ML25168A136

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ANS 2025 Workshop - NRC IC Regulatory Overview
ML25168A136
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Issue date: 06/17/2025
From: Samir Darbali, Martinez-Navedo T
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NRC I&C Regulatory Overview Tania Martinez Navedo, Acting Director Samir Darbali, Senior Electronics Engineer Division of Engineering and External Hazards Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission The information and conclusions presented herein are those of the authors only and do not necessarily represent the views or positions of the US Nuclear regulatory Commission.

Outline

  • NRC Mission
  • Digital I&C Regulatory Infrastructure Modernization

- Organization and Goals

- Accomplishments

- Ongoing Activities 2

NRC Mission The NRC protects public health and safety and advances the nations common defense and security by enabling the safe and secure use and deployment of civilian nuclear energy technologies and radioactive materials through efficient and reliable licensing, oversight, and regulation for the benefit of society and the environment.

3

DIGITAL I&C REGULATORY INFRASTRUCTURE MODERNIZATION 4

I&C Regulatory Infrastructure Organization Regulatory Guides (RGs)

Endorsed Industry Standards, Recommended Practices, and Guides (e.g., IEEE, IEC, EPRI, ISA, NEI)

  • Regulations Title 10, Code of Federal Regulations (10 CFR)
  • Staff Requirements Memoranda (SRMs)

Policy and Requirements

  • Standard Review Plan (SRP) o Branch Technical Positions (BTPs) o Interim Staff Guidance (ISGs)
  • Design Specific Review Standard (DSRS)
  • Design Review Guide (DRG)

NRC Staff Review Guidance Regulatory Guidance 5

Modernization Goals Clear 10 CFR 50.59 expectations Endorsement of updated industry standards Efficient, timely and predictable licensing 6

ACCOMPLISHMENTS 7

  • Licensing Review Guidance
  • Common-Cause Failure Policy and Guidance
  • Regulatory Guides
  • Regulatory Issue Summaries
  • Inspection Guidance
  • I&C Regulatory Infrastructure Mapping 8

Accomplishments

SRM-SECY-15-0106 SRM-SECY-16-0070 (Integrated Action Plan)

ISG-06, Rev. 2 RIS 2002-22, Supplement 1 SECY-18-0090 (CCF Policy Clarification)

SECY-19-0112 (NRC Vision)

Design Review Guide RG 1.187, Rev. 3 IP 52003, Rev. 1 BTP 7-19, Rev. 8 SECY-22-0076 (Expanded CCF Policy)

RG 1.250, Rev. 0 SRM-SECY-22-0076 (Expanded CCF Policy)

RG 1.152, Rev. 4 Regulatory Infrastructure Mapping BTP 7-19, Rev. 9 DI&C OpESS 2023/01 ADVANCE Act RIS 2025-01 Executive Orders 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 I&C Regulatory Infrastructure Modernization Licensing Review Guidance Common-Cause Failure Policy and Guidance Regulatory Guides Inspection Guidance 50.59 Guidance RG 1.187, Rev. 2 9

Licensing Review Guidance - LWRs DI&C-ISG-06 (ISG-06)

  • Licensing review process for digital I&C modification LARs.
  • Part of the Standard Review Plan.

Revision 2 of ISG-06

  • Issued in December 2018.
  • Introduced the Alternate Review Process.

DI&C-ISG-06, Licensing Process, Revision 2 (ML18269A259) 10

Licensing Review Guidance - Non-LWRs Design Review Guide (DRG)

  • Issued in February 2021.
  • Risk-informed.
  • Performance-based.
  • Technology-neutral.

Design Review Guide (DRG), Instrumentation and Controls for Non-Light-Water Reactor (Non-LWR) Reviews (ML21011A140)

Regulatory Guide 1.233, Guidance for a Technology-Inclusive, Risk-Informed, and Performance-Based Methodology to Inform the Licensing Basis and Content of Applications for Licenses, Certifications, and Approvals for Non-Light-Water Reactors, Revision 0 (ML20091L698).

11

Common-Cause Failure Policy SECY-22-0076

  • Issued in August 2022.
  • Requests the Commission to expand the common-cause failure (CCF) policy.
  • Use of risk-informed approaches to determine appropriate level of defense-in-depth and diversity (D3).

