Text

HI-2220511, Revision 7, SMR-300 Regulatory Engagement Plan
	ML23356A136
Person / Time
Site:	99902049
Issue date:	12/22/2023
From:	; Holtec, SMR
To:	; Office of Nuclear Reactor Regulation
Shared Package
ML23356A134	List: ML23356A135;
References
	160-USNRC-073 HI-2220511, Rev 7
	Download: ML23356A136 (1)
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Revision Log Revision Description of Changes 0

Initial Issue. ML22200A252 1

Revision 1 makes minor editorial changes and schedule updates noted through discussion with the NRC staff as well as from the SMR Director. ML22210A033 2

Revision 2 makes minor editorial changes and schedule updates noted through discussion with the NRC staff as well as from the SMR Director. ML22276A086 3

Revision 3 makes changes to Table 3-1 for the Proposed PSAR chapters and schedule updates noted through discussion with the NRC staff as well as from the SMR Director and NRC PMs. Revision 3 will be the schedule update for 1Q23.

ML23003A003 4

Revision 4 makes minor editorial changes and schedule updates, and will be the schedule update for 2Q23. ML23088A003 5

Revision 5 makes minor editorial changes and schedule updates, and will be the schedule update for 3Q23. ML23180A006 6

Revision 6 makes changes to reflect the uprated SMR design, updates contact information, and updates the schedule for 4Q23.

7 Revision 7 provides updates to the uprated SMR-300 design and updates the schedule for 1Q24.

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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.

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Table of Contents 1.0 Introduction.................................................................................................................... 4 1.1 Purpose of Regulatory Engagement Plan............................................................. 4 1.2 Contact Information.............................................................................................. 4 1.3 Company and Project Structure............................................................................ 5 1.4 Summary of Strategic Approach and Goals.......................................................... 5 2.0 Technology Summary..................................................................................................... 5 3.0 REP and PSAR Guidance and Content.......................................................................... 6 3.1 Selection of Applicable Guidance......................................................................... 6 3.2 Principal Design Criteria....................................................................................... 8 3.3 Use of Standards and Industry Guidance............................................................. 9 4.0 Pre-application Engagement.......................................................................................... 9 4.1 Identification of Topics.......................................................................................... 9 4.2 Types and Frequency of Interactions...................................................................12 4.3 Technical Discussions and Written Submittals....................................................14 4.4 Information Sharing and the Potential Escalation of Issues.................................15 4.5 Schedule Considerations.....................................................................................15 5.0 Other Topics..................................................................................................................15 5.1 Readiness Assessment Audit and Application Submittal.....................................15 5.2 Budget.................................................................................................................15 6.0 References....................................................................................................................16 7.0 List of Appendices.........................................................................................................16 List of Figures Figure 2-1: SMR-300 Reactor Coolant System.......................................................................... 6 List of Tables Table 3-1: Proposed PSAR Elements........................................................................................ 8 Table 4-1: Topics for SMR Pre-Application Engagement..........................................................10 Table 4-2: Anticipated Licensing Topical Report Submittals......................................................14

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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 (Reference 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:

Andrew Brenner Director of Licensing, SMR Holtec International 1 Holtec Boulevard Camden, NJ 08104 Phone: 215-704-8387 Email: A.Brenner@holtec.com Copy to:

Kelly Trice President SMR, LLC, a wholly owned subsidiary of Holtec International 1 Holtec Boulevard Camden, NJ 08104 Phone: 865-617-3713 Email: K.Trice@holtec.com Jean Fleming Vice President, Licensing, Regulatory Affairs & PSA Holtec International 1 Holtec Boulevard Camden, NJ 08104 Phone: 609-970-9771 Email: J.Fleming@holtec.com

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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 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 is 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 (i.e., interface) 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 future pursuit of a two-step licensing process for the SMR project. Holtec, in collaboration with an owner/operator, intends to submit a power reactor construction permit application (CPA) under 10 CFR Part 50, Domestic licensing of production and utilization facilities. Per regulation 10 CFR 50.34, the application for a construction permit will contain a preliminary safety analysis report (PSAR) and an environmental report as addressed in 10 CFR 51.50. The application for an operating license (OLA) as described in 10 CFR Part 50, to include submittal of the final safety analysis report and an environmental report as addressed in 10 CFR 51.50, would be predicated on 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 reactor coolant pumps 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.

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Figure 2-1: SMR-300 Reactor Coolant System 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, Standard Review Plan, Introduction - PART 2 for the Review of Safety Analysis Reports for Nuclear Power Plants: Light-water Small Modular Reactor Edition, Revision 0, 2014 Regulatory Guide 1.206, Application for Nuclear Power Plants, Revision 1, 2018

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Regulatory Guide 1.70, Standard Format and Content of Safety Analyses Reports for Nuclear Power Plants, Revision 3, 1978 NEI 18-06, Guidelines for Development of a Regulatory Engagement Plan (REP),

Revision 0, 2018 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. Regulatory Guide 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 and 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 SMR DSRSs to assist in informing the NRC staffs review of specific pre-application topics and elements of the PSAR. See Section 4.1 for selected REP discussion topics.

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 instructions are intended for applications developed under 10 CFR 52. RG 1.70 provides instructions for the form and content of Safety Analysis Reports for applications developed under 10 CFR 50, but that guidance has not been updated since 1978 and is not consistent with other regulatory guidance. Holtec therefore intends to align the SMR PSAR and FSAR with the NUREG-0800 sections as best as possible, 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 licensing applications.

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

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. Part 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 designs, and additional criteria may 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.

