ML22188A158

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Part 53 Preliminary Proposed Draft Rulemaking for Fitness for Duty and Access Authorization and Programs
ML22188A158
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Issue date: 07/14/2022
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Presentation to the Nuclear Energy Institutes Annual Fitness for Duty/Access Authorization Workshop NRC Program Update Part 53 Preliminary Proposed Draft Rulemaking for Fitness for Duty and Access Authorization Programs U.S. Nuclear Regulatory Commission 10 CFR Part 26, Fitness for Duty Programs July 13-14, 2022

Slide 2 Disclaimer The information provided in this presentation is a public service and solely for informational purposes and is not, nor should be deemed as an official NRC position, opinion, or guidance, or a written interpretation of the General Counsel under 10 CFR Part 26.7, on any matter to which the information may relate. The opinions, representations, positions, interpretations, guidance, or recommendations which may be expressed by the NRC technical staff regarding this presentation and discussion in response to a comment, question, or concern are solely the NRC technical staffs and do not necessarily represent the same for the NRC. Accordingly, the fact that the information was obtained through the NRC technical staff will not have a precedential effect in any legal or regulatory proceeding, such as inspection, licensing, or rulemaking.

Wikipedia, INL.gov and hyperleap.com USS Nautilus (SSN 571)

Slide 4

Camp Century (PM1-2A)

Bettmann Archives/Getty Images Slide 5

Slide 6 Advanced Reactors Nomenclature Modular Transportable Fast neutron reactors Manufactured reactors High-temperature gas-cooled reactors Pebble bed reactors - uranium oxycarbide Molten salt reactors of fluoride or chloride Brayton heat cycle - heat pipes Key Attributes Reactor size and electrical output Small or no containments - atmospheric pressure Core meltdowns may be a thing of the past Ultimate heat sink is the earth or environment Very low radiological consequences 3 - 8 year refueling cycles At-power reactor installation & replacements Whole system replacements Passive safety and security systems Automated controls, components, and systems Reduced reliance on human actions Potential for autonomous operation Scitechdaily.com

Slide 7 Advanced Fuel Designs Sciencedirect.com Enercon.com Internet; open source Internet; open source

Optimizing rule text to clarify intent, remove unnecessary requirements, and ensure consistency Optimizing Assessing and considering all stakeholder comments as rule text nears finalization Assessing Engaging stakeholders on consolidated rule through multiple opportunities Integrating and harmonizing Frameworks A and B Integrating Prioritizing and developing key guidance documents to support the rule and near-term applicants Developing Engaging Part 53 - Rulemaking Key Messages Slide 8

Under Development Part 53 - Key AA and FFD Guidance Slide 9

  • Concept of Operations/Staffing
  • Access Authorization
  • Physical Security
  • The Commission stated that it fully expects that vendors engaged in designing new standard (or custom) plants will achieve a higher standard of severe accident safety performance than their prior designs. (Ref. 1)
  • the Commission expects that advanced reactors will provide enhanced margins of safety and/or utilize simplified, inherent, passive, or other innovative means to accomplish their safety functions. (Ref. 2)
  • although the Commission strongly supports the use of the information and experience gained from the current generation of reactors as a basis for improving the safety performance of new designs, the NRC should not adopt industry objectives as a basis for establishing new requirements. (Ref. 3)

Part 53 - Commission Policy Statements Slide 10 Ref. 1 NRC Policy Statement, A Severe Reactor Accidents Regarding Future Designs and Existing Plants, 50 FR 32138, August 8, 1985.

Ref. 2 NRC Policy Statement, Regulation of Advanced Nuclear Power Plants, 59 FR 35461, July 12, 1994.

Ref. 3 SECY-90-016, Evolutionary Light Water Reactor (LWR) Certification Issues and Their Relationship to Current Regulatory Requirements, January 12, 1990, and associated SRM, June 26, 1990.

Policy Statement on the Regulation of Advanced Reactors*

  • Provided 14 attributes that could assist in establishing the acceptability or licensability of a proposed advanced reactor design, and therefore should be considered in advanced designs.
  • Of these 14, if effectively designed and implemented at the reactor facility, most all refer to technologically advanced SSCs using phrases like:

1.

Simplified safety systems; highly reliable, and less complex SSCs 2.

Slower accident progression - longer time constants 3.

Fewer SSCs subject to harsh environmental conditions - improved SSC operability 4.

Fewer SSCs that require human/operator actions - passive safety & security SSCs 5.

