ML21295A259

NRC Staff Presentation Slides for Public Meeting 10 CFR Part 53, Licensing and Regulation of Advanced Nuclear Reactors - Part 26, Fitness for Duty Programs, Preliminary Proposed Rule Language

ML21295A259
Person / Time
Issue date:	01/06/2022
From:	Robert Beall NRC/NMSS/DREFS/RRPB
To:
Beall, Robert
References
10 CFR Part 26, 10 CFR Part 53, NRC-2019-0062, RIN 3150-AK31
Download: ML21295A259 (55)

Text

10 CFR Part 53 Licensing and Regulation of Advanced Nuclear Reactors

10 CFR Part 26, Fitness for Duty

January 6, 2022

1 Agenda

1:00pm - 1:15pm Welcome / Introductions / Logistics / Goals 1:15pm - 3:30 pm Overview and Discussion of Part 26, Sections Related to Fitness for Duty (FFD) 3:30pm - 3:45pm Break

3:45pm - 4:45pm Open Discussion of Other Part 53 Sections and Subparts

4:45pm - 5:00pm Additional Public Comments, Questions, and Closing Remarks / Adjourn

2 Welcome/Introductions

Welcome:

• Sebrina Atack, Office of Nuclear Security and Incident Response (NSIR)

Speakers/Presenters:

• Bob, Beall, Office of Nuclear Materials Safety and Safeguards - Meeting Facilitator

• Paul Harris, NSIR

• Justin Vasquez, Office of Nuclear Reactor Regulation (NRR)

Public Meeting Slides: ADAMS Accession No. ML21295A259

3 Purpose of Todays Meeting

• Review preliminary proposed rule language for 10 CFR Part 26, FFD Programs

• Open discussion of other Part 53 sections and subparts

• Todays meeting is a Comment -Gathering meeting, which means that public participation is actively sought in the discussion of the regulatory issues during the meeting.

o This meeting is being held in a workshop format to facilitate the discussion of todays topics.

o The meeting is being transcribed and the transcription will be available with the meeting summary by February 4, 2022.

• No regulatory decisions will be made at todays meeting.

4 10 CFR Part 26, Fitness for Duty Programs

5 Presentation Approach

• Todays presentation will be in two parts:

• Part 1: Background and summary of the proposed FFD program presented during the NRC public meeting on June 10, 2021 o including two specific requests for public input

• Part 2: A summary of the proposed FFD framework (section-by-section review) o including a discussion about fatigue management

6 Part 1: Background, Summary of the June 10, 2021, Public Meeting, and Request for Public Input

7 Summary from the June 10, 2021, NRC Public Meeting on Part 53

For the proposed FFD program, the staff presented:

1. Key Messages

2. Administrative requirements

3. The FFD criterion - staff requested public input on its proposal

4. The FFD Flow Chart - how do the FFD requirements apply

• The June 10th iteration had two FFD-related criteria

• The current staff iteration has one FFD-related criterion

5. Considerations for fatigue management

6. Proposed performance-based requirement - FFD Performance Monitoring and Review

8 Key Messages - Summarized

1. The proposed approach leverages the existing requirements in 10 CFR Part 26, Subpart K, FFD Programs for Construction, that have been implemented by power reactor licensees o Subpart K has been implemented by power reactor licensees for over 8 years o The proposal (Subpart M) uses objective-and performance-based requirements

2. The proposed approach is inclusive of all reactor technologies o Requirements are applied in a graded manner based on risk consequences

3. The proposal includes a FFD performance monitoring and review and an FFD change control process

4. The proposal includes:

o Flexibilities in the conduct of drug and alcohol (D&A) testing

• Allows oral fluid and urine drug testing

• Allows the use of point of collection testing (POCT) and assessment devices for screening (random testing only) o Requirements that help ensure the facility integrates with the existing reactor community 9 Administrative Requirements for all FFD Programs

Subpart A - Administrative Provisions

• § 26.1 Purpose.

