NUREG—1409

Backfitting Guidelines

.S. Nuclear Regulatory Commission~ ~

Office for Analysis and Evaluation of Operational Data

D. P. Allison, J. M. Conran, and C. A. Trottier

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NUREG-1409

Backfitting Guidelines

Manuscript Completed: June 1990Date Published: July 1990

D. P. Allison, J. M. Conran, and C. A. Trottier

OAice for Analysis and Evaluation of Operational DataU.S. Nuclear Regulatory CommissionWashington, DC 20555

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ABSTRACT

The backfitting process is the process by which the U.S.Nuclear Regulatory Commission (NRC) decides whetherto issue new or revised requirement's or staff positions tolicensees ofnuclear power reactor facilities. Backfitting isexpected to occur and is an inherent part of the regulatoryprocess. However, it is to be done only after formal, sys-tematic review to ensure that changes are properly justi-fied and suitably defined. Requirements for proper justi-fication ofbackfits and information requests are providedby two NRC rules, Title 10 of the Code ofFederal Regula-tions, Sections 50.109 and 50.54(f). Three types ofbackfitsare recognized. Cost-justiTied substantial safety improve-ments require backfit analyses and findings of substantialsafety improvement and justified costs. Two types of ex-ceptions, compliance exceptions and adequate protectionexceptions, do not require findings of substantial safetyimprovements and costs are not considered. However,they are stillbackfits and they require documented evalu-ations to support use of the exceptions. Information re-

quests (as opposed to backfits) require an analysis of theburden to be imposed to ensure that they are justified inview of the potential safety significance of the informa-tion requested. NRC procedures on backfitting includethe Charter of the Committee to Review Generic Re-quirements for generic communications and NRC Man-ual Chapter 0514 and individual office procedures forplant-specific communications. Considemble guidancehas been developed, control mechanisms are in place, andtraining has been provided to NRC and industry person-nel. The Director of the Office for Analysis and Evalu-ation of Operational Data is responsible for oversight ofbackfitting programs, including obtaining industry com-ments. Initiatives are under way to better explain theprocess and conduct further training for industry andNRC personnel. Further initiatives are being consideredin response to industry comments obtained in a recentsurvey concerning the effects of the regulatory process onlicensees.

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Contents

Abstract .

Executive Summary

1 Introduction

2 Discussion

2.1 Nature and Types of Backfits .

2.1.1 Background.2.1.2 Backfit Determination2.1.3 Justification for Imposing Backfits .

2.2 Information Requests.2.3 Staff Process for Identifying and Imposing Generic Backfits2.4 Staff Process for Identifying and Imposing Plant-SpeciTic Backfits .

2.5 Filing a Backfit Claim or Appeal....2.6 Current Status.

3 Questions and Answers on Backfitting .

3.1 Backfit Determination and Imposition3.2 Generic Backfits3.3 Plant-Specific Backfits .

3.4 Backfit Analysis3.5 Appeals3,6 General questions .

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AppendiceS

A The 1985 Backfit Rule

B The 1988 Backfit Rule

C Committee To Review Generic Requirements Charter

D NRC Manual Chapter 0514, NRC Program for Management of Plant-Specific Backfittingof Nuclear Power Plants

E Background Information for CRGR Review of Gi-70 and Gi-94 Resolutions

F Sample Backfit Discussion (taken from NRC Bulletin 90-01)

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EXECUTIVE SUMMARY

The backfitting process is the process by which the U.S.Nuclear Regulatory Commission (NRC) decides whetherto issue new or revised requirements or staff positions tolicensees ofnuclear power reactor facilities. Backfitting isexpected to occur and is an inherent part of the regulatoryprocess. However, it is to be done only after formal, sys-tematic review to ensure that changes are properly justi-fied and suitably defined. The requirements of this proc-ess are intended to ensure order, discipline, andpredictability and to enhance optimal use of NRC staffand licensee resources.

Title 10 of the Code ofFederal Regulations, Section 50.109(10 CFR 50.109), contains the backfit rule, which theNRC revised in 1985 to provide specific guidance andstandards for backfitting decisions. The 1985 rule and theNRC manual chapter that implemented it were vacatedby the U.S. Court of Appeals in 1987. The court statedthat the rule was ambiguous about whether economiccosts would be considered in ensuring or redefining ade-quate protection for the public health and safety or thecommon defense and security. In 1988 thc NRC issued anamended backfit rule that was again subjected to court re-view and was upheld. The amended rule states clearly thateconomic costs willnot be considered in cases ofensuring,defining, or redefining adequate protection or in cases ofensuring compliance with NRC requirements or writtenlicensee commitments.

The backfit rule applies to both generic backfits andplant-specific backfits for power reactors. It defines abackfit as a modification of or addition to plant systems,structures, components, procedures, organization, designapproval, or manufacturing license that may result fromthe imposition of a new or amended rule or regulatorystaff position that became effective after specific dates.

- The rule recognizes three types of backfits. For backfitsthat do not meet one of the exceptions discussed below, abackfit analysis is required and it must be determined,based on that analysis, that the backfit willprovide a sub-stantial increase in overall protection of the public healthand safety (or common defense and security) and that thedirect and indirect costs for the facilityare justified in viewof the increased protection. Two types of exceptions arerecognized, involving compliance and adequate protec-tion. Such exceptions are stillbackfits, but they are justi-fied differently. A documented evaluation is required,which states the objectives and purpose of the backfit andthe basis for invoking the exception.

The rule (10 CFR 50.54(f)) requiring licensee responsesto both generic and plant-specific information requestswas revised along with the backfit rule. The rule stipulates

that, except for information sought to verify licensee com-pliance with the current licensing basis, the NRC mustprepare the reasons for the request to ensure the burdenimposed on licensees is justified in view of the potentialsafety significance of the issue to be addressed.

One of the controls on generic backfitting and generic in-formation requests is review by the Committee to ReviewGeneric Requirements (CRGR). This committee of sen-ior managers from various NRC offices was established inNovember 1981. Its objectives include eliminating unnec-essary burdens on licensees, reducing radiation exposureto workers while implementing requirements, and opti-mizing use of NRC and liccnsce resources to assure safeoperation. Following its review of a proposed genericcommunication the CRGR recommends approval, revi-sion, or disapproval to the NRC Executive Director forOperations (EDO). Ifthe office proposing the communi-cation does not agree with thc CRGR recommendation itmay refer thc issue to the EDO l'or decision. Thc CRGRoperates under a charter that specifically identifies thedocuments to be reviewed and the analyses, justifications,and findings to be provided. Thus, although the primaryresponsibility forproper backfit considerations belongs tothe organization proposing a communication, the CRGRcharter is a key implementing procedure for genericbackfitting.

Plant-specific backfits and requests for information aregoverned by NRC Manual Chapter 0514. In addition, allregional offices and the Office of Nuclear Reactor Regu-lation have approved procedures that implement themanual chapter. Alllevels of the NRC staff are responsi-ble for identifying potential backfits, which then arc to behandled in accordance with procedures that provide de-tailed guidance on identification, analyses, justification,and tracking of backfitting items. Training is provided atall staff levels in the principles of management and con-trol of plant-specific backfitting.

Manual Chapter 0514 also provides for licensee claims orappeals regarding plant-specific backfitting determina-tions. A licensee may claim that an action, which the staffdid not consider to be a backfit, is in fact a backfit. In an

appeal, a licensee may

~ ask that denial of a prior claim of backfit be re-versed

~ assert that a recognized backfit, which the staffconsidered to be an adequate protection or com-pliance exception, does not meet the criteria forthe exception

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~ ask that a proposed backfit, which the staff con-sidered to be a cost-justified substantial safety im-provement, be modified or withdrawn

The EDO delegated oversight responsibility of the plant-specific backfitting process to the Director of the Officefor Analysis and Evaluation of Operational Data(AEOD). This includes reviewing and concurring with of-fice procedures, conducting training for NRC staff and in-dustry, and informing licensees ofprogram and procedurechanges. AEOD conducts an annual assessment of thebackfitting process by reviewing plant-specific backfitsidentified by staff or industry and office procedures andselected records, interviewing office and regional staff,and obtaining industry comments.

In 1989 AEOD conducted the most recent series ofNRCstaff training sessions at the regional offices and con-ducted a survey of licensees to determine their percep-tions of the backfitting process and obtain specific cost in-formation. In late 1989 and.early 1990, the NRC staffconducted a broader survey of licensees concerning theeffects of the regulatory process. With regard to backfi-tting, these surveys indicate that licensees are concernedabout the number and overall burden ofgeneric commu-nications, the adequacy of the NRC's consideration of theeffects of cost and scheduling, the basis for issuing re-

quirements involving backfits, the NRC's treatment ofoptional actions and requests as if they were require-ments, the negative effects ifNRC perceives licensees tobe nonresponsive because they do not implement op-tional actions or because they file backfit claims or ap-peals, and a need foradditional training in backfitting forindustry and NRC personnel.

The NRC staff is taking several initiatives to improve thebackfitting process and is considering further initiatives.To make backfitting considerations and bases clear toreaders, a summary of backfitting considerations wasadded to generic letters and bulletins beginning in

De-'ember

1989. This report was prepared to explain thebackfitting process to industry and NRC staff. Workshopswith industry and NRC staff are planned for the near fu-ture. Changes have been proposed to the programs forsystematic assessment of licensee performance thatwould reduce any potential for penalizing licensees forsubmitting appeals. Senior NRC managers are consider-ing the information gathered from the broad survey of theeffects of the regulatory process on licensees to deter-mine what changes may be appropriate. For example, thepreliminary report on the broad survey, DraftNUREG-1395, indicates that the staff will examinemethods that willtake into account the cumulative effectsof new requirements.

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1 INTRODUCTION

Over the years, issues with regard to what constitutes abackfit and questions on agency policy and practices havebeen raised inside and outside the agency. This report isintended to address these issues and promote a clearerunderstanding of <he backfit rule and both the generic'nd plant-specific backfit policies and associated proc-esses that have been adopted by the U.S. Nuclear Regula-tory Commission (NRC).

The Commission revised the backfit rule (Title 10 of theCode of Federal Regulations, Section 50.109 [10 CFR50.109]) in 1985 to provide more specific guidance forbackfitting decisions and to provide formanagement con-trol and accountability ofbackfits. Although the 1985 rulehas been superseded, it is included as Appendix A be-cause its statement of considerations provides back-ground information on the development of current prac-tice.

The 1985 rule and the NRC Manual Chapter, which im-plemented the rule, were vacated by the U.S. Court ofAppeals in 1987. The court stated that the rule was am-biguous about whether economic costs would be consid-ered in ensuring or redefining adequate protection of thepublic health and safety. In 1988, a revised backfit rulewas published to clearly state that economic costs cannotbe considered (1) when a modification is necessaty tobring a facilityinto compliance with Commission rules orwritten licensee commitments, (2) when regulatory actionis necessary to ensure adequate protection of publichealth and safety, or (3) when the regulatory action in-volves defining or redefining the adequate protectionstandard. The court upheld the 1988 revised rule, which isincluded as Appendix B.

Backfits are expected to occur as part of the regulatoryprocess to ensure the safety ofpower reactors. It is impor-tant for sound and effective regulation, however, thatbackfitting be conducted by a controlled and definedprocess. The NRC backfitting process is intended to pro-vide for a formal, systematic, and disciplined review ofnew or changed positions before imposing them.

The backfit process enhances regulatory stability by en-suring that changes in regulatory staff positions are justi-fied and suitably defined. For example, even ifnot neededto meet the standard ofadequate protection or to ensurecompliance, backfitting is proper if a substantial safetybenefit is realized and the costs are justified by the safetybenefit.

In its implementing procedures, the Commission has de-fined two types of backfits, generic and plant-specific.Generic backfits apply to more than one facility whileplant-specific backfits apply to only one facility. Aftermanagement makes appropriate findings, proposed ge-neric backfits are reviewed by the Committee to ReviewGeneric Requirements (CRGR) to determine their com-pliance with the requirements of the backfit rule and toensure that new requirements and staff positions contrib-ute effectively and significantly to the health and safety ofthe public and lead to optimal utilization of NRC andlicensee resources. The CRGR Charter (Appendix C tothis report) provides specific procedures for handling ge-neric backfits.

Plant-specific backfits are implemented through use ofNRC Manual Chapter 0514, "NRC Program forManage-ment of Plant-Specific Backfitting of Nuclear PowerPlants," 1988 (Appendix D to this report). This proceduredefines the NRC staff responsibilities for implementingthe backfit rule for plant-specific applications. The NRCstaff, at all levels, is responsible for identifying plant-specific backfits. The cognizant NRC office director orregional administrator determines if the backfit is war-ranted and the type ofanalysis or evaluation required, andensures the proper implementation of the backfittingprocess.

In late 1989 and early 1990, the NRC conducted a broadsurvey throughout the industry regarding the effects ofNRC regulatory programs on licensees. The results weredocumented in Draft NUREG-1395„"Industry Percep-tions of the Impact of the U.S. Nuclear Power PlantActivities,"February 1990. The comments received aboutbackfitting generally confirmed and expanded on con-cerns that had been expressed in an earlier backfittingsurvey conducted in April 1989. Senior NRC managersare considering the information received in response tothe survey to determine if the NRC should change itsregulatory approach. Therefore, this report, which de-scribes the backfitting process as it exists now, could besuperseded in some areas by future changes. However, itwas considered appropriate to explain the current processand provide documented support for planned trainingand workshops with industry and NRC staff at this timerather than waiting for ultimate resolution of the issuesidentified in the survey.

Questions about the backfit process or this report may beaddressed to the NRC Office for Analysis and Evaluationof Operational Data (AEOD), which has responsibilityfor monitoring the backfit process.

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2 DISCUSSION

2.1 Nature and Types of Backfits

2.1.1 Background

Backfitting is defined in 10'CFR 50.109 as

(1) the modification of or addition to

~ systems, structures, components or design of afacility; or

~ ~ the design approval or manufacturing licensefor a facility; or

~ the procedures or organization required to de-sign, construct, or operate a facility;

to be imposed on responders, but this analysis has a lim-ited scope and depth relative to that required for a 10CFR 50.109 backfit.

The backfit rule applies to actions that impose positionsor requirements on licensees; it does not apply to re-quested actions that are optional or voluntary. Generally,it does not apply to relaxations.'owever, if require-ments are reduced but made mandatory, the backfit rulewould apply iflicensees are required to make the changesin order to achieve a greater level of safety.

The backfit rule does not apply to speciTic requirementsimposed by statute. For example, ifa statute requires arevision to license fee schedules, the backfit rule does notapply.

(2) may result from

and

The backfit rule does not apply to purely administrativematters. For example, a change in the number ofcopies ofsafety analysis reports that licensees must submit to theNRC would not be covered by the backfit rule.

~ a new or amended provision in Commissionrules or

~ the imposition of a regulatory staff positionthat is either new or different, from a previ-ously applicable staff position

and

(3) effective after specific dates keyed to the effectivedate of the backfit rule (see Section 2.1.2 of this re-port).

Note that the backfit rule and the definition ofbackfittingapply to cases of compliance and cases of adequate pro-tection as well as to cases of cost-justified substantialsafety improvement. They are all backfits, but requiredifferent types ofjustification as discussed further in Sec-tion 2.1.3(1) of this report.

The backfit rule applies to nuclear power reactors. Thescope of the rule includes all design and hardwa're aspectsof systems, structures, and components as well as sup-porting activities reflected by procedures and organiza-tion.

The rule is intended to encompass only positions or re-quirements that bring about improvements in safety.Therefore, NRC actions that merely request informationand do not impose changes (specifically in hardware, pro-cedures, or organization) are not covered under 10 CFR50.109, but may be addressed under 10 CFR 50.54(f). Theuse of 10 CFR 50.54(f) requires an analysis of the burden

Different standards apply to the imposition of more strin-gent safety requirements for standard design certifica-tions (SDCs) or early site permits issued under 10 CFRPart 52. For. example, during the pendency of an SDC,backfits of the SDC are permitted only for the sake ofcompliance or adequate protection. Those standards arenot covered in this report.

In its amended (1988) form, the rule requires a backfitanalysis, including consideration ofassociated implemen-tation costs, for all proposed backfits with the followingexceptions:

~ modifications necessary to bring a facility into com-pliance with its license or into conformance withwritten commitments by the licensee

~ actions necessary to ensure adequate protection

~ actions that involve defining or redefining what con-stitutes adequate protection

For these exceptions, instead ofa backfit analysis, the rulerequires a documented evaluation including a statementof the objectives ofand the reasons for the backfit and thebasis for invoking the exception.

Since 1985, the NRC has issued a number of bulletins,generic letters, and regulatory guides that have been

'For generic requirements, the CRGR Charter contains standards forrelaxations that do not appear in the backfit rule, as discussed in Sec-tion 2.1.3 of this report.

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considered backfits.'any of these actions were ex-

empted from the requirement for a backfit analysis, in-cluding cost considerations, because they were consid-ered necessary for adequate protection or compliance.Others were considered to be cost-justified substantialsafety enhancements on the basis of a backfit analysis.

2.1.2 Backfit Determination

A backfit involves a modtTication to the plant, designapproval, manufacturing license, procedures, or organi-zation. In addition, (1) a new or revised staff position orrequirement must be involved, that is, there must be achange in content or applicability of the previously appli-cable regulatory staff position (in the direction of in-creased safety requirements) and (2) this change must beissued after specified dates or milestones.

~ Applicable Regulatory Staff Position

A requirement or position already specifically im-posed on or committed to by a licensee is called anapplicable regulatory staff position. There are sev-eral different types of positions, such as

legal requirements, as in explicit regulations,orders, and plant licenses and in amendments,conditions, and technical specifications

written licensee commitments such as thosecontained in the final safety analysis report, li-censee event reports, and docketed correspon-dence, including responses to NRC bulletins,generic letters, inspection reports, or notices ofviolation and confirmatory action letters

NRC staff positions that are documented ex-

plicit interpretations of more general regula-tions and are contained in documents such as

the Standard Review Plan, branch technicalpositions, regulatory guides, generic letters,and bulletins

For the purpose of this report, a change in the appli-cable regulatory staff position willbe subsequentlyreferred to as a new or revised position.

As a legal matter, the backfit rule does not strictlyapply until the pointat which a backfit is required by, forexample, a rule or an order. How-ever, for thc purpose of this discussion, that legal distinction is not im-portant. The NRC backfit process, including the CRGR Charter andNRC Manual Chapter 0514, is defined on the principle that new posi-tions or requirements are to meet the standards of the rule before theyare issued to thc! icensec(s). New generic positions in documents, suchas generic letters, bulletms, and regulatory guides, as well as plant-snccific positions, arc to bc considered and justified as backfits beforethey are issued. For this reason, they often are discussed in thc same wayas legally required backfits.

~ Date of Issuance

When a new or revised position is issued, it is consid-ered a backfit if it is issued after

the issuance of the construction permit for thefacility'for facilities with construction permitsissued after May 1, 1985

6 months before the date of docketing of theoperating license application for the facilityforfacilities with construction permits issued be-fore May 1, 1985

the issuance of the operating license for the fa-cility

the issuance of the design approval under Ap-pendix M, N or 0 of 10 CFR Part 50 (now 10

CFR Part 52)

2.13 Justification for Imposing Backfits

Section 2.1.3(1) addresses the basic elements of findings,documented evaluations, and backfit analyses required byin the backfit rule. The NRC's internal procedures forimplementing the backfit rule address all of these sameelements but actually go beyond the rule and containadditional justification requirements as well; these addi-tional requirements are discussed in Sections 2.1.3(2) and2.1.3(3).

(1) Basic Backfit JusttTtcation (Backfit Rule)

The NRC staff is responsible for identifying plant-specific and generic backfits and for determining ifproposed new or revised positions would constitute a

backfit. Staff positions are not communicated to li-censees unless the NRC officialcommunicating thatposition determines whether the position is a back-fit. At any point during the process, it may be de-cided to drop the position because further work is

not likelyto show (a) that the resulting safety benefitis required forcompliance or adequate protection or(b) that the action would provide substantial addi-tional overall protection and the direct and indirectcosts of implementation would be justiTied.

(a) Documented Evaluation (Compliance andAdequate Protection)

In the case ofensuring compliance with existingrequirements or commitments, a backfit analy-sis is not required. Instead, a documentedevaluation of the type discussed in 10 CFR50.109(a)(6) is prepared and a finding is madethat the action is necessary to ensure compli-ance. The documented evaluation includes a

statement of the objectives of and the reasons

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for the action and the basis for invoking thecompliance exception.

Similarly, in the case of a backfit needed to en-sure adequate protection of public health andsafety, a backfit analysis is not required. Adocumented evaluation of the type discussed in10 CFR 50.109(a)(6) is prepared and a findingis made that the action is necessary for ade-quate protection. The documented evaluationincludes a statement of the objectives of andthe reasons for the backfit and the basis for in-voking the adequate protection exception. Theconcept of what constitutes adequate protec-tion is an evolving standard. It is expected thatthis standard willcontinue to change to keep upwith new information and with improvementsin nuclear power technology. For example, anamendment was recently proposed to 10 CFR50.61, "Fracture Toughness Requirements forProtection Against Pressurized Thermal ShockEvents." This was a case where new knowledgeindicated adjustments were needed in the pro-visions fordealing withvessel embrittlement inorder to maintain adequate protection.

For either the compliance case or the adequateprotection case, ifimmediately effective regu-latory action is needed, the required docu-mented evaluation may follow the issuance ofthe regulatory action.

(b) Cost-Justified Substantial Safety Enhance-ment

For backfits providing a cost-justified substan-tial safety enhancement, the staff must developa backfit analysis of the type discussed in 10CFR 50.109(a)(3) and 10 CFR 50.109(c) and afinding is made that there is a substantial safetybenefit to be achieved and that the costs arejustiTied by the benefit. The backfit analysisconsiders

~ how the backfit should be scheduled inlightofother ongoing regulatory activitiesat the facility

~ information available concerning any ofthe following factors as may be appropri-ate:

statement of the specific objectivethat the proposed backfit is designedto achieve

general fordescription of the activitythat would be required by the

licensee or applicant in order tocomplete the backfit

potential forchange in the risk to thepublic from the accidental offsite re-lease of radioactive material

'otential impact of radiological ex-posure to facility employees

installation and continuing costs as-sociated with the backfit, includingthe cost of facility downtime or thecost of construction delay (i,e., re-source burden on licensees)

the potential safety impact ofchanges in plant or operational com-plexity, including the relationship toproposed and existing regulatory re-quirements

the estimated resource burden onthe NRC associated with the pro-posed backfit and the availability,ofsuch resources

the potential impact ofdifferences infacility type, design, or age on therelevancy and practicality of the pro-posed backfit

whether the proposed backfit is in-terim or final and, ifinterim, the jus-tification for imposing the proposedbackfit on an interim basis

For this type of backfit, there first must be asubstantial increase in overall protection (orcommon defense and security), even for re-quirements that might bring about a net-costsavings. Ifthere is a substantial increase, thenthe cost justification must be considered. Thebackfit rule requires the NRC to consider thecost of facilitydowntime or construction delayas costs associated with the backfit.

~ Averted onsite costs can arise when it is esti-mated that the backfit will save money for li-censees, such as by reducing forced outagerates. These savings are riot treated as a benefit(safety enhancement). They are, however, con-sidered as a negative cost, that is, an offsetagainst other licensee costs. Averted ogsitecosts can result from an estimated decrease inaccident frequency or severity. These reduc-tions are tied directly to the public health andsafety and are considered as a benefit (safety

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enhancement). "Regulatory Analysis Guide-lines of the U.S. Nuclear Regulatory Commis-sion" (NUREG/BR-0058, Rev. 1, May 1984)provides further guidance on this subject.

For this type. of backfit, the backfit rule doesnot require a strict quantitative showing thatbenefits exceed costs, but rather "that there is asubstantial increase in the overall protection of

'he

public health and safety or the common de-fense and security to be derived from the back-fitand that the direct and indirect costs of im-plementation for that facility are justified inview of this increased protection" (emphasisadded). Qualitative factors can be considered.Many of the factors to be addressed in theanalysis may not be easily quantified and thebackfit rule permits consideration of otherrelevant and material factors.

(2) Regulatory Analyses (Staff Procedures)

Regulatory analyses are generally performed in ac-cordance with the directives and guidance ofNUREG/BR-0058 (Rev. 1, May 1984) andNUREG/CR-3568 ("AHandbook ofValue-ImpactAssessment," December 1983), which describe theneed for regulatory analyses and their

preparation.'he

complexity and comprehensiveness of theanalyses should be limited to what is necessary toprovide an adequate basis for a decision. NUREG/BR-0058, Section III.A.2, "Scope of the Analysis,"states: "The emphasis [in doing the analysis] shouldbe simplicity, flexibility,and common sense, both interms of the type of information supplied and in thelevel of detail provided."

For plant-specific backfits, Section 043 of NRCManual Chapter 0514 requires preparation of regu-latory analyses for backfits other than those that fitthe adequate protection or compliance exceptions.It also specifies the factors to be included in theregulatory analyses, which include those of a backfitanalysis as well as other factors. Thus, this type ofregulatory analysis would be the saine as a backfitanalysis, except that it would contain additional in-formation as well.

For generic backfits, Item IV(b)(5) of the CRGRCharter specifies preparation of regulatory analysesfor CRGR review packages. In this case the regula-

'ory analyses may omit some of the factors of a back-fitanalysis, such as the priorityand schedule for im-plementation, and they may contain additionalfactors, such as an analysis ofalternatives to the pro

'ltshould be noted that thc staff is in the process of revising these twoguidance documents.

~ posed action. Atypical way ofhandling this situationfor CRGR review packages is to address each backfitanalysis factor (which also is specifically listed in theCRGR Charter), making reference to the regulatoryanalyses ifit contains the necessary information. Anexample of this approach is provided in Appendix E.

Regulatory analyses generally contain a value im-pact (or cost benefit) analysis; however, as discussedearlier, it would not be appropriate (or permissible)for an adequate protection or compliance backfit toconsider the cost in deciding on imposition of thebackfit (except fordeciding which among several ac-ceptable alternatives to prescribe).

(3) Further Justification (Staff Procedures)

In addition to backfit analyses and regulatory analy-ses, NRC procedures contain further justificationrequirements.

For generic backfits, Section IV.B of the CRGRCharter contains a number ofother factors to be ad-dressed in all CRGR review packages for new ge-neric requirements or positions. For example, itemIV.B(iv) specifies the proposed method of imple-mentation and the concurrence (with any com-ments) of the Office of the General Counsel. ItemIV.B(ix) specifies the necessary findings and stan-dards for relaxations in requirements, which are notaddressed in the backfit rule. Finally, Section II.Dofthe charter exempts compliance and adequate pro-tection cases from the backfit analysis factors andspecifies the documented evaluations needed in ac-cordance with the backfit rulq...

For plant-specific backfits, Section 043 of NRCManual Chapter 0514 specifies some ofthe same ad-ditional factors as the CRGR Charter, but only forbackfits that are not compliance or adequate protec-tion backfits. The manual chapter further specifiesthat a proposed plant-specific backfit must be con-sidered for generic backfitting.

2.2 Information RequestsInformal oral information requests are not considered tobe backfitting and they should not be used by the staff oraccepted by licensees for the purpose of imposing back-fits. When written requests cite 10 CFR 50.54(f), requir-ing a response under oath or affirmation, a statement ofthe reasons for the request must be prepared and mustbeapproved by the Executive Director for Operations(EDO) or his designee (regional administrators, officedirectors and their deputies) except when the informationis needed to verify compliance with the current licensingbasis. As specified in the rule, this is done to ensure thatthe burden imposed on respondents is justified in view of

NUREG-1409

the potential safety significance of the issue to be ad:dressed. As further speciTied in NRC Manual Chapter0514 for plant-specific requests, such justification is notneeded when seeking information of the type routinelysought for licensing reviews of plants under constructionor when there is reason to believe that there is not ade-

quate protection.

Some information requests promulgate new or revisedstaff positions and request that licensees, in their re-sponses, state whether they willadopt the new positions.Even though these actions do not impose backfits, as amatter of internal staff practice they are identified asbackfits and justified accordingly before they are issued,as required by NRC procedures. As discussed in Section2.1.1, this is often the case with generic letters and bulle-tins. In the past, backfitting considerations have not beenexplicitly addressed in the generic letters and bulletinsthemselves and this has contributed to confusion aboutwhether the actions are backfits. In the future, genericletters and bulletins willcontain an explicit statement as

to whether the action is considered to be a backfit and, ifso, the type ofbackfit it is considered to be (see AppendixF for a sample).

2.3 Staff Process for Identifying andImposing Generic Backfits

Backfits that have been identified and justified by the staffand that are intended to apply to one or more classes ofcommercial nuclear power licensees, first go through theoffice concurrence chain. The appropriate office directorwill review the proposed action and disapprove or ap-.

prove it as a backfit (1) that falls under one of the backfitrule exceptions previously identified or (2) that provides a

substantial increase in the overall protection of publichealth and safety with direct and indirect costs of imple-mentation that are justiTied in view of this increased pro-tection.

When the office director approves the package, the pro-posed action and associated justification are forwarded tothe Committee to Review Generic Requirements(CRGR) for review. The six-member CRGR normallywill discuss the proposal with the sponsoring office toensure the proposal is well understood, to review its

justi-'ication,

and to make a recommendation to the EDOwhether the proposed generic requirement should beissued, issued with modifications, or not issued. If theCRGR recommends disapproval, or recommends majormodifications of a proposed requirement, it submits astatement of the reasons for its recommendations to theEDO.

The CRGR was formed in November 1981 and has re-viewed the generic requirements or staff positions im-posed by the NRC staff since that date. Its charter was

revised in 1986 to reflect the 1985 changes to the backfitrule (10 CFR 50.109) and again in 1987 to'reflect changesto the NRC organization. The responsibility for support-ing CRGR activities and oversight ofbackfitting was dele-gated from the EDO to the Director, Office for Analysisand Evaluation of Operational Data (AEOD), in April1987.

The objectives of the CRGR process are to eliminate orremove any unnecessary burdens placed on licensees, toreduce the exposure of workers to radiation in imple-menting new requirements, and to ensure the effectiveuse of licensee and NRC resources, while at the sametime ensuring the adequate protection of the publichealth and safety and furthering the review of new, cost-effective generic requirements and staff positions. Thecommittee is chaired by the Director of AEOD and con-sists of a member each from the Office of the GeneralCounsel (OGC), Nuclear Reactor Regulation (NRR),Research (RES), Nuclear Material Safety and Safeguards(NMSS), and a regional representative. CRGR membersare appointed by the EDO (the NRC General Counselconcurs in the appointment of the OGC member).

The types of documents to be considered by the CRGRinclude

~ staff papers proposing the adoption ofrules or policystatements affecting power reactors

~ staff papers proposing new or revised rules includingadvanced notices

~ proposed new or revised regulatory guides, StandardReview Plan (SRP, NUREG-0800) sections, andbranch technical positions

~ proposed generic letters, multi-plant orders, showcause orders, and generic information requests un-der 10 CFR 50.54(f)

~ proposed bulletins and unresolved safety issueNUREGs

~ new or revised standard technical specifications

~ any generic correspondence to licensees that may re-flect or interpret new NRC staff positions

Evaluations and approvals of generic topical reports are,examples of documents that sometimes need review. Alarge majority of these documents do not contain any newrequirements or positions; however, some of them do andthey are reviewed by the CRGR.

Examples of approved requirements that do not requireCRGR review are (1) positions or interpretationscontained in the above documents that were issued be-fore November 12, 1981 or (2) positions taken after

NUREG-1409

November 12, 1981, that already have been approvedthrough the established generic review process.

In reviewing proposed new staff positions or require-ments, the committee speciTically focuses on (1) the needfor a new requirement and whether it may have any ad-verse effect on safety and (2) ifnot required foradequateprotection or compliance, whether the new requirementprovides a substantial improvement in safety and is cost-justified. In conducting this review, the CRGR normallywillconsider the factors specified for backfitting as dis-cussed in Section 2.1.3(1) as well as additional factors asdiscussed in Sections 2.1.3(2) and 2.1.3(3).

For those rare instances where it is judged that an emer-gency action is needed to protect the health and safety ofthe public, no prior review by the CRGR is necessary.However, the CRGR Chairman is notified by the officeoriginating the action. The objective of and reason for theemergency action requirements are documented and re-ported to the committee for information and are includedin a report to the Commission.

Fifteen copies of each review package are submitted toCRGR. The following type of information is submitted(see the CRGR Charter, Appendix C, for specific de-tails):

~ the proposed generic requirement or staff position

~ supporting documents

. the proposed method of implementation

a backfit analysis for cost-justified enhancements,generally conforming to the directives and guidanceof NUREG/BR-0058 and NUREG/CR-3568

For each proposed requirement not requiring emergencyaction, the proposing office identifies the requirement aseither Category 1 or 2.,Category 1 requirements are thosethat the proposing office rates as urgent and are approvedor otherwise dealt with within two working days of receiptby the CRGR. Category 2 requirements are those that donot meet the criterion for designation as Category 1.These are scrutinized carefully by the CRGR on the basisof oral discussion and written justiTication. Such justifica-tion is submitted by the proposing ol'fice along with theproposed requirements in advance of CRGR discussions.Meetings are generally held at regular intervals and agen-das are issued by the CRGR Chairman one to two weeksin advance of each meeting, except for Category 1 items.Available background material on each item to be consid-ered by the committee is issued to each CRGR member asit is received to permit sufficient advance review.

~ category of reactor to which the generic requirementor staff position is to apply

~ the office director's determinations

The CRGR may recommend approval, revision, or disap-proval or that further work be done by the staff and/orpublic comment be sought.

Awritten response is required from the cognizant officeto report agreement or disagreement with the CRGRrecommendations documented in CRGR meeting min-utes.

The CRGR staff ensures that there is an archival systemfor keeping records of all packages submitted, actions bythe staff, summary minutes of CRGR consideration ofeach package, including corrections and recommenda-tions by the committee. The submitted packages and thcsummary minutes fora meeting are released to the PublicDocument Room after the NRC has taken action on thcmatters discussed (c.g., issuance of a generic letter orbulletin) or after thc Commission has considered thematters in a public forum (e.g., public meeting on a pro-posed rule).

The CRGR staff prepares a report that is submitted bythe EDO to the Commission each month. The reportprovides a brief summary of CRGR activities. The reportis distributed as an enclosure to the EDO Weekly High-lights.

Figure 1 provides a schematic representation of how newgeneric requirements and staff positions are developed,revised, and implemented.

2.4 Staff Process for Identifying andImposing Plant-Specific Backfits

As noted previously, plant-specific backfitting involvespositions unique to a particular plant, whereas genericbackfit ting involves the imposition of the same or similarpositions on more than one plant. To be a plant-speciTicbackfit, the requirement or position will involve (1) onlyone plant (sometimes including identical units at onesite), (2) a new or revised requirement or staff position,and (3) a schedule for the imposition after key datesspecified in the backfit rule.

It is important that the necessity formaking backfit deter-minations not inhibit the normal informal dialogue be-tween NRC staff (e.g., technical reviewers and inspec-tors) and the licensee. The intent is to manage backfitimposition and not to constrain or eliminate suggestionsor inquiries in areas within the scope of 10 CFR 50.109.Only when these conversations convey a staff positionthat a licensee must change the design, construction, or

NUREG-1409

Unresolved safety issuesGeneric issuesRegulatory guidesBulletins & ordersProposed rulesOther

Prioritize anddevelop proposed

requirementincluding

regulatory analysis

Discussions withindustry,

ACRS,'ublic

Technical managementreview

Optional discussionswith industry

CRGR" review

Executive Directorfor Operations

Revise proposalor

solicit public commentor

no further work

Further reviewACRS, Commission

Licensee'sinput

Project managers workwith licensees

Integrate

!into

compositeLschedule Agreed-uponplant-specific

implementation schedule

'Advisory Committee on Reactor Safeguards"Committee To Review Generic Requirements

Figure 1 Schematic representation of new requirements review

NUREG-1409

operation of a facility would a backfit determination beneeded.

In this context, itshould be noted that actions proposed bythe licensee are not backfits, even though such actionsmay result from normal discussions between the staff andthe licensee concerning an issue and even though thechange or additions proposed by the licensee may other-wise meet the definition of a backfit.

The imposition of plant-specific backfits is governed byNRC Manual Chapter 0514, which establishes the staffrequirements and guidance for implementation for thisaspect of the backfit rule. The primary objective of themanual chapter is to ensure that plant-speciTic backfitsare required only (1) ifnecessary to provide an adequatelevel of safety, (2) ifnecessary to ensure compliance withCommission rules, orders, or written licensee commit-ments, or (3) to provide a cost-justified safety enhance-ment after approval of the required backfit analysis. Ifnobackfit analysis is required, the appropriate office direc-tor or regional administrator is to provide a documentedevaluation that provides the basis for invoking one of theexceptions.

The manual chapter identifies the NRC staff membersresponsible for implementing the procedure and assuringthat process controls are in place. For example, staffmembers at all levels are responsible for identifying po-tential plant-specific backfits. The office directors forNRR and NMSS and the regional administrators are re-sponsible for the final decision on whether a backfit isrequired and, ifso, to approve the backfit analysis or thedocumented evaluation. Further, each office is requiredto have a specific office procedure providing guidance inthe identification, handling, imposition, and tracking ofplant-specific backfits. li

Following approval of the regulatory analysis (backfitanalysis) or documented evaluation by the appropriateoffice director or regional administrator, review(ifany) bythe EDO, and issuance of the backfit requirement to thelicensee, the licensee may implement the backfit or ap-peal it. Following an appeal and subsequent final decision

by the appropriate office director or EDO, if the appealhas been denied the licensee willnormally implement thebackfit. Ifthe licensee still does not elect to implementthe backfit, itmay be imposed by order of the appropriateoffice director.

Implementation of a plant-specific backfit is normallyaccomplished on a schedule negotiated between the li-censee and NRC. Scheduling criteria include the impor-tance of the backfit relative to other safety-related activi-ties under way, such as the plant construction ormaintenance planned for the facilityin order to maintaina high-quality of construction or operations. For plants

'H

that have integrated schedules, the integrated schedulingprocess is used for this purpose.

Astaff-proposed backfit may be imposed by order beforecompleting any of these procedures, if the NRC officialwho authorizes the order determines that immediate im-position is necessary to ensure public health and safety orthe common deferise and security. In such cases, the EDOshall be notified promptly ofthe action and a documented

'valuationprepared (ifpossible in time to be issued withthe order).

Ifimmediate imposition is not necessary, staff-proposedbackfits should not be imposed, and plant construction,licensing action, or operation should not be interruptedor delayed by NRC actions during the staff's evaluationand backfit transmittal process, or a subsequent appealprocess, until final action is completed.

The prbposing headquarters office or regional officemanages each proposed plant-specific backfit using theNRC plant-specific backfit tracking system. This systemprovides references to all documents issued or received

by NRC staff relative to plant-specific backfits, includingrequests, positions, statements, and summary reports.Specific details on this system are found in office imple-menting procedures.

As stated earlier, the EDO has delegated responsibilityfor oversight of the plant-specific backfitting process tothe Director of AEOD. This includes reviewing and con-curring with office procedures, conducting training forNRC staff and industry, and informing licensees of pro-gram and procedure changes. An annual assessment isconducted that includes review of plant-specific backfitsidentified by staff or industry, review ofoffice proceduresand selected records, interviews with office and regionalstaff, and obtaining industry comments on the backfitting

'process.

Agraphical description of the plant-specific backfit proc-ess is given in Figure 2.

2.5 Filing a Backfit Claim or AppealAproposed staff position not identified by the NRC staffas a backfit may be claimed to be a backfit by a licensee.Alllicensee claims are to be sent in writing to the officedirector or regiona1 administrator of the NRC employeewho issued the position with a copy to the EDO. A licen-see claim that a requested action is a backfit needs to be

promptly addressed and evaluated to determine whetherit is, in fact, a backfit. Areport to the EDO and a responseto the licensee should be forwarded within three weeksafter receipt of the claim indicating the results of thedetermination and the plan for resolving the issue.