Significantly longer refueling periodicities 3 to 8 years vs 18 months - fewer C/Vs onsite 6.

Modular designs - potentially including modular replacement Part 53 - Commission Policy Statements

Slide 12 Providing an equivalent level of safety and security; this does not mean an equivalent set of requirements Maintaining reasonable assurance that individuals are fit for duty and trustworthy and reliable Leveraging operating experience from power and non-power reactors, and material licensees Engaging stakeholders early to obtain diverse views Part 53 Rulemaking Update Preliminary Draft The Key Messages for AA and FFD NatriumTM

Slide 13 Risk-informed Implementing a graded approach in the application of AA/FFD requirements based, in part, on radiological consequences Technology Regulatory flexibility enables current and future technologies Inclusive Innovative The proposed FFD framework uses objective-based requirements based on construction FFD requirements* and selected requirements from 10 CFR Part 26, Subparts A - I Performance Monitoring site FFD performance data, assessing this

-based performance against site, fleet, and industry historical performance, and implementing corrective actions Part 53 - The AA/FFD Preliminary Draft Proposed Framework

  • Objective-based requirements are those that require you to do something, but they do not tell you how Preliminary Draft

The radiological consequences from a hypothetical, unmitigated bounding event, unmitigated by human actions, 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 reference values defined in §§ 53.220(b)(1) and (2)

Both AA and FFD will refer to the proposed consequence-based criterion in §53.830(a)(2)(i)*

Part 53 - The Proposed AA and FFD Criterion

  • This is the same radiological risk consequence criteria proposed for the physical protection and cyber requirements.

Preliminary Draft eVinciTM Slide 14

Part 53 - The AA Framework A graded approach based on the proposed consequence-based criterion

  • If the applicant demonstrates that its facility would not meet the criterion, the AA program would be the same as that at a current operating power reactor
  • If the applicant demonstrates its facility would meet the criterion, the AA program would be scaled based on the programs at non-power production and utilization facilities and certain material licensees.

For this subset of licensees, this framework would maintain key elements of the existing trustworthy and reliability requirements in the AA programs for individuals requesting unescorted access (10 CFR Part 37 and 73.56)

Slide 15 Preliminary Draft

Apply 10 CFR Part 26 Physical & AA - §§ 73.54, 73.55, 73.56, 73.57 IMP - §§ 73.55(b)(7) & 73.55(b)(9)

Existing performance/prescriptive requirements on design to protect against the DBT Advanced Reactor Applicant Consequence Based Criterion, § 53.830(a)(2)(i)

Criterion Not Met

  • Consequences endanger public (radiological sabotage as defined in § 73.2)
  • Protect against the Design Basis Threat Criterion Met
  • Consequences do not endanger public (no radiological sabotage (as defined in § 73.2)
  • May elect to implement AA program or provide exemptions from certain requirements.

Safety Related Equipment

  • § 53.460 Safety Category and Treatment (use the scalable designation of equipment required for maintaining safety basis/operations to determine the need for access to equipment and plant areas)

Apply § 73.120

  • Criminal History
  • Granting/maintaining UA/Termination UA Licensee has no safety-related safety structures, systems, and components and only designated NSRSS structures, systems and components must meet the requirements of § 73.120 Apply Full § 73.56 AA performance requirements to provide high assurance that individuals are trustworthy and reliable, and do not constitute an unreasonable risk to public health and safety, the common defense and security, or radiological sabotage Part 53 - The Access Authorization Framework Slide 16 Preliminary Draft

Slide 17 Part 53 - The Access Authorization Framework Preliminary Draft If the criterion is met The proposed§53.120 general performance objectives states in part: Each licensee's or applicants access authorization program under this section must provide reasonable assurance that the individuals granted unescorted access are trustworthy and reliable, such that they do not constitute an unreasonable risk to public health and safety or the common defense and security...

§53.120 would require:

background investigation (e.g., FBI criminal history, verification of True-Id &

employment, credit history, reference check) with periodic reinvestigations behavioral observation including reporting, self-reporting, and the determinations of trustworthiness and reliability for CVs that support licensees in meeting the rule requirements are audited annually Also:

Roles and responsibility of the Reviewing Official has been clarified Record retention requirements will be maintained

Slide 18 Part 53 - The Access Authorization Framework Preliminary Draft NuScaleTM If the criteria is met, the following requirements are not required by proposed rule:

1.

AA-required BOP training - FFD still requires BOP training*

2.

Re-investigation periods will be a 10 years verses the 3 or 5 years**

3.