• § 26.3 Scope.

• § 26.4 FFD program applicability to categories of individuals.

• § 26.5 Definitions.

• § 26.7 Interpretations.

• § 26.8 Information collection requirements: Office of Management and Budget approval.

• § 26.9 Specific exemptions.

• § 26.11 Communications.

Subpart O - Inspections, Violations, and Penalties

• § 26.821 Inspections.

• § 26.823 Violations.

• § 26.825 Criminal penalties.

10 FFD Criterion

June 10th iteration (A & B) vs current iteration (A)

A. The criterion to be used for the analysis in § 26.603(c)(2) is proposed to be the criterion in 10 CFR 53.830(a)(2)(i), where:

o The radiological consequences from a hypothetical, unmitigated event involving the loss of engineered systems for decay heat removal and possible breaches in physical structures surrounding the reactor, spent fuel, and other inventories of radioactive materials result in offsite doses below the values in § 53.210 of this chapter.

o If the facility meets this criterion, drug and alcohol testing will not be required; however, a behavioral observation program will be required.

B. Plant technologies, engineered safety features, and controls provide reasonable assurance that without operator action the plant can achieve and maintain a safe stable condition and remove decay heat, and the radiological consequences resulting from design basis accidents and transients as described in the final safety analysis report do not exceed the dose limits in

§ 20.1301(a)(1) [100 mrem to member of the public in a year].

o Program will be tiered and based on current requirements in Part 26, Subpart K, FFD programs for construction of commercial power reactor facilities. 11 Preliminary Proposed FFD Requirements for Part 53 Licensees (rev. 1)

Licensee Part 53 FFD Program option using the One Criterion Part 26, Subpart M - §26.604 FFD Program Process 1. Must have a behavioral observation program and implement administrative requirements

Criterion 2. Enables, but does not require a D&A testing program met Part 26, Subpart M - §26.605 FFD Program Criterion 1. Requires D&A testing and behavioral observation not met 2. Prior to reactor operation, the licensee or other entity must implement an FFD program that meets the Part 26 requirements in Subpart C, FFD authorization; Subpart D, management actions/sanctions; Subpart H, FFD policy violations and determining fitness; Subpart I, fatigue Existing Part 26 FFD Programs management; and, Subpart N, recordkeeping, and reportability Subparts A-I, N, & O operational program Subpart K, construction program* Both the §26.604 and §26.605 FFD programs must:

Decommissioning program (TBD) 1. Be described to the NRC at the time of the Part 53 application

• Only by exemption 2. Annually report FFD performance data (e.g., individuals onsite and FFD policy violations) to the NRC

3. Implement a performance monitoring and review program (site-and industry-based measures and thresholds) and document its implementation biennially. This proposed requirement is based on current Part 26 requirements, §50.47(c)(1)(iii)(B) emergency plan, §50.48(c)(1) fire protection, and §50.65 maintenance performance reviews

4. Implement a change control process. This proposed requirement is based on Part 53,

§50.48(f))(3), §50.54(p), and §50.54(q)(3), and §50.59

5. Use urine or oral fluid if drug testing for any drug/alcohol test condition (e.g., pre-access testing)

Licensees may use oral fluid or urine POCT devices only for random testing

6. Use forensic toxicology reviews and U.S. Department of Health and Human Services (HHS) certified laboratories, and implement the Medical Review Officer (MRO) reviews required by §26.183 and 12

§26.185, if drug testing Seeking Public Input

1. Part 26 applicability to certain Holders of Manufacturing Licenses

2. Use of Hair Specimens for Drug Testing

13 FFD applicability to the Assembly and/or Fueling of a Reactor Module under an NRC Manufacturing License

• Currently, for facilities licensed under Parts 50 and 52, Part 26 does not apply to holders of a Manufacturing License o However, Part 26 does apply to licensees when assembling and fueling a reactor vessel at a reactor construction site licensed under Part 50 or 52

