ML19308C187
| ML19308C187 | |
| Person / Time | |
|---|---|
| Issue date: | 11/06/2019 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | |
| Wu, Irene NMSS | |
| References | |
| Download: ML19308C187 (10) | |
Text
1 PreSubmittalMeetingwith ExubrionTherapeutics November6,2019 MedicalRadiationSafetyTeam MedicalSafetyandEventsAssessmentBranch DivisionofMaterialsSafety,Security,State,andTribalPrograms OfficeofNuclearMaterialSafetyandSafeguards Agenda
- Introductionsandopeningremarks
- NRCpresentation
- Process
- Schedule
- Necessarycontentforapplication
- NRCandExubriondiscussion
- Publiccomments
2 Noticeof Intent(NOI) submitted Presubmittal meeting Application submitted Accepted for review?
Review and resubmit Publicmeeting summary issued Acceptance Review Requestsfor Additional Information(RAIs)
Issued RAI responses submitted RAI responses acceptable?
Review and resubmit DraftTechnical Evaluation(TE) issued FinalTE issued Yes Yes No No Acceptance letterissued 3
TentativeSchedule Milestone TentativeDatefor Completion Presubmittalmeetingheld November6,2019 Applicationreceived LateNovember2019 Acceptancereviewcompleted MidDecember2019 RAIsissued MidJanuary2020 RAIresponsesreceived MidFebruary2020 DraftTEissued MidApril2020 CommentsonDraftTEreceived LateApril2020 FinalTEissued Summer2020 4
3 PublicDoseRequirements
- 20.1301Doselimitsforindividualmembersofthe public(paraphrased)
- (a)Eachlicenseeshallconductoperationssothat
- (1)Thetotaleffectivedoseequivalenttoindividual membersofthepublicfromthelicensedoperation doesnotexceed0.1rem(1mSv)inayear,and
- (2)Thedoseinanyunrestrictedareafromexternal sourcesdoesnotexceed0.002rem(0.02 millisievert)inanyonehour 5
ReportingCriteria
- 10CFR20.2203Reportsofexposures,radiation levels,andconcentrationsofradioactivematerial exceedingtheconstraintsorlimits.
- (a)Eachlicenseeshallsubmitawrittenreport within30daysafterlearningofanyofthefollowing occurrences:
- (2)Dosesinexcessofanyofthefollowing:
- (iv)Thelimitsforanindividualmemberofthe publicin10CFR20.1301; 6
4 PublicDoseConsiderations
- Thesepublicdoselimitsapplytoeverydog,notto theaverage
- Licenseesareresponsibletoensurethesedose limitsaremet
- Strongscreeningcriteriaarenecessarytoensure publicdoselimitsaremetforproposeddoserateat timeofrelease
- Instructionsshouldnotberelieduponasthe primarywaytoensuringdoselimitsaremet 7
PublicDoseConsiderations(cont.)
- 10CFR20.1301(a)(2)- doselimitof0.002rem (0.02millisievert)inanyonehour
- Thisdoselimitisnotanaveragebutforanyone hour
- Distancesunderafootneedtobeconsidered.
- Screeningcriteriamaybenecessary.Instructions cansupportscreeningcriteria,butcannotbethe primarymethodwhichtheregulationismet.
8
5 RadiationArea
- 10CFR20.1003 Radiationarea meansanarea, accessibletoindividuals,inwhichradiationlevels couldresultinanindividualreceivingadose equivalentinexcessof0.005rem(0.05mSv)in1 hourat30centimetersfromtheradiationsourceor fromanysurfacethattheradiationpenetrates.
9 CurrentIssues
- Justificationseemstofocusonaveragesinsteadof individualdogs.Publicdoselimitisperdog.
- Currentdosereleaseproposalof0.5mR/hr ata1 meter
- SignificantlyhigherthanrecommendedforIodine131in cats,whichhasashorterhalflife
- Resultsinaradiationarea.Proposedmaximumdose rateattimeofreleasecannotexceedthislimit.
- Veryunlikely2mreminanyonehourcouldbemet followingdogrelease
- Closecontactwouldresultinhighdosesveryquickly, cannotbeignored 10
6 CurrentIssues(cont.)
- Attenuation
- Measurementdataneeded.Attenuationfordifferentsize dogsneedstobedemonstrated.
- Geometry,distances,anddoserateshouldbeincluded
- Closecontact(i.e.messages,dogwithlegsoverperson,lifting thedog,etc.)
- Assumptionsneedtobeconservativeorlicenseewillneed strongassuranceassumptionsaremetforeachanimal
- Figurestoshowdistanceswouldbehelpful
- Whataboutdosetoachild?
- Licenseesprocedureifadogcannotbereleased immediately 11 CurrentIssues(cont.)
12
7 ExampleAssumptionNeeding moreJustification
- Additionally,inmostposturesoflapsitting,the dogsbodywillserveasashieldformostofthe humantorsoforradiationcomingfromthedogs legsorthedogwouldbeinsuchapositionthatthe averagedistancewouldbeafootormore,i.e.
stretchedoutperpendiculartothehumanslegsor withthedogslegspointedtowardsthehumans knees.Therefore,doseratesandoccupancyfactors atadistanceof3inchesarenotdiscussedfurther.
13 InformationNeeded*
- Introduction
- ProposedGenericProceduresforRelease
- ProposedScreeningCriteria
- ProposedGenericInstructions
- TechnicalBasisSupportingProposal
- Reviewwillonlyconsiderinformationsubmittedas partofproposal.
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8 Introduction
- Scope
- Identifyinformationapplicantswillneedtoprovide
- AdministrationLimitations,i.e.
- Maximumactivity/isotope/form
- Locationoftreatment
- Minimumspacingbetweenprocedures
- Numberofdogstreatedperowner/homeoverwhat timeperiod
- TrainingspecifictoSn117muse 15 ProposedGenericProceduresfor Release
- Assumptionsandlimitations
- Releasedoserateormethodtocalculatedogspecific releasedoserates
- Screeningcriteria
- Instructions
- Survey,i.e.
- Location
- Surveymeter
- Contamination
- Documentation
- BoardingInformation 16
9 ProposedScreeningCriteria
- Definelicenseesresponsibilitytoensure 10CFRPart20ismetforeachindividualdogwithin theiruniquecircumstances.
- Describethescreeningcriteriayouproposethe licenseessubmitwiththeapplications.
- Provideproceduralstepsonhowlicenseesaregiven highconfidencethatscreeningissufficienttoensure publicdoselimitsaremet.
- Ifscreeninginitiallyshowsdogsbehaviorcouldresultin publicdoselimitbeingexceeded,describeifandhow licenseeswillallowownerstodemonstratedogscan meetmodifiedbehaviortoallowthemtobere screened.
17 ProposedGenericInstructions
- Distances
- Timelines
- Whattodointhecaseofemergencyordeath
- Ownersignature
- Describedoseifinstructionsarenotfollowed 18
10 TechnicalBasisDemonstrating Compliance
- Defendassumptions
- Provideattenuationdata
- Providedoseratedatafordifferentsizeanimals
- Figuresdemonstratingdistancesandgeometry
- Justificationforexpectedanimalbehavior
- Retentionstudies
- Totaldosesfor:
- Maximumdoseswithinstructionsandscreeningcompliance
- Maximumdosewithpoorinstructioncompliance
- Maximumlikelydosewithnoinstructionsand screeningcriteria 19