NRC Update on Regulatory Activities A ecting Industrial ... · NRC Update on Regulatory Activities...

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

NRC’s Category 3 Source Security and Accountability

Initiatives

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

NRC’s Program Review of 10 CFR Part 37

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]


•  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]


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.


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.


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.


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.


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.


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


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


30

ReportConclusion•  ReporttoCongresssubmi\edonDecember14,2016

Theanalysis[…]demonstratedthatPart37providesastrongregulatoryframeworktoensurethesecurityofCategory1and2radioac2vematerials.

ADAMSML16348A230

31

RELATED

ISSUES

32

Whattoexpect…•  FederalRegisterno@ces:

•  Mul@pletopicalandgeneralpublicmee@ngs(tradi@onalandwebinar)

•  Integratedrulemakingplandevelopment•  NRCstaffpresenta@ons•  Revisionstoguidance

•  NUREG-2155•  NUREG-2166

•  RegulatoryInforma@onSummaries(RIS)•  Follow-onGAOPart37auditforNRCandAgreementStatelicensees•  NewCommissioners?

33

Petition to Include Electronic Dosimeters in Part 34

Pe--onforRulemaking

•  NDTMA/ASNTLe\erdatedJuly14,2016•  DocketedasPRM-34-7

•  FederalRegisterNo@ce81FR78732•  Commentsrequestedonthreeques@ons•  13commentsreceived

•  NextSteps•  Evaluatecomments•  Pe@@onreviewboard•  Commissionapprovalneededforrulemaking

35

36

[email protected]

301-415-2598

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