• The staff is proposing that select Part 26 requirements apply to holders of a Part 53 manufacturing license if they assemble and/or fuel a reactor module at the manufactures site

• The staff proposal provides analogous treatment of assembly operations for safety-related structures, systems, and components, such as the reactor vessel and associated equipment

• See next slide

14 FFD applicability to the Assembly and/or Fueling of a Reactor Module under an NRC Manufacturing License

NRC is seeking input on whether to apply select FFD requirements to manufacturing licensees who assemble and/or load nuclear fuel in a reactor module at the manufacturer s site

Questions

1. Should the NRC consider the application of Part 26 to the assembly of the reactor module?

2. How should the NRC describe the milestone for when the FFD program should start?

15 Use of Hair Specimens in the Current Part 26 requirements

• Currently, for facilities licensed and operating under Part 50 or 52, Part 26, Subparts A

- I, N, and O, do not allow licensees or other entities to use hair specimens for drug testing

• However, for facilities that are being constructed under Part 50 or 52, Part 26, Subpart K, FFD Programs for Construction, section 26.405(d) does not preclude the use of a hair specimen (or oral fluid specimens) for drug testing if:

o The Part 26 panel of drugs and drug metabolites are used; o The cutoffs used are at the cutoff levels specified in this part, or comparable cutoff levels if specimens other than urine are collected for drug testing; o The initial drug test uses an immunoassay that meets the requirements of the U.S. Food and Drug Administration (FDA) for commercial distribution; o Privacy and quality controls are implemented; o [P] ositive initial drug test results are subject to confirmatory testing by a laboratory that meets stringent quality control requirements that are comparable to those required for certification by the HHS; and, o The Medical Review Officer (MRO) reviews the drug test results prior to issuance of an FFD policy violation. 16 Seeking Public Input on the Staff-proposed use of Hair Specimens in the Part 53 FFD framework

• NRC is seeking input on whether hair testing should be integrated into the FFD program to improve program effectiveness. For example:

1. Should hair testing be used to supplement or used in lieu of urine or oral fluid drug testing?

2. Should only HHS-certified laboratories be used, or should NRC enable laboratories, who may be certified by other organizations, to test hair specimens for drugs and drug metabolites?

3. If the proposal enables (i.e., does not require) the use of hair specimens for drug testing, are current or future NRC licensees and other entities interested in voluntarily using hair specimens to improve FFD or access authorization program effectiveness?

4. Are stakeholders aware of recent operating experience (e.g., studies of paired test results) demonstrating the effectiveness of hair testing? 17 Part 2: Summarized FFD framework (section-by -section review)

18 Comparing the Current and Proposed FFD Frameworks

Construction

Must either Requirements Implement all Part 26 requirements, except Subparts A-I, Subparts I and K, for all individuals Prescriptive Reqs M, N, and O, i.e., the full program except I and K Operation OR Milestone Must implement all Part Part 50 or 52 (1) Implement all Part 26 requirements, Subparts A-I, Before PA established 26 requirements, except Licensees except Subparts I and K, for individuals in Prescriptive Reqs N, and O, or for Subpart K, for all

§26.4(e) except I and K §52.103(g) finding applicable individuals in

§26.4 and (2) Implement an FFD program that meets the requirements in Subpart K program for Objective-based ReqsSubpart K those individuals in §26.4(f) Note Construction Illustration does not address Requirements manufacturing licensees Fatigue Management Must either BOP, assembling and loading fuel 10 CFR Part 26, Subpart I performance into a reactor vessel module Implement the full monitoring, program described above FFD Criterion change control Part 53 except Subparts K and M and admin.