Appeals with regard to backfit determinations are gener-ally of two types and involve two different situations:

NUREG-1409

Plant-specificposition

Determinednot tobe abackfit bythe officialissuing theposition

Issuedtolicensee

Licensee mayclaim to oflicedirector orregional adminis-trator of staff thatproposesposition that it isa backfit Qi

Determinednot tobeabackfit

Determinedto be a backfit

Prepare any required regulatory analysis

Issued tolicensee

1

I

II

Licensee mayappealtoresponsible officedirector (I) toreverse denial ofa claim that the

ition is aackfit or (2)

that an identifiedbackfit does notmeet the compli-ance or adequateprotectionexception (D

Issued tolicensee may appeal

to ExecutiveDirector forOperations

Determinedtobe abackfit

Clg

Determinedto becompliance

Determinedto bc adequateprotection.by director ofNRR or NMSS

Determinedto be cost-justifiedsubstantialim rovement

Docuinentedevaluationprepared anda roved byJ@dor regionaladministratorevaluation mayollow issuance

in urgent cases)

Regulatoryanalysis preparedand approved byoffice directoror deputyor regionaladministratoror deputyand forwardedto ExecutiveDirector forOperationsbefore issuance

Issued tolicensee

Issued tolicensee

Licensee mayappeal tooffice directoror regionaladministratorof stalfthat proposesposition tomodify orwithdraw Ql

Notes: I. Copy to be addressed to thc Executive Director for Operations.2. Report to Executive Director for Operations and inform licensee within 3 weeks of results of determination and plans to resolve issue.3. Report to Executive Director for Operations within 3 wee:ks on plan for resolving and inform licenscc promptly and periodically of plans.4. Staff may decide the backfit is not hkely to be justified and close the action.5 Approval by Execuiive Director for Operations before issuance is not required.

Figure 2 NRC plant-specificbackftt, claim and appeal process defined in NRC Manual Chapter 0514

(1) appeal to an office director or regional administratorproposing to modifyor withdraw a backfit forwhich aregulatory analysis has been prepared and transmit-ted to the licensee

(2) appeal to the responsible program office director (a)to reverse a denial of a prior licensee claim that anaction is a backfit or (b) to determine that a backfitthat the staff found to meet the adequate protectionexception or the compliance exception does notmeet the exception

Licensees should address an appeal of a proposed backfitto the appropriate office director or regional administra-tor with a copy to the EDO. The appeal should indicatedeficiencies in the staff's analysis or provide other infor-mation in support of the appeal. In all cases, the appealshould include sufficient documentation to justify theposition taken. The office director or regional administra-tor, within three weeks, reports to the EDO on the planfor resolving the issue and informs the licensee in writingof the staff plan. Appropriate documents should be in-cluded in the backfit tracking system. Licensees shall notbe penalized by the staff for raising backfit questions orfilingbackfit appeals. As stated in NRC Manual Chapter0514, ifimmediate imposition is not necessary, staff pro-posed backfits should not be imposed and plant construc-tion, licensing action, or operation should not be delayedduring an appeal.

The decision of the office director or regional administra-tor on a plant-specific backfit appeal may be appealed tothe EDO, in which case the EDO willresolve the appealand state the basis.

Summaries ofall appeal meetings are prepared promptly,provided to the licensee, and placed in appropriate publicdocument rooms. After an appeal and subsequent finaldecision by the appropriate office director or regionaladministrator or the EDO, ifthe appeal has been denied,the licensee may implement the backfit resulting from thedecision. Ifthe licensee does not elect to implement thebackfit, it may be imposed by order of the appropriateoffice director. Additional details on the backfit claim andappeal process can be found in NRC Manual Chapter0514. A graphical description of this process is given inFigure 2.

The regional offices and the Office of Nuclear ReactorRegulation have procedures that govern the specificmethods of reviewing backfit appeals. These proceduresprovide further detail beyond the requirements of NRCManual Chapter 0514 and the details differ somewhatamong the offices. However, all of the procedures con-form to the provisions ofManual Chapter 0514 discussedabove

2.6 Current Status

In 1989 the Office of AEOD conducted the most recentseries of NRC staff training sessions at the regional of-fices. AEOD also, in April 1989, conducted a survey oflicensees to determine their perceptions of the back-fitting process and obtain specific cost information. Inaddition, in late 1989 and early 1990, the NRC staff con-ducted a broader survey with regard to the effects of theregulatory process on licensees. With regard to backfi-tting, licensees expressed concern about the number andoverall burden of generic communications, the adequacyofNRC's consideration of cost and schedule impacts, thebasis for issuing requirements involving backfits, thetreatment ofoptional actions and requests as ifthey wererequirements, the negative effects ifNRC perceives li-censees to be unresponsive because they do not imple-ment optional actions or because they file backfit claimsor appeals, and a need for additional training in back-fittingfor industry and NRC personnel.

The NRC staff is taking several initiatives to improve thebackfitting process and is considering further initiatives.To make backfitting considerations and bases clear toreaders, a summary of backfitting considerations wasadded to generic letters and bulletins beginning in De-cember 1989. This report has been prepared to explainthe backfitting process to industry and NRC staff. Aseriesof workshops with industry and NRC staff is planned forthe near future. Changes have been proposed to theprogram for systematic assessment of licensee perform-ance that would reduce any potential for penalizing licen-sees for submitting appeals. Senior NRC managers areconsidering the informatibn gathered from the broad sur-vey of the effects of the regulatory process on licensees todetermine what changes may be appropriate. For exam-

ple, the preliminary report (Draft NUREG-1395) indi-cates that the staff will examine methods to take intoaccount the cumulative effects of new requirements.

NUREG-1409

3 QVESTIONS AND ANSWERS ON BACKFITTING

During the conduct of staff training and in the communi-cation with licensees, a number ofquestions and observa-tions have been raised regarding the NRC policies andpractices for backfitting. These questions and observa-tions have been grouped into six general categories andare presented below followed,by the approved staff re-sponse.

1

3.1 Backfit Determination andImposition

(1) 2 number ofgeneric letters and bulletins recently issuedrequest orrequire actions, yet thereisno baclfit analysisaccompanying the documents. Is this appropriate?

Many of the bulletins and generic letters issued in1988 and 1989 were not justified by a backfit analysissimply because they were determined to fall underthe compliance exception listed in 10 CFR 50.109.When action is needed to ensure compliance withexisting regulations or to ensure that an adequatelevel ofprotection is maintained, a backfit analysis isnot required. However, a documented evaluation isneeded to support the use of the

exception.'he

backfit analyses or documented evaluations areavailable in the Public Document Room. However,this was not readily apparent in the past becausethey were not cited in the generic letters and bulle-tins themselves. In the future, backfit analyses ordocumented evaluations willbe cited in the genericcommunications. An example is provided in Appen-dix F to this report.

(2) IVhere does a confirmatory action letterfallin theback-fitprocess?

Aconfirmatory action let ter (CAL)is issued to con-firm a licensee's agreement to implement specificactions, which can include agency requirements andstaff positions. The CALmerely documents a licen-see's agreement and does not impose or implementany new or revised staff positions or requirements.Thus, it falls outside of the backfit process becausethe licensee has volunteered to take the course ofac-tion identiTied in the letter.

'Aswasstatedearlier,genericlettetsandbullctinsdonot imposeback-fits.Therefore, they a re not required by regulation tobe accompaniedby backfit analyses or documented evaluations. Nonetheless, it isNRCpiacticetojustifythemasbackfits, ifappropriatc,bcforeissuingthem.

(3)

(4)

(5)

The bacLfit rule does not provide a clear erplanation ofthe criteria the NRC willuse to document the need foraneiv "level ofprotection."

Specific criteria have not been established to deter-mine when it may be necessary to redefine adequateprotection. See Federal Register, Vol. 53, No. 108,(June 6, 1988), pages 20608 (col. 3) and 20609 (col.1) (Appendix B to this report).

How does the bacl fit rule apply to new staffpositionsthat reflect an evolving understanding of technical is-sues?

New or revised staff positions are backfits when theyare imposed on licensees and result in a change instructures, systems, design, or procedures (as de-scribed in 10 CFR 50.109). A backfit analysis is re-quired whenever new or revised positions are im-posed to achieve cost-justiTied substantial safetyenhancements. A backfit analysis is not required ifthe new or changed position is imposed to bring a fa-cilityinto compliance or ifit is necessary to provideassurance of adequate protection. In those cases,however, a written evaluation is needed to providethe objectives of and reasons for the modificationand the basis for invoking the exception.

An evolving understanding of issues does not, by it-self, define which category. fits a particular backfit.Judgment must be applied to the facts of each par-ticular case to determine whether the backfit is forcompliance, to provide adequate protection, to re-define adequate protection, or to achieve a cost-justiTied substantial safety enhancement. For exam-ple, with regard to compliance, the 1985 statementof considerations for 10 CFR 50.109 indicates that"the compliance exception is intended to addresssituations where the licensee has failed to meetknown and established standards of the Commissionbecause of omission or mistake of fact....new ormodiTied interpretations ofwhat constitutes compli-ance would not fall within the exception...."

Must back/its be identified by the staff when they areimposed?

Yes, plant-specific and generic backfits must bedetermined in advance and the proper proceduresfollowed before imposition. For example, a backfitanalysis is required for actions that are cost-justiTiedsubstantial safety enhancements. Ifa new require-ment or staff position meets the complianceexception or the adequate protection exception, abackfit analysis is not required, but the action is still

NUREG-1409 12

0

considered as a backfit and a documented evaluationproviding the objectives of and the reasons for themodiTication and the basis for invoking the exceptionis needed.

Is a backfit analysis needed forinformation requests thatare verbally communicated? Many such requests canrepresent a significant burden to a licensee.

Oral information requests do not fall under thebackfit rule. They should not be used by the staff oraccepted by licensees for the purpose of imposingbackfits.

NRC management should be informed of inappro-priate requests for information in order to assureproper authorization and justification. NRC super-visors and managers are sensitive to this issue andlicensees should not be penalized by the staff forraising it.

Isit appropriate for the NRC staff to rely on informal orformal communications to other licensees as ogicialNRC positions? What about NRC tacit approval ofdocuments?

Informal or formal communications to one licenseeare not officialpositions to all licensees. Section 053,of Manual Chapter 0514 identifies what can be ap-plied as officialstaff positions in a plant-specificcon-text. They are legal requirements such as containedin explicit regulations, orders, and plant licenses;written commitments such as contained in finalsafety analysis reports, licenses event reports, anddocketed correspondence; and documented, ap-proved explicit interpretations such as contained inthe SRP, branch technical positions, regulatoryguides, generic letters, and bulletins. Orders,licenses, and written commitments are applicableonly to a particular licensee.

Ifthe staff previously exempted a licensee from a le-gal requirement or approved position, it is not appli-cable to that licensee for the purpose ofbackfit con-sideration. Explicit exemption would be doneformally in writing. The Appendix to NRC ManualChapter 0514 discusses tacit approval underreanalysis of issues. Two situations are covered. Inthe first case, staff review of a previously acceptedlicensee action or. program may result in a requestedchange. This would be classified as a backfit becauseit represents a change in a previous staff position andwould require a backfit analysis (or a documentedevaluation ifit meets one of the exceptions listed inthe backfit rule). In the second case, a licensee sub-mittal committing to a specific course of action thathas not received timely NRC staff review is imple-mented by the licensee. In this case, it is considered

(9)

that the NRC staff tacitly accepted the licensee's ac-tion since timelynotice to the contrary was not given.Ifthe NRC staff subsequently adopts a different po-sition and requests a change in the licensee action,this change maybe classified as a backfit and thus re-quire a backfit analysis (or a documented evaluationifit meets one of the exceptions listed in the backfitrule).

Is it a plant-specific backfit to apply an approved andissued regulatory guide to an operating plant?

As part of the generic review process, the responsi-ble office director determines and the CRGR re-views which plants or groups of plants are affectedby new or modiTied regulatory guide provisions. Im-plementation in accordance with the generic appli-cability is not an additional plant-speciTic backfit andis, therefore, not governed by the plant-speciTicbackfit procedures. Alicensee may appeal, however,and assert that the generic analysis does not justifythe backfit.

Any staff-proposed plant-specific implementationof a regulatory guide provision, whether orally or inwriting, for a plant not encompassed by the genericimplementation determination is, however, consid-ered a plant-specific backfit. In other words, staff ac-tion with regard to a specific licensee that expandson, adds to, or modifies a generically approved regu-latory guide, such that the position taken is differentthan intended in the generic positions, is a plant-specific backfit.

How is a compliance bachfit a+ected ifa licensee for-mally withdraws or substantially revises the commit-ment that forms the basis for the compliance backfit?

Licensees are free to change commitments that havenot been imposed by rule or order. However, doingso may raise questions about staff acceptance of li-censee programs. Of course, ifthe revised commit-ment is fullyacceptable to the staff, then the super-seded or outdated commitment would not be used asa basis for a compliance backfit. If, on the otherhand, the revised commitment is not acceptable,then the previous commitment or its equivalent mayform the basis for a compliance backfit. Circum-stances and judgment would play a significant role inthis case. For example, the date of the original com-mitment and that for the revised commitment couldbe important. It would not be appropriate for theNRC staff to cite a previous commitment that.hadbeen revised with staff knowledge and tacit approvalfor several years.

(10) How does one appeal a generic backfit?

Licensees may certainly appeal generic backfits asthey may appeal any staff position. However, the

13 NUREG-1409

CRGR Charter, which is the NRC's generic back-fittingprocedure, does not address appeals. Thus, inappealing generic backfits, the staff advises licen-sees to followthe guidelines in NRC Manual Chap-ter 0514 for appealing plant-specific backfits to theextent practical. (In the recent past the EDO hasreferred such appeals to the CRGR to obtain its rec-ommendations before making a decision.)

3.2 Generic Backfits

Does CRGR look at the difference between genericletters and bulletins?

H%y is 10 CFR 50.54+ cited in many generic letters?

When 10 CFR 50.54(f) is cited in a generic letter, it isto establish a basis for requiring a response. Thismay be to determine whether the agency will takeaction regarding the specific license or it may bedone to determine whether a generic requirement isneeded based on the information obtained.

It seems like the stag too frequently claims that a neivstag position is consistent with existing Commissionrules'and positions just to avoid performing a backfitanalysis.

The compliance exception in 10 CFR 50.109 is cer-tainly meant to be used only when specificallyauthorized and justified by the appropriate office di-rector. Further, the CRGR Charter provides addedassurance that new requirements and staff positionsare fullyconsistent with the provisions of the backfitrule. In reviewing proposed generic requirementsthat are identified as compliance issues, the commit-tee considers whether they are needed to ensurecompliance with existing requirements or whetherthey represent a new staff position that needs to bereviewed under other provisions of 10 CFR 50.109.

Yes, when CRGR reviews generic communicationsconsideration is given to the form and its application.The general guidelines used by the CRGR are thatbulletins should be used to request action by licen-sees on a short-term basis to correct or address asafety concern for which timely action is necessaryand that generic letters should be used to request in-formation from licensees and to transmit informa-tion regarding a new staff position. In general, ge-neric letters are used to clarify NRC policy on howthe agency intends to implement a regulatory re-quirement, assist the agency in determining whethernew requirements are needed, or seek information

'on licensees conformance to existing staff positions.

(4) Ithas been our observation that the stagestimate ofin-stallation and continuing costs associated with thebackfit is often grossly underestimated.

During its review, CRGR takes into account staff es-timates of the required licensee and staff resourcesto implement the requested action. Frequently staffestimates are giv'en in terms of a range as well as anaverage cost because it is recognized that some licen-sees may be required to spend more than other li-censees. The CRGR review usually focuses on whatis projected to be an average cost over all affectedfacilities. For adequate protection and complianceactions, cost estimates provided to CRGR have beenused for background information and not as a condi-tion for acceptance.

As part of the AEOD April1989 survey, a question-naire requesting estimates with actual costs was in-cluded. The purpose for requesting this informationwas to assist the staff and CRGR in evaluating esti-mated costs for proposed actions. Apreliminary re-view of the licensee's responses indicate that, for themost part, the staff estimates have been reasonableand have not been grossly underestimated in rela-tion to average costs.

(5) How does the agency ensure that the bachfit rule is- properly implemented in issuing generic communica-tions such as bulletins and generic letters?

As discussed in the responses to other questions, be-fore any generic communications such as bulletinsand generic let ters are issued, the proposed staff po-sitions are reviewed for the method and impact ofimplementation by the responsible office directorand, in turn, by the CRGR. A specific focus of theCRGR review is the basis for the generic communi-cation and whether backfit considerations have beenappropriately addressed by the staff.

It seems that the staffis circumventing the requirements

of10 CFR 50.109 by citing10 CFR 5054I as the basisfor imposing major new regulatory requirements.

When 10 CFR 50.54(f) is cited in a generic'letter orbulletin, it simply establishes a requirement to sub-mit a response to the letter. Thus, there is no intentin citing 10 CFR 50.54(f) to circumvent 10 CFR50.109. To the contrary, although generic letters andbulletins do not impose new or revised staff posi-tions, they are reviewed by the CRGR to ensure thatthe provisions of the backfit rule are implemented.In the future, generic letters and bulletins willcitethe backfit analysis or other evaluation performed inthis regard.

The spirit and intent ofthe bach/it 'rule does not appearto have been met in all cases, as an example, issuance of

NUREG-1409 14

3.3

Bulletin 88-11is completely lacking any 10 CFR 50.109justification.

Although the justification was not printed in the bul-letin, NRC Bulletin 88-11, "Pressurizer Surge LineThermal Stratification," was justified as a backfit. Itis an example ofa backfit that was determined by theresponsible NRC official to be required as a matterof compliance with existing requirements and com-mitments. The CRGR reviewed the bulletin andconcurred. The regulations currently require licen-sees to meet the applicable codes of the AmericanSociety of Mechanical Engineers (ASME), Boilerand Pressure Vessel Code. Because of the staff's con-cern with the integrity of the surge line, licenseeswere requested to perform their fatigue analysis inaccordance with the latest ASME Section III re-quirements that incorporate high cycle fatigueanalysis. The justification provided by the staff wasthat previously unconsidered thermal stratificationphenomenon may invalidate the existing analysisperformed to confirm the integrity of the surge line.

Subsequently, itwas understood that some licenseesbelieved that the staff',s rationale was in error be-cause they were not committed to the latest ASMESection III requirements by virtue of their licensecommitment. However, the issue became moot be-cause these licensees undertook the analysis volun-tarily in view of the safety importance of the issueand the fact that previous versions of the ASMECode did not completely address the concern.

Plant-Specific Sackfits

Ifan inspector has previously accepted (i.e., providedtacit approval of) a licensee's method, does a specific re-quest forchange constitute a baclfit andifso,is a back-fitanalysis required?

A new or revised staff position affecting the designofsystems, structures, and components or the proce-dures or organization required to design and con-struct or operate a facilityafter issuance of the oper-ating license is a backfit. Whether a backfit analysisis required depends on the basis for the backfit. Abackfit analysis is required when the backfit wouldresult in a cost-justified substantial suety enhance-ment. Ifa determination is made that the action isneeded to provide an adequate level ofprotection orrequired to bring a fa'cility into compliance, then no

'ackfitanalysis is required. In these cases, a docu-mented evaluation of lesser scope is needed as dis-cussed in the response to previous questions.

Cases where an inspector provides tacit approval arerelatively rare. Simply not challenging a licensee's

practice normally would not be considered tacit ap-proval. The only example provided in Manual Chap-ter 0514 is a case where the NRC has indicated tacitapproval by not acting in a reasonable time on a li-censee submittal and the licensee has moved aheadto implement the proposal described in the submit-tal. For the purpose of this question, it would mostlikely arise in connection with review of a licenseeresponse to an inspection report.

Explicitapproval could be provided in an inspectionreport that states that a particular approach is ac-ceptable. However, conclusions of that nature areusually made in safety evaluation reports rather thaninspection reports.

What is the definition of timely" in the context ofapproval?

The appendix to Manual Chapter 0514 provides thefollowing:

~ when the licensee has made a submittal com-mitting to a specific course ofaction to meet anapplicable position

~ the licensee has moved ahead in thc interven-ing time to implement the proposed action

~ the staff did not provide a response for an ex-tended period (or within a reasonable time notdelaying the applicants implementation plans

then subsequent staff action to make changes is (ormay be considered) a backfit.

There is no specific time period assigned. Some sub-mittals may require a detailed analysis and could beexpected to take several months to complete, whileothers are administrative and can be completed inseveral weeks. Discussions need to be held with li-censees relating to the agency's progress in review-ing submittals in order to reduce the probability ofmisunderstandings, excessive delays, and the reedfor backfit determinations.

Is the guidance contained in tlie NRC InspectionManual approved positions?

No, inspection procedures are not approved staffpositions, which is the reason they arc not reviewedby CRGR. They exist only for staff usc in conductinginspections. NRC inspection procedures govern thescope and depth of staff inspections associated withlicensee activities, such as design, construction, andoperations. They define those items the staff is toconsider in its determination ofwhether the licenseeis conducting its activities in a safe manner.

15 NUREG-1409

(4)

(5)

(6)

Licensees cannot be required to implement posi-tions discussed in an inspection procedure or manualunless the same positions exist in the form of anapproved regulatory staff position. Examples of ap-proved staff positions are described in ManualChapter 0514 and include the SRP, branch technicalpositions, regulatory guides, generic letters, and bul-letins.

Are NRR offiice letters considered approved staffposi-tions?

No, office letters issued by the OfficeofNuclear Re-actor Regulation (NRR) fall into the same categoryas inspection procedures and do not constitute ap-proved staff positions. They are not reviewed byCRGR and exist solely as guidance for staff withinNRR.

Are staffpositions that reject an industry practice thatwaspreviously approved (either tacitlyor explicitly)con-sidered to be bachfits?

A change in staff position regarding previously ap-proved industry practice would be considered abackfit as described in the appendix to ManualChapter 0514. A backfit analysis is required (or adocumented evaluation is required if the actionmeets the exceptions listed in 10 CFR 50.109). Iftherevised staff position had generic implications,CRGR review would be needed.

Tacit approval is not broadly defined. The only ex-ample given in Manual Chapter 0514 is where theNRC has indicated tacit approval by not acting in areasonable time on a licensee submittal and the li-censee has moved ahead to implement the proposedaction described in the submittal.

The distinction between a staff recommendation thatasks a licensee to consider a proposed action and onethat directs the licensee to take a proposed action issometimes difficultto determine. How does the backfitprocess address this fine but important difference?

In the conduct of agency business, there are manyoccasions when the staff willsuggest or even recom-mend that licensees consider various actions. Suchsuggestions and recommendations are not necessar-ilybackfits and licensees may evaluate such recom-mendations and make the appropriate decision onimplementation.

Discussion or comments by the NRC staff identify-ing deficiencies or weaknesses, whether in meetingsor written reports, do not constitute backfits. Defini-tive statements to the licensee directing a specificac-tion to satisfy staff positions are backfits unless the

(7)

(8)

(9)

action is consistent with an explicit regulatory staffposition applicable to that facility(see the responseto Question 3.1(8) for further discussion). In a simi-lar manner, pressure upon a licensee to adopt aspecific staff position (for example to have a pro-gram found acceptable) would be prohibited unlessthe action is consistent with an explicit staff positionapplicable to that facility.

There seems to be an apparent trend to inspect licenseesto a rising standard ofacceptability ivithout an atten-dant modification to the specific regulatory require-ments. How does the backfit process ensure that the in-spection standards are properly controlled?

Inspectors are expected to look beyond mere com-pliance with regulations and to focus on the safetyimplications and margins at each facility.As a result,licensees may be encouraged to consider programenhancements and other actions. Licensees are ex-pected to evaluate such suggestions and recommen-dations and make a decision on implementation;however, such informal requests are not require-ments or staff positions. Further, such suggestionsor recommendations are not within the scope of thebackfit process. The staff should be questioned re-garding the safety significance, authority, or justifi-cation of any recommendations whenever the basisis not clear. Licensees shall not be penalized by thestaff for such questioning.

Howfar can aninspectorgoininterpreting NRC rulesindevelopinginspection findings and requiring licensee ac-tions without performing a bachfit analysis?

In the normal course of inspecting to determinewhether the licensee's activities'are being conductedsafely, inspectors may examine and make findings inspecific technical areas where prior NRC positionsand licensee commitments do not exist. Examiningsuch areas and making findings are not consideredbackfits. Likewise, discussion of findings with the li-censees is not considered a backfit. Ifduring suchdiscussions, the licensee agrees that it is appropriateto take action in response to the inspector's findings,such action is not a backfit provided the inspectordoes not indicate that the specific actions are theonly way to take corrective actions. On the otherhand, ifthe inspector indicates that a specific actionmust be taken, such action is a backfit unless it isconsistent with an applicable regulatory staff posi-tion (see the response to Question 3.1(8) for furtherdiscussion). Further, ifthe licensee provides a writ-ten claim that the inspector's findings are a backfit,the staff must make a specific backfit determination.Examples can be found in the appendix to ManualChapter 0514 (see Appendix D to this report).

What are the ground rules for applying the StandardReview Plan in operating license reviews? Can the staff

NI7R FG-1409 16

modify the acceptance criteria forspecific cases or when

a safety concern has been identified?

The SRP delineates the scope and depth of staff re-viewof licensee submittals associated withvarious li-censing activities. Itis an NRC staff interpretation ofmeasures which, if taken, will satisfy the require-ments of the more generally stated, legally bindingbody ofregulations primarilyfound in 10 CFR. SinceOctober 1981, changes to the SRP are reviewed andapproved through a generic review process involvingthe CRGR and the extent to which the changes ap-

~ ply to classes ofplants is defined. Consequently, ap-plication of a current SRP in a specific operating li-cense review is not, in general, a plant-speciTicbackfit, provided the SRP was effective six monthsbefore the start of the operating license review. Ask-ing questions ofan applicant foran operating licenseto clarify staff understanding of proposed actions todetermine whether the actions willmeet the intentof the SRP is not considered a backfit.

On the other hand, using acceptance criteria morestringent than those contained in the SRP or takingpositions more stringent than or in addition to thosespecified in the SRP, whether in writingor orally, isaplant-specific backfit. During meetings with the li-censee, staff discussion or comments regarding is-sues and licensee actions volunteered that are in ex-

cess of the criteria in the SRP usually do notconstitute plant-specific backfits; however, if thestaff indicates that a specific action in excess of thealready applicable staff position is the only way forthe staff to be satisfied, the action is considered aplant-speciTic backfit whether or not the licenseeagrees to take such action. It should also be recog-nized, however, that a verbally implied or suggestedaction should not be accepted by a licensee as anNRC position of any kind, backfit or not; only writ-ten and authoritatively approved position state-ments should be taken as NRC positions.

(10) Is it appropriate for the staff'to use the latest version ofthe SRPin the review oflicense amendment requests andother changes?

There is not a single answer. In the review of a li-cense amendment request, the staff should consider

, the guidance in the implementation section of theSRP and in Manual Chapter 0514 and exercise judg-ment in determining the applicability of current

'SRP.

During reload or other reviews subsequent to issu-ance of the operating license, staff-proposedpositions with regard to technical matters not re-lated to the changes proposed by a licensee are con-sidered to be backfits.

(11) Assume that a plant has not complied with an approvedstaffposition that is committed to in the FSAR and the

staff ssafety evaluation report (SER) was ivritten on thebasis that the staff position would be implemented.However, the position has not been implemented. Is itabaclfitto impose the position on the licensee afterissu-ance ofthe operating licensee?

Generally, it does not appear that the staff would bechanging its position in this case. If there is nochange ofpositions, imposing the licensee's commit-ment would not be a backfit.

(12) Do plant-specific orders come within the scope of thebackfit rule? What about those that confirm licensee ac-tions?

An order issued to cause a licensee to take actionsthat are not otherwise applicable regulatory staff po-sitions is a plant-specific backfit. An order effectingprompt imposition of a backfit may be issued beforecompleting any of the backfit procedures, if the ap-propriate office director determines that prompt im-position is necessary.

Aconfirmatory action order is intended to confirm a

voluntary licensee commitment to specific actionand may involve a compliance backfit.

(13) What about a notice ofviolation requesting a descri-ptio ofthe licensee's corrective action orstaffrequests forlicensees to consider certain additional actions. Hiethese backfits?

Anotice ofviolation requesting a description of a li-censee's proposed corrective action is not a backfit.The licensee's commitments in the description ofcorrective action are not backfits.' request by thestaff for the licensee to consider some specific actionin response to a notice ofviolation also is not a back-fit.Ifthe staff is not satisfied with the licensee's pro-posed corrective action, however, and requests thatthe licensee take additional actions, those additionalactions are a backfit, unless they are an applicablestaff position.

Discussions during enforcement conferences and re-sponses to the licensee's requests for advice regard-ing corrective actions are not backfits.

Definitivestatements to the licensee directing a spe-cificaction to satisfy staff positions are backfits, how-ever, unless the action is consistent with an applica-ble regulatory staff position.

(14) Can bulletins and generic letters be applied in all re-.spects to every facilityor will there be cases where theplant-specific bachfit process is to be used?

'Generally, adequate correct ivc actions would be required pursuant to10 CFR 50, Appendix D, Criterion XVI.

17 NUREG-1409

NRC bulletins undergo generic review by theCRGR. Therefore, it is not necessary to apply theplant-specific backfit review process to the actionsrequested in a bulletin (see the response to Ques-tion 3.1(8) for further discussion). If the, staff ex-pands the actions requested in a bulletin for a spe-cificlicensee, however, such expansion is considereda plant-specific backfit.

(15) What happens when a review concludesthat a licensee sprogram in a specific area does not satisfy a regulation,license condition, or commitment?

Where the staff previously accepted the licensee'sprogram as adequate, any staff-specified change inthe program would be classified as a backfit.

For example, in the case ofa plant with an operatinglicense, once the SER is issued signifying staff accep-tance of the programs described in the safety analy-sis report (SAR), the licensee should be able to con-clude that its commitments in the SAR satisfy theNRC requirements for a particular area. Ifthe staffwere to subsequently require that the licensee agreeto additional action other than that specified in theSAR for the particular area, such action would con-stitute a backfit. In the case described in the ques-tion, it is likely that the compliance exception in 10CFR 50.109(a)(4) would apply (i.e., it would be acompliance backfit).

A somewhat different situation exists when the li-censee has made a commitment to a specific courseof action and the staff has not yet responded. Ifthelicensee has moved ahead in the intervening time toimplement the actions the licensee proposed in thesubmittal and the staff has failed to provide a timelyresponse, the staff position may be considered abackfit. Thus, ifa licensee has implemented a tech-nical resolution intended to meet an applicableregulatory staff position, and the staff for an ex-tended period simply allows the licensee resolutionto stand with tacit acceptance, indicated by nonac-tion on the part of NRC, a subsequent action tochange the licensee's design, construction, or opera-tion is a backfit.

(2)

(3)

mechanism for imposition as long as the cost of thenew position or requirement can be demonstrated tobe justified.

Thereisincreasing evidence ofthe Commission's appar-ent willingness to accept subjective cost/benefit analysis.How can such analyses be consistent with the backfitrule?

The backfit rule requires an analysis. This analysiswillvary depending on the nature of the issue, theextent and type of information available, and theease to which a complex situation can be analyzed byeither quantitative or qualitative factors. In somecases, the'Commission makes decisions on the basisof qualitative factors. Some of the factors to be ad-dressed in the backfit analysis are not easily quantiTi-able. In addition, the rule includes consideration ofother "relevant and material" factors, some ofwhichmay be qualitative.

Quantitative factors, where known, are used, butneed not be the only basis for approving a backfitanalysis. The complexity and comprehensiveness ofthe analysis should be appropriate (limited) to whatis necessary to provide an adequate base for makinga decision. Section III,A.2, "Scope of the Analysis,"of NUREG/BR-0058 states: 'The emphasis [indo-ing the analysis] should be simplicity, flexibility,andcommon sense, both in terms of the type of informa-tion supplied and in the level ofdetail provided." Allbackfit analyses are to be approved by the cognizantoffice director or regional administrator and, ifge-neric requests or requirements are involved, a fur-ther review by CRGR is also necessary.

In issuing Generic Letter 88-01, "NRC Position onIGSCCin BWR Austenitic Stainless Steel Piping,"whydid the stagnot consider plant-specific differences thatmight affect the conclusion of the generic cost-benefitanalysis?

Generic Letter 88-01 was issued on the basis of en-suring compliance with existing regulations; therebymeeting one of the exceptions in the backfit rule fornot performing a backfit analysis. Accordingly, acost-benefit analysis was not required for this action.

3.4 Backfit AnalysisWhen is a backfit analysis needed?

A backfit analysis is needed when a new staff posi-tion or legal requirement goes beyond what is neces-sary for adequate protection and it is not needed tobring a facilityinto compliance. In other words, iftheproposed action would provide a substantial en-hancement to safety, the backfit rule provides a

In the case of a cost-justified substantial safety en-hancement, the costs are analyzed, a finding thatthey are justified is made by the cognizant officedirector and is further evaluated by the CRGR.Plant-speciTic differences and the associated cost in-formation are used when such information is avail-able. In these cases, the estimated range of costs isused by the committee in its review. The overall im-pact on the industry is generally known with reason-able accuracy, but the development ofa speciTic and

NUREG-1409 18

detailed cost estimates for each facility is generallynot practical.

(4) Does the utilityhave toformallysayitis filinga claim ofbackfit under 10 CFR 50.109? iVithwhom does the li-censee file the backfit claim?

3.5 AppealsSometimes a licensee will state that a specific actionlooks like a backfit, but willchoose not topursue theis-sue at the time. Xs theinspector required to do anything?

No, the inspector need not take any action. ManualChapter 0514 provides a mechanism for licensees tofilea backfit claim whenever they believe an uniden-tiTted backfit is imposed on them. The procedureprovides guidance on how to file and to whom theclaim should be addressed. There are no provisionsfor verbal claims and no action would be required ofinspectors in the circumstances posed unless theclaim is filed in writing. Licensees should be advisedto file a claim in writing in accordance with the pro-cedures of Manual Chapter 0514.

How does the staffhandle a situation wherein responseto enforcement action the licensee claims that a bac/fitis involved? For example, some licensees are claimingbac/fit in responses to the 10 CFR 50.49 rule. Howshould any inspector handle such claims particularly ifthey involve a generic requirement?

Backfit claims need to be in writingand each claimshould be handled on its individual merits by the of-fice responsible for the requested action. At thistime, no specific appeal process has been estab-lished for generic issues that have been evaluatedand reviewed by the CRGR and/or implemented bythe Commission. Thus, in such cases licenseesshould be advised to implement claims of improperbackfit in accordance with the plant-specific proce-dures contained in Manual Chapter 0514.

In response to a notice ofviolation, ifthe licensees usethe word "bacAfit,"is the agency required to respond?

As with any response to a notice of violation, thestaff will review and act, as appropriate, on thelicensee's response. However, indicating that an un-authorized backfit may have occurred in a responseto a notice of violation does not constitute a properbackfit claim that initiates the appeal process set outin Manual Chapter 0514. While the NRC may con-sider the information surrounding the licensee'sclaim, no specific agency action is required unlessthe licensee files a formal backfit claim in accor-dance with Manual Chapter 0514.

(5)

The benchmark which the staff uses in requiring li-censee actions is the assurance of safety. Ifthere is adisagreement between the staff and the licensee onwhat actions are necessary to ensure an adequatelevel ofsafety, it can usually be resolved through dis-cussion. Ifthe staff requires actions beyond applica-ble regulatory staff positions, a backfit would seemto be involved. The nature and justification forback-fitting actions are to be consistent with 10 CFR50.109 and relevant staff guidelines. For further in-formation, refer to the appeal process in ManualChapter 0514.

3.6 General Questions

lVhy is there rt baclfit standard in senior executiveservt'ce (SES'1 contracts? Doesn't tliat send a message

that there should not be bach/its?

The backfit standard in SES contracts holds NRCmanagers responsible for proper implementation ofthe backfit process. SES contracts also contain astandard on ensuring safety, which is of overridingimportance and works with the backfit standard. Thepurpose for including the backfit standard is to em-phasize to the staff that management needs to beaware of and to control staff activities to ensure theagency's adherence to the backfit rule and ManualChapter 0514. Backfits are expected, but theyshould be properly identified as backfits and handledin accordance with specified procedures. Thepurpose of instituting controls is to eliminate un-authorized backfits, and the preparation of the SEScontract item is to help ensure appropriate manage-ment review and oversight over these controls.

Manual Chapter 0514 states that a written claim ofbackfit should be sent to the appropriate office di-rector or regional administrator with supporting ra-tionale and backup information. There is no need toreference the rule since the manual chapter exists toimplement the backfit rule. However, the claimmust be in writing and should clearly state itspurpose.

Some individuals believe that the staffis attempting toimpose net standards on tlieindustry through enforce-ment. How can licensees use the bachfit process to re-solve theseissues?

19 NUREG-1409

APPENDIX A

THE 1985 BACKFITRULE

NUREG-1409

38097

Rules and Regulations Federal Reftister

Vol SIL No. 183

Friday. September 20. I98$

This seeters ot thecorllsips regllstory9Chefer aDDk~lrtyOl which ere keyedthe Code of Federprrbkshed tmder 50U.S.C, 1510.The Cods Df Federby the Sr4serrrrlehdePrtees of De» bookfirst FEOERAL REGweek,

EDERAL REGISTERments having

ed legal etleeL mostto sfid codkfied ih

Regrrtetens. wtseh is«les pursuant to 44

Regrrlstiohs ts soldt of Cocumehts.

are Ested in theTER rssrre of each

DEPARTMENT OF

Food Safety and I

9 CFR Part 381

(Docket Ho. 83407

New Turkey Inspe

Co+ection

ln FR Doc. SS-22

page 37MS in the iSeptember 13. 1following correctio

On page 3. 513. fsection number inwhich reeds -f 31-f 381.W".

~rtLlrr4 coDE ssesorM

GRICULTURE

spection Service

tlon System

beginning onue of Monday,making the

st colutnn. thee section heading,8". Should read

NUCLEAR REGULATORYCOMMISSION

10CFR Parts2and50

Revision of Bacttfittlng Process forPower Reactors

Ao!NOTS Nuclear Regulatory

AcTioN: Final tule.

suMMARv:The Nuclear RegulatoryCofllllilssion is rc'vtshlg its regu'Stions toeerrtbll»h standards and an agencydismplino for future management ofbackfining for power reactors.BasLfittfng is ~ process which caninclude both pitrnt specific changes andgeneric chirr ges as applied to one ormore classes of power reactors. Asdescribed in the rule. backfittmg isdefined as the modification of oraddition to systems. Structures.components. Or design of a facility:orIhe design approvrsl or Inanufacturinglicense for a fee!Iity: or the proceduresor organization required to design.construct or operate a facilitytany of

which may result from a new oramended provision in the Commissionrules or the imposition of new ordifferent regulatory staff positioninterpreting the Commission rules afier(i) the date of issu'ance of theconstruction permit (CP) for Ihc facilityfor fae!I!Iles having construction permitsissued after October 21. 1985: or (li) sixmonths before the date of docketing ofthe operating license (OL) application.for the facility for facilltfes havingconstruction permits Issued beforeOctober 21, 1985: or (ill) the date ofissuance of the operating license for thefacility for facilities having operatinglicenses: or (iv) the date of issuance ofthe design approval under Appendix M.N. Or 0 of 10 CFR Part 50.EFFSOTtva 0ATE: October 21, 1985.FOll FIIRTNER INFORMATION

CONTACT'ames

ILTourtellotte. Chairman.Regulatory Reform Task Force.V.S.Nuclear Regulatory Commission,Washington, DC 20555. Phone: (202) 834-3300.SUPPLEMKNTARY INFORMATIOIC

BackgroundThe Commission Initiated this

rulemaklng proceeding for the purposeof establishing requirements for thefuture management of backfitting forpower reactors. Backfittlng can includeboth plant. specific changes and genericchanges applicable to one or moreclasses of power reactors.

Section 50.109 of the Commission'scurrent power reactor regulationsprovides the following standard forbackfitting decisions: Backfitting may berequired where the Commission finds"that such ection willprovidesubstantiaL additlonrtl protection whichis required for the public health andsafety or the common defense andsecurity." On Its face. this appears to bea relatively high standard. In practice,however. $ 50.109 has rrtrely beenformally Invoke*and It fs thereforediflicultto tell the extent to wnich thisstandard has actually been applied toprevious backfitting decisions. TheCommission has decided that a new,more spetdfic standard and relatedprocedures should be applied by rule tobackfit ting decfslonL

The Commission published anadvance notice of proposed rulemokingand policy statement on this subject at48 FR 44217 (September 2L 1983) andmore recently, a notice of proposed

rulemaking at 49 FR 47034 (November30. 1984). The complete record of thisproceeding is available for review in theCommission's Public Document Room at1717 lf Street. NW Washington. DC.

Public Comments

The comment period OHicfally closedJanuary 29.1985. A number of commentswere received afier that time. the last ofwhich was fi!ed onMarch12.1985. bythe Advisory Committee on ReactorSafeguards. Allcomments wereconsidered in formulation of the finalrule.

Fifty.seven comments were filed asfollows: utilities. 30: vendors. 3: architectengineers and service companies. 5:industry groups and trade assoefations.3; consulting engineering firms. 3:various individuals and groups. 10:federal a ency.1(DOE);states.1(illinois):Adklsoty Committee onReactor Safeguards, 1.

As a result of the responses to theadvance notice of proposed rulemaking.

d.questions and other unnumberedquestions in the notice of proposedrulemaking. The responses to thesequestions have assisted the Commissionin reaching its determination on thecontent of the final rule.

