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Category 3 Public Meeting NRC Presentation 10 CFR Part 53 Licensing and Regulation of Advanced Nuclear Reactors Subpart B Preliminary Proposed Rule Language
	ML20318A007
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Issue date:	11/18/2020
From:	Robert Beall; NRC/NMSS/DREFS/RRPB
To:	;
	Beall, Robert
Shared Package
ML20318A005	List: ML20318A007; ML20336A180; ML20350B359;
References
	10 CFR Part 53, NRC-2019-0062, RIN 3150-AK31
	Download: ML20318A007 (59)
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10 CFR Part 53 Licensing and Regulation of Advanced Nuclear Reactors Subpart B Preliminary Proposed Rule Language November 18, 2020 1

Agenda 12:00pm - 12:10pm Welcome/Introductions/Logistics 12:10pm - 2:00pm Part 53 Rulemaking Strategy & Schedule 2:00pm - 2:15pm BREAK 2:15pm - 4:00pm Subpart B - Technology-Inclusive Safety Requirements 4:00pm - 4:30pm Additional Public Comments/Closing Remarks 2

Welcome/Introductions Welcome:

Ho Nieh, NRR - Office Director John Segala, NRR - Branch Chief of the Advanced Reactor Policy Branch Speakers/Presenters:

Bob Beall, NMSS - Rulemaking PM & Meeting Facilitator Nanette Valliere, NRR - Technical Lead Bill Reckley, NRR - Technical Lead Marc Nichol, Nuclear Energy Institute Cyril Draffin, U.S. Nuclear Industry Council Public Meeting Slides: ADAMS Accession No. ML20318A007 3

Purpose of Todays Meeting

Discuss U.S. Nuclear Regulatory Commission (NRC) staff plan to address Commission direction on Part 53 rulemaking

Review preliminary proposed rule language for Part 53 o This is the first of many public meetings the NRC staff will be hosting to discuss preliminary proposed rule language

Todays meeting is a Category 3 public meeting, which means that public participation is actively sought in the discussion of the regulatory issues during the meeting.

o The meeting is being transcribed and the transcription will be available with the meeting summary by December 18, 2020.

No regulatory decisions will be made at todays meeting.

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Part 53 Rulemaking The Part 53 Rulemaking Process*

The process depicted in this schematic is unique to the Part 53 rulemaking and varies in some ways compared to a similar A Typical Rulemaking Process schematic available on the NRCs public website.

5

Background

Nuclear Energy Innovation and Modernization Act (NEIMA; Public Law 115-439) signed into law in January 2019 requires the NRC to complete a rulemaking to establish a technology-inclusive, regulatory framework for optional use for commercial advanced nuclear reactors no later than December 2027 o (1) ADVANCED NUCLEAR REACTORThe term advanced nuclear reactor means a nuclear fission or fusion reactor, including a prototype plant with significant improvements compared to commercial nuclear reactors under construction as of the date of enactment of this Act, 6

SECY-20-0032 Rulemaking Plan

In SECY-20-0032, Rulemaking Plan on Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors, (ADAMS ML19340A056), dated April 13, 2020, NRC staff proposed:

o Developing a new 10 CFR part that could address performance requirements, design features, and programmatic controls for a wide variety of advanced nuclear reactors throughout the life of a facility o Focusing the rulemaking on risk-informed functional requirements, building on existing NRC requirements, Commission policy statements, and recent activities o Seeking extensive interactions with external stakeholders and the Advisory Committee on Reactor Safeguards (ACRS) on the content of the rule 7

Staff Requirements Memorandum (SRM) -

SECY-20-0032, Rulemaking Plan

In SRM-SECY-20-0032, dated October 2, 2020 (ADAMS ML20276A293), the Commission:

o Approved the staffs proposed approach for the rulemaking o Directed the staff to provide:

a schedule with milestones and resource requirements to achieve publication of the final Part 53 rule by October 2024 key uncertainties impacting publication of the final rule by that date options for Commission consideration on licensing and regulating fusion energy systems o Directed the staff to develop and release preliminary proposed rule language intermittently, followed by public outreach and dialogue 8

30-Day Commission Memo

On November 2, 2020, staff submitted a Commission memorandum responding to the SRM direction to provide a schedule with milestones and resources to complete the final rule by October 2024 (ADAMS ML20288A251).

