Information Notice 2001-03, Incident Reporting Requirements for Radiography Licensees

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Incident Reporting Requirements for Radiography Licensees
ML010800026
Person / Time
Issue date: 04/06/2001
From: Cool D A
Office of Nuclear Material Safety and Safeguards
To:
Smith B W
References
-RFPFR IN-01-003
Download: ML010800026 (9)
v • d • e


UNITEDSTATESNUCLEARREGULATORYCOMMISSIONOFFICEOFNUCLEARMATERIALSAFETYANDSAFEGUARDSWASHINGTON,D.C.20555April6,2001NRCINFORMATIONNOTICE2001-03:INCIDENTREPORTINGREQUIREMENTSFORRADIOGRAPHYLICENSEES

Addressees

Allindustrialradiographylicensees.

Purpose

TheU.S.NuclearRegulatoryCommission(NRC)isissuingthisInformationNotice(IN)toprovideupdatedguidanceonreportingrequirementsforradiographers.Licenseesshould reviewthisinformationforapplicabilitytotheirownproceduresandconsideractions,as appropriate.Thisincludesmanufacturersofradiographyequipmentwhoadviseradiography licenseesorpotentiallicenseesontherequirementsof10CFRPart34.However,information containedinthisnoticearenotnewNRCrequirements;therefore,nospecificactionnorwritten responseisrequired.Background:NRCissuedIN1996-04onJanuary10,1996,toalertlicenseesto,andinformthemof,thereportingrequirementsunder10CFR34.30.ThisINsupersedesIN1996-04.Theguidance providedinAttachment1ofIN1996-04hasbeenrevisedtoreflecttheamendedrequirements in10CFR34.101andhasbeenincorporatedintothisINasAttachment1.AswithIN1996-04, itisexpectedthatlicenseesusethisnoticeasaguidewhenpreparingreportsinaccordance with10CFR30.50(b)(2)and10CFR34.101.DescriptionofCircumstances:SincetheissuanceofIN1996-04,NRChasidentifiedseveralinstanceswherelicenseeshavefailedtonotifyNRC,within24hours,inaccordancewithrequirementsin10CFR30.50(b)(2),

