ML003773219
| ML003773219 | |
| Person / Time | |
|---|---|
| Issue date: | 11/30/2000 |
| From: | Vietti-Cook A L NRC/SECY |
| To: | Beedle R E Nuclear Energy Institute |
| References | |
| 60FR47716, PRM-50-62 SECY-00-0214 | |
| Download: ML003773219 (7) | |
Text
November30,2000Mr.RalphBeedleNuclearEnergyInstitute 1776IStreet,NW Washington,DC20006-3708
DearMr.Beedle:
IamrespondingtothepetitionforrulemakingthattheNuclearEnergyInstitute(NEI)submittedtotheNuclearRegulatoryCommission(NRC)byaletterfromMr.PhillipBayne,datedJune8, 1995.ThepetitionwasdocketedbytheCommissiononJune19,1995,andassignedDocket No.PRM-50-62.ThepetitionrequestedthattheNRCamend10CFR50.54(a)tochangethe criteriathatnuclearpowerplantlicenseesarerequiredtousetopermitchangestotheirquality assurance(QA)programswithoutpriorNRCapproval.Accordingtotheproposal,changes involvingunreviewedsafetyquestionswouldrequireNRCapprovalpriortoimplementation.OnSeptember14,1995(60FR47716),theNRCannouncedthereceiptofyourpetitioninaFederalRegisterNoticeandprovidedanopportunityforpubliccomment.Seventeencommentletterswerereceivedplusonecommentletterthatsupplementedoneoftheoriginalletters.Of the18letterssubmitted,11weresentbynuclearpowerplantlicenseesandNEI,allsupporting theproposedchangeintheregulations.Theremainderofthepubliccommentscamefrom individualconcernedcitizens,allofwhomexpressedoppositiontotherelaxationofregulatory controlofchanges.TheCommissionhasconsideredthemeritsofNEI'spetition,andthepublic commentssupportingandopposingit,andhaspreviouslyacceptedthepetitioninpart,with regardtotheneedtobroadenthescopeofunilaterallypermittedQAprogramchanges.TheNRCpublishedadirectfinalrulethatamended10CFR50.54(a)toallowlicenseestomakechangestoselectedaspectsoftheirQAprogramswithoutpriorNRCapproval,as previouslyrequired.ThedirectfinalrulebecameeffectiveonApril26,1999.TheNRCnow permitsalicenseetomakethefollowingchangesunilaterally,providedthattheycontinueto meettherequirementsinAppendixBto10CFRPart50and10CFR50.34(b)(6)(ii):1.TheuseofaQAstandardapprovedbytheNRCthatismorerecentthantheQAstandardinalicensee'scurrentQAprogramatthetimeofthechange;2.TheuseofaqualityassurancealternativeorexceptionapprovedbyanNRCsafetyevaluation,providedthatthebasesoftheNRCapprovalareapplicabletoa licensee'sfacility;3.Theuseofgenericorganizationalpositiontitlesthatclearlydenotethepositionfunction,supplementedasnecessarybydescriptivetext,ratherthanspecifictitles; 4.Theuseofgenericorganizationalchartstoindicatefunctionalrelationships,authorities,andresponsibilities,or,alternately,theuseofdescriptivetext;5.Theeliminationofqualityassuranceprograminformationthatduplicateslanguageinqualityassuranceregulatoryguidesandqualityassurancestandardstowhicha licenseeiscommitted;and6.OrganizationalrevisionsthatensurethatpersonsandorganizationsperformingQAfunctionscontinuetohavetherequisiteauthorityandorganizationalfreedom, includingsufficientindependencefromcostandscheduleconsiderations,when thoseconcernsareinconflictwithsafetyconsiderations.ThegoalofthisrulemakingeffortwastoproviderelieftolicenseesbyeliminatingtheneedfordiscussionsbetweentheindustryandtheNRCstaffonchangesthatpreviouslywouldhave constitutedreductionsincommitmentthatneedpriorstaffapproval,butwhichareofminor safetysignificance.OnJune7,2000,thestaffconductedapublicworkshoptosolicitfeedbackontheimplementationoftherevisionto10CFR50.54(a)andtogatherinformationtodeterminethe needforandfeasibilityofdevelopingavoluntaryalternativerulebasedontheNEIpetition.
