HazardousWasteRegulatoryComplianceAssistance:

Biotechnology,PharmaceuticalandMedicalDeviceIndustry

LilianaMejia,HazardousMaterialsSpecialistIVSanMateoCountyEnvironmentalHealthServices

Agenda•  SanMateoCountyCUPA•  HazardousWasteGeneratorProgram•  CommonViolaDons•  RegulatoryUpdates•  FacilityClosureRequirements

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CUPAProgramsSanMateoCountyEnvironmentalHealthisaCerDfiedUnifiedProgramAgency(CUPA)designatedbythestatetoimplementthefollowingprograms:• HazardousMaterialsBusinessPlan• HazardousWasteGenerator• HazardousWasteTreatment• CaliforniaAccidentalReleaseReporDng• AbovegroundPetroleumStorageAct• UndergroundStorageTanks

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HazardousWasteGeneratorProgramRegulatoryRequirements•  HealthandSafetyCode,Division20,Chapter6.5•  CodeofFederalRegulaDons,Title40•  CaliforniaCodeofRegulaDons,Title22

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Biotechnology,PharmaceuticalandMedicalDeviceIndustry•  CharacterisDcs-SanMateoCounty•  Research,developmentandmanufacturing•  Smallandlargescale

•  Requirementsfornewhazardouswastegenerators•  EPAIDnumber(CalorFederal)•  ObtainaCUPApermit•  HMBPifoverreportablethreshold

•  Typesofwaste•  Solvents•  Labdebris•  Expiredchemicals(unused)

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HazardousWasteGeneratorProgram•  TypesofGenerators•  SmallQuanDtyGenerator(SQG)•  <1,000kgofhazardouswasteof<1kgofacutehazardouswaste

•  LargeQuanDtyGenerator(LQG)•  ≥1,000kgofhazardouswasteof≥1kgofacutehazardouswaste

•  InspecDonFrequencySMC•  SQG–Every2years•  LQG–Annually

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COMMONHAZARDOUSWASTEVIOLATIONS

Biotechnology,PharmaceuDcalandMedicalDeviceIndustry

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CommonViolations•  Hazardouswastedetermina0on:Failuretodetermineifthewastegeneratedisahazardouswasteandtomaintainanalysisresultsforthreeyears.22CCR1266262.11,66262.40(c)•  Isitawaste?•  Ithastobediscarded•  NopotenDaluse•  ExpiraDondate

•  TypesofdeterminaDon•  TesDngthewaste•  ApplyingknowledgeofthehazardcharacterisDcofthewasteinlightofthematerialsortheprocessesused

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CommonViolationsCont.Closecontainers:FailuretoproperlyclosehazardouswastecontainerswhennotinacBveuse(addingorremovinghazardouswaste).22CCR1566265.173•  Containerneedstobedesignedtobeclosed.•  ApplicabletoSatelliteAccumulaDonContainers.•  EPARO14826(2009)•  Acontainer"closed"whentheyaresealedtotheextentnecessarytokeepthehazardouswasteandassociatedairemissionsinsidethecontainer.

•  Liquidhazardouswaste:allopeningsorlidsareproperlyandsecurelyaffixedtothecontainer.

•  Solidsandsemi-solidshazardouswaste:completecontactbetweenthelidandtherimallaroundthetopofthecontainer.Containersopenedbyafootpedalorwithaself-closingswingdoorareacceptable.

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CommonViolationsCont.Trainingrequirements:•  SQG:FailuretoensureemployeesarefamiliarwiththehandlingandcomplianceofhazardouswasteregulaBonsandemergencyresponse.22CCR1266262.34(d)(2);40CFR1262.34(d)(5)(iii)

•  LQG:FailuretoprovideemployeeswithinthefirstsixmonthsaJerthedateoftheiremployment,orassignmenttothefacility,ortoworkunsupervised,ortoanewposiBonatafacilitywithhazardouswastetrainingtoensureemployeesarecompetentinthefollowingareas:hazardouswastemanagementproceduresrelevanttotheposiBonsinwhichtheyareemployed,emergencyresponseandemergencyequipment,andproceduresforusing,inspecBng,repairing,andreplacingfacilityemergencyandmonitoringequipment.FacilitypersonnelmusttakepartinanannualreviewoftheiniBaltrainingandmaintainadequaterecords.22CCR1566265.16

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CommonViolationsCont.Satelliteaccumula0on:Failuretocomplywith22CCR§66262.34andHSC§25123.3(d)•  ThewasteisaccumulatedincontainersattheiniDalaccumulaDonpoint,whichisatorneartheareawherethewasteisgeneratedandwhichisunderthecontroloftheoperatoroftheprocessgeneraDngthewaste.

•  Thegeneratoraccumulatesamaximumof55gal.ofhazardouswaste,onequartofacutelyhazardouswaste,oronequartofextremelyhazardouswaste.

•  ThegeneratordoesnotholdthewasteonsiteformorethanoneyearfromtheiniDaldateofaccumulaDon,orforlongerthantheapplicableaccumulaDonperiodforSQGorLQG.

