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Pre-Application Documents for the SMR (Holtec) Design

The U.S. Nuclear Regulatory Commission (NRC) considers public involvement in, and information about, our activities to be a cornerstone of strong, fair regulation of the nuclear industry. As such, the NRC believes that nuclear regulation should be transacted as openly and candidly as possible to maintain and enhance the public's confidence. Ensuring appropriate openness explicitly recognizes that the public must be informed about, and have a reasonable opportunity to participate meaningfully in, the NRC's regulatory processes. Toward that end, this page provides access to documents and correspondences related to the pre-application activities with SMR, LLC, a Holtec International Company, regarding its initial design, SMR-160, and its uprated design, SMR-300.

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Topical Reports for the SMR (Holtec) Design

The following table provides access to topical reports that SMR (Holtec) has submitted for NRC staff review and approval:

Submittal Date Title Topical Report Submittal ADAMS Accession No. Staff Final Safety Evaluation Report ADAMS Accession No.
09/28/23 HI-2230815, Rev. 0, “Quality Assurance Program for Holtec International’s Small Modular Reactor Design and Construction” ML23271A009 Under Review

Revised Information Needs:
ML24079A078
Information Needs:  ML24022A077

Completeness Determination:  ML23297A006
03/04/21 HI-2201064, Rev. 2, "Elimination of the Large Break Loss of Coolant Accident (LOCA) and Establishment of LOCA Acceptance Criteria" ML21064A037 Withdrawn

ML22018A171

ML22028A024
06/04/14 HI-2135649-NP, Quality Assurance Program ML14156A384 ML14174B150

During the review of the topical reports (TRs), the NRC staff may issue requests for additional information (RAIs) that are needed to determine the acceptability of methods and approaches described in each TR. The applicant's responses to RAIs may result in revisions to a TR and the issuance of TR supplement that incorporates all changes. Only the latest revision of the TR is listed above.

Additional information can be obtained from ADAMS using a search by docket number 99902049.

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White Papers for the SMR (Holtec) Design

The following table provides access to White Papers that SMR (Holtec) has submitted for NRC staff review and feedback:

Submittal Date Title White Paper ADAMS Accession No. Staff Feedback or Assessment ADAMS Accession No.
11/08/23 SMR, LLC, Whtie Paper, “Soil Structure Interaction Analysis” ML23301A007 See 11/08/23 Meeting Summary
ML23352A397 ML24052A004
09/26/23 SMR, LLC, 160-USNRC-064, “Limited Work Authorization Requirements Applicable to SMR, LLC” ML23269A171 See 11/01/23 Meeting Summary
ML23342A229 Assessment pending
08/25/23 SMR, LLC/Mitsubishi Electric Corp., JEXK-0143-1049-P(R0), “Two Division Safety System Compliance with Applicable Rules and Regulations” Proprietary See 09/13/23 Meeting Summary
08/11/23 SMR, LLC/Mitsubishi Electric Corp., JEXK-0143-1050-P(R0), “Functional Independence Evaluation Based on ISG-04” Proprietary See 08/23/23 Meeting Summary
07/13/23 SMR, LLC JEXK-0143-1048-P, "Diversity Evaluation Based on NUREG/CR-6303." Proprietary See 07/26/23 Meeting Summary
06/14/23 SMR, LLC Report HI-2210328, "HFE Functional Requirements Analysis and Function Allocation for Chemical and Volume Control System" Proprietary See 06/20/23 Meeting Summary
05/23/23 SMR, LLC Report Hl-2230397 Rev. 0, SMR-160 LOCA Exemption Request Language and Acceptance Criteria White Paper for May 25, 2023 Proprietary See 05/25/23 Meeting Summary
05/11/23 SMR, LLC Report HI-2210473, Revision 0, "SMR-160 PSA Risk Significance Determination Methodology" Proprietary See 05/17/23 Meeting Summary
03/29/23 SMR, LLC Report Hl-2230279 Rev. 0, LOCA Exemption Update White Paper (P) ML23088A028 See 04/05/23 Meeting Summary
01/23/23 SMR, LLC, SMR-160 Hazard Analysis for l&C System Methodology Report No. Hl‑2230060, Rev. 0 ML23023A006, part of ML23023A002 See 02/08/23 Meeting Summary
12/19/22 SMR, LLC, Preapplication Meeting Materials for January 25, 2023 ML22353A297 See 01/25/23 Meeting Summary
12/19/22 SMR-160 Reactor Coolant Makeup White Paper ML22353A294 See 01/11/23 Meeting Summary
11/01/22 Enclosure 2: SMR-160 PDHR and SOHR Containment Isolation White Paper Report No. HI-2220845, Rev. O (Redacted) ML22305A511, part of ML22305A508 See 11/30/22 Meeting Summary
11/01/22 SMR, LLC, SMR-160 GDC 40 Compliance White Paper Report No. Hl-2220836 Rev. O ML22305A500 See 11/16/22 Meeting Summary
10/14/22 SMR, LLC, Hl-2220583, Rev. 1, SMR-160 I&C Architecture White Paper ML22287A012, part of ML22287A008 ML22325A343
10/06/22 Enclosure 3: HI-2220717, "SMR-160 Spent Fuel Pool Makeup White Paper" ML22279A006 See 10/18/22 Meeting Summary
10/03/22 SMR, LLC Basis for Future LOCA Exemption Request for October 19, 2022 ML22276A070 See 10/19/22 Meeting Summary
09/13/22 HI-2188193, Revision 1, "SMR 160 Control Rod Assembly Design Criteria Document" ML22271A741 See 09/13/22 Meeting Summary

