ML22130A523

Presentations - May 11, 2022 Advanced Reactor Stakeholder Meeting

ML22130A523
Person / Time
Issue date:	05/10/2022
From:	NRC/NRR/DANU
To:
References
10 CFR Part 53, NRC-2019-0062, RIN 3150-AK31
Download: ML22130A523 (142)

Text

1 Advanced ReactorStakeholderPublic Meeting May 11, 2022 Microsoft Teams Meeting Bridgeline: 301-576-2978 Conference ID: 556 455 490#

2 Part 53 Rulemaking Process (Steve Lynch)

Time Agenda Speaker 10:00 - 10:15 am Opening Remarks/ Adv. Rx Integrated Schedule (Shelley Pitter - Logistics, Steve Lynch)

NRC 10:15 - 10:45 am Part 53 Rulemaking Process (Steve Lynch)

NRC 10:45 - 11:15 am Part 53 Framework B Development and Integration Update (William Jessup/Candace de Messieres)

NRC 11:15 am - 12:00 pm Development of ISG for Assessment of Non-LWR PRA Standard (Trial RG 1.247)

Applicability (Hanh Phan)

NRC 12:00 - 1:00 pm Lunch Break All 1:00 - 1:30 pm Overview of Guidance Supporting Part 53 - Discuss Timing of Guidance Release (Jordan Hoellman)

NRC 1:30 - 2:30 pm Results of Nuclear Energy Institute and U.S. Nuclear Industry Council 2022 Part 53 Industry Survey (Marc Nichol, NEI / Cyril Draffin, USNIC)

NEI/USNIC 2:30 - 2:40 pm Break All 2:40 - 3:00 pm NuScale Lessons Learned (Omid Tabatabai-Yazdi)

NRC 3:00 - 4:35 pm Development of 50.59 guidance (Michael Tschiltz)

Southern Company 4:35 - 4:55 pm Update on Pre-Application Engagement on Advanced Reactor Licensing (Courtney Banks, Adrian Muniz, Mallecia Sutton)

NRC 4:55 - 5:00 pm Future Meeting Planning and Concluding Remarks NRC

3 https://www.nrc.gov/reactors/new-reactors/advanced/integrated-review-schedule.html

4 Part 53 Rulemaking Process (Steve Lynch)

Part 53 Rulemaking Vision, Process, and Status Steven Lynch, Acting Chief Advanced Reactor Policy Branch 5

Pathway to New Regulatory Framework Part 53 Rulemaking by July 2025

• Nuclear Energy Innovation and Modernization Act (NEIMA) requirement

• Technology-inclusive, risk-informed and performance based regulatory framework

• Commission direction SRM-SECY-20-0032

• Builds on current activities, including the Licensing Modernization Project

• Significant stakeholder engagement 6

7 Part 53 rulemaking addresses plant lifecycle with appropriate flexibilities and safety focus 7

P A R T 5 3 l T R A N S F O R M A T I V E Part 53 builds on a strong foundation of Commission policies and decisions F E A T U R E S o Evolves use of risk o Leverages performance-based requirements o Modernizes licensing basis change process o Includes consequence-oriented scalable requirements o Enables operational flexibility o Optimizes balance between flexibility and predictability Establishes a Transformative Regulatory Framework 8

9

PROPOSED RULEMAKING TERMS Current Step in Part 53 Rulemaking Preliminary Proposed Rule Goals:

• Develop reliable, responsive, and informed rulemaking

• Increase transparency

• Promote engagement

• Improve clarity 10

RULEMAKING STATUS Stakeholder Engagement o 16 public meetings and 15 ACRS meetings o Recent: 3/29 public meeting on key issues, 5/11 stakeholder meeting on Framework B and guidance prioritization o Planned: 5/19 ACRS meeting on Framework A, 5/25 public meeting on Framework A, early-June public meeting on Framework B o Future: 6/23-24 ACRS SC meeting on Framework B, 7/6-9 ACRS FC meeting, 7/21 Commission meeting, Focus Areas o Continue stakeholder engagement o Finalize rule language o Develop rule package (SOCs, regulatory analysis, etc.)

o Developing guidance Industry Input o Over 1500 public comments received Rule Language o 2021: definitions (A), safety criteria (B), design and analyses (C), siting (D), construction/manufacturing (E), operations and programs (F), decommissioning (G), licensing processes (H), maintenance of the licensing basis (I), reporting (J), security, access authorization, FFD, traditional alternatives.

o 2022: consolidated rule package (Feb.), 2nd iteration Framework A (May), & 1st iteration Framework B (June) 11

12 Feb 2023 Draft Proposed Rule to Commission Jun 2023 Publish Proposed Rule and Draft Key Guidance Oct 2023 Public Comment Period -

60 days Dec 2024 Draft Final Rule to Commission Apr 2025-Jun 2025 Office of Management and Budget and Office of the Federal Register Processing Jul 2025 Publish Final Rule and Key Guidance Nov 2023-Nov 2024 Public Outreach and Generation of Final Rule Package CURRENT PART 53 TIMELINE Oct 2020-Aug 2022 Public Outreach, ACRS Interactions and Generation of Proposed Rule Package

13 Part 53 Framework B Development and Integration Update (William Jessup/Candace de Messieres)

Part 53 Framework B Development and Integration Update 14

• Part 53 Licensing Framework Overview

• Systematic Development Process for Part 53 Framework B

• Part 53 Framework B Integration

• Part 53 Framework B Technical Requirements

• Use of Risk Information in Part 53

• Part 53 Framework B: Alternate Evaluation for Risk Insights (AERI)

• Next Steps and Additional Information Outline 15

Subpart A - General Provisions Subpart B - Safety Requirements Subpart C - Design Requirements Subpart D - Siting Subpart E - Construction/Manuf.

Subpart F - Operations Subpart G - Decommissioning Subpart H - Licensing Processes Subpart I - License Maintenance Subpart J - Reporting Subpart K - Quality Assurance Subpart N - Purpose/Definitions Subpart O - Construction/Manuf.

Subpart P - Operations Subpart Q - Decommissioning Subpart R - Licensing Process Subpart S - License Maintenance Subpart T - Reporting Subpart U - Quality Assurance Part 53 Licensing Frameworks Framework A

• Probabilistic Risk Assessment (PRA)-led approach for developing the licensing basis and safety case

• Functional Design Criteria Framework B

• Traditional use of risk insights

• Includes an Alternative Evaluation for Risk Insights (AERI) approach

• Principal Design Criteria 16

17

Part 53 Framework B From Part 53 Framework A with some variations Leverages Part 50, 52, 53 Framework A, international standards, and state of practice New provisions Subpart N - Purpose/Definitions Subpart O - Construction Subpart P - Operations and Programs Subpart Q - Decommissioning Subpart R - Licensing Process Subpart S - License Maintenance Subpart T - Reporting Subpart U - Quality Assurance Subpart A - General Provisions Framework A Subparts B - K Framework B Subparts N - U 18

Framework B Subpart R: Licensing Processes From Part 53 Framework A with some variations Leverages Part 50, 52, 53 Framework A, international standards, and state of practice New provisions

§ 53.4700 General Provisions.

§ 53.4730 General technical requirements.

§ 53.4731 Risk-informed classification of structures, systems, and components.

§ 53.4740 Limited work authorizations.

§ 53.4750 Early site permits.

§ 53.4800 Standard design approvals

§ 53.4830 Standard design certifications.

§ 53.4870 Manufacturing licenses.

§ 53.4900 Construction permits.

§ 53.4960 Operating licenses.

§ 53.5010 Combined licenses.

19

Subpart R:

§ 53.4730 General Technical Requirements

§ 53.4730(a)(1) - (37) provide technical requirements for applications for each licensing process (e.g., construction permit, operating license) as specified

• § 53.4730(a)(1): Site Parameters.

• § 53.4730(a)(2): Facility description.

• § 53.4730(a)(4): Design bases.

• § 53.4730(a)(15): Emergency plans.

• § 53.4730(a)(23): Technical specifications.

• § 53.4730(a)(34): Description of risk evaluation.

• § 53.4730(a)(36): Functional containment.

20

Part 53 Licensing Frameworks - Risk Evaluation Perspective Perform transient and accident analyses Perform design basis accident radiological consequences analyses Identify and analyze the bounding event Finish PRA development Select LBEs Select DBAs Classify SSCs Continue design and licensing activities Evaluate defense in depth Comprehensive and systematic initiator search and event sequence delineation without preconceptions or reliance on predefined lists Select licensing events Select licensing framework Perform transient and accident analyses Perform design basis accident radiological consequences analyses Elect to develop PRA Finish PRA development Alternative Evaluation for Risk Insights (AERI)

Q1 - Develop demonstrably conservative risk estimate using the bounding event Q3 - Develop risk insights by reviewing all event sequences Q2 - Search all event sequences for severe accident vulnerabilities Continue design and licensing activities Continue design and licensing activities A

Part 53 Framework A Part 53 Framework B B

C D

E F

G H

I J

K L

M N

O ye s

no Applicant decision DG-XXX1, Technology-Inclusive Identification of Licensing Events DG-XXX2, Alternative Evaluation for Risk Insights Framework LMP guidance - NEI 18-04, Rev. 1, as endorsed in RG 1.233 AERI entry conditions met?

P ye s

n o

Q Alternative Evaluation for Risk Insights (AERI) 21

AERI Draft Preliminary Proposed Rule Text 53.4730(a)(34) Description of risk evaluation.

A description of the risk evaluation developed for the commercial nuclear plant and its results. The risk evaluation may be based on:

(i)

A probabilistic risk assessment (PRA), or (ii) An alternative evaluation for risk insights (AERI), provided that:

(A) The dose resulting from a postulated bounding event to an individual located at any point on the boundary of the exclusion area does not exceed 1 rem TEDE over the first four days following a release, an additional 2 rem TEDE in the first year, and 0.5 rem TEDE per year in the second and subsequent years, and (B) The distance from each radionuclide source in the commercial nuclear plant to the boundary of the exclusion area is less than 100 meters (328 feet).