Question 1. Should l 50.109 also applyto backfitting imposed throughrulemaktngl When a modification isimposed by rule or regulation. shouldthe affected licensee be afforded anappeal to the EDOT What is the basis forthis'positionT

The Union of Concerned Scientists(UCS) staled that I 50.109 should notapply to rulemaking. They assert thatthe Atomic Energy Act and prevailingcase law do not permit the considerationof cost in determining minimum safetystandards. (See UCS 1983 comtnents,pages 4-7.) An appeal to the EDO from arequirement imposed by rule cannot belegally permitted. according to UCS. andthe Commission may not circumvent thelegal requirements of the AdministrativeProcedure Act. 5 USC Section 553. bypermitting appeals outside of the publicforum to the Executive Director forOperations.

The Ohio Citizens For ResponsibleEnergy (OGRE) also oppose applicationof f 50.109 to ruiemaking Lreeause theysay -licensees are afforded enoughopportunities in the ruiemaking andadministrative process to contest the

eAppendix A NUREG-1409

38098 Federal Register / Val. SO. No. 183 / Friday. September 20, 1985 / Rules and Regulations

rules." They suggest that a petition forwaiver of a rule under 10 CFR 2.758 oran exemption under 10 CFR 50.12

rovides sufficient remedies foricensees.

The Nuclear UtilityBacHitting andReform Croup (NUBARG)believes thatbackfit ting controls should apply toscility modifications imposed byslcmaking. They state four reasons for

their position. First. in terms of publichealth and safety, they state thepractical impacts of backfitting byrulcmaking or backfitting on a plantspecific basis are the same. Therefore.NRC regulations should require adocumented analysis of a backfltregardless of the source of therequirement. Second. there is noapparent jusUficstion for excludingbackfit modilications im'posed by

~ rulemaking. They suggest that the NRCshould satisfy itself of the need for andefficacy of any backfit required. Third.ifthe backfithng rule did not apply torulemaklng. there may be a naturaltemptation by the staff to avoid theeffects of the backfitting rule by

'mposingrequirements throughrulemaking. Fourth. there would be noadditional burden because much ofwhat the rule would require alreadytakes place during the CRGR review ofpropascthlxlcvÃUII?~sa es Ihe(Ãdoes not advocate the preparation of a

lant-speciiic backfitting analysis forackfits proposed in the context of a

rulcmaking.NUBARG also believes that an

opportunity for an appeal to theExecvtive Director for Operationsshould exist. The licensee. they say.should be given the opportunity todemonstrate that the modificationestablished by rule or regulation shouldnot be mquired for its facilitybecausethat facility is substantially diffemntfrom the type. design. or eatage offacilities evaluated in the modification-ri:lI .:i 6: I as a result. findings made'„- is~ant to I 50.109 are not applicable.They go on to cite the need for fiexibilitIn the rulcmaking process as ~ bash fprtheir position. The Atomic IndustrialForum (AIF) and other industrycominenters appear to be in generalagreement vith the positions taken byNUBARG.

DOE also states that $ 50.109 shouldapply to rulemaking since ruleinakingand orders are "thc only two avenuesthrough which a backfit should beimposed by the Commission." Theyoppose appeal to the EDO. however.and suggest use of a waiver requestunder 10 CFR 2.758.

Question 2. Should Ij 50.109 limitbackfitting to backhts imposed by rule.regulation or order? If thc imposition of

backfits is not limited to rules.regulations or orders. what othermechanisms should be employed?

UCS opposes such a limitation. statingthat thc effect would "undoubtedly be toeliminate the condition which theSupreme Court found legally necessaryto justify two.stage licensing." clUngPower Reactor Development Companyv. Union. 361 US. 396. 41'1961).

OGRE takes a somewhat differentposition. They state that the AtomicEnergy Act."clearly states that theCommission' safety standards are to beimposed by rulc or order... However.the NRC is in the habit of Imposingregulatory requirements through non.enforceable means (e.g. Reg. Guides.

'RP). OGRE states that because legally'indingrequirements are those reached

through rulemaking or adjudicaUon andbecause these processes inherentlyinvolve weighing pros and cons of.adverse parties. they are reasoned. opendeliberated processes subject to judicialreview and therefore need no furtheranalytical requirements. OGREcontinues. "While it would be preferableifall regulatory requirements resultedfrom rules or orders, it is a fact of life'hat thc staff hnposes regulatoryrequirements on Its own." OGREappears to not take ~ position eitherway on the question but is willingtoaccept curmnt staff practice as a "fact oflife."

NUBARG ta'kes a strong position that5 50.109 should limit

backfit

tin to thosemodifications Imposed by rules,regulations or order. They state thatcurrent and past staff practice ofrequiring licensees to backfit fac|iitieson the basis of non binding guidancerequirements is illegal. Regarding thesecond part af the question, NUBARG~ tates that them are no means otherthan rules. regulations ar orders bywhich the Commission may lawfullyrequire a licensee to modify its facility.In short. it is NUBARG's position thatSecUon S0.109 would violate the statute

y Ifit permitted Imposition ofbackfits byany means other than rules, regulationsor order. The AIFand other industry i

commenters appear to be in generalagreement with NUBARG'a position.

DOE states that backfltUng shouldonly be imposed by rule. regulation ororder and that all analyses, reviews anddecisions required by the proposed ruleshould apply to au methods ofbackfitting.

Question 3. Should a documentedanalysis of a proposed backfit comebefore the backfit is issued or only afteran affected licensee lodges an appeal?USC urges that there be no

requirement for'a detailed analysiLunless the licensee appeals because such

AI

analyses in absence of an appeal would.ln their words."bc anutter waste of timeand resources."

OGRE suggests that to requireanalysis of every proposed backfitwould create too great a burden on thestaff. OGRE appears to reserve the term"backfit" for "non'-enforceableregulatory requireinents" and therefore,"licensees should feel free to contest aproposed backfit."

NUBARC takes the position that thereshould be ~ documented analysis by theNRC whenever its proposes to requirelicensees to modify their facilities. Theystate. "a plant modification has thesame impact regardless of who initiateslt. Therefore. just as the licensee mustalways develop ~ sound technical basisin support of a proposed facilitymodification. so should the staff." Such

~ an analysis is necessary, they argue. sothat the NRC can be as!ured that thebackfit it wishes to Impose h trulyneeded to enhance safe reactoroperations and that it willhave theintended effects.

AIFsuggests that such evaluations areneided to determine whether theproposed backfit does increase safety,to what extent. and at what costs.Further, It is needed "to imposediscipline into thc backfit process." AIFalso suggests that licensees should notbe placed in a position of having toinvoke procedure in order to initiatebackfit analysis. To do so. they say.places the licensee in a position ofhaving to jeopardize its relationshipwith the staff by opposing a change thatthe staff is requiring.

AIF also suggests that. in addition tothe seven factors proposed in theFederal Register notice. the followingfactors should be considered in makingan analysis of a proposed backfit.

1. h precise statement of thc specificobjectives that the proposedmodiTication is designed to achieve.

2. h general description of the activitythat would be required by thc licenseesor applicants in order to complete themodification.

3. Alternatives to the proposed backfitand how these alternatives (includingthe recommended alternative) willaffectother proposed or imposed facilitybackfits: and

4. A priority ranking by safetysignificance of each proposed backfitrelative to other proposed or imposedbackfits.

5. Whether. after balancing of allappropriate factors (including those inthis paragraph) thc demonstrationsrequired in 5 S0.109(a) have been madei

DOE states that the burden of prooffor deinonstrating that an increase in

NUREG-1409 Appendix A

Federal Register / Vo). 50. No. 183 / Fridav. September 20. 1985 / Rules and Regulations 38099

safety is needed should rest with thestaff rather than requiring the licensee toprove that such an increase Isunnecessary. Their reasoning is that.-reouiring a written basis and analysisof a proposed backlit before lt lsimposed willIr:crease the likelihood ofimproved safety and increasecnnfidence that its effects areunderstood."

Question f. Should backfittlng bedefined as "the imposition of newregulatory requirements or themodification of previous requirements"(the cause) or defmed as a "modificationor addition required by the Commissionto the facilityor to the structure.

'ystemsor components of such facility.the design thereof. or the procedures ororganixaticn required to construct oroperate such facility"(the effect)7 Whatis the basis for this posit)out

UCS believes that neither definition isappropriate. citing its 1983 comments.pages 10-30. in support of its position.VCS further suggests that exc)usion ofrules. regulations and orders'from thedefinition of regulatory requirementsraises questions about what is meant.

OGRE states that backfttting shouldbe defined as -the iinposltion of newrequirements: i.e the cause, not theeffect." Its reasoning is that "Since weinterpret backfit to apply only to thenon.enforceabie requirements, licenseesare free to use alternative methods tocomply. This. again. is ~ difficult'pointwhich should be resolved by bringingthe NRCs practices into line with theAtomic Energy Act (AEA): l.e.. alliequircmer ts imposed by rule or order.-

AIFsuppest that the definition shouldhe stated in terms of the effect whichthey suppest should read:

As used in ibis secuon. "backfillin"of apiooiiclioflof uilflzxuon iacilllymeans amo tihceuom oi'sddiiion required by theCommisiiim io the desisn approval.mziiu! ciurmg bcense. or facilityor io thestructures. systems or components of suchIuatuy. the dcsittn ibereof. or ihe proceduresor organixsuon required io construct or.opeiaie such faciiuy. ~(ier... (timesspeafmd in proposed rule).

They also suggest that backftts shouldinclude requirements to performextensive analytical efforts or tests.regardless of whether modifications oradditions io the structures. systems orcomponents of a facilityor design resultfrom such analytical efforts or tests. Thebasis for rejecting regulatoryrequirements as a part of the definitionis directly related to their previousargument that backfits may only belegally imposed by rule. regulations or„ader. AIFs position is generallysupported by oiher industry comments.

DOE would recommend the followingin lieu of either the "cause" or effect"definition:

1. A -modiBcation." means a changerequired by the Commission to ~ sitepermit: a design approvah a productionor utilixation facility. or the structures.systems. or components of a facility. tothe procedures pursuant to which afacility is to be constructed or operated:or to the organization required toconstruct or operate such a facility.

2. A ".backfit" means -a modilicationnot imposed by the Commission forachieving compliance with aconstruction permit or operating license,at the time of issuance or as amended.or contained in the requirementsincorporated by reference in the permitor license.-

The State of Illinois rejects the use of-regulatory requirements" as tooambiguous and suggests the definition

. be more precise for clarity and scope.Question S. The industry's proposed

standard for justification of a backfit is"substantial improvement in the ove'rail)safety of the plant considered over itsremaining life." Is it appropriate toinclude the concept of "over itsremaining IIfe"7 What other standardcould be

used'CS

suggest that it ls not appropriateto consider the concept of "over itsremaining life" for the followingreasons:

1. Such analysis can only be based onprobabillstic risk assessment and thatmethodology is noi appropriate.

2. The concept creates an incentive fordelay and obstructionism and rewardedthose who delay the most.

3. "Benefits" are currently expressedby NRC in terms of annual average dose-avoided" and this is inconsistent withthe concept of "remaining life".

4. The concept does not arcount forprohleirs cause by aping anddeterioration of equipment which arelikely to increase as a plant ages.

5. There is no justification in law orpolicy for subjecting people aroundolder plants to a greater risk than thosewho live around newer plants.

OGRE ~ Iso objects to the use of thestandard because of what they perceiveto be implication of required use ofprobabilistic risk assessments.

NVBARG suggests that use of theconcept is appropriate as being onefactor among many that should beconsidered when a backfit ls required.industry commenters generally supportthis position.

Question 8. To what extent may theCommission consider cost. including theeconomic costs in backfitting decisions

'nderstandards and processesproposed in 5 50.109? '

USC cites its previous 1983 commentsIn support of its position that costs maynot be considered under the AtomicEnergy Act and established case law.OGRE also opposes cost considerationas a part of the decision process.

AIF takes the position that cost maybe considered and that such costashould include:

1. Costs of evaluation. engineering.construction. material procurement.Allowance for Funds Used DuringConstruction. (AFUDC) andInvestigations:

2. An attributable portion ofreplacement power coats during down

.time for implementation:3. Operating costs due to changes ln

specifications. procedures. operatorretraining and training manuals.increases in manpower requirementsand net generation losses:

.4. Impact on preoperational startup.operator training. proceduredevelopment and system turnoverduring plant constructloru and

5. Any incremental increase in manrem exposure as a result of Instal)ationand subsequent operation of themodification.

As a basis for the position stated. AIFattaches to their comment a legalmemoronduin entitled. "Considerationof Cost and Benefits in Connection withBackfitting."This memorandum takesthe position that the Atomic Energy Actand its legislative history. courtdecisions. Commission regulations anddocuments. the Energy ReorganixationAct and Executive Order 12291 and theNRC's General Counsel memorandumdated May a. 19M. all support theconclusion that costs may be considereoin connection with backfit ting. Industrycomment generally supported the AIFposition.

DOE also conducted a legal analystsof the cost question. They stated:

Tbe legal conclusion which emerges fromthe forettoinx is ihau except for deciding thenarrow quesuoo of wheiher a bsckfit shouldbe required for consirucuon permiiiees ioeliminate or reduce io ~ threshold level aparticular nsk in order io meet ihe "adequaieproiecuon" lest. the NRC bss broaddiscreiion io consider the relationshipbetween benefits and costs in decidinpwhether io impose ~ bsckiit.

The Commission also requestedcomments on whether reliance uponprobabilistic risk assessments isprohibited by the Atomic Energy Act assuggested by UCS. OCRE agreed withthe UCS position.

AIF takes the position that UCSmischaracterixes the industry positionon the use and value of probabilistic riskassessment (PRA). They point out that

Appendix A NUREG-1409

S81pp Federal Register / Vol. 50, No. 183 / Friday. September 20. 1985 / Rules and Regulations

PRAs should support. nat supplant.determinative requirements. NUBARGpoints out that neither the industry northe proposed backiitting rule mandatesthe use of PRAs. They point to the factthat the proposed indusuy rule wouldrequire the use of PRAs only "whereappropriate and where pertinent data isavailable." They also suggest that theAtomic Energy hct does not prohibit theuse of PRAs.

The Commission requested commentson the correctness of the UCS positionthat "the Commission exercises itsrulcmaking authority to establishnuclear reactor safety standards, andlicenses may avoid those standards onlyby obtaining a waiver under 10 CFR2.758." NUBARG states that UCSmisunderstands 5 8.758 and theoperation of the backfit rule. Theyfurther suggest that neither of theproposed backfit ting rules canreasonably be read as permitting)icensees to avoidrequirementsapplicable to their facilities. Those rules.they state. would simply require thestaff to document the basis for itsconclusion that a backfit Is required.

The Commission requested commentson whether the elements of the proposedbackfittlng rule are too prescriptive andare truly needed to ensure that the staffconsiders all factors that areappropriate before It Imposes a backilt,NUBARG points out that virtuallyall ofthe elements of the analysis have beenused by NRC before and are sufficientlybroad to be applied inmost. Ifnot all. bybackfitting situations. Thc Slate ofIllinois remarked: "The DepartmentjStatej believes that the seven factorscontained in the proposal provide anappropriate means for balancing all

'actorsin determining whetherbackftttlng should apply." AIF agreedwith the seven factors but suggested theaddition of five more.

The Commission also expressed aconcern over whether preparation of a

acLfitting analysis should be requiredas a condition precedent to thc issuanceof a license amendmcnt. NUBARGstated that "unless requested by alicensee. the staff should not berequested to prepare ~ backfittinganalysis as a condition precedent toissuance of a license amendment ifthelicensee requests an amendmentpursuant to 10 CFR $ SOAKS." NUBARGpoints out that application for significantamendments requries a description ofthe proposed modilication and thepreparation of ~ safety analysis reportby the licensee. Since the licenseepresumably willhave subjected theamendinent to an internal costcflectiveness review. a backfitting

analysis by the NRC would appear to beneither necessary nor appropriate. A!Fwas in general agreement with thisposition and stated further that theoption to allow a licensee to request absckfitting analysis should be retained.AIF suggested that there are instanceswhen licensees are under inlormal butintense regulatory pressure to submit anamendment request. In thiscircumstance. backlit ting analysisshould precede the issuance ol a licenseamendment according to AIF. Generalcomments Crom other meznbers of theindustry tend to support the NUBARGand AIFpositions.

Comineats on tha Additional Views ofCommissioner Assclsthic

Commissioner Asselstine's additionalviews were generally supported byEcology/AlcrL Federal Conservationistof Westchester County. Inc OhioCitizens for Responsible Energy. andUCS. Industry comment generallyopposed Commissioner hsselstine'sapproach. Similarly, the Department ofEnergy did not support CommissionerAsselstine's alternative backfit rule. andthe State of Illinoishad a mixedresponse..

hlthougli UCS endorsesCommissioner hsselstine's position, it~ uggests two changeL First, it takesexception to Commissioner hsselstine'srule to the extent that it prohibitsconsideration of monetary costs at theoperating license stage only for backiitsrelated to safety marters that were leftunresolved at the time of issuance of theconstruction permiL UCS believes thatso long as construction permits are to begranted on the basis of preliminarydesign concepts, It is not legitimate toconsider as backfits. changes requiredbetween the construction permit andoperating license. or to consider costs atthat stage. Second. USC objects becauseCommissioner hsselstine' proposaldoes not provide for formal publicparticipation in backfilling decisions.USC believes that the declsionmaklngprocess should be open and accessibleto all persons who might be affected.

OCRE also suggested two changes toCommissioner hsselstine's proposaLFirst. they would remove review byCRGR because. they say. CRGR doesnot further the mission of theCommission but serves only todiscourage ncw saCety improvements.Secon* they. like UCS, would providean opportunity for public comment forboth generic and plant spetdfic backiits.

ln its discussion rejecting theproposed use of "regulatoryrequirements" ln thedefinition ofbackfitting. tbe State of Illinois endorses-the more precise deiinitions of

backfiring proposed by CommissionerAsselsiine and the industry" and to thatextent. could be considered as endorsingCommissioner Asselstine's approach.However. the State of illinois also statedthat they did not agree withConunissioner Asselstine's proposals tospecify In the regulations a presumptionin favor of the backfiL They believe thatseven factors contained in the proposalprovide an appropriate means forbalancing all factors in determiningwhether backptting should apply.

The thrust of the industry positionappears to be that many of the termsused by Commissioner Asselstine in hisproposed rule are ambiguous andundefined and in other instances. wherethe standard is well understood. it issimply misconceived. For example.NUBARG points to CommissionerAsselstine's proposal to define backfitsin terms of changes to facilitydesign.construction or operation "imposed bythe staff to... satisfy a regulatory stafC

, position" developed aCtcr ~ specifiedperiod. NUBARG complains that"regulatory staff position",is notdefined. AIFstates that thc word"satisfy" in this context cannot beanchored to any applicable statutorystandard. not to any prevailing doctrineof administrative jurisprudence.NUBARG questions thc ultimateeffectiveness of such an alternative rulebecause, they argue. backfits may not b'

legally imposed on the basis of suchdocuments.

Industry takes a different tack withregard to the position espoused byCommissioner Asselstine that the basicpremise ol nuclear regulation should beto -reduce the risk to the public causedby. these factlitics to a level that is aslow as reasonably achievable.-NUBARG suggests that this approachreverses the presumption ol regularityassociated with past NRC licensingdecisions. Those who have already beengranted licenses and thus have beendeemed "safe enough" by the NRCcould. according to NUBARG. findtheinselves having to justify routinelywhy their licenses should not bemodilie*This. NUBARG states. raisesserious legal questions of fundamentalfairness and due processs. and appearsto be at odds with the AdministrativeProcedure Act. NUBARG also complainsthat the standard suggested byCommissioner hsselstine is potentiallyopenandc*

AIF further suggested that the AtomicEnergy hct requires "reasonableassurance of the public health andsafety- cnd reasonable assurance is no<

equated with "as low as reasonablyachievable.- AIFfurther states that!hit

NUREG-1409 Appendix A

~0 'i (Federal Register /. Vol. 50, No. 183„/ Fnday,',September..20.,1985 /, Rules an(k.Regulations~-.38101

standard is at odds with section 103(b)of the AtomicEnergy Act. which'-provides, In part. that 'The Gommissionshall issue such licenses... Io personsapplying therefor... (Io) who areequipped to observe and who agree toobserve such safety standards to protecthealth and to minimize danger to life orproperty as the Commission may. by

'ule.establish: ...." AIF suggests thatthis language has been interpreted bythe Commission In Its regulations torequire -reasonable assurance"thatlicensed activities of the Commissioncan be conducted without endangeringthe health and safety of the public.citing, for example, 10 CFR 50.57(a)(3).They also cite Citizens forSafe Power,Inc. v. Nuclear Regulatory Commission.524 Fed. Second 129K 1297 (D.C. Circuit1975) for the proposition that "absoluteor perfect assurances are not requiredby AEAand neither present technologyor public policy admit of such astandard.",

'geDepartment of Energy'also doesnot support Commissioner Asselstine'salternative proposed backflt rule. Thisproposed rule. DOE states. "de'tracts, .from the basic yurposc for institutmg anew backflit rule and. if,adopted, wouldperpetuate tbe'signiflcant deliciencics ofbackfitting practices of the past." DOEfurther suggests t?iat CommissionerAsselstine's definition ofback!it ting Istoo narrow; that the "as low as isreasonably achievable" standard isinappropriate, and would probably beinconsistent with safety goals should

'hosebe established: that the limitationson the use of quantitative cost benefitbalancing would be "overly rest'rictive"and would be -a r'egressive step formodern analysis techniques'". that thcdecision criteria are not identiflicd inCommissioner Asselstine's rule: andthat the implementation proceduresha ve several deficiencies.

Commission PosiUon

The Commission is appreciative of thetime and effort expended by those whosubmitted comments. Backiitting ls amatter of considerable importance andIhe views expressed in the commentshave been very helpful to theCommission in its deliberation. To someextent, the final rule willbe modified "from the proposed rule to reflect theviews expressed." ~

Since there is no practical differencebetween a backfit that is imposedpursuant to a rule or a staff position-interpreting a rule, the Commission will.alter the final rule to require a

'ocumentedanalysIs of requiredbackfits regardless of the source. A "plant.spectflc backfit analysis'will notbe required In rulemaking and the

factors spectfled in the rule willbe;reviewed only on a generic basis forrulemaking putposes. Because there.must be safety reasons for the agency toimpose any changes to a regulatory

.requirement 'or a staff position.applicable Io tbe licensee. because thesafe consequences are unknown untilanalyzed.and because the Commissionshould fullyunderstarid the effect of aproposed backfit'before its imposition. itIs of little conseq'uence how a backflit

is"'mposed.Safety and sound managementrequire that analysis precede impositionof a new or modified regulatoryrequirement or staff position. It followsthat those backfits irhposed byrulemaking should undergo the samescrutiny as pr'oposed by other means. Italso follows that changes in regulatoryrequireme'nts orstaff positions forprocedures and organization should alsobe analyied before iinplernentation todetermine;inter alia, the safetysignfllcimce of arly such proposed .change. The final rule reflects thisposition.

'Many'df the most important changes

in plant design. construcUon.operation,'organiiaUon.and training have been p'ut

in place at a level of detail that is,expressed'in staffguidance documentswhich Interp'r'ct the intent of broad,generally worked "regulations. The NRChas deteimined that the correct focus forbacklit.regulation Is the establishment ofeffective inanagement controls onexisting staff processes for Ibeinterpretation of regulations that areknown to'result in valuable upgrades inindustry safety performance. Thus. theCommission opts to adopt amanagcmentyrocess not only for thepromulgaflon of regulations as beckfitinstrumentsi but also for the lower tierstaff review and Inspection processesknown to result in reactor plant changes.

The Commission agrees with those, who su'ggest that the Staff shou! d not berequired to prepare a backfitting ~

analysis as a condition precedent toissuance of a license amendment if thclicensee requested the amendmcntpursuant to10CFR50.90:Ifalicensee

'elievesthat the amendment process isbeing used by the staff to impose abackfit, tbe licensee may invoke the rulcunder Ij 5L309i it is unnecessary toamend the rule in this regard sincemention of the point here providesadequate direction to the Staff andlicensees.

Considerab'ic attention was given tothe question ofwhether backfittingshould be ddined in terms of its cause

'r

its effects. After due considcraUon, .the Commission believes Ibat thedefinition for backfitting should take

/1

into account both the cause aniI the."

effects. Therefore, the definition ismodified accordingly. ~ ",

Question 5 concerned the Industry'sproposed standard for justiflcatioo of abackfit and the suggestion that the"substantial improvement in overallsafety of the plant considered over itsremaining life"should be incorporatedinto the rule. In our view. the concept of"over its remaining life"is alreadyincorporated in the rule under5 50.109(d)(8]. There is no need to placethat concept in the rule at another place.

The additional factors suggested bythe industry for inclusion under5 50.109[c) generally appear to bereasonable and not unduly'burdensome.Therefore. the thrust of the additionalfactors willbe included as appropriatein tbe final rule.

As the accountable manager I'orbackfilling. the Commission has directedthe EDO to establish backflt proceduresand to ensure appropiiate rights ofappeal. Thc Commission believes it isunnecessary to include fn'tbe rulc a ..section establishing appeal rfghts to theExecutive Director for Operafions....\ ~ nConsideration of Costs in Backfit:Decisions

In the current rulcmaking, comincntswere filed by UCS and AIFstatfng.strongly contrasting legal viewsconcerning the Coinmission's authorityto consider the costs of new'safety ..requirements which the Commission .would impose ifcosts were not a factorin the decision:(See Qbestion'8. supra.)In view of the importance of the costissue and thc strongly diveigent viewsstated in the comments, it is importantto set forth the Commission's lega( andpolic'y views on this rnatter. '

Thc costs associated with proposednew safety requirements may beconsidered by the Commission providedthat the Atomic Energy'Act finding "noundue risk" to the public health andsafety can be made. There may be anynumber of ways by which thcCommission can arrive at such aconclusion. Each approach could havedifferent costs associated with it and itcannot bc seriously argued that in suchcircumstances the Commission isstatutorily prevented from choosing themost cost effective means ofprotectingpublic health and safety.

Similarly, it may be presumed that thecurrent body of NRC safety regulationsprovides adequate protecUon. Where.new information indiqates that„improvements are needed Io ensure.. „.there is "no undue risk" on either a

"

.plant. specific or generic basis which theCommission believes to be the minimum

Appendix A NUREG-1409

30102 Federal Register / Vok Sp, No. 183 / Friday, September.20„1985 /'ules and Regulations

necessary. such requirements must beimposed. However, where there arealternatives for achieving theimprovements. which have dilferent

"'ssociatedcosts'. su'ch costs may beconside'red..

Cost corisiderations have been a partof the Commission's regulatoryapproach in many other instances. Forexample, the ALARAprinciple requiresCommission lice'nsees to meet anabsolute'set of radiation exposure

- staridards but also requires furtherreductions in exposure where the cost ofthe exposure avoided outttteighs the costof implementing controls to avoid the,exposure.'Commenters who addressed",the proposed backfit rule aid opposedthe u'se ol costs did not'address thispoint. Itwould appear that the only

, si(uation where the consideration ofcosts inay be seriously challenged is

'herea new req'uirement is necessary'o

provide aii absolutely minimum levelof protection to the public health'and.safety ttndno alternative means of, '

achieving such protection are apparent.~ In general, the consideration ofcosts;

associated with incremental safety .,',itnprovements Is withiiithe NRC'sstatutory mandate. How'ever. the cost ofnew safety requirements willnot beconsidered where such requirements arenecessaiy'to ensure there is no undue,risk.to the"p'ublic health'and safe'ty and

. no,alternately'cs ar'e a'vailable.'fter'remviewingall of,the comments ",

'nd popitions stated, the Cotntnission: .

believes'that there is sufficient au'thorityin"thestatu'tes.caselaw.and ';.', -..

Cninmission practice to justily makitig .,

'ost considerati'ons in backfitting'ecisions.Since consideration of costs .

wiis"a part o( the proposed rule. the rule. willrem'ain'.unchanged in this regard.... The,Commission'also rejects as withoutmerit the s'uggesUon that probabilistic ",

risk assessments are precluded by law.~ Descnption of Final Rule

The p'roposed amendment of lt 50.54(l)ensures that except for information'sought to yerify licensee compliancewith the current licensing basis for thatfacility, the'reasoii or reasons for eachinformation request"must be'prepared

~ prior'to its issuance todetermine'hether

thri request is for informationalrea'dy'n the possession of the,applicant or licensee or instead willrequire the Institution of studies.procedures, or other extensive elfort to,generate'he necessary data to respond..'fextensive'eflort is reasonablyanticipated, th'e r'eoqu'e'st willbe.'..evaluated to deterndne whether

the'urden

imposed by the inforntation,'.'qsuestis ju'stified fn view of the "

potential salety significance of the issue Nevertheless, staff Interpretations of,""-

to be addressed.. ~ u .s, " " .. broadly stated rules are often necessaryIt should be noted that.5 50.54(f) does to give a rule effect and in some'">'": ..

not by its terms apply to the review of: instances may be a causal factor in"""" 'applications for lic4nses or, '. ' .. ~ initiating a backfit. '":""' ':. '".":

'mendments.Consequently. Kthe tttaff d Section 50109(a)(2) requires'a"''seeks Information of a type rouUnely "... systematic and documented analysii assought as a part'of the standard: .' . a condition precedent to the impositio'ntprocedures applicable to the review of..'fa backfit;This willensure

that'the":.'pplicaUons,

no analysis willbe .;. ~ safety significance of any modiftc'ation~necessary. Ifthe request is not part of and its relation to other relevant factorsroutine licensing review and falls within is well understood before changes are",the purview of Ii 50.109. however. a full required.analysis is most likely Indicated .; .. The standard against which'propo'sedRequests for information to determine . backfits would be measured ls 'stated incompliance with existing facility.'..: g 50.109(a)(3) as "substantial I'ncie'ttse Iiirequirements or for fact-finding reviews the ov'erall protection of the public

".,".".„'nspectionsand Invesbgations of ... ~ 'ealth ind safety or the common" ''.'ccidentsor incidents. however. usually defense and security." Substantial"-.,".

are nbt made pursumtt to tj 5o.54(f) nore means"important or'significarit in a""".are such requests normally considered d large amount. extent, or degree."

Under'ithinthe scope'of the backfit iuie: ".: such a standard, the Conimlsston would.Amendment of this section also.', - not ordinarily expect that safety '.".,',provides for management control and " improvements would be r'equtred as '.;,accountability for ttackftts by requirin8 ~ backfits which result in an insignUicaiitthat staff evaluatioris be ~mewed by t or small benefit to public health.andithe Executive Director for OPeraUons «sa fety or the common deferise'an'd„';:„ihfs designees prior to the issuance ol the security. regardless of therequest.' " ':.'.".' "' '

implementation costs.'On the other",.",:.The amendment of lj 5054(0 should be hand. th'e standard, is not'inten'ded to be

read as indicatIng a strong concern " int'erpreted in'a manner that;would. ',the part of the Commission that, result'Iri disapprovals ofworthwhile ~~~ ~

extensive information requests be safet or security Improv'ements'havin8carefully"s'crudnlzed by staff „''

costs that are jusUfied'in view"of,tjte"'.';:.,management prior to irdUaUng such '.

~ increase'd'protection that wouldbe".,'.-",d'equests.The Comiid'ssion recognizes

that there'may be Instances where it isnot clea'r whether a backfit willfollow te Phr e. " .ral Pro ".. nmo %e:an information reque'st. Those cases 'ublic health and iafety or the'commorn,

shoujd be resolved in favor of analysis.' deferise an'd security,".In'the ProPosed.:: .

In short;staff management should '..'. backfii'stari'dard also deserves some.j.::

develop an intern'al review process to dike'usslon, The PrinciPal PurPose'of.;,':

ensure that there Is a rational basis for 'equiring c'onsldenUon of the overall%all I~brmation reouests, even where it 'rotection that would be provided by a':

is not clear that a backftt wifiresult.', Proposed backfit is to ensure that both.

, Section 50109(a) sets out the ..'ts negative aiid Positive effects.are.>,"'efinition

ofbackfitting, the analysis "'aken Into account in decidingwhether'equirement.

the standard to be used in" the backfit is jqstified. Abackfit for ii ~ ~

determining whether a backfit should be p»t of a plant should be evaluated in .'.

imposed and the exceptions to the rule. Ii8ht of the net incr'ease'Iri overall," "-The definition focuses on modifications'rotection that'the entire plant

would'o

systems, structures, cotnponents, ~ '='«vide as a result of the backfit,taking'esigns,

procedures or organization -"". Into account the effects itwould have on

which may be caused by new or ': other aspects of the plant. Thus. the net

modified Commission rules or orijers o'r" 'enefit of a backfit.to the protection, ~

staff interpretations of Commission - .. Pro vided by the plant as a whole is the ~

rules or orders.'Thus, this definition .", 'verriding consideration;not just the+'ncludesboth cause and effect of . benefit to the part of the plant bein'g.="s»

backfitting.Itmayalsobenotedthat"

. »ckft«e*"::" d,.» "..:e--';:s's « ':"cause" includes not only Commission": .-. However. the Commis'sion does nout'd",

rule's and orders, but staff interid use of the phrase"overall'nterpretationsof those rules and orders. protecUon".in the b'ackfit standa'id

to'."'his

is not to say that staff =; 'ignai a d~p~~ture from Its.traditional""interpretations of rules are viewed by reliance on defense jn,'depth and"'„.-~".-

the Commfssion as being legal ..'. d»erst ty forprotectiott ofpublic h'ealth ~

requirements. Clearly, they are not.. "'' aid.safety ~ Therefore; safety'"- " "> i:.

rmnroyemenls In'one hde of defense'

e I r I s r I r,'Sslnsr nndne ilsk'sh'o'rdd nor tr'ens

thst tenn ls synonymous with "tule. disapproved or.'app'roved based'solely '

4

NUREG-1409 Appendix A

Federal Register / VDL 50, No. 183 / Friday, September 20. 1985 / Rules and Regulations 38103

an the presence or absence of anotherline of defense to cope with the failureof the first. For example. safetyimorovements in the integrity of thereucior coolant system should not bedismissed merely because an emergencycore cooling system has been prosddedto protect public health and safety withhigh confidence in the event that theinteonrity of the reactor coolant system islost. On the ot)ter hand. such asuggested improvement may beprecluded because it does not meet thesubstantial test. or does not Increaseoverall protection provided by the plantdue to. for example. Ihe negativeitnpacts on other aspects of the phnt.The proposed requirement that the costsof backfits be considered and justified inview of the increased protection topublic health and safety or security isbased on the Comm!salon's view that itshould. in these circumstances. considerthe direct and Indirect casts ofimplementation in making safetydecisions under the Atomic Energy Act.

The consideration and weighing ofcosts conteinplated by the rule appliesIo backfits that are intended to result inincremental safely improvements for apiant that already provides anacceptable level of protection. In thisarea the Commission believes thatdirect and indirect implementation costsare especially relevant. WIthout cost asa competing consideration in thesecircumstances. the regulatory process

'akeson the characteristics of a questfor a risk-free plant. an unattainableobjective as recognized by Congress inestablishing the standard of no unduerisk in the Atomic Energy Act.

Section 50.109(a)(4) creates exceptionsfor modifications necessary to bring afacility into compliance or to ensurethrough immediately effective regulatoryaction that a licensee meets a standard

- no undue risk to public health andriy !n cases involving the

cnmplldnce exception, backfit analysisis not required and the standard doesnot apply. The compliance exception isintended to address situations in whichthe licensee has failed to meet known2nd established standards of theCommission because of omission ormistake of fact. It should be noted thatnew or modified interpretations of whatconstitutes coinpliance would not fallwithin the exception and would requirea backfit analysis and application of thestandard.

The exception for immediately«I(ective regulatory actions that arenecessary to ensure that a licenseemeets Ihe standard of no undue risk tothe public health and safetypermits the Commission to act in

emergency situations to ensure thatoperation of the backfit rule willnotpreclude the Commission from ensuringthat minimum standards are met toprotect public health and safety. Theexception anticipates the existence ofsignificant new information or theoccurrence of an event which clearlydemonstrates that the standard of noundue risk to Ihe public health andsafety cannot be maintained without thedesignated modilication. Moreover, thepresumption of safety which ordinarilyaccompanies the issuance of any licensemust be overcoine in order for theexception to be used. As with2he

"

compliance exception. there is no intenton the part of the. Commission to includewithin the scope. of the exception new ormodified Interpretations of whatconstitutes no ttndue risk to the publichealth and,safety. In such a case, therule applies..T)re rule also provides thata backfit imposed by immediatelyeffective regulatory action shall not

.relieve the Commission of performing ananalysis after the fact to document thesafety significance and appropriatenessof the action taken.

For those modifications which are toensure that the facilityposes no unduerisk to the public health and safety andwhich are not deemed to requireimmediately elfective regulatory action,analyses are required; these analyses,however, should not involve costconsiderations except only insofar ascost contributes to selecting the solutionamong various acceptable alternativesio ensuring no undue risk Io publichealth and safety.

To ensure that the discipline ismaintained in the process and that theexceptions do not become the rule. theCommission directs the staff todocument each exception.Documentation shall include a precisestatement of the specific objectives ofand reasons lor the modification and thebasis for the exception. It may alsoserve useful regulatory purposes toInc)ude such matters as a generaldescription of the activity that would berequired by the licensees or applicantsin order to complete the modiTicationand the identification by 11pe, designand vintage of Ihe design approvals.manufacturing licenses for production orutilization facilities to which themodification would apply.

Section Ql.109(b) "grandfathers"backfits imposed prior to the effectivedate of this rule.

Section 50.109(c) sets out nine factorsto be used by the staff In its backfitanalysis. Finally. f 50.109(d) explicitlyrccognlses the responsibilify of theExecutive Director for Operations to

manage the Commission's backfiningprogram in general and requiresapproval of backfit analyses by IheExecutive Director for Operations or hisor her designee.

As a matter of information. It may benoted that the nine factors in 5 50.109(c)have precedent in existing NRCpractices as seen in the RegulatoryAnalysis Guidelines of the US. NuclearRegulatory Commission. NUREG/BR-0058. the approved CRGR Charter andthe Commission's approved plan for themanagement of plant. specificbackfitting. SECY~21.s

'he

nine factors to be used by theStaff lor a systematic and documentedanalysis are listed under f 50.109(c) andread as follows: "(1) Statement of thespeci!le objectives that the proposedbacUit Is designed to achieve: (2)general description of the activity thatwould be required by the licensee orapplicant in order to complete thebackfit: (3) potential change in risk tothe public from the accidental offsiterelease of radioactive materialsi (4)potential impact on radiologicalexposure of facilityemployees; (5)installation and continuing costsassociated with backfit. Inc)uding thecost of facilitydown time for the coat olconstruction delay. (8) Ihe potentialsafety impact of changes in plant oroperational complexity Including theeffect on other proposed and existingregulatory requirements: P) theestimated resource burden on the NRCassociated with the proposed back!it.and the availability of such resources:(8) the potential impact of dilferences infacility type. design or age on therelevancy and practicality of theproposed backfit: (9) whether theproposed backfit Is interim or final and.ifinterim. the justiTication for imposingthe proposed backfit on an Intenmbasis. These nine factors are to be usedas balancing mechanisms in thedecisionmaking process for backfitting.

During internal review of the rule. aquestion was raised as to whetherlicensing action should be withheldduring backfit resdew. The answer isthat the rule never contemplated such awithholding. To the contrary, until abackfit analysis is complete. Iicensi gaction should continue along a course

'Tbc Retulatory Analysis Guidelines of the US.Nuef ear Rctula tory Commis stoa. NUREGfSR~SLis svsrlsblc for ms preston or copymS for ~ fce in thcNRC Public Document Room. 1712 H Sueet. NWWsshinrion. D.C. This repott msy be purehssedfmm thc U.S. Governmeni Prinnna Oflice ICPOI bycslhnc 2'-21$ -20v0 or by wntrnS ihe GpO.p.O.Sou srna >. Ivsshintton. DC 20012-70tt2. It msy ~ isobe purchased from tne Ns»onal Teehmealinfomis»on Service. US. Dcpsnmcnt of Commerce.Seas Pun kovsl Road. Spnnshcld. VA2 101,

Appendix A NUREG-1409

consistent with normal practice. ForclariTication of the point. j 50.109(d) wasadded to the final rule.

Section 50.109(e) emphasizes andcodifies the Commission's intent thatbackflt management ls af paramountimportance to responsible regulatorypractice. Accordingly. the ExecutiveDirector for Operations is responsiblefor implemtntation of tht backAt rule.

It may be noted that the resolution ofany backfit case can be by Commissionrule or order, or by written commitmentof a licensee. Recognition ol this pointcompletes the design of thebackfitmanagement process and establishesthat license~ compliance with approve'dbackfits may be accomplished byvoluntary commitment. but that tht legalinstrument of a rule or order can andwillbe used ifnecessary.

