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{{#Wiki_filter:Using the Toolkit A Reset and Refresher onBackfittingand Issue Resolution Today's Session PutsBackfittingin Context"Reset" and refresh thinking on backfittingand issue resolution3 key objectives:Primer on backfittingin the context of licensing basis and issue resolutionRefresher on promptly raising and resolving safety/security issuesPreview of NRC's planned activities on backfitting 2
{{#Wiki_filter:Using the Toolkit A Reset and Refresher on Backfitting and Issue Resolution
 
Todays Session Puts Backfitting in Context Reset and refresh thinking on backfitting and issue resolution 3 key objectives:
Primer on backfitting in the context of licensing basis and issue resolution Refresher on promptly raising and resolving safety/security issues Preview of NRCs planned activities on backfitting 2
 
Primer on Backfitting 3
Primer on Backfitting 3
BackfittingRelates to New or Changed Requirements or InterpretationsBackfitting is a Code of Federal Regulationsrequirement for the NRCStructured approach for imposing a new requirementAssumes it is an entity with such protectionsBackfitscan occur after a regulatory approval if there are:Changed or new requirements (regulation, technical specification, license condition, order)Changed or new position imposedby the staff (including implied or inferred imposition)Backfitsaffect:systems, structures, or components (design or the actual equipment)organization or procedures for design, construction, or operation 4 Only Certain Entities Are ProtectedPower reactors (10 CFR 50.109)New power reactors (various similarprovisions in 10 CFR Part 52, termed issue finalityinstead of backfitting
 
)Fuel cycle facilities (10 CFR 70.76
Backfitting Relates to New or Changed Requirements or Interpretations Backfitting is a Code of Federal Regulations requirement for the NRC Structured approach for imposing a new requirement Assumes it is an entity with such protections Backfits can occur after a regulatory approval if there are:
)ISFSIs (10 CFR 72.62)Gaseous diffusion plants (10 CFR 76.76) [none currently regulated]
Changed or new requirements (regulation, technical specification, license condition, order)
5 10 CFR 50.109 Is the Most Familiar Example of the "BackfitRule"(a)(1): definition of backfitting
Changed or new position imposed by the staff (including implied or inferred imposition)
-applicability and scope(a)(2): requirement for a systematic and documented analysis, except where an exception applies(a)(3): requirement for substantial increase in overall protection of the public health and safety or the common defense and security, and that implementation costs are justified, except where an exception applies(a)(4): three exceptions to (a)(2) and (a)(3) related to compliance and adequate protection (to be discussed later), with documented evaluation needed(a)(5): always require backfittingif it is necessary for adequate protection(a)(6): details of documented evaluation under (a)(4)(a)(7): choice among ways to achieve compliance (including consideration of cost)(b): timing(c): considerations to be made in determining (a)(3)(d): no licensing action will be withheld during backfitanalysis(e): responsibility of the Executive Director for Operations 6
Backfits affect:
NRC Must Take Action on Matters of Adequate Protection or Common Defense and SecurityIf backfittingis necessary to ensure adequate protection, then it is required by the Atomic Energy Act.No explanation or cost justification is required.10 CFR 50.109(a)(5
systems, structures, or components (design or the actual equipment) organization or procedures for design, construction, or operation 4
): The Commission shall always require the backfittingof a facility if it determines that such regulatory action is necessary to ensure that the facility provides adequate protection to the health and safety of the public and is in accord with the common defense and security.
 
7 Two Categories of BackfitsAre Excepted from the Need for a BackfitAnalysisAdequate protectionNecessary to ensure that the facility provides adequate protection to the public health and safety and is in accord with the common defense and security May involve redefiningwhat level of protection to the public health and safety or common defense and security should be regarded as adequateExample:orders on mitigation of beyond
Only Certain Entities Are Protected Power reactors (10 CFR 50.109)
-design-basis events after the Fukushima Dai
New power reactors (various similar provisions in 10 CFR Part 52, termed issue finality instead of backfitting)
-Ichi accidentComplianceNecessary to bring a facility into compliance with a license, rules, or orders, or into conformance with written commitments by the licenseeInvolves facts that were mistaken or omitted when the activity was authorized, so something needs to changeNotpure enforcement (where requirement is clear) and notnew or revised interpretations of what was needed to comply with NRC requirements at the time of approval
Fuel cycle facilities (10 CFR 70.76)
ISFSIs (10 CFR 72.62)
Gaseous diffusion plants (10 CFR 76.76) [none currently regulated]
5
 
10 CFR 50.109 Is the Most Familiar Example of the Backfit Rule (a)(1): definition of backfitting - applicability and scope (a)(2): requirement for a systematic and documented analysis, except where an exception applies (a)(3): requirement for substantial increase in overall protection of the public health and safety or the common defense and security, and that implementation costs are justified, except where an exception applies (a)(4): three exceptions to (a)(2) and (a)(3) related to compliance and adequate protection (to be discussed later), with documented evaluation needed (a)(5): always require backfitting if it is necessary for adequate protection (a)(6): details of documented evaluation under (a)(4)
(a)(7): choice among ways to achieve compliance (including consideration of cost)
(b): timing (c): considerations to be made in determining (a)(3)
(d): no licensing action will be withheld during backfit analysis (e): responsibility of the Executive Director for Operations 6
 
