................................................................................................... 1 1.1 Purpose of Regulatory Engagement Plan............................................................. 1 1.2 Contact Information.............................................................................................. 1 1.3 Company and Project Structure............................................................................ 2 1.4 Summary of Strategic Approach and Goals.......................................................... 2 2.0 Technology Summary..................................................................................................... 3 3.0 REP and PSAR Guidance and Content.......................................................................... 4 3.1 Selection of Applicable Guidance......................................................................... 4 3.2 Principal Design Criteria....................................................................................... 5 3.3 Use of Standards and Industry Guidance............................................................. 6 4.0 Pre-application Engagement.......................................................................................... 6 4.1 Identification of Topics.......................................................................................... 6 4.2 Type and Frequency of Interactions..................................................................... 7 4.3 Technical Discussions and Written Submittals..................................................... 7 4.4 Information Sharing and the Potential Escalation of Issues.................................. 8 4.5 Schedule Considerations...................................................................................... 9 5.0 Other Topics................................................................................................................... 9 5.1 Readiness Assessment Audit and Application Submittal...................................... 9 5.2 Budget.................................................................................................................. 9 6.0 References....................................................................................................................10 Appendix A Past Topics for SMR Pre-Application Engagement.......................................... A-1 List of Figures Figure 2-1: SMR-300 Reactor Coolant System.......................................................................... 3 List of Tables Table 3-1: Proposed PSAR Elements........................................................................................ 5 Table 4-1: Upcoming Topics for SMR Pre-Application Engagement........................................... 7 Table 4-2: Anticipated Licensing Topical Report Submittals....................................................... 8 Table A-1: Past Topics for SMR Pre-Application Engagement................................................ A-1 Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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1.0 INTRODUCTION

1.1 Purpose of Regulatory Engagement Plan The purpose of this Regulatory Engagement Plan (REP) is to guide interactions and enhance communication between Holtec International (Holtec) and the Nuclear Regulatory Commission (NRC) during the pre-application activities that support the development of a construction permit application (CPA) as part of a two-step license approach under Title 10 of the Code of Federal Regulations (CFR) Part 50, Domestic licensing of production and utilization facilities. This REP identifies the planned regulatory approach and describes the interactions and roles and responsibilities between Holtec and the NRC staff to establish open communications and minimize regulatory uncertainty with the licensing process.

This REP contains a register of anticipated pre-application engagement topics and an approximate schedule for each engagement. This REP is expected to be a living document and will be updated and expanded as plans evolve to support future licensing actions and regulatory decisions. All changes to this REP will be discussed and communicated with the NRC staff. The structure of this plan is based on NEI 18-06, Guidelines for Development of a Regulatory Engagement Plan [1]. Holtec will maintain this REP and solicit NRC staff input for consideration and inclusion into the REP.

1.2 Contact Information The following are points of contact for all correspondence:

Phil Lashley Director of Licensing, SMR Holtec International 1 Holtec Boulevard Camden, NJ 08104 Phone: 856-559-3783 Email: P.Lashley@holtec.com Copy to:

Kelly Trice President Holtec International 1 Holtec Boulevard Camden, NJ 08104 Phone: 865-617-3713 Email: K.Trice@holtec.com Jean Fleming Vice President, Licensing, Regulatory Affairs Holtec International 1 Holtec Boulevard Camden, NJ 08104 Phone: 609-970-9771 Email: J.Fleming@holtec.com Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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Justin Hawkins Executive Director, Reactor Projects SMR, LLC, a wholly owned subsidiary of Holtec International 1 Holtec Boulevard Camden, NJ 08104 Phone: 609-941-5765 Email: J.Hawkins@holtec.com Clark Shurtleff Licensing Manager, SMR Holtec International 1 Holtec Boulevard Camden, NJ 08104 Phone: 856-460-8717 Email: C.Shurtleff@holtec.com Correspondence relating to environmental and siting issues should also include:

Steven Mitchell Site Licensing Manager, SMR Holtec International 27780 Blue Star Hwy, Covert, MI 49043 Phone: 269-764-2000 Email: S.Mitchell@holtec.com 1.3 Company and Project Structure Holtec International is a diversified energy technology company headquartered in Jupiter, FL.

SMR, LLC, based in Camden, NJ, is a wholly owned subsidiary of Holtec International whose designated activities include establishing business alliances with other companies, business and project management of small modular reactor projects, and promoting global acceptance of SMR. Licensing interactions for the SMR-300 technology on behalf of SMR, LLC are the responsibility of the Holtec licensing staff. Responsibilities of the Holtec licensing staff will include: (1) develop, maintain and manage the licensing strategy for SMR and (2) act as the primary point-of-contact with the NRC staff.