Workshopparticipantsacknowledgedthesignificantburdenreductionalreadyachievedthrough the1999revisionto10CFR50.54(a).Asaresultofthediscussionsattheworkshop,NEI concluded,andtheNRCagreed,thataseparaterulemakingon10CFR50.54(a)isnot needed.NEInotedthataseparaterulemakingon10CFR50.54(a)isnotneededsinceQA specialtreatmentrequirementsarebeingaddressedundertheNRC'sRisk-InformingPart50, Option2initiative.ByletterdatedAugust15,2000(AccessionNo.ML003755305),NEI documenteditsbeliefthatitisnotnecessarytopursuefurtherchangesto10CFR50.54(a) relatedtoitspetition.BylettertoNEIdatedSeptember5,2000,thestaffconfirmedNEI'sintent towithdrawtheremainderofthe1995petition.Consequently,theCommissioniscompleting actiononyourpetition.ForamoredetaileddiscussionontheNRC'sreasoninginthismatter pleaseseetheenclosedFederalRegister Notice.Sincerely,/RA/AnnetteL.Vietti-Cook
Enclosure:
FederalRegisterNotice
[7590-01-P]NUCLEARREGULATORYCOMMISSIONPRM-50-6210CFRPart50ChangestoQualityAssurancePrograms;WithdrawalofRemainingIssuesConcerningaPetitionforRulemakingAGENCY:NuclearRegulatoryCommission.ACTION:Petitionforrulemaking:Withdrawal.
SUMMARY
- TheNuclearRegulatoryCommission(NRC)isterminatingitsplanstodevelopavoluntaryoptionalternativetoitsregulationstoallowlicenseestomakeunilateralchangesto theirqualityassurance(QA)programdescriptions.Thisactionisbeingtakenbecausethe petitioner,theNuclearEnergyInstitute(NEI),haswithdrawntheremainingissuesraisedinits petitionforrulemakingsubmittedonJune8,1995(DocketNo.PRM-50-62).NEI'sactionis relatedinparttoarevisiondatedFebruary23,1999,totheCommission'sregulationsthatwas implementedinresponsetothepetitionandprovidedtheindustrywithareductionof unnecessaryregulatoryburden.Theeffectofthisactionisthatfurtherrevisionstothe Commission'squalityassuranceregulationsarenotbeingdeveloped.ADDRESSES:Copiesofthepetitionforrulemaking,thepubliccommentsreceivedonthenoticeofreceiptofthepetition(60FR47716;September14,1995),NRC'sresponsetothe petitioner,publiccommentsreceivedonthedirectfinalrule(64FR9029;February23,1999),
NRC'sresponsetocommentsreceivedonthedirectfinalrulepartiallygrantingthepetition(64 FR42823;August6,1999),thePetitioner'sletter(AccessionNo.ML003755305),statingthatit isnotnecessarytopursuefurtherchanges,andNRC'sconfirmationletter(AccessionNo. ML003747685),pertainingtothewithdrawalofthepetitionareavailableforpublicinspectionorcopyingforafeeintheNRCPublicDocumentRoom(PDR),OneWhiteFlintNorth,Room O-1F21,11555RockvillePike,Rockville,Maryland20852.Thesedocumentsarealsoavailable forperusalattheNRC'srulemakingwebsitehttp://ruleforum.llnl.gov.Questionsorcomments regardingthiswebsiteshouldbedirectedtoCarolA.Gallagherat301-415-5905or CAG@NRC.GOV.FORFURTHERINFORMATIONCONTACT:MichaelT.Bugg,OfficeofNuclearReactorRegulation,U.S.NuclearRegulatoryCommission,Washington,DC20555-0001,telephone 301-415-3221,e-mailmtb@nrc.gov.SUPPLEMENTARYINFORMATION:BACKGROUNDByletterdatedJune8,1995,NEIpetitionedtheNRCtoamenditsregulationscontrollingchangestonuclearpowerplantlicenseeQAprograms.Thepetitionwasreceived bytheCommissiononJune19,1995,andassignedDocketNo.PRM-50-62.Thepetitioner requestedthattheNRCmodify10CFR50.54(a)topermitanuclearpowerplantlicenseeto makeabroaderrangeofchangestoitsQAprogramswithoutpriorNRCapproval.Atthetime ofthepetitionsubmittal,10CFR50.54(a)(3)allowedalicenseeto"...makeachangetoa previouslyacceptedqualityassuranceprogramdescriptionincludedorreferencedintheSafety AnalysisReport,providedthechangedoesnotreducethecommitmentsintheprogram descriptionpreviouslyacceptedbytheNRC."NEIrequestedthattheCommissionamendthis requirementtoallowalicenseeto"...makeachangetoapreviouslyacceptedquality assuranceprogramdescriptionincludedorreferencedinitsSafetyAnalysisReportwithout priorCommissionapprovalunlesstheproposedchangeinvolvesachangeinthetechnicalspecificationsincorporatedinthelicenseorinvolvesanunreviewedsafetyquestion,"consistent