aftertheoccurrenceofanunintentionaldisconnectionofthesourceassemblyfromthecontrol cable,andaninabilitytoretractthesourceassemblytoitsfullyshieldedandsecuredposition.ML010800026 IN2001-03Page2of3Discussion:ChangestoReportingRequirementsinPart34OnMay28,1997,NRCamendedtheregulationsinPart34.Thisamendment,inadditiontootherchanges,modifiedthereportingrequirementsandrelocatedthemfrom10CFR34.30to 10CFR34.101.ThesereportingrequirementscanbefoundontheNRCwebpageat http://www.nrc.gov/NRC/CFR/PART034/index.htmland,asguidance,questionsandanswersconcerningtheserequirementsarelistedinAttachment1.NotificationtoNRCofUnintentionalSourceDisconnectsandSourceHang-Ups10CFR30.50containsconditionsfornotifyingtheNRCOperationsCenterofevents immediatelyandwithin24hours.Notificationsarethenfollowedbywrittenreportswithin 30days.Therequirementsapplytoalllicenseeswhoselicensesareissuedinaccordancewith 10CFRPart30.Therequirementmostapplicabletoradiographylicenseesis 10CFR30.50(b)(2).ThetextofthisrequirementcanbefoundontheNRCwebpageat http://www.nrc.gov/NRC/CFR/PART030/index.html.Pursuanttotherequirementsin10CFR30.50(b)(2),unintentionaldisconnectionofthesourceassemblyfromthecontrolcableandtheinabilitytoretractthesourceassemblytoitsfully shieldedandsecuredposition(i.e.,sourcedisconnectsandhang-ups)areexampleswhere licenseesmustnotifyNRCwithin24hours.Disconnectswouldincludenotonlyseparationof thesourceassemblyfromthedrivecable,butalsolossofradioactivematerialfromthesource capsule,separationofthesourcecapsulefromthesourceassembly,andseparationofthe drivecablealongitslength.Hang-upsmayoccuratanypointalongtheintendedtravelofthe source,includingtheS-tube,theoutletfittings,theguidetube,andanyfittingsconnectedtothe endoftheguidetube(e.g.,collimator,endstops,etc.).Thenotificationmustbemadeby telephone(301-816-5100)totheNRCOperationsCenter,inaccordancewith 10CFR30.50(c)(1).ThetextofthisrequirementcanbefoundontheNRCwebpageat http://www.nrc.gov/NRC/CFR/PART030/index.html.InadditiontonotifyingNRCwithin24hours,thelicenseemustalsosubmitawrittenreporttoNRCwithin30daysoftheoccurrence,asrequiredby10CFR30.50(c)(2)and 10CFR34.101(a)(1)[sourcedisconnect]or(2)[sourcehang-up].Onereportcansatisfyboth oftheserequirements,butitmustincludeinformationrequiredby10CFR30.50(c)(2)and 10CFR34.101(b).Guidanceonthecontentsofthisreportandtowhomthereportshouldbe sentiscontainedinAttachment1.ReportingsuchproblemstoNRCisimportantbecauseitprovidestheopportunityforNRCtoverifythatthematerialhasbeenproperlysecuredandhasnotbeenreleasedintothepublic domain.Ifnotifiedearly,NRCcanhelpensurethatallnecessaryregulatoryactions arecompleted.NRCreviewsinformationsubmittedinreportstodetermineiftrendsorgenericsafetyissuesexistthathavethepotentialtocauseasignificantsafetyhazard.Ifagenericsafetyissueis IN2001-03Page3of3identified,thoselicenseesthatmaybeaffectedwillbenotifiedandinformedoftheproperactionstoreduceoreliminatesimilarincidentsinthefutureandtoprotectthehealthandsafety ofoccupationalworkersandthepublic.Licenseefailuretomaketherequiredreportshampers thiseffortandviolatesNRCregulations.Summary:TheradiographyreportingrequirementsdiscussedaboveandinAttachment1arethosemostspecifictoindustrialradiographylicensees.NUREG-1556,Vol.2,"Program-SpecificGuidance AboutIndustrialRadiographyLicensees,"providesacompletelistingofreportingrequirements, includingthosecontainedin10CFRParts20and30,andcontainsadditionalguidance.This NUREGandotherscanbefoundontheNRCwebpageat http://www.nrc.gov/NRC/NUREGS/indexnum.html.AnylicenseewithquestionsconcerningcompliancewithNRCorAgreementStaterequirementsrelatedtoreportingindustrialradiographyincidentsshouldcontacteitherNRCRegional personneloritscorrespondingAgreementStateforadvice.Manufacturersofradiography equipmentmayalsowanttodistributethisINtocustomersorincorporatethisinformationinto guidanceprovidedtocustomers.Thiscouldhelplicenseesavoidviolationsofregulatory requirementsandprovidevaluableinformationtoNRC.Trendsorgenericissuesassociated withtheconstructionoruseofradiographyequipmentcanbeidentifiedandappropriateactions canbetakentoreduceoreliminatesimilarincidentsinthefuture.ThisINrequiresnospecificactionnorwrittenresponse.TheguidancecontainedinthisINisintendedtoinformlicenseesofsomeregulatoryreportingrequirementsthathavebeen overlookedinthepast.ThisINisnotallinclusive,andlicenseesshouldrefertoanupdated copyoftheCodeofFederalRegulationstoensurefullcompliance.Ifyouhaveanyquestions aboutthismatter,pleasecontactthetechnicalcontactlistedbelow,ortheappropriateNRC regionaloffice.ThisINandotherscanbefoundontheNRCwebpageat http://www.nrc.gov/NRC/GENACT/GC/index.html#IN./RA/JosephineMPiccone,ActingforDonaldA.Cool,Director DivisionofIndustrialandMedicalNuclearSafetyOfficeofNuclearMaterialSafetyandSafeguardsTechnicalcontact:BrianW.Smith,NMSS(301)415-5723 E-mail:bws1@nrc.gov