EPA Early Phase and Intermediate Phase Protective Action Guidelines Underlying assumptions for the 100-meter entry condition:

Linear no threshold dose-response model Uniform population density Power law dose vs. distance model (NUREG-0396)

Exclusion area boundary (EAB) = Emergency Planning Zone (EPZ) boundary Bounding event does not require evacuation or relocation, if it occurs If the entry conditions and underlying assumptions are met, then the conditional individual latent cancer fatality risk is approximately 2E-6 per event If reactor trip frequency is 1/year, then meet the QHO Can always elect to develop a PRA 22

AERI Results and Implementation

• Demonstrates that QHOs are met, searches for severe accident vulnerabilities, and provides risk insights without a requirement for a PRA

• Inherently addresses the mitigation of beyond-design basis events requirements when AERI entry conditions are met Results

• Must be maintained (AERI is not a one-and-done approach)

• Voluntary risk-informed applications (e.g., SSC classification, risk-managed technical specifications) require PRA Implementation 23

Next Steps Release draft preliminary proposed rule language and hold public meeting to discuss Framework B (tentative June 2022)

Discuss with Advisory Committee on Reactor Safeguards

• Subcommittee:

June 23 - 24, 2022

• Full Committee:

July 6 - 9, 2022 24

Additional Information Additional information on the 10 CFR Part 53 rulemaking is available at https://www.nrc.gov/reactors/new-reactors/advanced/rulemaking-and-guidance/part-53.html For information on how to submit comments go to https://www.regulations.gov and search for Docket ID NRC-2019-0062 For further information, contact Robert Beall, Office of Nuclear Material Safety and Safeguards, telephone: 301-415-3874; email:

Robert.Beall@nrc.gov 25

26 Development of ISG for Assessment of Non-LWR PRA Standard (Trial RG 1.247) Applicability (Hanh Phan)

Update on the NLWR PRA Standard Applicability and Gap Assessment

Purpose

• Provide an update on the NLWR PRA Standard Applicability and Gap Assessment

• Further engage with stakeholders on NLWR PRA-related guidance development Slide 28

Comprehensive search for initiators Applicant elects enhanced use of PRA Comprehensive definition of event sequences Select licensing events Perform consequenc e analyses Identify the maximum accident Risk Insights Evaluation

1. Develop demonstrably conservative risk estimate

2. Develop risk insights

3. Search for severe accident vulnerabilities Conservativ e risk estimate

> QHOs?

Select licensing events Compare to QHOs A

K M

N S

N Y

Applicant elects traditional use of PRA Select LBEs Select DBAs Classify SSCs Compare to QHOs O

P Q

R ENHANCED USE OF PRA (Part 53-E, Parts 50 or 52 with voluntary LMP)

TRADITIONAL USE OF PRA (Part 53-T, Parts 50 or 52 without LMP)

ALTERNATIVE TO PRA (Part 53-BE, Parts 50 or 52 with exemption from PRA requirement)

C D

E F

H I

N Y

Y N

Develop PRA Comprehensive search for initiators Comprehensive definition of event sequences START Develop PRA Comprehensive search for initiators Comprehensive definition of event sequences CONTINUE LICENSING B

J PRA in complementary/supporting role CONTINUE LICENSING CONTINUE LICENSING increasing use of PRA and risk insights Licensing Pathways Slide 29 Path 1 Path 2 Path 3

P.2 Traditional Use of PRA

• Parts 50 or 52 without LMP

• Part 53 Framework B (PRA without LMP)

P.1 Enhanced Use of PRA

• Parts 50 or 52 with voluntary LMP

• Part 53 Framework A (PRA with LMP)

P.3 Alternative Evaluation for Risk Insights

• Part 53 Framework B (AERI pathway)

RG 1.233 Endorsement ML20091L698 DG-XXXX TICAP ISG-XXXX ARCAP Roadmap LWR PRA (includes ALWRs and SMRs)

NLWR PRA DG-XXX1 Initiators and Event Sequences Licensing Events DG-XXX2 AERI Guidance NEI 20-09 Peer Review NLWR PRA Standard RG 1.247 Endorsement ML21235A008 ISG-XXXX PRA Standard Applicability RG 1.200 PRA Standard Endorsement White Paper:

Acceptability of PRA Results ML21015A434 Consequence Uncertainty Guidance LPSD Fire PRA Guidance DC/COL-ISG-028 PRA Applicability ML16130A468 SRP Chapter 19.0 LWR Level 3 PRA Standard LWR Level 2 PRA Standard LWR Level 1/LERF Standard ALWR PRA Standard LWR LPSD PRA Standard LWR PRA Multi-Unit Standard RG 1.246 RIM ML21120A185 NLWR PRA-Related Guidance Slide 30 NEI 18-04 LMP NEI 21-07 TICAP

NLWR PRA Standard Scope Addresses all radiological sources at the plant

- Reactor cores

- Spent fuel

- Fuel reprocessing facilities

- Accident scenarios that lead to a radioactive release from multiple radiological sources Addresses all hazards (excludes LPSD Fire)

- All internal hazards (e.g., internal initiating events, internal floods, internal fires)

- All external hazards (e.g., seismic events, external floods, high wind events)

Addresses all plant operating states (e.g., at-power, low-power, shutdown)

A Level 3 PRA

- Develop the frequencies of accident scenarios from the occurrence of an initiating event until the release of radioactive materials to the environment

- Estimate the consequences that result from the release Slide 31

PRA Elements High Level Requirements Supporting Requirements Includes:

18 PRA elements 247 high level requirements (HLRs) 1,233 supporting requirements (SRs)

~ 617 notes in the nonmandatory appendices 238 definitions NLWR PRA Standard ASME/ANS RA-S-1.4-2021 Slide 32

Examples of Supporting Requirements That Only Apply to Certain Plant Licensing Stages No.

SR CC-I CC-II Remarks 1

POS-A1 IDENTIFY a representative set of plant evolutions to be analyzed IDENTIFY a representative set of plant evolutions to be analyzed, Applies to all licensing stages 2

POS-A5 For PRAs performed during the pre-operational stage, ENSURE the level of detail in delineating the POSs is consistent with the level of detail of the design information available Applies during plant design and construction 3

RCAD-A8 For PRAs performed on a bounding site, IDENTIFY assumptions made due to the lack of site details that influence the atmospheric transport and dispersion conditions.

Only applies prior to site selection 4

WFR-A3 For PRAs conducted on a specific site, ENSURE that the wind fragilities are site-specific.

Applies after site selection 5

SHA-A1 For the seismic hazards analysis, either:

(a)

IDENTIFY the site at which the reactor being analyzed is located, or (b)

DESCRIBE a bounding site and JUSTIFY that the bounding site bounds the list of sites in the scope of the PRA.

Part (a) applies after site selection Part (b) applies prior to site selection 6

POS-A4 For operating plants, ENSURE the level of detail in the delineation of POSs is consistent with the as-built and as-operated plant sufficient Applies after initial fuel load 7

POS-C1 Within the selected plant evolutions, CALCULATE the mean duration and the mean time after shutdown for each POS based on a review of applicable plant-or design-specific record.

Applies after operating experience accrues Slide 33 Slide 33

ISG Objective Convey the NRC staff position on the use of NLWR PRA standard ASME/ANS RA-S-1.4-2021 for PRAs performed in support of design certification (DC),

standard design approval (SDA), manufacturing license (ML), combined license (COL), construction permit (CP), and operating license (OL), at initial fuel loading, and during first update/upgrade, with or without LMP process, specifically:

The applicability of each high-level requirement (HLR) and supporting requirement (SR) in the PRA standard The expected capability category, CC I or CC II New SRs necessary for specific conditions of the PRA performed to support LMP application Slide 34

Applicable Regulations and Applications

• This ISG applies to applications for NLWR licensing under 10 CFR Part 50

- Current regulations do not require applicants for Part 50 construction permits or operating licenses to provide PRA-related information

- Rulemaking Incorporation of Lessons Learned from New Reactor Licensing Process (Parts 50 and 52 Licensing Process Alignment), Docket NRC-2009-0196, RIN-3150-AI66

• This ISG applies to applications for NLWR licensing under 10 CFR Part 52

- Subpart B - Standard Design Certification (DC)

- Subpart C - Combined License (COL)

- Subpart E - Standard Design Approval (SDA)

- Subpart F - Manufacturing License (ML)

• This ISG may apply to the proposed 10 CFR Part 53

- Rulemaking Risk Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors, Docket NRC-2019-0062, RIN 3150-AK31

• This ISG applies to the PRAs at initial fuel loading and first update/upgrade Slide 35

Examples of PRA Standard High-Level Requirements and Supporting Requirements Applicability Slide 36

Demonstrating Acceptability of PRA and Its Results Used in an Application - RG 1.247, Section C.3 For all applications, the PRA-related information provided in the submittal should:

Describe the PRAs scope, level of detail, and degree of plant representation Demonstrate that the PRA has been developed and used in a technically acceptable manner, including the appropriateness of the assumptions and approximations Identify the application-specific acceptance criteria and demonstrate that they have been met Slide 37

What else is missing?

Slide 38

ACRONYMS/ABBREVIATIONS AERI alternative evaluation for risk insights ANS American Nuclear Society ASME American Society of Mechanical Engineers CC capability category COL combined license (10 CFR Part 52, Subpart C)

CP construction permit (10 CFR Part 50)

DBA design-basis accident DC design certification (10 CFR Part 52, Subpart B)

DG draft regulatory guide HLR high-level requirement HR human reliability ISG interim staff guidance LBE licensing-basis event LMP licensing modernization project LPSD low-power and shutdown ML manufacturing license (10 CFR Part 52, Subpart F)

NLWR non-light water reactor OL operating license (10 CFR Part 50)

POS plant operating state PRA probabilistic risk assessment QHOs quantitative health objectives RI risk-informed RIM reliability and integrity management SDA standard design approval (10 CFR Part 52, Subpart E)

SR supporting requirement SSC system, structure, and component Slide 39

40 Overview of Guidance Supporting Part 53 - Discuss Timing of Guidance Release (Jordan Hoellman)

Overview of Guidance Supporting 10 CFR Part 53 May 11, 2022 41

NRCs Vision & Strategy (2016)

Executing the Vision:

Implementation Action Plans (2017) 42

Modernizing the Regulatory Framework Advanced Nuclear Reactor GEIS Functional Containment (SECY-18-0096)

Physical Security for Advanced Reactors Emergency Preparedness (SECY-22-0001)

Adv Rx Siting (SECY-20-0045)

TICAP/ARCAP Application Level of Detail Licensing Modernization Project NEI 18-04 RG 1.233 Part 53 Technology-Inclusive, Risk-Informed Regulatory Framework Fuel Qualification (NUREG-2246)

See SECY-22-0008, Advanced Reactor Program Status 43

Licensing Modernization Project A risk-informed, consequence-oriented approach to establish licensing basis and content of applications (see Regulatory Guide 1.233 https://www.nrc.gov/docs/ML2009/ML20091L698.pdf) 44

SECY-20-0032 and SRM, Rulemaking Plan The staff should accelerate its timeline while balancing the need to produce a high-quality, thoroughly vetted regulation to achieve publication of the final rule by October 2024.