withthecriteriaof10CFR50.59.AccordingtoNEI'sproposal,changesinvolvingunreviewed safetyquestions(USQs)wouldrequireNRCapprovalbeforeimplementation.THEPETITIONNEIstatedthat10CFR50.54(a)issometimesinterpretedbytheNRCasrequiringNRCapprovalforanychangesintheQAprogram,regardlessofthesafetysignificanceassociated withthechange.Asaconsequence,thereareoftenprolongedandsometimesunnecessary regulatorydebatesaboutthecorrectinterpretationoftheterm"reductionincommitment."NEI presentedthefollowingexamplesofchangesthatitbelievedcouldbemadewithouttheneed forpriorNRCapprovalbutthathavebeenviewedas"reductionsincommitment,"requiringprior NRCapproval:1.Changesinthelevelofapprovalofadministrative,implementation,orpolicyprocedures,regardlessofthesafetysignificance;2.Changesinthecompanyorganizationasitisdescribedinalicensee'soriginalquality plan;3.Changesinfrequencyforaudit,review,orsurveillanceactivitiesthathaveminimal,ifany,safetysignificance;4.Adoptionofamorerecentnationalstandardthatmay,ormaynot,havebeenendorsedbytheNRCstaff,thatresultsinadifferentimplementationmethodology,yetfulfills thesamefunctionandachievesthesameobjectiveastheoriginalstandarddescribedinthe QAprogramdescriptionthroughtheuseofenhancedtechnologyorotherdevelopments;and 5.Adoptionofqualityprocessesdifferentormoreeffectiveandefficientthanthosedescribedinalicensee'soriginalqualityplanbasedonthesafetysignificanceandpast operatingperformance.NEIestimatedthatNRCreviewandapprovalofthesetypesofchangescosttheindustryinexcessof$1millionperyear.Inaddition,NEIassertedthatlicenseesoccasionally werehesitanttopursueQAprogramimprovementsbecauseoftheresourcesrequiredforNRC approval,eventhoughtheultimateresultwouldbeimprovementsinefficiency,quality,or safety.NEIalsonotedthattheNRC'smainpurposeforthecurrentrequirementin10CFR50.54(a)(whichwasadoptedin1983)wastoprecludelicenseesfrommakingcertainchanges toQAprogramswithoutpriorNRCapprovalbecause,inthepast,someQAprogramshadbeen changedandnolongerconformedtoNRCregulations.NEIclaimedthatitsproposedapproach inPRM-50-62wouldstilladdresstheNRC'sconcernsbecauseQAprogramchangeswould continuetobereportedperiodicallytotheNRCasrequiredby10CFR50.71(e)asprogram updates,andchangesthatinvolveaUSQorcauseachangetothetechnicalspecifications wouldbesubmittedtotheNRCforapprovalbeforetheyareimplemented.Thepetitioner reiteratedthatthisisthesameprocessusedforchangecontrolformanyotheraspectsofthe facilitydesignandoperation,andshouldbeusedforQAprogramsaswell.NEIfurtherstated thattheproposedamendmentwouldimprovetheconsistencyoftheregulatoryprocessand wouldresultinincreasedsafetyofcommercialnuclearpowerplantsthroughmoreefficientuse ofNRCandindustryresources.COMMENTSRECEIVEDONTHEPETITION OnSeptember14,1995(60FR47716),theNRCpublishedanoticeofreceiptoftheNEIpetitionforrulemakingandprovidedanopportunityforpubliccomment.Thedocument requestedthatpubliccommentoneightspecificquestionsoncriticalregulatoryaspectsofthe NEIpetition.Seventeencommentletterswerereceived,plusonecommentletterthat supplementedoneoftheoriginalletters.ElevenofthepubliccommentlettersweresentbynuclearpowerplantlicenseesandNEI;allsupportedtheproposedchangeintheregulations.Thesixnon-NEI/non-licensee lettersweresentbyindividualconcernedcitizens(twoarecurrentlyemployedinthenuclear field);allexpressedoppositiontotherelaxationofcurrentrequirementsthataddresschanges inQAprograms.Allofthecommentlettersaddressedissuesraisedinthepetition,particularly theappropriatenessofusingthe10CFR50.59criteriaforQAprogramchanges.COMMISSIONDECISIONTheCommissionagreedwithNEIthatthe10CFR50.54(a)criteriaunderwhichalicenseewasallowedtomakeunilateralQAprogramchangeswastoostringentbecauseit preventedalicenseefrommakingQAprogramchangesofminorsafetysignificancewithout firstobtainingNRCapproval.TheCommissiondecidedthatnewcriteriashouldbeadoptedto broadenthescopeofchangesthatcouldbemadebyalicenseewithoutpriorNRCapproval.