The memorandum included a discussion of key uncertainties that could impact publication of the final rule by that date.

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30-Day Commission Memo Milestone Schedule Major Rulemaking Activities/Milestones Schedule Public Outreach, ACRS Interactions and October 2020 to April 2022 Generation of Proposed Rule Package (19 months)

Submit Draft Proposed Rule Package to May 2022 Commission Publish Proposed Rule and Draft Key Guidance October 2022 Public Comment Period - 60 days November and December 2022 Public Outreach and Generation of Final Rule January 2023 to February 2024 Package (14 months)

Submit Draft Final Rule Package to Commission March 2024 Office of Management and Budget and Office of July 2024 to September 2024 the Federal Register Processing Publish Final Rule and Key Guidance October 2024 10

30-Day Commission Memo

Key uncertainties in meeting the Commission directed rulemaking schedule:

o NRC-stakeholder alignment on the scope of the rulemaking o Engagement on key issues within the NRC and communication with external stakeholders and ACRS o Timing of guidance document development o Ability of the public to review the proposed rule within the proposed 60-day public comment period o Ability to include the regulatory framework and requirements for fusion facilities 11

NRC Staff Plan to Develop Part 53 Subpart B Subpart C Subpart D Subpart E Subpart F Subpart G Project Life Cycle Requirements Design and Siting Construction Operation Retirement Definition Analysis

Fundamental Safety Functions

Prevention, Mitigation, System Testing Surveillance Performance Criteria Design Maintenance (e.g., F-C Targets)

Normal Operations Component Configuration (e.g., effluents) Design Control

Other Design Changes Plant/Site (Design, Construction, Configuration Control)

Clarify Controls Analyses (Prevention, Mitigation, Compare to Criteria) and Distinctions Between Plant Documents (Systems, Procedures, etc.)

LB Documents (Applications, SAR, TS, etc.) Subparts H & I 12

NRC Staff Engagement Plan Stakeholder Interactions Framework Safety Criteria Design Siting Construction Operations Decommissioning Licensing General/Admin Sept 20 Nov 20 Dec 20 Jan 21 Feb 21 Mar 21 Apr 21 May 21 Jun 21 Jul 21 Consolidated Technical Sections Aug 21 Sept 21 Consolidated Technical Sections Oct 21 Nov 21 Consolidated Rulemaking Package Dec 21 Jan 22 ACRS Full Committee Feb 22 Mar 22 Apr 22 May 22 Draft Proposed Rulemaking Package to the Commission Jun 22 Jul 22 Aug 22 Sept 22 Oct 22 Concept Discussion Closure 13

Stakeholder Suggested Plan

NEI Input on the NRC Rulemaking Plan on, Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors (RIN-3150-AK31; NRC-2019-0062), dated October 21, 2020 (ADAMS ML20296A398)

NEI letter focuses on three elements recommended for a successful rulemaking:

o a well-defined vision and suggested goals for the final rule o a systematic approach to the rulemaking effort with a proposed five step process o predictable and meaningful stakeholder interactions

NEI suggested a five-step process o Step 1 - Frame the Part 53 rulemaking effort (November 2020) o Step 2 - Establish the scope of the final rule (January 2021) o Step 3 - Create the safety paradigm (June 2021) o Step 4* - Identify how to document the regulatory framework (September 2021) o Step 5 - Develop the proposed rule (October 2022)

Write the draft proposed rule language 14

Stakeholder Suggested Plan

NRC staff believes the overall concepts in NEI process are reasonable.

NRC staff does not believe all steps can be done in series, as suggested, while still completing the rulemaking on the Commission-directed schedule.

As directed by the Commission, the staff will be using an iterative process to get stakeholder input.

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U.S. Nuclear Industry Council Comments regarding Part 53 at NRC Part 53 Rulemaking Meeting Rulemaking Strategy & Schedule Cyril W. Draffin, Jr.