The prospective applicant may choose to receive NRC feedback on its White Papers during a public meeting. The NRC feedback provided during the public meeting is documented in the meeting summary.

Additional information can be obtained from ADAMS using a search by docket number 99902049.

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Public Meeting Materials and Meeting Summaries for the SMR (Holtec) Design

Meeting Date Meeting Topic Meeting Materials ADAMS Accession No. Meeting Summary ADAMS Accession No.
05/08/24 SMR-300 Design Overview Pending Pending
05/01/24 Update on Risk Significance Topical Report Submission ML24109A290 Pending
04/10/24 Chapter 15 Analysis ML24092A410 CANCELLED
04/03/24 Initial Environmental and Site Characterization ML24086A580 Pending
03/27/24 Quality Assurance Program Description Topical Report – Revised Information Needs ML24079A078 Pending
02/26/24 Fire Protection Program ML24044A240 ML24058A341
02/07/24 GDC 17 – Electric Power Systems ML24026A028 ML24033A287
02/26/24 Quality Assurance Program Description Topical Report – Information Needs ML24022A077 ML24039A003
02/07/24 Chapter 16 Technical Specification Development ML23319A433 ML24002A697
01/26/24 Soil Structure Interaction Analysis ML23301A002 ML23339A038
11/01/23 Limited Work Authorization Process ML23269A168 ML23276B484
10/25/23 Risk Determination Methodology Topical Report ML23283A282 ML23318A079
10/04/23 Applicability of Three-Mile Island Action Items to the SMR-160 Design ML23265A215 ML23291A014
09/27/23 SMR-160 Fuel Management ML23262B222 ML23293A046
09/20/23 Dual Unit Simulator Fidelity for the SMR-160 Design ML23254A364 ML23292A255
09/13/23 Applicability of IEEE 603 to the SMR-160 Design ML23249A106 ML23296A001
08/30/23 Follow-up on RG 1.99 Limitations ML23229A591 ML23254A242
08/23/23 SMR-160 Conformance with DI&C ISG-04 – Highly Integrated Control Rooms ML23223A103 ML23289A099
08/09/23 Update on SMR-160 Seismic MethodologyUpdate on SMR-160 Seismic Methodology ML23212B206 Meeting rescheduled to 11/01/23
07/26/23 SMR-160 Defense-in-Depth and Diversity (D3) ML23194A056
ML23213A038		 ML23156A182
07/19/23 SMR-160 Verification & Validation of Codes ML23177A184
ML23206A030		 ML23121A009
07/12/23 SMR-160 Emergency Planning Zone Methodology ML23180A001 ML23216A092
06/28/23 Applicability of 10 CFR Part 50, Appendix K – Emergency Core Cooling System Evaluation Models ML23165A105 ML23151A629
06/20/23 Human Factors Engineering Programs ML23165A080
ML23171A001		 ML23216A133
06/07/23 Anticipated Transients without Scram ML23145A023 ML23200A002
05/25/23 Follow-up to Loss-of-Coolant Accident Analysis Update No. 1 ML23142A004 ML23116A066
05/17/23 SMR-160 Risk Topics ML23131A044 ML23167A067
05/10/23 Fuel Qualification and Testing ML23114A026 ML23116A034
05/03/23 SMR-160 Design Overview (Proprietary) ML23109A001 ML23115A022
04/19/23 Chapter 13 – Operational Programs ML23107A001 ML23045A070
05/04/23 Loss-of-Coolant Accident Analysis Update No. 1 ML23088A028 ML23045A052
03/22/23 Main Control Room Staffing ML23072A001 ML23045A037
03/08/23 Simulator, Operator Training/Qualifications, and Operating Experience Reviews ML23060A008 ML23045A021
02/22/23 Reactor Pressure Vessel Embrittlement ML23045A001 ML23045A010
02/21/23 Chapter 15 Analysis ML23018A009 ML23019A270
02/15/23 Fire Protection ML23031A059, ML23034A043 ML23044A014
02/08/23 Instrumentation & Control Hazards Analysis ML23023A002 ML23019A004
01/25/23 Parts of a Construction Permit Application, and Table of Contents of the Preliminary Safety Analysis Report and Environmental Report ML22353A295 ML22355A658
01/11/23 Reactor Coolant Makeup System Design and General Design Criterion 33 ML22353A291 ML22354A112
12/06/22 Quality Assurance Guidance None ML22329A005
12/05/22 SMR-160 Passive Core Cooling System Design for Non-Loss-of-Coolant-Accident Analyses (Regulatory Treatment of Nonsafety Systems) ML22320A002 ML22304A131
11/30/22 Closed System Isolation Valves Design (General Design Criterion 57) ML22305A508 ML22307A238
11/16/22 Passive Containment Heat Removal System (General Design Criterion 40) ML22305A498 ML22305A691
10/27/22 Technical Specifications None ML22297A105
10/19/22 Potential Loss-of-Coolant Accident Analysis Exemption ML22276A069 ML22263A388
10/18/22 Spent Fuel Pool Makeup ML22279A002 ML22263A380
10/18/22 Reactivity Control and Materials Aspects of the Control Rod Drive System ML22256A019 ML22263A420
10/04/22 White Paper: Instrumentation and Control Architecture ML22262A102, ML22287A008 ML22263A014
09/27/22 Seismic Analysis Method ML22266A126 ML22259A128
09/13/22 Control Rod Drive System ML22271A737 ML22252A181
08/31/22 Loss-of-Coolant Accident Topics ML22236A529 ML22243A010