Therefore,theCommissionacceptedthepetitioninpartandissuedadirectfinalrule(64FR 9029;February23,1999)thatrevised10CFR50.54(a)toallowalicenseetomakeadditional changestoselectedelementsofitsQAprogramwithouthavingtoobtainpriorNRCapproval.
AsofApril26,1999,alicenseeispermittedtomakethefollowingtypesofunilateralchangesto itsQAprograms: 1.TheuseofaqualityassurancestandardapprovedbytheNRCthatismorerecentthantheQAstandardinalicensee'scurrentQAprogramatthetimeofthechange;2.TheuseofaqualityassurancealternativeorexceptionpreviouslyapprovedbyanNRCsafetyevaluation,providedthatthebasesoftheNRCapprovalareapplicabletoa licensee'sfacility;3.Theuseofgenericorganizationalpositiontitlesthatclearlydenotethepositionfunction,supplementedasnecessarybydescriptivetext,ratherthanspecifictitles;4.Theuseofgenericorganizationalchartstoindicatefunctionalrelationships,authorities,andresponsibilities,or,alternately,theuseofdescriptivetext;5.Theeliminationofqualityassuranceprograminformationthatduplicateslanguageinqualityassuranceregulatoryguidesandqualityassurancestandardstowhichalicenseeis committed;and6.OrganizationalrevisionsthatensurethatpersonsandorganizationsperformingQAfunctionscontinuetohavetherequisiteauthorityandorganizationalfreedom,including sufficientindependencefromcostandscheduleconsiderations,whentheseconcernsarein conflictwithsafetyconsiderations.LicenseesshallcontinuetoconformtotherequirementsinAppendixBto10CFRPart50and10CFR50.34(b)(6)(ii)andtonotifytheNRCofthesechangesasrequiredby 10CFR50.71(e).Thedirectfinalruleprovidedimmediaterelieftolicenseesbyclearlydefining sixcategoriesofQAprogramchangesthatdonotrequireNRCapprovalpriorto implementation.OnJune7,2000,theNRCstaffconductedapublicworkshoptosolicit feedbackontheimplementationoftherevisionto10CFR50.54(a)andtogatherinformationto determinetheneedforandfeasibilityofdevelopingavoluntaryalternativerulebasedonthe NEIpetition.Workshopparticipantsacknowledgedthesignificantburdenreductionalready achievedthroughthe1999revisionto10CFR50.54(a).Asaresultofthediscussionsattheworkshop,NEIconcluded,andtheNRCagreed,thataseparaterulemakingon10CFR 50.54(a)isnotneededatthistime.ByletterdatedAugust15,2000(AccessionNo.
ML003755305),NEIdocumenteditsbeliefthat"itisnotnecessarytopursue"furtherchanges to10CFR50.54(a)relatedtoitspetition.BylettertoNEIdatedSeptember5,2000,theNRC staffconfirmedNEI'sintenttowithdrawtheremainderofthe1995petition.InthedirectfinalrulepublishedonFebruary23,1999(64FR9029),theNRCnotedthatcompletionoftheNEIpetitionshouldbeaccomplishedintwostages.Thefirststagewasthe immediateburdenreliefofpartiallygrantingtheNEIpetitionthroughthedirectfinalrule.The secondstageproposedwasafollow-onrulemakingactioninwhichcriteriawouldhavebeen developedfordeterminingotherareasinwhichunilateralchangescouldbemadebylicensees withoutpriorNRCapprovalthatwouldnotnegativelyimpactontheeffectivenessofthe licensee'sQAprogram.However,giventhepetitioner'sbeliefthatitisnotnecessarytopursue furtherchangesandbaseduponfeedbackfromapublicworkshopontheimplementationofthe directfinalrule,theNRChasdecidednottopursuethepreviouslyplannedsecondrulemaking.Forthesereasons,theNRCfindsthatalloutstandingissuesrelatingtoPRM-50-62areresolved.ThiscompletesNRCactiononPRM-50-62.DatedatRockville,Maryland,this30thdayofNovember,2000.FortheNuclearRegulatoryCommission./RA/________________________________AnnetteL.Vietti-Cook, SecretaryoftheCommission.