1.4 Summary of Strategic Approach and Goals As discussed above, this REP will guide pre-application activities between Holtec and the NRC staff. Holtec plans to use these interactions to inform the pursuit of a multi-step licensing process for the SMR project. Holtec intends to submit a power reactor construction permit application (CPA) under 10 CFR Part 50, Domestic licensing of production and utilization facilities, for a dual-unit SMR-300 plant collocated with the existing Palisades Nuclear Plant.

Holtec plans to submit a limited work authorization (LWA) application as the first part of the CPA under 10 CFR 2.101(a)(9). The LWA application will discuss, at a minimum, the construction of the foundations of several major buildings. The second part of the CPA will cover construction of the remainder of the plant. The LWA is planned to be submitted by early 2026, while the CPA is planned to be submitted by mid-2027.

Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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As required by 10 CFR 50.34, the CPA will contain a preliminary safety analysis report (PSAR) and an environmental report as addressed in 10 CFR 51.50. The LWA application (the first part of the CPA) would include the information required by 10 CFR 50.10(d)(3), while the second part of the CPA would contain the remainder of the information required by §50.34. The environmental report associated with an LWA application is governed by 10 CFR 51.49. An application for an operating license (OLA) as described in 10 CFR Part 50, to include submittal of a final safety analysis report and a supplement to the CPA environmental report as addressed in 10 CFR 51.53, would be predicated on approval of the CPA.

2.0 TECHNOLOGY

SUMMARY

The SMR-300 is an advanced, passively safe, pressurized light water nuclear power plant with 300 MW(e) rated net electric output. The SMR-300 is designed with forced circulation utilizing two cold legs each with a vertically mounted reactor coolant pump (RCP), two hot legs, and a single once-through steam generator (OTSG) with an integral pressurizer stacked on top of the OTSG (see Figure 2-1). The use of RCPs during normal operation is necessary to produce the rated power; however, the design utilizes passive, gravity driven safety systems that do not rely on pumps, external water, external power, or operator action. The annular reservoir (AR), the large body of water situated between the containment structure and containment enclosure structure, serves as the SMR-300 ultimate heat sink.

Figure 2-1: SMR-300 Reactor Coolant System Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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3.0 REP AND PSAR GUIDANCE AND CONTENT 3.1 Selection of Applicable Guidance Holtec used the following references, in part, for the development of this REP:

NUREG-0800, Introduction - Part 2: Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: Light-water Small Modular Reactor Edition, Revision 0, 2014 [2]

Regulatory Guide 1.206, Application for Nuclear Power Plants, Revision 1, 2018 [3]

Regulatory Guide 1.70, Standard Format and Content of Safety Analyses Reports for Nuclear Power Plants, Revision 3, 1978 [4]

NEI 18-06, Guidelines for Development of a Regulatory Engagement Plan (REP),

Revision 0, 2018 [1]

These references inform the content in this REP, and will also be referenced, in part, to support future licensing actions and regulatory decisions as the REP pre-application activities progress.

NUREG-0800 provides the guidance used by NRC staff to perform safety reviews of construction permit or operating license applications under 10 CFR Part 50. While the SRP is not a substitute for the regulations, and compliance is not a requirement, for most application types, the regulation requires an assessment of the facility/design against the SRP in effect six months prior to docketing of the application. The SRP describes review criteria and procedures/methods used by NRC staff to conduct the review. Areas where the review standards are not anticipated to be relevant (e.g., exceptions to review and/or acceptance criteria) to the specific application will be especially important for early engagement and discussion. RG 1.70, like NUREG-0800, describes a standard format and the required content of safety analysis reports for light-water reactors acceptable to NRC staff under 10 CFR 50.

RG 1.206 provides additional guidance regarding information to be submitted in a combined license application. All of these references discuss the importance of the REP.

Additionally, Design-Specific Review Standards (DSRSs) are intended to be a design-specific augmentation of the standard review plan (NUREG-0800), adding review criteria where the SRP does not adequately cover the design, or taking exception to SRP criteria where the SRP may not apply to the design. There have been DSRSs developed for other small modular reactors.

The general consensus amongst the NRC staff and the industry is that the DSRS effort is a useful concept but is limited in its value because of the natural tension between the need for early identification/resolution of issues and the availability of sufficiently detailed design information to enable the NRC staff to draw final conclusions early enough in pre-application interactions to make binding conclusions in a DSRS. During the pre-application engagement activities, Holtec may consider referencing previous DSRSs to assist in informing the NRC staffs review of specific pre-application topics and elements of the PSAR.