NRC Must Take Action on Matters of Adequate Protection or Common Defense and Security If backfitting is necessary to ensure adequate protection, then it is required by the Atomic Energy Act.
No explanation or cost justification is required.
10 CFR 50.109(a)(5): The Commission shall always require the backfitting of a facility if it determines that such regulatory action is necessary to ensure that the facility provides adequate protection to the health and safety of the public and is in accord with the common defense and security.
7
 
Two Categories of Backfits Are Excepted from the Need for a Backfit Analysis Adequate protection Necessary to ensure that the facility provides adequate protection to the public health and safety and is in accord with the common defense and security May involve redefining what level of protection to the public health and safety or common defense and security should be regarded as adequate Example: orders on mitigation of beyond-design-basis events after the Fukushima Dai-Ichi accident Compliance Necessary to bring a facility into compliance with a license, rules, or orders, or into conformance with written commitments by the licensee Involves facts that were mistaken or omitted when the activity was authorized, so something needs to change Not pure enforcement (where requirement is clear) and not new or revised interpretations of what was needed to comply with NRC requirements at the time of approval 8


==Reference:==
==Reference:==
ML12054A735 (post
ML12054A735 (post-Fukushima order)
-Fukushima order) 8 For All Other Backfits, a BackfitAnalysis Supports the ActionUnless an exception exists (previous slide), a backfitanalysis must be performed and documented to show:First, that a substantial increase in overall protection of the public health and safety or the common defense and security.Then, that direct and indirect costs of implementation are justified in view of the increased protection.Note:"Substantial" is sometimes discussed in terms of the safety goals, but Commission clarified "substantial" means "important or significant in a large amount, extent, or degree
 
."Not imposing insignificant but inexpensive safety improvementsNot disapproving worthwhile safety improvements with justified costs 9
For All Other Backfits, a Backfit Analysis Supports the Action Unless an exception exists (previous slide), a backfit analysis must be performed and documented to show:
First, that a substantial increase in overall protection of the public health and safety or the common defense and security.
Then, that direct and indirect costs of implementation are justified in view of the increased protection.
Note: Substantial is sometimes discussed in terms of the safety goals, but Commission clarified substantial means "important or significant in a large amount, extent, or degree.
Not imposing insignificant but inexpensive safety improvements Not disapproving worthwhile safety improvements with justified costs 9


==Reference:==
==Reference:==
ML003760758 (SRM-SECY-93-086); 50 FR 38097 (1985 rule)Publicly available through PDR but not in public ADAMS.
ML003760758 (SRM-SECY-93-086); 50 FR 38097 (1985 rule)
What's New in Backfitting 10 Compliance Exception Has Always Been Applicable in Narrow Circumstances1985 Statement of Considerations for the BackfitRule stated:Exception limited to omission or mistake of fact New or revised interpretations of what was needed to comply with existing NRC requirements did not fall within the exception
Publicly available through PDR but not in public ADAMS.
 
Whats New in Backfitting 10
 
Compliance Exception Has Always Been Applicable in Narrow Circumstances 1985 Statement of Considerations for the Backfit Rule stated:
Exception limited to omission or mistake of fact New or revised interpretations of what was needed to comply with existing NRC requirements did not fall within the exception 11


==Reference:==
==Reference:==
50 FR 38097 (1985 rule) 11 2015 Compliance Exception Use for Byron/Braidwood Was OverturnedIn imposing backfit, staff asserted that the NRC erred in previous approvals, by basing approval in part on the ability of valves to pass water and recloseUpheld on appeal to NRRDirector, but overturned on appeal to EDOThe EDO found that NRC staff exercised reasonable and well
50 FR 38097 (1985 rule)
-informed engineering judgement in previous approvals  
 
-not a mistake of factThe EDO found that staff had not relied upon a known and established position to support its use of the compliance backfitPotential for backfiton other bases (e.g., adequate protection, cost
2015 Compliance Exception Use for Byron/Braidwood Was Overturned In imposing backfit, staff asserted that the NRC erred in previous approvals, by basing approval in part on the ability of valves to pass water and reclose Upheld on appeal to NRR Director, but overturned on appeal to EDO The EDO found that NRC staff exercised reasonable and well-informed engineering judgement in previous approvals - not a mistake of fact The EDO found that staff had not relied upon a known and established position to support its use of the compliance backfit Potential for backfit on other bases (e.g., adequate protection, cost-justified substantial safety enhancement) was not decided in the appeals 12
-justified substantial safety enhancement) was not decided in the appeals


==References:==
==References:==
50 FR 38097 (SOC), ML16246A247 (appeal decision) 12 Commission Provided New Guidance on Compliance Exception (SRM
50 FR 38097 (SOC), ML16246A247 (appeal decision)
-COMSECY-16-0020)Limited situations involving omission or mistake of fact with bothof: 1.NRC staff incorrectly perceived facts, performed or failed to recognize flawed analyses, or failed to properly draw direct inferences from those facts or analysesdue to NRC, licensee, or third
 