SECY-22-0076, Expansion of Current Policy on Potential Common Cause Failures in Digital Instrumentation and Control Systems (ML22193A290) 12

Common-Cause Failure Policy SRM-SECY-22-0076

  • Issued in May 2023.
  • Approved the staffs recommended expanded CCF policy with edits.
  • Provided direction to staff to develop implementing guidance.

SRM-SECY-22-0076, Staff RequirementsSECY-22-0076Expansion of Current Policy on Potential Common-Cause Failures in Digital Instrumentation and Control Systems (ML23145A181 and ML23145A182) 13

Common-Cause Failure Staff Guidance Branch Technical Position (BTP) 7-19 Revision 9

  • Issued in May 2024.
  • Incorporates the expanded CCF policy.
  • Provides review guidance for:

- risk-informed D3 assessments

- use of design techniques or mitigation measures other than diversity Branch Technical Position 7-19, Guidance for Evaluation of Defense in Depth and Diversity to Address Common-Cause Failure Due to Latent Design Defects in Digital Instrumentation and Control Systems, Revision 9 (ML24005A077) 14

Regulatory Guides Regulatory Guide (RG) 1.152, Revision 4

  • Issued in July 2023.
  • Endorses IEEE Std 7-4.3.2-2016 with some exceptions and clarifications.
  • Criteria for programmable digital devices.

Regulatory Guide 1.152, Criteria for Programmable Digital Devices in Safety-Related Systems of Nuclear Power Plants, Revision 4 (ML23054A463)

IEEE Std 7-4.3.2-2016, IEEE Standard Criteria for Programmable Digital Devices in Safety Systems of Nuclear Power Generating Stations 15

Regulatory Guides RG 1.250, Revision 0

  • Issued in October 2022.
  • Acceptance of safety integrity level (SIL) certification in commercial-grade dedication.

Regulatory Guide 1.250, Dedication of Commercial-Grade Digital Instrumentation and Control Items for Use in Nuclear Power Plants (ML22153A408)

NEI 17-06, Guidance on Using IEC [International Electrotechnical Commission] 61508 Safety Integrity Level (SIL) Certification to Support the Acceptance of Commercial Grade Digital Equipment for Nuclear Safety Related Applications, Revision 1 16

Regulatory Guides RG 1.187, Revision 3

  • Issued in June 2021.

Regulatory Guide 1.187, Guidance for Implementation of 10 CFR 50.59, Changes, Tests, and Experiments, Revision 3 (ML21109A002)

NEI 96-07, Guidelines for 10 CFR 50.59 Evaluations, Appendix D, Revision 1, Supplemental Guidance for Application of 10 CFR 50.59 to Digital Modifications 17

RIS 2002-22, Supplement 1

  • Issued in May 2018.

Regulatory Issue Summaries RIS 2002-22, Supplement 1, Clarification on Endorsement of Nuclear Energy Institute Guidance in Designing Digital Upgrades in Instrumentation and Control Systems (ML18143B633)

NEI 01-01, Guideline on Licensing Digital Upgrades: EPRI TR-102348, Revision 1, NEI 01-01: A Revision of EPRI TR-102348 To Reflect Changes to the 10 CFR 50.59 Rule 18

Regulatory Issue Summaries RIS 2025-01

  • Issued in January 2025.
  • Seeks information to prepare for upcoming digital I&C preapplication activities and submittal of LARs.
  • To inform the NRCs budget and resource planning.

RIS 2025-01, Pre-Application Communication and Scheduling for Licensing Actions Related to Digital Instrumentation and Controls (ML25007A014) 19

Inspection Guidance Inspection Procedure (IP) 52003, Revision 1

  • Issued in July 2021.
  • Guidance for regional inspections of digital I&C modifications approved by a license amendment.
  • Includes inspection guidance of modifications performed under the ISG-06 Alternate Review Process.

Inspection Procedure 52003, Digital Instrumentation and Control Modification Inspection (ML21113A169) 20

Inspection Guidance Operating Experience Smart Sample (OpESS) 2023/01

  • Issued in February 2024.
  • Guidance to support baseline inspections of digital I&C modifications performed under 10 CFR 50.59.