The content and structure of the PSAR are well-defined by existing NRC regulations and guidance. Holtec will be using the REP pre-application engagement activities to inform the development of the PSAR elements provided in Table 3-1 below. RG 1.206 format and content Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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instructions are intended for applications developed under 10 CFR 52. RG 1.70 provides instructions for the form and content of SARs for applications developed under 10 CFR 50, but it has not been updated since 1978 and is not always consistent with other regulatory guidance.

Holtec therefore intends to align the SMR-300 PSAR and FSAR with NUREG-0800 to the extent practical, while incorporating guidance from RG 1.70 and RG 1.206 to provide information in the locations expected by the NRC. This strategy is intended to facilitate and ease NRC review of future applications.

Table 3-1: Proposed PSAR Elements Ch RG 1.70 RG 1.206 SMR-300 PSAR 1

Introduction and General Description of Plant Introduction and Interfaces Introduction and General Description of Plant 2

Site Characteristics Site Characteristics and Site Parameters

Site Characteristics and Site Parameters 3

Design of Structures, Components, Equipment, and Systems 4

Reactor 5

Reactor Coolant System and Connected Systems 6

Engineered Safety Features 7

Instrumentation and Controls 8

Electric Power 9

Auxiliary Systems 10 Steam and Power Conversion System 11

Radioactive Waste Management 12 Radiation Protection 13

Conduct of Operations 14 Initial Test Program Initial Test Program and ITAAC Initial Test Program 15 Accident Analyses

Transient and Accident Analysis 16 Technical Specifications 17 Quality Assurance 18 Human Factors Engineering 19 Severe Accidents PRA and Severe Accident Evaluation

Chapter title specifically referenced and discussed in DNRL-ISG-2022-01 [5].

3.2 Principal Design Criteria 10 CFR 50, Appendix A, establishes General Design Criteria (GDC) that are considered the minimum requirements for principal design criteria (PDC) for water-cooled nuclear power plants similar in design and location to plants for which construction permits have been issued by the Commission. § 50.34 requires an application to contain principal design criteria for a construction permit. The PDC establish the necessary design, fabrication, construction, testing and performance requirements for structures, systems and components important to safety, i.e.,

structures, systems, and components that provide reasonable assurance that the facility can be operated without undue risk to the health and safety of the public. Pursuant to Appendix A, the GDC are not necessarily sufficient for all light water reactor designs, and additional criteria may Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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be needed in the interest of public safety. Similarly, not all GDC may be necessary or appropriate for a given design, in which case departures from the GDC must be identified and justified. In past practice, such departures have sometimes required an exemption. Holtec licensing staff plans to engage the NRC staff on selected PDC during the pre-application engagement process as listed in Section 4.1.

3.3 Use of Standards and Industry Guidance Consensus standards (ANS, ASME, ANSI, IEEE, etc.) and industry guidance (NEI, EPRI, etc.)

will be utilized when appropriate during pre-application activities and the development of the PSAR. These consensus standards and industry guidance will assist in describing various aspects of the SMR-300 design, methodology for design and analysis, siting, etc. Particularly to the extent a given standard has not been endorsed by the NRC staff, or is being used in a novel way, Holtec plans to present the specific information as part of the REP to establish dialogue and a common understanding with the NRC staff.

4.0 PRE-APPLICATION ENGAGEMENT Holtec will facilitate pre-application engagement meetings (teleconferences, videoconferences, and face-to-face) with NRC staff to identify, assess, and mitigate potential regulatory risks associated with the discussion topics listed in this section. These interactions will also inform the development of the PSAR elements and environmental assessments as part of future application development. Primary benefits of pre-application engagement are to inform the NRC of Holtecs planned approach in areas of regulatory risk, and to ensure that eventual applications contain sufficient information to meet NRC expectations. Holtec will engage in frequent open and closed meetings with NRC staff during these pre-application activities to ensure that NRC staff has timely and accurate information to support future safety determinations and agency resource planning. Holtec understands the need to notify the public of agency meetings and will support efforts for early meeting notification. Holtec will also work with the NRC staff to coordinate an appropriate schedule of meetings, taking into account all of the potential attendees.

4.1 Identification of Topics Table 4-1 below includes topics that have been identified as important to address in upcoming pre-application engagements. As the project progresses, Holtec expects that other topics for pre-application engagement may be identified and added to the table below. The NRC will be promptly notified in the event additional topics are added for planning and budgeting purposes.

Timely pre-application engagement for each identified topic below will be important to keep the NRC staff informed and aligned on the schedule. Topics for pre-application engagement that were previously discussed or submitted are listed in Appendix A.

Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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Table 4-1: Upcoming Topics for SMR Pre-Application Engagement Topic Description Engagement Approx. Date SMR-300 Modularity Topical Report and SSI Topical Report Pre-Submittal Discuss scope and timing of the SMR-300 Modularity topical report and the SMR-300 Soil Structure Interaction (SSI) Analysis Methodology topical report Public Meeting 10/30/2025 Additional Items TBD Note ( * ) designates a topic of interest to environmental stakeholders (NMSS).

4.2 Type and Frequency of Interactions The type and frequency of interactions with the NRC will be managed by Holtec licensing staff and coordinated with the SMR project team and the NRC staff. The number and frequency of these interactions will be key to maintaining a consistent understanding of the status of issue identification and resolution. These interactions will include frequent phone calls, emails, teleconferences, and meetings to solicit feedback on proposed technical approaches, review of licensing topical reports, technical reports and white papers, audits of engineering information and potential inspections of testing facilities that support the pre-application engagement topics and PSAR development.

Holtec is proposing the following meetings with NRC staff:

Monthly calls between NRC Director, Division of New and Renewed Licenses (DNRL) and Holtec Vice President, Licensing and SMR Managing Director.

Monthly, or more frequent, calls established between the NRC Branch Chief, New Reactor Licensing Branch (NRLB), Holtec SMR Director of Licensing, and Holtec SMR Licensing Manager.

Biweekly (every two weeks), or more frequent, calls established between the assigned NRC project manager (PM), Holtec SMR Director of Licensing, and Holtec SMR Licensing Manager, or designated Holtec SMR Licensing Engineer.

Additional planning meetings and drop-ins, as needed.

In addition, with respect to the pre-application engagement topics presented in Table 4-1, Holtec proposes engaging with the NRC using any of the following methods for each topic:

Conduct a meeting, typically a remote session with presentation materials that describe the SMR-300 approach to the topic and any questions for the NRC staff.

Submit a white paper, letter, technical report, or licensing topical report on the selected topic for the NRC staffs review. Feedback for white papers may be provided in written form, in a subsequent meeting, or informally.

4.3 Technical Discussions and Written Submittals Initial discussions between Holtec and NRC staff will be concerned primarily with the planned strategies for development of the PSAR. Topics for these discussions, as well as follow-up interactions, will be developed by the Holtec SMR Director of Licensing or the Holtec SMR Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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Licensing Manager, and shared with the NRC staff and may focus on individual topics or several topics combined for efficiency.

Written submittals will be provided on the docket, including white papers, letters, presentations, technical reports, and licensing topical reports. White papers will be employed to address high level issues, summarize proposed approaches, and describe positions on a specific topic. To ensure clarity with respect to the use, application, and review of all written submittals (white papers and/or technical reports) during preapplication activities, frequent communication between Holtec and NRC staff will be conducted as detailed above. Licensing topical reports will be submitted when seeking an NRC safety evaluation for a specific topic that may be referenced in future licensing submittals. The anticipated licensing topical report submittal schedule is provided in Table 4-2.

Table 4-2: Anticipated Licensing Topical Report Submittals Topic Projected Submittal Date MELTAC Safety System Digital Platform Under NRC Review ML23167C168 Quality Assurance Program Description Approved ML24248A162 Risk Significance Determination Methodology Approved ML25051A209 Radiological Consequences Methodology Under NRC Review ML25157A142 SMR-300 I&C Design October 2025 SSI Analysis Methodology December 2025 SMR-300 Structural Modularity Design December 2025 Nuclear Analysis Codes and Methods Qualification Mid 2026 Applicability of Framatome Fuel Methodology, CHF Correlations, and COBRA FLX to SMR-300 Late 2026 Internals Structural Analysis Methodology Late 2026 Subchannel Analysis Methodology Late 2026 Applicability of GOTHIC to SMR-300 Late 2026 Large-Break LOCA Evaluation Methodology Early 2027 Small-Break LOCA Evaluation Methodology Early 2027 Non-LOCA Evaluation Methodology Mid 2027 Long-Term Cooling Methodology Mid 2027 Rod Ejection Accident Methodology Mid 2027 4.4 Information Sharing and the Potential Escalation of Issues A Holtec electronic reading room will be established to allow Holtec to share documents with the NRC staff, including program procedures, presentations, drawings, white papers, and technical Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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reports. A more detailed discussion of the electronic reading room can be found in the SMR, LLC Online Reference Portal Information Access Agreement [6].