• Staffs response to SRM identified timing of guidance document development to support the Part 53 rulemaking as an uncertainty in meeting the accelerated schedule o Focus resources on developing the proposed rule language o Possible need to publish proposed rule before completing draft supporting guidance o Continue engaging external stakeholders to ensure common prioritization of guidance documents o Support early applications under Parts 50/52 (e.g., DOEs Advanced Reactor Demonstration Program) 45

Key Guidance Overview

• Licensing Modernization Project (NEI 18-04 & RG.

1.233)

• Siting Criteria (RG 4.7)

• Fuel Qualification Framework (NUREG-2246)

Existing

• Analytical Margin

• Chemical Hazards

• Manufacturing

• Technical Specifications

• Facility Safety Program

• Contents of Applications for Framework B Future Under Development Near-Term

• Non-LWR PRA Standard

• TICAP/ARCAP (NEI 21-07)

• High Temp Materials (ASME III-5)

• Reliability & Integrity Mgt (ASME XI-2)

• Fuel Qualification (technology-specific)

• PRA Level of Detail (NEI-led)

• Seismic Design/Isolators

• Emergency Planning

• Change Process (SNC-led)

• QA Alternatives (NEI-led)

• Operator Training Program Part 53

• Initiating Events

• Qualitative Risk Estimate/Insights (AERI)

• Operator licensing Exam

• Human Factors Engineering

• Concept of Operations/ Staffing

• Fitness for Duty

• Access Authorization

• Cyber Security

• Physical Security

• Materials Compatibility ISG 46

Existing Guidance

• Licensing Modernization Project (NEI 18-04 & RG. 1.233)

• Siting Criteria (RG 4.7)

• Fuel Qualification Framework (NUREG-2246)

Existing

• Existing guidance documents currently exist and will be referenced in the Part 53 rulemaking package as key guidance.

• Conforming changes will be needed to ensure they are applicable to Part 53.

• Revision will occur between proposed rule and final rule stages.

47

Guidance Under Development Under Development Near-Term

• Non-LWR PRA Standard

• TICAP/ARCAP (NEI 21-07)

• High Temp Materials (ASME III-5)

• Reliability & Integrity Mgt (ASME XI-2)

• Fuel Qualification (technology-specific)

• PRA Level of Detail (NEI-led)

• Seismic Design/Isolators

• Emergency Planning

• Change Process (SNC-led)

• QA Alternatives (NEI-led)

• Operator Training Program Part 53

• Initiating Events

• Qualitative Risk Estimate/Insights (AERI)

• Operator licensing Exam

• Human Factors Engineering

• Concept of Operations/ Staffing

• Fitness for Duty

• Access Authorization

• Cyber Security

• Physical Security

• Materials Compatibility Near-term guidance documents are currently under development and will be referenced as key guidance.

These will be issued prior to the finalization of Part 53 to support near-term applicants and will need conforming changes to ensure they are applicable to Part 53.

Revision will occur between proposed rule and final rule stages.

Part 53-specific guidance documents are currently under development and are expected to be included with the Part 53 rulemaking package as key guidance.

48

Future Guidance

• Analytical Margin

• Chemical Hazards

• Manufacturing

• Technical Specifications

• Facility Safety Program

• Contents of Applications for Framework B Future

• Future guidance documents are identified as future guidance that may need to be developed to support Part 53.

• These guidance documents may be referenced in the Part 53 rulemaking document as under development and are expected to be completed to support the final rule.

• Additional operational program guidance and reporting requirements guidance may be provided with the final rule.

49

ARCAP and TICAP - Nexus Outline Safety Analysis Report (SAR) -

Based on TICAP Guidance

1. General Plant Information, Site Description, and Overview of the Safety Case

2. Methodologies and Analyses

3. Licensing Basis Event (LBE) Analysis

4. Integrated Evaluations

5. Safety Functions, Design Criteria, and SSC Safety Classification

6. Safety Related SSC Criteria and Capabilities

7. Non-safety related with special treatment SSC Criteria and Capabilities

8. Plant Programs Additional Portions of Application

• Technical Specifications

• Technical Requirements Manual

• Quality Assurance Plan (design)

• Fire Protection Program (design)

• Quality Assurance Plan (construction and operations)

• Emergency Plan

• Physical Security Plan

• SNM physical protection program

• SNM material control and accounting plan

• Cyber Security Plan

• Fire Protection Program (operational)

• Radiation Protection Program

• Offsite Dose Calculation Manual

• Inservice inspection/Inservice testing (ISI/IST) Program

• Environmental Report

• Site Redress Plan

• Exemptions, Departures, and Variances

• Facility Safety Program (under consideration for Part 53 applications)

Audit/inspection of Applicant Records Calculations Analyses P&IDs System Descriptions Design Drawings Design Specs Procurement Specs Probabilistic Risk Assessment Safety Analysis Report (SAR) structure based on clean sheet approach Additional SAR Content -Outside the Scope of TICAP

9. Control of Routine Plant Radioactive Effluents, Plant Contamination, and Solid Waste

10. Control of Occupational Doses

11. Organization and Human-System Considerations

12. Post-construction Inspection, Testing and Analysis Programs

• Additional contents of application outside of SAR are still under discussion. The above list is draft and for illustration purposes only.

50

THANK YOU Questions?

Jordan.Hoellman2@nrc.gov 51

52 Results of Nuclear Energy Institute and U.S. Nuclear Industry Council 2022 Part 53 Industry Survey (Marc Nichol, NEI / Cyril Draffin, USNIC)

Powered by Results of Nuclear Energy Institute and U.S. Nuclear Industry Council 2022 Part 53 Industry Survey For Public Release at U.S. Nuclear Regulatory Commission (NRC)

Advanced Reactor Stakeholder Meeting 11 May 2022 Cyril W. Draffin, Jr.

Senior Fellow, Advanced Nuclear U.S. Nuclear Industry Council Marcus Nichol Senior Director, New Reactors Nuclear Energy Institute 53

Respondents Characteristics (Q1-Q3)

Understanding and Support (Q4-Q6)

Benefits / Concerns / Opportunities (Q7-Q9)

Frameworks A & B and Licensing Approach (Q10-Q11)

Comparison to Goals for Part 53 (Q12-Q14)

Other comments (Q15)

QHO analysis Comparison to 2021 USNIC Part 53 Survey Concluding High Level Insights Appendix 54 NEI/USNIC Part 53 2022 Survey Topics

55 Q1: Companies Completing NEI/USNIC Part 53 Survey - April 2022 1.

Alpha Tech 2.

ARC Clean Energy 3.

BWXT 4.

Constellation 5.

Energy Northwest 6.

Framatome 7.

GE-Hitachi Nuclear Energy 8.

General Atomics 9.

Holtec International

10. Kairos Power

11. Moltex Energy

12. NuScale Power

13. Oklo

14. Radiant Industries

15. Southern Company

16. TVA

17. TerraPower

18. UAMPS (Carbon Free Power Project)

19. Ultra Safe Nuclear Corp.

20. Westinghouse

21. X-energy

22. Xcel Energy This comprehensive survey of Part 53 was sent to NEI/USNIC members that are potential applicants to the NRC.

The survey was sent to senior regulatory affairs personnel (VP or Director) and represents the organizations perspective.

A few companies (not listed) declined to complete the survey, with the following reasons provided:

• Not sufficiently familiar with NRC Part 53 rulemaking

• Part 53 is not relevant, pursuing design approval under Part 52

• Not planning to deploy design in the U.S.

Q2: What type of applicant to the NRC are you? (Select all that apply)

Answered: 22 Skipped: 0 0

2 4

6 8

10 12 Owner/Operator (would apply for a construction permit, operating license, etc.)

Both Owner/Operator and Designer/Developer Designer/Developer (would apply for a design approval or support an application for an operating license) 6 Both Owner/Operator and Designer/Developer 10 Designer/Developer Only 6 Owner/Operator Only 56 12 Owner/Operator Responses

Q2: What type of applicant to the NRC are you?

57

1) Note about Comments for all questions: These are formatted to draw out the main conclusions related to the particular question, rather than present the raw comments that sometimes contains ancillary perspectives.

Key Insights from Comments1

1. Role of owner/operator and/or designer/developer may be project dependent

2. Interest in manufacturing license (which was not explicitly identified as a choice, but implied in developer/designer)

Q3: How engaged are you with the NRC regarding current or future licensing applications? (Select all that apply)

Answered: 22 Skipped: 0 0

2 4

6 8

10 12 14 No plans to submit an application by 2025 Expect to Submit an Application no later than 2025 Submitted a response to RIS 2020-02 Are in pre-application activities with the NRC Have Submitted an application to the NRC Constitutes 15 of 22 respondents1 58

1) Note: Sum of bars is more than total respondents with these three categories, because multiple selections were allowed.

Q3: How engaged are you with the NRC regarding current or future licensing applications?

59 Key Insights from Comments

1. Many respondents have been engaged with the NRC for a long time in developing a modernized regulatory framework

2. Some designers/developers are not engaging the NRC until they have their first project (customer), but are working on their design.

Q4: What is your familiarity with each of the following? (score 0 to 5, with 5 being the most familiar)

Answered: 22 Skipped: 0 0

1 2

3 4

5 6

7 8

9 NRC Preliminary Rule Language from February 4, 2022 (ML22024A066)

NEI/USNIC Comments Submitted on November 5, 2021 (ML21309A578)

NRC/Stakeholder Interactions in Public Meetings 0

1 2

3 4

5 Rule and NEI/USNC Comments Content Familiarity

• Very (score 4 or 5) = 10

• Somewhat (2 or 3) = 10

• Not Very (0 or 1) = 2 Public Meeting Familiarity

• Very (4 or 5) = 9

• Somewhat (2 or 3) = 7

• Not Very (0 or 1) = 4 60 Score: 3 Score: 3 Score:

3 Score: 5 Score: 5 Score: 5

Q4: What is your familiarity with each of the following?

61 Key Insights from Comments

1. Respondents that had a low familiarity with rule and comments tended to be those that have not been involved in public meetings.

Q5: To what degree do you support the following? (score 0 to 5, with 5 being the most agreement)

Answered: 21 Skipped: 1 0

1 2

3 4

5 6

7 8

9 10 NRC Preliminary Rule Language from February 4, 2022 (ML22024A066)

NEI/USNIC Comments Submitted to the NRC on November 5, 2021 (ML21309A578) 0 1

2 3

4 5

High support Degree of Support1, 2 NRC Draft Rule Language:

• High Support (score 4 or 5) = 11% (2)

• Moderate Support (score 2 or 3) = 83% (15)

• Low Support (1) = 6% (1)

NEI/USNIC Comments:

• High Support (score 4 or 5) = 78% (14)

• Moderate Support (score 3, not 2) = 22% (4)

• Low Support (no 0 or 1) = 0% (0) 62 Score: 3 Score: 3 Score: 5 Score: 5

1) Moderate support for NRC rule language is consistent with NEI/USNIC comments, in which NEI/USNIC support some of the NRC approaches, but have concerns in key areas.