Senior Fellow, Advanced Nuclear U.S. Nuclear Industry Council 18 November 2020

Rulemaking Strategy & Schedule USNIC supportive of NRCs effort to develop Part 53 as transformational rule that provides reasonable assurance of public health and safety for advanced reactors

Regular NRC Part 53 stakeholder meetings (every ~6 weeks) has merit

USNIC provided comments on Part 53 for:

o 20 August 2020 NRC meeting (slides) o Each of 14 issues that NRC raised in their July 2020 NRC Staff White Paper (50 comments),

available at: https://adamswebsearch2.nrc.gov/webSearch2/main.jsp?AccessionNumber=ML20244A229 o 22 Sept 2020 NRC meeting (slides) o todays meeting

NRC provided helpful current thinking regarding planned Subparts A-J 17 l U.S. Nuclear Industry Council - Nov 2020 - Part 53

Rulemaking Strategy & Schedule (continued)

Ensure requirements for licensing and regulating advanced nuclear reactors are clear, appropriate, and focused on the adequate protection of public health and safety.

Avoid regulations not needed to provide reasonable assurance of adequate protection of health and safety

eliminating or streamlining requirements that are overly prescriptive or not relevant will reduce the need for future exemptions.

NRC should not use the development of this rule to rachet up requirements 18 l U.S. Nuclear Industry Council - Nov 2020 - Part 53

Rulemaking Strategy & Schedule (continued)

Because of accelerated timeline, there is tension between having "broad, significant changes from the current regulatory framework" and just repackaging prior safety standards and regulations o NRC: "Some industry stakeholders have expressed a desire for a clean sheet approach in the Part 53 rulemaking and are seeking broad, significant changes from the current regulatory framework for licensing new reactors. The staffs primary goal is to develop a transformational rule that provides reasonable assurance of public health and safety for advanced reactors for Commission consideration.

To achieve that goal, it will be necessary to focus the scope of this rulemaking on the essential elements that will enable safety focused, timely licensing decisions, and construction and transition to operation for new advanced reactors.

19 l U.S. Nuclear Industry Council - Nov 2020 - Part 53

Rulemaking Strategy & Schedule (continued)

Agree with NEI 21 Oct 2020 input regarding Part 53 vision and goals:

Part 53 to be most efficient option for all new reactor applicants o meet industry needs for schedule, cost and predictability-- consistent with Congressional directives and NRCs advanced reactor policies, initiatives, and Principles of Good Regulation

Safety Focused

Technology Inclusive

Efficient

Flexible (licensing for diverse set of uses including process heat, hydrogen production, desalinization)

Informed (considering international regulatory frameworks)

Clarity 20 l U.S. Nuclear Industry Council - Nov 2020 - Part 53

Rulemaking Strategy & Schedule (continued)

Agree with general approach contained in NRC staffs 2 Nov 2020 memo regarding staff requirements for SECY-20-0032

Reaching alignment on scope o Agree with staffs desire for transformational rule o Large studies undertaken suggest zero threshold associated with linear no-threshold model is not appropriate for assessing health effects of radiation--

Part 53 should add flexibility as science and analysis improves (e.g. if commission decides zero threshold is no longer justified)

Timing of guidance document o What is possible role of standards organizations such as International Standards Organization (e.g. for ISO 9000 QA standards) or ASME?

21 l U.S. Nuclear Industry Council - Nov 2020 - Part 53

Part 53 Rulemaking Strategy &

Schedule Discussion 22

MEETING BREAK Meeting to resume in 15 minutes 23

Part 53 General Layout

Subpart A, General Provisions

Subpart B, Technology-Inclusive Safety Objectives

Subpart C, Design Requirements

Subpart D, Siting

Subpart E, Construction and Manufacturing Requirements

Subpart F, Requirements for Operation

Facility Safety Program

Subpart G, Decommissioning Requirements

Subpart H, Applications for Licenses, Certifications and Approvals

Subpart I, Maintaining and Revising Licensing Basis Information

Subpart J, Reporting and Administrative Requirements 24

10 CFR Part 53 Subpart B Layout

§ 53.20 - Safety Objectives

§ 53.21 - Safety Functions

§ 53.22 - First Tier Safety Criteria

§ 53.23 - Second Tier Safety Criteria

§ 53.24 - Licensing Basis Events

§ 53.25 - Defense in Depth

§ 53.26 - Protection of Plant Workers 25

Subpart B Flowchart ATOMIC ENERGY ACT Safety Objectives Adequate Protection (Sec. 182) and Minimize Danger (Sec. 161)