As part of the pre-application activities, it may be necessary to resolve conflicts between existing regulatory infrastructure and new features in the SMR-300 design. Early identification and appropriate escalation of the issues will be useful in ensuring a timely resolution. Holtec licensing staff will work with the NRC staff to resolve these issues early in the process and at the appropriate level. As the REP is updated and expanded throughout the pre-application activities, Holtec may reassess issues and/or conclusions reached in previous discussions to identify needed exemptions from NRC regulations and/or deviations from regulatory guidance.

4.5 Schedule Considerations Holtec and the NRC held initial meetings to establish the REP and initiate preapplication engagements in 2022. Regular meetings have continued as cataloged in Table 4-1 and are planned to proceed in accordance with the schedule proposed therein. Any potential program audits and inspections will be coordinated with the NRC staff.

5.0 OTHER TOPICS 5.1 Readiness Assessment Audit and Application Submittal A readiness assessment audit should occur with sufficient time to resolve any identified issues prior to the submittal of an application. Holtec may request that the NRC staff conduct a readiness assessment audit of a completed, or nearly completed draft PSAR. This readiness assessment is a comprehensive review of the material over several days. The conclusion of the audit is a series of observations by the NRC staff, focusing on issues that might preclude acceptance of the application if left unresolved or uncorrected. A secondary objective of the readiness assessment audit is to identify areas for which clarifications or supplemental information could preclude or minimize staff requests for additional information. Depending on the results of the various pre-application engagement activities and reviews discussed above, the schedule for submittal of a PSAR may change. Changes to the PSAR schedule will be noted in regular updates to the REP and routine discussions between Holtec and NRC staff.

5.2 Budget Budgeting considerations are important in establishing and maintaining the pre-application engagement schedule. NRC staff review fees, including review hours, will be estimated at the time the selected topic is presented for review and monitored on an ongoing basis. Both Holtec and NRC staff will communicate any expected changes in the level of estimated NRC staff review fees, resource availability, or funding restrictions. The Holtec budget estimate for each topic listed in Table 4-1 will be in the range of 30 - 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br />.

Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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6.0 REFERENCES

[1]

Nuclear Energy Institute (NEI) 18-06, Guidelines for Development of a Regulatory Engagement Plan (REP), Revision 0, 2018

[2]

NUREG-0800, Introduction - Part 2: Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: Light-water Small Modular Reactor Edition, Revision 0, 2014

[3]

Regulatory Guide 1.206, Application for Nuclear Power Plants, Revision 1, 2018

[4]

Regulatory Guide 1.70, Standard Format and Content of Safety Analyses Reports for Nuclear Power Plants, Revision 3, 1978

[5]

DNRL-ISG-2022-01, Safety Review of Light-Water Power Reactor Construction Permit Applications, Interim Staff Guidance, October 2022

[6]

SMR, LLC Online Reference Portal Information Access Agreement, (ML22215A031),

August 23, 2022.

Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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Appendix A Past Topics for SMR Pre-Application Engagement Table A-1: Past Topics for SMR Pre-Application Engagement Topic Description Engagement Completed Date REP Discuss REP content and NRC REP feedback Informal Discussion Jul-2022 LOCA Exemption Discuss LOCA Questions and Previous Topical Report Submittal Public Meeting ML22243A010 Aug-2022 Critical Piping Clarification question on SRP Section 3.6 Informal Discussion Sep-2022 CRDS Operability QA Program Discuss CRDS operability QA program with mechanical group Public Meeting ML22252A181 Sep-2022 Computer Programs Clarification question on the use of STAAD.PRO Informal Discussion Sep-2022 Seismic Methodology Discuss seismic methodology for SRP Section 3.7 Public Meeting ML22259A128 Sep-2022 Instrumentation and Control (I&C)

Discuss an overview of the SMR-160 I&C architecture Public Meeting ML22263A014 Oct-2022 Spent Fuel Pool (SFP)

Makeup Systems Discuss SMR-160 SFP makeup system compliance Public Meeting ML22263A380 Oct-2022 Follow-up: CRDS Operability QA Program Discuss CRDS operability QA program with reactors group Public Meeting ML22263A420 Oct-2022 Technical Specifications (TSs)

Discuss TSs, specifically the requirements and guidance for TSs in an CPA Public Meeting ML22297A105 Oct-2022 LOCA Exemption Justification List Discuss a potential LOCA exemption justification items list Public Meeting ML22263A388 Oct-2022 Containment Heat Removal System Testing (GDC 40)

Discuss passive containment heat removal system testing and potential exemption Public Meeting ML22305A691 Nov-2022 Closed System Isolation Valves (GDC 57)

Discuss primary and secondary decay heat removal system closed system isolation valves and potential exemption Public Meeting ML22307A238 Nov-2022 Various Informal Discussions Discuss various email topics during the 4Q23.