-party error or omissionat or before the time of its determination that a known and established standard of the Commission was satisfiedas judged by standards and practices that were prevailing among professionals or experts in the relevant area at the time 2.Those facts, analyses, or inferences have now been properly perceived, performed, or drawn.
Commission Provided New Guidance on Compliance Exception (SRM-COMSECY-16-0020)
Limited situations involving omission or mistake of fact with both of:
: 1. NRC staff incorrectly perceived facts, performed or failed to recognize flawed analyses, or failed to properly draw direct inferences from those facts or analyses due to NRC, licensee, or third-party error or omission at or before the time of its determination that a known and established standard of the Commission was satisfied as judged by standards and practices that were prevailing among professionals or experts in the relevant area at the time
: 2. Those facts, analyses, or inferences have now been properly perceived, performed, or drawn.
13


==References:==
==References:==
ML16334A462 (SRM), ML16355A258 (summary of details) 13 Compliance Exception May NotBe Used for New PositionsCannot use the compliance exception based on:Approaches that were not the prevailing way at the time of the original NRC determinationNew approaches developed or accepted after the original NRC determinationThink: If we knew this (the corrected error or omitted information) then, would we have made a different decision?
ML16334A462 (SRM), ML16355A258 (summary of details)
 
Compliance Exception May Not Be Used for New Positions Cannot use the compliance exception based on:
Approaches that were not the prevailing way at the time of the original NRC determination New approaches developed or accepted after the original NRC determination Think: If we knew this (the corrected error or omitted information) then, would we have made a different decision?
14
14


==References:==
==References:==
ML16334A462 (SRM), ML16355A258 (summary of details)
ML16334A462 (SRM), ML16355A258 (summary of details)
Commission Also Addressed Design Criteria and Cost ConsiderationGeneral Design Criteria (GDCs) should only be used as the basis for compliance backfittingin certain casesFor operating plants, NRC already found that the design basis of the plant (as reflected in the principal design criteria) meets or exceeds the minimum criteria in the GDCsApproval process typically yields more specific requirements (e.g., technical specifications)Can rely on GDCsif it provides more than just a performance standard and has not been superseded by other requirementsConditions outside the GDCsshould first be considered as matters of adequate protectionCompliance backfittingmust involve somecost considerationFollows on Michigan v. EPA Supreme Court decisionGuidance for staff on cost considerations is being prepared 15
 
Commission Also Addressed Design Criteria and Cost Consideration General Design Criteria (GDCs) should only be used as the basis for compliance backfitting in certain cases For operating plants, NRC already found that the design basis of the plant (as reflected in the principal design criteria) meets or exceeds the minimum criteria in the GDCs Approval process typically yields more specific requirements (e.g., technical specifications)
Can rely on GDCs if it provides more than just a performance standard and has not been superseded by other requirements Conditions outside the GDCs should first be considered as matters of adequate protection Compliance backfitting must involve some cost consideration Follows on Michigan v. EPA Supreme Court decision Guidance for staff on cost considerations is being prepared 15


==References:==
==References:==
ML16334A462 (SRM), ML16355A258 (summary of details)
ML16334A462 (SRM), ML16355A258 (summary of details)
New Direction Results in Updated Approach to BackfittingFirst, determine if the proposed action is needed for adequate protection. If so, develop the documented evaluation.If the proposed action is not needed for adequate protection, then determine if the compliance exception applies. If so, develop the documented evaluation (including cost consideration).If neither of the exceptions apply to the proposed action, then perform a backfitanalysis to determine if costs are justified by the safety/security benefit.Guidance is being updated for Commission approval (due April 2018).
 
16 Raising and Resolving Safety/Security Issues 17 You Are Essential to the NRC's Safety/Security MissionRaise and support the resolution of issues through appropriate processes, including urgent action for immediate safety issuesUnderstand the applicable history and licensing basis before taking actionDo not imply to licensees that a particular approach should be taken (except where there is a clear requirement)Follow backfitprocess (including updated guidance when ready) if new requirements or staff positions need to be imposedWork with management, Project Manager, and other staff (including backfitPOCs) to answer questions and resolve issues 18 See Something  
New Direction Results in Updated Approach to Backfitting First, determine if the proposed action is needed for adequate protection. If so, develop the documented evaluation.
-Say Something:There Isa Process for Your ConcernIn an inspectionTalk to your team, supervisor, etc.Ask the licensee "why" (in a neutral, relevant way)Kick off another process if needed, particularly for generic concernsIn a licensing reviewTalk to your Project Manager, review team, supervisor, etc.Ask for or audit additional information (if it is necessaryfor the finding)Kick off another process (if it's concerning but unrelated)In generalAddress urgent safety concerns immediately (engage management)Seek to understand why something is the way it is, thenconsider whether that's rightLicensee may address on their own without NRC action (Note: Additional processes exist if you disagree with an ongoing/final agency decision) 19 NRC Response Depends onCurrent RequirementsUnderstand requirements vs. staff positionNRC should not imply that a particular approach to meet a general requirement is essentialSimpler cases when licensees have committed to an approach (e.g., specific Regulatory Guide)Change in (perception of) what is acceptable to meet a requirement can result in backfitdiscussionsUnderstand licensing basisMay take research (microfiche is your friend!)NRC/licensee may disagree on interpretation
If the proposed action is not needed for adequate protection, then determine if the compliance exception applies. If so, develop the documented evaluation (including cost consideration).
-may need to consider context, other licensees, etc.Change in (perception of) NRC position can result in backfitdiscussions 20 Enforcement Process Only Applies when Legally Binding Requirements Are Not MetTypical inspection/violation spaceIdentify legally
If neither of the exceptions apply to the proposed action, then perform a backfit analysis to determine if costs are justified by the safety/security benefit.
-binding requirement (clearly in licensing basis)Contrary to- (describe how the licensee failed to meet it)Enforcement that relies on a different interpretation of the requirements than is clear in the licensing basis, or enforcement that does not account for previous plant
Guidance is being updated for Commission approval (due April 2018).
-specific approvals such as exemptions or amendments, will likely result in backfitdiscussionsNeed to interpret requirements in appropriate context, including what was known at the time of approval 21 BackfittingClaims Can Arise fromCasual DiscussionsStaff are expected to raise issues and ask questionsLicensees may hear these as backfits:Suggestion of how a task "should" be doneQuestions about the design capability of a system (especially older systems)Comparisons of one facility to another (with a different licensing basis
16
)Clear understanding of licensing basis may resolve licensee concernCall the project manager and/or office/region backfittingpoint of contact (last slide) if there are questionsUse the backfittingprocess-one tool in our toolbox
 