Licensees OR YES, meets criterionrequirements Implement the proposed §26.604 FFD Program Milestone Operation Subpart M FFD program D/A testing, Before the loading of Must implement Part 26 for the applicable NO, doesnt meet BOP, nuclear fuel in the reactor requirements to align with individuals in §26.4 §26.605 FFD Program performance vessel module the rest of the commercial monitoring, industry change control and admin. 19 requirements Comparison of Principal FFD Requirements

20 Section-by-Section - Amendments to Part 26 for Part 53 Licensees

• 26.3, Scope o Amended to include Part 53 licensees

• 26.4, FFD program applicability to categories of individuals o Amended to include individuals working at the Part 53 facility

• 26.5, Definitions o Amended to apply to an FFD program at a Part 53 facility

21 Section-by-Section - Amendments to Part 26 for Part 53 Licensees

• Subpart M, FFD Program for Commercial Power Plants Licensed under Part 53

• 26.601, Applicability statement

• 26.602, FFD program applicability to categories of individuals

• 26.603, General provisions

a. FFD Program Description - provided to the NRC during the Part 53 license application phase

b. FFD Program Implementation and Availability.

c. FFD Criterion and Analysis

22 Section-by-Section - Amendments to Part 26 for Part 53 Licensees

• 26.603, General provisions

d. FFD Performance Monitoring and Review

1. The program must be documented, justified, and maintained and include the following elements:

i. Performance measures for FFD policy violations and program weaknesses A. If not performing D&A testing, must monitor the behavioral observation program B. If D&A testing, must monitor pre-access, random, and subversion attempts ii. Trending - year-to-year comparisons, timely conducted as data is received iii. Thresholds - developed prior to program implementation, using comparable FFD data, including FFD programs (multiple sites in the same program) and industry -wide data

2. Qualitative Measures

i. Appeals process ii. Laboratory Test Results and MRO performance iii. Change control process

3. Corrective Actions - timely implemented to address adverse trends, designed to restore performance

4. Program Review Periodicity - biennial, documented by Nov 15 of every even year

5. Regulatory guidance will be issued

23 FFD Performance Monitoring and Review - Illustration 1 of 2

Random Positive Test Rate: Licensee Employees

5% 2016 2017 2018 2019 Avg +1 SD 2%

4%

3%

2%

1%

0%

The data provided is draft and aggregated from licensee-reported FFD performance data to the NRC The x-axis represents the NRC -licensed facilities subject to 10 CFR Part 26 24 FFD Performance Monitoring and Review - Illustration 2 of 2

Random Positive Test Rate Contract Vendors (C/V)

2016 2017 2018 2019 avg +1 SD Fixed 2%

5%

4%

3%

2%

1%

0%

The data provided is draft and aggregated from licensee-reported FFD performance data to the NRC The x-axis represents the NRC -licensed facilities subject to 10 CFR Part 26

25 Section-by-Section - Amendments to Part 26 for Part 53 Licensees

• 26.603, General provisions

e. FFD Program Change Control

1. Changes not requiring NRC approval

• Changes that do not reduce FFD program effectiveness (i.e., performance)

Examples: Changes caused by a change to Part 26 Changes caused by a change to DHS Mandatory Guidelines for Federal Workplace Drug Testing

2. Changes requiring NRC approval

• Changes that cause or may cause a reduction in program effectiveness (i.e., performance)

• Must obtain NRC approval prior to implementation Examples: Increasing cutoffs or removing drugs to be tested Changing when random testing is to be conducted Reducing management/supervisory oversight of plant staff (behavioral observation)

3. Changes to the credited technical analysis used to justify meeting the FFD criterion

4. Substantial changes must be provided in the annual FFD performance report submitted to the NRC

5. D&A program changes must have a Forensic Toxicologist review

6. Changes must be documented, justified, and maintained 26 Section-by-Section - Amendments to Part 26 for Part 53 Licensees

W h y? To maintain FFD program effectiveness if licensee implements program changes

Based on: Existing change control processes in Sections 50.48(f)(3), 50.54(p) and (q)(3), the change control processes for fire protection, security and emergency plans, § 50.59, and that proposed in Part 53

Program Flexibilities

• May use either urine or oral fluid

• May use of POCT and assessment devices - if certain requirements are met

• May use of offsite collection facilities - must be audited

• Specimen collection, storage, shipping are per manufacturer s instructions

• The framework will require Forensic Toxicologist review for D&A program changes