Operating Experience Smart Sample (OpESS) 2023/01, Digital Instrumentation and Controls (ML23235A248) 21

  • Mapping of nine technical areas related to I&C safety and security.
  • Each technical area contains a detailed mapping of applicable regulatory requirements, guidance, and endorsed industry standards.

(https://www.nrc.gov/reactors/digital/modernize.html)

I&C Regulatory Infrastructure Mapping 22

RG 1.47, Rev. 1 Bypassed and Inoperable Status Indication for NPP Safety System RG 1.62, Rev. 1 Manual Initiation of Protection Actions RG 1.75, Rev. 3 Independence of Electrical Safety Systems RG 1.53, Rev. 2 Application of the Single-Failure Criterion to Safety Systems RG 1.22, Rev. 0 Periodic Testing of Protection System Actuation Functions RG 1.118, Rev. 3 Periodic Testing of Electric Power and Protection Systems ANSI/IEEE Std 338-1987 Criteria for Periodic Surveillance Testing IEEE Std 379-2000 Application of the Single-Failure Criterion to Nuclear Power Generating Station Safety Systems IEEE Std 384-1992 Standard Criteria for Independence of Class 1E Equipment and Circuits NUREG-0800 Standard Review Plan, Chapter 7 - I&C 7.1 - Introduction, 7.2 - Reactor Trip System, 7.3 - Engineered Safety Features Systems, 7.4 - Safe Shutdown Systems, 7.5 - Information Systems Important to Safety, 7.6 - Interlock Systems Important to Safety, 7.7 - Control Systems, 7.8 - Diverse Instrumentation and Control

Systems, 7.9 - Data Communication Systems BTP 7-8 Guidance for Application of Regulatory Guide 1.22 BTP 7-19
  • Guidance for Evaluation of Defense-in-Depth and Diversity to Address CCF due to Latent Design Defects in Digital I&C Systems ISG-06
  • Licensing Process (D.1 - System Description, D.2 - System Architecture, D.6 - IEEE Std 603/IEEE Std 7-4.3.2 Compliance/Conformance) 10 CFR Part 50 Construction Permit (CP),

Operating License (OL) 10 CFR Part 52 Design Certification (DC),

Combined Operating License (COL), Standard Design Approval (SDA),

Manufacturing License (ML) 10 CFR Part 50, Appendix A General Design Criteria 1,2,4,13,19, 20,21,22,24,25,29,34 10 CFR Part 50, Appendix B Quality Assurance Criteria 50.55a(h)

IEEE Std 603-1991 IEEE Std 279-1971 SRM-SECY-22-0076, SRM-SECY-93-087

  • Item 18 Regulatory Requirements & Policy Regulatory Guidance Staff Guidance Criteria for Safety Systems
  • Digital-Specific RG 1.30, Rev. 1 Installation, Inspection, and Testing for Class 1E Power, Instrumentation, and Control Equipment at Production and Utilization Facilities IEEE Std 336-2020 Recommended Practice for Installation, Inspection, and Testing for Class 1E Power, Instrumentation, and Control Equipment at Nuclear Facilities Criteria for Safety Systems RG 1.153, Rev. 1 Criteria for Safety Systems RG 1.28, Rev. 5 Quality Assurance Program Criteria (Design and Construction)

ASME NQA-1b-2011 Addenda to NQA-1-2008, NQA-1-2012, and NQA-1-2015 23

IEEE Std 7-4.3.2-2016 Standard Criteria for PDDs in Safety Systems of Nuclear Power Generating Stations NUREG-0800 Standard Review Plan, Chapter 7 BTP 7-17

  • Guidance on Self-Test and Surveillance Test Provisions BTP 7-19
  • Guidance for Evaluation of Diversity and Defense-in-Depth in Digital Computer-Based I&C Systems BTP 7-21
  • Guidance on Digital Computer Real-Time Performance ISG-04
  • Highly-Integrated Control Room Communications ISG-06
  • Licensing Process (D.1 - System Description, D.2 - System Architecture, D.5 - Applying a Topical Report, D.6 - IEEE Std 603/IEEE Std 7-4.3.2 Compliance/Conformance, D.8 - SDOE)