-when neededWorking with other technical staff and attorneysAssess basis and prepare justification 22 Summary 23 What Were the Pre
Raising and Resolving Safety/Security Issues 17
-Test Answers?
 
1.The BackfitRule is a requirement applied to NRC activities. TRUE 2.All NRC licensees have "protection" under the BackfitRule. FALSE 3.The BackfitRule was created in response to the Three Mile Island accident. FALSE 4.The NRC cannot consider costs for adequate protection backfittingor compliance backfitting. FALSE 5.If the NRC can justify a backfittingsituation as either adequate protection backfittingor compliance backfitting, then we can use either justification. FALSE 6.A compliance backfitcan be used when the NRC determines that a licensee's method of compliance, approved by the NRC ten years ago, is no longer an acceptable method of compliance.FALSE 7.The NRC can impose a new or changed requirement as long as the benefits that would result outweigh the costs to the licensee. FALSE 24 Agency-Level BackfitGuidance Updates Are Due to Commission in April 2018Management Directive 8.4, "Management of Facility
You Are Essential to the NRCs Safety/Security Mission Raise and support the resolution of issues through appropriate processes, including urgent action for immediate safety issues Understand the applicable history and licensing basis before taking action Do not imply to licensees that a particular approach should be taken (except where there is a clear requirement)
-Specific Backfittingand Information Collection" (ML12059A460)Roles and responsibilities, overview of requirements, process flowchartsBeing revised to reflect Commission direction, lessons learned, generic backfitsNUREG-1409, "BackfittingGuidelines" (ML032230247
Follow backfit process (including updated guidance when ready) if new requirements or staff positions need to be imposed Work with management, Project Manager, and other staff (including backfit POCs) to answer questions and resolve issues 18
)Types of backfits, staff processes, questions and answers, examplesBeing revised to reflect Commission direction, lessons learnedNUREG/BR-0058, "Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission" (ML042820192)Being revised to include cost
 
-benefit considerations for backfitting, including cost consideration for compliance backfits 25 More Training and ResourcesAre on the WayBackfittingCommunity of Practice (group of office/region experts)New "just-in-time" training and knowledge management resources on the internal Web (by January)Better means of retrieving key docketed information (beginning in January)Office/region implementing guidance (after agency guidance is finalized)More detailed training on licensing/design basis and backfitting(2018)26 Points of Contact Have Been DesignatedNMSS:James Downs NRO: George Tartal, Bill Reckley NRR:Timothy ReedNSIR:Doug HuyckOCHCO:Steve Cochrum O E:Robert FretzOGC:Howard Benowitz, Adam GendelmanRegion I:Tony DimitriadisRegion II:Shakur WalkerRegion III: Nestor Feliz-Adorno, Julio LaraRegion IV: Thomas FarnholtzOffice/Region Points of Contact:NMSS:Scott MooreNRO: John MonningerNRR:Ray LorsonNSIR:John LubinskiRegion III:Darrell RobertsOGC:Cathy ScottCRGR-Chair Ed Hackett (RES) [support: Les Cupidon, Nick DiFrancesco
See Something - Say Something:
]27CRGRWorking Group Co-Chairs Theresa Clark (NMSS) and Sheldon Stuchell (NRR)
There Is a Process for Your Concern In an inspection Talk to your team, supervisor, etc.
Ask the licensee why (in a neutral, relevant way)
Kick off another process if needed, particularly for generic concerns In a licensing review Talk to your Project Manager, review team, supervisor, etc.
Ask for or audit additional information (if it is necessary for the finding)
Kick off another process (if its concerning but unrelated)
In general Address urgent safety concerns immediately (engage management)
Seek to understand why something is the way it is, then consider whether thats right Licensee may address on their own without NRC action (Note: Additional processes exist if you disagree with an ongoing/final agency decision) 19
 