2) Not shown are three Dont Know responses. Percentages are of those providing responses other than Dont Know/skip.

Only moderate support Score: 1

Q5: To what degree do you support the following?

63 Key Insights from Comments1 1.

Additional understanding of details of NRCs proposed approaches is needed (through statements of consideration and guidance) to fully know whether Part 53 will be usable.

2.

Some believe there are a number of un-defined approaches, such as 53.450 other generally accepted risk-informed approach.

3.

Measuring support of NRC language as a whole does not reveal the nuances of complex rule.

(e.g., parts of NRC language appear workable, but other parts are not workable - see NEI/USNIC comments).

4.

Some identified specific needs for more efficiency - consistent with NEI/USNIC comments.

1) More insights are provided in responses to Question 12 regarding the efficiency of Part 53 to achieve the same level of safety as Parts 50 and 52.

Q6: For applications submitted in 2025 and beyond, what is the likelihood that you will use the NRC Part 53 Framework A, if the Final Rule adopts the language and approaches in its current form? (Note that later questions will ask about Framework B, and the overall two-framework approach)

Answered: 21 Skipped: 1 0

1 2

3 4

5 6

7 8

9 Will not use Framework A of Part 53 (e.g., substantial increases in regulatory burden over Parts 50 and 52, with minimal if any benefits)

Not likely to use Framework A of Part 53 (e.g., current NRC proposal does not appear to be better than Parts 50 and 52)

May use Framework A of Part 53, but need to see demonstrated benefits (e.g., current NRC proposal may provide advantages over Parts 50 and 52, but they must be demonstrated by other applicants first)

Will likely use Framework A of Part 53, but not for the first application (e.g., requirements are not conducive to licensing a first-of-a-kind design)

Framework A of Part 53 is the likely first choice (e.g., substantial benefits in comparison to Parts 50 and 52)

Likely to use

= 24%

Have not seen benefits of Framework A = 38%

Not Likely to use = 38%

64

Q6: For applications submitted in 2025 and beyond, what is the likelihood that you will use the NRC Part 53 Framework A, if the Final Rule adopts the language and approaches in its current form?

65 Key Insights from Comments The efficiency of Part 53 (as compared to Parts 50 and 52) to achieve the same level of safety is a determining factor in interest to use Part 53.

1.

Many respondents dont plan to use Part 53 a)

Part 53 perceived to not be timely for deployment plans b)

Part 50 and 52 approval is sufficient to achieve long term business/deployment plans and no incentive to switch to Part 53 later c)

Part 53 perceived to be significant increase in regulatory burden (as compared to Parts 50 and 52) to achieve same level of safety 2.

Many have not seen demonstrated benefits --are unsure due to too many uncertainties and untested processes, and need it to be demonstrated first.

3.

A few believe Part 53 is more efficient, and are likely to use it.

4.

Some that are not likely to use Framework A are hopeful that Framework B would be useable.

5.

A potential licensee mostly interested in the burden placed on plant operations.

Q7: Which of the following areas of the current NRC preliminary language and approaches in Part 53 provide significant benefits over Parts 50 and 52? (score 0 to 5, with 5 being the most beneficial)

Answered: 20 Skipped: 2 Part 53 Content Most (4 or 5)

Least (0 or 1)

Dont Know Increased use of performance-based approach for Security 80% (16) 0% (0) 10% (2)

Technology-inclusive requirements (e.g., safety functions, design criteria, design features) 75% (15) 5% (1) 10% (2)

Increased use of performance-based approach for Operators (e.g., certified operator option) 60% (12) 5% (1) 15% (3)

Increased use of performance-based approach for Fitness for Duty 55% (11) 5% (1) 15% (3)

Fewer exemptions will be required 42% (8) 5% (1) 42% (8)

Increased functionality for Manufacturing Licenses 32% (6) 0% (0) 21% (4)

Organization and structure of the rule (e.g., separation of design, analysis, operations, etc.)

30% (6) 0% (0) 20% (4)

Two frameworks (A and B) in rule based on role of PRA 26% (5) 16% (3) 21% (4)

Inclusion of Quantified Health Objectives in the Rule, rather than keeping as a Policy 21% (4) 47% (9) 11% (2)

Facility Safety Program 5% (1) 32% (6) 26% (5) 66 Best at providing benefits

Q7: Which of the following areas of the current NRC preliminary language and approaches in Part 53 provide significant benefits over Parts 50 and 52?

67 Key Insights from Comments 1.

Two-Frameworks (A and B) a)

Some believe multiple frameworks make little sense, and a single framework that utilizes guidance for details for different approaches would be more appropriate.

b)

Some are in favor of using Framework B instead of Framework A, but not as written (likely referring to Part 5X that is expected to be basis for Framework B).

2.

Facility Safety Program a)

This program is untested so it is tough to know what the burden or value will be.

b)

Some believe licensee-led, industry-overseen framework for oversight of facility programmatic matters has some potential benefits in reducing regulatory burden without impacting safety; however, it is not clear that current NRC language will actually achieve greater efficiency.

3.

Exemptions - Some believe what may be required to meet Part 53 is uncertain, and there was suggestion to leverage the Technology Inclusive Risk-Informed Configuration Evaluation (TIRICE) effort to develop 50.59-like process with clear performance criteria (53.895 was viewed as never-ending risk reduction measures).

Q8: How concerned are you about the following areas of the current NRC preliminary language and approaches in Part 53? (score 0 to 5, with 5 being the most concerned)

Answered: 20 Skipped: 2 Part 53 Content Most (4 or 5)

Least (0 or 1)

Dont Know Expanding ALARA to be a design requirement 68% (13) 0% (0) 5% (1)

Proliferation of duplicative and unnecessary programs 68% (13) 0% (0) 5% (1)

Increased regulatory burden for non-safety SSCs 67% (12) 11% (2) 6% (1)

Safety objectives that are different than those in the Atomic Energy Act 63% (12) 0% (0) 11% (2)

Expansion of design basis to include Beyond Design Basis Events 61% (11) 11% (2) 6% (1)

Lack of clarity in the purpose and application of some requirements 58% (11) 0% (0) 5% (1)

Lack of clear measurable goals for regulatory efficiency 50% (10) 5% (1) 15% (3)

Missed opportunity to integrate safety, security, EP and siting 50% (10) 6% (1) 20% (4)

Facility safety program 50% (9) 0% (0) 17% (3)

Inclusion of QHOs in the Rule, rather than keeping as a Policy 50% (9) 11% (2) 6% (1)

Lack of consistency in use of regulatory terminology (e.g., PDC vs FDC) 44% (8) 5% (1) 17% (3)

Lack of clarity on the safety paradigm 39% (7) 0% (0) 28% (5)

Only allowing an enhanced/leading use of PRA licensing approach 28% (5) 17% (3) 17% (3)

Two distinct frameworks (A and B) in the rule based on role of PRA 28% (5) 22% (4) 17% (3) 68 Greatest concerns

Q8: How concerned are you about the following areas of the current NRC preliminary language and approaches in Part 53?

69 Key Insights from Comments

1. Some believed it is difficult to measure the efficiency of Part 53 without working examples, and it is a judgment call at this point.

2. Some believed Part 53 efficiency needs to be considered for licensing of fleets of the same design, and not just licensing of design the first time.

3. Some believed efficiency should be considered for international deployments, e.g.,

alignment with IAEA language and guidance would make it more efficient to export designs approved by the NRC.

4. Some believe NRC has integrated safety, security, EP and siting too much, and scaling back to a Part 53 that simply removes LWR-specific requirements from Parts 50 and 52 would have been (and perhaps still could be) a more useful rule.

Q9: Which of the following innovations that the NRC is not pursuing would greatly enhance the value of Part 53? (score 0 to 5, with 5 being the most beneficial Answered: 21 Skipped: 1 Part 53 Content Most (4 or 5)

Least (0 or 1)

Dont Know Streamlining of licensing reviews and regulatory approvals 79% (15) 0% (0) 5% (1)

Streamlining of program requirements 68% (13) 0% (0) 5% (1)

Treating ALARA as a Policy rather than requirements in the Rule 67% (14) 0% (0) 10% (2)

Streamlining of oversight and inspections 65% (13) 0% (0) 10% (2)

More performance-based and modern siting requirements 60% (12) 0% (0) 10% (2)

Integrating safety, security, emergency planning and siting 57% (12) 9% (2) 5% (1)

QA requirements that explicitly allow ISO-9001 for safety-related 52% (11) 0% (0) 10% (2) 70

Q9: Which of the following innovations that the NRC is not pursuing would greatly enhance the value of Part 53?

71 Key Insights from Comments

1. Streamlining of licensing reviews and approvals - Some believe NRC should include measurable improvements in schedule and costs.

2. Performance-based and Risk-informed - Some believe many requirements remain deterministic, e.g., Human Factors Engineering (which is the same whether or not the plant has risk-significant operator actions or not).

3. Oversight and inspections - Some noted concern that NRC has not even developed initial framework for advanced reactor oversight for Parts 50 and 52.

Q10: Which of the following Framework A approaches and preliminary rule language should, and should not, be incorporated into Framework B (Traditional use of PRA, and No use of PRA options)?

Answered: 13 Skipped: 9 Part 53 Content Include in Framework B Do Not Include Increased functionality for Manufacturing Licenses 92% (11) 8% (1)

Organization and structure of the rule (e.g., separation of design, analysis, operations, etc.)

90% (9) 10% (1)

Technology-inclusive requirements (e.g., safety functions, design criteria, design features) 85% (11) 15% (2)

Increased use of performance-based approach for Security 85% (11) 15% (2)

Increased use of performance-based approach for Fitness for Duty 83% (10) 17% (2)

Increased use of performance-based approach for Operators (e.g., certified option) 75% (9) 25% (3)

Facility safety program 25% (3) 75% (9)

Expanding the design basis to include Beyond Design Basis Events 17% (2) 83% (10)

Proliferation of duplicative and unnecessary programs 15% (2) 85% (11)

Inclusion of Quantified Health Objectives in the Rule, rather than keeping as a Policy 15% (2) 85% (11)

Safety objectives that are different than those in the Atomic Energy Act 9% (1) 91% (10)

Increased regulatory burden for non-safety structures, systems and components (e.g.,

programmatic controls similar to those needed for safety-related SSCs) 0% (0) 100% (13) 72

Q10: Which of the following Framework A approaches and preliminary rule language should, and should not, be incorporated into Framework B?