The record retention period is 3 years instead of 5 years**

BOP training includes characteristics of fitness, as well as characteristics of trustworthiness and reliability Required by the existing AA program for LLWRs

Slide 19 The Framework The Graded Approach Technical Messages Key Program Elements

Comparison of Principal Requirements

Other FFD Requirements

Performance Monitoring and Review

Margin - The Key Concept

Change Control Process Small Staff Sizes Geographically-remote Locations Part 53 - The Fitness for Duty Framework Preliminary Draft X-energy Xe-100 X-energy Xe-Mobile X-energy

Slide 20 Preliminary Draft Georgetown.edu ocregister.com etcourse.com The FFD Framework A graded approach based on the proposed consequence-based criterion A new Subpart M in Part 26 is proposed for Part 53 applicants, licensees, and other entities The proposal is based on Part 26, Subpart K, FFD Program for Construction and the FFD program in Subparts A - I, N, and O A Part 53 facility will not be allowed to implement Subpart K If the applicant meets the criterion, drug and alcohol testing would not be required Navy.mil

Existing 10 CFR Part 26 FFD Programs Subparts A-I, N, & O, full program Subpart K, construction program*

Decommissioning program (TBD)

Part 26, Subpart M - 10 CFR 26.604 FFD Program

1. Must have a behavioral observation program and implement administrative requirements
2. Enables, but does not require a drug/alcohol testing program Part 26, Subpart M - 10 CFR 26.605 FFD Program
1. Requires drug/alcohol testing and behavioral observation
2. Prior to reactor operation, the licensee or other entity must implement an FFD program that meets the Subpart C, FFD Authorization; Subpart D, Mgt actions/sanctions; Subpart H, FFD Policy Violations and Determining Fitness; Subpart I, fatigue management; and, Subpart N, recordkeeping and reportability requirements Criterion not met Criterion met Options for a Part 53 utilization facility
  • only by exemption Preliminary Draft Options for a Holder of a ML for assembly and/or fueling a manufactured reactor Part 53 - The FFD Graded Approach Slide 21

Slide 22 Risk-informed - proposal based on FFD program requirements for commercial power reactors under construction, and informed by standards at non-power production and utilization facilities Technology Inclusive - proposal enables:

Urine or oral fluid testing for all test conditions (required)

Hair for pre-access testing of Schedule I drug metabolites (enabled)

Point of Collection Testing and Assessment Devices (enabled for random screening)

Passive drug and alcohol screening devices at Protected Area portals (enabled)

Innovative Regulatory Framework Licensee developed, implemented, and maintained FFD procedures Licensees may leverage the HHS Guidelines by section (HHS-certified labs)

Performance-based requirements Part 53 - FFD Technical Messages

RVM - reactor vessel module (i.e., a manufactured reactor) assembly and/or fueling under an NRC-issued Manufacturing License Part 53 - Comparison of Principal FFD Requirements Preliminary Draft Slide 23

Slide 24 Part 53 - Other FFD Requirements Requirements for every FFD program Subpart A - Administrative Requirements Purpose Scope FFD program applicability to individuals Definitions Interpretations Information collection requirements: OMB Specific exemptions Communications Subpart O - Inspections, Violations, and Penalties Inspections Violations Criminal penalties Other requirements for every FFD program Written policy and procedures Behavioral observation Sanctions Protection of information Review process (i.e., appeals)

Audits Recordkeeping and reporting Suitability and fitness evaluations Preliminary Draft

Slide 25

  • Performance measures, thresholds, and corrective actions
  • Review required as FFD data occurs, i.e., a FFD policy violation occurs
  • Applies to sites that meet or do not meet the criterion and applies to manufacturing licensees during the assembly and/or fueling of the manufactured reactor Compare:

site performance to previous year site performance - year-to-year site performance to FFD Program performance (the corporate fleet of reactors) site performance to industry performance Categorize: Licensee employees Contractor vendors Labor category, e.g., licensed operators, supervisors, security, etc.

Audits - routine and periodic qualitative reviews o

Worker protections (appeals process, privacy, and info protection o

Laboratory and MRO performance o

Change control process o

Offsite collection facilities Part 53 - FFD Performance Monitoring and Review Preliminary Draft

Slide 26 Proposed Performance Measures 1.

Conduct of the behavioral observation program 2.

Occurrence of FFD policy violations categorized by LE, C/V, and labor category 3.

Occurrence of individuals with PDI or who possessed FFD prohibited items 4.