NRC Response Depends on Current Requirements Understand requirements vs. staff position NRC should not imply that a particular approach to meet a general requirement is essential Simpler cases when licensees have committed to an approach (e.g., specific Regulatory Guide)
Change in (perception of) what is acceptable to meet a requirement can result in backfit discussions Understand licensing basis May take research (microfiche is your friend!)
NRC/licensee may disagree on interpretationmay need to consider context, other licensees, etc.
Change in (perception of) NRC position can result in backfit discussions 20
 
Enforcement Process Only Applies when Legally Binding Requirements Are Not Met Typical inspection/violation space Identify legally-binding requirement (clearly in licensing basis)
Contrary to (describe how the licensee failed to meet it)
Enforcement that relies on a different interpretation of the requirements than is clear in the licensing basis, or enforcement that does not account for previous plant-specific approvals such as exemptions or amendments, will likely result in backfit discussions Need to interpret requirements in appropriate context, including what was known at the time of approval 21
 
Backfitting Claims Can Arise from Casual Discussions Staff are expected to raise issues and ask questions Licensees may hear these as backfits:
Suggestion of how a task should be done Questions about the design capability of a system (especially older systems)
Comparisons of one facility to another (with a different licensing basis)
Clear understanding of licensing basis may resolve licensee concern Call the project manager and/or office/region backfitting point of contact (last slide) if there are questions Use the backfitting processone tool in our toolboxwhen needed Working with other technical staff and attorneys Assess basis and prepare justification 22
 
Summary 23
 
What Were the Pre-Test Answers?
: 1. The Backfit Rule is a requirement applied to NRC activities. TRUE
: 2. All NRC licensees have protection under the Backfit Rule. FALSE
: 3. The Backfit Rule was created in response to the Three Mile Island accident. FALSE
: 4. The NRC cannot consider costs for adequate protection backfitting or compliance backfitting. FALSE
: 5. If the NRC can justify a backfitting situation as either adequate protection backfitting or compliance backfitting, then we can use either justification. FALSE
: 6. A compliance backfit can be used when the NRC determines that a licensees method of compliance, approved by the NRC ten years ago, is no longer an acceptable method of compliance. FALSE
: 7. The NRC can impose a new or changed requirement as long as the benefits that would result outweigh the costs to the licensee. FALSE 24
 
Agency-Level Backfit Guidance Updates Are Due to Commission in April 2018 Management Directive 8.4, Management of Facility-Specific Backfitting and Information Collection (ML12059A460)
Roles and responsibilities, overview of requirements, process flowcharts Being revised to reflect Commission direction, lessons learned, generic backfits NUREG-1409, Backfitting Guidelines (ML032230247)
Types of backfits, staff processes, questions and answers, examples Being revised to reflect Commission direction, lessons learned NUREG/BR-0058, Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission (ML042820192)
Being revised to include cost-benefit considerations for backfitting, including cost consideration for compliance backfits 25
 
More Training and Resources Are on the Way Backfitting Community of Practice (group of office/region experts)
New just-in-time training and knowledge management resources on the internal Web (by January)
Better means of retrieving key docketed information (beginning in January)
Office/region implementing guidance (after agency guidance is finalized)
More detailed training on licensing/design basis and backfitting (2018) 26
 
Points of Contact Have Been Designated CRGR - Chair Ed Hackett (RES) [support: Les Cupidon, Nick DiFrancesco]
NMSS: Scott Moore                    NSIR: John Lubinski NRO: John Monninger                  Region III: Darrell Roberts NRR: Ray Lorson                      OGC: Cathy Scott Office/Region Points of Contact:
NMSS: James Downs                      OGC: Howard Benowitz, Adam Gendelman NRO: George Tartal, Bill Reckley        Region I: Tony Dimitriadis NRR: Timothy Reed                      Region II: Shakur Walker NSIR: Doug Huyck                        Region III: Nestor Feliz-Adorno, Julio Lara OCHCO: Steve Cochrum                    Region IV: Thomas Farnholtz OE: Robert Fretz CRGR Working Group Co-Chairs Theresa Clark (NMSS)                             27 and Sheldon Stuchell (NRR)
 
Questions?
Questions?
28 Backup 29 Training Results from EDO
28
-Directed BackfittingAssessmentJune and December 2016 taskingsfrom EDOAssess agency backfittingguidance, training, and knowledge managementIncorporate recent backfittingdecisionsJune 2017 report from Committee to Review Generic Requirements (CRGR)Opportunities exist to improve backfittingpracticesBroad communication of Commission direction, increased management involvement, and improved training will yield greatest improvements3 near-term actionsMake report publicIssue interim guidance (Yellow Announcement 17
 
-007 8/16/17)Require "reset" training
Backup 29
 
Training Results from EDO-Directed Backfitting Assessment June and December 2016 taskings from EDO Assess agency backfitting guidance, training, and knowledge management Incorporate recent backfitting decisions June 2017 report from Committee to Review Generic Requirements (CRGR)
Opportunities exist to improve backfitting practices Broad communication of Commission direction, increased management involvement, and improved training will yield greatest improvements 3 near-term actions Make report public Issue interim guidance (Yellow Announcement 17-007 8/16/17)
Require reset training 30


