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.govAttachments: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.govAttachments:

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

ishelpful.

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

canbeproperlycatalogedbytheCommission.

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 CertificateofComplianceholders.

______________________________________________________________________________________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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