The proposal to amend 10 CFR Part50. Appendix 0 is necessary ta conformAppendix 0 ta the final rule. Theamendment provides that informationrequests to the approval holderregarding an approved design shall beevaluated prior to issuance to ensurethat tht burden to be imposed onrespondents is justified in view of thtpotential safety significance of the issueto be addressed in thc requestedinformation. Each such evaluationptrlonned by tht NRC staff shall be inaccordance with 10 CFR 50W[f) andshall be approvedby the ExecutiveDirector for Operations or his designeesprior to issuance of the request.

Section 2204 is amended to tnsurethat any order for modification of alicense invelving a backfit is subject tothe provisions of the new 5 50.109.

Coinmissioner Asselstine andCommissioner Bcmthal disapprove thisfinal rule. The separate views andcomments of Cammissiontrs follow.

Separate Statement of ChairmanPails dino

Desirc -., '.true as Chairman. I havescu-ht a near system of backfit controlsfor NRC that would ensure that a backfit

~ is analyzed and that an explicitjudgment of its safety and cost.onscquencts is made. This new rultines just that.

Although a previous version of anNRC backfit rulc has been on the books.it has rarely been followed. In addition.documentation in too many cases hasbeen nonwxisttnt or inadequate toidentify and justify the safety and costconsequences of past NRC-imposedbackfits.

The steps to this new backiit rulenave been deliberate and. I believe.thorough. In 1983 we issued a policystatement announcing intcnm backfitcontrols cnd our intent to canauct

security, rettsrdtess oi the tmplememstioncosts. On the othsrhsnd. the standard ts oat

rulemaking to establish a new backfitrule. 48 FR 44173 (1983). At the sametime. we published an advanced noticeof rulemaking solidting publiccomments on various proposals for thclong-term management of the backfitfingprocess, both plant-specific and gentric.48 FR 44217 (1983). In November 1984,we published a notice of proposedrulemaking. seeking public comment onan NRC proposal and on a number ofspecific questions designed to elicitpublic viewsun significant issues andalternatives. The Commission held anumber of public meetings onbackfittiag. and received the advice oftht Regulatory Reform Task Force andsenior agtncy offidals.

Tht rule that emerged is a good one.Contrary to the claim of CommissionerAsselstine. the rult is not designed tostymie rtgulation. What the ruierequirts is an analysis and an explicitjudgment that a proposed safe'ryrequirement Is justified. A Commissionconcerned about the protection of publichealth and safety-which tldsCommission is, CommissionerAsselstine's commentsnotwithstanding-will find amplefreedom to make sound safety decisionsbased on analysis. Further, the ruleprovides that its requirements do notapply lfa proposed safety measure isneeded to assure compliance with NRCrequirements or protection againstimminent public risk,

lt seems somewhat late in the day fora Commissioner now to argue for thefirst time that this backfit rulemaking.which we initiated almost twa yearsago. fs unnecessary. To my knowledge.when we started. all Commissionersagreed that our experience under thtexisting NRC backfit rule had not beensatisfactory and that backfit controls ofsome sort were needed. The dedsion toincorporate controls into a rule willmean that the Commission can be heldaccountable in th'e future for how itimplements those controls. Further, thedecision to adopt a rule also means thatmodificatians of the controls willinvolve public participatio.

Similarly unfounded Is CommissionerAsstlstine's criticism of the backfitstandard in this rule. The Commissiongave considerable attention to thcstandard during the rulemaking andadopted the following explanation of"substantial increast- ln protection ofhealth and safety:

Subsisniisl means -important or sigaiiicsnin c lsrtte amount. extent. or degree." Undersuch s standard. the Commission would aaiordinarily expect thai ssftiy improvementswould be rsquiipd as bsckfits which result inan insizaificant or small bensfit to publichssiih std ssleiy or ihc eommoii*fsnse an

intended io be ioisiprsisd in s manner ihsi,would rssutt io disapprovals of worthwhilesafety or secuniy improvements having cosisthat tie iiisufisd in view o( ihs tocressedproiecitoa that would be provide*

I do nat believe that this standard canreasonably bt criticized as "intended toblock ntw saftty requirements."

Commissioner Asselstine simplyignores the words of the rule whtn hecontends that it requires a backfitanalysis that is skewtd against new r

safety requirements. Section 5L109(c)provides that "any... informationrelevant and material to the proposedbeckfit" may be considered in thetna)ysis and. thus. taken inio account inthe safety decision. This languageprovides. in my judgement. ample roomfor Commission reliance on. amongother things. thc cxpertist of its staff tosupplement other analytical tools inorder to provide an adequate basis for aparticular bsckfit decision.

In response to CommissionerBcrnthal's statement. I am disappointedthat we cauld not agree on haw to applybcckfit controls to future rulemakings. Ibelieve that our differences are reallyvery smali

Modifications to plants or plantprocedures can result from new ormodified NRC requirements adopted byrulemsking. Thertfort, futurerulemakings should be covered inprinciple by backfit controls. Thealternative would be a system whereplant specific backfits are analyzed anddocumented but generic rule backfits arenot. Such an alternative would leave asignificant area of backfitting lormallyuncontrolled without apparent reason.

Moreover. I believe that theCommission would be creatingquestions without apparent answers if itchose to control plant specific backfitsby a backfit rule and generic rulebackfits by internal agency managementand guidance. By subordinating gentncrule beckfits to internal agencymanagtmtnt for the stated reason olpreserving "flexibility."the Commissioncould be seen as sending the messagethat it does not wish to be htldaccountable for the application ofbackfitting controls to futurerulemakings. This outcome could wellservt to undermine the agency's eflortsto manage backfitting.

Apphcation of tht backfit rule willnotresult in the Commission makingunsound safety or backfit dccisians infuture rulcmakings. The main thrust ofthe backfit cult is to apply analysis.including analysis of costs. before a

d bsckfit is imposed The rule only

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NUREG-1409Appendix A

Federal Register / Vol. $0. Yo. 183 / Friday. ScPtetnber 20. 1985 / Rules and Regulations 38105

requires analysis of "such... factors asmay be appropriate..." The derisionalstandard is only that the costs of thebackfit be -justified in view of theprotection to public health and safetyafforded by the backfit." Further. asnoted earlier. the rule provides that itsrequirements do not apply ifa proposedsafety measure is needed to assurecompliance with NRC requirements orprotection against imminent public risk.Thus. the backfit rule provides sufficient "

flexibilityfor the Commission in future .

rulemakings.Finally. the Commiskion can suspend

the backflt rule in a futur~ rulemaking ifthere is good reason. Thus. while it isour intent that this rule apply tobackfit ting that arises from futurerulemaking. the final judgment on thisissue willrest with the Commission. Ifitbelieves that there is good cause. theCoinmission could state, in the notice ofproposed rulemaking for a future rule.that it was proposing not to apply someor all of the provisions of this backfitrule and request public comment on theunderlying reasons. If. afler consideringpublic cominents. the Commission findsgood cause. it can so state in the noticeof final rulemaking.

I concur in the views ofCommissioners Roberts and Zech.

Comments of Comndssioner Roberts andCoinmissioner Zech

Safety is paramount to the executionof our mission. We believe that thebackfit rule is entirely compatible withand supportive of this principle.Unmanaged. uncoordinated andinadequately analyzed backfits. on theother hand. are not. There is nothing inthe backfit rule which would stand inthe way of a Commission action whichis needed to protect the public healthund safety or in the way of the adoptionof policy changes which a majority ofthe Commission believes are warrantedin the circumstances.

W ~ believe that in the execution ofour mission to provide reasonableassurance that the public healtji andsafety are protected. we must have inplace criteria and a system for thetimely application of justified changes inregulatory requirements. The soealledbackfitting regulation which has been inplace for many years has not completelysat!sfied this need. Although itestablished a broad standard. it did notalso provide for a system to assure thatbackfitting decisionmaking to apply thestandard is done in a disciplined.systematic manner. The regulatorysystem needs a backfilling rule which iscomplementary to our overall regulatorymission and which is practical toimplement. Our chief reason for voting

to adopt this backflt rule is that itprovides for a disciplined andformalized review of regulatoryrequirements to assure that there is arational basis for modifications to anuclear power plant. The rule. alongwith its explanatory statement. alsoprovides guidance and direction to thestaff regarding backflt management andcontrol. This disciplined approach tobackfltting will,in our judgment.improve the overall effectiveness andcertainty in the regulatory process. thusenhancing our regulatory mission.

Discipline and management ofbackfitting do not mean that safetyactions which are justified willbeobstructed. or that the Commission willnot continue to have the discretion toadopt policies and rules which Itbelieves willserve to enhance theprotection of the public health andsafety. Instead. they mean that attentionand priorities willbe focused on areaswhere action ls justified to carry out ourregulatory responsibilities. Inadequatelymanaged and controlled backfitting. onthe other hand, provide no assurancethat modifications, individually andcollectively, are in the best overallinterest of protecting the public healthand safety.

We have carefully considered theviews of our dissenting colleagues. andalthough we respect them. we see thematter quite differently. As we havenoted. we believe that this backfittingrule serves a vital regulatory need. Wesee no reason why the important subjectof rulemaking which may involvegeneric backfitting should be excludedfroin coverage. It is true. as one of ourcolleagues points out. that rulemaking issubject to the procedures in theAdministrative Procedure Act. It is alsocorrect that we have in place aCommittee to Review GenericRequirements (CRGR) and haveinformal practices which, in theirtotality may, in an individual case, servethe purpose of the rule ifeverything fallsinto place properly In a rulemakingproceeding. The chance of thishappening. however, is not to us anacceptable substitute for the systemwhich is being put in place as a matter „,

of overall Commission policy in thebackfitting rule. And even assumingthat. under its present charter and underits incumbent chairman, the CRGR didcover all of the elements of thebackfitting rule. this is not theequivalent of published Commissionpolicy which states the applicablecriteria and procedures. The policy andsystem which are set forth In the backfitrule provide a much sounder foundationfor Commission controiaver future

rulemaking requirements than relyingexclusively on existing procedures.

We believe that the proceduralrequirements of the AdministrativeProcedure Act and the functions of theCRGR are compatible with theobjectives of the back!it rule. However.we also believe that application of therule to rulemaking is necessary to assureconsistent application of the.backfittingpolicy under a prescribed uniformsystem. regardless of whether aproposed change is generic or plantspecific.

The APA does not provide such asystem. but does. of course. provide forthe important procedural requirement ofassuring that there is adequate publicnotice and opportunity to coinment. Thisdoes not provide the assurance neededthat the substantive matters covered inthe backfit rule willbe considered eitherby the staff or the Commission in theCommission's rulemaking deci! Ion.There is no requirement for anyone toparticipate in a rulemaking proceeding.and even for those who choose toparticipate. there is no provision toassure that there willbe systematic andcomprehensive coverage of backfittingIssues. Indeed. R appears unusual foreither the staffs recommendation to theCommission or for the final rulemakingdecision to address In any detalL IfatalL the application of new requirementsto existing licenses and applications. Arulemaking proceeding which meets allof the procedural requirements of theAPA would not necessarily as!ure thatthe subject matter in the backfit rule isindeed covered. This is not surprisingbecause the objectives of the APA andthe backfit rule are. as noted.fundamentally different. Furthermore.we are not able to distinguish. forpurposes of the objectives of thisbacklit ting rule. between backfittingmodifications which are imposed byindividuals in specific plant-by plantsituations and modifications which areimposed by a change in a regulation In arulemaking proceeding. In each instancea disciplined system should be followedto assure that the backfit is fullyunderstood and justified in terms of itssafety relationship and its related costs.

Ifthe backfitting policy and systemare sound and are needed. as we believethey are. the straightforward way to goabout dealing with the backfit problemis to publish a Commission policy. Thisis what the backfltting rule does.

We do not share the concern of ourdissenting colleague regarding thelitigative risks because rulemaking iscovered. We are informed that that riskshould be minimal. But regardless ofwhether it is or it Isn'. if the rule is

Appendix A NUREG-1409

needed. iflt makes sense. and lf it is aresponsible regulatory action on ourpart. we should be prepared to defendour decisions in its application.

In summary. we support fully theback(it rule. including its coverage ofrulemaking. The rule willbringdiscipline and accountability to theimposition of plant modifications by theCominission by, establishing criteria anda system for rational decisionmaking.Without any question. we believe thisapproach willenhance the qua! ity of ourmission to assure that the public healthand safety arc protected in our licensingand regulatory requirements decisions.

Separate Views of ComadssioaerAsselstiac

In adopting this backfitting rule. theCommission continues its inexorablemarch down the path toward non-regulation of the nuclear industry. Intwo previous decisions the Commissionfound acceptable the present level ofrisk of a severe accident at the mosthighly populated site foran operatingnuclear plant in this country. See.Consolidated.Edison Company of¹wYork (Indian Point. Unit No. 2), CU 85-8,21 NRC 1043 (1985). The Commission'decision was made without an adequateexplanation or rationale: it was madewithout an adequate analysis of theissues: and it was made by ignoring theenormous uncertainties in our methodsfor estimating risks. The Commissionthen extended that decision to allnuclear plants through its SevereAccident Policy Statement. Sce, "PolicyStatement on Severe Reactor AccidentsRegarding Future Designs and ExistingPlants." 50 FR 32138 (August IL1985).This backfitting rule is another part ofthe Commission's withdrawal fromactive regulation of the industry.

The Commission's rule in effect saysthat nuclear reactor risks are soacceptable and so weil understood

that'he

burden of proof for lowering the riskto the publicmustbe placed on theproponent of Improved safety even ifthat proponent is the Commission itself.This optimistic view of the risks posedby nuclear power plants is unjustified.The Commission's adoption of this ruleis truly an unprecedented step m theannals of mgulation. I can think of noother instance in which a regulatoryagency has been so eager to stymie itsown ability to carry out itsmsponsibilities. Indeed. the adoption ofthis rule is the most compelling evidenceto date of the Commission majority'sopen hostility to the regulatory missionof this agency.

I do not believe that them is a needfor a formal Cominissioa regulationrestriming the Commission's ability to

requim safety improvements for nuclearpower reactors. Myopinion is shared byour reactor safety technical staff.including the Commission's chief safetyofficer. Thc Coinmission's purportedreason for promulgating this rulc is toadd "discipline" to the backfittingprocess. The Commission can adddiscipline to the backfit ting processwithout at tbe same time unnecessarilylimitingits own discretion to iinposcnew safety requirements by fetteringitself with thjs rule. Further. by addinglayer u pon layer of procedures to thebackfitting process the Commission hascreated ~ lawyer's paradise in whichlitigation over procedural Irmgularitiesmay hamper the Commission's ability toimpose needed safety requirements.

Even if( felt that a backfit tule wereappropriate. I would not support a ruleas poorly thought out as Is this one. Thisrule sets a threshold standard forimprovements to safety which Is muchtoo high given our presentunderstanding of risk and theuncertainties associated with ourmetho'ds ofestimating risk Further, thefactors to be considered in determiningwhether a backGt should bc imposed areskewed against imposing newrequirements. In addition. the.Commission's determination of risk Inthe cost-benefit balance ls to be basedon unreliable risk analyses.

The consequence of this rule is to limitthe NRC staffs and even theCommission's ability to identify andcorrect safety weaknesses at the nuclearpower planta In operation and under .construction in this country. As a result.these weaknesses are likely to persistuntil they cause serious operating eventsor accidents which pose a dimct threatto the health and safety of the public.This rule. then. further ensures acontinuation of the piecemeaL reactiveapproach to safety which has beenresponsible formany of the failures ofthe past. By this step, the Commission ismoving in the wrong direction-adimction that vrllllikely result in furtherserious operating events. moreaccidents, and a lower level of safetythan that achieved In many moreforward.thinking countries in the world.I discuss each of my reasons foropposing this rule in more detail below.

The Nature of tbc BackGt ting ProblemWhen asked to describ the

backfit ting problem. most ofourlicensees point to the substantialnumber of hardware modifications.procedural changes and human factorsimprovements which have been requiredby the NRC Ia recent years. The bulk ofthese ncw requirements can be traced tothree sources: the Commission's fire

protection rule: its rule requiring theenvironmental qualification of electricalequipment: and thc Commission'sresponse to the Three Mile islandaccident. It ls worth noting that each ofthese broad safety initiatives wasadopted by the Commission itself inresponse to the identiGcation ofsigniGcant areas of safety vuinerabilitywithin the industry.

Typically. the industry does aotchallenge the need for improvements infirn protection or the need to assure thatsafety. related electrical equipment willbe able to function under seriousaccident conditions. Nor does theIndustry deny the need to address thenumerous safety weaknesses brought tolight by tbe Three Mile island accident.Rather. the industry largely focuses itscriticlsins on the process used totranslate those broad areas of neededImprovccnent into specHic modification "'o

plant hardware. procedures andoperations.

The industry raises five spcciGccomplaints. FirsL our licensees arguethat new requirements often fail todefine dearly what ls expected of theindustry. Second. they contend that thebnplementation of these requimmcnts-the process by which morc generaldirectives arc translated into specificinodiGcations —is not well managed. Insupport of this argument. the industrypoints to some past failures indocumentiag proposed modifications. inensuring consistency in making plant-speciGc implementation decisions. inproviding effective managementoversight of plant. specific decisions. andln providing a fair opportunity to appealobjectionable staff proposedmodifications. ThirtLour licenseesassert that speciTic p'lant modiiicationsare proposed by staff members whohave a siagle narrow area of interest.and little consideration is given to theoverall safety impact of the proposedchange. Fourth. the inductiy argues thatthe staff's implementation process alltoo often fails to provide a final decisionfroin the staff on the adequacy of thelicensee's efforts to comply with arequirement until ofter the licensee hasmade the modification to its plant. Thisprocess. they contend. exposes theindustry to second guessing by the NRCstaff and sometimes leads to makingrepeated modiiications to address thesame problem. Finally. the licenseesargue that the Coaunission sometimesadopts arbitrary and unrealisticdeadlines for the implementation of newrequirements. More than anything else.these complaints focus on themanagement of the backfitting process.

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NUREG-1409 10 Appendix A

Federal Register / Vol. 50. No. 183 / Friday. September 20. 1985 / Rules and Regulatlans 38107

ln the literally thousands ofbackfitting decisions made by the NRCover the past several years I am surethat some examples can be found tosupport each of these complaints.However. I believe that each of theindustry's valid concerns is addressedby the administrative backfillingmanagement improvements alreaifyadopted by the Commission.

IVhyARuleP'he

Commission cIaims that this ruleis necessary to provide a "managementprocess" for the adoption of Commissionregulations and staff interpretations ofthose regulations. Implicit in theCommission's explanation of this rule isa feeling on the part of the Commissionthat it is necessary to add discipline tothe bsckfitting process. The Commissionnever clearly explains why ifaddeddiscipline ls necessary they must embedthat discipline or management process ~

in a formal agency rule. TheCommission also refuses to explain theconnection between discipline and thenecessity for a substantial threshold thatmust be surmounted before safety canbe improved. Further. the Commissionnever adequately explains why it cannotaccomplish improved management ofthe backfitting process without at thesame time fimitingits own discretion torequire safety improvements byrequiring that Commission rules complynot only with the AdministrativeProcedure Act. but also with this rule.

By choosing to adopt this rule theCommission adinits failure. TheCommission admits that it has beenincapable of solving administrativelywhatever problems it sees with themanagement of the backfit ting process.By adopting this rule. the Commissionsays to the world that 0 so mistrusts itsown ability to act in a sensible mannerand it so mistrusts its ability to controlthe NRC staff that it must have a formalrule which limits the Commission'ss.»cretion and which can be used as abludgeon to control the staff.

The Crony of this all is that theadministrative actions taken by theCommission to formaiize the backfittingprocess have already been successful insrlding discipline to the process and inaddressing the valid concerns of theindustry. A senior officialof one of theutilities mvolved mast actively in thebackfit debate recently told ine thatwhen his company first expressed itsconcerns about backfitting all it wantedwas to get NRC management to payattention to backfitting problems. Thecompany simply wanted a brief writtensiaiement for each praposed backfitdescribing the proposed change and theNRC staff's reasons for requiring the

change. together with the right to appealto upper NRC management the decisionsbeing made at the lower levels af theNRC staff. Their objective. this officialsaid. Is already being achieved by theCommission's internal managementdirections to the NRC staff.

Whatever "backiitting problem"exists is really a management problem.The Commission's statement ofconsiderations acknowledges that. And.the problem is being correctedindependently of this rule. Why thenmust this rule be promulgated withoutdelay? Apparently it is because themovement to put in place a backfit ruleis much like an avaianch-once it startsrolling it cannot be slowed down orchanged in course.

Lowyer's Paradise

By embedding the Commission'sbackfit management process in the formof a rule. the Commission has chosen toformalize a process which ought to be apurely internal management tool. In

. doing so. the Commission has imposedupon itself a particular managementprocess as a legal requirement whichcannot be ignored. adapted tocircumstances. or changed without onceagah going through formal rulemaldngprocedures. The rule provides a myriadof opportunities for licensees to invokeprocedural irregularities ln challengingthe Commission's rules and itsbackfitting decisions. The rule lendsitself readily to being used as ~ delayingtactic by uncooperative licensees. and ithas the potential for hamstringing theCommission's ability to impose neededsafety improvements while the legalwrangling goes on and on and on.

The Commission's decision to includeCommission rulemaking within thecoverage of the backflt rule I~ anexcellent exemple of theoverproceduralization of the backfitprocess. The Administrative ProcedureAct and cases interpreting it set outrequirements for rulemaking. Interestedparties are given an opportunity tocomment on the proposed agency actionbefore it goes into effect. TheCommission must then take thosecomments into account beforepromulgating a final rule. The courts canthen review Commission action and testit for reasonableness and rationality.The Commission wishes to add on tothese legal requirements a very highstandard or threshold the Commissionmust meet before it can institute safetyimprovements. Further. the rule requiresa strict cast. benefit balance. somethingthe courts have not found is required bythe Atomic Energy Act or theAdministrative Procedure Act. Contraryto Chairman Palladino's assertion. the

Commission cannot decide whether tofollow these new. more stringentrequirements in individual rulemakingproceedings on a case.bywase basis.This regulation now becomes binding onthe Commission. and must be followedin all future rulemakings.

In addition to this. the backfit ruleapplies to staff interpretations ofCommission tales. By the rule's literalterms. any staff interpretation of aCommission rule would also have tomeet the requirements of the backfitrule. Thus. the Cominission would berequired to meet a high threshold andperform a cost-benefit balance for ahyrule it issues. and the staff would thenhave to again meet the saine highthreshold and perform a new cost-benefit balance before it cauld interpretthat rule. That is absurd. but that iswhat the rule appears to require.

Even ifrulemaking were not to beincluded within the scope of this rule,staff interpretations of Cominissionrules would be. This presents aninteresting dilemina. The Commission's1985 Policy and Planning Guidancestates: "The Commission intends to shiftits regulatory emphasis away fromdeta0ed, prescriptive requirementstoward performance criteria." See.NUREG-0885 Issue s. 'VS. NuctearRegulatory Commission Policy andPlanning Guidance 1985." This meansthat new rules willtend to be general innature. It is difficultfor safety reviewersand inspectors to review and inspectgeneralities. They need to developpositions on acceptance criteria.hardware requirements. applicablequality assurance provisions. technicalspeciTications. etc. The rule wouldrequire that these interpretations meetthe requirements of the backfit rule.Thus. ifruleinakings are outside thescope of the backfit rule, butinterpretations of those rules are nat. itmay create a situation where the staffcannot adequately interpret the rulebecause the interpretations would notmeet the backfitting requirements. eventhough the Commission's rule has beenotherwise legally promulgated.

Ifthese are the results theCommission intended. then theCommission's backfit rule makes nosense whatsoever. If this is not what theCominission intended. then theCommission should make thatabsolutely clear. Such ambiguities donothing but provide fodder for litigation.These problems illustrate further howpoorly written and how poorlyexplained is this rule. These are thekinds of issues one should not have toinske guesses about.

Appendix A NUREG-1409

381M Federal Register / Vol. 50. No. 183 / Friday, September 20. 1985 / Rules and Regulations

It is interesting to note that mycolleagues constantly complain aboutthe length and over-legalization of thelicensing process. often arguing that-ere are too many procedures and that

me process is too formal. Yet. thosesame Commissioners who want to makeinc licensing process as simple endinformal ac possible have here addedlayer upon layer of procedures to thebackflttlng process. In fact. they haveadded procedures far beyond thosewhich are legally required. and in theprocess have added new oppqrtunitiesfor litigation.

Barrier ta lmpnn'ed SafetyThe Commission's rule seta up e

threshold standard that the Commission—..ustmeet before it can adopt newsafety requirements. Under this rule. theCommission cannot reduce theradiological risks to the public unlesc Itfirst determines that a proposed safetyImprovement provides a "substantialincrease in the overall protection of thepublic health and safety or the cominondefense end security." Section50.109(a)(3). Thus. the Conunissioncreates a significant barrier to reactorsafety improvements.

The Commission's explanaton In thestatement of conciderations of what Itmeans by "substantial hcresse" ls sounclear as to be useless. However. anindication of what the Commissionreally intends can be found in theCommission's recent Indian Pointdecision. 21 NRC 1043. In that

roceeding. the Comndcsion's technicalsff and licensing Board urged the

.~mmisclon to require a set of safetyimprovements for the reactors sited atthe most highly populated locations inthis country. Upon learning that thoseImprovements only cut the ncks to thepublic in half, the Commiscion rejectedthem as not providing a -subctanUel"Increase in protection.21 NRC1043.

I would prefer a standard which doesnot set such a high threshold for theiinposition of safety improvements. Infact. I proposed such a standard. Undermy proposed standard the Agencywould require improved safety upon adetermination that a proposedmeasureprovides a net Increase in the protectionof the public health and safety and thatthe costs of this improvement are notincommensurate with the increasedprotection, This standard would allowmore improvements in safety thanwould the Commission's standard butwould still exclude proposed changeswhich would result in only trivialsafetyimprovements. The Commission rejectedibis standard because it does notpresent a high enough barrier to blocknew safety requirements. Apparently,

the Commission is interested in morethan simply bringing discipline to thebsckfiitting process. Rather. It is reallyInterested in tying Its own and the staffshands<a restrict the number of safetyImprovementa Ifthe Commission reallyonly wanted discipline and soundthinking to be brought to the backflttlngprocess, it would not feel the need topropose such a stringent threshold forsafety improvementL

Tipping the Scale Against SafetyThe rule speclfies nine factors that

"are to be used es balancingmechanisms in the declslonmakfng

rocess for backfit ting". See, $ 5L109(c)or list of factorL lfone cuts through the

extraneous matterin that section of therule, one findc that the Commissionrequires coat beneflt analyses to beperformed on all proposals for backfits.Of course. In cost. benefit analyses thebottom line depends on whet factors,one chooses to put on the scale.

Not aaUsfied that a high threshbldstandard willsufficiently limitthenumber ofbackfits. the Commission hasalso decided to stack the coat-benefitbalance. The only benefit theCommission Is able to Identify as beingappropriately considered in decisions onwhether safety should be improved Isthe "potential change In the risk to thepublic &om the accidental off-siterelease of radioactive material" Section50.109(c)(3). Risk is typiceuy defined asthe probability of an accident mulUpliedby the consequences. with the latterexpressed as the collective dose to thepubuc (person.rem). However. even herethe Agency'a typical practica Is to ignoresocietal doses beyond ~ 50 mile radius.As calculations of accidentconsequences indicate. thh procedurecaptures less than half of the healthconsequences of core meltdownaccidentL

The Commission refuses to includeamong the "balancing factors" theaverted costa of off.site property

'amage resulting from radiologicalreleases. The Commission does notseem to realize that core meltdownaccidents can contaminate off-siteproperty to hazardous radiation levelsend that there is a real benefit inpreventing that from occurring. Avertingthe necessity to decontaminate suchproperty is a real benefit of backfitswhich lessen the likelihood ofoff sitereleases of radioactive materials. Sincethese costs in some instancessubstantially exceed the monetizedvalue of averted health effects resultingfrom accidents. the Commission has nodefensible basis for omitting from the"balancing factors" off.site propertydecontamination costa.

The Commission also rejects theinclusion of the benefits derived fromaverting damage to the plant itself. TheTMI-2accident. which apparently didnot result in extensive melting of thereactor core or substantial offsitereleases of radioactivity, resulted inbillions of dollars in plant damage. plantclean up and power replacement costs.The Commission' rule fails to recognizethat preventing such costs has a publicbenefit. The Commission chooses toignore averted replacement power costsassociated with safety improvements

'hatprevent accidents. However. inorder to inflate the coctc aide of theequation which weighs againstbackfitting. the rule requiresconsideration of the replacement powercosts for the facilitydowntimeassociated with Implementing a backfiL

At the same time the Commissionignores the benefits of backfits. theCommission tries to inciude everyconceivable "cost" of the backfit In thebalance. The rule includes coats such asInstallation and other costa associatedwith physically changing the plant: thecost of facilitydowntime.e.g.replacement power costs, etc the cost ofconstruction delay, and. radiologicalimpact on facilityemployees. TheCommission has even thrown the cost tothe NRC (resource burden on the NRC)into the balance. Obviously this stackingof the deck against safety Improvementsindicates once again that theCommission is interested in more thanjust adding discipline to the backfittingprocesL

The Commission majority tries toargue that the balance of costs andbenefits Ic not slanted because otherbenefits beyond those enumerated in therule can be considered. Their ownactions contradict this argument. Inadopting this rule, the Commissionmajority expressly rejected proposals toInclude additional hea! th and safety andeconomic benefits of proposed backfitsthat would have resulted in a fair andeven-handed consideration ofallrelevant costs and benefits. Given itsown actions. the true intent of theCommission majority is beyond doubt.

Reliance on Indefensible Analyses

The Commission's rule places greatreliance on ProbabilisUc Risk Analyses(PRA's). In determining the "change inrisk" as required by this tule. theCommission intends to rely on thebottom. line results of PRA's.Unfortunately. numbers produced bythese analyses amount really to onlyestimated guesses: yet. the Commissionintends to rely heavily on thesenumbers. which nearly all PRA

NUREG-1409 12 APPendiX A

Federal Register / Vol. 50. No. 183 / Friday, September 20. 1985 / Rules and Regulations SSMg

practitioners agree are unreliable. indetermining whether to requireimprovements in safety.

Preparation of a PRA requires that theanalyst calculate the core meltdownprobability. Given a particular coremeltdown scenario. the analyst mustthen calculate the containment failuremode. the quantity of radioactive fissionproducts released from the containment(the "source tenn-). the dispersion af thefission products in the atmosphere and

'inallythe radiation doses to the public.The calculated probabilities from all ofthc above are multiplied by thcaggregate doses to the public. This is therisk to the public.

To calculate the change in risk asrequired by this rule. the analyst mustfirst calculate thc risk to the publicbefore a proposed safety improveinent isimplemented, and then calculate the riskassuming the improvement is made.Unfortunately the necessarycalculations cannot be made based ondata. and scientHically acceptedprinciples and methodologies. Becauseof major inadequacies in the data base.because of the vast complexity ofnuclear plants; because a tremendousnumber of assumptions must be mtide.because all contributor to risk cannotbe quantified and because coremeltdown phenomena are poorlyunderstood. no one calculation of riskyields a remotely meaningful value ofrisk l discussed the meaningless natureof these risk estimates in more detail inmy separate views on the SevereAcciaent Policy Stataaient.

Our experience with the Davis Besseplant provides an excellent example ofthe inadequacies of PRA's for truelypredicting nsk. lt also illustrates thesnoricomings of a system which reliesheavily on strict cost benefit balancesfor making decisions on safetyimprovements. The Davis Besse plant:.u~ one of the most (ifnot the most). -.iehab!c emergency feedwater systems(EFS) of any nuclear plant in this .country. The NRC staffhas been tryingto require Davis Besse to upgrade itsEFS reliability. However. for the lastseveral years. the licensee has beenusing reliabilityand cost benefitanalyses to argue that substantialupgrades should not be required. Twoindependent reliability analyses (one bythe utilityand one by the NRC staff)were performed on the EFS at DavisBcsse. The resu)ts of these two studiesdiffered by a factor of 100 in theirestimate of the reliability of the systems.The studies also differed on what wasthe most cost. effective way to upgradethe system. The utilityargued that itscost. benefit analyses showed that only

some lowwost minor changes werejustifiable while the staff argued that itscost benefit analyses sup ported moresignificant modifications. Because theCommission-required cost-beneBtanalyses could not demonstrate thenecessity of a particu)ar way to upgradethe EFS reliability, the staff could notrequire a substantial upgrade of thatsystem even though the plant continuedto operate with an unreliable but crucial

'afetysystem during the several yearsof the PRA debate between the staff andthe utility.

The June tL 1985 Davis Besse eventdemonstrated that the PRA analyseswere wrong. Davis Besse had ~ loss ofall feedwater that involved the failure of14 separate pieces of equipment. (See,NVREG-1154. "Loss af Main andAuxiliaryFeedwater Event at the Davis-Besse plant on June 9.1985"), The eventled the Agency's chief safety officer toobserve: "lbelieve that the recentDavis.Besse event illustrates that. in thereal world. system and componentreliabilltles can degrade below those weand the industry routinely assume Inestimating core melt frequencies." (Seememorandum from Harold LDenton toWilliam J. Dircks. dated June 27, 1985).Further. it appears that the steam andfecdwater rupture control system had asignificant role in causing the loss ofemergency feedwater. Yet that systemwas not even inc)udcd as a possiblecontributor to the unre)iabi)ity of theemergency feedwater system in either ofthe independent reliability studies.Despite this clear evidence of theweaknesses in PRA studies and theirpotential for manipulation anddistortion. the Commission persists inusing them and in requiring their use bythe staff in this ru)e as the basis fordeciding on safety improvements.

Although this rule willhave anegative impact an all aspects of theCommission's reactor safety activities.its effects are likely to be greatest in thearea of improving human performance.Recent operating experience indicatesthat roughly half of all significantoperating events can be traced toinadequate human performance in suchareas as reactor operations. surveillancetesting and maintenance. A number of .the Commission's post-TMIrequirements have focused on huinanperformance. but recent operatingexperience demonstrates the need forfurther improvements in this area.indeed. virtuallyall members of theCommission have advocated furthermeasures to improve the qualifications.experience and training of plantpersonneL Specifically. members of theCommission have spoken in favor of

increasing the engineering knowledgeand skills of plant operators andrequiring the use of plant referencesimulators for operator training andtesting. Common sense and soundengineering judgment tell us that suchmeasures willhave a positive effect inimproving plant performance. Yet. it willbe especially difficultto assess howsuch proposed requirements willreducethe risk of a core'melt accident whichmight result in harm to the public. Thus.the practical effect of this rule willbe tothwart the efforts of the NRC staff todevelop new safety requirements in thearea ofhuman performance where suchrequirements could be of the greatestsafely benefiL

Ignoring Uncertainties

The Commission also fails to dealwith the huge uncertainties associatedwith the risks of nuclear reactors. Theactual risks could be up to 100 tiines thevalue frequently picked by theCommission. One would think that theuncertainties about the level of safetyachieved at the operating reactorswould have a bearing on whetherreactor safety should be iinproved. Iproposed that the Commission articulateits expectations on the handling ofuncertainties in the backfitttngdecisionmaking process before allowingthis ru)e to become effective. TheCommission rejected my proposal.There is no reference in this rule touncertainties in reactor risks or to howuncertainties are to be factored intosafely decisions. The Commission's~1lence simply reaffirms its practice ofignoring the enormous uncertainties innuclear risks when deciding whether toimprove the protection of the publichealth and safety.

Sclecli ve Application of ihc Rule

The Commission's stated manner ofapplying this nde is also troubling. First.according to the statement ofConsiderations. a licensee may requestan amendment to its license and theNRC staff is not required to considerwhether the amendment represents a"substantial increase in the overallprotection of the public health andsafety." However. ifthe NRC staffwants to amend a license to establish amore stringent standard. the staff mustfirst demonstrate that the amendmentmeets that backfitting standard. Thus.the rule stacks the deck in favor of theindustry and against the NRC staff.

But more troubling is theCommission's apparent intent to applythis backfit rule with its high thresholdand cost-benefit analysis only to thosenew Coinmission requirements which

APPentjix h l3 NU RE(.r-1409

38i10 Federal Register / Vol. 80. No. 183 / Friday. September 20. 1985 / Rules and Rettujatians

are intended to improve safety. Ifonereads the Commission's tule literally. itapplies to ony change in Commissionrequirements. both a change to makerequirements more stringent and one torelax requirements. Further. theCommission states in its statement of

nsiderations: "(T)here is no intent onine part of the Commission to Includewithin the scope of the exceptions (tothe rule) new or modified interpretationsof what constitutes no undue risk to thepublic health and safety. In such a case,the rule applies." Allof this seems toindicate that the backfit rule appliesacross the board to new Commissionregulations and interpretations.

However, the Commission's actionsand rhetoric would seem ta indicateotherwise. The Commission has beendevoting and continues to devoteconsiderable agency resources totelaxing the current emergency carecooling regulations and the emergencyplanning regulations. Fot example. thestaff is developing new and relaxed(relative to the current staff position)acceptance criteria for emergency corecooling systems thai would effectivelyallow the licensees to Increase thepower level of the operating reactors.Likewise. the Commission assignsresources to work on a tule that wouldallow less comprehensive evacuationplanning. Both actiiities involve new orrnodilied interpretations of whatconstitutes compliance. involve a

- tnoditied interpretation of whatconstitutes "no undue risk," and do notfall within any of the exemptions to thebackiit rule. Thus. ifone reads tbebackfit rule literally. the Commissionmust determine that increasing thepower level of reactors and diminishingthe level of emergency preparednessresult In a "substantial increase in theoverall protection of the public healthena saieiy or common defense andsecurity." It would take quite a bit afconvoluted argument to find thatrelaxing safety standards meets the ~

rule's substantial increase requirement.Onc can only condude that either theCommission is wasting resources onthcsc activities or that it does not intendto apply the backfit rule to acnonswhich relax existing safety standards.

This problem of Interpretation isanother example of bow poorly thobghtout and how poorly written is this rule.'Ihe Commission should n:ake clearexactly what is the scope of this rule,and should revise the rule accordingly.Otherwise. this apparent ambiguity onceagain produces nothing but fuel forhtigation.

Conclusion'

might be as sanguine as is theCommission about the current state ofreactor safety. and I might bc wilL'ng torestrict the Commission's ability torequire safety Improveinents If therewere a dear understanding of the levelof safety already achieved at plants andifthat understanding demonstrated thatthe potential for severe accidents isindeed very remote. Unfortunately, theCommission does not have a clearunderstanding of the level of safety ofcurrent reactors.

The Conunission does not knoivwhere we are on the learning curve forreactor performance. and thete is adistinct possibility of one or more severeaccidents In the foreseeable future.Operating experience indicates that atotal loss of a safety system Is not a rareevent. that multiple independent failuresdo occur. that there are component andreliabilityproblems. that operating,practices are frequently dcfidenL andthat there are a wide range of adversesystems interactions. The Commission isr luctant to face these facts and todemand improved safety because thatmight suggest to the public that theexisting teactors are unsafe and mighthinder the further development of thenuclear industry.

In my view, another severe accidentmay well bring to a halt furtherdevelopment of the nuclear industryand. ifpeople are injured, mayjeopardize continued operation ofexisting reactors. The Commission hassaid there is about a 50-$0 chance ofanother severe accident in the nexttwenty years. The Commission findsthat risk so acceptable that it can now,through this tule. put roadblocks in theway of further safety improvements. Ifind the Coinmission's actions to be notonly unwise but harmful to the publicinterest and potentially hazardous to thepublic health and safety.

The Commission willnext turn itsattention to the forth and final actionthat willcomplete the framework fordeciding whether the NRC and theindustry willpursue safety issues beforeacddents occur, Le. the Safety GoalPolicy Statement. That willbe the finalopportunity to come to grips with thepivotal issues the Commission hassteadfastly avoided over the la'st se'veralyears. As I wrote in my separate viewson the Severe Accident PolicyStatement. n is encouraging that thereappears to be an emerging consensuswithin the NRC senior technical staffand within the ACRS in favor of safelyin:provements to reduce severe accidentrisks. However. It is dismaying that theCommission. having lost all sight of the

broadest lessons learned from the TMI-2 acddent. bas chosen to hinderenhancing the protection of the publichealth and safety through this backfltrule.

Views of Commissioner BernthalI had fullyexpected to support the

Commission's final rule on backfrt ting.Unfortunately. an eleventh-howdecision by the tnajoiity has added a,destructive provision that at best canonly confuse the public and ourlicensees by its misrepresentation of tberole and options of the Cominission inrulemaking. at worst It contains theseeds for rulemaking chaos, withlitigative risks. unpredictability, and

'engthenedtiinetables that willresult inmore. rather than less uncertainty in theCommission's entire licensing andregulatory process. Such a backfittingrule is surely not in the public interest orin the Interest of our licensees.

