IdentifyingPriorityChemicalsforEPAReviewWendyCleland‐HamnettTheOfficeofPollutionPreventionandToxicsAnAgencyPriority“Morethan30yearsafterCongressenactedtheToxicSubstancesControlAct,itisclearthatwearenotdoinganadequatejobofassessingadequateassessingandmanagingtherisksofchemicalsinconsumerproducts,theworkplaceandtheenvironment.ItisnowtimetoreviseandstrengthenEPA’schemicalsmanagementandriskassessmentprograms.”EPAAdministrator,LisaJacksonJan232009OfficeofPollutionPreventionandToxics|2Jan.23,2009EnhancedChemicalMgmtEfforts•Programincludes:―Gettingtheinformationneededtounderstandchemicalrisks.Ifti―ncreasingpublicaccesstoinormaonaboutchemicals.―Targetingrioritchemicalsforaction.py―EPAhasreleasedtenchemicalactionplansthatoutlinearangeofriskmanagementactivitiesk―Regulatoryandotherrismanagementactions.OfficeofPollutionPreventionandToxics|3GoalofChemicalPrioritization•IdentifyhighestprioritychemicalstodeterminewhetherriskissignificantandhetherriskmanagementorotheractionnderTSCAsignificantwmanagementuiswarranted.–Forhazard,beginwiththosechemicalswithextensivelyrevieweddatadd/dllinicatingtheyarecarcinogens,causereprouctiveeveopmentaconcerns,orarePBTs.–Forexposure,beginwiththosechemicalstowhichchildrenand/ortheligenerapopulatonmaybeexposed.•Releaseinitialgroupofchemicalsforpriorityreviewbylatefall.–EarlyidentificationwillprovideinterestedpartiesanopportunitytoprovideadditionalrelevantinformationtoinformEPA’sreview.OfficeofPollutionPreventionandToxics|4Two‐StepPrioritizationProcess•Step1:IdentifyprioritychemicalsforreviewIdtifiitilfdidthilfi–enyannagroupocanaecemcasorrevewbyconsideringhazardandexposurepriorityfactors.–Chemicalsmeetingatleastonehazardandoneexposurefactorwouldbecomepartoftheinitialgroupofprioritychemicalsforreview.•StepSelectprioritychemicalsassessment2:prioritychemicalsforassessment–Useadditionalexposureandhazarddatasourcestofurtherprioritizethechemicals–Selectchemicalsforreviewandassessment,includingpossibleriskmanagementaction.OfficeofPollutionPreventionandToxics|5f fStep1Questions•EPAwouldlikepublicinputontheprioritizationfactors:–Chemicalsidentifiedaspotentiallyofconcernforchildren’shealth(e.g.,chemicalswithreproductiveordevelopmentaleffects).chemicalsreproductivedevelopmentaleffects).–Chemicalsidentifiedaspersistent,bioaccumulative,andtoxic(PBT).–Chemicalsidentifiedasprobableorknowncarcinogens.Chi li’t–emcasusednchildrensproducs.–Chemicalsusedinconsumerproducts.–Chemicalsdetectedinbiomonitoringprograms.•Whatotherfactors,ifany,shouldtheAgencyadd,andwhy?•ShouldanyofthefactorsproosedbyEPAnotbeused,andwhy?pOfficeofPollutionPreventionandToxics|6––Foranyadditionalprioritycriteriafactorsyoumightpropose,whatdatasourcesshouldbeconsideredtoidentifychemicalsmeetingthosefactors?–ShouldanyofthedatasourcesinTable1notbeusedandwhy?Step1Questions•EPAwouldliketogetpublicinputonthedatasourcesthattheAgencyintendstousetoidentifychemicalsthatmeetoneormoreoftheStep1prioritycriteriaf tldiacors,incung:–Whichotherdatasources,inadditiontothoselistedinTable1below,shouldtheAgencyconsiderinordertoidentifychemicalsthatmeetthelistedfactors?Whydatasourcesshouldsuchsourcesbeadded?ShouldanyofthedatasourcesinTable1notbeused,andwhy?–Shouldanyfactorsordatasourcesreceivegreaterweightthanothers,andwhy?OfficeofPollutionPreventionandToxics|7Table1:DataSourcesforOverallIdentificationPBTTRIPBTRuleGreatLakesBinationalToxicsStrategyCanadianCategorizationEPARegion5PBTIdentificationProject(SyracuseResearchCorp.)ChemicalsproposedtoUNECELRTAPPOPsandStockholmConventiononPOPsCarcinogenicityIntegratedRiskInformationSystem(IRIS)InternationalAgencyforResearchonCancer(IARC)NationalToxicologyProgram(NTP)CaliforniaProposition65(SafeDrinkingWaterandToxicEnforcementActof1986)PotentialChildren’sHealthConcernVoluntaryChildren’sChemicalEvaluationProgramCaliforniaProposition65(SafeDrinkingWaterandToxicEnforcementActof1986)IRISNTPCERHRMonographsOfficeofPollutionPreventionandToxics|8NTPCERHRMonographsTable1:DataSourcesforOverallIdentificationChildren’sProductUseWashingtonStateChildren’sSafeProductActInventoryUpdateReporting(IUR,2006)ConsumerProductUseInventoryUpdateReporting(IUR,2006)NationalInstitutesofHealth(NIH)HazardousSubstancesDataBankDanishConsumerProductStudiesHumanBiomonitoringNationalHealthandNutritionExaminationSurvey(NHANES)NationalHumanAdiposeTissueSurvey(NHATS)NationalHumanExposureAssessmentSurvey(NHEXAS)TotalExposureAssessmentMethodologyOfficeofPollutionPreventionandToxics|9ShouldcertaindatasourcesbeconsideredmoreimportantintheAgency’sanalysisthanothers?Whyorwhynot?Step2Questions•EPAwouldliketogetpublicinputonthedatasourcesthattheAi