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NRC Update on Regulatory Activities Affecting
Industrial Radiography
Duncan White Office of Nuclear Material Safety and Safeguards
Division of Material Safety, State, Tribal, and Rulemaking Programs
February 16, 2017
Agenda
• Category 3 Source Security and Accountability Initiatives
• Program Review of 10 CFR Part 37
• Petition to Include Electronic Dosimeters in Part 34
2
How We Got Here
2007
2009 2016
• Part 37 Program Review• GAO Audit & Investigation
• Staff Requirements Memorandum (SRM) COMJMB-16-0001
GAO (Government Accountability Office) Licensing Investigation
Initial Category 3 Evaluation
2017 2018
GAO Audit on Part 37
Category 3 Re-Evaluation
4
Who is Impacted
?Agreement
States MedicalCommunity
IndustrialCommunity
ReactorCommunity
HighDoseRemote
A:erloaders
Welllogging
Radiography Largerfixedgauges
5
GAO 2007 Licensing InvestigationGAO-07-0138T
• Obtained valid NRC license for Category 4 quantity of material using fake company
• Withdrew Agreement State application due to State’s plans for a site visit
• Ordered sufficient devices to obtain Category 3 quantity of material
• Report and testimony July 12, 2007
• Three recommendations by GAO1) Improve guidance for
screening new applicants
2) Conduct periodic oversight of license reviewers
3) Prevent the counterfeiting of NRC licenses
• NRC considers all the recommendations closed
6
Ini@alCategory3Evalua@on• January2009:Licenseesbeginrepor@ngCategory1and2sourcestotheNa@onalSourceTrackingSystem(NSTS)
• June2009:§ StaffrequestedCommissionapprovaltodeferrulemakingonexpandingtheNSTS;thisrequestwasnotapproved
§ StaffrequestedCommissionapprovaltopublishafinalruletoamend10CFRParts20and32toexpandrepor@ngtotheNSTStoincludeCategory3sources;thisrequestwasnotapproved
• Ra-onale:Originalrecommenda@onlackedadequatetechnicalbasisandopera@ngexperienceforproposedregulatoryac@on
7
Part37ProgramReview• Review found Part 37
requirements to be effective in ensuring security of risk significant radioactive material. – Report to Congress submitted on
December 14, 2016 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML16347A398)
– Comprehensive staff review conducted, supplemented by external assessment by independent consultants
8
GAO 2016 Licensing Audit and InvestigationGAO-16-330
• Obtained valid NRC license for Category 3 quantity of material using fake company
• Rented storefront/warehouse space to demonstrate legitimacy
• Unsuccessful in 2 of 3 attempts
• Obtained one license and used it to order two sources (one with valid license and one after altering license
• Two sources, in aggregate, totaled a Category 2 quantity of material
• Three recommendations made by GAO
1) Take steps needed to include Category 3 sources in NSTS and add Agreement State Category 3 licenses as quickly as reasonably possible
2) At least until such time that Category 3 sources can be verified using the License Verification System (LVS), require that transferors of Category 3 quantities confirm the validity of the recipient’s license with the appropriate regulatory agency before the transfer until such time such verification can be done using LVS
3) Consider requiring that an onsite security review be conducted for all unknown applicants of Category 3 licenses to verify that the applicant is prepared to implement the required security measures before taking possession of licensed radioactive materials
9
NRC Response to 2016 GAO Audit and Investigation
• Short and longer term actions performed– Self-assessments– Communication to Agreement States– Refresher training– Formation of two NRC/Agreement State working
groups Enhancements
to Pre-Licensing Guidance
License Verification and
Transfer of Category 3
Sources
10
Specific Tasksfrom SRM-COMJMB-16-0001
1. Evaluation of pros and cons of different methods for verification of license’s validity
2. Evaluation of pros and cons to include Category 3 sources in NSTS
3. Assessment of any additional options for addressing GAO recommendations on source accountability
4. Vulnerability assessment5. Regulatory impact analysis of benefits and costs of any
recommended changes6. Discussion on potential actions that do not require
regulatory changes and monitoring their implementation through the Integrated Materials Performance Evaluation Program (IMPEP)
7. Assessment of the risk of aggregation of Category 3 sources into Category 2 quantities
8. Collaborate with all affected stakeholders 9. Any other factors to help inform Commission’s decision