In a word. my principal quarrel withthe tule adopted by the Commission IsIts inclusion of rulemaldng in thedefinition ofbackfitting. Indeed. themere idea of imposing its own rule onthe statutory procedures for rulemakingas set forth In the AdininistratlveProcedures Act should have given theCommission majority long pause. to saythe least.

But In its apparent desire to appear tohave voluntarily circumscribed its ownauthority and flexibilityfor rulemaking(when it cannot, of course. ultimately doso). the Commission has instead chosento run the risk of creating new. legallybinding requirements for rulemaking.requirements which willonly widen thetarget for anyone seeking to challenge afinal rule.

it is not even clear just who it is theCommission believes willbe served bythis action. Far from lending disciplineand order to the rulemaking process.

; what the Commission majority has donewillhelp insure that our often long andtortured consideration of rules willbecome even longer, more tortured. andmore confusing. More ominously. shoulda future Cominission find common-sensepublic health and safety measuresunduly confused and obstructedby thebackfit rule. It may in frustration choosesimply to begin issuing by order "tules"that today would be subjected to thecarefuL disciplined process set forth intbe Administrative Procedures Act.

The only rationale the majority hasoffered for wanting to includerulcmaking under the backfit rule is to"discipline- the Commission (i.e toprotect the Commission from itself). Ifthe Commission is incapable ofdisciplining flself in the rulemaking

NUREG-1409 14 Appendix A

Federal Register / Vo), 50. No. 183 / Friday. September 20. 1985 / Rules and Regulations SB111

process as it stands (what with theexisting Committee to Review GenericRequirements and the Commission'sincontestable authority and ineluctableresponsibility to instruct the staff). thenI doubt that rule laid upon rule willdomuch to teach the Commission the virtueof self discipline.

More specifically, the Commissionmajority presumably knows that thebackfit threshold criteria applied toruleinaking would apply not just on 8plant. specific basis (which it should berecalled was the intent of the originalbackfitting initiative). but to genericdecisions that may affect dozens ofplants, and in fact to rulemaking on a/Ibut procedural matters. rulemaking thatmsy or may not have the remotestconnection to what the public and ourlicensees normally consider 8 plant-backfit". The scope of Commissionrulemaking responsibilities thus ofteninvolves broad public policyconsiderations. and thoseconsiderations can rise above elementsss siinple as cost. benefit analysis toreach issues as fundamental as fairnesssnd individual rights. The Commission'sbackfit rule. Ifapplied to rulemakingitself. willthus serve only to trivialize inappearance and confuse in practice themany factors to be weighed inrulemaking.

As one small example of the morassinto which the Commission majority haswandered. consider (as the Commissioncurrently is considering) whether thereshould be a requirement that radiationworkers be provided their dose recordsannually. The -benefit" of this "backfit-af Commission rules may seem clear.but it might very well never pass thecost benefit lest. Indeed. it is difficult toin:agine s rulc that would involve thehuman. factors element of plantoperations. and that would also beamenable to straightforward cost-benefit analysis.

Itu!emeking as it exists involvesnumeious inherent procedural checksand balances to insure that eachproposal is carefully considered prior toadaption. Indeed. rulemaking is thefaruin which provides the greatestnumber of checks against arbitraryaction by the Staff or Commission. Muchof the analysis (including cost. benefit)which the new bsckfitting rule wouldrequire is already done informallythroughout the process of consideringsnd adopting new regulations.

If thc Commission wishes to insurestill more structure in the rulemakingprocess. structure which could lake intoaccount every single factor sct forth inihe backfit rule and morc. there areample means of doing so by simpleinternal agencv management. Such

inethods would reaffirm existingCommission guidelines to the Staffwithout opening the door to additionalneedless litigation as 8 consequence ofvague new. legally enforceable.Commission-created rights added tothose already available to all partiesunder the APA.

The entire backfit rulemaking wssundertaken to bring order andaccountability to plant modificationsheretofore soinetimes imposed withoutthe benefit of systematic evaluation sndjustification. In rulemaking per se. thatobjective has always been well withinthe Commission'8 grasp-it is. after all.the Commission that makes rules. For

'oodmeasure. the Commission also hasthe Administrative Procedures Act as amatter of law, and its own Committee toReview Generic Requirements as amatter of internal administrative policyto assist it in carrying out suchconsidered decision making. Casting thenet of the new backfit rule bverCommission rule-making (almost as anafterthought, as it happened in this case)is thus at best an exercise in pointlesssymbolism. and at worst potentiallydestructive of the Commission's entirerule.making process.

Unneeded law is bad law. andunneeded regulation is bad regulation.The Commission majority has imposedon this agency new regulatoryobligations in rulemaking that are notonly unneeded. but which theCommission majority itself hopes andtrusts willbe of little practical (i.e.legally enforceable) consequence. To theextent that this rule willaffectrulemaking. it will therefore be a badrule. In sum. the Commission majorityhas inexplicably insisted on fixingnotonly what is. but what ain't broke. I willnot be 8 party to such poor judgmenL

Environmental Impact: CategoricalExc)us(an,

The NRC has determined that thisfinal rule is the type of action describedin categorical exclusion 10 CFR5122(c)(3). Therefore. neither anenvironmental impact statement nor anenvironmental assessment has beenprepared for this final rule.

Paperwork Reduction Act Statement

This final rule does not contain a newor amended information collectionrequirement subject to the PaperworkReduction Act of 1980 (44 U.S.C. 3501 etseq.). Existing requirements wereapproved by the Office of Managementand BudgeL Approve)Nuinber 3150-0011.

Regulatory FlexibilityAct Certification

in accordance with the RegulatoryFlexibilityAct of 1980. 5 U.S.C. 605(b).the Commission hereby certii'ies thatthis final rule. ifpromulgated. willnothave s significant economic impact on asubstantial number of small entities. Theaffected facilities are licensed under theprovisions of 10 CFR 50.21(b) and 10CFR 50.22. The companies that own,these facilities do not fall within thescope of "small entities" as set forth inthe Regulatory HexibilityAct or theSmall Business Size Standards set forthin regulations issued by the SinallBusiness Administration in 13 CFR I'art121.

List of Subjects

)0CFRPort2

Administrative practice andprocedure, Nuclear power plants sndreactors. hazardous waste.

J0 CFR Port 50

Antitrust. Classified information. Fireprevention. Incorporation by reference.intergovernmental relations. Nuclearpower plants and reactors, Penalty.Radiation protection. Reactor sitingcriteria. Reporting and rccordkeepingrequirements.

For the reasons set out in thepreamble and under the authority of the

'Atomic Energy Act of 1954. as amended.Ihe Energy Reorganization Act of 1974.as amended. and 5 U.S.C. 553. Ihe NRCis adopting the following amendments to10 CFR Parts 2 and 50.

PART 50-DOMESTIC LICENSING OFPRODUCTION AND UTILIZATIONFACILITIES

1. The authority citation for Part 50continues to read as follows:

huthorit)e Secs. 103. 104. 16't. 185 183. )85.189. 68 Slat. 935. 937. 948. 953. 95l. 9 $5. 956. asamended. sec. 23l 63 StaL 1244. as amended(42 US.C. 2133. 2134. 2201, 2232. 2233. 2236.2239. 2282): secs. 201. 202. 2NL 68 Stat. 1242.1244. 1246. ss amended (42 U.S.C 58ll. 5842.5846), unless otherwise noted.

Sec. 50.7 also issued under Pub. L9$-601.sec. 10. 92 SlaL 2951 (42 US.C. 5851). Secuons5057(d). 40~ 5031. snd 50.92 also Issuedunder Puh. L 97%15. 95 Sist. 2071. 2073 (42Us.c. 2133. 2239). section 50.78 also issuedunder see. 122. 68SiaL 939 (42 U.S.C. 2I$2).Sections 50A&4MIalso Issued under sec.164. 58 Sist. 9$4. as amended (l2 US.C ~4).Seciians 50.100-$ 0.102 also issued under sec.

,186. 68 SieL 9$ $ (42 US.C. 2236).

For ihe purposes of sec. 223. 68 Slat. 958. ssamended (42 US.C. 2273). II50.10 [4). (h).and Ic). 50.44. 50.46. 50.4L 5L54. and 50.M(a)are issued under sec. 16th. 68 SiaL 946. as~ mended (42 U.S.C. 2201(h)); II 50.10 Ih) cnaIcl and $0.54 are issued under sec. 151(. 68

Appendix A 15 NVj<L'0-)409

30112 Federal Register / Vol. 50. No. 183 / Friday, September 20. 1985 / Rules and Regu)at(ons

Slat.949. as amended (42 US.C 220l(t)): nnd4 1 Sa55(c). 5089(b). SL70. S0.71. 50.72. 50.73. ~and 50.78 are issued under eee. 16lo. 86 Stat.950. as amended (42 US.C 2201(o)).

2.1n 5 5044. paragraph (0 ls revised toread as follows:

$ 50.54 Condttlons of ffeenses.0 v ~ ~ ~

(f) The licensee shall at any timeefore exp)ratio)1 of the )icense. upon

"

:quest of the Commission submitwritten statements. signed under oath orafiirmation. to enable the Commission todetermine whether or not the licenseshould be modified. suspended orrevoked. Except for information soughtto verify licensee compliance with thecurrent licensing basis for that facility.1he NRC must prepare the reason orreasons for each information requestprior to issuance to ensure that theburden to be imposed on respondents lsjustified ln view of the potential safetysignificance of the issue to be addressedln the requested information. Each'suchjustiiication provided for an evaluationperformed by the NRC staff must beapproved by the Executive Director forOperations or lds or her designee priorto Issuance of the request.u v v ~ ~

3. ln $ 50.109, paragraph (8) is revised.paragraph (b) is remove* paragraph (c)is revised and redesignated as (b), andstew paragraphs (c), (d) and (e) areadded to read as follows:

5 50.109 Bsekflttlng.

(a)(1) Baekfitting is delined as themodification of or addition to systems.structures. components. or design of afacl)ity. or the design approval ormanufacturing license for a facility. orthe procedures or organization requiredto design. construct or operate a facility:any of which may result from a new oramended provision in the Commissionrules or the imposition of a regulatory' p;sviionmterpreting theCommfss(on rules that is either new ordifferent from a previously applicable.staff position after.

(I) The date of issuance of the.onstruction permit for the fadlity forfadlities having construcuon permitsissued after October 21. 1985: or

(ii) Six months before the date ofdocketing of the operating licenseapplication for the facility for facilities

- having construction permits issuedbefore October 21. 1985: or

(iii)The data of issuance of theoperating license for the facility forfad(it(as having operating licenses: or

(iv) The date of issuance of the designapproval under Appendix M. N or 0 ofthis part.

(2) The Commission shall require asystematic and documented analysispursuant to paragraph (c) of this sectionfor backfits which it seeks to impose.imposition of a backfit pursuant toparagraph (a)(4)(ii) of this section shallnot relieve the Comndssion ofperforming an analysis after the fact todocument the safety significance andappropriateness of the action taken.

(3) The Commission shall require thebackfit ting ol a facilityonly when itdetermines, based on the analysisdescribed h paragraph (c) of thissection. that there is a substant)alincrease in the overall protecfion of thepublic health and safety or the commondefense and security to be derived &om .the backfit and that the direct andindirect costa of ifnplementation for thatfacility are justified in view of thisincreased protection.

(4) The provisions of paragraphs (a)(2)and (a)(3) of this section areinapplicable and. therefore. backfitanalysis is not required and the

'tandarddoes not apply where the stafffinds end declares, with appropriatedocumented evaluation for Its finding.either.

(I) That a modification is necessary tobring a facility Into compliance with 8license or the ru)es or orders of theCommission. or into conformance withwritten commitments by the licensee or

(ii)That an immediately effectiveregulatory action js necessary to ensurethat the facilityposes no undue risk tothe public health and

safety.'uch

docufnented evaluation shallinclude a statefnent of the objectives ofand reasons for the modification and thebasis for invoking the exception.

(b) Paragraph (a) of this section shallnot apply to backflts imposed prior toOctober 21. 1985.

(c) ln reaching the determinationrequired by paragraph (a) of this section.the Commission willconside~rqw thebackfit should beIpr(ont>itcand~ chediil ed ln eehi oToater tcgu aiatyactlv(t(es ongoing at the facilityand. Inaddition. willconsider Informationavailable concerning any of thefollowin'gfactors as may be appropriateand any other information relevant andfnaterial to the proposed backfit

(1) Statement of the spedficobjectives that the proposed backlit Isdesigned to achieve;

'For ehoec modirieauone whi*aiu lo cneuec chefthc facilitypoece no undue ric to ehc pubhe health~ nd eefety and which aec not deemed ln inquireiinincdiaecly cffcenvc ecgulaioiy eeeinix analyece~ rc ecqwred: these analyece. however. ehould nohinvolve coee cnneidceenone except only ineofee eecoee eon<nbuece eo aclccting the aotuunn amongvenoue acceptable al<cmanvce to cneunng nounuue neh eo punhe heeuh and eafchy.

'2)

General description of the activitythat would be required by the licenseeor applicant In order to complete thebackqt:

,(3) Potential change in the risk to thepublic from the acddental olE-siterelease of radioactive materiah

(4) Potential bnpact on radiologicalexposure of facilityemployees:

(5) installation and continuing costa,associated with the back(it. Includingthe coat of facilitydowntbne or the costof construction delay;

(8) The potential safety Impact ofchanges in plant or operationalcomplexity, including the relationship toproposed and existing regulatoryrequirements:

P) The estimated resource burden onthe NRC assodated with the proposedbackfit and the availability of suchresources:

(8) The potential impact of differencesIn fadlity type. design or age on therelevancy and practicality of theproposed backfit

(9) Whether the proposed backfit isinterim or final and. it interim. theustiiication for Imposing the proposedackfit on an interim basis.(d) No licensing action willbe

withheld during the pendency ofbackfitanalyses required by the Commission'sruleL

(e) The Executive Director forOperations shall be responsible forimplementation of this section and allanalyses required by this section shallbe approved by the Executive Directorfor Operations or his designee.

4. In Appendix 0 to 10 CFR Part 50. anew section (8) is added to read asfollows:

Append)x 0-Standardization ofDesign; Staff Review of StandardDesigns

6. Information requests lo the approvalholder regarding an appfoved design shall beevaluated prier to ieeuenee to ensure that theburden to be imposed on respondents ialuetfffed tn view of tbe potential safetysignificance of the Issue to be addressed intbie requested information. Each sucheveiwtion performed by the NRC staff shallbein accordance with 10CFR 5054(fl end~ hall be approved by the Executive Directorfor Operations or hie or hcr designee prior toissuance oi the request.

r

PART 2-{AMENDED)

5. The authority citation for Part 2continues to read as follows:

Aulbority:Sees. 181. 181. 88 Sian 94L 953.ae amended (Cz US.C 2201, 2231): ece. 191. aeamcndc*pub. I 84-615. 76 Sfah 408 (42

NUREG-1409 16 hppt.'tttjtx A

Federal Register / Vol. 50. No. 183 / Fridav. September 20. 1985 / Rules snd Regulations 38113

U.S.C. 2241): sec. 201. 88 Stet. 1342. asamended (l2 US.e 5841): 5 US.e 552.

Sec. 2.101 es issued under secs. $252 63.81.101. 104. 10$ . 58 St 4 1. 930. 032. 932 93$ . 035.037. 038. es emended (42 U.S.C. 2073. 20922092 2111. 2133. 2134. 21 3$ ): sec. 102 Pub. L01-190. 63 Stet. 6RI. es emended (42 U.S.C.4332l: sec. 301. 88 stat. 1248 (42 U s c. $871).Secltons 2.102. 2153. 2104. 2.10$ . 2..21 alsoissued under secs. 102. 103. 104. 10$ . 183.189.65 SI ~ I. 036. 037. 035.QSl.0$ $ . as emended (42US.e 2132. 2132'2134. 213$ . 2233. 2239).Section 2.15$ also issued under Pub. L 97-41$ . 06 Stat. 2073 (42 US.e 2230). Sections2200-2206 ebo issued uhder secs. 165. 234.68 Stet. 0$5. 83 Stet. 444. as emended (42US.e 223IL 2252): sec 2aa 65 Stet. 1246 (42US.e $846). Sections 2300-2309 also issuedunder Pub. L07-4 1$ . 96 St ~ t. 2071 (42 U.S.C.2133). Sections 2800-2605 also issued undersec. 102. Pub. L QI-190. 83 Stet. 8$3 esamended (42 US.e 4332). Sections 2.7oas.2.781 also Issued under 5 U.S.C. $$4. Sections2754.27frL2770.2780slso Nsued under5US.e 557. Section 2790 ebo issued undersec.103.68StsCQM. as amended (42 USe2133) end 5 US.e $52. Sections 2600 and2808 ~ lso issued under S US.e 5$3. Section2809 also Issued under 5 U.S.C. 553 end sec.29. Pub. L8$-2$L 71 Stat. 570. as amended(42 US.e 201Q). Appendix A also issuedunder sec.6. Pub. L QI-58L 84 Stet.1473 (42US.e 2135).

6. Section 2204 is revised to read asfollows:

52204 order for modlftcatton of license.

The Commission may modify s licenseby issuing an amendment on notice tothe licensee that the licensee msydemand a hearing with respect to sll orany part of the amendment withintwenty (20) days from the date af thenotice or such longer period as thenotice msy provide. The amendmentwillbecome effective on the expirationof the 204(sy period during which thelicensee may demand s hearing. If thelicensee requests s hearing during this20-day period. the amendment willbecome effective on the date specifiedin an order made following Ihe hearing..When the Commission finds Ihst Ihepublic health. safety. or interest sorequires. the order may be madeimmediately effective. Ifthe amendmentinvolves s bsckfit. Ihe provisions offi 50.109 of this chapter shall befollowed.

Dated ~ I Washington. D.C Ihi~ 17th dey ofSeptember. 108S.

For the Nuclear Regulatory Commission.Samuel I. Ch Uk.

Secretory ofrhe Comm asian.(FR Doc. 8$-2%72 Filed 0-10-5$ : 6NS em)~«Kleo COOK 1$ 00444I

DEPARTMENT OF EALTH ANDHUMANSERVICE

Social Security Ad Inistration

20 CFR Part 404

lRegutsuon No. 4)

Federal Old Age,Disability InsuranImpairments —Me

Correction

rvlvara, and; Ustlng ofal Disorders

In FR Doc. 85-2035038 in the issue28.1985, make the

l. On page 35040seventh line from tshould read "or".

2. On page 35044fourth Comment. siword -only- betwe

3. On page 35045third Comment. six

'ead "be".4. On page 35046

fourth Comment. sbottom. "patient's""patients".

5. On page 35048second Comment.should raid "large'.

On page 3M49ftrst Response. Iweshould read "nece

7.0n the same pin the first Respanthe bottom. -indivi-individuals-. Als"12.04,Menral Rcr-120S Mental Ref

L On page 35068complete parsgra preed "inc)ude".~ ILKOIO COOK 1~1M

2 beginning on pageWednesday. August)lowing corrections:third column ~

e bottom."of'rst

column. in theth line. insert then "if'nd-one".third column. in Iheh line, "by" should

first column. in theond line from thehould read

first column. in thcrst line. -larger-

first column. in thefth line. -necessary"srily".ge, second column.. second line fromusl- should readin the third column.ation" should readation".

third column. first. "including- should

20 CFR Part 404

Social Se'curity elite; Coverage OIEmpioyeea of Prl te NonprofitOrganizations, W k Outside UnitedStates, Etc.

Correction

In FR Doc. 85-2136571 in the: issue9.1085.make thc f

Onpsge3857? fOATES paragraph:

1. In the Arst andate of publicstio-September 9. 1

2. In the eleventshould have read

'lLUNCCOOK ~ 54'

21. beginning pageMonday. Septemberlowing corrections:st column. in the

second lines, "(insert" should have read

line "received"eceive".

Food snd Drug A

21 CFR Part 520

Inistration

Oral Dosage FormNot Subject To Ce tMegtumine Paste

*aENcv: Food sndAOTICN: Final rule.

ew Animal Drugsification; Flunixin

rug Administration.

SIIMMANYIThe FooAdministration (animal drug regulaapproval of s newapplication (NADCorp.. providing fopaste. The paste isto alleviate inflsmInusculoskeletal diEFFECTIVE OATE: SFOII FURTHElt INFOSandra K. Woods.Medicine (HFV-llAdministration. 5Rockville. hlDSUPPLEMENTAIIYINSchering Corp GaKenilworth. NJ 070137-409 for Bsnsmmeglumine). Flunifor the alleviationpain associated widisorders in horsesapproved snd thesmc:nded to reAectbasis for approvalfreedom of inform

In accordance winformation

provis'FR

Part 20) snd fjCFR 514.11(e)(2)(ii)safety snd effectivinformation submiapproval of this spin the Dockets Ma(HFA-305). Food 8Administration. RLane. Rockville. Mto 4 p,m.. Monday

The agency hssCFR 2524(d)(l)[AI)16636) that this sctdoes not indtvtdushave a significantenvironmenb Thercnvtronmentsl assenvironmental imrequired.

List of Subjects inAnimal drugs. or

Therefore. underDrug. and Cosrnetiauthority delegateaf Food snd Drugsthe Center for Vete520 is amended as

snd Drug) is amending Ihe

ons to reAectnimsl drugfiled by ScheringAunixin meglumincor oral use in horsesstion snd pain fromorders.tember 20. 1085.ATION CCINTACT:

enter for Veterinary). Food snd Drug

Fishers Lane,~ 301~3-3420.oIIMATIotcTheoping HillRd.3, has filed NADAc Paste (Ilunixin

n meglumine paste isinAsmmstion andnuts culo skeletal

The NADAisgulstions arehe approval. Thediscussed in the

ion summary.h the freedom ofns of Part 20 (2114.11(e)(2)(ii) (21a summary of

ness data snded to supportlication msy be seengement Branch

d Drug4-62. 5600 Fishers20857. from 9 a.rn.rough Friday.tcrmined under 21

April26. 1985: 50 FRn is of a type that

y or cumulativelyfeet on the humanore. neither ansment nor an

p ct statement is

CFR Part $20

I use.

he Federal Food.Act snd underto Ihe Commissionernd redclegated toinsry hiedicine. PartI(owe:

Appendix A 17 N U I<I:Ci-(409

APPENDIX B

THE 1988 BACKFITRULE

NVREG-14D9

Federal Register / Vol. 53. No. 108 / Monday, June 8, 1MS / Rules nnd Regulations 20603

Guatemalan Seerdino s

Ajax ta-T)Taylor

Booth 3.

WC

Srookshte

TABLEI~nulf

3rd Mon1st Mon BcplI IM CNI1st Mon Sept3rd MonIn Man Sept2nd Mon Sept3rd Mon2nd Mon2nd Mon Sept3rd Man1st Mon2nd Mon4th Man Sept3rd Mon Sept4th MOn3rd Mon Ocl~Ih CNC OCI4 th Man Sept4th Mon Sept4th Mon Sept2nd Mon4th Mon1st Mon3rd'Ill Oal3r Oct

M OCC«d M CNCNd M INI4h Mon OcL2nd Mon Ocl3nl Mon Ocldih Mon1st Mon Nov3rd Lion Nov1st Mon Oec3rd Mon Dec2nd Mon Nov4th Lian Nav2nd laon Nov4th Mon Nov3rd Mon Nov1st Mon Dec2nd Mon Dec3rd Mon Deo4th Mon Dec2nd Mon Jan4th Mon Jan2nd Mon Deo~2hl O2rd Mon Deo~IhM ONdM I5th Man

EtienNs asnad

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W')

121$13322412105

le3024151210td25

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14la1412181412le14ld202420101012

"12101210Ibld141210131112100

13

I4IId

ddt 2/154-5/ tb3-an 03 1/10

2-14/ te3-tone4-3/15

3 ts/Ib3-0/163 1/15

3~/10~/104 lnd

3 land3 1 ~Itb3 10/103 14nb3-0/18~/td'30/10~nb

3 11/103-ldnd

3NT/103-lane~/Id

3-2/16~/1634M15

3-12n84-3/m4 1/ld

3 ta/td3-0/10

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3 12nd3-10/16~/103 0/10

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3-0/ td

vocados ol the west Indian type vadeses and 0» west bxsan type seedsnss not fated elseoshere In Table LAv/cados ot ere Guaternahn type vadeses, hybrid vanebes. and unidentdced se«snss not sated elsewhere h Tales L

Dated:Robert C.

Deputy DiDiriaio/LlFR Doc.

arLLbro

ay 31. 195Leeaey,c/or. Fiuiiand Vegetable

12551 Filed 5-3-I: 8:4$ aml

NUCLEARREGULATORYCOMMISSION

10 CFR Part 50

Revision of Backflttjng Process forPower Reactora

AGEHcv: Nuclear RegulatoryCouiniisslonACTIOtn Final rule.

suMMAnv:The Nuclear RegulatoryCommission is promulgating an

amended rule which governs the,beckfitting ofnuclear power plants. Thisaction is necessaty In order to have a

backfit tule which unambiguouslyconforms with the August 0, 1992

decision of the U.S. Court of Appeab forthe District of Columbia In Union ofConcerned Scientists. et ei v. U8.2Nuclear Regulatory Commission. Thisaction ls Intended to clarify wheneconomic costs may be consMered inbackfit ting nuclear power plants.,EFFEDTlvE DATE: July 5, 198L

Appendix B NUREG-1409

20804 Federal Register / Vol. 53, No. 108'/ Monday, June 8, 1988 / Rules and Regulations

FOR FURTHER INFORMATIONCONTACl,Steven F. Crockett, Office of the GeneralCounsel, U.S. Nuclear RegulatoryCommission. Washington, DC 20555.Phone: (202) 492-1$ XL

supplEMENTARY INFoRMATIolc

Background

, OnSeptember20.1985,afteranextensive rulemaking proceeding whichincluded sequential opportunities forpublic comment on an advanced noticeof proposed rulemaking (48 FR 44217;September 281983) and a notice ofproposed rulemakfng (49 FR 47034;November 30, 1984), the Commissionadopted final amendments to its rulewhich governs the backfitUng of nuclearpower plants, 10 CFR 50.109 (50 FR38097; September 20,1985). Backfittlng lsdefined In some detail in the rule, but forpurposes of discussion here lt meansmeasures which are directed by theCommission or by NRC stafE In order toimprove the safety of nuclear powerreactors, and which reflect a change In aprfor Commission or staff position onthe safety matter fn question.

judicial review of the amendedbackfit rule and a related Internal NRCManual chapter which partiallyimplemented It was sought an* onAugust 4, 1987. the U.S. Court ofAppeals for the DC Circuit rendered itsdecision vacating both the rule and theNRC Manual chapter whichImplemented the rule In part. UCS v.NRC, 824 F.2d 103.,The Court concludedthat the rule, when considered alongwith certain statements in the rulepreamble published in the FederalRegister, did not speak unambiguouslyin terms that constrained theCotrunlssion from considering economiccosts fn establishing standards to ensureadequate protection of the public healthand safety as dictated by section182ofthe Atomic Energy Act. At the sametfme. the Court agreed with theConunisslon that once an adequate leveloE safety protection had been achievedunder section 182. the Commission wasfullyauthorized under section 181i of theAtoinicEnergy Act to consider and takeeconomfc costs Into account In orderingfurther safety improvements. The Courttherefore rejected the position oEpetitioners in the case. Urdon ofConcerned Scientists, that economiccosts may never be a factor In safetydecisions under the Atomic Energy Act:'ecause the Court's opinion regardingthe circumstance's fn which costs maybe considered in making saEetydecisions on nuclear power plants wascompletely in accord with theCommission's own policy views on thisimportant subject, the Commission

decided not to appeal the decision.instead, the Commission decided toamend both the rule and the relatedNRC Manual chapter (Chapter 0514) sothat they. conform unambiguously to thcCourt's opinfon. On September 10, 1987,the Commission published proposedamendments to the rule (52 FR 34223)and provided for a comment periodending on October 13, 1987.'he finalrule as set out fn this document fssubstantially the same as the proposedrule (52 FR 34223; September 10, 1987).

ln'this rulemaking the Commissionhas adhered to the following safetyprinciple for all of lts backfittingdecisions. The AtomicEnergy Actcommands the Commission to ensurethat nuclear power plant operationrovidcs adequate protection to theealth and safety of the public. In

defining. redefining or enforcing thisstatutory standard of adequateprotection, the Commission willnotconsider economic costs. However,adequate protection is not absoluteprotection or zero risk Hence safetyimprovements beyond the minimumneeded for adequate protection arepossible. The Commission ls empoweredunder section 181 of the Act to impostadditional safety requirements notneeded for adequate protectfon and toconsider economic costs in doing so.

''The 1985 revfsion of the backfit rule,

which was the subject of the Court'sdecision, required, with certainexceptions, that backfits be imposedonly upon a finding that they provided asubstantial Increase ln the overallprotecUon of the public health andsafety or the common defense andsecurity and that the direct and indirectcosts of implementation were justified inview of Ibis Increased protection. Theamended rule, set out In this document,restates the excepUons to thisrequfrement for a finding, so that thcrule willclearly be in accord with thesafety principle stated above.

~ In ua comments oa Ihc ptoposcd amcndtnenis.the Union of Concerned Sdcniisis ssutis that theFedetst Regbiat aoiice of Ihe ptupoudamcndmeatAvas Icchaftaiiy defective. UCS atguesIhai ~Ince the Court had vacated Ihc cnibe tufa. IheFedetsi Regbiet noses should have ptoposedenactment ofan enute. amended. tub. rather Ihsnsimply emendmenis Io Ihe vacated ndc. In weighiagthe Iechnkat metli oi UCS'rgument iishould benoied thai es of the date of the Federal Rsglsistnotice. the mandate of the Conti had not yet isswdand the nde was thus siiiilegally In effectHowever. the mote Impatient contldctason 4 thaiIhe notice deatiy tevcaicd Ihe Commission's Iaicaiio tab sue the bcekfuI rulc once iibad beenconformed io Ihe Conti's dedsbtaUCS understoodIhb hieni and took the oppotiuniiy Io resubmit theooauacnis ithad submitted during the tulemakingleading up Io Ihe I955 tevision of the ndc. In enyevent. the Commbs ion is pubiisMng Ihe caste tuleia Ihi~ document.

Particularly in response to the Court'sdecision, the ru)e now provides that Ifthe contemplated backft t involvesdefinlng or redefining what level ofprotection to the public health and

'afetyor common defense and securftyshould be regarded as adequate, neitherthe rule's "substantial increase"~ tandard, nor Its "costs justified"standard. see 5 50.109[a)(3). Is to beapplied. (See $ 50.109(s)(4)(iii).) Also inresponse to the Court's decision. see 824Fdd at 119, thc rule now also explicitlysays that the Commission shall alwaysrequire the backlit ting of a fscffftyifItdetermines that such regulatory action lsnecessary to ensure that the facility

rovides adequate protection to thesaith and safety of the public and is in

accord with thc cotnmon defense andsecurity.

On instruction from the Commission,the NRC staff has amended its Manualchapter on plant. specific backfittfng toensure consistency with the Court'sopinion. Copies of the revised chapterare available for public inspection In theCoirunission's Public Document Room,1717 H Street NW Washington. DC20555.a

Response to Comments

Comments were received from 12utilities, one Federal agency (DOE), onevendor, seven individuals, sevencfUzens'roups. and two industrygroups. Lengthy and detailed commentswere submitted by the Union ofConcerned Scientists (UCS) and theNuclear UtilityBackfitting and ReformGroup (NUBARG).Both organizationswere active in the ruleinaklng which ledto the 1985 revision of the rule. Thecomments submitted by these twogroups encompassed most of thecomments made by others. Below, theCommission paraphrases the chiefconunents and responds to them. TheCommission has given carefulconsideration to every comment. Theoriginal comments may be viewed in theNRCs Public Document Room fnWashington, DC.

s Sevetai coauneniets etgue thai the tevbedManual chapter shouidundetgo what amounts Ionotice and conuueni tuicmakiag. Mowevct. theManual chspiet. ifIIIs a ndc at alL Is a tule of~ gcncy otganiseuon. pmcedute. or ptsciice. andIhetvfote is noi sub)cot Io Ihe noses end commenttequttemcnis of the Adminisitsiive ptocedute Aci.See 5 IkSC. 5$$(b)(Ak see ciao I 5Q(a)(Z). TheCommiulon did pubiish for comment an catiietvctsion of Manual Chap(ct (s9 FR ICOOk AprilZtt195chbui Ihai vetsbn was already ia affect when IIwas pub))abed forcomment. and itwas publishedfofcomment only because Iha Commission was siiQIn the ptocess of making fundament ~I changes IoIhe bstkfftung ptoceu and wanted commeai on Iheptocedutes then ia affect. See Id.

NUREG-1409 Appendix B

Federal Register / Vol. 53. No. 108 / Monday. June 6, 1988 / Rules and Regu)aflons ZD605

"Adequate ProtecUon

The great majority of the commentersraised issues about the rule's use of thephrase "adequate protection". Thisphrase is used in the rule's exceptionprovisions. See $ 50.109(a)(4). Generally.the rule requires. among other things,that it be shown for a given proposedbackfit that implementation of thebackiit would bring about a "substantialincrease" in overall protection to publichealth and safety. and that the directand indirect costs of the backfit are "

justiflied by that substantial increase.See 5 50.109(a)(3). However.5 50.109(a)(4) also requires that thesetwo standards not be applied in threesituations:

First, where the backfit is required tobring a facility into compliance withNRC requirements or the licensee's ownwritten commitments:

Second. where the backfit lsnecessary to ensure that the facilityprovides adequate protecUon to thehealth and safety of the public and is inaccord with the common defense andsecurity: and

Third. as noted above, where thebackfit involves defining or redefiningwhat level of protecUon to the publichealth and safety or common defenseand security should be regarded asadequate.

The comments on the rule's use of the.phrase "adequate protection" generallytook two forms, each discussed morefullylater on in this notice. The firstform, most fully represented by

UCS'omments,was that the rule itselfshould actually (nclude a delin(Uon of-adequate protection" (the final rule setout In this document does not). a phrasenowhere explicitly defined in generalterms. either in the Atomic Energy Act,from which the phrase comes. or in thefromm(go(on's regulaUons.

The second. more modest. form of thecomments on "adequate protection".most fullyrepresented by NUBARG'scoinments. was that one or another ofthe three. exception provisions ln therule was redundant (none ls). While notamounting to a call for a definition of"adequate protection", NUBARG'scomments displayed some of

UCS'ncertaintyabout what the Commissionmeant by the phrase.

Each group had difficultyapplying thephrase to characterize past Commissionaction ln backfitting. UCSclalmed thatthe Commission had never backfitted lnorder to achieve something beyond"adequate protection." NUBARG, .

however. claimed that the Comnt(salonhad never required a backfit on thegrounds that compliance with theregulations was not enough to provide

adequate protecUon. These views.differing ln emphasis, reflect the twogroups'pposite concerns about thepossibility that the Commission woulduse the phrase "adequate protection"arbitrarily. UCS is concerned that theCommission might interpret the phrase"adequate protection" to refer to a levelof safety such that every proposedimprovement would be subjected tocost. benefit analysis. Conversely, theIndustry appears concerned that theCommission might Interpret the phrase"adequate protection" to refer to a levelof safety such that no proposedImprovement would be subjected tocost. benefit analysis.

The Commission certainly did notintend that this rulemaking should focuson the meaning of the phrase "adequateprotection". The main point of thisrulemaking was s(mply to negate themislmpregslon left by two statements lnthe preamble to the 1985 version of thebackfiit rule. UCS puts forward twogrounds for its emphasis on the phrase"adequate protection". First, UCSasserts that "(t)he crucial decision as towhether cost benefit analysis willbeused in assessing the need forbackfitting ls dependent on whether theparticular backfitting underconsideration ls needed to ensureadequate safety ' '"Second. UCSclaims that the Court "ordered- theCommission to "stop trying to obscureits intentions through ambiguous andvaguelanguage' '"

However, as willbe explained more ~

fullybelow, the Court's dec(sion turnednot on the rule's lack of a definition of"adequate protection" but rather on twostatements which seemed to the Court toimply that the Commission intended totake costs Into conslderabon indetermining what -adequate protection"required: the meaning of "adequateprotection" was simply not an Issue Inthe litigation. Moreover. UCSoverestimates the role the phraseadequate protection" plays in the

backfit rule. The threshold decision inconsidering a proposedbackfit, and veryoften the only d eels(on that need bemade,a is not whether adequateprotection is at stake but rather whetherthe facility Is in compliance with theCommission's requirements and thelicensee's written commitments.

Even ifUCS ls right about thebnportance of the phrase "adequateprotection", there is nothing unusual or

~ For instance. a malodty of the piant~c .,bachfits carrfcd oui during the first year aber thetoss re:~" orihc bachfit ndc became cffccavewere for the sate of compliance. Sce SECY~Eve faction of hta nsging Pie ni Speci fic EachfiiRequirements (November Zl. Isac), Enclosure I.

Imprudent, and certainly nothing Olegal,about decisions which ultimately turnon the application—by duly constitutedauthority and after fullconsideration ofall relevant information-of phrases

>which are not fullydefined. Cons(daricfor instance, the "reasonable assurande"determination the Commlsgionmust r

make before issuing an operaUnglicense.a Indeed. most of theCommission's rules and regulations areultimately baaed on unquantified and, aswe note below, presenUy unquantifiableideas of what constitutes "adequateprotection".

Were there something peculiarly ~

critical about the role of "adequateprotection" in the backflt rule. the issueof the phrase's meaning could have beenraised in the rulemaking for the 1985rule. Two of the three exceptionprovisions set out above were in the1985 revision of the rule. where theyused the equivalent phrase "undue risk"Instead of "adequate protection". Also.as the Court in UCS v. NRC noted. 824F.2d at 119, the statement ofconsiderations which accompanied the1985 version of the rule quite explicitlyat least twice limited the considerationof costs in backfitUng decisions to

«situations where "adequate protection"was already secured a

Nonetheless, an issue which Is aconcern of almost every commenter inthis rulemaking should not be Ignored.Therefore, the Comnugsion willansweras best it can the questions thecommenters have ra(sed concern(ng therule's use of the phrase "adequateprotection". We begin with UCS'all foran objective and generttlly applicabledelinition of "adequate protection". Weargue that such a definifion Is notpossible In the near future, but that thepublic and licensees are nonethelessprotected against misuse of the phrase.

'n

the course of responding toUCS'omments.we shall. of necessity, be

making at least preliminary,responses tomost of NUBARG's comments also.

UCS argues that the rule permits theagency to escape its legal responsibility

a"' '(A)nopcreting)icenscmeybeiswedbythe Commnsion' upon finding that'

't)hereIs reasonable aswrance ' that the- activities authorised by the operating license can be

conducted without endangering the hcaith andsefetyofthepubrrc' . tocfRgsgr( ~)(gb '.

~ Ibe consMeration and weighing of costscontempfaied by 0» wic applies to bachfits thaf ereIntended lo result In Incremental safety IImprovement ~ for ~ pfsnl thai already provMes an~ cccpiabie degree ofproiection(.)" so FR ssNL coLn abo. (t)he cost ~ assodated with proposed newsafety requirements msy be considered by theCommission provided that the Atomic Energy hiafinding 'no undue rtsV can be made." M. ai sat trLcoL s.

Appendix B NUREG-1409

20606 Federal Register / Vok 53, No. 108 / Monday, June 6. 1988 / Rules and Regulations

to articulate the factors on which itbases its backfitting decisions. UCSasserts that the rule should "enunciatecriteria and guidelines about whatconstitutes redefining and defining

'adequate protection levels, whatconstitutes an adequate as opposed to abeyond adequate protection level, andwhat factors place a particularcircumstance within the rule or withinthe exceptions," Another commentasserts that any definition of "adequateprotecUon" should Include the resolutionof all outstanding safety issues. Yetanother calls for "objective criteria","some real numbers" on releases,accident consequences, and the like.

There does not exist, and cannotexist, at least not yet, a generallyapplicable definition of "adequateprotection" which would guard againstevery possible misuse of the phrase.Congress established "adequateprotecUon" as thc standard theCommission Is to apply in licensing aplant. see 42 U.S.C. 2232(a), and gave theCommission authority to issue rules andregulations necessary for protection ofpublic health and safety, see 42 U.S.C.2201. but Congress did not define"adequate protection", nor did itcommand the Commission to define lt.