73 Key Insights from Comments

1. Some believe Framework B should share the performance-based technology-inclusive requirements of Framework A (e.g., safety functions, design criteria, design features)

2. Some believe additional requirements may need to be made performance-based technology-inclusive, and that there may need to be more consideration on how all requirements are technology-inclusive from a size perspective, not just from coolant perspective (e.g., Aircraft Impact Assessment and maintenance rule).

3. Some believe that the kinds of information may be similar regardless of reactor design (e.g., ranging from micro to large), but there should be graded approach to scope of such information in safety analyses, programs, etc.

4. Some potential owner/operators believed that licensing framework (either A or B) is not their concern, but is the concern for the designer/developer.

Q11: If you use Part 53, which type of licensing approach would you most likely use?

Answered: 221 Skipped: 0 0

2 4

6 8

10 12 No PRA (e.g., Technology Inclusive Risk Informed Maximum Accident)

Maximum Credible Accident with a confirmatory PRA IAEA approach Traditional PRA (e.g., similar to use in Part 52)

Enhanced/leading Probabilistic Risk Assessment (e.g., Licensing Modernization Project)

Notes

• If Part 53 used, 46% (10 of 22) of respondents plan to use what NRC defines as an enhanced role of the PRA

• 36% (3+1+4=8) of respondents plan to use PRA in a way not permissible by current Framework A rule text

• Of remaining 18% (4 of 22), two do not plan to use Part 53, one does not care which approach is used, and one did not identify which approach (though they did say they are using a PRA) 74

1) Four responses were Other, as described in side bar above.

Q11: If you use Part 53, which type of licensing approach would you most likely use?

75 Key Insights from Comments

1. In terms of licensing, some believe that there is no fundamental difference among (1) enhanced PRA, (2) traditional PRA, and (3) IAEA.

a) Identified that NRC has approved topical report for the implementation of NEI 18-04 that would not meet the NRCs definition/requirements for enhanced/leading PRA in Part 53.

b) This seems to align with perspectives that Part 53 should be a single framework that allows range of uses of the PRA by focusing rule on performance criteria of the design, and utilizing guidance to focus on methods of evaluation (i.e., role and use of the PRA).

Q12: In achieving a similar level of safety, the overall efficiency of the current NRC Part 53 preliminary rule language, as compared to Parts 50 and 52, is:

Answered: 17 Skipped: 5 0

1 2

3 4

5 6

7 8

9 10 Less efficient About the same efficiency More efficient Much more efficient 76

Q12: In achieving a similar level of safety, the overall efficiency of the current NRC Part 53 preliminary rule language, as compared to Parts 50 and 52, is:

77 Key Insights from Comments 1.

Specific areas where respondents see reductions to efficiency.

a)

Some expressed concerns that while the safety objectives are performance-based, Part 53 imposes extensive burden on demonstrating compliance and corresponding NRC reviews, as well as through requirements for additional duplicative programs.

b)

Some questioned why Part 53 increases regulatory burden (to achieve similar level of safety) when designs being developed have much higher safety margins than plants previously approved by NRC.

c)

Some believe that neither Framework A or B will be more efficient for the first review of a design.

2.

Specific areas where respondents see improvements to efficiency.

a)

Some appreciate Part 53 efficiency in obtaining a design certification after receiving operating license.

3.

Measuring efficiency overall is difficult.

a)

Some see reductions in burden in some areas, but significant increases in burden in other areas.

b)

Some suggested getting experience with proposed rule through table tops in order to better understand whether it will be efficient.

4.

Some believe Parts 50 and 52 are currently very inefficient in achieving current level of safety, and that there was great hope that NRC would have addressed those inefficiencies in Part 53. (See Question 9 for more details)

Q13: How well do you think the NRC has met the following goals, so far, for the Part 53 rulemaking? (score 0 to 5, with 5 being the most fulfilled)

Answered: 18 Skipped: 4 Part 53 Content Most (4 or 5)

Least (0 or 1)

Dont Know Continue to provide reasonable assurance of adequate protection (SECY 20-0032)1 78% (14) 0% (0) 11% (2)

Establish requirements that address non-LWRs (SECY 20-0032) 50% (9) 0% (0) 17% (3)

Safety Focused (industry goal) 44% (8) 0% (0) 17% (3)

Technology-inclusive (July 2021 Unified Industry Position letter) 44% (8) 0% (0) 17% (3)

Risk-informed (July 2021 Unified Industry Position letter) 33% (6) 6% (1) 22% (4)

Reduce requests for exemptions (SECY 20-0032) 33% (6) 17% (3) 28% (5)

Recognize technological advancements in reactor design (SECY 20-0032) 33% (6) 22% (4) 22% (4)

Credit the response of advanced reactors to postulated accidents (SECY 20-0032) 28% (5) 17% (3) 22% (4)

Flexible (industry goal) 22% (4) 11% (2) 17% (3)

Goals that are most met by current preliminary Part 53 rule language 78

1) Other comments expressed concern that the NRC has increased standards and regulations for public protection (e.g., Beyond Design Basis, ALARA, Programs) - see Q8.

Note: Many key goals (e.g. technology-inclusive, risk-informed & reduced exemption requests, flexible) received low scores (less than half 4 or 5) indicating key goals have not been demonstrated

Q13: How well do you think the NRC has met the following goals, so far, for the Part 53 rulemaking? (score 0 to 5, with 5 being the most fulfilled)

Answered: 18 Skipped: 4 Part 53 Content Most (4 or 5)

Least (0 or 1)

Dont Know Efficiency (July 2021 Unified Industry Position letter) 11% (2) 39% (7) 22% (4)

Promote regulatory stability, predictability and clarity (SECY 20-0032) 22% (4) 28% (5) 22% (4)

Clear (industry goal) 5% (1) 22% (4) 11% (2)

Usefulness (July 2021 Unified Industry Position letter) 11% (2) 22% (4) 22% (4)

Recognize confidence in licensee controls (July 2021 Unified Industry Position letter) 0% (0) 17% (3) 28% (5)

Requirements at a high level with utilization of guidance to address details (SRM-SECY-20-0032-ML19340A056) 17% (3) 17% (3) 28% (5)

Regulatory framework using methods of evaluation that are flexible and practicable for application to a variety of technologies (NEIMA) 11% (2) 11% (2) 11% (2)

Goals that are least met by current preliminary Part 53 rule language 79 Worst at meeting goals Note: Many key goals (e.g. clear, efficient, useful) received very low scores (less than 20% 4 or 5, and many 0 or 1) indicating key goals have not been demonstrated

Q13: How well do you think the NRC has met the following goals, so far, for the Part 53 rulemaking?

80 Key Insights from Comments

1. Flexibility a) Some believe that a Part 53 rule with a single framework that allows for a variety of methodologies (with details for methods addressed in guidance) would be more flexible.

b) Some understand purpose of the two framework approach is to increase flexibility; however, they believe the two-framework solution is compensating for a reduction in flexibility - compared to Parts 50 and 52 - in the original Part 53 (now Framework A) by only allowing a binary set of licensing approaches.

Q14: How satisfied are you with the NRC engagement with stakeholders on Part 53? (score 0 to 5, with 5 being the most satisfied)

Answered: 21 Skipped: 1 0

1 2

3 4

5 6

7 8

9 10 Prompt and clear rationale provided by the NRC for proposed approaches Opportunities offered by NRC to inform and comment on the proposed rule language NRCs feedback in response to industry comments is prompt, clear and rational NRC is receptive to modify approaches based upon stakeholder comments 0

1 2

3 4

5 NRC Engagement Satisfaction1 NRC Rationale for approaches

• High (score 4 or 5) = 5

• Moderate (2 or 3) = 12

• Low (0 or 1) = 2 Opportunities offered to inform/comment

• High (4 or 5) = 11

• Moderate (2 or 3) = 7

• Low (0 or 1) = 1 NRC Feedback on industry comments

• High (4 or 5) = 3

• Moderate (2 or 3) = 7

• Low (0 or 1) = 8 NRC Receptivity to Input

• High (4 or 5) = 3

• Moderate (2 or 3) =11

• Low (0 or 1) = 5 81 Score:

3 Score:

3 Score:

3 Score:

3 Lukewarm satisfaction Lukewarm satisfaction High satisfaction

1) Not shown are three Dont Know responses. Percentages are of those providing responses other than Dont Know/skip.

Low satisfaction

Q14: How satisfied are you with the NRC engagement with stakeholders on Part 53?

82 Key Insights

1. Many did not feel NRC is receptive to making changes to address feedback.

a) NRC has said that they will not respond to or resolve comments.

b) NRC appears open to receiving comments, but has made few changes (e.g.,

incorporation of non risk-based approach) in the draft language to address them.

c) NRC has not addressed some feedback (e.g., QHOs in the rule rather than as policy), and there should be an expectation that the NRC provides detailed reasons they arent addressing feedback that has consistently expressed significant concerns.

2. Many believe sharing NRC draft rule text early in the process is useful in helping potential users of a new rule to fully understand and comprehend potential improvements or challenges with the rule (e.g., in order to assess whether it is potentially relevant to their business/deployment plans).

83 Q15: Other comments on Part 53 Key Insights from Comments 1.

Some identified concerns that NRCs language does not achieve the goals of NEIMA for efficiently regulating advanced reactors, so that they can be a solution for climate change.

a)

Part 53 needs to give more consideration to efficient licensing of dozens of plants with a standardized design, and not just efficiency of licensing a design once.

b)

For applicant using NEI 18-04 licensing approach, Part 53 does not seem onerous, but it also does not appear to have clear gains in regulatory efficiency for licensing and regulation of advanced reactors.

2.

Some had suggestions for improvements a)

Even if Part 53 rule language addresses concerns, NRC still needs to implement an efficient licensing process.

b)

NRC should minimize burden of additional requirements of utilizing Part 53 in comparison to Parts 50 and 52, such as requirements for ALARA and the Facility Safety Program.

c)

Ensure IAEA approach is an integrated option (currently it appears to be secondary consideration in Framework B).

3.

In rules current state, it is unclear how to assess value of Framework B (only Part 5X has been released); however, this language is interesting for cases where maximum hypothetical/credible approach may be used.

4.

There was suggestion for NRCs next steps:

a)

The NRC needs to (1) issue rule language, (2) entertain and resolve industry comments, and (3) support one or two applicants with different designs in use of Part 53 to establish precedents. This exercise must be free or a reasonable (nominal) charge to the applicant.