==References:==
==References:==
ML16133A575/ML16344A004 (taskings), ML17174B161 (report) 30 EDO Directed Multiple Actions in Response to CRGRReportJuly 19, 2017 memo supported near
ML16133A575/ML16344A004 (taskings), ML17174B161 (report)
-term and longer
 
-term actions, including:"Reset training" for all staff and managers with backfittingresponsibilities by January 31, 2018 (today's session)Updated agency
EDO Directed Multiple Actions in Response to CRGR Report July 19, 2017 memo supported near-term and longer-term actions, including:
-wide and office/region
Reset training for all staff and managers with backfitting responsibilities by January 31, 2018 (todays session)
-level guidanceQualification and refresher trainingKnowledge management resourcesCRGRcharter changes to include consultation on facility
Updated agency-wide and office/region-level guidance Qualification and refresher training Knowledge management resources CRGR charter changes to include consultation on facility-specific backfits, role in appeals, and public meetings Added two actions:
-specific backfits, role in appeals, and public meetingsAdded two actions:Report on current availability of key docketed information categories , as well as the resource implications of making such information more readily availableReport on resources needed to complete actions on an expeditious schedule, as well as whether these resources are already budgetedActions have been tasked and are being worked over the next year.
Report on current availability of key docketed information categories, as well as the resource implications of making such information more readily available Report on resources needed to complete actions on an expeditious schedule, as well as whether these resources are already budgeted Actions have been tasked and are being worked over the next year.
31


==Reference:==
==Reference:==
ML17198C141 31}}
ML17198C141}}

Revision as of 23:26, 21 October 2019

Backfit Reset Training Slides Without Notes and Videos
ML18038B340
Person / Time
Issue date: 02/21/2018
From: Tim Reed
Office of Nuclear Reactor Regulation
To:
Reed T
References
Download: ML18038B340 (31)


Text

Using the Toolkit A Reset and Refresher on Backfitting and Issue Resolution

Todays Session Puts Backfitting in Context Reset and refresh thinking on backfitting and issue resolution 3 key objectives:

Primer on backfitting in the context of licensing basis and issue resolution Refresher on promptly raising and resolving safety/security issues Preview of NRCs planned activities on backfitting 2

Primer on Backfitting 3

Backfitting Relates to New or Changed Requirements or Interpretations Backfitting is a Code of Federal Regulations requirement for the NRC Structured approach for imposing a new requirement Assumes it is an entity with such protections Backfits can occur after a regulatory approval if there are:

Changed or new requirements (regulation, technical specification, license condition, order)

Changed or new position imposed by the staff (including implied or inferred imposition)

Backfits affect:

systems, structures, or components (design or the actual equipment) organization or procedures for design, construction, or operation 4

Only Certain Entities Are Protected Power reactors (10 CFR 50.109)

New power reactors (various similar provisions in 10 CFR Part 52, termed issue finality instead of backfitting)

Fuel cycle facilities (10 CFR 70.76)

ISFSIs (10 CFR 72.62)

Gaseous diffusion plants (10 CFR 76.76) [none currently regulated]

5

10 CFR 50.109 Is the Most Familiar Example of the Backfit Rule (a)(1): definition of backfitting - applicability and scope (a)(2): requirement for a systematic and documented analysis, except where an exception applies (a)(3): requirement for substantial increase in overall protection of the public health and safety or the common defense and security, and that implementation costs are justified, except where an exception applies (a)(4): three exceptions to (a)(2) and (a)(3) related to compliance and adequate protection (to be discussed later), with documented evaluation needed (a)(5): always require backfitting if it is necessary for adequate protection (a)(6): details of documented evaluation under (a)(4)

(a)(7): choice among ways to achieve compliance (including consideration of cost)

(b): timing (c): considerations to be made in determining (a)(3)

(d): no licensing action will be withheld during backfit analysis (e): responsibility of the Executive Director for Operations 6

NRC Must Take Action on Matters of Adequate Protection or Common Defense and Security If backfitting is necessary to ensure adequate protection, then it is required by the Atomic Energy Act.

No explanation or cost justification is required.

10 CFR 50.109(a)(5): The Commission shall always require the backfitting of a facility if it determines that such regulatory action is necessary to ensure that the facility provides adequate protection to the health and safety of the public and is in accord with the common defense and security.

7

Two Categories of Backfits Are Excepted from the Need for a Backfit Analysis Adequate protection Necessary to ensure that the facility provides adequate protection to the public health and safety and is in accord with the common defense and security May involve redefining what level of protection to the public health and safety or common defense and security should be regarded as adequate Example: orders on mitigation of beyond-design-basis events after the Fukushima Dai-Ichi accident Compliance Necessary to bring a facility into compliance with a license, rules, or orders, or into conformance with written commitments by the licensee Involves facts that were mistaken or omitted when the activity was authorized, so something needs to change Not pure enforcement (where requirement is clear) and not new or revised interpretations of what was needed to comply with NRC requirements at the time of approval 8

Reference:

ML12054A735 (post-Fukushima order)

For All Other Backfits, a Backfit Analysis Supports the Action Unless an exception exists (previous slide), a backfit analysis must be performed and documented to show:

First, that a substantial increase in overall protection of the public health and safety or the common defense and security.