• Nothing in Subpart M prohibits a Part 53 licensee or other entity specified from subjecting all individuals to an FFD program that meets:

o Subpart M o All the requirements in this part, except Subparts K and M o A drug testing program described in the HHS Guidelines 27 Section-by-Section - Amendments to Part 26 for Part 53 Licensees

• 26.604, FFD program for Part 53 facilities that meet the FFD criterion

a. The FFD program:

1. Applies to the individuals in § 26.602

2. Implements the program elements in § 26.603

3. Implements the following subparts and requirements:

i. Subpart AAdministrative Provisions ii. Subpart OInspections, Violations, and Penalties iii. § 26.23, Performance objectives iv. § 26.606, Written policies and procedures

v. § 26.608, FFD program training vi. § 26.609, Behavioral observation vii. § 26.610, Sanctions viii. § 26.611, Protection of information ix. § 26.613, Review process

x. § 26.615, Audits xi. § 26.617, Recordkeeping and reporting xii. § 26.619, Suitability and fitness determinations 28 Section-by-Section - Amendments to Part 26 for Part 53 Licensees

• 26.605, FFD program for facilities that do not meet the FFD criterion or is a holder of a Manufacturing License for assembling and/or fueling a reactor module under Part 53

a. For construction or construction activities, or is a holder of a Manufacturing License for assembling and/or fueling a reactor module under Part 53

1. Applies to the individuals in § 26.602

2. Implements the program elements in § 26.603

3. Implements the following subparts and requirements:

i. Subpart AAdministrative Provisions ii. Subpart IManaging Fatigue (limited applicability) iii. Subpart OInspections, Violations, and Penalties iv. § 26.23, Performance objectives

v. § 26.606, Written policies and procedures vi. § 26.607, D&A testing vii. § 26.608, FFD program training viii. § 26.609, Behavioral observation ix. § 26.610, Sanctions

x. § 26.611, Protection of information xi. § 26.613, Review process xii. § 26.615, Audits xiii. § 26.617, Recordkeeping and reporting xiv. § 26.619, Suitability and fitness determination 29 Section-by-Section - Amendments to Part 26 for Part 53 Licensees

• 26.605, FFD program for facilities that do not meet the FFD criterion

b. Before (1) the loading of fuel onsite into a reactor vessel, (2) integrating a fueled reactor module into the facility, or (3) operating, testing, performing maintenance of, or directing the maintenance or surveillance of security-related equipment or equipment that a risk-informed evaluation process has shown to be significant to public health and safety, the licensee shall establish, implement, and maintain an FFD program that:

1. Applies to the individuals in § 26.602

2. Implements the program elements in § 26.603(a) - (e)

3. Implements the following subparts and requirements:

i. Subpart AAdministrative Provisions ii. Subpart CGranting and Maintaining Authorization iii. Subpart DManagement Actions and Sanctions to be Imposed iv. Subpart HDetermining Fitness -for-Duty Policy Violations and Determining Fitness

v. Subpart IFatigue Management vi. Subpart NRecordkeeping and Reporting Requirements vii. Subpart OInspections, Violations, and Penalties viii. § 26.23, Performance objectives ix. § 26.606, Written policy and procedures

x. § 26.607, D&A testing xi. § 26.608, FFD program training xii. § 26.609, Behavioral observation xiii. § 26.611, Protection of information xiv. § 26.613, Review process 30 xv. § 26.615, Audits Section-by-Section - Amendments to Part 26 for Part 53 Licensees

• 26.606, Written policy and procedures

• 26.607, Drug and alcohol testing

1. Must deter and detect substance abuse

2. Must use urine or oral fluid biological specimens and split specimen collections

3. Must be conducted for the pre-access, random, for-cause, post-event, and follow-up test conditions

i. Random testing must be 50 percent for both licensee employees and contractor/vendors (see next slide)