Informal Discussions Nov-2022 SECY-94-084 PCCS Safe Shutdown Criteria Discuss safe shutdown criteria applicable to SMR-160 design Public Meeting ML22304A131 Dec-2022 SMR-160 Quality Assurance Program Discuss potential revision to SMR-160 approved Quality Assurance Topical Report (2014)

Public Meeting ML22329A005 Dec-2022 RCS Makeup (GDC 33)

Discuss RCS Makeup (GDC 33) Compliance Public Meeting ML22354A112 Jan-2023 CPA Parts and TOC Discuss NRC CPA Parts and TOC Expectations Public Meeting ML22355A658 Jan-2023 Instrumentation and Control (I&C)

Discuss I&C Hazard Analysis Methodology Public Meeting ML23019A004 ML23137A208 Feb-2023 MELCO I&C LTR Initial call supporting MELCO with scheduling I&C platform LTR revision.

Phone Call Feb-2023 Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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Topic Description Engagement Completed Date Fire Protection Discuss/Clarify Fire Protection Questions -

ensure JH is included in discussion Public Meeting ML23044A014 Feb 2023 Chapter 15 Analysis Methods Discuss accident analysis methods, progress, timelines, Appendix K, and expectations Public Meeting ML23018A009 Feb-2023 RG 1.99 Limitation (Embrittlement-Tc / Flux)

Discuss the limitations of RG 1.99 as it relates to the development of P-T curves for SMR-160 Public Meeting ML23045A010 Feb-2023 Simulator and Operator Training/Qualifications Discuss the SIM CERT process, OP training timelines, HFE OER, ITAAC (staff ideas PT

50)

Public Meeting ML23045A021 Mar-2023 MCR staffing 50.54(m)

Discuss SMR-160 MCR staffing, HFE Public Meeting ML23045A037 Mar-2023 International Projects Conduct discussion (part of EDO/COMM drop-in)

Drop-in Visit Mar-2023 REP (Quarterly Revision)

REP Rev 4 Submission ML23088A003 Mar-2023 LOCA Exemption Justification (Update #1)

Quarterly Update to discuss and present SMR-160 LOCA Exemption justification progress Public Meeting ML23045A052 Apr-2023 (4/5/23)

Chapter 13 Operational Programs Discuss Chapter 13 Operational Programs and the expected thresholds for each in the PSAR Public Meeting ML23045A070 Apr-2023 (4/19/23)

Electronic Submittal Process Discuss the NRCs License Application Electronic Submittal Process and Lessons-Learned Clarification Call 10:00-11:00 Apr-2023 (4/19/23)

SMR-160 Design Overview Agenda Discuss and present a high-level design overview of the SMR-160 to the NRC staff Closed Meeting ML23115A022 May-2023 (5/3/23)

Fuel Qualification and Testing Discuss the SMR-160 fuel qualification and testing plan Public Meeting ML23116A034 May-2023 (5/10/23)

PRA/PSA Topics Discuss Risk Significance Criteria and RG 1.200 Methodology and Approaches Public Meeting ML23167A067 May-2023 (5/17/23)

LOCA Roadmap (F/U to 4/5/23 Mtg)

Discuss Potential LOCA Exemption Roadmap and Wording Public Meeting ML23116A066 May-2023 (5/25/23)

Discuss ATWS Discuss SMR-160 Compliance with the ATWS Rule (50.62) and potential exemptions Public Meeting ML23200A002 Jun-2023 (6/7/23)

HFE Program Discuss HFE Program, Procedures, Methodology, Questions Public Meeting ML23216A133 Jun-2023 (6/20/23)

Discuss Appendix K Applicability Discuss 10 CFR 50 Appendix K applicability to SMR-160 and potential exemptions Public Meeting ML23151A629 Jun-2023 (6/28/23)

REP (Quarterly Rev)

REP Rev 5 Submission ML23180A006 Jul-2023 (7/1/23)

EP/EPZ Development Methodology

Discuss EP and EPZ development methodology and results Public Meeting ML23216A092 Jul-2023 (7/12/23)

Discuss V&V of Codes Discuss V&V plans, timelines, potential LTRs, potential code-to-code benchmarking Public Meeting ML23121A009 Jul-2023 (7/19/23)

Instrumentation and Control (I&C)

Discuss I&C D3 assessment and coping analysis Public Meeting ML23156A182 Jul-2023 (7/26/23)

Instrumentation and Control (I&C)

Discuss I&C unit bus design, bidirectional communication, and system independence Public Meeting ML23289A099 Aug-2023 (8/23/23)

Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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Topic Description Engagement Completed Date Follow-up on RG 1.99 Limitations Discuss (follow-up) RG 1.99 Limitation topic from February 2023.