Then, that direct and indirect costs of implementation are justified in view of the increased protection.

Note: Substantial is sometimes discussed in terms of the safety goals, but Commission clarified substantial means "important or significant in a large amount, extent, or degree.

Not imposing insignificant but inexpensive safety improvements Not disapproving worthwhile safety improvements with justified costs 9

Reference:

ML003760758 (SRM-SECY-93-086); 50 FR 38097 (1985 rule)

Publicly available through PDR but not in public ADAMS.

Whats New in Backfitting 10

Compliance Exception Has Always Been Applicable in Narrow Circumstances 1985 Statement of Considerations for the Backfit Rule stated:

Exception limited to omission or mistake of fact New or revised interpretations of what was needed to comply with existing NRC requirements did not fall within the exception 11

Reference:

50 FR 38097 (1985 rule)

2015 Compliance Exception Use for Byron/Braidwood Was Overturned In imposing backfit, staff asserted that the NRC erred in previous approvals, by basing approval in part on the ability of valves to pass water and reclose Upheld on appeal to NRR Director, but overturned on appeal to EDO The EDO found that NRC staff exercised reasonable and well-informed engineering judgement in previous approvals - not a mistake of fact The EDO found that staff had not relied upon a known and established position to support its use of the compliance backfit Potential for backfit on other bases (e.g., adequate protection, cost-justified substantial safety enhancement) was not decided in the appeals 12

References:

50 FR 38097 (SOC), ML16246A247 (appeal decision)

Commission Provided New Guidance on Compliance Exception (SRM-COMSECY-16-0020)

Limited situations involving omission or mistake of fact with both of:

1. NRC staff incorrectly perceived facts, performed or failed to recognize flawed analyses, or failed to properly draw direct inferences from those facts or analyses due to NRC, licensee, or third-party error or omission at or before the time of its determination that a known and established standard of the Commission was satisfied as judged by standards and practices that were prevailing among professionals or experts in the relevant area at the time
2. Those facts, analyses, or inferences have now been properly perceived, performed, or drawn.

13

References:

ML16334A462 (SRM), ML16355A258 (summary of details)

Compliance Exception May Not Be Used for New Positions Cannot use the compliance exception based on:

Approaches that were not the prevailing way at the time of the original NRC determination New approaches developed or accepted after the original NRC determination Think: If we knew this (the corrected error or omitted information) then, would we have made a different decision?

14

References:

ML16334A462 (SRM), ML16355A258 (summary of details)

Commission Also Addressed Design Criteria and Cost Consideration General Design Criteria (GDCs) should only be used as the basis for compliance backfitting in certain cases For operating plants, NRC already found that the design basis of the plant (as reflected in the principal design criteria) meets or exceeds the minimum criteria in the GDCs Approval process typically yields more specific requirements (e.g., technical specifications)

Can rely on GDCs if it provides more than just a performance standard and has not been superseded by other requirements Conditions outside the GDCs should first be considered as matters of adequate protection Compliance backfitting must involve some cost consideration Follows on Michigan v. EPA Supreme Court decision Guidance for staff on cost considerations is being prepared 15

References:

ML16334A462 (SRM), ML16355A258 (summary of details)

New Direction Results in Updated Approach to Backfitting First, determine if the proposed action is needed for adequate protection. If so, develop the documented evaluation.

If the proposed action is not needed for adequate protection, then determine if the compliance exception applies. If so, develop the documented evaluation (including cost consideration).

If neither of the exceptions apply to the proposed action, then perform a backfit analysis to determine if costs are justified by the safety/security benefit.

Guidance is being updated for Commission approval (due April 2018).

16

Raising and Resolving Safety/Security Issues 17

You Are Essential to the NRCs Safety/Security Mission Raise and support the resolution of issues through appropriate processes, including urgent action for immediate safety issues Understand the applicable history and licensing basis before taking action Do not imply to licensees that a particular approach should be taken (except where there is a clear requirement)

Follow backfit process (including updated guidance when ready) if new requirements or staff positions need to be imposed Work with management, Project Manager, and other staff (including backfit POCs) to answer questions and resolve issues 18

See Something - Say Something:

There Is a Process for Your Concern In an inspection Talk to your team, supervisor, etc.

Ask the licensee why (in a neutral, relevant way)

Kick off another process if needed, particularly for generic concerns In a licensing review Talk to your Project Manager, review team, supervisor, etc.

Ask for or audit additional information (if it is necessary for the finding)

Kick off another process (if its concerning but unrelated)

In general Address urgent safety concerns immediately (engage management)

Seek to understand why something is the way it is, then consider whether thats right Licensee may address on their own without NRC action (Note: Additional processes exist if you disagree with an ongoing/final agency decision) 19

NRC Response Depends on Current Requirements Understand requirements vs. staff position NRC should not imply that a particular approach to meet a general requirement is essential Simpler cases when licensees have committed to an approach (e.g., specific Regulatory Guide)

Change in (perception of) what is acceptable to meet a requirement can result in backfit discussions Understand licensing basis May take research (microfiche is your friend!)