11
Category 3 Source Security and Accountability Working Group
• NRC/Agreement State working group
• Four Principal Activities1. Expand on analysis and recommendations developed by
License Verification and Transfer of Category 3 Sources Working Group
2. Perform a vulnerability assessment3. Perform a regulatory impact/cost benefit analysis4. Solicit feedback from affected communities
• Commission Paper due August 2017
12
Strategy Diagram of Interrelated Category 3 Source Security and Accountability Activities
Non-rulemaking recommen-dation: guidance, training, IMPEP
Measures for License
Verification and Transfer of
Sources
Pre-Licensing Process
Enhancements
Response to 2016 GAO Audit/Investigation of NRC and Agreement State Materials Licensing
Rulemaking recommen-dation related to safety/ security equipment
Implement Recomm-endations Rulemaking
Response to SRM-COMJMB-16-0001 “Proposed Staff Re-Evaluation of Category 3 Source Accountability”
NSTS and LVS Expansion Evaluation
Vulnerability Assessment Cost-Benefit
Analysis Stakeholder Outreach
FRN January 2017
10 CFR Part 37 Program Review
SECY-16-0113
Rulemaking Implement Recomm-endations
NEI-PRM-37-01
Use as input Use as input
Implement potential recomm-endations
CommissionPaper
August 2017
Rulemaking
Recommen- dations deferred due to overlap with new working group
10
Strategy Diagram of Interrelated Category 3 Source Security and Accountability Activities
Non-rulemaking recommen-dation: guidance, training, IMPEP
Measures for License
Verification and Transfer of
Sources
Pre-Licensing Process
Enhancements
Response to 2016 GAO Audit/Investigation of NRC and Agreement State Materials Licensing
Rulemaking recommen-dation related to safety/ security equipment
Implement Recomm-endations Rulemaking
Response to SRM-COMJMB-16-0001 “Proposed Staff Re-Evaluation of Category 3 Source Accountability”
NSTS and LVS Expansion Evaluation
Vulnerability Assessment Cost-Benefit
Analysis Stakeholder Outreach
FRN January 2017
10 CFR Part 37 Program Review
SECY-16-0113
Rulemaking Implement Recomm-endations
NEI-PRM-37-01
Use as input Use as input
Implement potential recomm-endations
CommissionPaper
August 2017
Rulemaking
Recommen- dations deferred due to overlap with new working group
Regulatory Basis Development
10 CFR Parts 30, 40, 70, 37, additional parts TBD
(also includes Part 30 rulemaking changes for financial assurance)
11
Outreach• FederalRegisterno@ce(FRN)issued,whichincludes
specificques@onsforstakeholderstoconsider• Publicmee@ngs/webinarstofacilitatefeedbackonthe
FRN• NRCHeadquarters• Houston,TX• Boston,MA
• Presenta@onstoindustrygroupsandprofessionalorganiza@ons
• Category3website:h\ps://www.nrc.gov/security/byproduct/[email protected]
15
EnhancementsunderConsidera@onAccess Controls/ Physical Barriers
Program Reviews
Incident Response
Monitoring Of Shipments
Background Checks
Law Enforcement Coordination
Written Plans/ Procedures
License Verification
SourceSecurityandAccountability
• Verification of Category 3 licenses through the License Verification System or the regulatory authority as is done with Category 1 and 2 licenses
• Inclusion of Category 3 sources in the National Source Tracking System as is done with Category 1 and 2 sources
• Expanding physical security requirements to include Category 3 quantities of radioactive material along with Category 1 and 2 quantities of radioactive material
16
Provide your input: • FRN (82 FR 2399) • Attend public meetings or
webinars Addi@onalQues@ons?
DuncanWhiteEmail:[email protected]
Phone:(301)415-2958IreneWu
Email:[email protected]:(301)415-1951
17
Whydidwedothis?§ Sec@on403,“SecuringRadiologicalMaterial,”ofPublicLaw113-235,
ConsolidatedandFurtherCon2nuingAppropria2onsAct,2015(Appropria@onsAct)
§ Sec@on402(a),“ReducingandProtec@ngVulnerableRadiologicalMaterial,”ofdra:SenateCommi\eeonAppropria@ons,EnergyandWaterDevelopmentforFY2015
§ ReportGAO-14-193,"NuclearNonprolifera@on:Addi@onalAc@onsNeededtoIncreasetheSecurityofU.S.IndustrialRadiologicalSources”
§ ReportGAO-12-925,"NuclearNonprolifera@on:Addi@onalAc@onsNeededtoImproveSecurityofRadiologicalSourcesatU.S.MedicalFacili@es”andPublicLaw113-76,theConsolidatedAppropria2onsAct,2014o theNRCcommi\edtoprovidingareportonsecurityofradioac@ve
sourcesatmedicalfacili@es-reportsubmi\edinApril2014
19
Part37ProgramReview
Inspec@o
nEven
ts
T&R
Aggregate
Training
NSTS
Internat’l
External
Outreach
Evaluateinspec-onresultsforNRClicenseesfromfirsttwoyearsofPart37implementa-ontolookfortrendsinlicenseecompliancewiththerule.