Attachments:

1.QuestionsandAnswersforRadiographyReportingRequirements 2.ListofRecentlyIssuedNMSSInformationNotices 3.ListofRecentlyIssuedNRCInformationNotices IN2001-03Page3of3identified,thoselicenseesthatmaybeaffectedwillbenotifiedandinformedoftheproperactionstoreduceoreliminatesimilarincidentsinthefutureandtoprotectthehealthandsafety ofoccupationalworkersandthepublic.Licenseefailuretomaketherequiredreportshampers thiseffortandviolatesNRCregulations.Summary:TheradiographyreportingrequirementsdiscussedaboveandinAttachments1and2arethosemostspecifictoindustrialradiographylicensees.NUREG-1556,Vol.2,"Program-Specific GuidanceAboutIndustrialRadiographyLicensees,"providesacompletelistingofreporting requirementsandcontainsadditionalguidance.ThisNUREGandotherscanbefoundonthe NRCwebpageathttp://www.nrc.gov/NRC/NUREGS/indexnum.html.AnylicenseewithquestionsconcerningcompliancewithNRCorAgreementStaterequirementsrelatedtoreportingindustrialradiographyincidentsshouldcontacteitherNRCRegional personneloritscorrespondingAgreementStateforadvice.Manufacturersofradiography equipmentmayalsowanttodistributethisnoticetocustomersorincorporatethisinformation intoguidanceprovidedtocustomers.Thiscouldresultinlicenseesavoidingviolationsof regulatoryrequirementsandprovidingvaluableinformationtoNRC,astrendsorgenericissues associatedwiththeconstructionoruseofradiographyequipmentcanbeidentifiedand appropriateactionscanbetakentoreduceoreliminatesimilarincidentsinthefuture.ThisINrequiresnospecificactionnorwrittenresponse.Ifyouhaveanyquestionsaboutthismatter,pleasecontactthetechnicalcontactlistedbelow,ortheappropriateNRCregional office.ThisINandotherscanbefoundontheNRCwebpageat http://www.nrc.gov/NRC/GENACT/GC/index.html#IN./RA/JosephineM.Piccone,ActingforDonaldA.Cool,Director DivisionofIndustrialandMedicalNuclearSafetyOfficeofNuclearMaterialSafetyandSafeguardsTechnicalcontact:BrianW.Smith,NMSS(301)415-5723 E-mail:bws1@nrc.gov

Attachments:

1.QuestionsandAnswersforRadiographyReportingRequirements 2.ApplicableRegulations 3.ListofRecentlyIssuedNMSSInformationNotices 4.ListofRecentlyIssuedNRCInformationNoticesG:\smith\radrepreqin2.WPDML010800026OFCMSIBNMSSMSIBMSIBIMNSNAMEBSmithEKrausEK*FBrownREZ*JHickeyJWH*DCool/RA/