First Tier Second Tier Two Tiers § 20.1301 - Normal Ops ALARA for Normal Ops

§ 50.34/52.79 - Unplanned NRC Safety Goals for unplanned of Safety Criteria Events events Retention of radionuclides (1) Retention of radionuclides (2)

Safety Functions - Control heat generation - Control heat generation

- Control heat removal - Control heat removal

- Control chemical interactions - Control chemical interactions Design Features and Safety Classification Special Treatment Programmatic Tech Specs Licensee Programs Controls Chapter 15 26

§§ 53.20 & 53.22/53.23 Objectives and Criteria

Safety Objectives o Reasonable assurance of adequate protection of the public health and safety and the common defense and security o Additional measures to minimize danger to life and property, when considering various factors

Safety Criteria o Two-Tiered structure 27

§ 53.22 - First Tier Safety Criteria (Adequate Protection)

Normal operations (§ 20.1301) o Contribution to total effective dose equivalent (TEDE) to individual members of the public from normal plant operation does not exceed 0.1 rem (1 mSv) in a year o Contribution to dose in any unrestricted area does not exceed 0.002 rem (0.02 millisievert) in any one hour

Licensing basis events (§§ 50.34(a)(1)(ii)(D) & 52.79(a)(1)(vi))

o Upper bound frequency > once per 10,000 years o An individual located at exclusion area boundary for any 2-hour period following the onset of release would not receive a radiation dose in excess of 25 rem (250 mSv) TEDE o An individual located at outer boundary of the low population zone exposed to the radioactive cloud resulting from the postulated fission product release (during the entire period of its passage) would not receive a radiation dose in excess of 25 rem (250 mSv) TEDE

Additional requirements established by the NRC for reasonable assurance of adequate protection 28

§ 53.23 - Second Tier Safety Criteria (Substantial Additional Protection)

Estimated TEDE to the public from effluents during normal plant operation are as low as reasonably achievable (ALARA) o Performance objectives for liquid and gaseous effluents (10 CFR Part 50, Appendix I)

Design features and programmatic controls must:

o Ensure plant structures, systems, and components (SSCs), personnel, and programs provide necessary capabilities & reliabilities to address licensing basis events o Provide measures for defense-in-depth o Maintain overall cumulative plant risk from licensing basis events within NRC safety goals 29

§ 53.21 - Safety Functions

Safety Functions o Primary safety function is to limit the release of radioactive materials from the facility o Additional functions supporting the retention of radioactive materials must be defined o Design features and programmatic controls fulfill the safety functions 30

Safety Functions Concept NGNP Concept 31

§ 53.24 - Licensing Basis Events

Licensing basis events must address combinations of malfunctions of plant SSCs, human errors, and the effects of external hazards

Licensing basis events must be used to o Confirm the adequacy of design features and programmatic controls needed to satisfy first and second tier safety criteria o Establish related functional requirements for plant SSCs, personnel, and programs 32

§ 53.25 - Defense in Depth

Measures must be taken to ensure appropriate defense in depth is provided to compensate for uncertainties

Measures can include increased safety margins and provide alternate means to accomplish safety functions

No single design or operational feature should be exclusively relied upon 33

§ 53.26 - Protection of Plant Workers

Ensure radiological dose to plant workers does not exceed occupational dose limits from 10 CFR Part 20

Use procedures and engineering controls to keep occupational dose levels ALARA 34

Additional Discussion Topics

Consideration of unmitigated consequences from event scenarios to support Part 53 o Department of Energy Orders & American Nuclear Society Standard 2.26 (Seismic design)

Embedded mechanisms to apply analytical safety margins to gain operational flexibilities o Example is alternative offsite dose thresholds being considered for emergency planning zones and siting 35

Integrated Approach Siting near densely populated Functional areas EP for SMRs Containment and ONTs Licensing Modernization Project Insurance and Liability Environmental Reviews Consequence Based Security 36

Part 53 Rulemaking Marc Nichol Senior Director New Reactors November 18, 2020

Project Requirement for Safety Criteria Goal: Define performance-based safety criteria that demonstrate adequate protection Constraints