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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 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 dialog 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 any 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. The primary benefit planned for this engagement is alignment on the risk-informed content of the topics, and the scope and depth of the NRC review. 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 in making safety determinations with respect to agency resource availability. 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 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.

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Table 4-1: Topics for SMR Pre-Application Engagement Topic Description Engagement Approx.

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 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

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Topic Description Engagement Approx.

Date 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)

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)

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Topic Description Engagement Approx.

Date QAPD LTR Submit QAPD LTR Submission ML23271A009 Sep-2023 (9/29/23)

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 Nov-2023 (11/1/23)

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

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

REP (Quarterly Rev)

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

GDC 17 Exemption Request Inform NRC of anticipated GDC 17 exemption request Public Meeting Late Jan 2024 Fire Protection Discuss the SMR-300 approach to compliance with RG 1.189 Public Meeting Mid Feb 2024 ISET/EMDAP Update Update the NRC on SMR-300 IET/SET plans and overall EMDAP process.

Public Meeting Early Mar 2024 CRDS Update Update the NRC on SMR-300 CRDS including testing needs.

Public Meeting Late Mar 2024 Environmental Specific topics TBD Public Meeting Q1 2024 PAM Instrumentation Discuss the SMR-300 post-accident monitoring instrumentation scheme Public Meeting Q2 2024 Security Discuss target-set development for the SMR-300 Closed Meeting Q2 2024 ISI/IST Programs Discuss example in-service inspection and in-service testing PSAR content Public Meeting Q2 2024 SMR-300 I&C LTR Scope Provide an overview of the intended scope for a future SMR-300 I&C design licensing topical report Public Meeting Q2 2024 Risk Significance LTR Submit Risk Significance Determination Methodology licensing topical report Submission Q2 2024 SMR-300 Design Overview Discuss and present a high-level design overview of the SMR-300 to the NRC staff Closed Meeting Late Apr 2024 Additional Items TBD Note ( * ) designates the topic for interest to environmental stakeholders (NMSS).

4.2 Types 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

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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:

bi-monthly (every 2 weeks) meeting with NRC project managers and technical reviewers quarterly status that describes accomplishments, progress, remaining outstanding items and additional areas of focus to assess the status of the pre-application engagement 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 pre-submittal meetings with the NRC for a selected topic, typically a remote session with presentation materials describing expectations (including a potential schedule and budget) for the associated review Submit white paper or technical report on the selected topic presented to provide material for the NRC staffs review Receive feedback from NRC staff regarding alignment on expectations, allocated resources, budget and schedule for the review of the selected item Hold a post-review meeting with the NRC staff to obtain feedback (the format of this should be agreed on between Holtec licensing and NRC staff, and may be in the form of a phone call or another informal method of interaction)

Prior to and following the submittal of white papers or technical reports for the selected pre-application engagement topics, routine and frequent interaction is expected via phone and email between the NRC and Holtec. The communication plan and interaction frequency listed below can be amended as necessary to support healthy communications and common understanding of the status of all the pre-application engagement activities:

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

Periodic drop-in visits and meetings between Holtec and NRC staff (which may include participation by various levels of Holtec and NRC management) will be conducted to exchange

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general information on nontechnical topics such as planning for future interactions and status/schedule updates. Limited discussion of technical issues can occur, but typically it will be in the context of status of review or identification of topics for separate discussion.

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 Director of Licensing, SMR, 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, presentations, technical reports, and licensing topical reports. White papers will be utilized to present information and describe positions on a specific topic with the objective of increasing understanding and seeking alignment with NRC staff. The use of white papers will be employed to address high level issues, summarize proposed approaches, and seek clarification on methodologies, guidance, and technical issues. 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 Q2 2023 Quality Assurance Program Description Q4 2023 Risk Significance Determination Methodology Q2 2024 SMR-300 I&C Design Q1 2025 SSI Analysis Methodology Mid 2025 Nuclear Analysis Codes and Methods Qualification Mid 2025 Radiological Consequences Methodology Mid 2025 Applicability of Framatome Fuel Methodology to SMR-300 Mid 2025 Applicability of CHF Correlations to SMR-300 Mid 2025 Applicability of COBRA FLX to SMR-300 Mid 2025 Rod Ejection Accident Methodology End 2025 Subchannel Analysis Methodology End 2025 Applicability of GOTHIC to SMR-300 End 2025 Internals Structural Analysis Methodology Early 2026 LOCA EM, Non-LOCA EM, and Long-Term Cooling Methodology Mid 2026

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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 reports. A more detailed discussion of the electronic reading room and online reference portal information access agreement can be found in the NRC Agencywide Documents Access and Management System (ADAMS) under ML22215A031 dated August 23, 2022.

As part of the pre-application activities, it may be necessary to resolve conflicts between existing regulatory infrastructure and new features in the SMR 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 any 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 the 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 material 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 complexity and 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

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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 />.

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, Standard Review Plan (SRP), Introduction - PART 2 SRP 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]

NEI white paper, Issue Escalation Process (Model for ROP Task Force), (ADAMS Accession No. ML20017A089), dated January 13, 2020

[6]

DNRL-ISG-2022-XX, Safety Review of Light-Water Power-Reactor Construction Permit Applications, Draft Interim Staff Guidance (ML21165A157)

[7]

DRAFT Pre-application Engagement to Optimize Advanced Reactors Application Reviews, May 2021 (ML21145A106) 7.0 LIST OF APPENDICES None.

ML23356A136

Text

1.0 INTRODUCTION

SUMMARY

6.0 REFERENCES

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