4. Validity, initial, and confirmatory testing must be conducted at an HHS -certified laboratory (issuance of sanctions)

5. Must used FDA-cleared devices

6. May use a POCT device for screening - for random testing only

7. Specimen collections may be conducted at a local hospital of collection facility - State certified or nationally accredited, and must be audited against Part 26, Subpart E, Collecting Specimens for Testing

8. Must used approved Custody and Control Forms

9. Must have MRO reviews

10. Worker protections: limitations of testing, donor consent, testing of split specimens, MRO reviews, protection of information, and privacy 31 Random Testing Rate - a Discussion and Illustration

Proposed Random testing at those facilities that must conduct D&A testing shall ensure that:

• Testing is conducted at an annual 50 % random rate

• The 50 % random rate must be applied to both the licensee employees & contractor/vendor populations

32 Section-by-Section - Amendments to Part 26 for Part 53 Licensees

• 26.608, FFD program training o Training Periodicity - conducted prior to pre-access testing, with periodic refresher training o Training Review - periodically evaluated and revised as appropriate to reflect site and industry experience

• 26.609, Behavioral observation

• 26.610, Sanctions

• 26.611, Protection of information

• 26.613, Review process

• 26.615, Audits o Program elements, which are not part of the FFD program performance and monitor review described in § 26.603(d), must be audited at a frequency that ensures their continuing effectiveness and that corrective actions are taken to resolve any problems identified 33 Section-by-Section - Amendments to Part 26 for Part 53 Licensees

• 26.617, Recordkeeping and reporting o Records must be maintained o Reports to NRC - 24-hour reports and annual reports using the NRC -provided electronic reporting forms o Reports to other licensees regarding FFD -related information to support FFD and access authorization program implementation

• 26.619, Suitability and fitness determinations o Procedures for evaluating whether to assign individuals to perform or direct those duties and responsibilities making them subject to this subpart.

o Procedures must provide reasonable assurance that the individuals are fit to safely and competently perform their duties and are trustworthy and reliable, as demonstrated by the avoidance of substance abuse.

34 Discussion

35 10 CFR Part 26, Subpart I, Managing Fatigue Considerations for Part 53 Licensees

36

• For Part 26, Subpart I, Managing Fatigue, not much will be changing in the rule text.

o Changes under consideration are primarily administrative in nature, serving to apply Subpart I requirements to Part 53 licensees.

• Key consideration: For work hour controls, the NRC is considering enabling flexibility under the existing rule text.

o Degree of flexibility permissible will depend on the results of the applicants risk-informed safety evaluation o Applicants may be able to demonstrate that work hour controls are not needed for the same individuals or in the same circumstances as they would traditionally be needed for a large light water reactor site.

37 An example of how work hour controls could be considered with flexibility - designs with less reliance on operator actions for safe operation

• The work hour controls listed in 10 CFR 26.205 are applicable to the individuals listed in

§ 26.4(a).

o § 26.4(a)(1) ties in individuals whose duties include operating or onsite directing of the operation of systems and components that a risk -informed evaluation process has shown to be significant to public health and safety.

• If an applicant determined, through their risk -informed evaluation, that operators at a facility will not be operating risk -significant systems or components, those operators may not need to be subject to work hour controls.

o Such facilities would likely be those that incorporate designs relying on a greater degree of automation, passive safety features, and/or inherent safety characteristics for safe operation.

o The associated risk evaluation would need to demonstrate that the systems relied upon for safety are adequately robust and incorporate sufficient defense-in-depth into their design. 38 Another example - designs for which operator actions are relied upon for safety only during limited periods of operation

• A licensees risk-informed evaluation could determine that operator action is only relied upon for safety during certain plant evolutions.

o For example, the applicants evaluation could conclude that plant safety during the startup of a facility relies on operator action, while plant safety does not rely on operator action during periods of normal/steady-state operation.

• In such instances, operators may only need to be subject to work hour controls during certain periods.

o In the example above, operators would need to be subject to work hour controls during startup, but they might not need to be subject to work hour controls during periods of normal/steady-state operation.