Define in terms of direct radiological risks to public heath and safety to the maximum extent possible (e.g., dose and probability)

Address categories of individuals for protection: Public and occupational workers

Address plant operating conditions: Normal, design basis accident, beyond design basis

Consistency: Safety goals, Part 50 dose limits, NEI 18-04

Flexibility: able to approve a design without a site, allow applicants to propose functional surrogates

Safety Criteria - Adequate Protection of Public Adequate protection - Design Basis Accidents

NRC proposed 53.22(b) is necessary and sufficient

Consistent with 50.34(a)(1)

Further consideration of boundary type (e.g., site boundary)

Further consideration of location of numerical probability

Consideration of implications that most designs expected to meet more restrictive EPA PAG (site boundary EPZ)

Safety Criteria - Minimize Danger to Public Normal Operations

NRC proposed 53.22(a) is necessary and sufficient

Consistent with 20.1301 Beyond design basis events

Not consistent with current approach 50.155(b) - mitigation Need technology-inclusive equivalent

53.22(c) is problematic - requirements created for each applicant

53.23(b)(2) is not necessary - QHO addressed by other requirements Also lacks clarity, difficult to implement

As Low As Reasonably Achievable NRC should not have ALARA requirements in Part 53

ALARA not necessary to protect the public health, minimize danger or to meet other requirements in the Atomic Energy Act Furthermore, NRC proposed approach 53.23(a) and 53.26(b) is problematic

Appears inconsistent with 20.1003 and 20.1101

Part 50 Appendix I based on large LWRs

Reasonable Assurance of Adequate Protection (NRC Proposed 53.20)

No current equivalent in Part 50 (presumed by meeting requirements)

A separate requirement by itself lacks clarity on what else will need to be required on case-by-case basis Benefits to clarifying reasonable assurance of adequate protection in the regulations

E.g., high-level principles from NMSS memo Could be introduction for performance based criteria

53.22(b), 53.22(a) and 50.155(b)-equivalent

Requirements Related to Safety Construct (How) - Not Safety Criteria (What)

Revisit when creating the safety paradigm (how to demonstrate safety criteria are met)

Safety Functions - 53.21

Design features and programmatic controls

Licensing Basis Events - 53.24

Defense in Depth - 53.25

Reliability - 53.23(b)(1)

Rule text observations Use reasonable assurance standard rather than high confidence Opportunities to make more performance-based Phrasing, terms and specifics may need more work

Occupational Worker Dose NRC Proposed 53.26(a)

Refers to 20.1201 through 20.1208

Appears appropriate for Part 53 licensees

QUESTIONS?

By Third Way, GENSLER

U.S. Nuclear Industry Council Comments regarding Part 53 at NRC Part 53 Rulemaking Meeting Safety Requirements Cyril W. Draffin, Jr.

Senior Fellow, Advanced Nuclear U.S. Nuclear Industry Council 18 November 2020

Safety Requirements - Introduction

Goal to meet adequate protection standards in way that focuses on public health and safety

Criteria should be focused on what information is essential to demonstrating the safety case with a level of detail that is commensurate with its contribution to the safety case arguments- and not add additional requirements not necessary for safety case.

Reduced source term for advanced reactors and high level performance-based requirements bring significant opportunities to reduce requirements to just those providing adequate safety protection.

48 l U.S. Nuclear Industry Council - Nov 2020 - Part 53

Safety Requirements - Specific Comments/Questions

53.20 For additional measures, how does NRC plan to balance the factors indicated (including public health, economic costs, technology changes, operating experience)?

53.20 How will NRC determine what is needed for facility safety program?

53.22 c) Why does NRC need to add additional requirements?