84 Topic Analysis: QHOs in the Rule (1 of 3)

For Q7, four respondents with score 4 or 5 for significant benefits of including QHOs in Framework A:

Plans to use Framework A Plans to submit Type of application Type of applicant First Choice No plans to submit Enhanced PRA Owner/operator and design/developer Not sure Expect to submit applications by 2025 Traditional PRA Owner/operator and design/developer Will likely not use because Part 53 is not timely Expect to submit applications by 2025 Enhanced PRA Owner/operator and design/developer Little confidence Part 53 will be effective by 2025 Expect to submit applications by 2025 No preference on use of PRA Owner/operator only

85 Topic Analysis: QHOs in the Rule (2 of 3)

For Q7, nine respondents with score of 0 or 1 with no or very limited benefits of including QHOs in Framework A:

Plans to use Framework A Plans to submit Type of application Type of applicant First choice Expect to submit applications by 2025 MCA with PRA Designer only Likely to use In pre-application MCA with PRA Designer only Likely to use No plans to submit Enhanced PRA Designer only May use Expect to submit applications by 2025 Enhanced PRA Owner and designer May use Expect to submit applications by 2025 Enhanced PRA Designer only May use Expect to submit applications by 2025 IAEA Approach Designer only May use Submitted RIS response MCA with PRA Designer only Not likely to use Expect to submit applications by 2025 MCA with PRA Owner and designer Not likely to use In pre-application Will use PRA but did not specify which approach Owner and designer

86 Topic Analysis: QHOs in the Rule (3 of 3)

Key Takeaways

1. Very few (4) want QHOs in the rule, and of those a) Only 1 plans to use Framework A b) Only 2 plan to use enhanced PRA approach

2. Many (9) do not want QHOs in the rule, and of those a) Most (7 of 9) are likely to use, or considering using, Framework A b) All plan to use PRA, and 3 plan to use enhanced PRA

3. Perspective on QHOs in the rule does not have statistical dependence on whether they are owner/operator or designer/developer

87 Comparison of 2022 Part 53 Industry Survey to 2021 Part 53 Industry Survey Scope 2022 NEI/USNIC: 16 developer/designers (6 also owner/operators) and 6 only owner/operators 2021 USNIC: 22 developer/designers (some also owner/operators)

Similarities Mostly dissatisfied with Part 53 language; some somewhat satisfied (slight improvement vs. 2021) 35-40% plan on using significant PRA input (similar to LMP/Framework A); majority do not Most (2/3) oppose QHO in rule Differences 2022 survey has quantitative assessments of benefits and concerns (similar benefits/concerns vs. 2021 survey but 2022 survey quantified concerns like expanding ALARA as design requirement)

Concluding High Level Insights (1 of 2)

Comprehensive survey 12 owner/ operator responses and 10 designer/developer only responses Key active organizations provided responses-- 15 of 22 respondents have submitted application to NRC, are pre-app with NRC, or submitted RIS response to NRC Support for, and interest in using, Part 53 is directly related to perceptions of whether Part 53 will be more efficient than Parts 50 and 52 in achieving same level of safety Strong support for NEI/USNIC comments is consistent with some support for NRC Part 53 rule language; NEI/USNIC comments supported some NRC approaches but presented significant concerns overall Ten Part 53 items create significant concerns (e.g. expanding ALARA to be design requirement, proliferation of unnecessary programs, increased regulatory burden for non-safety SSCs, and safety objectives different than in AEA)

Four Part 53 items have benefits (e.g. increased use of performance-based approaches for security, and technology-inclusive requirements) 88

Concluding High Level Insights (2 of 2)

Innovations needed included streamlining of licensing reviews, regulatory approvals and program requirements Input provided to assist NRC in determining what in Framework A should-- and should not-- be included in Framework B (Industry still prefers a single flexible framework)

Diversity in use of PRA and type of licensing approach to be used Most do not want QHOs in the rule (3 are likely to use and 4 may use Framework A); very few want QHOs in rule (1 likely to use Framework A and 1 undecided) - all plan to use PRA Many goals for Part 53 are not met by current language, but some goals are met Not met: Improving regulatory efficiency, predictability, stability, clarity, and flexibility Part 53 development and review is time-consuming process, but only limited support for current language, and many areas where improvements needed to address concerns Lukewarm satisfaction for NRC rationale for proposed approaches and receptivity to stakeholder response High satisfaction with opportunity to comment, but low satisfaction on NRCs feedback to industry 89

90 Nuclear Energy Institute and U.S. Nuclear Industry Council 2022 Part 53 Survey For questions contact Cyril W. Draffin, Jr.

Senior Fellow, Advanced Nuclear, U.S. Nuclear Industry Council Cyril.Draffin@usnic.org Marcus Nichol Senior Director, New Reactors Nuclear Energy Institute mrn@nei.org

Appendix:

Selective Part 53 Slides from Results of U.S. Nuclear Industry Council 2021 Advanced Nuclear Survey (presented at 26 August 2021 NRC Advanced Reactor Stakeholder Meeting) 91

2021: Advanced Nuclear Developers Completing 2021 USNIC Advanced Nuclear Anonymous Survey l U.S. Nuclear Industry Council 2021 Advanced Nuclear Survey Advanced Reactor Developers: USNIC members (17)

Advanced Reactor Concepts BWXT Centrus Framatome Inc.

GE Hitachi Nuclear Energy General Atomics Kairos Power, Inc Lightbridge MUONS Inc.

NuScale Power Oklo Inc.

TerraPower Terrestrial Energy Ultra Safe Nuclear Corporation URENCO (U-Battery)

Westinghouse Electric Company X-energy Advanced Reactor Developers: Non USNIC members (7)

(Part 53 only)

Columbia Basin Consulting Group Flibe Energy Holtec Hybrid Power Technologies MIT (HTGR)

Southern Company (molten chloride reactor)

Thorcon Note: This is comprehensive survey with large sample size of US developers:

All answers include 100% (1 company, Oklo) in NRC licensing review, 100% (2 companies, X-Energy & TerraPower) with DOE ARDP Demo awards, 60% (3 of 5 companies) with DOE risk reduction awards, and over 80% (5 of 6 companies) of microreactor developers For Part 53 questions, survey includes 100% of DOE ARDP Demo, Risk Reduction, and ARC-20 awardees (all 10 organizations). Also, USNIC member and non-USNIC member organizations representing 75% (21 of the 28) non-Light Water Reactor (LWR) designs responded to survey, as well as LWR Small Modular Reactors companies (e.g. NuScale).

92

Excellent, one of the best draft regulations Very satisfied, comprehensive and useful Somewhat satisfied, needs improvement in a few locations Somewhat dissatisfied, substantial changes are necessary Very dissatisfied, not useful with only limited improvement of current Part 50 and 52 Not helpful at all so far 2021 Q7: How satisfied are you with the usefulness of Part 53 based on current (ML21148A062) language and explanations provided by NRC 0%

0%

41%

36%

5%

18%

USNIC & non USNIC members 59%

l U.S. Nuclear Industry Council 2021 Advanced Nuclear Survey 0

0 9

8 1

4 22 organizations 93

94 2021 Q8: Comment on Part 53 issues - PRA We plan on using significant PRA input (similar to LMP) 35%

We plan on using medium PRA input (similar to existing regulatory framework) 24%

We plan on using minor PRA input (similar to maximum credible accident approach) 29%

We plan on taking another licensing methodology approach 12%

Note: (a) Only 35% plan on using significant PRA input; 65% plan to use medium/minor/no PRA input.

(b) Parenthetical similarities present an example-a developer using LMP may use PRA consistent with existing regulatory framework in terms of what goes into the application.

(c) Future discussion will be required as NRC presents Graded PRA approach, recognizing only a minimal PRA may be appropriate at the Construction Phase.

USNIC & non USNIC members 94 l U.S. Nuclear Industry Council 2021 Advanced Nuclear Survey 6

4 5

2 17

95 2021 Q8: Comment on Part 53 issues - QHO in rule Comments:

• Include quantitative health objectives only if guidance is available to demonstrate how to meet and is only an initial licensing requirement

• Subpart H is of interest to our company to expand the available options for phased/progressive licensing of designs and projects

• What we plan to do in near-term implementation should not be driver for content of the rule if it is going to make it prescriptive for all technologies USNIC & non USNIC members Yes, Include quantitative health objectives 36%

No, do not include quantitative health objectives 64%

95 l U.S. Nuclear Industry Council 2021 Advanced Nuclear Survey 5

9 14

96 NuScale Lessons Learned (Omid Tabatabai-Yazdi)

Periodic Advanced Reactor Stakeholder Meeting NRC Staffs Lessons Learned from the Review of NuScale Design Certification Application Omid Tabatabai May 11, 2022 97

Presentation Topics

• Background

• Best Practices

• Challenges during the Review

• Recommendations for Future Applicants

• Recommendations for the NRC Staff

• NuScale Letter to NRC - Recommendations for the NRC Staff

• NEI Letter to NRC - Recommendations for the NRC Staff

• Questions/Comments 98 98

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Background===

In August 2020, staff completed its safety and environmental reviews of NuScale DCA and met the established public 42-month schedule (ahead of schedule by two weeks).

In November 2020, NRR kicked off a lessons learned effort to identify (1) best practices, (2) areas for improvement, and (3) recommendations for improving future new reactor licensing reviews.

Overall, the Staffs Lessons Learned Report (ML22088A161) found that the staff conducted the review in accordance with the NRCs Principles of Good Regulation, however, there are opportunities for continuous improvement.

The lessons learned report is a proactive and forward-looking document that the staff intends to utilize in review of future applications.

99 99

Best Practices

1. Strong pre-application engagements

2. Focus on highly challenging issues

3. Continue to streamline the process for SERs

4. Encourage applicants to identify unique areas of the design that deviate from traditional compliance approaches (e.g., Regulatory Gap Analysis)

5. Use of topical reports for novel design features

6. Use risk-informed approaches to facilitate reaching safety determinations.

7. Disciplined approach to issuing RAIs

8. Increased use of technology to facilitate more efficient development SER

9. Conduct NRC staff audits in areas involving FOAK design features and use of eRR

10. Early NRC senior management review of SER

11. ACRSs focus on reviewing only risk-significant and novel design attributes

12. Continuity of the technical, project, and legal reviewers 100 100

Challenges during the Review Most significant review challenges, and areas for improvement, fell into the following four overarching categories:

1.

Design finalization at application and changes during licensing 2.

Holistic risk-informed review strategy 3.

RAIs/audit enhancements 4.

Schedule/resource management 101 101

Recommendations for Future Applicants

1. At the beginning of the licensing review, applicants should identify all design aspects that are still undergoing finalization, testing, or analysis or that are otherwise subject to change, especially if these deviate from discussions between the applicant and the NRC during preapplication meetings.