EvaluatereportedincidentsoftheGorlossofradioac-vematerialtodeterminewhethertheincidentsareindica-veofregulatoryframeworkgap.
Evaluaterequirementsandguidanceforconduc@ngbackgroundinves@ga@onsandtrustworthinessandreliabilitydetermina@ons.
Evaluateconfigura@onsusedforwellloggingsourcesandassesstheofdefini@onofaggrega@on.EvaluatetrainingprogramforNRCandAgreementStateinspectorsonsecurityofrisk-significantradioac@vematerial.
EvaluatetheNa@onalSourceTrackingSystemuserinterfaceandaccoun@ngofcategory1and2sources.
ComparePart37requirementsandguidanceagainstinterna@onalrecommenda@onsandmaterialsecurityprograms.
ExternalassessmentofPart37byindependentconsultantseachwithsignificantexperienceinsafetyandsecurityofradioac@vematerials
Gatherandevaluatestakeholderinputregardingeffec@venessandclarityofPart37.
ProgramReviewTeam
Reportto
Congress
Staffdirec@on
onPart37
Ac-vity–ScopeandMethodology StaffEvalua-on
CommissionDecision
ProgramReviewSteeringCommi\ee
StaffRecommenda-onDevelopment
Commission
Pap
er
ProgramReviewof10CFRPart37
NRCEnforcementPolicy
Severitylevelassignedtoviola2onsconsidering:• Actualsafety/security
consequences,• Poten2alsafety/security
consequences,• Poten2alforimpac2ngNRC
abilitytoperformregulatoryfunc2on,and
• AnywillfulaspectsSeverityLevelreflectsdifferentdegreesofsignificance:• SeverityLevelsI,II,III,andIV
andminorviola2ons(SLIhighestsignificance)
Evaluateinspec@onresultsforNRClicenseesfromfirsttwoyearsofPart37implementa@ontolookfortrendsinlicenseecompliancewiththerule.[mandated]
ProgramReviewof10CFRPart37
• 255inspec@ons,somelicensees>1• NoSLIorSLIIviola@ons
– Indicatestherewerenoviola@onswithactualsafetyorsecurityconsequences
• 10%ofviola@onswereSLIII– Resultedin,orcouldhaveresultedin,moderate
safetyorsecurityconsequences– Groupedissues
• 90%ofviola@onswereSLIV– Indicatesnotorela@velyinappreciablepoten@al
safetyorsecurityconsequences
21
• NRC’sNuclearMaterialEventsDatabase• Reportsofthe:orlossofcategory1or2
materialssinceeffec@vedateoforders• Category1–noreportsofthe:• Category2–sixreportsofthe:
– Circumstancesreviewed,nogapsiden@fiedinsafetyandsecurityrequirements
– AllsixreportsinvolvedmobileIr-192radiographydevices
• Onedevicenotrecovered–sourcequicklydecayedbelowrisk-significantthreshold
Evaluatereportedincidentsofthe:orlossofradioac@vematerialtodeterminewhethertheincidentsareindica@veofregulatoryframeworkgap.[mandated]
ProgramReviewof10CFRPart37Apar2allistofsafetyandsecurityrequirementsfromParts20,34,and37applicabletoradiographylicenseesmovingdevicestoandfromremotesites:• 20.1801,securelicensedmaterialfromunauthorizedremoval
• 20.1802,controlandmaintainconstantsurveillanceoflicensedmaterialnotinstorage
• 34.23,lockradiographydevices,storagecontainers,andsourcechangerswhennotunderdirectsurveillance/control
• 34.35,package(inapprovedTypeBcontainer)label,lock,andphysicallysecuredevicestopreventtamperingandunauthorizedremovalintransit
• 37.43,>category2quan22es,establishsecurityplanandimplemen2ngproceduresforopera2ons.Ensurepersonsimplemen2ngsecurityprogramunderstandresponsibili2esandtrainedannually
• 37.49,>category2quan22es,detectwithoutdelayunauthorizedentriesintosecurityzoneandimmediatelydetectunauthorizedremovalfromsecurityzone
• 37.53,>category2quan22esimmobilizevehiclewhendevicesarestoredwithinandnotunderdirectcontrol/surveillance
22
2006:truckstolenwithradiographydeviceonboardVehiclewithkeysle:unlocked.