Future public meetings may be found through the calendar on the main NRC public site.

Additional information can be obtained from ADAMS using a search by docket number 99902049.

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Correspondences

The following table provides access to letters and other pre-application correspondence between SMR, LLC, a Holtec International Company, and NRC regarding the SMR (Holtec) design.

Date Description
03/26/24 SMR, LLC, Regulatory Engagement Plan, HI-2240423, Revision 0
02/13/24 2-13-2024 - Email to A. Brenner, SMR (Holtec) re - Collaborative Activities with the United Kingdom Office of Nuclear Regulation on the SMR (Holtec) Design (Project No. 99902049)
12/22/23 SMR, LLC Regulatory Engagement Plan, Revision 7 (Project No. 99902049)
09/27/23 SMR, LLC Regulatory Engagement Plan, Revision 6 (Project No. 99902049)
06/29/23 SMR, LLC, Submittal of Regulatory Engagement Plan, Revision 5
04/06/23 SMR, LLC, Submittal of Regulatory Engagement Plan, Revision 4
01/11/23 SMR, LLC Regulatory Engagement Plan, Revision 3 (Project No. 99902049)
01/03/23 SMR, LLC, Online Reference Portal Information Access Agreement (Project No. 99902049)
10/03/22 SMR, LLC Update to Voluntary Response to NRC Regulatory Issue Summary 2020-02 and Proposed Regulatory Engagement Plan, Revision 2 (Project  No. 99902049)
07/29/22 SMR, LLC Proposed Regulatory Engagement Plan, Revision 1 (Project No. 99902049)
11/10/20 SMR, LLC, Submittal of Voluntary Response to NRC Regulatory Issue Summary 2020-02
05/07/15 SMR Inventec, LLC Establishment of a Safeguards Information (SGI) Program and Request for SGI Use and Storage Approval
01/30/14 Voluntary Response to Regulatory Issue Summary (RIS) 2013-18 (Non-Proprietary)
03/20/13 Voluntary Response to Regulatory Issue Summary (RIS) 2012-12 (Non-Proprietary)

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Clarification Questions related to the SMR (Holtec) Design

The following table provides access to clarification questions between SMR (Holtec) and the NRC staff.