DATE3/01/012/28/013/01/013/01/013/21/01OFFICIALRECORDCOPY*seepreviousconcurrence Attachment1IN2001-03 Page1of4QUESTIONSANDANSWERSFORRADIOGRAPHYREPORTINGREQUIREMENTS1.WHATINCIDENTSMUSTBEREPORTED?10CFR34.101(a),paragraphs(1)-(3),describethetypesofeventsthatmustbereportedtotheU.S.NuclearRegulatoryCommission(NRC)inawrittenreportwithin30daysofthe occurrence.Theseeventsinclude:(1)unintentionalsourcedisconnectsinvolvingaseparation ofthesourcecapsuleorsourceassemblyfromthedrivecable;(2)hang-upsthatpreventthe sourceassemblyfrombeingretractedtothefullyshieldedposition,andtobesecuredinthis position,asdesignedandintended;and(3)thefailureofanyothercomponent(criticaltosafe operationofthedevice)oftheradiographyequipmentthatcouldcausetheequipmentto operateinanunsafemanner.Disconnectswouldincludenotonlyseparationofthesource assemblyfromthedrivecable,butalsolossofradioactivematerialfromthesourcecapsule, separationofthesourcecapsulefromthesourceassembly,andseparationofthedrivecable alongitslength.Hang-upsmayoccuratanypointalongtheintendedtravelofthesource, includingtheS-tube,theoutletfittings,theguidetube,andanyfittingsconnectedtotheendof theguidetube(e.g.,collimator,endstops,etc.).Examplesofthefailureofothercomponents tooperateproperly,causingthedevicetooperateinanunsafemanner,include:(1)failureof thelockorsecuringmechanismtoadequatelysecurethesourceassemblyinthefullyshielded position,therebyallowingunintendedmovementofthesourceassembly;(2)failureoftheguide tubeorcontrolstoconnecttotheexposuredeviceasintended,oroperateproperly;(3)failure ofthecouplingbetweenthesourceassemblyandthecontrolcable;and(4)failureofsource positionindicatorstoshowactualsourceposition.Thelicenseeisresponsibleforevaluating eventsthatmaybereportableunder10CFR34.101(a)andusingappropriatejudgmentasto whethertheeventisreportable.If,afterevaluation,thelicenseeisnotsurewhethertoreport theevent,werecommendthatthelicenseemakethereporttotheCommission,accordingto 10CFR34.101,andincludethereasonswhythelicenseeisunsurewhethertheevent isreportable.AsdiscussedinthebodyofthisInformationNotice(IN),thelicenseeshoulddetermineifthiseventisalsoreportable,under10CFR30.50(b)(2),andmakethenecessarynotifications.In addition,inaccordancewith10CFR21.21(a),thelicenseeshouldconsiderwhetherthefailure constitutesanequipmentdefectthatcouldcreateasubstantialsafetyhazard.Additional guidanceoncompliancewith10CFRPart21isavailableinIN91-39,"Compliancewith10CFR Part21,ReportingofDefectsandNoncompliance."

Attachment1IN2001-03 Page2of42.WHENANDWHERESHOULDTHEREPORTSBESENT?Within30daysofaneventthatisdeterminedtobereportableunder10CFR34.101(a),twocopiesofthereportmustbesubmittedtoNRC,totheaddresseeslistedin10CFR34.101(a).