Public Meeting ML23254A242 Aug-2023 (8/30/23)

Instrumentation and Control (I&C)

Discuss IEEE 603 applicability to the SMR-160 design Public Meeting ML23296A004 Sep-2023 (9/13/23)

Dual Unit Simulator Fidelity Discuss questions related to dual unit simulator fidelity Public Meeting ML23292A255 Sep-2023 (9/20/23)

Fuel Management

Discussion of fuel management plan for life cycle including licensing aspects.

Public Meeting ML23293A049 Sep-2023 (9/27/23)

QAPD LTR Submit QAPD LTR Submission ML23271A007 Sep-2023 (9/28/23)

REP (Quarterly Rev)

REP Rev 6 Submission ML23270B183 Oct-2023 (10/1/23)

TMI Requirements Discuss TMI requirements and compliance table for SMR-160 applicability. Also, discuss potential exemptions to these requirements.

Public Meeting ML23291A017 Oct-2023 (10/4/23)

Risk Significance Methodology Pre-Meeting Provide an overview of the SMR Risk Significance Methodology LTR prior to formal submission Public Meeting ML23318A080 Oct-2023 (10/25/23)

Limited Work Authorization for Part 50 Discuss process and expectations for an LWA coupled with a Part 50 CPA Public Meeting ML23276B487 Nov-2023 (11/1/23)

Update on Seismic Methodology Results Discuss non-linear SSI methodology and results Public Meeting ML23339A050 Nov-2023 (11/8/23)

Chapter 16 TS Development Provide an update on technical specification development for the SMR design Public Meeting ML24002A707 Nov-2023 (11/29/23)

REP (Quarterly Rev)

REP Rev 7 Submission ML23356A136 Dec-2023 (12/22/23)

GDC 17 Exemption Request Inform NRC of anticipated GDC 17 exemption request Public Meeting ML24033A291 Feb-2024 (2/7/24)

Fire Protection Discuss the SMR-300 approach to compliance with RG 1.189 Public Meeting ML24058A341 Feb-2024 (2/26/24)

REP (Quarterly Rev)

REP Rev 0 (Issued under new report number)

Submission ML24087A212 Mar-2024 (3/26/24)

Environmental and Site Characterization Overview Provide an overview of Palisades site characterization work and schedule that will support the SMR-300 Environmental Report Public Meeting ML24312A207 Apr-2024 (4/3/24)

QAPD LTR Submit QAPD LTR Rev 1 Submission ML24110A088 Apr-2024 (4/19/24)

Risk Significance Methodology Update Provide an update of the SMR Risk Significance Methodology LTR prior to formal submission Public Meeting ML24176A109 May-2024 (5/1/24)

SMR-300 Design Overview Discuss and present a high-level design overview of the SMR-300 to the NRC staff Public Meeting ML24197A246 May-2024 (5/8/24)

QAPD LTR Clarification Clarification of Remote Source Verification in QAPD LTR submittal Clarification Call ML24152A002 May-2024 (5/31/24)

QAPD LTR Submit QAPD LTR Rev 2 Submission ML24155A285 Jun-2024 (6/3/24)

I&C Overview Discuss skipped session from the May 8th Design Overview meeting.

Public Meeting ML24180A171 Jun-2024 (6/5/24)

Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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Topic Description Engagement Completed Date Risk Significance LTR Submit Risk Significance Determination Methodology licensing topical report Submission ML24163A399 Jun-2024 (6/11/24)

REP (Quarterly Rev)

REP Rev 1 Submission ML24173A232 Jun-2024 (6/21/24)

Environmental Qualification Discuss the SMR-300 Environmental Qualification Program Public Meeting ML24215A393 Jul-2024 (7/11/24)

LWA Scope*

Discuss planned SMR-300 LWA application, including scope, timeline, and how it fits into the overall licensing strategy Public Meeting (in person)

ML24226B361 Jul-2024 (7/19/24)

Reliability Assurance Program Discuss development of the SMR-300 Reliability Assurance Program Public Meeting ML24229A132 July-2024 (7/24/24)

Cyber Security Discuss SMR-300 Cyber Security Plan and architecture Public Meeting ML24262A002 Aug-2024 (8/13/24)

QAPD LTR Submit QAPD LTR Rev 2 - Approved Submission ML24248A162 Sep-2024 (9/4/24)

LWA Letter Submit LWA letter Submission ML24250A155 Sep-2024 (9/6/24)