Such a definition would have to takeone of two forms, one of them incapableaf preventing the abuses thecommenters are concerned about. andthe other simply not possible yet. Thefirst of these would be a verbaldefinition of the kind encountered in, forinstance. the various "reasonable man"standards in the common law. After the

pattern

of these, the Commission couldsay, correctly, that "adequateprotection" is not zero risk, that It is thesame as "no undue risk", that it haslong-term and short-term aspects, andthat it Is that level of safety which theAtomic Energy Act requires for initialand continued opera! Ion of a nuclearpower plant. However, such a definitionclearly willnot. of Itself, prevent theabuses VCS and NUBARG areconcerned about. nor is such a"standardsufficiently helpful to the NRC staff inactual practice.

Thus, Ifthere ls to be a useful andgenerally applicable definition of"adequate protection", It must takeanother, more precise farm, namely,quantitative. Several of the commentersseem to have such a definition in mindwhen they call for "objective criteria".

~

~

ome "real numbers", and the like. Insct. the Commission ls actively

pursuing reliable quantitative measuresof safety. and some quantitative andgenerally applicable definition of"adequate protection" may eventually

emerge as a byproduct of theCommission's efforts, still in their carlystages, to implement its general safetygoals, which take a partly quantitativeform. (See 51 FR 30028; August 21. 19M.Policy Statement on Safety Goals.)However. given the state of the art inquantitative safety assessment, it is notreasonable to expect that theCommission could make licensingdecisions —!et alone decisions onwhether to consider coat In backfittlng-wholly on a quantitative definIUon of"adequate protecUon". Surprisingly,some of the commenters who cell for"objective criteria". "some realnumbers", and the like. have in the pastcriticized quantitative risk assessments.

Nonetheless, even ln the absence of auseful and generally applicabledefinlfion of "adequate protection", theCommission can still make soundjudynents about what "adequateprotection" requires, by relying uponexpert engineering and scientificjudgment. acUng in the light of allrelevant and material information. AsUCS Itself said in its comments on theproposed 1985 revision of the rule,"(u)It!mately. the determination of whatstandards must be met In order toprovide a'reasonable assurance that thepublic health and safety willbeprotected comes down to the reasonedprofessional judynent of the responsibleoflicial."

The Commission's exercise of thisjudynent willtake two familiar forms.of which the most Important Is rule andregulaUon. An essential point of theCommission's having regulations Is toflesh out the "adequate protection"standard entrusted to the Commissionby Congress. See UCS v. NRC. 824 Fddat 117-1L Exercising engineering andscientific judgment in the light of allrelevant and material information, theNRC identifies potential hazards andthen requires that designs be able tocope with such hazards with sufficientsafety margins and reliable backupsystems. RegulaUons and guidancearrived at in this way do not, strictlyspeaking, "define" adequate protection.sinqe there willbe times when thc NRCissues rules which require somethingbeyond adequate protecUon.Nonetheless, compl!ance with such

'regulations and guidance may bepresumed to assure adequate protectionat a minimum. As the Commission hassaid onmany occasions, compliancewith the Commission's regulaUons andguidance "should provide a level of

, safety sufficient for adequate pro)ectionof the public health and safety andcommon defense and security under theAtomic Energy Act." (49 FR 47034. 47038.

col. 2. November 30. 1984, proposed 1985rule: see also 50 FR 38097,38101, col. 3,September 20, 1985, final 1985 rule; 51 FR30028, col.1. August 21 ~ 1988, PolicyStatement on Safety Goals.)

Because "adequate protection" Ispresumptively assured by compliancewith the regulations and other licenserequirements, all the versions of thebackfit rule—the 1970 rule, the 1985 rule.a'nd the one set out in this document, see5 50.109(a)(4)(i)-have a -compliance"exception: plants out of compliance maybe backfitted without findings of"substantial increase" in protection or a"jusUfication" of costs.

However-and here is where the lackof a general definlUon for "adequateprotection" poses a challenge-"adequate protection" is onlyprcsumpUvely assured by compliance.As the Commission said in promulgatingthe 1985 revision. the presumption maybe overcome by, for instance. newinformation which indicates thatimprovements are needed to ensureadequate protection. (50 FR 38101, col.3.) Such new informatfon may reveal anunforeseen stgnificant)razard or asubstantially greater potential for aknown one, or Insuflicient margins andbackup capability. Engineering judgmentmay. In the light of such information,conclude that restoration of the level ofprotection presumed by the regulationsrequires more than compliance. Thusboth the 1985 revision and the revisionbelow contain exemptions for backfitsnecessary to assure -adequateprotection". or, as the 1985 ruleequivalently said, "no undue risk". See550.109(a)(4)(II) of the rule set out In thisdocument.

Ifcompliance does not assureadequate protection, the Commissionmust be able to determine how muchmore protection is required, and aprecise snd generally applicabledefinition of "adequate protection"would facilitate that determination. Butsuch a definition would have only alimited role to play. The first and mostcrucial quesUon b whether the proposedbackfit is required to bring a plant Intocompliance. Only if the proposed back!itrequires more than compliance withNRC regulations and license conditionsneed there be a determination as towhat "adequate protection" requires.Given this relation between complianceand "adequate protection", the industrymight be more concerned than UCS Isabout the lack of a general delinition of"adequate protection", for UCS willatleast have the comfort of knowing thatcompliance willbe secured before costls considered. but the industry cannot be

NUREG-1409 Appendix B

Federal Register / VOL 53, No. 108 / Monday.'June 8, 1988 / Rules and Regulations '. 20607

sure how much more than compliancemay be asked of it despite the cost. "

Where, as in the cases contemplatedby the second exception provision of therule, morc than compliance is requiredand quantitative criteria do not def)ne"adequate protection", the agency mustfall back on the second familiar form inwhich engineer(ng judgment is exercised

.by the Commission, namely, case by.case. Administrative agencies are notrequired to proceed by rule alone, forthe method of case.blase judgment lsquite capable of meeting therequirement that the factors on whichadministrative decisions are based be

,articulated. Rather than proceeding byan almost ministerial application of"object tve criteria", the Commissionmust fashion a series of case by~sejudgments Into a well-reasoned andfactually well.supported body ofdecisions which, acting as reasonedprecedent, can control and guide theCommission's exercise of the discretiongranted it by Congress in precisely theway in which common law precedentscortrol and guide the common lawjudge's exercise ofhls or her judgment.Sce Nader v. Ray, 383 F.Supp. 946. 934-55 (D3).C. 19i 3) (determining whetconstitutes adequate protection calle forexercise of discretion In a judgmentalprocess very different from acting inaccord with a clear, non-discretionary "

legal duty).The Commission foresaw the need to

proceed case-by-case on occasion andtherefore made It a princ)pal aiin of thebackfit rule to central(ge theresponsibility and document the basesfor case-by. case decisions for suchdecisions. The Commission therebyhoped to better assure that suchdecisions as might of necessity be case-bywase would form a reasoned ardcoherent body.4

~ UCS slieges thai in three Instances iheCommission has abused Ih disctvUcn by applying

'ostconsidetauons in specific ccses whetelicensees are In comp!lance bui adcquaic piolecuonls al slake. Howevtt. UCS is misinfotmtd shoal thefirst of Uie Ihtce cases. and iis ai!ego uons about theother two tedact simple io dlsagieeevni over «hoiconstitutes sdequaie ptotcdion. Lye bticflydiotvas

'hethree cases below.'Ung stadt ioumsl aruclcs which quoie unnamedNRC ooutcts, UCS deims ihal the back liindecaused ihc NRC etc 9 io change iis mind abouistqviring two licensets io Candu@ cctialnInspeciions end anslyseo In order io iusufyconanved opetaiions. The iwo pianis ln quesuon ~

hod tee ciot puep coolani she fm simile t io ones«hlch elsewhere had shown ~ Idgh probabaiiy of~headng offundec ct tie in condiuons. UCS assertoIhsi "Iw)e ' 'earn (tom this example theInhtttni loc'k of logic and circularity embedded Inthe ru!m sRC lo prevenieiL by opetauon of the tule.from sskhl qvcsuons needed io learn the dhgree ofsisk of ~ Lnown equipeenl problem because ihcy donoik..o» the snswtts In Fuvanc«

NoLIIng in the Court's ruling in UCS v.NRC forbids the Commission's approach

Howevtt. Ihe fade of the sliuaUcmt weunciwhat UCS allcges thea io have boom Indeed thehacklli rulc was not hvoived. Lease wee seni onAprU 22. 1246 ttquirlng ihe licensees io submitwithin 2O days Informs Non which would "cnabieihe Comnd stion io dotcnuhe wheihet ot noi (their)license( ~ ) shou!6 be modified." Such hfonnaiionIncluded lnfonnsaon on design. Opetauonil hlstoty,~chedales for inspection. phns for opetaiot etinhg.~ nd "any analysi ~ performed tubs cqueai io ihooedont fot ihc FS*R (Fina! Safeiy Analysis Repoti)which would addtess ihe consequences of a lockedtutus ot bmken shaN event dating planl opttaUon."1 hose letters were seat undec ihe fast part of 10

CFR SL54(lj. This patt outhouses such hfotmauontequcots without consideration of cosL As an t a silatdtafi of the Apdl 22 letter available In the NRC'sPublic Document Room shows. Ihe NRC hadplant& io ask fot new analyses under ihier patiof I IILsc(l)whhh auihothco requests not requitedlo estate adequate ptoiecuon If "ihe bedcn lo bebnposcd ' 's )ustified In view ofihe poitnualsafciy signl!icantu of Ih» Issue io be addressed Inihe tcquesied information." 10 CER SQ4(Q. abls"safety significanc'e siandatd. by iio enphasis on"poienUal". reqvites Iem than!a te aired by the"(aciuml) svbstanual hcres se" «andotd ln Ihebsckfil rule and also avoids iht cbculadty UCS

'

llegts.) Ho«aves. the stan sensibly opicd fot litsiaskhg «heihet such analyses had abcady beendone, In foci they ho*orwere undstway «ticn Ihcloners were scnL 'Ihe backlii su!c played no partbete.

UCS'econd Instance of aBtgcd abuse involvesihe MarL I coniainmtnL shoat «hose petfotmenct .h beyonWss(g..bash accidents (onto whichbivoivc doeogc lo ihc feociot catt) Ihett is~vbsionual uncetiainiy. UCS assert ~ that costconsldctauons have blocked staff acuon whichwouM have brought aboui a slgni5ca ni reduction Inseine of ihc figures whIQI toueaic ihc plobsbllliyihaiihc hfatk I «ouldfsilin cetiahk!Odsofbtyonddtslipv basis ecddcnis. UCS odds in passing0 e I those figures te prese ni undue thk. The hTICsisff hss alteidy made ~ fonna! reply Io simBatchooses of undue the Ses. C.g Boston Edison Co.(higtim Nudest CcnetaUng Station). InhtimDistant's DechionundetIOCER 22ca Dthey-142s NRc sr. 0$-Ioe (Iocrh sidflce lihere io say thaithe NRC staff has by no mesne cenpleied asconsiderauons of the Mcrk I conishmcn4bui that.given present hfoteauoa. Ihc staff hao condudedthat overall scvete~cddent shks ai phnis «tihhie ok I coniahments ate not undue. Id. at 104-letUCS I~ conicni io put fotwatd only unsupportedessetuons io the conitoty. Thus ihe staNmeylegiiieaitlyconsider cost when dtddhg wheihet lobackai she Mstk I conialnmcnh.

UCS'hltd aNega Non of abuse tobaccoes pan ofns Ftbruaty1L Iosr I~MNPCUUon lo theCommioshn for Immed'aie ection io teueveallegedly undue risks po ted by nudcat powerplants designed by tht Babcock a WiicnxCompany.The NRCs Diteciot of Nucleot Rtsdot Regulation

responded tully io she PC UN'enying ILonoctober 1IL 1ssr (UGF commenh on iktptoposedbscLRI tule were subuducd on Ociobct 1$ ). SeeDirector' Dodolon Under 10 CER 22OL Dfhey-IL2s hRC-(October 1s. ItalThe Daeciot amd ad ed

thai "rhett are no tubstanihl bet!Ui and safetyIssues ihai would wanani she susptnshn otrevocation of any license ot pennii fot suchfs dlliiet." Slip Opinion a I Oh Simply becsust UCSdisagrees wnh such condusic ns does nol mean shotthe Commission la misuoiag the adequaieprote:Uon" standard.

to adequate pro'tection". UCS boldlyasserts that the proposed rule ~

*'completelyfail(ed) to comport with theorders and directions of the Court'of:Appcab in UCS v. O'RC", that the Court"could not have been more clear abbutthe defects of the backfit rule" thatjtheproposed revised rule "suffers fromdhe

'xactsame defects" as the one vacited, "

that. Indeed. "the new proposal ls evenmore devoid of objective guidance or-criteria ' 'han was its predecessor."

UCS'riticisms are based on part'of esingle paragraph In the Court's decisioii.In pertinent pa'rt. that paragraph says,"' 'n our view, the backfit t(ng ruIe

"

Is an exemplar of ambiguity ondvagueness; indeed, we suspect that theCommiss)on designed the rule toachieve this very result. The rule doesnot explicate the scope or meaning ofthe three listed 'exceptions'. The ruledocs not explain the action theCommission will(In italics) take when abackfit falls within one of theseexce'ptions. In short. the rule does notspeak in terms that cons!ra(n theCommission from operating outside thebounds of the statutory scheme." (LT4 .

Fdd at 119.'CS

says that this portion of a ~

paragraph was an "order" by the Courtto gct the Commission to "stop trying toobscure Its intentions throughambiguous and vague language'

'."'hether

the Cou:t's! anguage amountsto an "order" or only strong advice, wehave followed it. For one thing. the rule.explicitly says that backfits fal)(ngwithin the exceptions willbe Imposed(inexplicably, UCS asserts that theproposed rule did not have thisprovision). See 5 50.109(a)(4). Foranother, both in what we have alreadysaid. and in what we shall be saying inresponse to NVBARG's comnients onthe exceptions provisions. we shall haveexplicated the scope and n:eaning of thethree listed exceptions.

However. we have not taken thequoted language of the Court to meanthat, after years of making rules andadjudicating cases which ultimatelydepend on the Commission's judgmentabout what "adequate protection"requires, the Comndsslon should beobliged to give a

mechanics))y'pplicable

definition of "adequate ~~

protection" in order to avoid using thetime-honored method of case-by.cake, ~

precedent-guided, judgment toImp)en ent only a pert of the backfi) .rule. Certain)y. the CouH never evennoted a lack of a general deiinition of"adequate protection" in the rule. Iet

'lone"ordered" the Commission toprovide such a definition.

Appendix B'UREG-1409

20MB Federal Register / Vot. 53. No. 108 / Monday. June 6. 1988 / Rules and Regulations

UCS'osition lacks all sense of and "costs justified" standards»RU notproportion. Wc must emphashe Ihe core apply to backfits necessary to provideof the Court's decision, rather then get adequate protection to pubfic health endbogged down by transforming a safety. NUBARG calla this provisionsuspic1on and a few ctIUcisms of the redundant to the exception for backfits,rule into an order to undertake an required for the sake of cornpfiance.unprecedented task of definIUon. 5 SL109(a) [4)[i).As was noted above,'. Reviewing the exceptions in the rule, NUBARG reports that Its research hasand various statements in the Federal 'ncovered no case in which theRegister noUce accompanying the rule. Commfsslon "has recognised that somethe Court said, "We conceivably could additional measures not contained inread the terms of this rule to comply exisUng requirements are necessary towith the statutory scheme we have „~ ensure that a facilitycontinues to meetdescribed above (that Is, a scheme in the current level ofadequacy." Twow!dch economic costs can play no part other commenters believe that thein establhhlng what adequate protection exception provisfon added because ofrequires)." ld. Moreover, the Court says the litigation, 5 5L109[a)[4)(UI). shouldthis despite the lack of any summary, be deleted. as being redundant to thegeneral,"objective" delinltlon of provision NUBARGwould like to see.-adequate protection" ln the nde. delete*

But the Cour t then went on to say. No matter which of the two ptovisfons"Statements that the Commission has the commenter would Uke to seemade In ptomulgaUng the rule and in deleted, the commenter would Uke somedefending it before this court; however. restrictions placed on the use of thedisfncfinc us from fnterpretlag the tul«n remaining one. The restriction by fsr thethh fashion." Id. Again, It fs not the lack most frcquenUy proposed is that noof a dcfinition of adequate ptotecUon action msy be taken under thethat disfncfined the Court from saving temalning exception provisfonla thethe rule, but rather certain statements absence of-significan new Informationthe Commission had made which or the occurrence ofan event whichseemed to suggest that the Commission clearly shows" that the action ismfght consider economic cost whendeciding what adequate protectionrequired. In sum. these commenters either

reopen an issue settled in 1985 or theyThe Three ExcepUons . 'recommend deleUng that part of the nde

Echoing thc Court's remark Uiat 'the which directly responds to the Court's

rule "does not expficate the scope or ruling. We take neither course. for. even

meaning of the three Usted putting the 1985 rule and the Court's'exceotions', id., NUBARG "believes ndlng aside, Ifeither of the two

'hatt)rere is a substantial amount of 'rovisions were to be deleted, anoverlap in these excepUons and that essenUal power of the Commissionthey have not been adequately defined would be remain unimplemented.or explained in the proposed rule." . First, the exception for backfitsNUBARGand others representing the necessary to secure adequate protection,Industry are concerned that the two g 5o.109(a)(4)(U), must be retained,excepfion provlslons which use the because lt must be made clear that

'hrase"adequate ptotecUon"r Commfssion action Is not to bej5 50.109[a)[4) (U}snd (Ul). rusy '- obstructed by cost consideratfons fn a"swallow" the rule. One industry ~ situaUon where complhnce has Indeedcommenter objects to the notion. Impfied proved to be Instdfrcfeat to secure theby $ 5L109(a) [4)(ii), that adequate, Eve} of protection presumed In the rule,protection might requite mote than order. or commlttnent In questiomcompliance. Another Is concerned Ihat Despite the results of NUBARG's5 SL109[a)[4)(iii). the exception w)dc}s research, such sltuaUons have arisen.has been added in response to the . See, e.g SECY-88-341L "EvaluafionofCourt's r«Ung. might lead to. ',Ianaging plant cipecfilc BacMitredefinltions of "adequate protection" Requirements". November 21, 19SLthat wouM threaten loss of Ucenses. i Accordingly, this exception proidsfon fs

To avoid these results, NUBARG aad not redundant to the exception fotothers reconuaend deleting one of the bacUits necessary to restore

'wo

exception provisions which use thc compliance'. Neltherht It reduadsnt tophrase "adequate protection". '. = the exception for backfits involving theNUBARG's choice Is j 50.109(a)(4)(ii). defining or redefining of -adequateretained from Ihe1985 versfon of the i protection", for the latter exceptfonrule, where Itused the equ'!valent assumes some change in the NRC'sphrase.,"no undue risk". This section judgment of what level of

protecUon'rovides

that thc "substantial !acreage" should be regarded as "adequate".

'etainlt.g

$ 50.109[a)[4)(II) wlfinotgive the Commission the power toproclaim at wiU that compfiance ls noteaough. As we said In the statement of

'onsiderationsaccompanying the 1985rule, and have ln part reiterated In theresponse to UCS'omments, theregtdaUons, though they do not define"adequate protection", are presumed toeasure it, and. in the absence of aredefinIUon of "adequate protection",that presumption can be overcome onlyby signUicant new information or someshowing that the regulations do notaddress some significant safety issue."(I)t may be presumed that the currentbody of NRC safety regulatiqns provide'sadequate protection. Where newinformation indicates that Improvimentsare needed to ensure there ls 'no unduerisk'on' 'a'basis whlchtheCommission believes to be the minltyumnecessary, such requirements must beimposed." (50 FR at 38101-102.)

Second, the exception provision forbackfits which are necessary under adefining or redefining of "adequateprotection", Ir SL109(a)(4)(ifi), must beretained because It must be made clear

.that. as the Court held. cost may not bea factor in setting the level of protect! onjudged as "adequate".s As NUBARGacknowledges, clfing Power ReactorDevelopment Co. v. International Unionof Electrical, Radio and MachineWorkers. AH CI0,387 U.S. 3'08(1981), the Commlsslonhas both thepower to define "adequate ptotectfon",and the power to redefine it a Withoutthis last exception provision, lt mightappear from the tule either that theCommission had no such power or thatit was rcstrfctcdby cost considerations,contrary to the Court's tuling. Norshould this exception provision belimited to situations Involving"significant new informaUon," asproposed in several comments.

This last exception may be thought bysome to threaten to swallow the backfittule. We believe. however, thatinstances ofbackfits based on a"redefiniUon" of "adequate protection"wfilbe rare. Moreover, the case by.caseapproach which is required In the

AU i I ISOIWNi l ynonetheless ba a constdcierlon Illchoosing Ihemeans of achieving adequate protecnon .

~ %he vrords defining or re*going" In this thinterr capuon shouM not br construed ncccssarttr tomean providing a uscfut end gcnersttr appiicsbtcdelinlrion". el least not antii such a dcnnlrlonbecomes posstbte. Under present conditions. IheCommisiion sr!It have "defined or redefined vrbatlevel ofprotection ls tobe regarded es adequate" IfIt makes a judgment that. el:hough compliance~ scores the level of protect ton that hed beenthought of as adequate. shet leve1 of protectionshouid no tor4cr be constdercd adequate.

I

NUREG-1409 Appendix B

Federal Register / Vo). 53, No. 108 / hfonday,'une 6, 1988 / Rules and Regulations- 20609

absence of a general definifion of"adequate protection" proi4deslicensees-ond the public-a largemeasure of protection from arbitraryaction by the Commission. Ctttng case ~

law. NUBARG says that, ln applying thislast excoptiort provlslon. theCommission "must act raUonally andconsistently In light ofayallableev'Idence", and "must apply a reasonedanalysis indicating the prior policies andstandards are being changed, not.casually Ignored' ',"We wholly.agree, and believe that the approachenvisioned by the backfit rule will,facilitate the Commission'i actintt

"'ccordingly.r

Other MattersTwo other comments bearing on the

"phrase "adequate protection" require anexplicit response. First, severalcommenters from the industry wouldprefer that the rule state that the"documented evaluation" which theNRC must prepare in connection +9thany action under one of the excepUonprovhions. see $ 50.109(a)(4), shouldInclude consideration of as many of thefactors which 5 50.109(c) requires of a"bscklit analysis" as are appropriate.

The suggested modification of the rulewould have only limited utility.Few ofthe factors listed in 5 50.109(c) of therule are appropriate for consideration ina documented evaluation justifyingaction under the compliance exceptionin the rule. It ls true that several of thefactors in 5 50.109(c), Indeed, eII of thembut those In paragraphs (c) f5) and (7)and some of those in paragraph (c)(8)are appropriate for consideration underthe "adequate protection" excepUon, tothe extent that they require a showing ofexacUy what the licensees must do anda showing that the backfit in question

. actually contributes to safety. However,the Commhsion believes that the rule'srequirement that the documentedeualuat(on "include a statement of theobjectwes of and reasons for themodification and the basis for invokingthe exception" adequately assures thatthe factors in 5 50.109(c) willbeconsidered to the extent relevant,

'ithouttheir being Asted and labeled asIfthey were a part of a 5 50.109(c)analysts. Thus, little, ifanything. Is to begained by an explic!t requirement that5 50.109(c) factors be considered in a,documented ev'aluation. ~

Second, one citizens'roup assertsthat the backfit rule should not apply torulemoking. This issue was thoroughlydhcussed in 1985. However, this group'scomment puts the issue ln a slightly .

altered light. and provides anotheropportunity to clarify the meaning of"adequate protection". The group argues

that since rules "deline" "adequateprotection", the Commission cannotapply the rule's "substantial lacrosse"and "coat justifie" standards in .

rulemaklng without appjylng costconsiderations in setUng the standard ofadequate protection. contrary to theCourt's holding.

The answer to this comment h, of.course, that the rules do not. strictly

'peaking."define" "adequateprotecUon", and they onlypresumpUvbly assure It. Not only maythere, as stated above, be Individualcases that require actions that go

'eyondwhat Is necessary under the .

regulations to assure adequateprotection, there willalso be thnes whenthe NRC hsues a ru!e which requiressomething beyond adequate protection.This follows directly from theCommission's pmver under section 161of the Atomic Energy Act, affirmed bythe.CourL to issue rules or orders to"minimize danger to life or property."See 42 U.S.C.2201; see also USC v. NRC,824 Fdd at 118. Ifa proposed rulerequires something more than adequateprotection,'pplying a cost standard tothe proposed rule willnot be Introducingcost considerations into the setting ofthe adequate protecUon standard and lstherefore permitted. Of couise ifthe rule

's

directed at either establishing whetlevel ofprotection is "idequate- orassuring that such a level of protecUonIs met, then cost willplay no role.

The backfit rule as set out below lssubstantially the same as the ruleproposed in the Federal Reghter. (See 52FR 34223; September 10, 1981.),Provisions which appeared at the end of5 50.109(a)(4) of the proposed rulc, or Inthe footnote to that paragraph. appearbelow In new paragraphs (a) (5) throughP) ~

Environmental ImpocL" CategoricalExclusion

~ The NRC has determined that Qdsfinal rule ls the type of ection describedin categorical exclusion 10 CFR51.22(c) f3). Therefore. neither

an'n>4ronmentalImpact statement'nor anenvironmental assessment has beenprepared for this Anal rule.

Paperwork ReducUon Act Statement

~ This final rule does not contain a newor amended information collectionrequirement subje'ct to ihe PaperworkReduction Act of 1980 (44 U.S.C. 3501 et'seq.). Existing requirements wereapproved by the OfAce of Managementand Budget, Approval Number 3140-0011.

Regulatory Analysis~ The recision to 10 CFR 50.109 willbring It Into conformance with theholding In Union of ConcernedScientists, et al., v. U.S. Nuclear>Regulatory Commission, D.C. Cif. Nos.85-1757 and I-1219 (August 4. 1087).The revision clarifies the backiit rule torefiect NRC practice that, in determiningwhether to adopt a backfit requirement,economic costs willbe considered onlywhen addressing those backfitsInvolving safety requirements beyondthose needed to ensure the adequateprotection of public health and safety.Such costs are not considered whenestab1lshlng the'adequate protection ofpublic health and safety. This revised *

rule does'not have a slgnilicant impact'n

State and local governments andgeographical regions. public health andsafety, or the environment: nor does Itrepresent substantial costs to license~s.the NRC, or other Federal agenci'es. ThisconsUtutes the regulatory analysis forthis rule.

Regulatory FloxibllltyAct CertLrcation

~ In accordance with the RegulatoryFlexibilityAct of 1980. 5 U.S.C. 605(b)the Commission hereby certilies thatthis Anal rule, ifpromulgated. willnothave a significant economic impact on asubstantial number ofsmell entities. Theeffected facilittes are licensed under theprovisions of10 CFR 50.21 fb) and 10CFR 50M. The companies that ownthese facilities do not follwithin thescope of "small entities" as set forth inthe Regulatory HexibilityAct or theSmall Business Size Standards set forthin regulations hsued by the SmellBusiness Adrnlnistration In 13 &RPart121.

Backfit Analysh

The NRC has determined that abackfit analysis ls not required for this .rule because it'does not Imposeiequirements on 10 CFR Part 50licensees.

Ust of Subjoets In 10 CFR Part 50

Antitrust. Class Uied information. Piroprevention. Incorporation by reference,Intergovenuncntal relallons, Nuclear,power plants and reactors. Penalty.Radiation protection. Reactor sitingcriteria. Reporting and Recordkeeplng

~ requirements.For the reasons set out ln the

preamble and under the authority bf theAtomic Energy Act of1954. as amended,the Energy Reorgsnhatlon Act of 1%4,

,

as atnended. and 5 U.S.C. 552 and 553,the NRC is adopting the followingamendments to 10 CFR Part 50.

Appendix B NUREG-1409

ZDSM Foderal Register / Vo). 53. No. 108 / Monday, June 8, 19gg / Rules ard Rcgulatfons

PART 50-DOMESTIC LICENSIN OFPRODUCTION AND UTILIZATIONFACILmES

1. The authority dtation forPart 50 isrevised to read 36 folhws:

huiherittc Secs. 102. 1M, 10l. 1%. 101, 162,183, 168, 1 to. 06 Stc t. 93tL 937, 938, 910, M3,95].955. 958. as amended. ccc. 234. 63 Stat.1244, as amended (42 U S G 2132. 2133. 2134.2135. 2201, 2232, 2233, 2238, 2239, 2282): scca201, as emended; ~~ 200, 88 Stat 1242, asamended, 1244, 1240 (42 US.C. Sttcl. 5842.5848).

Section 50.7 ebo issued under Pub. L9$-0)to scc 10 92 SicL 2951 (42 US.G 5851).Section 5010 alsotscacd ender sec@101.185.LtStat. 938. 955. sc amended (42 US.C. 2131.ESSED scc. 102. Pub. L91-190. 63 StcL 6S3 (42US.G 4332). Sections QL23. 50.3S. 5055. cnd50.50 cbo Issued under scc. 185. 08 Stat. 9$ 5I42 U.S.C. 2%5 J. Sections 50.33c. 50.55s sndAppcndtx Q also bsucd under scc. 10 Pub.L 91-190. 63 Stet. 853 (42 US.G 4332).Sections QL34 cnd 5054 cbo Issued underscc. 204. 88 Sic L 1245 (42 U.RG 5844LSections QL58. Saot. cad QL92 also issuedunder Feb. L97-415,90 SLat. 2%3 (42 US.C.2239l. Section 50.70 also bsucd under ccc.122. 08 Stat. 939 (42 US.C. 2152). SectionQL80 'tL61 also tscvcd under ccc. 10t. 08 Sist.954. cs amended (42 US.C. 2234]. Section50.103 also Issued under ccc. 1tXL 08 Stat. 909.cs emended (42 US.C. 2138)..

Appendix F cbo issued under ccc.18T. 08Stat.9$ $ (42 US,C. 2237).

For thc puiposcs of ccc.~. 08 Stat. 958. asamended I42 U.s.c. 2223); 4 I 50.10 (sl. (bJ.end IcJ. 5044. 50A8. SOA8. 5044. end 50.80(s Icrc bsucd under ccc. 10lb. 08 Stat. 94tL csemended I42 USC. 2'(b)J: 44 QL10 ib) sndic). cad 5044 are 4cuc 6 under ace. 18l 4 08Stat. 949. as amended (42 US.C. 2201(i)J: cnd44 50.9, 50.55(c). 5059(b). 50~ 50 tLQL22.50.23. sod QLre crc 4cucd under scc. lalo,caSist. 950. as emended (42 U.S.C. ~(o) J.

2. Section SIL109 h revised to read aafolhwsr

$ 50.109 Bsckflttln9.(e)(1) Bsckfitting is defined as the

modification of or addition to systems,structures. components, or design of 8facility:or the design approval ormanufecturhg license for a facility;orthc procedures or orgenhatlon requiredto design. construct or operate 8 facility;any of which may result froin a new oremended provision ln the Commissionrules or the Imposition of8 regulatorystaffposition interpreting theCommfsslon rules that is either new ordifferent from 8 previously applicablestaff position after.

(i) The date of Issuance of theconstruction permit for thc fedlity forlicilitleshaving construction permitsIlsucd after Oclober 21, 1985: or"(ii)Stx months before the date ol

docketing 'of the operating licenseapplication for the facilityfor fadlitieshaving construction pcrndts Issued

. before October 21, 1985: or

(ill)The ch te of Issuance of theoperathg license for the facilityforfedlittes having operating Ihenses: or

(Iv)The date of issuance of the designapproval under Appendix hLN. or 0 ofthh par.

(2) Except as provided in paragraph(a) [4) of this section, thc Commissionshall require 8 systematic anddocumented analysh pursuant toparagraph (c) of this section for beckfitswhich it seeks to impose.

(3) Except as provided in paragraph(8)(4J of this section, the Commhsionshall require the

hackfit

tin of8 facilityonly when it determines, based on thcanalysis described In paragraph (c) of

'hissection, that there ls 8 substantialincrease in the overall protection of thepub!!c health and safety or the commondefense snd security to be derived fromthe backfit and that the direct andIndirect costs of implementation for thatlacilityare justified In view of this

'ncreasedprotection.(4) The provisions of paragraphs (8)(2)

cnd (a)(3) of thh section crcInapplicable and. therefore. backfitenalysh is not required and thestandards in paragraph (a)(3) of Qdssection do not apply where theCommission or staff, as appropriate.finds and dederes, with appropriateddocuinented evaluation lor its firdhg.either.

(fJ That 8 modification fs necessary tobring a facilityInto compliance with alicense or the rules or orders of theCommission. or Into conformance withwritten conunitments by the licensee; or

(ii]That regulatory action ls necessary .to ensure that the facilityprovidesadequate protection to the health endsalety of the public and h In accord withthe common defense an'd security; or

(fit)That the regu)atory actionInvolves defining or redefining whatlevel of protection to the public healthend safety or common defense andsecurity should be regarded asadequate.

(5) The Comndsslon shall alwaysrequire the bcckfittlngof a facilityifit

, determines that such regulatory action lsnecessary to ensure that the fadlity

rovldes adequate protection to theealth and safety or the public and h h,

accord with the common defense endsccurity,

(8) The documented cvetuatlonrequired by paragraph (e)(4] of thissection shall hclude a statement of theobjectives of and reasons for thcmodification and the basis for Invokhgthe exception. IfImmediately effectiveregulatory action ls required. then thedocumented evaluation mey followrather then precede the reguietoty

'ction.

')lfthere arc two or morc way, to

achieve compliance with 8 license. or therules or orders of the Commission, orwith written Iiceniee commitments. orthere are two or morc ways to reach elevel ofprotection which ls adequate,then ordincrily the applicant or licenseels free to choose the tvay which bestsuits lts purposes. However, should lt bonccc'ssery or appropriate for theCommission to prescribe a speci(le wayto comply with Its requirements or toachieve adequate protection, then costmey be a factor ln selecting the vsay,provided that the objective ofcompliance or adequate protection hmet.

(b) Paragraph (a)(3) of this section~hall not apply to backiits imposed priorto October 21. 1985.

(c) In reaching the determinationrequired by paragraph (a)(3) of tidesection. the Commission willconsider'how the backfit should be scheduled inlight of other ongoing reydatoryccth4t Ice at the fadlity and, in addition.willconsider information availableconcerning any of the fpllowhg factorsas may be appropriate and any otherinformation relevant and material to the,proposed backfiL

(1) Statement of the spccilicobjectives that the proposed backfit isdesigned to ech!eve:

(2) General dcscription of the activitythat would be required by the licenseeor applicant in order to complete thebackfiL

(3) Potential change in the risk to thepublic I'rom the accidental offwitcre!ease of radioactive material:

(4) Potential impact on radiologicalexposure of lacilltyemployees:

(5) Inste)lation and continuing costsassociate:d with the backfit, indudingthe cost of facilitydowntime or the costof construction delay; ~

(6) The potential safety ln:pact ofchanges ln plant or operationalcomplexity, including the relationship toproposed and existing regulatoryrequirements;

P) The estimated resource burden onthe NRC assodated with the proposedbsckfit and the availability of suchresources;

(6) Thc potential impact ofdifferencesIn facility type, design or ege on therelevancy end practicality of theproposed beckfit;

(9) Whether the proposed beckfit hinterim or final end. ifhterim. theustification lor Imposing the proposedecldit on an Interim basis.(d) No licensing action willbe

withheld during the pendency of br ckfitanalyses required by the Commission'srules.

NUREG-1409 Appendix B

Federal Register / VoL S3, NIL 108 / Monday, June 6, 1888 / Rules and Regulations 20611

DEPARTMENT OF E TREASURY

Comptroller of the Urrency

12 CFR Part 4

IDockat No. 88-0]

Description of OificPublic Information;Counsel (Operation

ACENOY: ComptrollTfea SilfylAcrtcnc Final rule.

, Procedurea,puty Chief

) otal.

of the Currency.

of the Lawice of the

ency ("OCC')nge*This finaldescri ptlons for

y Chief Counseluty Chief Counse]

suMMARY:The strucDepartment of the 0Comptroller of the Chas recently been crule sets forth the nethe posiUons of Dep(Operations) and De(Policy).EFFECTIVE OATE: JuilFOR FURTNER INCORFerne Fisherman RuAdvisory Services D1880,Office of the CCurrency, 490 L'EnfaWashington. DC 202SUPPLEMENTARY INF6. 1988. the OCC's Cannounced certain cpositions of Deputy(Operations) and De(Policy): this emendchanges.

Notice and Commen

The OCC has deteand comment are unUS.C. 553(b)(3)(A) sipertains to rules of aand procedure.

Reason for Iinmcdiat

This final rule infoabout a change in thorganization that haConfusion could resposition descriptionsimmediately.

6, 1988.TION CONTACTI ~

n. Attorney, Legallsion. (202) 447-ptroller of the

I Plaza East. SW„

RMATION:On Aprfiief Counselanges to thehief Counseluty Chief Counselnt reflects these

ined that noticeecessary under Sce this final ruleency organize Uon

Effective Dates the public

Lew Department'salready occurred.I ifthe properre not employed

(e) The Executive Director forOperations shell be responsible forimplementation of this secUon, and allanalyses required by this section shallbe approved by the Executive Directorfor Operations or his designee.

Dated ~ I Rockvtlle.34aryland. Uits 31st dayof May, 108L

For the Nudcar Regulatory Commission.Samuel J. Ctutk,

Secretory ofthe Commis siotL(FR Doc. 86-1 2824 Filed~ 8:45 am]aiLUNC coos iss4414I

Regulatory FlexibilityAct

A Regulatory HexibilityAnalysh hrequired only for rules hsued for noticeand comment. Because thh fina] ridepertains to office organize Uon and htherefore exempt fromnoUceandcomment procedures. no Regu]atotyHexibilityAnalysis wll]be prepared.

'ExecuUve Order 12291

Section 1(a)(3) ofExecutive Order12291 exempts from the requirementsthat a Regulatory Impact Ana(ysis beprepared those reguleUons related toagency organization. management orpersonnel Since this final rule is soclassified. no Regulatory ImpactAnalysis h requited

List of Subjects in 12 CFR Part 8

National banks, Organization andfunctions (government agencies). PublicInformetioIL Offictal forms, Districtoffices, Field offices. Psocedures.Delegation.

For the reasons given in the preamble,Part 4 of Chapter I,Title12 of the Codeof Federal Regulations is amended asfollow+

PART 4—DESCRIPTION OF OFFICE,PROCEDURES, PUBUC INFORMATION

1. The authority citation forPart 8continues to read as follows:

Aiithottiy:12 US.C. 1 sN scg 5 US.C.unless otherwise noted

'.

In Part 4, 5 4.1a is amended byrevising paragraph (a) (20) and ( toread as follows:

$ 4.1a Central and Iield or9antz on;dcle9auona

(a) ~ ~ ~

(20) Deputy Chief Couns 1

(Operations). The Deputy ef Counsel(Operations) is responsi le for LawDepartment administr ion, the DiatnctCounse]s. and the Le slaUve andRegu]atory Analysis ivislon of the LawDepartment.

(21) Deputy Chi fCounsel(policy).The Deputy Chi Counsel Policy) isresponsible for e Enforcement endCompliance, gal Advisory Servtces.Litigation. Securities and CorporatePracUces D'sions of the LawDepartm~ ~ ~ ~ ~

Date: ay 27. 190L

RobciS Ctaska.

Comp lierofinc Currency.(FR oc. 88-lZIOS Fi1cd~ ra$ am]

a4 coos sale ~

FEDERAL HOME LOAN BANKBO

12CFR Part563,

Iko. 88-427]

Miscellaneous ConforndnilTechnical Amendments is

Date: 84ay SL 108K

AOENcv'Federal Home 'BankBoardAcTICN: Final cuir, ml llaneousconforming and techn al amendzaents.

sUMMARY:TheFed I Home LoanBankBoard ("Board"),a the operating headof the Federal Sav and Loan .

Insurance Corpo Uon ("FSLIC"J, hemending its re lations In order tocorrect typogr hical and othertechnical err s. and to correct areference to Board's recordkeeplngrequireme withrespect to accountsheld in ln itutlons the deposits of whhhare insur d by Ihe FSLIC ("1nsuredInstltu ns").EFFE VE OATE'une 8, 1988.

FOR RTNER INFORMATIONCONTACT"

Jer e L Edelstein, (202) 377-7057,D uty Director. or Carol J. Rosa, (202)3 7-7037, Paralegal Specialist.

egulations and Legislation Divhion,Office of General Counsel. FederalHome Loan Bank Board. 1700 G StreetNW Washington. DC 20552.