If drug and alcohol testing, performance measures must also include:

a) pre-access and random positive testing rates b) random testing rate for LE and C/Vs set at 50 percent for each population c) number of subversion attempts categorized by LE, C/V, and labor category Thresholds - licensee determined, based on historical industry performance Corrective Actions - must be taken when the threshold is received NRC Regulatory Guide will be issued with the draft rule Preliminary Draft Part 53 - FFD Performance Monitoring and Review PDI - potentially disqualifying information

1. Random drug and alcohol testing
2. Behavioral observation
3. For-cause and post-event testing
4. Peer reviews (teamwork)
5. Periodic access reviews
6. Quality control and verification Pre-Access Activities Inside the Protected Area Contrarian FFD Performance
1. High random positivity rate
2. High for-cause testing rate (BOP)
3. High subversion attempt rate or occurrences
4. FFD training failures
5. Event or re-work with an FFD-related apparent cause Protected Area Screening Behavioral observation Package screening (x-ray)

Personal screening (true identify)

All FFD/AA requirements met Performance Observations

  • An FFD-related prohibited item is like alcohol, marijuana, subversive paraphernalia Slide 27 Preliminary Draft Part 53 - FFD Preliminary Draft Proposed Framework Example - Contrarian Performance: Pre-access vs. Protected Area
1. FFD consent
2. FFD training
3. Pre-access drug and alcohol testing
4. Self-disclosure/suitable inquiry
5. Behavioral observation
6. Access authorization requirements Pre-Access FFD Performance
1. Very low positivity rate
2. Very low subversion rate
3. Few FFD training failures
4. Few FFD-related prohibited items identified at PA portal

Defense-in-Depth, in part, provided by:

1. Post-maintenance testing, re-work, and operability determinations
2. Teamwork, peer review, and management oversight
3. Training and qualifications
4. Quality assurance, verification, and control
5. Audits, performance monitoring, and procedures Margin provided by the FFD program elements:

1.

Safety and security of the Part 53 facility 2.

Self-disclosures, suitable inquiries, and consent to test 3.

Pre-access, random, for-cause, and follow-up testing 4.

Behavioral observation 5.

Authorization 6.

Policy, procedures, training, and auditing 7.

Protection of sensitive information 8.

Medical Review Officer evaluation of test results 9.

Fitness determinations (Substance Abuse Experts)

10. HHS-certified laboratories FFD Performance Objectives 10 CFR 26.23 NRC Mission Proposed FFD Performance Monitoring and Review Program 10 CFR 26.603(d)

Margin provided by the 10 CFR regulatory framework Margin provided by the 10 CFR Part 26 FFD program elements and the PMRP thresholds Indicators of Weakening FFD Performance:

1. Increased random testing positivity rate
2. Increased re-work or for-cause testing
3. Increased human errors or workplace accidents
4. Increased documentation or procedural errors
5. Increased MRO or laboratory errors
6. Increased FFD training failures
7. Inadequate control of sensitive information Historical FFD Performance Part 53 - FFD Margin - The Key Concept Preliminary Draft Slide 28

Slide 29

  • A change may be made if it does not reduce FFD program effectiveness
  • Forensic toxicology reviews needed for technical and process changes
  • Requirement is based on §§ 50.54(p) and (q), security and emergency plan changes
  • The licensee shall retain a record of each change made under this section for a period of at least five years from the date the change was implemented and summarize this change in its annual FFD performance report required by §§ 26.617(b)(2) or 26.717, as applicable.
  • Examples of what could be made o

Changes in response to HHS Guideline changes o

Changes in the site conduct of urine and oral fluid testing o

Change to a point of collection testing and assessment device (random screening) o Used of an on or offsite collection facility o

Use of hair specimens for pre-access screening Part 53 - FFD Change Control Process Preliminary Draft

Slide 30 Small staff sizes can degrade behavioral observation (identification and mitigation of an insider threat) and challenge NRC Safety Culture.

Small group dynamics Different cultural and social norms Geographically-remote locations may exacerbate the small staff size challenge.