Nuclear Codes Verification and Validation Provide an update on the SMR-300 core design and discuss code V&V plans Public Meeting ML24297A271 Sep-2024 (9/10/24)

Integral and Separate Effects Testing Programs Discuss SMR-300 I/SET facility scaling and test plan Public Meeting ML24281A002 Sep-2024 (9/19/24)

Modularity Discuss the use of modularity for constructing SMR-300 structures and how modules will be accounted for in structural analysis Public Meeting ML24337A198 Sep-2024 (9/23/24)

REP (Quarterly Rev)

REP Rev 2 Submission ML24270A175 Sep-2024 (9/26/24)

CRDS Update Update the NRC on SMR-300 CRDS including testing plans Public Meeting ML24303A348 Oct-2024 (10/1/24)

Risk Significance LTR Submit Risk Significance Determination Methodology LTR Rev 1 Submission ML24292A045 Oct-2024 (10/18/24)

Risk Significance Determination Methodology LTR Discuss Conditions and Limitations associated with Risk Significance Determination Methodology LTR Public Meeting ML25007A012 Dec-2024 (12/12/24)

REP (Quarterly Rev)

REP Rev 3 Submission ML24351A041 Dec-2024 (12/16/24)

Environmental Report PRA Needs*

Discuss risk assessment scope for the environmental report Public Meeting ML25177A042 Feb-2025 (2/13/25)

SMR-300 Radiological Consequences Methodology Overview Discuss scope and timing of the SMR-300 Radiological Consequences Methodology topical report Public Meeting ML25080A027 Feb-2025 (2/18/25)

Risk Significance LTR Submit Risk Significance Determination Methodology LTR Rev 1 - Approved Submission ML25051A209 Feb-2025 (2/20/25)

Emergency Planning Exemption Request Request feedback on intended exemption request to support SMR-300 use of the 10 CFR 50.160 Emergency Preparedness for SMRs rule Public Meeting ML25121A270 Mar-2025 (3/19/25)

REP (Quarterly Rev)

REP Rev 4 Submission ML25084A122 Mar-2025 (3/25/25)

Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

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Topic Description Engagement Completed Date Environmental and Site Characterization Update*

Provide an update on Palisades site characterization work that will support the SMR-300 Environmental Report Public Meeting ML25241A194 Apr-2025 (4/28/25)

Fire Protection Strategy Discuss SMR-300 Fire Protection Strategy Public Meeting ML25160A228 May-2025 (5/8/25)

Radiological Consequences Methodology LTR Submit Radiological Consequences Analysis Methodology LTR Submission ML25157A142 Jun-2025 (6/6/25)

Combustible Gas Control for SFP Discuss Combustible Gas Control Considerations for SMR-300 SFP Public Meeting ML25223A160 Jun-2025 (6/26/25)

REP (Quarterly Rev)

REP Rev 5 Submission ML25178A821 Jun-2025 (6/27/25)

Modularity Methodology Discuss structural modularity methodology and upcoming LTR Public Meeting Aug-2025 (8/12/25)

LWA Planning Updates Discuss plans for Palisades SMR LWA Public Meeting Aug-2025 (8/27/25)

I&C LTR Pre-Submittal Discuss scope, objectives, and timeline for upcoming I&C LTR Public Meeting Sep-2025 (9/4/25)

Radiological Consequences Methodology LTR Submit Radiological Consequences Analysis Methodology LTR Rev 1 Submission ML25248A283 Sep-2025 (9/5/25)

Approach to EMDAP and Ch. 15 PSAR Discuss approach to PSAR Ch. 15 for Palisades SMR-300 including EMDAP and analysis methods Closed Meeting Sep-2025 (9/9/25)

LWA PSAR Content Discuss content for the LWA PSAR Ch. 2 and Ch. 3 Closed Meeting Sep-2025 (9/23/25)

Note ( * ) designates a topic of interest to environmental stakeholders (NMSS).

Notice of Non-Appropriation of Information Holtecs valuable technical background intellectual property is embedded in the material being provided herein to the recipient with the explicit understanding that it must not be divulged to any third party (person or entity) except as permitted pursuant to the governing contractual relationship under which this work product is being provided. Deliberate or inadvertent transfer of this information to anyone not bound by the applicable confidentiality and intellectual property covenants should be treated as a patently unlawful act which will do immense harm to Holtecs business interests and expose the recipient organization to significant compensatory costs. Recipients from government entities are exempted from this notice. We rely on their adherence to established legal and regulatory frameworks governing the use and protection of information.

ML25272A265

Text

Title:

1.0 INTRODUCTION

SUMMARY

6.0 REFERENCES

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