2. At the beginning of a licensing review, and potentially during preapplication, the applicant should prepare and present to the NRC staff its approach to performing its risk assessment and the key conclusions. This should include sufficient detail and completeness for the NRC staff to reach early conclusions on the relative risk significance of various aspects of the design.

3. Applicants should review NRC RAIs and audit plans and promptly raise any concerns and request clarification calls as necessary. Additionally, applicants should meet commitments for RAI responses and communicate any anticipated delays early. Applicants should acknowledge the impact of delays on the review schedule and resources.

102 102

Recommendations for NRC Staff

1. Establish an interdisciplinary review team to prioritize early engagement and dedicate resources to timely decision making on the applicants risk insights. Additionally, the NRC should use this information to conduct an integrated and holistic review of the design, develop schedules, and allocate resources.

2. Evaluate the information provided by the applicant to ensure schedules and resources are appropriately allocated. Conduct an early assessment of the potential risk-significance of these areas and discuss with the applicant any potential impacts on schedules or resources.

3. Ensure that RAIs and audits conform to NRC guidance and assess whether there are more efficient means to gather the information.

4. Continue to achieve safety through transformative efforts in how we plan, schedule, and manage resources. Be transparent with applicants on performance, including identifying early any challenges to meeting our goals whether as a result of applicant decisions (e.g.,

design changes) or NRC performance.

103 103

NuScale Letter to NRC - Recommendations for the NRC Staff NuScale - Letter dated February 19, 2021 (ML21050A431)

Establish an appeal process to resolve disagreements between applicants and the NRC staff with respect to preliminary interpretations of requirements and guidance. (The staff does not agree)

Implement risk-informed decisionmaking consistent with SRM SECY 19-0036.

(The staff agrees)

Define credible. (The staff partially agrees)

Rely on downstream requirements (App. B, ITAAC, ASME Code, etc.) as part of NRC safety findings (The staff partially agrees)

Clarify the role of the ACRS (The staff partially agrees) 104 104

NEI Letter to NRC - Recommendations for the NRC Staff NEI - Letter dated June 9, 2021 (ML21160A246)

Establish More Reasonable Review Duration and Cost Targets (The staff agrees)

Improving Efficiency in the Review Process (The staff agrees)

Realign on the appropriate level of detail and content of applications (The staff agrees)

Implement a clearly defined appeal process (The staff does not agree)

Open communication and alignment on project scope and plan (The staff agrees)

Reinforce audit best practices (The staff agrees)

Clarify the Role of the ACRS (The staff partially agrees) 105 105

QUESTIONS/COMMENTS?

106 106

107 Development of 50.59 guidance (Michael Tschiltz)

108 May 11, 2022 Mike Tschiltz, Project Team Leader, Consultant to Southern Company Steve Nesbit, LMNT Consulting, Lead for White Paper Justin Wheat, Enercon, Lead for Tabletop Exercises NRC Advanced Reactor Stakeholder Meeting Technology - Inclusive Risk - Informed Change Evaluation (TIRICE)

109 109 Topics

- Project Overview, Objectives and Schedule

- Options for the implementation of the guidance

- Overview of White Paper

- TIRICE Process for 10 CFR 50.59 Change Evaluation

- Outline of White Paper

- Issues for Discussion

- Table Top Exercises

- Questions Meeting Agenda

110 110 Project Overview, Objectives and Schedule Overview Phase 3, (TIRICE portion) of the utility led Licensing Modernization Project (LMP), is intended to build upon the work accomplished by the prior LMP activities (Phase 1, NEI 18-04 and TICAP Phase 2, NEI 21-07) to create guidance for evaluating changes to the facility as described in the UFSAR for those licensees that have used LMP (NEI 18-04 and NEI 21-07).

Advanced non-LWRs may elect to follow NEI 18-04 for selection of licensing basis events; safety classification of structures, systems, and components and associated special treatments; and determination of Defense-in-Depth (DID) adequacy.

The resulting LMP-based affirmative safety case is substantially different from the traditional deterministic, compliance-based safety cases in place for LWRs licensed by the NRC.

During development of TICAP guidance it became clear that there is a need to develop technology-inclusive, risk-informed guidance for evaluating changes to a facility as described in the Updated Final Safety Analysis Report (UFSAR) (10 CFR 50.59).

The attributes of the LMP-based affirmative safety case require additional guidance for efficient application of 10 CFR 50.59 or alternative change evaluation process.

111 111 Project will develop guidance for implementation of change evaluation for Advanced Non-LWRs that are licensed under 10 CFR Part 50 or 52 that utilize NEI 18-04 to develop safety case and NEI 21-07 guidance to determine application content.

The objectives of the guidance include:

• Provide regulatory confidence that the threshold for prior regulatory review and approval of changes will be effectively established and efficiently managed;

• Minimize the unnecessary burden to the regulator and operators for determining if changes require a license amendment; and

• Establish a clear understanding and process for how the criteria for making changes without prior NRC approval may be met.

Project Overview, Objectives and schedule

112 112 Schedule Develop guidance to be endorsed by NRC Draft document to be provided for the NRC for review in August 22 NRC review and endorsement FY23 Project Plan developed and Project Team established (Dec-Jan 22)

Scope and Process papers (Feb-Mar 22)

Utilized as inputs to white paper White Paper (Apr-June 22) x Identify specific steps to be performed during the change evaluation process x

Summarize efforts to date and obtain ARRTF feedback (April 25 - May 2) x Provide draft white paper to NRC for review (May 6) x Meeting with NRC to describe white paper content (May 11)

NRC comments (May 20)

Meeting to discuss comments and proposed responses ( TBD)

Revise White Paper and use to conduct Table Top exercises Project Overview, Objectives and Schedule

113 113 Schedule (cont.):

Develop Table Top Guidelines and Objectives (Apr-June 22)

Develop Annotated Outline for Guidance (Apr - Jun)

Conduct Tabletop Exercises (Jun - Jul)

• Conduct Table Tops with 2 Advanced Reactor Developers

• Develop Lessons Learned and incorporate into white paper revision Develop Southern Co. guidance document (Jul - Aug)

Convert to NEI document and submit for formal NRC review and endorsement (FY 23)

Project Overview, Objectives and Schedule

114 114 There are 2 options being considered for implementing this guidance.

Option 1: Develop a process and associated guidance, for an advanced non-LWR that has utilized NEI 18-04 and NEI 21-07, for evaluating if a proposed change, test or experiment requires prior NRC approval via license amendment under 10 CFR 50.90.

This process is envisioned to be implemented via: 1) a license condition to incorporate by reference the guidance that will be approved by the NRC and 2) an exemption to 10 CFR 50.59 to ensure clarity that 10 CFR 50.59 does not apply.

Option 2: Develop the same process and proposed guidance and use it with endorsement by the NRC that it is an acceptable means of implementing 10 CFR 50.59 Options for the implementation of the guidance

115 115 Overview of the White Paper

• Goal: Document the proposed approach to change control guidance in order to

- Facilitate socialization with industry

- Obtain feedback from NRC

- Support tabletop exercises

• Approach: Build off of existing 10 CFR 50.59 guidance in NEI 96-07 by addressing differences for an advanced non-LWR following NEI 18-04 (Licensing Modernization Project or LMP)

- Retain and use as much of the NEI 96-07 structure and guidance as possible

- Focus on areas in which NEI 18-04 and NEI 21-07 enable focused and efficient approaches to change control

- Guidance can be tailored to either implementation option

116 116 TIRICE Process for 10 CFR 50.59 Change Evaluation

117 117 TIRICE Process for 10 CFR 50.59 Change Evaluation (cont.)

118 118 Outline of the White Paper

• Chapter 1: Introduction (including background)

• Chapter 2: Addresses NEI 96-07 Chapters 1-3 (Introduction, Defense-in-Depth Philosophy, and Definitions)

• Chapter 3: Addresses NEI 96-07 Chapter 4 (Implementation Guidance) with specific sections on

- Applicability

- Screening

- Evaluation

• Chapter 4: Addresses NEI 96-07 Chapter 5 (Documentation and Reporting)

• Chapter 5: Summary

119 119 Issues for Discussion

• Treatment of NEI 18-04 licensing basis events (LBEs) as accidents evaluated in the SAR

- Includes anticipated operational occurrences (AOOs), design basis events (DBEs), beyond design basis events (BDBEs), and design basis accidents (DBAs)

• Treatment of NEI 18-04 Required Safety Functions as design bases functions

• Treatment of NEI 18-04 Required Safety Functions, risk-significant functions, and safety functions required for adequate DID as design functions

• Treatment of NEI 18-04 safety related and non-safety-related with special treatment (NSRST) structures, systems and components (SSCs) as important to safety SSCs

• Use of specific NEI 21-07 SAR sections to identify functions and SSCs

120 120 Issues for Discussion (cont.)

• Applicability

- Changes to the probabilistic risk assessment (PRA) not subject to 10 CFR 50.59 but addressed by non-LWR PRA Standard

>> Changes to methods of evaluation for AOOs, DBEs, and BDBEs are part of the PRA and therefore not subject to 10 CFR 50.59

- Changes to state of knowledge not subject to 10 CFR 50.59

>> Potential for changes to state of knowledge from operating experience, experimental data, testing, etc., may be greater for first non-LWR advanced reactors than current LWRs

• Screening

- Changes to the facility or procedures that render a safety-significant SSC unable to meet its reliability or capability targets would screen in for an evaluation

121 121 Issues for Discussion (cont.)

• Evaluation (general)

- Current eight criteria in 10 CFR 50.59 are tailored for typical LWR deterministic safety case based on general design criteria

>>Not ideally suited for a reactor with an LMP-based affirmative safety case

- 10 CFR 50.59 criteria sorted in to three categories

>>Accidents

>>SSCs

>>Methods of evaluation

- General structure and wording of current 10 CFR 50.59 criteria retained to the extent practical

- White paper proposes six LMP 50.59 criteria to be used instead of current eight 10 CFR 50.59 criteria

122 122 Issues for Discussion (cont.)

Accident criteria (10 CFR 50.59 criteria i, iii, and v) a)

Result in a change to the frequency or consequences of one or more AOOs, DBEs, or BDBEs documented in the final safety analysis report (as updated) in a manner that would exceed the NEI 18-04 Frequency-Consequence Target or change an LBE from non-risk significant to risk significant according to NEI 18-04 LBE risk significance criteria.

b)

Result in more than a minimal increase in the consequence of a Design Basis Accident documented in the final safety analysis report (as updated).

c)

Result in one or more an AOO, DBE, or BDBE that is (i) not previously evaluated in the UFSAR and (ii) classified as risk significant according to NEI 18-04 LBE risk significance criteria.

123 123 Issues for Discussion (cont.)