Regulatory Guidance Staff Guidance Criteria for Safety System Programmable Digital Devices Criteria for Safety System Programmable Digital Devices

IEEE Std 603-1991 IEEE Std 279-1971 SRM-SECY-22-0076, SRM-SECY-93-087

  • Item 18 Applicable IEEE Std 7-4.3.2-2016 Clauses 5.1 Single-Failure Criterion 5.5 System Integrity 5.5.1 Design for PDD Integrity 5.5.2 Design for Test and Calibration 5.5.3 Fault Detection and Self-Diagnostics 5.5.4 Prioritization of Functions 5.6 Independence 5.7 Capability for Testing and Calibration 5.8 Information Displays 5.9 Control of Access 5.11 Identification 5.15 Reliability 5.16 Common Cause Failure Criteria 5.18 Simplicity Regulatory Requirements & Policy RG 1.152, Rev. 4 Criteria for Programmable Digital Devices in Safety-Related Systems of NPPs 24

ONGOING ACTIVITIES 25

Ongoing Activities

  • ISG-06 Guidance Clarification
  • Non-LWR Licensing Workshops
  • Regulatory Guide Updates

Implementing the ADVANCE Act

  • The NRC is implementing the ADVANCE Act, including Sections 505 and 507.
  • The goal is to make licensing reviews more efficient, predictable and timely.
  • The staffs ongoing efforts to modernize the I&C regulatory infrastructure are being tracked under the ADVANCE Act Sections 505 and 507 implementation activities.

27 https://www.nrc.gov/about-nrc/governing-laws/advance-act.html

ISG-06 Guidance Clarification

  • The staff is gathering lessons-learned from the use of the ISG-06 Alternate Review Process to improve:

- the quality of applications

- the efficiency and clarity of the review process

  • Digital I&C Lessons Learned Workshop held on March 13-14, 2025:

- shared lessons learned and insights

- received feedback

- identified areas for improvement 28 Digital Instrumentation and Control Public Workshop Meeting Summary (ML25098A087)

  • The staff plans to update the ISG-06 guidance after completion of current licensing reviews.
  • Move the interim guidance to the Standard Review Plan.
  • Improve the guidance and add clarity for applications that fall between the Traditional and Alternate review processes.
  • Include clearer guidance on interfacing with other technical areas:

- (e.g., human factors engineering, equipment qualification)

ISG-06 Guidance Clarification 29

  • The staff has been holding periodic public workshops with applicants and industry stakeholders on use of the DRG and RG 1.233 in relation to advanced reactor I&C designs.
  • Lessons learned from these pre-application engagements, and initial licensing reviews of the near-term applications will be captured in a future update to the DRG, and if required to RG 1.233, as appropriate.

Non-LWR Licensing Workshops 30 https://www.nrc.gov/reactors/new-reactors/advanced/modernizing/guidance/digital-instrumentation-and-control.html

IEEE Std. 603-2018 Rulemaking and Guidance

  • To provide regulatory confidence to use the 2018 version of the standard.
  • A draft regulatory guide is being developed to accompany the rulemaking effort.
  • Staff is planning to issue the draft rulemaking and guidance for public comment later this year.

IEEE Std 603-2018, IEEE Standard Criteria for Safety Systems for Nuclear Power Generating Stations 31

Software Regulatory Guides

  • Revise RGs 1.168 - 1.173 to endorse the latest industry guidance.
  • Explore the organization of the set of software development RGs (1.168 - 1.173) to determine improvements, level of effort and maintenance involved.

RG 1.168, Verification, Validation, Reviews, and Audits for Digital Computer Software Used in Safety Systems of Nuclear Power Plants IEEE Std 1012-2016, IEEE Standard for System, Software, and Hardware Verification and Validation 32

NEI 20-07, Revision E

  • Draft Revision E submitted by NEI in July 2023.
  • Provides industry guidance for a risk-informed graded approach and an iterative systems engineering process for addressing digital I&C CCFs.
  • NRC staff provided comments which were discussed during various public meetings (March-October 2024).
  • A tabletop is being planned for 2025.

NEI 20-07, Guidance for Addressing Common Cause Failure in High Safety-Significant Safety-Related Digital I&C Systems, Draft E 33

QUESTIONS?

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