39 Key consideration for applicants that intend to utilize flexibility in applying work hour controls:

Applicants that intend to not apply work hour controls to operators during any period while the plant is operating will need to provide sufficient justification in their risk-informed evaluations.

40 Another consideration: w ork hour control applicability to remote w orkers

• In various instances throughout the § 26.4(a) text, the requirements refer to the onsite directing of activities associated with risk -significant structures, systems, and components.

• Some facilities licensed under Part 53 may, as part of their design basis, perform applicable operations or maintenance activities from a remote facility (for example, a remote control room or a remote control station/console).

o In such instances, the NRC would consider such a remote facility to be an extension of the site for the purposes of considering onsite directing.

41 Discussion

42 Discussion of Other Part 53 Sections and Subparts

43 Other Part 53 Sections and Subparts

• Subpart B - Technology-Inclusive Safety Requirements (3rd iteration)

(ML21202A162)

• Subpart C - Requirements for Design and Analysis (3rd iteration)

(ML21202A162)

• Subpart F - Requirements for Operation (Staffing) (ML21267A006)

• Subpart H - Licenses, Certifications, and Approvals (ML21267A004)

• Subpart I - Maintaining and Revising Licensing Basis Information (ML21202A175)

• Subpart J - Reporting and Other Administrative Requirements (ML21225A224)

44 Other Part 53 Sections and Subparts

Discussion

45 Final Discussion and Questions

46 Future Public Meetings

• The NRC staff will continue to announce public meetings to discuss and receive feedback on various regulatory topics and preliminary proposed rule text.

o Preliminary proposed rule language will be posted on regulations.gov under docket ID NRC-2019- 0062 before the public meetings.

• The NRC staff is scheduled to meet with the ACRS on February 2, 2022.

o Subpart F - Requirements for Operations. Discussions on staffing, personnel qualifications, training, and human factors requirements

47 Closing Remarks Rulemaking Contacts Robert.Beall@nrc.gov 301-415-3874 Nanette.Valliere@nrc.gov 301-415-8462

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

48 Acronyms and Abbreviations

ACRS Advisory Committee on Reactor Safeguards

ADAMS Agencywide Document Access Management System

BOP Behavioral observation program

C/V Contract Vendors

D&A Drug and Alcohol

CFR Code of Federal Regulations

FDA U.S. Food and Drug Administration

FFD Fitness for Duty

HHS U.S. Department of Health and Human Services

MRO Medical review officer NRC U.S. Nuclear Regulatory Commission

NRR Office of Nuclear Reactor Regulation

PA Protected area

POCT Point of collection testing

49 Background Slides

50 First Principles

See: SECY-18-0096, Functional Containment Performance Criteria for Non-Light -Water-Reactors, and INL/EXT-20-58717, Technology -Inclusive Determination of Mechanistic Source Terms for Offsite Dose -Related Assessments for Advanced Nuclear Reactor Facilities 51 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 52 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.

53

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,

54 NRC Staff Plan to Develop Part 53

Subpart B Subpart C Subpart DSubpart E Subpart F Subpart G Project Life Cycle Design and Siting Construction Operation Retirement Requirements Definition Analysis External Facility Safety

• Safety Objectives Hazards Construction/ Program

• Safety Criteria System

• Safety Functions & Component Manufacturing Surveillance Design Site Characteristics Ensuring Maintenance Analysis Capabilities/

Requirements Environmental Reliabilities Configuration Considerations Control Safety Change Control Categorization Staffing &

& Special Environmental Human Factors Treatment Considerations Programs Security, EP

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

Subpart A Clarify

General ProvisionsAnalyses (Prevention, Mitigation, Compare to Criteria) Controls Subpart J and

Admin & Reporting Plant Documents (Systems, Procedures, etc.) Distinctions Other 10 CFR Between Parts LB Documents (Applications, SAR, TS, etc.) Subparts H & I 55