SSC Criteria (10 CFR 50.59 criteria ii, iv, vi, and vii) d)

Result in an increase in the frequency or consequences of a malfunction of any safety-significant SSC that would change the classification of the SSC from non-risk significant to risk-significant.

e)

Result in an increase in the frequency or consequences of a malfunction of a safety-significant SSC that would have a more than minimal adverse effect on defense-in-depth adequacy or lead to a change in safety classification from NST to NSRST to maintain adequate defense-in-depth.

124 124 Issues for Discussion (cont.)

SSC Criteria (10 CFR 50.59 criteria ii, iv, vi, and vii) (cont.)

- LMP 50.59 Defense-in-Depth (DID) criterion (e) focuses on NEI 21-07 documentation of Integrated DID (plant capability and programmatic DID) in SAR Section 4.2.3

>>Criterion is that more than minimal adverse effect on DID adequacy requires a license amendment

>>Expectation is that licensee will establish guidelines for more than minimal during the development and documentation of the LMP affirmative safety case, in the SAR or plant records

125 125 Issues for Discussion (cont.)

• SSC Criteria (10 CFR 50.59 criteria ii, iv, vi, and vii) (cont.)

- No LMP 50.59 criteria correspond directly to fission product barrier design limits (10 CFR 50.59 criterion vii)

- LMP safety case - including the DID approach - is fundamentally different from LWR general design criteria-based approach to DID

>>Three barrier fission product barrier DID model is specific to LWR technology and may not apply to other designs

>>With LMP, impacts of changes on all safety-significant SSCs (not just fission product barriers) and DID are addressed by LMP 50.59 criteria (d) and (e).

>>A traditional LWR fission product barrier may be classified as a safety-related or NSRST SSC but such SSCs are not elevated above other SSCs

126 126 Issues for Discussion (cont.)

• Method of Evaluation Criterion (10 CFR 50.59 criterion viii) f)

Result in a departure from a method of evaluation described in the FSAR (as updated) used in establishing the design bases or in the safety analyses, with the exception of LBE evaluation methods under the change control of the Non-LWR PRA Standard.

- This wording is equivalent to current 10 CFR 50.59 criterion (viii) for design basis accidents except that

>>Those LBE evaluations (and associated methods) performed in the PRA (i.e.,

AOOs, DBEs, and BDBEs) are not subject to a 10 CFR 50.59 evaluation

>>They are instead covered by the Non-LWR PRA Standard

127 127 Objectives

• Guidance is being developed to evaluate changes to advanced reactor facilities that plan to be licensed using NEI 18-04 methodology (e.g., 50.59 guidance for AR)

• The objective is to exercise the change evaluation guidance with reactor developers to:

- Demonstrate usability of the process

- Validate thresholds

- Incorporate lessons learned to improve the process Preliminary Schedule

• Planning - 6/6 to 6/10/2022

• Execution - 6/13 to 6/17/2022

• Develop lessons learned - 6/20 to 6/24/2022

• Complete deliverables - 6/27 to 6/30/2022 Tabletop Exercises - Objectives & Schedule

128 128

• Remote work with a combination of individual evaluation and team meetings

• TICAP team will work with reactor developer team lead to create technology-specific examples that will be evaluated using the change evaluation guidance

• Tabletop participants will be provided the examples, ad hoc procedures, and other source materials during a kickoff meeting

• Technical leads will evaluate examples and then convene with the larger group to ask questions, discuss the proposed answers to the criteria and the bases for those answers, etc.

• Meeting minutes will capture key discussions and challenges to develop the lessons learned & actions Tabletop Exercises - Format Example Changes to the Facility LMP 50.59 Criteria 1

Criterion (a) 1, 4 Criterion (b) 1 Criterion (c) 2 Criterion (d) 2 Criterion (e) 2 Criterion (f) 3 Criterion (g) 5, 6, 7 Whole process AD/Screen/Eval

129 129

• Evaluation, with a documented basis, for each of the criteria selected for each example (some examples will test applicability and screening)

• Meeting minutes that include key discussions and considerations

• Summary of lessons learned

• Recommendations for improving the guidance Tabletop Exercises - Deliverables

130 130 Questions

131 131 BACKUP SLIDES

132 10 CFR 50.59 Evaluation Criteria for an LMP-based Affirmative Safety Case 10 CFR 50.59(c)(2) Criteria LMP 50.59 Criteria for an LMP-based Affirmative Safety Case Comments Category 1 - Accidents (i) Result in more than a minimal increase in the frequency of occurrence of an accident previously evaluated in the final safety analysis report (as updated);

(iii) Result in more than a minimal increase in the consequences of an accident previously evaluated in the final safety analysis report (as updated);

[See NEI 96-97 Sections 4.3.1 and 4.3.3, respectively]

(a) Result in a change to the frequency or consequences of one or more AOOs, DBEs, or BDBEs documented in the final safety analysis report (as updated) in a manner that would exceed the NEI 18-04 Frequency-Consequence Target or change an LBE from non-risk significant to risk significant according to NEI 18-04 LBE risk significance criteria.

(b) Result in more than a minimal increase in the consequence of a Design Basis Accident documented in the final safety analysis report (as updated).

Risk significance of an LBE in LMP context and in the non-LWR PRA standard requires the consideration of the combination of frequency and consequence effects. There are no criteria to evaluate these components of risk separately.

LMP DBAs are evaluated deterministically like LWR accidents.

Therefore, determining if a change leads to a more than minimal increase in DBA consequences should follow the existing NEI 96-07 Section 4.3.3 guidance.

v) Create a possibility for an accident of a different type than any previously evaluated in the final safety analysis report (as updated);

[See NEI 96-07 Section 4.3.5]

(c) Result in one or more an AOO, DBE, or BDBE that is (i) not previously evaluated in the UFSAR and (ii) classified as risk significant according to NEI 18-04 LBE risk significance criteria.

Newly identified LBEs or changes to LBE frequencies and consequences that are not risk significant should be documented in the next final safety analysis report update but the associated change does not require prior NRC review.

133 10 CFR 50.59 Evaluation Criteria for an LMP-based Affirmative Safety Case (ii) Result in more than a minimal increase in the likelihood of occurrence of a malfunction of a structure, system, or component (SSC) important to safety previously evaluated in the final safety analysis report (as updated);

(iv) Result in more than a minimal increase in the consequences of a malfunction of an SSC important to safety previously evaluated in the final safety analysis report (as updated);

[See NEI 96-07 Sections 4.3.2 and 4.3.4, respectively]

(vi) Create a possibility for a malfunction of an SSC important to safety with a different result than any previously evaluated in the final safety analysis report (as updated);

[See NEI 96-07 Section 4.3.6]

(d) Result in an increase in the frequency or consequences of a malfunction of any safety-significant SSC that would change the classification of the SSC from non-risk significant to risk-significant.

(e) Result in an increase in the frequency or consequences of a malfunction of a safety-significant SSC that would have a more than minimal adverse effect on defense-in-depth adequacy or lead to a change in safety classification from NST to NSRST to maintain adequate defense-in-depth.

10 CFR 50.59(c)(2) criteria (ii), (iv), (vi),

and (vii) are addressed collectively by LMP 50.59 criteria (d) and (e).

Changes with the impacts on the LMP-based affirmative safety case described in (d) or (e) are deemed to require prior NRC approval.

10 CFR 50.59(c)(2) Criteria LMP 50.59 Criteria for an LMP-based Affirmative Safety Case Comments Category 2 - SSCs

134 10 CFR 50.59 Evaluation Criteria for an LMP-based Affirmative Safety Case 10 CFR 50.59(c)(2) Criteria LMP 50.59 Criteria for an LMP-based Affirmative Safety Case Comments Category 2 - SSCs (vii) Result in a design basis limit for a fission product barrier as described in the FSAR (as updated) being exceeded or altered;

[See NEI 96-07 Section 4.3.7]

No specific criterion The DID provided by LWR fission product barriers is addressed in a holistic manner in NEI 18-04. There is no need to single out fission product barriers in LMP 50.59 criteria; instead, impacts of changes on all safety-significant SSCs (not just fission product barriers) and DID are addressed by LMP 50.59 criteria (d) and (e).

135 10 CFR 50.59 Evaluation Criteria for an LMP-based Affirmative Safety Case 10 CFR 50.59(c)(2) Criteria LMP 50.59 Criteria for an LMP-based Affirmative Safety Case Comments Category 3 - Methods of Evaluation (viii) Result in a departure from a method of evaluation described in the FSAR (as updated) used in establishing the design bases or in the safety analyses.

[See NEI 96-07 Section 4.3.8]

(f) Result in a departure from a method of evaluation described in the FSAR (as updated) used in establishing the design bases or in the safety analyses, which the exception of LBE evaluation methods under the change control of the Non-LWR PRA Standard.

Evaluation of changes to methods of evaluation should follow NEI 96-07 Section 4.3.8 guidance.

Note that methods of evaluation used in the PRA are not addressed by 10 CFR 50.59 (see Section 3.1.6 of this guidance). Such methods are instead managed by New Methods and Configuration Control requirements in the non-LWR PRA Standard ASME/ANS RA-S-1.4-2021. These include methods of evaluation for AOOs, DBEs, and BDBEs.

136 Update on Pre-Application Engagement on Advanced Reactor Licensing (Courtney Banks, Adrian Muniz, Mallecia Sutton)

Pre-Application Engagement on Advanced Reactor Licensing Adrian Muniz, Mallecia Sutton, and Courtney Banks Advanced Reactor Licensing Branch 1

NRC staff view on pre-application engagement and current status The NRC staff encourages pre-application interactions with advanced reactor potential applicants and vendors to provide stability and predictability in the licensing process through early identification and resolution of technical and policy issues that would affect licensing.

Seven advanced reactor potential applicants and vendors have submitted new or revised regulatory engagement plans in the past year that include many of the activities addressed in the NRC staff draft white paper, Pre-application Engagement to Optimize Advanced Reactors Application Reviews (ADAMS Accession No. ML21145A106), issued in May 2021.

138

By-the-Numbers Snapshot of Pre-Application Engagement Activities

• 10 regulatory engagement plans submitted

• Topical Reports

- 10 completed

- 8 under review

- 37 projected to be submitted in the next 2 years

• White Papers

- 18 completed

- 10 under review

- 38 projected to be submitted in the next 2 years 139

Advanced Reactor Webpage 140 https://www.nrc.gov/reactors/new-reactors/advanced.html

Advanced Reactor Webpage

• Discuss updates to website

• https://www.nrc.gov/reactors/new-reactors/advanced.html

• Provide a demo of the advanced reactor page

• New Listserve subscriptions 141

Questions?

142