Information Notice 2001-03, 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) | |
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 IN2001-03Page2of3 Discussion
- 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
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
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
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
provision,thetextofwhichcanbefoundontheNRCwebpageat
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