NRC/licensee may disagree on interpretationmay need to consider context, other licensees, etc.

Change in (perception of) NRC position can result in backfit discussions 20

Enforcement Process Only Applies when Legally Binding Requirements Are Not Met Typical inspection/violation space Identify legally-binding requirement (clearly in licensing basis)

Contrary to (describe how the licensee failed to meet it)

Enforcement that relies on a different interpretation of the requirements than is clear in the licensing basis, or enforcement that does not account for previous plant-specific approvals such as exemptions or amendments, will likely result in backfit discussions Need to interpret requirements in appropriate context, including what was known at the time of approval 21

Backfitting Claims Can Arise from Casual Discussions Staff are expected to raise issues and ask questions Licensees may hear these as backfits:

Suggestion of how a task should be done Questions about the design capability of a system (especially older systems)

Comparisons of one facility to another (with a different licensing basis)

Clear understanding of licensing basis may resolve licensee concern Call the project manager and/or office/region backfitting point of contact (last slide) if there are questions Use the backfitting processone tool in our toolboxwhen needed Working with other technical staff and attorneys Assess basis and prepare justification 22

Summary 23

What Were the Pre-Test Answers?

1. The Backfit Rule is a requirement applied to NRC activities. TRUE
2. All NRC licensees have protection under the Backfit Rule. FALSE
3. The Backfit Rule was created in response to the Three Mile Island accident. FALSE
4. The NRC cannot consider costs for adequate protection backfitting or compliance backfitting. FALSE
5. If the NRC can justify a backfitting situation as either adequate protection backfitting or compliance backfitting, then we can use either justification. FALSE
6. A compliance backfit can be used when the NRC determines that a licensees method of compliance, approved by the NRC ten years ago, is no longer an acceptable method of compliance. FALSE
7. The NRC can impose a new or changed requirement as long as the benefits that would result outweigh the costs to the licensee. FALSE 24

Agency-Level Backfit Guidance Updates Are Due to Commission in April 2018 Management Directive 8.4, Management of Facility-Specific Backfitting and Information Collection (ML12059A460)

Roles and responsibilities, overview of requirements, process flowcharts Being revised to reflect Commission direction, lessons learned, generic backfits NUREG-1409, Backfitting Guidelines (ML032230247)

Types of backfits, staff processes, questions and answers, examples Being revised to reflect Commission direction, lessons learned NUREG/BR-0058, Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission (ML042820192)

Being revised to include cost-benefit considerations for backfitting, including cost consideration for compliance backfits 25

More Training and Resources Are on the Way Backfitting Community of Practice (group of office/region experts)

New just-in-time training and knowledge management resources on the internal Web (by January)

Better means of retrieving key docketed information (beginning in January)

Office/region implementing guidance (after agency guidance is finalized)

More detailed training on licensing/design basis and backfitting (2018) 26

Points of Contact Have Been Designated CRGR - Chair Ed Hackett (RES) [support: Les Cupidon, Nick DiFrancesco]

NMSS: Scott Moore NSIR: John Lubinski NRO: John Monninger Region III: Darrell Roberts NRR: Ray Lorson OGC: Cathy Scott Office/Region Points of Contact:

NMSS: James Downs OGC: Howard Benowitz, Adam Gendelman NRO: George Tartal, Bill Reckley Region I: Tony Dimitriadis NRR: Timothy Reed Region II: Shakur Walker NSIR: Doug Huyck Region III: Nestor Feliz-Adorno, Julio Lara OCHCO: Steve Cochrum Region IV: Thomas Farnholtz OE: Robert Fretz CRGR Working Group Co-Chairs Theresa Clark (NMSS) 27 and Sheldon Stuchell (NRR)

Questions?

28

Backup 29

Training Results from EDO-Directed Backfitting Assessment June and December 2016 taskings from EDO Assess agency backfitting guidance, training, and knowledge management Incorporate recent backfitting decisions June 2017 report from Committee to Review Generic Requirements (CRGR)

Opportunities exist to improve backfitting practices Broad communication of Commission direction, increased management involvement, and improved training will yield greatest improvements 3 near-term actions Make report public Issue interim guidance (Yellow Announcement 17-007 8/16/17)

Require reset training 30

References:

ML16133A575/ML16344A004 (taskings), ML17174B161 (report)

EDO Directed Multiple Actions in Response to CRGR Report July 19, 2017 memo supported near-term and longer-term actions, including:

Reset training for all staff and managers with backfitting responsibilities by January 31, 2018 (todays session)

Updated agency-wide and office/region-level guidance Qualification and refresher training Knowledge management resources CRGR charter changes to include consultation on facility-specific backfits, role in appeals, and public meetings Added two actions:

Report on current availability of key docketed information categories, as well as the resource implications of making such information more readily available Report on resources needed to complete actions on an expeditious schedule, as well as whether these resources are already budgeted Actions have been tasked and are being worked over the next year.

31

Reference:

ML17198C141