tdtf thlthilgencynensousetoureranayzeechemcasforreview,including:–ShouldadditionaldatasourcesbeyondthoselistedinTables2and3belowbeincluded?Whatsources,andwhy?–ShouldanyofthedatasourceslistedinTables2and3notbeused?Whynot?–OfficeofPollutionPreventionandToxics|10Table2:ExposureandUseDataUsesInventoryUpdateReportingInventoryReporting(IUR)Pre‐manufactureNotice(PMN)Database(confidential)HighProductionVolume(HPV)ChallengeSubmissionsScreeningInformationDataSetsSIDSDocuments()NationalInstitutesofHealth(NIH)HouseholdProductDatabaseNIHHazardousSubstancesDataBankEnvironmentalreleasesToxicsReleaseInventory(TRI)NationalEmissionInventory(NEI)DatabaseU.S.EPAPreliminaryAssessmentInformationRule(PAIR)OrganizationforEconomicCooperationandDevelopment(OECD)EmissionScenarioNIHHazardousSubstancesDataBankOfficeofPollutionPreventionandToxics|11,Table2:ExposureandUseDataGeneralhumanexposures,includingindooraircontaminantsChildren’ExposuretoPersistentPesticidesandOtherPersistentOrganicPollutantsChildrensTotalExposurePersistentPesticidesPersistentOrganicPollutants(CTEPP)StudyBrownetal.,IndoorAir,4:123‐134,1994.DaiseyAtmosphericEnvironment,‐3562,etal.,AtmosphericEnvironment,28(22):35571994.Kellyetal.,EnvironmentalScience&Technology,28(8):378A‐387A,1994.NOPESFinalReport,EPA/600/3‐90/003(NTISPB90‐152224),January1990.Samfield,M.M.Indoorairqualitydatabasefororganiccompounds.Govt.ReportsAnnouncements&Index(GRA&I),Issue12.EPA‐600‐R‐92‐025(NTISPB92‐158468),1992.ShahandSingh,EnvironmentalScience&Technology,2(12):1381‐1388,1988.Sheldonetal.,IndoorPollutantConcentrationsandExposures,CaliforniaAirResourcesBoard,ContractA833‐156,FinalReport,January1992.Shields,etal.,IndoorAir,6:2‐17,1996.OfficeofPollutionPreventionandToxics|12Table2:ExposureandUseDataEnvironmentalExposuresContaminantExposureandEffects‐TerrestrialVertebratesdatabase(CEE‐TV)EPAEnvironmentalMonitoringandAssessmentProgram(EMAP)EPA’sDatabasesonMonitoringandAssessingWaterQualityListofDrinkingWaterContaminantsandtheirMaximumContaminantLevels(MCLs)NationalAirQualitySystem(AQS)U.S.EPANationalContaminantOccurrenceDatabase(NCOD)U.S.EPACurrentNationalRecommendedWaterQualityCriteriaU.S.EPANationalWater‐QualityAssessmentProgram(USGSNAWQA)EPAFishTissueStudiesNationalSedimentInventory(NSI)TissueDataN ilTdP(NSTP)atonaStatusandrensrogramNationalStreamQualityAccountingNetwork(NASQAN)SurfaceWaterandSedimentDataU.S.G.S.OfficeofPollutionPreventionandToxics|13Table2:ExposureandUseDataWorkerExposuresInventoryUpdateReportingChemicalDataReporting(IUR/CDR)InventoryReportingandChemicalReporting(IUR/CDR)NationalOccupationalExposureSurvey(NOES)OccupationalSafetyandHealthAdministration(OSHA)monitoringstudiesPreliminaryAssessmentInformationReporting(PAIR)OECDEmissionScenarioDocumentsNIHbttkHazardousSusancesDaaBanOfficeofPollutionPreventionandToxics|14Table3:HazardDataNationalLibraryofMedicineDatabasesBiomedicalCitationsFromPubMedToxicologyCitationsFromPubMedToxicologyCitationsRegistryofToxicEffectsofChemicalSubstances(RTECS)NLMTOXLINEonTOXNETAgencyforToxicSubstancesandDiseaseRegistry(ATSDR)MedicalManagementGuidelinesATSDRPublicHealthStatementsATSDRToxicologicalProfilesATSDRToxFAQSTSCATS– TheToxicSubstanceControlActTestSubmissionDatabaseUSEPA–OfficeofPesticideProgramsReregistrationandInertsDatabasesUSEPA–AmbientWaterQualityCriteriaDocumentsUSEPA–DrinkingWaterStandardsHealthEffectsSupportDocumentsUSEPA–ECOTOXDatabaseIPCSConciseInternationalChemicalAssessmentDocuments(CICADs)OfficeofPollutionPreventionandToxics|15