Date Topic ADAMS Accession No.
09/05/23 NRC Staff Response to Questions re: Guidance for Multi-unit Probabilistic Safety Analysis (Project 99902049) ML23249A003
08/14/23 NRC Staff Response to Questions re: Seismic Methodology (Project 99902049) ML23226A138
08/10/23 NRC Staff response to Question re: Seismic Probabilistic Risk Assessment for a Construction Permit Application (Project 99902049) ML23222A009
07/31/23 NRC Staff Response to Questions re: Electrical Separation for the SMR-160 design (99902049) ML23213A018
07/25/23 NRC Staff Questions and SMR (Holtec) Responses re: July 19, 2023, Public Meeting Materials - SMR-160 Code Verification and Validation and Evaluation Methodologies (99902049) ML23206A030
07/17/23 NRC Staff Response to Questions on IEEE 603-1991 and Completion of Protective Action (Project 99902049) ML23213A026
07/10/23 NRC Staff Response to Questions re: Quality Assurance for the SMR-160 Design (99902049) ML23213A014
06/07/23 Clarification Question Regarding Potential SECY Timeline Required for Potential FOAK Exemption (99902049) ML23158A040
05/16/23 NRC Staff Response to Clarification Question re: RHR System Classification (99902049) ML23158A036
03/31/23 NRC Staff response to Follow-up Question re: Polar Crane Analysis for the SMR-160 design (Project Number 99902049) ML23158A025
03/31/23 NRC Staff response to Question re: Manual Initiation of Protective Action for the SMR-160 design (Project Number 99902049) ML23158A033
03/10/23 NRC Staff Response to SMR (Holtec) Follow-up Question re: RCS Flow Instrumentation (Project 99902049) ML23069A015
03/08/23 NRC staff response to SMR-160 question re: Polar Crane Analysis (Project 99902049) ML23067A011
02/22/23 NRC Staff Response to SMR (Holtec) Questions re: NonSafety Structures. ML23054A268
02/02/23 NRC Staff Response to Follow-up Questions re: Water Source for Fire Protection ML23034A043
01/25/23 NRC Staff Response to SMR (Holtec) Questions re: Radwaste Management (RG 1.143) ML23031A159
01/24/23 NRC Staff Response to SMR (Holtec) Question re: Wet Bulb Temperature ML23031A158
01/12/23 NRC Staff Response to Questions regarding RG 1.99 Revision 2, Radiation Embrittlement of Reactor Vessel Materials (Project No. 99902049) ML23030A005
01/05/23 NRC Staff Response to Follow-up Questions after the November 30 Public Meeting re: Closed Systems Isolation Valves ML23031A080
01/04/23 NRC Staff Response to Follow-up Questions regarding the Scope of PRA and Turbine Missiles (RG 1.115) ML23031A070
12/28/22 NRC Staff Response to Question regarding "Equivalent Materials" for the SMR-160 Design ML23031A055
12/28/22 NRC Staff Response to Question regarding Water Source for Fire Protection ML23031A059
12/19/22 NRC Staff Response to Clarification Question re: Reactor Coolant System Flow Instrumentation ML23030B657
12/08/22 NRC Technical Paper re: Passive SMRs presented at IAEA Conference ML23030B656
11/29/22 NRC Staff Response to SMR (Holtec) Clarification Question re: Aircraft Impact Assessment ML23030B807
11/29/22 NRC Staff Response to SMR (Holtec) Clarification Question re: Turbine Missiles ML23031A140
10/27/22 NRC Staff response to questions re: Common-Cause Failure, Common Mode-Failure, and Level/Pressure/Temperature Transmitters ML23030B805
10/26/22 NRC Staff Response to Questions re: SECY-94-084 ML23030B803
10/26/22 NRC Staff Response to Questions re: Aircraft Impact Analysis ML23030B804
10/25/22 NRC Staff Response to Follow-Up Question re: CRDS (SRP 3.9.4) ML23030B655
10/24/22 NRC Staff Response to Clarification Question regarding Codes and Standards ML23030B654
10/21/22 NRC Staff Responses to Clarification Questions regarding Containment Stress Limits (SRP 3.9.3) ML23030B835
10/17/22 NRC Staff Responses for Some Questions Supporting the Oct 18 SFP Public Meeting ML23030B834
09/26/22 NRC Staff Response to the Clarification Question regarding Software for Structural Analysis ML23030B833
09/09/22 NRC Staff Response to the Clarification Question regarding Piping Design and Analysis for the SMR-160 Design ML23031A102

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Page Last Reviewed/Updated Wednesday, May 1, 2024