TheaddresseescanbefoundontheNRCwebpageat http://www.nrc.gov/NRC/CFR/PART034/index.html.Iftheeventalsorequiresawrittenreportunder10CFR30.50(c)(2),thereportmustbesubmittedtoNRCtotheaddressincludedinthat provision,thetextofwhichcanbefoundontheNRCwebpageat http://www.nrc.gov/NRC/CFR/PART030/index.html,withacopytotheappropriateNRCRegionaloffice.NRCRegionalofficeaddressescanbefoundin10CFR30.6(b)(2)oronthe NRCwebpageathttp://www.nrc.gov/NRC/WHATIS/directio.html.3.WHATMUSTTHEREPORTSINCLUDE?Therequirementsforwhatmustbeincludedinareportarecontainedin10CFR34.101(b),andaredetailedbelow:ÿAdescriptionoftheequipmentproblem;Thedescriptionshouldincludethetypeofincident(disconnect,hangup,lockfailure,etc.)alongwithanexplanationofhowthe eventoccurred.Thisexplanationcouldincludethenumberofexposurestakenbefore theincidenthappened,thearrangementoftheequipmentatthetimeoftheincident, andtheenvironmentinwhichtheincidentoccurred(aroadsidetrench,anexposurecell, excessivelyhot,cold,orhumidconditions,etc.).Thereportshouldalwaysincludehow theincidentwasnoticed.Forexample,adisconnectmaybenoticedbyasudden releaseintensiononthecableorahighsurveymeterreadingapproachingthe exposuredevice.ÿCauseofeachincident,ifknown;Thelicenseeshouldattempttodeterminetherootcauseoftheincidenttothebestofitsabilityanddescribeitinthereport.Weare especiallyinterestedinwhyalicenseebelievesaparthasfailed,whethercausedbya manufacturingproblem,adesignflaw,improperuse,orinsufficientmaintenance.ÿManufacturerandmodelnumberofequipmentinvolvedintheincident;Thiswouldincludethesourceassembly,exposuredevice,guidetube,controlassembly,andany fittings,placedontheendoftheguidetube,thatwereinvolvedintheincident.Inall cases,informationonthecameraandsourceassemblyinvolvedintheincidentshould beprovided.Thissectiondoesnotrequireserialnumbersofequipment,althougha licenseemayincludeserialnumber(s)inthereport,andinsomecases,thisinformation ishelpfu Attachment1IN2001-03 Page3of4ÿPlace,time,anddateoftheincident;Theplaceshouldbeacompletestreetaddress,ifpossible.Ifthesitehasnoaddress,thelicenseeshoulddescribethesitetothebestof itsability,includingthenameofthesite,thenearestroadtothesite,thenearesttownor city,andanyotherdescriptiveinformationthatwouldbeusefulinidentifyingthelocation oftheincident.Thetime(includinga.m.orp.m.)theincidentoccurredandthedate(s)it occurredonmustalsobeincludedinthereport.Ifthedescriptionoftheincident includeseventsthatoccurredoverseveraldays,thedateeacheventoccurredshould beclear.ÿActionstakentoestablishnormaloperations;Thisincludesanyaction,takenbythelicenseeorotherpersons,aftertheincident,toreturntoanormalandsafesituation.It wouldincludeactionslikeattemptingtogettheequipmenttooperateproperly,posting barriersandmaintainingsurveillanceoftheareawhileasourceisexposed,andsource retrievalprocedures.Itdoesnotincludeinvestigationintothecauseoftheincidentnor correctiveactionsaftertheinvestigation(seenextsection).ÿCorrectiveactionstakenorplannedtopreventrecurrence;Thisincludestrainingpersonneltobetterdetectincidentsandbetterrespondduringincidents.Italsoincludes investigationsintothecausesoftheequipmentfailure,anyrepairsmadeonthe equipment,whethersuchequipmentwereremovedfromservice,andwhethersuch equipmentweresentfortesting.Iftestingtookplace,theresultsfromsuchtesting shouldbeprovided.ÿQualificationsofpersonnelinvolvedintheincident.Thissectiondoesnotneedtobeextensive.Allthatisneededisadescriptionofthetypesofpersonnelinvolved.For instance,wastheradiographerortheradiographer'sassistantoperatingtheequipment whentheincidentwasnoticed?Whowasoperatingtheequipmentbeforethattime?

Wastheradiationsafetyofficerinvolvedatanytime?Specificnamesarenotrequired, onlythepositionsofthepeopleinvolved.However,thefieldexperienceofthe personnelinvolvedmaybeusefulinformationtoinclude.Ifthereportisalsobeingsubmittedinaccordancewith10CFR30.50(c)(2),itshouldalso containthefollowing:ÿTheextentofexposureofindividualstoradiationortoradioactivematerialswithoutidentificationofindividualsbyname.Thisinformationcanincludepersonneldosimetryresults,self-readingdosimeterreadings,andestimatesbasedoncalculations.The informationprovided,however,shouldnotcontaintheindividuals'namesorany personalprivacyinformation(e.g.,socialsecuritynumbers,phonenumbers,datesof birth,etc.).

Attachment1IN2001-03 Page4of44.WHATIFDETAILSOFTHEINCIDENTAREREPORTABLEUNDERANOTHERREGULATION?Unlessaspecificexclusioniscontainedintheregulations,allreportsrequiredintheregulationsmustbesubmitted,regardlessofwhethertheinformationhasbeenprovided inaccordancewiththeregulationsinanotherseparatereport.However,insome situations,onereportcanbesubmittedtomultipleaddresseestosatisfyseveral requirements.AnexampleofthisisdescribedinthebodyofthisIN

[i.e.,10CFR30.50(c)(2)and10CFR34.101(a)].Asanotherexample, 10CFR34.101(b)requiresthatreportsofoverexposure,submittedunder 10CFR20.2203,whichinvolvefailureofsafetycomponentsofradiographyequipment, mustalsoincludetheinformationspecifiedfurtherinthatparagraph(discussedin Number2,above).Therefore,thereportsubmittedunder10CFR34.101(b)mayalso besubmittedtomeetpartoralloftherequirementscontainedin10CFR20.2203.