Part 53 - FFD and Small Staff Sizes Preliminary Draft Pele

Slide 31 Small Group Dynamics Negative Characteristics

  • Weak, dominating, or narcissistic leadership
  • Excessive deference to offsite authority
  • Passive-aggressive behavior
  • Over-accountability
  • Withdrawal - the reactor runs itself...
  • Group think - lack of critical thinking
  • Motivation Reasoning/Confirmatory Bias
  • An impaired individual reduces staff size Positive Characteristics
  • Small groups can perform very well
  • Strong ownership and accountability
  • Comradery - micro-teams, peer checking
  • Self-reliance - We can do this
  • Fungibility of staff members
  • Baseline BOP I see the person every day We operate like a family Part 53 - FFD and Small Staff Sizes teaching.usask.ca humanesociety.org Preliminary Draft

Slide 32 Potential Impact on Human Performance Elements More solo operations Less teamwork Fewer peer checks Fewer for-cause tests Problem identification & resolution challenges Remote technical and management oversight With a small staff size, is it possible that in certain situations the relative contribution of an individual to safety and security is greater than that of other facilities with larger staff sizes, despite advances in passive and automated technologies?

Part 53 - FFD and Small Staff Sizes Preliminary Draft Unsplash.com Amit Serper, Twitter.com

Slide 33 NRC Safety Culture Policy Statement* - Attributes 1.

Leadership Safety Values and Actions 2.

Work processes 3.

Questioning attitude 4.

Problem Identification and Resolution 5.

Environment for raising safety concerns 6.

Effective safety communications 7.

Respectful work environment 8.

Continuous learning 9.

Personal accountability The NRC's approach to safety culture is based on the premise that licensees bear the primary responsibility for safety The NRC provides oversight of safety culture through expectations detailed in policy statements, safety culture assessor training for NRC inspectors, the oversight process, and the allegation and enforcement programs Part 53 - FFD and Small Staff Sizes https://www.nrc.gov/about-nrc/safety-culture/sc-outreach-edu-materials.html#sctt

Slide 34 Geographically-remote site locations:

Arid or Winter regions U.S., Caribbean, and Pacific Islands Potential uses for micro and very small reactors Communities Desalinization water plants Hospitals, universities, national laboratories, amusement and water parks Heavy Industry - refineries, steel production, oil sands, mining (including crypto)

Transportation infrastructure Part 53 - FFD Preliminary Draft Proposed Framework Both - internet open source

Slide 35 Geographically-remote Site Locations Substance abuse - Will the drug profile and prevalence be different?

Cultural considerations - equity, self-reliance, independence Social and economic considerations - families, jobs, and community State oversight - remote or periodic Self-rule - Native American Indian Tribes (tribal police force)

Protectionism - You look under the weather, why dont you go home?

Infrastructure - roads, airfields, healthcare (emergency response)

Medical treatment - impairment (for-cause) and post-accident testing

Drug/alcohol testing - availability of collection facilities, clinics, postal service

Fitness Determinations - Medical Review Officer, all by tele-medicine?

Substance Abuse Professionals - follow-up treatment programs, tele-medicine?

Part 53 - FFD Preliminary Draft Proposed Framework Preliminary Draft

Slide 36 Part 53 Rulemaking Schedule Part 53 - FFD Preliminary Draft Proposed Framework

Slide 37 Part 53 - References and Links Rulemaking Docket ID NRC-2019-0062; RIN 3150-AK31 at Regulations.gov Consolidated preliminary rule language, second iteration, was released in May 2022 (ADAMS accession no. ML22125A000)

Regulatory guidance is being developed More public meetings will be conducted, https://www.nrc.gov/about-nrc/regulatory/rulemaking/public-involvement.html NRC welcomes stakeholder comments, https://www.regulations.gov/docket/NRC-2019-0062 Pele

Part 53 Rulemaking Contacts Robert.Beall@nrc.gov 301-415-3874 Jordan.Hoellman2@nrc.gov 301-415-5481 Subscribe to GovDelivery:

https://service.govdelivery.com/accounts/USNRC/subscriber/new Part 53 - FFD Preliminary Draft Proposed Framework Slide 38

Slide 39 Office of Nuclear Security and Incident Response Division of Physical and Cyber Security Policy Paul Harris, Senior Program Manager, Fitness for Duty, Drug & Alcohol Testing Paul.Harris@nrc.gov (301-287-9294)

Brian Zaleski, Specialist - Fitness for Duty/Access Authorization Brian.Zaleski@nrc.gov (301-287-0638)

Brad Baxter, Security Specialist - Access Authorization Brad.Baxter@nrc.gov (301-287-3615)

Office of Nuclear Reactor Regulation Division of Reactor Oversight Justin Vazquez, Reactor Operations Engineer, Human Factors, Fatigue Justin.Vazquez@nrc.gov (301-415-0530)

NRC Fitness for Duty Program Staff

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