2006:truckstolenwithradiographydeviceonboardKeysle:invehicleandsecurityalarmnotac@vated.
2011:truckbrokenintoandradiographydevicestolenSecurityalarmnotac@vated;devicestolen;notrecovered.
2012:truckbrokenintoandradiographydevicestolenNotproperlystored,le:invehicle,andstolen.Surveillancevideocapturedperpetrator.
2015:truckstolenwithradiographydeviceonboardVehiclewithkeysle:unlocked.GPSusedtolocatevehicleanddevicerecovered
2015:employee“the:”Radiographernoshowatjobsite;a\emptstocontactunsuccessful;muchlaterreturnedtofamilyresidence.Familymemberreturnedvehicleanddevicetolicensee.
Evaluatereportedincidentsofthe:orlossofradioac@vematerialtodeterminewhethertheincidentsareindica@veofregulatoryframeworkgap.[mandated]
ProgramReviewof10CFRPart37
23
AccessAuthorizaDon
Licenseesmustdevelopanddocumenttheirownplanfortheconductofbackgroundchecks.Theymustinclude,amongotherthings,inthatplan:
• Proceduresforconduc@ngbackgroundchecks,andreinves@ga@ons
• Howtheinforma@ontheygatherfrompersonnelwillbeprotected.
• Signedacknowledgementsfromeachpersonthattheyunderstandandsubmittothebackgroundcheck.
• Whatcriteriatheywillusetodetermineifapersonissufficientlytrustworthyandreliableandcanhaveunescortedaccesstothematerial.
• Proceduresforconduc@nganannualreviewoftheaccessauthoriza@onprogramtoensurecon@nualevalua@onandimprovement,ifnecessary.
• Requirebackgroundchecksforpersonnelpriortoallowingthemunescortedaccesstocategory1and2quan@@esofradioac@vematerial
• Noprescribeddisqualifyingcriteria• PRTexamined
– ThevexngprocessesinusebyotherFederalagencies(e.g.,DOT,TSA,CDC)
– ResponsesofinspectorstoTemporaryInstruc@on– Specificinspec@onissues
Evaluaterequirementsandguidanceforconduc@ngbackgroundinves@ga@onsandT&Rdetermina@ons.
ProgramReviewof10CFRPart37
24
AggregaDon
• Licenseesmustimplement10CFRPart37physicalprotec@oniftheywillaggregate≥category2.
• Iftheirlicenseallowsthemtopossess≥category2theyareallowedtouseprocessesandprocedurestoavoidaggrega@on.
• Proceduresmustbedocumented.
• Inspectorsverifycorrectimplementa@onofphysicalprotec@onforradioac@vematerialregardlessofaggregatedstatus.
• TheGAOrecommendedin2014thattheNRCreconsiderthedefini@onof“collocated”(notusedordefinedinPart37).
• Collectedpicturesofvariousstorageconfigura@ons
• InterviewedinspectorsfromNRCandAgreementStates
• Specificques@onsprovidedtostakeholdersfordiscussionatpublicmee@ngs
• Evalua@onofavailableguidance
Evaluateconfigura@onsusedforwellloggingsourcesandassessmentofdefini@onofaggrega@onofmaterial.
ProgramReviewof10CFRPart37
25
Training
EnsurethatbothNRCandAgreementStateinspectorsarequalifiedtoconductrigorousinspec@onsofphysicalprotec@onmeasuresatalltheregulatedfacili@esaninspectormustcomplete:
• Professional/educa@onalbackground:science,engineering,physicalprotec@on,military,lawenforcement
• Formaltrainingcourses
• Qualifica@onpanel
• Supportfromsupervisors,otherstaff,andexperiencedinspectorsfornewinspectorsviainspec@onshadowinganddiscussions
• Maintainqualifica@onsthroughcon@nuingeduca@onandtrainingac@vi@es
• Evaluatethecontentdepthandbreadthofphysicalprotec@ontrainingcourses
• Understandhowcoursesaremodifiedbasedonstudentfeedback
• Evaluatetherefreshercourserequirementstomaintaininspectorqualifica@ons– possiblyexpandspecificsubjects
• Conductedinterviews– bothnewandexperiencedinspectors– alllicenseetypes– bothNRCandAgreementState
EvaluatetrainingprogramforNRCandAgreementStateinspectorsregardingsecurityofrisk-significantradioac@vematerial.