Reportssubmittedunderregulationsotherthan10CFR34.101shouldcontaina statementthattheincidentisalsoreportableunder10CFR34.101,sothatthereports canbeproperlycatalogedbytheCommissio Attachment2IN2001-03 Page1of1LISTOFRECENTLYISSUEDNMSSINFORMATIONNOTICES_____________________________________________________________________________________InformationDateof NoticeNo.SubjectIssuanceIssuedto

_____________________________________________________________________________________

2001-01TheImportanceofAccurateInventoryControlstoPrevent theUnauthorizedPossession ofRadioactiveMaterial03/26/01Allmateriallicensees.2000-22MedicalMisadministrationsCausedbyHumanErrors InvolvingGammaStereotactic Radiosurgery(GAMMAKNIFE)12/18/00Allmedicaluselicenseesauthorizedtoconductgamma stereotacticradiosurgery treatments.2000-19ImplementationofHumanUseResearchProtocolsInvolving U.S.NuclearRegulatory CommissionRegulated Materials12/05/2000Allmedicaluselicensees.2000-18SubstandardMaterialSuppliedbyChicagoBulletProof Systems11/29/2000All10CFRPart50licenseesandapplicants.

Allcategory1fuelfacilities.

All10CFRPart72licenseesand applicants.2000-16PotentialHazardsDuetoVolatilizationofRadionuclides10/5/2000Alllicenseesthatprocessunsealedbyproductmaterial.2000-15RecentEventsResultinginWholeBodyExposures ExceedingRegulatoryLimits9/29/2000Allradiographylicensees.2000-12PotentialDegradationofFirefighterPrimaryProtective Garments9/21/2000Allholdersoflicensesfornuclearpower,research,andtest reactorsandfuelcyclefacilities.2000-11LicenseeResponsibilityforQualityAssuranceOversightof ContractorActivitiesRegarding FabricationandUseofSpent FuelStorageCaskSystems8/7/2000AllU.S.NRC10CFRPart50andPart72licensees,andPart72 CertificateofComplianceholder ______________________________________________________________________________________OL=OperatingLicense CP=ConstructionPermitAttachment3IN2001-03 Page1of1LISTOFRECENTLYISSUEDNRCINFORMATIONNOTICES_____________________________________________________________________________________InformationDateof NoticeNo.SubjectIssuanceIssuedto______________________________________________________________________________________2001-02SummaryofFitness-for-DutyProgramPerformanceReports forCalendarYears1998and 199903/28/01Allholdersofoperatinglicensesfornuclearpowerreactors,and licenseesauthorizedtopossess oruseformulaquantitiesof strategicspecialnuclearmaterial (SSNM)ortotransportformula quantitiesofSSNM2001-01TheImportanceofAccurateInventoryControlstoPrevent theUnauthorizedPossession ofRadioactiveMaterial03/26/01Allmateriallicensees2000-17,Supp.2CrackinWeldAreaofReactorCoolantSystemHotLegPiping atV.C.Summer02/28/01Allholdersofoperatinglicensesfornuclearpowerreactorsexcept thosewhohasceasedoperations andhavecertifiedthatfuelhas permanentlyremovedfrom reactorvessel2000-22MedicalMisadministrationsCausedbyHumanErrors InvolvingGammaStereotactic Radiosurgery(GAMMAKNIFE)12/18/00Allmedicaluselicenseesauthorizedtoconductgamma stereotacticradiosurgery treatments2000-21DetachedCheckValveDiscnotDetectedbyUseof AcousticandMagnetic NonintrusiveTestTechniques12/15/00AllholdersofOLsfornuclearpowerreactorsexceptthosewho haveceasedoperationsandhave certifiedthatfuelhasbeen permanentlyremovedfromthe reactor


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