SUPPLEMENTARY INFoRMATIoIcOnAugust 15, 1988. the Board adopted finalamendments expanding and clarifyingits regulation concerning basic loanrecords that lnsUtutions chartered bythe Board or insured institutions andtheir service corporations are requiredto maintain. 51 FR 30848 (August 29.1988). One of the amendments revised12 CFR 563.17-1(c) by providing thatrecords related to accounts held ininsured institutions refiect the Board'srecent deletion of the requirement thatfor insurance of accounts purposes theinsured institution's records disclose thenames of the settlor(grantor) andtrustee of a trust and contain a signaturecard for the tiust executed by thetrustee. The Board's deletion of thisrecordkeeping requirement was adoptedon April4. 1986. 51 FR 12122 (April9.1986). The April1986 revision of 12 CFR564.2 to delete paragraph(b)(3) wasintended to decrease the recordkeepingrequirements associated with obtainiitgtrust accounl insurance coverage and loexpedite settlement of insurance c]aimson such accounts. This amendment

was'ot

intended to apply to loanrecordkeeping requirements of anInsured institution or its servicecorporations but only to insurance

Appcntjix JJ NUREG-1409

APPENDIX C

CHARTER

COMMITTEETO REVIEW GENERIC REQUIREMENTS

(Revision 4, April1987)

NUREG-1409

Revision 4.April 1987

TABLE OF CONTENTS

I Purpose. ~ ~ ~ ~ ~ ~ ~ ~ \ ~ ~ ~ ~ ~ ~ ~ ~ ~

TI. Membership.......

III. CRGR Scope

IV. CRGR Operating Procedures.................

V. Reporting Requirements .

Pacae

~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ 1

~ ~ ~ 2

~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ 5

Attachment 1: New Generic Requirement and Staff Position Review Process

Attachment 2: Procedures to Control Communication of Generic Requirements andStaff Positions to Reactor Licensees

APPROVED BY THE COMMISSION JUNE 16, 1982 (SECY-82-39A)

REVISION 1 APPROVED BY THE COMMISSION (SECY MEMO DTD JANUARY 6, 1984)

REVISION 2 APPROVED BY THE COMMISSION (COMSECY-86-5, JUNE 20, 1986)

REVISION 3 APPROVED BY THE COMMISSION (SECY MEMO DTD AUGUST 13, 1986)

REVISION 4 APPROVED BY THE EDO (MEMO TO COMMISSIONERS, APRIL 6, 1987)

Appendix C NUREG-1409

Revision 4-April 1987

I. PURPOSE

The Committee to Review Generic Requirements (CRGR) has the responsibility toreview and recommend to the Executive Director for Operations (EDO) approval ordisapproval of requirements or staff positions to be imposed by the NRC staffon one or more classes of power reactors. This review applies to staff propos-aTs of requirements or positions which reduce existing requirements or posi-tions and proposals which increase or change requirements. The implementationof this responsibility shall be conducted in such a manner so as to assure thatthe provisions of 10 CFR 2.204, 10 CFR 50.109 and 10 CFR 50.54(f) as pertainingto generic requirements and staff positions are implemented by the staff. Theobjectives of the CRGR process are to eliminate or remove any unnecessary bur-dens placed on licensees, reduce the exposure of workers to radiation in imple-menting some of these requirements, and conserve NRC resources while at thesame time assuring the adequate protection of the public health and safety andfurthering the review of new, cost-effective requirements and staff positions.The CRGR and the associated staff procedures will assure NRC staff implementa-tion of 10 CFR 50.54(f) and 50. 109 for generic backfit matters. The overallprocess will assure that requirements and staff positions in place or to beissued (a) do in fact contribute effectively and significantly to the healthand safety of the public, and (b) do lead to utilization of both NRC andlicensee resources in as optimal a fashion as possible in the overall achieve-ment of protection of pub) ic health and safety. By having the Committee submitrecommendations directly to the EDO, a single agencywide point of control willbe provided.

The CRGR will focus primarily on proposed new requirements and staff positions,but it will also review selected existing requirements and staff positionswhich may place unnecessary burdens on licensee or agency resources. In reach-ing its recommendation, the CRGR shall consult with the proposing office toensure that the reasons for the proposed requirement or staff position are wellunderstood and that the provisions of 10 CFR 50.109, 50.54(f), and 10 CFR

2.204, if applicable, are appropriately addressed by the staff proposal. TheCRGR shall submit to the EDO a statement of the reasons for its recommenda-tions. This statement shall provide a clear indication of the basis for therecommendation and, when appropriate, relate this basis to the provisions of 10CFR 50.109, 50.54(f), and 10 CFR 2.204.

Tools used by the CRGR for scrutiny are expected to include cost-benefit analy-sis and probabilistic risk assessment where data for its proper use are ade-quate. Therefore, to the extent possible, written staff justifications shouldmake use of these evaluation techniques. The use of cost-benefit analyses andother tools should help to make it possible to determine which proposed re-quirements and staff positions have real safety significance, as distinguishedfrom those proposed requirements and staff positions which should be given alower priority or those which might be dropped entirely. When such techniquescannot be applied for lack of available, appropriate, or relevant data, othermethods will be used.

The EDO may authorize deviations from this Charter when the EDO, after con-sulting with the Chairman, finds that such action is in the public interestand the deviation otherwise complies with applicable regulations including

Appendix C NUREG-1409

Revision 4-

April 1987

10 CFR 2.204, 50.54(f) and 50. 109. Such authorization shall be written andshall become a par t of the record of CRGR actions. The rulemaking proposal,presented to and considered by the CRGR, and ultimately, if presented to theCommission, should include any necessary exemption request with supportingreasons for the proposed exemption.

ZI. MEMBERSHIP

This Committee shall be chaired by the Office Director, AEOD, and it shallconsist of, in addition to the CRGR Chairman, one individual each from NRR,

NMSS, the Regions, and RES appointed by the Executive Director for Operationsand one individual from OGC appointed by the EDO with the concurrence of theGeneral Counsel. The regional individual shall be selected from one of theregional offices, and this assignment shall be considered developmental, with a

new selection made by the appointing official after that official judges thatsufficient experience has been gained by the incumbent regional representative.The CRGR Chairman shall assure that process controls for overall agency manage-

ment of the generic backfit process are developed and maintained. These pro-cess controls shall include specific procedures, training, progress monitoringsystems, and provisions for obtaining and evaluating both staff and industryviews on'the conduct of the backfit process. The CRGR Chairman is also respon-sible for assuring that each licensee is informed of the existence and struc-ture of the NRC program described in th s Charter. The CRGR Chairman shallassure that substantive changes in the Charter are communicated to all licen-sees.

AEOD will provide staff support. The Committee may use several non-NRC personsas consultants in special technical areas.

New members will be appointed as the need arises. 'If a member cannot attend a

meeting of the CRGR, the applicable Office Director may propose an alternativefor the appointing official s approval. It is the responsibility of the alter-nate member to be fully versed on the agenda items before the Committee.

III. CRGR SCOPE

A. The CRGR shall consider all proposed new or amended generic requirementsand staff positions to be imposed by the NRC staff on one or more class-es of power reactors. These include:

(i) All staff papers which propose the adoption of rules or policystatements affecting power reactors or modifying, any other rule so

as to affect requirements or staff positions applicable to reactorlicensees, including information required of reactor licensees orapplicants for reactor licenses or construction permits.

(ii) All staff papers proposing new or revised rules of the type de-

scribed in paragraph (i), including Advanced Notices.J

NUREG-1409 Appendix C

Revision 4-Aoril 1987

(iii) All proposed new or revised regulatory guides; all proposed new orrevised Standard Review Plan (SRP) sections; all proposed new orrevised branch technical positions; all proposed generic letters;all multiplant orders, show cause orders, and 50.54(f) lettersall bulletins and circulars; and USI NUREGs; and all new or re-vised Standard Technical Specifications.

l

All staff proposed generic information requests will be examinedby the CRGR in accordance with 10 CFR 50.54(f). Except forinformation sought to verify licensee compliance with the currentlicensing basis for a facility, the staff must prepare the reasonor reasons for each information request prior to issuance toensure that the burden to be imposed on respondents is justifiedin view of the potential safety significance of the issue to beaddressed in the requested information. CRGR examination ofgeneric letters will include those letters proposed to be sent toconstruction permit holders. For those plants for which anoperating license is not yet issued, an exception to staff analy-sis may'be granted by the Office Director only if the staff seeksinformation of a type routinely sought as part of the standardprocedures applicable to the review of applications; If a requestseeks to gather information pursuant to development of a new staffposition, then the exception does not ap„iy and the reasons forthe request must be prepared and approved prior to issuance of therequest. When staff evaluations of the necessity for a requestare required, the evaluation shall include at least the followingelements:

(a) A problem statement that describes the need for the infor-mation in terms of potential safety benefit.

(b) The licensee actions required and the cost to develop a re-sponse to the information request.

(c) An anticipated schedule for NRC use of the information.

The CRGR shall consider all licenses, license amendments, approvals ofPreliminary Design Approvals (PDAs) and Final Design Approvals (FDAs),minutes of conferences with owners groups, licensees or vendors, staffapprovals of topical reports, information notices, and all other docu-ments, letters or communications of a generic'nature which are presented

1 It is expected that the offices will develop internal procedures to ensurethat information requests are developed in accordance with 50.54(f)

Appendix C NUREG-1409

Revision 4.April 1987

to reflect or interpret NRC staff positjons, unless such documents referonly to requirements or staff positions previously applicable to theaffected licensees and approved by the appropriate officials. Thefollowing are examples of approved staff positions not requiring CRGR

review:

C.

positions or interpretations which are contained in regulations,policy statements, regulatory guides, the Standard Review Plan,branch technical positions, generic letters, orders, topical ap-provals, PDAs', FDAs, licenses and license amendments which havebeen promulgated prior to November 12, 1981. Any document or com-munication of this type shall cite and accurately state the posi-tion as reflected in a previously promulgated regulation, order,Regulatory Guide, SRP, etc.

(ii) positions after November 12, 1981 which have been approved throughthis established generic review process.

For those rare instances where it is judged that an immediately effec-tive action is needed to ensure that facilities pose no undue risk tothe health and safety of the public (10 CFR 50.109(a)(4)(ii)), no priorreview by the CRGR is necessary. However, the staff shall conduct adocumented evaluation which includes a statement of the objet'.ives ofand reasons for the actions and the basis for invoking the exception.The analysis referenced in 50;109(a)(2) may be conducted either beforeo" after the action is taken and shall be subject to CRGR eview. Thisanalysis shall document the safety significance and appropriateness ofthe action taken and consideration of how costs contribute vo selectingthe solution among various acceptable alternatives. The CRGR Chairmanshould be notified by the Office Director originating the action. Theseimmediately effective requirements will be reported to the Committee forinformation and will be included in the report to the Commission.

D. For each proposed requirement or staff position not requiring immedi-ately effective action, the proposing office is to identify the require-ment as either Category 1 or 2.

Category 1 requirements and staff positions are those which the propos"ing office rates as urgent to overcome a safety problem requiring imme-

diate resolution or to comply with a legal requirement for immediate ornear-term compliance. Category 1 items are expected to be infrequentand few in number, and they are to be reviewed or otherwise dealt withwithin 2-working days of receipt by the CRGR. If the appropriateness ofdesignation as Category 1 is questioned by the CRGR Chairman, and if thequestion is not resolved within the 2 working-day limit, the proposed

2 It is expected that the offices shall develop internal procedures to en-sure that the documents and communications referenced above will containonly previously approved requirements or staff positions.

NURE(3-1409 Appendix C

Revision 4 ~

April 1987

requirement or staff gosition is to be forwarded by the CRGR Chairman tothe EDO for decision.

E.

Category 2 requirements and staff positions are those which do not meet-the criteria for designation as Category 1. These are to be scrutinizedcarefully by the CRGR on the basis of written justification, which mustbe submitted by the proposing office along with,the proposed requirementor staff position.

Staff proposed generic modifications considered necessary to bring fa-cilities into compliance with licenses or the rules or orders of theCommission, or into conformance with written commitments by licensees,will not require analyses of the type described in Section IV (B)(vii).The proposed action shall be presented to the CRGR Chairman with a docu-mented evaluation including a statement of the objectives of and reasonsfor the proposed requirement or staff position and the basis for involv-ing the exception under 10 CFR 50.109(a)(4)(i).

The CRGR Chairman shall compile and maintain a list of projected genericrequirements and staff positions based on input from the NRC offices.The CRGR may receive early briefings from the offices on the proposednew generic requirements or staff positions before the staff hasdeveloped the requirements or positions and held discussions with theACRS.

F. The CRGR may b =onsulted on any issue deemed appropriate by the CRGR

Chairman.

IV. CRGR OPERATING PROCEDURES

A. Meetin Notices

B.

Meetings will generally be held at regular intervals and will be sched"uled well in advance. Meeting notices will generally be issued by theCRGR Chairman 2 weeks in advance of each meeting, except for Category 1items, with available background material on each item to be consideredby the Committee.

Contents of Packa es Submitted to CRGR

The following requirements apply for proposals to reduce existing re-quirements or positions as well as proposals to increase requirements orpositions. Each package submi'tted to the CRGR for review shall includefifteen (15) copies of the following information:

(i) The proposed generic requirement or staff position:as it is pro-posed to be sent out to licensees.

3 The requirements of the backfit rule and the Commission guidance for re-laxation of requirements and staff positions shall continue to apply.

Appendix C NUREG-1409

Revision 4.April 1987

(iii)

(iv)

(v)

(vi)

(vii)

Draft staff papers or other underlying staff documents supportingthe requirements or staff positions. (A copy of all materialsreferenced in the document shall be made available upon request tothe CRGR staff. Any committee member may request CRGR staff toobtain a copy of any referenced material for his or her use.)

Each proposed requirement or staff position shall contain thesponsoring office's position as to whether the proposal would in-crease requirements or staff positions, implement existing re-quirements or staff positions, or would relax or reduce existingrequirements or staff positions.

The proposed method of implementation along with the concurrence(and any comments) of OGC on the method proposed.

Regulatory analyses generally conforming to the directives andguidance of NUREG/BR-0058 and NUREG/CR-3568.

Identification of the category of reactor plants to which the ge-neric requirement or staff position is to apply (that is, whetherit is to apply to new plants only, new OLs only, OLs after a cer-tain date, OLs before a certain date, all OLs, all plants underconstruction, all plants, all water reactors, all PWRs only, somevendor types, some vintage types such as BWR 6 and 4, jet pump andnonjet pump plants, etc.).

For each such category of reactor plants, an evaluation which dem-onstrates how the action should be prioritized,and scheduled inlight of other ongoing regulatory activities. ='The evaluationshall document for consideration information available concerningany of the following factors as may be appropriate and any otherinformation relevant and material to the proposed action:

(a) Statement of the specific objectives that the proposed actionis designed to achieve;

(b) General description of the activity that would be required bythe licensee or applicant in order,to complete the action;

(c) Potential change in the risk to the public from the accidentaloffsite release of radioactive material;

(d) Potential impact on radiological exposure of facility employ-ees and other onsite workers.

(e) Installation and continuing costs associated with the action,including the cost of facility downtime or the cost of con-struction delay;

NUREG-1409 Appendix C

Revision 4 .

April 1987

~ (f) The potential safety impact of changes in plant or operational"complexity, including the relationship to proposed and exist-ing regulatory requirements and staff positions;

(g) The estimated resource burden on the NRC associated with theproposed action and the availability of such resources;

(h) The potential impact of differences in facility type, designor age on the relevancy and practicality of the proposedaction;

(i) Whether the proposed action is interim or final, and if inter-im, the justification for imposing the proposed action on aninterim basis.

(viii) For each evaluation conducted pursuant to 10 CFR 50. 109, the pro-posing office director's determination, together with the r ation-ale for the determination based on the considerations ofparagraphs (i) through (vii) above, that

(a) there is a substantial increase in the overall protection ofpublic health and safety or the common defense and security tobe derived from the proposal; and

(b) the direct and indirect costs of implementation, for the fa-cilities affected, are justifieo in view of this increasedprotection.

(ix) For each evaluation conducted for proposed relaxations or de-creases in current requirements or staff positions, the proposingoffice director's determination, together with the rationale forthe determination based on the considerations of paragraphs (i)through (vii) above, that

(a) the public health and safety and the common defense andsecurity would be adequately protected if the proposedreduction in requirements or positions were implemented, and

(b) the cost savings attributed to the action would be substantialenough to justify,taking the action.

C. CRGR Staff Review

CRGR staff shall review each package for completeness. If the'packageis not sufficient for CRGR consideration, it shall be returned by theCRGR Chairman to the originating office with reasons for such action.Prior notice to the Committee is not needed; however, CRGR members shallbe informed of such actions.

An accepted package shall be scheduled for CRGR consideration;however, scheduling priorities shall be at the discretion of theCRGR Chairman.

Appendix C NUREG-140o

Revision 4.April 1987

All requests for particular scheduling shall be made to the CRGR

Chairman.

D.

The CRGR staff may obtain additional information from industry andconsultants on such proposals, particularly with respect to thecost of implementation, realistic schedule for implementation andthe ability of licensees to safely and efficiently carry out thefull range of safety-related activities at each facility whileimplementing the proposed requifement or staff position. The CRGR

staff normally shall provide a brief summary analysis of eachpackage to CRGR members prior to the meetings.

CRGR Meetin Minutes

At each meeting, for each package scheduled for discussion, the sponsor-ing office shall present to the CRGR the proposed generic requirement orstaff position and respond to comments and questions. A reasonableamount of time, within the discretion of the CRGR Chairman, shall bepermitted for discussion of each item by Committee members. At the con-clusion of the discussion, each Committee member shall summarize hisposition. The minutes of each meeting, including CRGR recommendationsand the bases therefor shall be prepared. Minutes normally shall becirculated to all members within 5-working days after the the meeting,and each member shall have 5-working days to comment in writing on theminutes. It s the responsibility of each member to assure that theminutes accurately reflect his views. All comments rece ved within thatperiod shall be part of the minutes of the meeting.

The Committee shall recommend to the EDO, approval, disapproval, modifi-cation, or conditioning of generic proposals considered by theCommittee, as well as the method of implementation of such requirementsor staff positions and appropriate scheduling for such implementation,which shall give consideration to the ability of licensees to safely andefficiently carry out the entire range of safety-related activities ateach facility. The minutes shall give an accurate description of thebasis for the recommendations and shall accurately reflect the consensusdecision of the Committee. Copies of the minutes shall be distributedto the Commission, Office Directors, Regional Administrators, CRGR Mem-

bers, and the Public Document Room. The EDO's action taken in responseto the Committee's recommendations shall be provided in writing to theCommission.

E. Recordkee in S stem

The AEOD Assistant for CRGR Issues will assure that there is an archivalsystem for keeping'ecords of all packages submitted to the CRGR Chair-man, actions by the staff, summary minutes of CRGR consideration of eachpackage including corrections, recommendations by the Committee, anddecisions by the EDO.

NUREG-1409 8 Appendix C

Revision 4.April 1987

V. REPORTING RE UIREMENTS

The AEOD Assistant for CRGR Issues shall prepare a report to be submitted bythe EDO to the Commission each month. The report will provide a brief summary.

of CRGR activities, including a list of all items that have been sent to theCRGR and their current status. The report shall be distributed to CRGR

Hembers, Office Directors, Regional Administrators and the Public DocumentRoom.

Appendix C NUREG-1409

I

Attachment 1 toCRGR Charter

September1'evision s

NEW GENERIC RE UIREMENT AND STAFF POSITION REVIEW PROCESS

C

The attached chart is a schematic representation of how new generic require-~nts and staff positions are developed, revised and implemented.

In the early stages of developing a proposed new requirement or staff position,it is contemplated that the staff may have discussions with the industry, ACRS

and the public to obtain preliminary information of the costs and safetybenefits of the proposed action. On the basis of this information, the pro-posing office will prepare the package for CRGR review.

The CRGR may recommend approval, revision, or disapproval or that furtherpublic comment be sought. After CRGR and EDO approval, there may be furtherreview by the ACRS or the Commission. Decisions by the Commission arecontrolling.

Once final approval is received, the individual project managers will normallywork with each licensee to develop a plant"specific implementation scheduletaking into consideration all of the other requirements and staff positions thatare being implemented at ;ach plant.

)

NUREG-1409 10

I

Appendix C

April 1987

SCHEMATIC REPRESENTATION OFNEW REQUIREIVIENTS REVIEW

L51s6eneric,issuesReg. Guideslu'f letins 4 OrdersProposed RulesKtc.

Prioritize andDevelop Proposed

Requirementincluding

Regulatory Analysis

Discussions WithIndustry, ACRS,

PubSc

Technical iianayementReview

Optional DiscussionsIlith industry

C>9R Revtew

BIO

Further ReviewACRS, Commission

Revise Proposalor

Solicit Public Cogentor'o

Further irorI

UcenseasInput

PMs Work WithLicenaeee

IntegrateIntoCornposlteSchedule

bees ~~~ ~ ~ Agreed Upon PIantSpecific Implementation

Schedule

Appendix C NUREG-1409

Attachment 2 to.CRGR Charter

r'pi rl 198/Revision 4

PROCEDURES TO CONTROLGENERIC REQUIREMENTS AND STAFF POSITIONS

A. ~Back round

In a memorandum from the Chairman to the Executive Director for Operations dat-ed October 8, 1981, the Commission expressed concern over conflicting or incon-sistent directives and requests to reactor licensees from various components ofthe NRC staff. By that memorandum, the Commission outlined certain recommendedactions to establish control over the number and nature of requirements placedby NRC on reactor licensees. These included: establishing a Committee toReview Generic Requirements (CRGR); establishing a new position of DeputyExecutive Director for Regional Operations and Generic Requirements (DEDROGR);conducting a survey of formal and informal mechanisms to communicate withreactor licensees; and developing and implementing procedures for controllingcommunications involving significant requirements covering one or more classesof reactors. In February 1987 the Commission approved a NRC reorganizationthat, among other changes, placed the CRGR operations under the Office ofAnalysis and Evaluation of Operational Data (AEOD). CRGR responsibilitiesand authorities were not directed to change under the new organizationalstructure; only the organizational location was chanc. d. The following pro-cedures have been established for controlling generic requirements or staffpositions and are designed to implement the provisions of 10 CFR 50. 109,50.54(f) and 2.204.

B. Committee to Review Generic Re uirements CRGR

Except for immediately effective actions, the CRGR shall review all proposednew generic requirements and staff positions to be imposed on one or moreclasses of power reactors in accordance with the Charter of the Committee,before such proposed requirements or staff positions are forwarded to the EDO

and Commission and imposed on, or communicated for use or guidance to, any re-actor licensee.

C. Office Res onsibilit

Each office shall develop internal procedures to assure that the following pol-icy requirements regarding reactor licensees are carried out:

(1) All proposed generic requirements and staff positions (Table 1 attached)shall be submitted for CRGR review. Such submittals shall conform to theprovisions of the CRGR Charter relating to the contents of suchsubmittals.

(2) All generic documents, letters and communications that establish, reflector interpret NRC staff positions or requirements (Table II attached) shallbe submitted for review by CRGR unless these documents refer only to re-quirements or staff positions approved prior to November 12, 1981. In thelatter case, the previously approved requirement or staff position shouldbe specifically cited and accurately stated. Offices should be careful to

NUREG-1409 12 Appendix C

Attachment 2 toCRGR Charter

Ap> il 1987Revision 4

review new or specific interpretations to assure that they are only case-specific applications of existing requirements rather than initialapplications having potential generic use. Case-specific applications aregoverned by NRC Manual Chapter 0514.

(3) For all other communications with licensees (Table III, attached), nostatements shall be used that might suggest new or revised genericrequirements, staff positions, guidance or recommendations unless suchstatements have been approved by the EDO or the Commission.

(4) In developing a proposed new generic requirement or staff position forCRGR review, an office may determine that it is in possession of importantsafety information that should be made available to licensees. It is theresponsibility of that office to take immediate action to assure that suchinformation is communicated to the licensees by the appropriate office.Such actions may be taken before completion of any proposed or ongoingCRGR reviews.

D. Immediatel Effective Action

For those rare instances where it is judged that an immediately effective ac-tion is needed to ensure that facilities pose no undue risk to the health andsafety of the public (10 CFR 50. 109(a)(4)(ii)), no prior review by 'e CRGR isnecessary. However, the staff shall conduct a documented evaluation which in-cludes a statement of the objectives of and reasons for the actions and thebasis 'or invoking the exception. Tl e analysis referenced in 50. 109(a)(2) may

be conducted either before or after the action is taken and shall be subject toCRGR review. This analysis shall document the safety significance and appro"priateness of the action taken and consideration of how costs contribute toselecting the solution among various acceptable alternatives. The CRGR

Chairman should be notified by the Office Director originating the action.These immediately effective requirements will be reported to the Committee forinformation and will be included in the report to the Commission.

Appendix C 13 NUREG-1409

Attachment 2 to.CRGR Charter

april 1987Revision 4

TABLE I

PRINCIPAL MECHANISMS USED BY NRC STAFF TOESTABLISH OR COMMUNICATE GENERIC RE(UIREMENTS AND STAFF POSITIONS

Advanced NoticesProposed NoticesFinal RulesPolicy Statements

Other Formal Re uirements 2

Multiplant orders including show cause orders andconfirmatory orders

Staff Positions

BulletinsCircularsMultiplant letters (including 10 CFR 50.54f and TMI Action

Plan letters)Regulatory GuidesSRP (including 'ranch Technical Positions)Standard Tech SpecsUSI NUREGs

1 While Rulemaking is an action of the Commission rather than the staff,most rules are proposed or prepared by the staff.

2 The document itself imposes a legal requirement; e.g., regulatory ordersor license conditions.

3 Documents that reflect staff positions which, unless complied with or asatisfactory alternative offered, the staff would impose or seek to haveimposed by formal requirement.

NUREG-1409 14 Appendix C

Attachment 2 toCRGR Charter

l', s 537Revision 4

TABLE II

HECHANISHS OFTEN USED TO INTERPRET GENERIC REQUIREHENTS OR STAFF POSITIONS

Action and Petitions for Rulemaking

Action on 10 CFR 2.206 Requests

Approval of Topicals

Facility Licenses and Amendments

SERs

FDAs, PDAs

I&E Hanual

18E (Hg) Positions

NUREG Reports (other than USIs)

Operator Licenses and Amendments

Single Plant Orders

Staff Positions on Code Committees

Unresolved Issues Resulting from Inspections

Appendix C 15 NUREG-1409

Attachment 2 toCRGR Charter

April 1 ulRevision 4

TABLE III

ADDITIONAL MECHANISMS SOMETIMES USED TO COMMUNICATEGENERIC REQUIREMENTS OR STAFF POSITIONS

DES 8 FES

Entry, Exit and Management Meetings

Information Notices *

Licensee Event Reports; C'onstruction Deficiency Reports (Sent to OtherLicensees)

NRC Operator Licensing People Contact with Licensees

Phone Calls or Site Visits by NRC Staff or Commission to Obtain Information(i.e., Corrective Actions, Schedules, Conduct Surveys, etc.)

Pleadings

Preliminary Notifications

Press Releases

Proposed Findings

Public Meetings, Morkshops, Technical Discussionst

Resident Inspector Day-to-Day Contact

SALP Reports

SECY Papers (Some Utilities Apparently Sent Operators to College Based on Re-

cent SECY Paper on Operator gualifications)

Special Reports

Speeches to Local Groups or Industry Associations

Technical Specifications

Telephone Calls and Meetings with Licensees, Vendors, Industry Representatives,Owners Groups

Testimony

NUREG-1409 16 Appendix C

APPENDIX D

U.S. NUCLEAR REGULATORYCOMMISSION

MANUALCHAPTER 0514t

NUREG-1409

U.S. NUCLEAR REGULATORY COMMISSIONNRC MANUAL

Volume: 0000 General Administrati onPart: 0500 Health and Safety AEOD

CHAPTER 0514 NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFICBACKFITTING OF NUCLEAR POWER PLANTS

0514-01 COVERAGE

011 This chapter establishes the requirements and guidance for NRC

staff implementation of 10 CFR 50.109 and the provisions of 10 CFR 50 Appen-dix 0, 10 CFR 50.54(f), and 10 CFR 2.204, relating to plant-specific back-fitting. Staff requirements and guidance for implementing the provisions of10 CFR 50.109 pertaining to rules and other generic backfitting are beyondthe scope of this chapter. Pertinent requirements and guidance for genericbackfitting are contained in the CRGR Charter. Test and research reactorlicensees are not covered by the provisions of the chapter.

012 This chapter defines the objectives, authorities, and responsibil-ities and establishes basic requirements for actions to be taken in instanceswhere the NRC staff imposes new plant-specific regulatory staff positions ona nuclear power plant licensee.. This practice is commonly referred to as"backfitting" and for the purposes of this chapter is defined as the modifica-tion of or addition to systems, structures, components, or design of a facil-ity; or the procedures or organization required to design, construct or oper'-ate a facility: any of which may result from a new or amended provision in theCommission rules or the imposition of a regulatory staff position interpretingthe Commission rules that is either new or different from a previously appli-cable staff position. It should be . clearly under stood that backfits areexpected to occur and are a part of the regulatory process to assure andimprove the safety of nuclear power plants. However, it is important forsound and effective r egulation that backfitting be conducted in a controlledprocess. Plant-specific backfitting is different from generic backfitting inthat the former involves the imposition on a licensee of positions unique toa particular plant, whereas generic backfitting involves the imposition ofthe same or similar positions on two or more plants. This chapter governsthose plant-specific backfits communicated to the licensees or identified bythe licensees after July 6, 1988.

013 The management of plant-specific backfitting, for which guidanceis provided in this document, does not relieve licensees from achieving and

See Section 05 of this chapter for a definition of "licensee."

Approved: August 26, 1988

4Appendix D NUREG-1409

N R C-0514-02NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS

maintaining adequate protection of the public health and safety2 or complyingwith the Commission's regulations, orders, license, or written licensee commit-ment. The management process is intended to provide disciplined NRC reviewof new or changed positions prior to imposing them.

The plant-specific backfit management process will enhance regulatory stabil-ity by assuring that changes in regulatory staff positions are in fact requiredto ensure that the facility provides adequate protection to public health andsafety or to provide a substantial increase in the overall protection of thepublic health and safety or common defense and security. Such plant-specificbackfitting is entirely proper given the agency's responsibility to ensure anadequate level of protection and the agency's authority'to iinprove safety be-yond this

level.'514"02

OBJECTIVES

021 It is the overall objective of this program to assure that plant-specific backfitting of nuclear power plants is justified and documented andto specify that the Executive Director for Operations is responsible for theproper implementation of the backfit process.

022 The specific objectives of this program are (a) to ensure that facili'-ties provide adequate protection of the public health and safety; and (b) toallow for substantial improvements in the levels of protection of public healthand safety beyond adequacy while avoiding any unwarranted burdens on theNRC, public or licensees in implementing backfits.

023 The program should assure to the extent possible that backfits to beissued will in fact contribute effectively and significantly to the health andsafety of the public or the common defense and security. This objective isattained by assuring that plant-specific backfits will be communicated to thelicensee only if necessary to provide 'an 'adequate level of safety, or afterrequired regulatory analyses are completed and approved as described in Sec-tion 0514-042 of this chapter. The backfit and supporting regulatory. analysesare approved by the appropriate Office Director or Deputy Director, or Reg-ional Administrator or Deputy Regional Administrator, and forwarded to theExecutive Director for Operations before the backfit and appropriate support-ing analysis are communicated to the licensee.

0514-03 RESPONSIBILITIES AND AUTHORITIES

031 The Executive Director for 0 er ations EDO is responsible to theCommission for plant-specific backfit actions. The EDO may review and modifyany plant-specific backfit decision at his or her initiative or at the request

2Ade uate rotection of the ublic health and safet means the same as no un-due risk and reasonable assurance of not endan erin ublic health and safetIn NRC ractice these standards are interchan cable.

Approved: August 26, 1988 0NUREG-1409 Appendix D

NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFICBACKFITTING OF NUCLEAR POWER PLANTS NRC-0514-032

of a licensee in accordance with Section 044. The EDO may authorize deviationsfrom this chapter when the EDO finds that such action is in the public inter-est and the deviation otherwise compiles with the applicable regulations.

032 The Director Office for Anal sis and Evaluation of 0 erational Data~AEOD, shall assure that process controls for overall agency management andoversight of the plant-specific backfit process are developed and maintainedand shall coordinate the implementation of procedures within the other Officesand Regions. These process controls shall include specific procedures, train-ing, progress monitoring systems, and provisions for obtaining and evaluatingboth staff and industry views on the conduct of the backfit process. The Di-rector, AEOD, is also responsible for assuring that each licensee is informedof the existence and structure of the NRC program described in this chapter.The Director, AEOD, shall assure that substantive changes in the chapter andrelated procedures are communicated to the licensees.

033 The Director Office of Nuclear Reactor Re ulation NRR), shall as-sure that an overall procedure for managing plant-specific backfitting thatinvolves positions taken by NRR is developed, implemented, and maintained, inaccordance with the chapter. The overall procedure shall be coordinated withAEOD and approved by the EDO. The Director, NRR, shall consult and coordi-nate with Regional Administrators and the Office of Nuclear Material Safetyand Safeguards, as appropriate, to develop resolutions of proposed plant-specific backfits in program areas for which NRR has responsibility.

For backfits within NRR's program area of responsibility which are proposed byNRR staff, the Director or Deputy Director, NRR, without further delegation,shall approve the regulatory analysis prior to communicating the backfit andanalysis to the licensee. For all backfits within the NRR program area ofresponsibility which are appealed by a licensee, the Director, NRR, shall makethe decision on imposition of the backfit. The decision is subject to EDOreview under Section 0514-031. The Director, NRR, shall assure NRR staffperformance in accordance with this chapter.

034 The Director Office of Nuclear Material Safet and Safe uards~NMSS, shall assure that an overall procedure for managing plant-specificbackfitting that involves positions taken by NMSS is developed, implemented,and maintained, in accordance with this chapter. The overall procedure shallbe coordinated with AEOD and approved by the EDO. The Director, NMSS,shall consult and coordinate with Regional Administrators and the Directorof the Office of Nuclear Reactor Regulation', as appropriate, to develop re-solutions of proposed plant-specific backfits in program areas for whichNMSS activities may affect reactor plant licensees.

For backfits within the NMSS program area of responsibility which are pro-posed by NMSS staff, the Director or Deputy Director, NMSS, without furtherdelegation, shall approve the regulatory analysis prior to communicating thebackfit and analysis to the licensee. For all backfits within the NMSS pro-gram area of responsibility which are appealed by a licensee, the Director,NMSS, shall make the decision on imposition of the backfit. The decisionis subject to EDO review under Section 0514-031. The Director, NMSS, shallassure NMSS staff performance in accordance with this chapter.

Approved: August 26, 1988

Appendix D NUREG-1409

NRC-0514-035NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS

035 Re ional Administrator s shall assur e that an overall procedure formanaging plant-specific backfitting that involves positions taken by a Regionin any program area for which the Region has been delegated authority, is de-veloped, implemented, and maintained, in accordance with the chapter. Theoverall procedure shall be coordinated with AEOD and approved by the EDO.

Regional Administrators shall consult and coordinate with the Directors of theOffices of Nuclear Reactor Regulation and Nuclear Matet ial Safety and Safe-guards, as appropriate, to identify issues and develop resolutions of proposedplant-specific backfits where such backfitting would result from positionstaken by the Region.

For backfits proposed by the Region, the Regional Administrator or Deputy Re-gional Administrator, without further delegation, shall approve the regulatoryanalysis prior to communicating the backfit and analysis to the licensee. Forbackfits proposed by the Region and appealed by the licensee, the Administra-tor is responsible for the conduct of the appeal process within the Region;however, if agreement cannot be reached at the Regional lev'el, the decisionon imposition of the backfit shall be made by the Director of the programoffice having responsibility for the program area relevant to the backfit.The decision is subject to EDO review under Section 0514-031. Each RegionalAdministrator shall assure Regional staff performance in accordance with this

. chapter.

036 The Directors Offices of Nuclear Reactor Re ulation and NuclearMaterial Safet and Safe uards and Re ional Administrators, shall approveregulatory analyses initiated by .their staff members, who propose backfitswithin other program office areas of responsibility which have been delegatedto them for implementation and decision authority, prior to communicating thebackfit and analysis to the licensee.

4

037 The Director Office of Administration and Resources Mana ement,shall, in coordination with the Office Directors, and Regional Administrators,develop and,maintain the overall NRC data base management system, identifiedand described in Section 046 of this chapter.

038 NRC staff positions may be identified as potential backfits either byNRC staff or by persons who are not members of the NRC staff. Such identi-fications will be considered by the Office Director/Reglorial Administratorhaving responsibility to develop staff positions on the matter at issue. ThisOffice Director/Regional Administrator will be responsible to make the deter-mination as to whether the staff position is a backfit and whether the pro-posed backfit should be imposed on the licensee.

0514-04 BASIC REQUIREMENTS

041 Information Re uests Pursuant to 10 CFR 50.54 f . Paragraph 10 CFR50.54(f) authorizes the NRC to require its licensees to provide additionalsafety information to enable the Commission to determine whether or not alicense should be modified, suspended, or revoked. This paragraph (as amend-ed in 50 FR 38097) requires the NRC to justify such information requests by a

Approved: August 26, 1988

NUREG-1409 Appendix D

NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFICBACKFITTING OF NUCLEAR POWER PLANTS NRC-0514-041.a

supporting analysis which finds that the burden to be imposed is justified inview of the potential safety significance of the issue to be addressed in therequested Information. The exceptions to this requirement are as follows:

a. No finding is required whenever there is reason to believe that thepublic health and safety may not be adequately protected and safetyinformation is needed to decide if this is the case and to take anynecessary corrective action.

b. Concerning the review of applications for licenses or amendments, orthe conduct of inspection activities, for plants under construction,no finding will be necessary if the staff seeks information of a typeroutinely sought as a part of the standard procedures concer ningthe review of applications. If the request is not part of routinelicensing review (for example, if it seeks to gather informationpursuant to development of a new staff position), a staff analysis ofthe reasons for the request and a finding must be prepared andapproved prior to issuance.

C. Concerning licensing review or inspection activities for operatingplants, information requests seeking to verify licensee compliancewith the current licensing basis for the facility are exempt from thenecessity to prepare the reason or reasons for the request and tomake a finding. Requests for information to determine compliancewith existing facility requirements including fact-finding reviews,inspections and investigations of accidents or incidents, usuallyare not made pursuant to Section 50.54(f), nor are such requestsnormally considered within the scope of the backfit rule or thischapter.

The Directors of. NRR and NMSS and Regional Administrators shall developinter nal office procedures to ensure that there is a rational basis for allinformation requests not clearly excepted from the finding, whether or not itis clear that backfit action would result from staff evaluation of the infor-mation supplied by the licensee. The request must be evaluated to determinewhether the burden imposed by the information request is justified in view ofthe potential safety significance of the issue to be addressed. The informa-tion request and the staff evaluation must be approved by the cognizant OfficeDirector or Regional Administrator prior to transmittal of the request forinformation to a licensee.

NRC staff evaluations of the necessity for an information request shallinclude at least the following elements:

a. A problem statement that describes the need for the information interms of potential safety benefit.

b. The licensee actions required and the cost to develop a response tothe information request.

c. An anticipated schedule for NRC use of the information.

Approved: August 26, 1988

Appendix D NUREG-1409

N R C-0514-042NRC PROGRAM FOR MANAGEMENT OF PLANT"SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS

042 Identif in Plant-S ecific Backfits. The NRC staff shall be respon-sible for identifying proposed plant-specific backfits as defined by Sec-tion 05 of the chapter. The staff at all levels will evaluate any proposedplant-specific position with respect to whether or not the position qualifiesas a proposed backfit pursuant to Section 05 of this chapter. No staff posi-tion should be communicated to a licensee unless the NRC official communicat-ing that position has ascertained whether or not the position is to be iden-tified as a backfit. NRC Appendix 0514 provides information to help in iden-tifying backfits arising from selected staff activities. When a staff pro-posed position is identified as a backfit the staff should determine expedi-tiously whether the backfit is needed to ensure adequate protection of thepublic health and safety or to comply with Commission rules or orders, thelicense, or written licensee commitments. If, and only if the backfit doesnot meet this test, the appropriate staff office should proceed promptly withthe preparation of a regulatory analysis (Section 043) 'or approval inaccordance with this chapter.

Economic cost can never be a consideration either in defining what is anadequate level of protection or in ensuring that an adequate level of protectionis achieved and maintained.

The staff may, at any point in the development of the regulatory analysis,decide that further analysis is likely to 'show either that the proposedsafety benefit is not likely to be substantial additional overall protection, orthat the direct and indirect "costs of implementation are not likely to be justi-fied. In this case, the issue may be closed, with appropriate notice sent toall parties and recorded in the recordkeeping system described in Section 046.

When (a) a staff proposed position is necessary to bring a facility into com-pliance with a license or the rules or orders of the Commission (Sections052-a, 053-a), or into conformance with written commitments by the licensee(Sections 052-a, 053-b), or (b) the Director of NRR or NMSS determines thatimposition of a backfit is necessary to ensure that the facility providesadequate protection to public health and safety, no regulatory analysis isrequired. Instead, the appropriate Director/Regional Administrator is to pro-vide a documented evaluation to support the action taken.