ProgramReviewof10CFRPart37
26
NSTS
PartoftheIntegratedSourceManagementPorzolio,whichincludestheWeb-BasedLicensingSystem(WBL)andtheLicenseVerifica@onSystem(LVS).IstheUnitedStates’na@onalregistryofdiscretecategory1andcategory2radioac@vesources.
• ~88,000sources
• ~50%category1,~50%category2
• ~1,800licensees
• ~7,500-10,000transac@onsmonthly
• Allmanufacture,import,export,transfer,disposalisaccountedfor
• Evaluateduserexperiencewithdataentryandchangestodata
• Systemhasbeenupdatedsincedeploymentin2009
• Earlychallengeswithauthorizingusersanddataintegrity
• Solicitedcommentsandsugges@onsonsystemfromusers
*DIDNOTCONSIDEREXPANSIONOFINCLUDEDSOURCES*
EvaluateNSTSuserinterfaceandaccoun@ngofcategory1and2sources.
ProgramReviewof10CFRPart37
27
InternaDonal
TheUnitedStatesmadeapoli@calcommitmenttotheIAEACodeofConductontheSafetyandSecurityofRadioac2veSourcesuponitsrevisionandpublica@oninOctober2003.TheUnitedStatesfurthercommi\edtothesupplementalGuidanceontheImportandExportofRadioac2veSources,andincorporatedthatguidanceintoregula@onsin10CFRPart110,ExportandImportofNuclearEquipmentandMaterials.Both10CFRPart37and10CFRPart110areconsistentwiththeUnitedStatescommitmenttotheCodeofConduct,andtophysicalprotec@onofradioac@vematerialsasawhole.
• ComparedtoapplicableIAEANuclearSecuritySeriespublica@ons
• Fivecountriescompared:– Australia– Canada– Finland– France– Spain
ComparePart37requirementsandguidanceagainstinterna@onalrecommenda@onsandmaterialsecurityprograms.
ProgramReviewof10CFRPart37
28
• Providedadegreeofobjec@vityinprogramreview• Extensiveknowledgeofradioac@vematerialsafetyandphysicalprotec@onprac@ces
• Examinedspecificareas:– Clarityoftherequirementsandtheimplemen@ngguidanceandbest
prac@cesdocuments;– CompletenessandthoroughnessofPRT’seffortsintheconductof
theprogramreview;and– TheNRC’srolloutofPart37,includingtrainingandguidancefor
inspectors,communica@ontostakeholders,andAgreementStaterolloutofcompa@blerequirements.
ExternalassessmentofPart37byindependentconsultants
ProgramReviewof10CFRPart37
29
StakeholderInputTheNRCorganiza@onalvaluesinclude:SERVICEtothepublicandotherswhoareaffectedbyourwork;OPENESSincommunica@onsanddecisionmaking,and;COOPERATIONintheplanning,management,andperformanceofagencywork.Inordertobeatrusted,independent,transparent,andeffec@venuclearregulatortheNRCinvolvesmembersofthepublic,theregulatedcommunity,andallotherstakeholdersinregulatoryfunc@ons,asmuchaspossible,asastandardprac@ce.
• Extensiveoutreachonstakeholderexperiences,perspec@ves,andchallengeareas.
• FederalRegisterno@cecontainingspecificques@onsaboutPart37.– 14wri\encommentle\ersreceived
• Held4webinarsand1publicmee@ng.– Over300par@cipants– Over150specificsugges@ons
• Allcommentsevaluatedtodetermineiffollow-upac@onwaswarranted.
Gatherandevaluatestakeholderinputontheeffec@venessandclarityofPart37andguidance
ProgramReviewof10CFRPart37
30
ReportConclusion• ReporttoCongresssubmi\edonDecember14,2016
Theanalysis[…]demonstratedthatPart37providesastrongregulatoryframeworktoensurethesecurityofCategory1and2radioac2vematerials.
ADAMSML16348A230
31
Whattoexpect…• FederalRegisterno@ces:
• Mul@pletopicalandgeneralpublicmee@ngs(tradi@onalandwebinar)
• Integratedrulemakingplandevelopment• NRCstaffpresenta@ons• Revisionstoguidance
• NUREG-2155• NUREG-2166
• RegulatoryInforma@onSummaries(RIS)• Follow-onGAOPart37auditforNRCandAgreementStatelicensees• NewCommissioners?
33
Pe--onforRulemaking
• NDTMA/ASNTLe\erdatedJuly14,2016• DocketedasPRM-34-7
• FederalRegisterNo@ce81FR78732• Commentsrequestedonthreeques@ons• 13commentsreceived
• NextSteps• Evaluatecomments• Pe@@onreviewboard• Commissionapprovalneededforrulemaking
35