Seems like an open ended path to load on requirements not required under first tier safety criteria that will undermine NRCs goal of predictability

53.23 Why would transformational new regs use Part 50 criteria (e.g. Appendix I)?

ALARA not necessary to include in this rule covered in Part 20. Language such as risk to individual be below two in one million years not necessary--

Atomic Energy Act does not require 49 l U.S. Nuclear Industry Council - Nov 2020 - Part 53

Safety Requirements - Protection of Plant Workers

53.26 Why do worker protections need to be put in this rule when they are covered in Part 20 (and there appears to be no changes in the exposure limits)?

o Although worker protection is important, it is adequately covered elsewhere and we oppose inclusion of worker protection under the definition of safety.

o Thresholds for public and worker protection are and should be significantly different. Workers are subject to substantial training and informed consent in a way that the public is not.

o The inclusion of worker protection under the umbrella of safety criteria can lead to the significant over-designation of SSCs and administrative controls as safety related. This approach probably reduces safety by diluting safety focus on the most important items for protection of public health and safety.

50 l U.S. Nuclear Industry Council - Nov 2020 - Part 53

Safety Requirements - Licensing Basis Events & AEA

53.22 & 53.24 o Is thinking that the "licensing basis events" includes the full spectrum of events covered in NEI 18 AOOs, DBEs, DBAs, and BDBEs? Clarity of the scope of events is needed.

o If there is to be requirements for beyond design basis events (BDBE), will there be a separate section within the rule that provides the performance objectives or criteria for those accidents?

o Is "licensing basis events" a defined term in Part 50 or Part 52?- if not it needs an explanation

Relationship between Atomic Energy Act (AEA) section 182 (license applications) and section 161 (general provisions) needs a explanation with respect to how those sections will influence the construction of this rule.

51 l U.S. Nuclear Industry Council - Nov 2020 - Part 53

Closing Remarks

Timely development and implementation of transformation Part 53 is important in providing greater certainty and efficiency for future advanced reactor applicants.

Current regulatory approval process should continue, including appropriate licensing modernization efforts, so no momentum is lost.

52 l U.S. Nuclear Industry Council - Nov 2020 - Part 53

U.S. Nuclear Industry Council Contact For questions or comments contact:

Cyril W. Draffin, Jr.

Senior Fellow, Advanced Nuclear, U.S. Nuclear Industry Council Cyril.Draffin@usnic.org 53 l U.S. Nuclear Industry Council - Nov 2020 - Part 53

Subpart B - Technology-Inclusive Safety Requirements Discussion 54

Final Discussion and Questions 55

Future Public Meetings

The NRC staff plans to host a public meeting every 4 to 6 weeks to discuss and receive feedback on various regulatory topics and preliminary proposed rule text.

o The next Part 53 public meeting will be scheduled for January 2021.

o Any preliminary proposed rule text will be posted on regulations.gov under docket ID NRC-2019-0062 before the public meeting.

The NRC staff will be meeting with the ACRS Future Plants Subcommittee every one to two months starting in January 2021.

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Closing Remarks Rulemaking Contacts Robert.Beall@nrc.gov 301-415-3874 William.Reckley@nrc.gov 301-415-7490 Regulations.gov docket ID: NRC-2019-0062 Please provide feedback on this public meeting using this link:

https://www.nrc.gov/public-involve/public-meetings/contactus.html 57

Acronyms and Abbreviations ACRS Advisory Committee on Reactor EPZ Emergency Planning Zone Safeguards F-C Frequency - Consequence ADAMS Agencywide Documents Access and Management System ISO International organization for standards AEA Atomic Energy Act LB Licensing basis ALARA As low as reasonably achievable LWRs Light water reactors ASME American Society of Mechanical mSv millisieverts Engineers NEI Nuclear Energy Institute AOO Anticipated operational occurrence NEIMA Nuclear Energy Innovation and Modernization Act BDBE Beyond design-basis event NGNP Next generation nuclear plant CFR Code of Federal Regulations NMSS Office of Nuclear Material Safety DBA Design-basis accident and Safeguards DBE Design-basis event NRC U.S. Nuclear Regulatory Commission EDO Executive Director of Operations NRR Office of Nuclear Reactor EP Emergency preparedness Regulation EPA U.S. Environmental Protection ONT Other new technologies Agency 58

Acronyms and Abbreviations PAG Protective action guides QA Quality assurance QHO Quantitative health objective rem Roentgen-equivalent man SAR Safety Analysis Report SMR Small modular reactor SRM Staff Requirements Memorandum SSCs Structures, systems, and components TEDE Total effective dose equivalent TS Technical specifications USNIC U.S. Nuclear Industry Council 59

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