The evaluation shall include a statement of the objectives of the reasonsfor the modification and the basis for invoking the exception. In the caseof a backfit needed to assure that the facility provides adequate protection,the documented evaluation shall also include an analysis to document thesafety significance and appropriateness of the. action taken. Should it be nec-essary or appropriate for the Commission to prescribe a way to achieve ade- .

quate protection, the evaluation can include a consideration of how costscontr ibute to selecting the solution among various acceptable alternatives.However, cost will not be a factor in determining what constitutes an adequatelevel of protection. Such an evaluation is to be issued with the backfit exceptthat, when an immediately effective regulatory action is necessary, and thesafety need is so urgent that full documentation cannot be completed, the docu-mentation may follow the backfit.

A proposed staff position which is not identified by the NRC staff as a

backfit position may be claimed to be a backfit position by a licensee. The

Approved: August 26, 1988

NUREG-1409 Appendix D

NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFICBACKFITTING OF NUCLEAR POWER PLANTS NRC-051 4-043

staff will promptly consider a licensee claim of backfit to determine if theclaimed backfit qualifies as such in accordance with Section 05 of this chapter.Licensees identifying such items should send a written claim of backfit (withappropriate supporting rationale) to the Office Director or Regional Administra-tor of the NRC staff person who issued the position with a copy to the EDO.If the NRC staff determination is that the issue is a backfit, the appropriatestaff office should proceed immediately with the preparation of any requiredregulatory analysis for approval in accordance with this chapter.

If the determination is that the proposed staff position is not a backfit,the appropriate staff office shall document the basis for the decision andtransmit it together with any documented evaluation required by this section tothe licensee. In any case, the appropriate Office Director/Regional Adminis-trator shall report to the EDO and inform the licensee, within 3 weeks afterreceipt of the written backfit claim, of the results of the determination and theplan for resolving the issue.

When a licensee is informed that a claimed backfit is, in the judgment ofthe NRC, not a backfit, the licensee may appeal this determination asdescribed in Section 044 of this chapter.

043 Re ulator Anal sis. Positions identified as plant-specific back-fits requiring t e regu atory analysis in this section shall be transmittedto licensees only after a determination that there is a substantial increasein the overall protection of the public health and safety or the common de-fense and security to be derived from the backfit, and that the direct andindirect costs of implementation for that facility are justified in view ofthe increased protection. The proposed backfit and supporting regulatoryanalysis must be approved by the appropriate Program Office Director orDeputy Director, or Regional Administrator or Deputy Regional Administratorand forwarded to the EDO before the backfit and its supporting regulatoryanalysis are transmitted to the licensee.

The regulatory analysis shall generally conform to the directives and gui-dance of NUREG/BR-0058 and NUREG/CR-3568, which are the NRC's governingdocuments concerning the need for preparation of regulatory analyses. Inpreparing regulatory analyses under this section, the staff should note thatthe complexity and comprehensiveness of an analysis should be limited to thatnecessary to provide an adequate basis for decisionmaking among the alterna-tives available. The emphasis should be. on simplicity, flexibility, and com-mon sense, both in terms of the type of information supplied and in the levelof detail provided. The following information and any other information rele-vant and material to the backfit shall be included in the regulatory analysis,as available and appropriate to the analysis:

a ~ A statement of the specific objective that thedesigned to achieve. This should also include aof the backfit proposed, and how it provides ain overall protection.

proposed backfit issuccinct descriptionsubstantial increase

b. A general description of the activity that would be required by thelicensee in order to complete the backfit.

Approved: August 26, 1988

Appendix D NUREG-1409

NRC-0514-043.cNRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NuCLEAR POWER PLANTS

c. The potential safety impact of changes in plant design or operationalcomplexity, including the relationship to proposed and existing,regulatory requirements.

d. Whether the proposed backfit is 'interim or final and, if interim,the justification for imposing the proposed backfit on an interim

'basis.,

e. A statement that describes the benefits to be achieved and the costto be incurred. Information should be used to the extent that it isreasonably available, and a qualitative assessment of benefits maybe made in lieu of the quantitative analysis where it would providemore meaningful insights, or is the only analysis practicable. Thisstatement should include consideration of at least the followingfactors:

(1) The potential change in risk to the public from the accidentaloffsite release of radioactive material.

(2) The potential impact on radiological exposure of facility em-ployees. Also consider the effects on other onsite workers, dueboth to installation of procedural or hardware changes and tothe effects of the changes, for the remaining lifetime of theplant.

(3) The installation and continuing costs associated with thebackfit, including the cost of facility downtime or the costof constr uction delay.

(4) The estimated resource burden on the NRC associated with theproposed backfit and the availability of such resources.

f. A consideration of important qualitative factors. bearing on the needfor the backfit at the particular facility, such „as, but not limitedto, operational trends, significant plant events, management effec-tiveness, or results of performance reports such as the SystematicAssessment of Licensee Performance.

0

g. A statement affirming appropriate interoffice coordination related tothe proposed backfit and the plan for implementation.

h. The basis for requiring or permitting implementation on a particularschedule, including sufficient information to demonstrate that theschedules are realistic and provide adequate time for in-depth engi-neering, evaluation, design, procurement, installation, testing,development of operating procedures, and training of operators andother plant personnel, as appropriate. For those plants with ap-proved integrated schedules, the integrated scheduling process canbe used for implementing this step and the following two proceduralsteps.

Approved: August 26, 1988

NUREG-1409 Appendix D

NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFICBACKFITTING OF NUCLEAR POWER PLANTS NRC-0514-044

i. A schedule for staff actions involved in implementation and verifica-tion of implementation of the backfit, as appropriate.

j. Importance of the proposed backfit considered in light of othersafety-related activities underway at the affected facility.

k. 'A statement of the consideration of the proposed plant-specificbackfit as a potential generic backfit.

of two types, applied to two distinctly different situations:

a. Appeal to an Office/Region to modify or withdraw a proposed backfitwhich has been identified, and for which a regulatory analysis hasbeen prepared and transmitted to the licensee; or

b. Appeal to an Office/Region to reverse a denial of a prior licenseeclaim either that a staff position, not identified by the NRC as a

backfit, is one, or that a backfit which staff believes falls withinone of the exceptions from the requirement for a regulatory analysis,does not.

In the first type of situation described, licensees should address an appealof a proposed backfit to the Office Director or Regional Administrator whosestaff proposed the backfit with a copy to the EDO. The appeal should providearguments against the iationale for imposing a backfit as presented in thestaff's regulatory analysis. The Office Director or Regional Administratorshall report to the EDO within 3 weeks after receipt of the appeal concerningthe plan for resolving the issue. The licensee should also be promptly andperiodically informed in writing regarding the staff plans. The decision of theOffice Director on an appeal of plant-specific backfit may be appealed to theEDO unless resolution is achieved at a lower management level. The EDO shallpromptly resolve the appeal and shall state his reasons therefor. Summaries ofall appeal meetings shall be prepared promptly, provided to the licensee, andplaced in appropriate Public Document Rooms. During the appeal process, pri-mary consideration shall be given to how and why the proposed backfit pro-vides a substantial increase in overall protection and whether the associatedcosts of implementation are justified in view of the increased protection.This consideration should be made in the context of the regulatory analysis aswell as any other information that is relevant and material to the proposedbackfit.

In the second type of appeal situation the appeal should be addressed to, andwill be decided by, the Director of the program office having responsibilityfor the program area relevant to the staff position, unless resolution isachieved at a lower management level. A copy of the appeal should also besent to the Executive Director for Operations. The appeal should take intoaccount the staff's evaluation, the licensee's response, and any other infor-mation that is relevant and material to the backfit determination. The EDO

may review and may modify a decision either at his or her own initiative orat the request of the licensee. If the licensee appeals to the EDO, the EDO

Approved: August 26, 1988

Appendix D NUREG-1409

NRC-0514"045NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS

shall promptly resolve the appeal and shall state the reasons therefor. Back-fit claims and resultant staff determinations that are reevaluated in responseto an appeal, and that are again determined by the NRC not to be backfits, orare excepted from the requirement for a regulatory analysis, are not to betreated further in the context "of this chapter. Such matters are to be dealtwith within the normal licensing or inspection appeal process and are notsubject to the requirements of this chapter.

045 Im lementation of Backfits. Following approval of any required reg-ulatory analysis by the appropriate Office Director or Regional Administrator,review if any by the EDO, and issuance of the backfit to the licensee, thelicensee will either implement the backfit or appeal it. After an appeal andsubsequent final decision by the appropriate Office Director or EDO, the li-censee may elect to implement a backfit resulting from the decision. If thelicensee does not elect to implement the backfit, it may be imposed by Orderof the appropriate Office Director.s

Implementation of plant-specific backfits will normally be accomplished on aschedule negotiated between the licensee and the NRC. Scheduling criteriashould include the importance of the backfit relative to other safety relatedactivities underway, or the plant construction or maintenance planned for thefacility, in order to maintain high quality construction and operations. Forplants that have integrated schedules, the integrated scheduling process canbe 'used for this purpose.

A staff-proposed backfit may be imposed by Orders prior to completing any ofthe procedures set forth in this chapter provided the NRC official authorizingthe Order determines that immediate imposition is necessary to provide ade-quate protection to the public health and safety or the common defense andsecurity. In 'such cases, the EDO shall be notified promptly of the action anda documented evaluation as described in Section 042 performed, if possible, intime to be issued with the order.

If "immediate imposition" is not necessary, staff proposed backfits shall notbe imposed, and plant construction, licensing action, or operation shall notbe interrupted or delayed by NRC actions, during the staff's evaluation andbackfit tr ansmittal process, or a subsequent appeal process, until final ac-tion is completed under this chapter.

046 Recordkee in and Re ortin . The proposing Headquarters Office orRegional Office shall administratively manage each proposed plant-specificbackfit using one agency recordkeeping system that provides for prompt re-trieval of current status, planned and accomplished. schedules, and ultimatedisposition. The system shall provide reference to all documents issued orreceived by NRC staff relative to a plant-specific backfit, including re-quests, positions, statements, and summary reports. Access to make changesto the system will be limited to those designated within each Office andRegion. Specific data required will include, but are not limited to:

sOnce an Order is issued, whether or not it is immediately effective, thischapter no longer ~aHes and appeals are governed by the procedures in 10CFR Part 2, Subpart B.

Approved: August 26, 1988

NUREG-1409 10 Appendix D

NRC PROGRAM FOR MANAGEMENT OF PLANT"SPECIFICBACKFITTING OF NUCLEAR POWER PLANTS NRC-0514-046. a

a. Licensee and facility affected.

b. Whether a backfit is identified by staff or by a licensee.

c. Identification and description of the document that either transmitsa staff-identified backfit or a licensee request for considerationof a licensee-identified backfit.

d. Substance of the backfit issue.

e. In the case of a licensee-identified backfit, the dates (predictedand completed) that determinations are made as to whether or not astaff position qualifies as a backfit, the substance of the deter-mination, and the organization and official responsible for makingthe determination.

f. A brief description of what action is pending, and the officialsresponsible to complete the action.

g. Action closing date, to include a description of licensee or staffaction and date of agr cement or order to implement; responsibleofficials and organization for each action.

047 ~Exes tines. Nothing in this chapter shall be interpreted as author-izing or'equiring the staff to make plant-specific backfits or assessmentsfor generic backfits that are, or have been, subject to review by the CRGRand approval by the EDO, or for generic backfits approved prior to November1981, unless the EDO determines that significant plant-specific issues werenot considered during the prior r eviews or the EDO authorizes a deviationunder Section 031.

048 References.

a; NUREG/BR-0058, Rev. 1, May 1984, "Regulatory Analysis Guidelinesof the U.S. Nuclear Regulatory Commission"

b. NUREG/CR-3568, December 1983, "A Handbook for Value-ImpactAssessment"

c. NUREG/CR-3971, October 1984, "A Handbook for Cost Estimating"

d. Revision of Backfit Rule, Code of Federal Regulations, 53 FR 20603(June 6, 1988)

0514-05 DEFI N ITIONS

051 Licensee. Except where defined otherwise, the word licensee as usedin this chapter shall mean that person that holds a license to operate a nu-clear power plant, or a construction permit to build a nuclear power plant, ora Preliminary Design Approval, Final Design Approval, or Design Certificationfor a Standardized Plant Design.

Approved: August 26, 1988

Appendix D NUREG-1409

N R C-0514-052RC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS

052 Plant-S ecific Backfit. Backfittlng is defined as the modificationof or addition to systems, structures, components, or design of a facility; orthe design approval or manufacturing license for a facility; or the proceduresor organization required to design, construct or operate a facility; any ofwhich may result from a new or amended provision in the Commission rules orthe imposition of a regulatory staff position interpreting the Commissionrules that is either new or different from a previously applicable staff posi-tion after certain specified dates. Backfitting is "plant-specific" when itinvolves the imposition of a position that is unique to a particular plant.

It should be noted that to be a plant-specific backfit a staff position mustmeet conditions involving both (a) the substance of the elements of a proposedstaff position and (b) the time of the identification of the staff position:

a ~ A staff position may be a proposed backfit if it would cause alicensee to change the design, construction or operation of afacility from that consistent with already applicable regulatorystaff positions. Applicable regulatory staff positibns are describedin Section 053.

b. A staff position as described in (a) above is a proposed backfitif it is first identified to the licensee after certain importantdesign, constr uction or operation milestones, involving NRC ap-provals of varying kind, has been achieved. Those times afterwhich a new or revised staff position will be considered a backfitare as follows:

(1) After the date of issuance of the construction permit for thefacility (for facilities having construction permits issuedafter May 1, 1985);

(2) After 6 months before the date of docketing of the OL applica-tion for the facility (for facilities having constructionpermits issued before May 1, 1985);

(3) After the date of issuance of the operating license for thefacility (for facilities having an operating license onMay 1, 1985);

(4) After the date of issuance of the design approval under10 CFR 50, Appendix M, N or 0.

NOTE: The EDO directives embodied in chapter NRC-0514 are effective as ofJuly 6, 1988.

053 A licable Re ulator Staff Positions. Applicable regulatory staffpositions are those already specifically imposed upon or committed to by alicensee at the time of the identification of a plant-specific backfit, andare of several different types and sources:

a. Legal requirements such as in explicit regulations, or ders, plantlicenses (amendments, conditions, technical specifications) ~ Note

Approved: August 26, 1988

NUREG-1409 12 Appendix D

NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFICBACKFITTING OF NUCLEAR POWER PLANTS N R C-0514-053

that some regulations have update features built in, as for example,10 CFR 50.55a, Codes and Standards. Such update requirements areapplicable as described in the regulation.

b. Written commitments such as contained in the FSAR, LERs, anddocketed correspondence, including responses, to Bulletins, re-sponses to Generic Letters, Confirmatory Action Letters, re-sponses to Inspection Reports, or responses to Notices ofViolation.

co NRC staff positions~ that are documented, approved, explicit inter-pretations of the more general regulations, and are contained indocuments such as the SRP, Branch Technical Positions, RegulatoryGuides, Generic Letters, and Bulletins; and to which a licensee oran applicant has previously committed to or relied upon. Positionscontained in these documents ar e not considered applicable staffpositions to the extent that staff has, in a previous licensing orinspection action, tacitly or explicitly excepted the licensee frompart or all of the position.s

~Requirements may be imposed by rule or order. Staff interpretations such asexamples of acceptable ways to meet requirements are not requirements in andof themselves.

Imposition of a staff position from which a licensee has previously been ex-cepted is a backfit.

Approved: August 26, 1988

Appendix D 13 NUREG-1409

NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFICBACKFITTING OF NUCLEAR POWER PLANTS NRC A endix 0514

CONTENTS

Guidance for Making Backfit Determinations

A. General....................B Lscens>ng..................

Pacae

~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ 11

1. Standard Review Plan..2. Regulatory Guides.3. Plant-Specific Orders.

~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~

~ ~ ~

123

C. Inspection and Enforcement....,.

1.2.3.

Inspections..........Notice of Violations..Bulletinsl ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~

Reanalysis of Issues.. ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ 0 ~ ~ ~

3444

Approved: August 26, 1988

NUREG-1409 Appendix D

NRC PROGRAM FOR MANAGEMENT OF PLANT"SPECIFICBACKFITTING OF NUCLEAR POWER PLANTS NRC A endix 0514

Guidance for Makin Backfit Determinations

A. General

In this section selected regulatory activities and documents are discus-sed in order to enable members of the NRC staff and the regulated indus-try. to better understand the conditions under which a staff position maybe viewed 'as a plant-specific backfit. It is important to understandthat the necessity for making backfit determinations should not inhibitthe normal informal 'dialogue between the technical reviewer or inspectorand the licensee. The intent of this process is to manage backfitimposition, not to quell it. The discussion in this appendix is intendedto aid in identifying backfits in accordance with the principles and thepractices that should be implemented by all staff members. This appendixis not intended to be an exhaustive, comprehensive workbook in which canbe found a parallel example for each situation that may arise. As isevident from the definitions in Section 05 of this chapter, a plant-specific backfit has the elements of a change from an already applicablestaff position where an applicable staff position is defined as thatestablished befog e certain defined milestones in the affected plant'slicensing histor y. There will be some judgment necessary to determinewhether a staff position would cause a licensee to change the design,construction or operation of a facility. In making this determination,the fundamental question is whether the staff's action is directing,telling, or coercing, or is merely suggesting or asking the licensee toconsider a staff proposed action.

Actions proposed by the licensee are not backfits under this chaptereven though such actions may result from normal discussions betweenstaff and licensee concerning an issue, and even though the change oradditions may meet the definitions of Section 0514-052 and 0514-053.

B. ~Licenein

Standard Review Plan (SRP) - The SRP delineates the scope anddepth of staff review of licensee submittals associated with variouslicensing activities. It is a definitive NRC staff interpretation ofmeasures which, if taken, will satisfy the requirements of the moregenerally stated, legally binding body of regulations, primarilyfound in Title 10 CFR. Since October 1981, changes to the SRP areto have been reviewed and approved through a generic review pro-cess involving the Committee to Review Generic Requirements (CRGR),and the extent to which the changes apply to classes of plants isdefined. Consequently, application of a current SRP in a specificoperating license (OL) review generally is not a plant-specificbackfit, provided the SRP was effective 6 months prior to the startof the OL review. Asking an applicant for . an operating licensequestions to clarify staff understanding of proposed actions, inorder to determine whether the actions will meet the intent of theSRP, is not considered a backfit.

On the other hand, using acceptance criter ia more stringent thanthose contained in the SRP or taking positions more stringent than

Approved: August 26, 1988

Appendix D 15 NURVO-1409

NRC A endix 0514NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS'n

addition to those specified in the SRP, whether in writing ororally, is a plant-specific backfit. During meetings with thelicensee, staff discussion or comments regarding issues and licen-see actions volunteered which are in excess of the criteria in theSRP gener ally do not constitute plant-specific backfits; however,if the 'taff implies or suggests that a specific action in excess

. of already applicable staff positions is the only way for the staffto be satisfied, the action is considered a plant-specific backfitwhether or not the licensee agrees to take such action. However,the staff should recognize that a verbally implied or suggestedaction should not be accepted by a licensee as an NRC position ofany kind, backfit or not; only written and authoritatively approvedposition statements should be taken as NRC positions.

Application of an SRP to an operating plant after the license isgranted generally is considered a backfit unless the SRP wasapproved specifically for oper ating plant implementation and isapplicable to such operating plant. It is impor tant to note,however, that in order to issue an amendment to a license, theremust be a current finding of compliance with regulations applicableto the amendment. As a specific example, review of a plant owner'sapplication for a license amendment to authorize installation andoperation of a new reactor core, commonly called a "reload appli-cation," may necessitate review of new fuel designs or new thermal-hydraulic correlations and associated operating limits. Such changesthat are clearly advances in design or operation may involve new orunreviewed safety issues, and may warrant review to SRP criteriawhich were approved subsequent to initial license issuance to thelicensee. This is not considered a backfit. However, such review tonewer SRP revisions is not necessarily required to determine currentcompliance with regulations. Licensee" proposed revisions in designor operation that raise staff questions only about potential reducedmargins of safety as defined in the basis for any technical speci-fication should be reviewed by reanalysis of the same accidentsequences and associated assumptions as analyzed in the FSAR forthe initial license issuance.

During reload reviews, staff - proposed positions with regard to.technical matters" not related to the changes proposed by a li-censee shall be considered backfits.

2- Regulatory Guides - As part of the generic review process pursuantto the CRGR Charter, it is decided which plants or groups of plantsshould be affected by new or modified Regulatory Guide p'rovisions.Such implementation is therefore not governed by the plant-specificbackfit procedures. However, any staff proposed plant-specificimplementation of a Regulatory Guide provision, whether orally orin writing, for a plant not encompassed by the generic imp'lementa-tion determination is considered a plant-specific backfit. A staffaction with respect to a specific licensee that expands on, adds to,or modifies a generically approved regulatory guide, such that theposition taken is more demanding than intended in the genericpositions, is a plant-specific backfit.

Approved August 26, 1988

NUMI '.(i-I 409 16 Appendix D

NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFICBACKFITTING OF NUCLEAR POWER PLANTS NRC A endix 0514

3.

C. Ins

Plant-Specific Orders - An order issued to cause a licensee to takeactions which are not otherwise applicable regulatory staff posi-tions is a plant-specific backfit. As described in Section 0514-045of this chapter, an order effecting immediate impo'sition of a back-fit may be issued prior to completing any of the procedures setforth in 'this chapter provided that the appropriate Office Directordetermines that immediate imposition is necessary.

An order issued to confirm a licensee commitment to take specificaction even if that action is in excess of previously applicablestaff positions, is not a plant-specific backfit provided the com-mitment was not obtained by the staff with the expressed or implieddirection that such a commitment was necessary to gain acceptancein the staff review process. Discussion or comments by the NRC staffidentifying deficiencies observed, whether in meetings or writtenrepor ts, do not constitute backfits. Definitive statements to thelicensee directing a specific action to satisfy staff positions arebackfits unless the action is an explicit and already applicableregulatory staff position.

ection and Enforcement

Inspections - NRC inspection procedures govern the scope and depthof staff inspections associated with licensee activities such asdesign, construction, and oper ation. As such, they define thoseitems the staff is to consider in its determination of whether theiicensee is conducting its activities in a safe manner. The conductof inspections establishes no new sta'ff positions for the licenseeand is not a plant-specific backfit.

Staff statements to the licensee that the contents of an NRC inspec-tion procedure are positions that must be met by the licensee con-stitute a plant-specific backfit unless the item is an applicableregulatory staff position. Discussion or comment by the NRC staffregarding deficiencies observed in the licensee conduct of activi-ties, whether in meetings or in written inspection reports, do notconstitute backfits, unless the staff suggests that specific cor-rective actions different from previous applicable regulatory staffpositions are the only way to satisfy the staff. In the normalcourse of inspecting to determine whether the licensee's activitiesare being conducted safely, inspectors may examine and make find-ings in specific technical areas wherein prior NRC positions andlicensee commitments do not exist. Examination of such areas andmaking findings is not considered a backfit. Likewise, discussionof findings with the licensee is not considered a backfit. If dur-ing such discussions, the licensee agrees that it is appropriateto take action in response to the inspector's findings, such actionis not a backfit provided the inspector does not indicate that thespecific actions are the only way to satisfy the staff. On theother hand, if the inspector indicates that a specific action mustbe taken, such action is a backfit unless it constitutes an appli-cable regulatory staff position. Further, if the licensee decides

Approved: August 26, 1988

Appendix D 17 N UR li(I-I409

NRC A endix 0514NRC PROGRAM FOR MANAGEMENT OF PLANT-SPECIFIC

BACKFITTING OF NUCLEAR POWER PLANTS

to claim that the inspector's findings are a backfit, then thestaff. must decide whether they are.a backfit under this chapter.

For example, if the licensee commits to ANSI-N18.7 in the SAR andthe inspector finds the licensee's implementing procedures do notcontain all the elements required by ANSI-N18 ~ 7, . telling the li-censee he must take action to include all the elements in theimplementing procedures is not a backfit. If the inspector findsthe licensee has included all the required elements of ANSI-N18 ~ 7,but has not included certain of the optional elements in the imple-menting procedures, inspector discussion with the licensee regard-ing the merits of including the optional elements is not a backfit.On the other hand, if the inspector tells the 'licensee that theimplementing procedures must include any or all of the optionalelements in order to satisfy the staff, inclusion of such elementsis a backfit, whether or not agreed to by the licensee.

2. Notice of Violations (NOV) - a NOV requesting des'cription of a li-censee's proposed corrective action is not a backfit. The licen-see's commitments in the description of corrective action are notbackfits. A request by the staff for the licensee to consider somespecific action in response to an NOV is not a backfit. However,if the staff is not satisfied with the licensee's proposed correc-tive actions and requests that the licensee take additional ac-tions, those additional actions (whether requested orally or inwriting) are a backfit unless they are an applicable regulatorystaff position.

Discussions during enforcement conferences and responses to thelicensees requests for advise regarding corrective actions arenot backfits; however, definitive statements to the licenseedirecting a specific action to satisfy staff positions are back-fits, unless the action is an explicit applicable regulatory staffposition.

3. Bulletins - Bulletins and resultant actions requested of licenseesundergo the general review process pursuant to the CRGR Charter.Therefore, in general, it is not necessary to apply the plant-specific backfit process to the actions requested in a Bulletin.However, if the staff expands the action requested by a Bulletinduring its application to a specific licensee, such expansion isconsidered a plant-specific backfit.

. 0

4. Reanalysis of Issues - Throughout plant lifetime, many individualson the NRC staff have an opportunity to review the requirements andcommitments incumbent upon a licensee. Undoubtedly, there will beoccasions when a reviewer concludes the licensee's program in a

specific area does not satisfy a regulation, license condition orcommitment. In the case where the staff previously accepted thelicensee's program as adequate, any staff specified change in theprogram would be classified as a backfit.

Approved: August 26, 1988

WulCrn-i40<> Appendix I)

NRC PROGRAM FOR MANAGEMENT OF PLANT"SPECIFICBACKFITTING OF NUCLEAR POWER PLANTS NRC A endix 0514

For example, in the case of an NTOL, once the SER is issued signi-fying staff acceptance of the programs described in the SAR, thelicensee should be able to conclude that his commitments in the,SARsatisfy the NRC requirements for a particular area. If the staff wasto subsequently require that the licensee commit to additional actionother than 'that specified in the SAR for the particular area, suchaction would constitute a backfit.

A somewhat different situation exists when the licensee has made asubmittal committing to a specific course of action to meet an applica-ble position, and the staff has not yet responded, and thereforehas not indicated that the commitment is or is not sufficient to meetthe applicable position. Subsequent staff action, which must betaken within a reasonable time not delaying the applicant's implemen-tation plans, to cause the licensee to meet the applicable regulatorystaff position is not a backfit. If the licensee has moved ahead inthe intervening time to implement that which the licensee proposed todo in its submittal and the staff has failed to provide a timelyresponse, then the staff position may be considered a backfit. Thus,if a licensee has implemented a technical resolution intended to meetan applicable regulatory staff position, and staff for an extendedperiod simply allows the licensee resolution to stand with tacit accep-tance indicated by non-action on the part of NRC, then a subsequentaction to change the licensee's design, construction, or operationis a backfit.

Approved: August 26, 1988

*ppendix D 19 NUREG-1409

. APPENDIX E

BACKGROUND INFORI'NATIONFOR CRGR REVIEWOF GI-70 AND GI-94 RESOLUTIONS

NUREG-1409

Encl osur e 1

Back round Information'for CRGR'Reviewo - an - eso ut ons

The following information is provided in the format specified in Section IVB(i) through IV B(ix) of Revision 4 of the CRGR Charter, dated April 1987. Foreach item, the request for information is given followed by a discussion of theresponse or a reference to where the information is provided.

The proposed generic requirement or staff position as it is proposed tobe sent out to licensees.

The proposed generic resolution is set forth in the proposed 10CFR50.54(f)generic letter 89-XX (see Enclosure 2).

Oraft staff papers or other underlying staff documents supporting therequirements or staff positions. (A copy of all materials referencedin the document shall be made available upon request to the CRGR staff.Any committee member may request CRGR staff to obtain a copy of anyreferenced material for his or her use.)

The relevant technical information for GI-70 is contained in NUREG-1316 (Enclosure 3) and related contractor reports and other referenceslisted therein. The relevant technical information for GI-94 iscontained in NUREG-1326 (Enclosure 10) and related contractor reportsand other references listed therein. Copies of any references willbe provided upon request.

Each proposed requirement or staff position shall contain the sponsoringoffice's position as to whether the proposal would increase requirementsor staff positions, implement existing requirements or staff positions,or would relax or reduce existing requirements or staff positions.

Technical findings related to the resolution of Gl-70 are containedin NUREG-1316 (Enclosure 3). Technical findings related to theresolution of GI-94 are contained in NUREG-1326 (Enclosure 10). Thesefindings have been incorporated in the proposed generic letter(Enclosure 2). They represent the final staff position on GI-70 andGI-94 and for certain operating PWR plants are additional requirements.

'orcertain recently licensed operating plants and certain plantscurrently under active construction the GI-70 technical findings do notrepresent additional requirements. The GI-94 technical findings do not. epresent additional requirements for Babcock and Wilcox plants.

Appendix E N UREG-1409

(iv)

(v)

(vi)

(vii)

The proposed method of implementation along with the concurrence(and any coments) of OGC on the method proposed.

OGC has no legal objection to the proposed action in Generic Letter'9-XX(Enclosure 2). All OGC coments have been incorporated in the proposedgeneric letter.

Regulatory analyses generally conforming to the directives andguidance of NUREG/CR-0058 and NUREG/CR-3568.

Regulatory analyses related to the resolution of GI-70 are containedin Section 5 of NUREG-1316 (Enclosure 3). The Regulatory. Analysis forthe resolution of GI-94 is provided in NUREG-1326 (Enclosure 10).

Identification of the category of reactor plants to which the genericrequirement or staff position is to apply (that is, whether it isto apply to new plants only, new OLs only, OLs after a certain date,OLs before a certain date, all OLs, all plants under construction,all plants, all water reactors, all PWRs only, some vendor types,some vintage types such as BWR 6 and 4, jet pump and nonjet pumpplants, etc.)

The proposed Generic Letter 89-XX (Enclosure 2) will be sent to PWRsand is applicable to all operating plants and future plantsincluding those currently. under construction. However, certainrecently licensed operating plants and certain plants currently underactive construction already satisfy the GI-70 recommendations of thegeneric letter, and certain plants are not impacted by the GI-70recommendations (CE plants without PORVs). With respect to the GI-94recommendation, Babcock and Wilcox plants are not impacted.

For each such category of reactor P1ants, an evaluation which demonstrateshow the action should be prioritized and scheduled in light of otherongoing regulatory activities. The evaluation shall document forconsideration information available concerning any of the followingfactors as may be appropriate and any other information relevant andmaterial to the proposed action:

Potential improvements to PORYs and block valves should be prioritizedand scheduled in conjunction with ongoing regulatory activities such as;review of inservice testing programs of valves in conformance withSection XI of 'the ASNE Code. Review of potential modifications totechnical specifications for low-temperature overpr essure protectionshould be prioritized in conjunction with these same activities.

(a) Statement of the specific objectives that the p. oposed actionis designed to achieve;

NUREG-1409 Appendix E

The objectives that the proposed actions are designed to achieve areto increase the reliability of PORVs and block valves to provideassur ance they will function as r equired, and to provide additionalassurance that LTOP systems will be available when required.

(b) General description of the activity that would be required by thelicensee or applicant in order to complete the action;

With respect to GI-70, for operating plants when PORVs and the associatedblock valves are used for any of the safety functions discussed inSection 2. 1 of NUREG-1316 the activity that would be required by thelicensee consists of the following actions:*

(1) Include PORVs and block valves in the operational qualityassurance program that is in compliance with 10 CFR 50,Appendix B.

(2) Provide a maintenance/refurbishment program for PORVs andblock valves.

(3) Testing in accordance with Section XI of the ASME Code forPORVs and block valves. Additional testing for PORV blockvalves will be included in the expanded MOV test programdiscussed in NRC Generic Letter 89-XX, "Safety-RelatedMotor Operated Valve Testing and Surveillance" dated (Later).

(4) Modify the limiting conditions of operation of PORVs and blockvalves in the technical specifications for Modes 1, 2, and 3

as contained in Attachments A-l, A-2, and A-3 of EnclosureA to the proposed Generic Letter 89-XX (Enclosure 2).

For future PWR plants and those currently under construction when PORVs

and the associated block valves are used for any of the safety functionsdiscussed in Section 2. 1 of NUREG-1316, these components should beclassified as safety related and a minimum of two PORVs and two blockvalves installed. Plants currently under active construction meet theserecommendations.

e

With respect to GI-94, Combustion Engineering and Westinghouse PWRs

should modify the current plant Technical Specifications for theOverpressur e Protection System to assure both channels are operable inModes 5 and 6, especially when water-solid as contained in Enclosure B

and its attachments to proposed Generic Letter 89-XX (Enclosure 2).Revisions to the plant cooldown and heatup (or filling and venting)procedures are also recommended. In addition, verification thatadmi nistrative controls and procedures regarding the LTOP design basisanalyses have been implemented is also recommended.

(c) Potential change in the risk to the public from the accidentaloffsite release of radioactive material;

"Certain recently licensed operating plants already satisfy these requirements.

Appendix E NUREG-1409

GI-70 Contractor analysis showed only a small change in risk basedon Indian Point 3 and Oconee PRA's. However, NUREG/CR-'5230showed that feed and bleed provides a significant reductionin core'melt probability for four representative plants. Theproposed actions would enhance feed and bleed capability.Even if only a fraction of the core melt . eduction indicatedin NUREG/CR-5230 is achieved, this would .esult in asubstantial reduction in risk to the public.

GI-94 The estimated total dose reduction is 14,500 person-rem overthe remaining license life of the PWRs impacted by theproposed resolutions.

(d) Potential impact on radiological exposure of facility employees andother onsite workers.

For GI-70, it is estimated that there would be little or no increase inexposure because:

(1) Host surveillance testing would be performed remotelyin situ.

(2) Exposure resulting from order ly,-planned maintenanceactivities is considered unlikely to result in exposurelevels any higher*than those resulting from unplanned majorrepairs after valves malfunction in service.

No ad'ditional exposure to facility employees or other onsite workers isexpected for the proposed resolution of GI-94.

(e) Installation and continuing costs associated with the action,,including the cost of facility downtime or the cost of const. uctiondelay;

The present worth of the utility cost impact for GI-70 for operatingPWR plants with two PORVs and two block valves is $ 127,200 for items(b)l through (b)4 discussed above. However, this cost will be morethan offset by the savings from less outage time because of PORV andblock valve problems. This work would be accomplished during scheduledrefueling/maintenance outages as a'part of existing plant programs.

The net present value of the estimated replacement power cost resultingfrom the proposed resolution of GI-94 is estimated to be $ 2,000 perplant, assuming a 5X discount rate and a 24 year average remaininglifetime for the plants impacted by GI-94. The average annual utilitycost is estimated to be $ 145.00.

(f) The potential safety impact of changes in plant or operationalcomplexity, including the relationship to proposed and existingregulatory requirements and staff positions;

NUREG-1409 Appendix E

For a certain number of operating plants the proposed revision to thetechnical specifications may be more restrictive. The proposedrecommendations for GI-70 are expected to increase the reliability ofPORVs in Modes 1', 2 and 3'and'therefore overall plant safety.

The proposed recommendations for GI-94 are expected to increasethe. availability of the LTOP systems in Modes 5 and 6 (especiallywhen water-solid) and therefore overall plant safety.

(g) The estimated resource burden on the NRC associated with theproposed action and the availability of such resources;

The estimated resource burden on the NRC is minimal, costs are estimatedin Section 5.5 of the Regulatory Analysis in NUREG-1316 (Enclosure 3)for GI-70, and in Section 5. 1.2 of the Regulatory Analysis in NUREG-1326(Enclosure 10) for GI-94.

(h) The potential impact of differences in facility type, design orage on the relevancy and practicality of the proposed action;

The potential impact of the proposed actions for GI-70 on PWRs withPORVs will vary from none to moderate. That i', on plants that receivedan OL since 1984 there would be no impact as these plants in general havesafety grade PORVs and block valves. On older PWRs with PORVs theimpact will be variable depending on the degree of compliance withitems (b)1 through (b)4 discussed above. CE plants without PORVs arenot impacted by the proposed resolution for GI-70

The potential impact of .the proposed actions for GI-94 are not expectedto be different based on facility type, design or age. However,Babcock and Wilcox PWRs are not impacted by the'roposed resolutionfor GI-94.

(i) Whether the proposed action is interim or final, and if interim,the justification for imposing the proposed action on an interimbasis.

The proposed actions are final with respect to the resolution of GI-70and GI-94.

Appendix E NURFG-1409

APPENDIX F

SAMPLE BACKFITDISCUSSION(TAKENFROM NRC BULLETIN90-01)

NUREG-1409

Backfft Discussion

The objective of the actions requested in this bulletin is toensure that transmitter failures due to loss of fill-oilarepromptly detected. Loss of fill-oilmay result in a trans-mitter not performing its intended safety function.

The actions requested in this bulletin represent new staffpositions and thus, this request is considered a backfit inaccordance with NRC procedures. Because established

regulatory requirements exist but wer'e not satisfied, thisbacldit is to bring facilities into compliance with existingrequirements. Therefore, a fullbackfit analysis was notperformed. An evaluation of the type discussed in 10CFR.109(a)(6) was performed, including a statement ofthe objectives of and reasons for the actions requestedand the basis for invoking the compliance exception. Itwillbe made available in the Public Document Room withthe minutes of the 179th meeting of the Committee toReview Generic Requirements.

Appendix F NURE6-1409

NRC FOAM 33512419 INRCM 1102,3201, 3202

2. TITLE AND SUBTITLE

U.S. NUCLEAR REGULATORY COMMISSION

BIBLIOGRAPHIC DATA SHEET(Spo instntctions on th p idyprsoi

1. REPORT NUMBER(Asslpnad by NRC. Add VoL, Suoo„Ray.,~nd Addsndutn Numbats, II any.l

NUREG-1409

Backfi tting Gui del ines3. DATE REPORT PUBLISHED

YEAR

jul'y 19904. FIN OR GRANT NUMBER

5. AUTHORISI

Allison, Dennis P.Conran, James H.Trottier, Cheryl A.

6. TYPE OF REPORT

7. PERIOD COVERED tlnctuth ~ oatml

B. PERFORMING ORGANIZATION—NAME AND ADDRESS lllHRC ptoridr Dhision, Otfinor Rtplon, MS. Hucltarnapu4tory Commiaion,andmailinpmhhosslllcontractor ptorit4noma and mallhtp addtusLI

Office for Analysis and Evaluation of Operational DataU.S. Nuclear Regulatory CommissionIilashington, DC 20555

9. SPONSORING ORGANIZATION- NAMEAND ADDRESS illHRC, typt "Sama as snow-; ilcontractor ptswida HRC 04iu'on, Ollicoor Rapion, tl3. lyucisar Rapu4sory Comnsisuon,~nd matthtp addrass.l

Same as above.

0. SUPPLEMENTARY NOTES

1. ABSTRACT t200 aunts or stssl

The backfitting process is the process by which the U.S. Nuclear RegulatoryCoeaission (NRC) decides whether to issue new or revised requirements orstaff positions to licensees of nuclear power reactor facilities. Require-ments for propet justification of backfits and information requests are providedby two NRC rules (Title 10, Code of Federal Regulations,'Sections 50.109 and50.54(f)). NRC procedures include the charter of the coaeittee to ReviewGeneric Requirements, NRC Manual Chapter 0514, and individual officeprocedures. Three types of backfits are recognized. Cost-justified substantialsafety improvements require backfit analyses and findings of (1) substantialsafety improvement and (2) justified costs. Compliance exceptions andadequate protection exceptions do not require findings of substantial safetyimprovements and costs are not considered. However, they are still backfitsand require documented evaluations to support the use of the exceptions.Information requests (as opposed to backfits) require an analysis of theburden to be imposed to ensure that they are justified in view of thepotential safety significance of the information requested.

12. KEY WORDS/DE SCR IPTORS ttist wonts or phtosas that winassist rtsaarchrrs ln tocatinp tha troott. Ibackfitbackf it anal ysi sinformation request

, regulatory analysiscost-benefit analysisgeneric communicationnew requirement

13. AVAILABILITYSTATEMENT

Unlimited1 ~ . SECIIRITY CLASSIFICATION

IThis Papal

Unclassifiedlynts Rrponl

Unclassified15. NUMBER OF PAGES

16. PRICE

NRC FORM 335 I24IQ)