•  TheiniDaldateofaccumulaDonisclearlymarkedandvisibleoneachcontainer,andthecontainersaremanagedaccordingtoregulaDon.

•  WithinthreedaysofreachingthequanDtylimits,thegeneratormustmarkthecontainerwiththedatethatlimitwasreached,andcomplywiththeotherapplicableregulaDons.

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CommonViolationsCont.SatelliteAccumula0on:Viola0ons•  IniDalaccumulaDonstartdateisnotclearlymarked.•  HazardouswasteisconsolidatedandearliestiniDalaccumulaDonstartdateisnotrecorded.

•  Nooperator=nolongerSatelliteAccumulaDon.•  OperatoroftheprocessthatgeneratesthewasteisnotresponsibleforthesatelliteaccumulaDoncontainer(SAC).

•  NoinspecDonsajerthecontainerisinthe90/180dayaccumulaDonarea.

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Otherviolations:•  Incompletelabel•  NoweeklyinspecDons•  Failuretomaintainandoperatethefacilitytominimizethepossibilityofafire,explosion,oranyunplannedsuddenornon-suddenreleaseofhazardouswasteorhazardouswasteconsDtuentstotheair,soil,orsurfacewaterwhichcouldthreatenhumanhealthortheenvironment

•  SQG–NoemergencyposDng

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REGULATORYUPDATES

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RCRAGeneratorImprovementRule

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RCRAGeneratorImprovementRuleCont.

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RCRAGeneratorImprovementRuleCont.•  ThehazardouswastegeneratorimprovementruledoesnottakeeffectinCaliforniaunDlDTSCadoptsit.

•  ToretainstateauthorizaDon,DTSCisrequiredtoadoptthoseprovisionswithintherulethataremorestringent.

•  DTSCmayadoptprovisionsthatarelessstringentorneitherlessnormorestringent,butisnotrequiredto.

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FACILITYCLOSUREREQUIREMENTS

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RegulatoryRequirementsforLQGs22CCR§66265.111ClosurePerformanceStandard•  Minimizestheneedforfurthermaintenance•  Controls,minimizesoreliminates,totheextentnecessarytoprotect human health and the environment, post-closureescapeofhazardouswaste,hazardousconsDtuents,leachate,contaminated rainfall or run-off, or waste decomposiDonproducts to the ground or surface waters or to theatmosphere. Sa

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RegulatoryRequirementsforLQGsCont.22CCR§66265.114DisposalorDecontaminaDonofEquipment,StructuresandSoils•  Contaminatedequipment,structuresandsoilshallbeproperlydisposedof,ordecontaminated

•  Removeallhazardouswasteandresidues

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RegulatoryRequirementsforLQGsCont.ReferencescitedinsecDon22CCR§66265.111relaDngtoclosure:•  66265.197ClosureandPostClosureCareofTankSystems•  66265.228ClosureandPostClosureCareofSurfaceImpoundments

•  66265.258ClosureandPostClosureCareofWastePiles•  66265.280ClosureandPostClosureCareofLandTreatment•  66265.310ClosureandPostClosureCareofLandfills•  66265.351ClosureofIncinerators•  6265.381ClosureofThermalTreatmentfaciliDes•  66265.404ClosureofChemical,PhysicalandBiologicalTreatmentfaciliDes

•  66265.1102ClosureofContainmentBuildings

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RegulatoryRequirementsforSQGs

66262.34(d)(2)

262.34(d)(4)

40CFR265.31MaintenanceandOpera0onsofFacility

Facilitymustbemaintainedandoperatedtominimizethepossibilityofafire,explosion,oranyunplannedsuddenornon-suddenrelease

ofhazardouswasteorhazardouswasteconsDtuentstoair,soil,orsurfacewaterwhichcouldthreatenhumanhealthorthe

environment.

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OtherViolationstoConsiderHSC6.5§25189(c) A person who inten0onally disposes or causes thedisposalofahazardousorextremelyhazardouswasteatapointthatisnotauthorizedaccordingtotheprovisionsofthischaptershallbesubjecttoacivilpenalty…

(d) A person who negligently disposes or causes thedisposalofahazardousorextremelyhazardouswasteata point which is not authorized according to theprovisions of this chapter shall be subject to a civilpenalty

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OtherViolationstoConsiderCont.

HSC6.5§25189.2(c)A person who disposes, or causes the disposal of, ahazardousorextremelyhazardouswasteatapointthatisnotauthorizedaccordingtotheprovisionsofthischapterisliableforacivilpenalty…

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OtherViolationstoConsiderCont.

HSC6.5§25189.5(a)Thedisposalofanyhazardouswaste,orthecausingthereof,isprohibitedwhenthedisposalisatafacilitywhichdoesnothaveapermit…oratanypointwhichisnotauthorized…

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OtherViolationstoConsiderCont.

HSC6.5§25189.5(b)Anypersonwhoisconvictedofknowinglydisposingorcausingthedisposalofanyhazardouswaste,orwhoreasonablyshouldhaveknownthatheorshewasdisposingorcausingthedisposalofanyhazardouswaste,atafacilitywhichdoesnothaveapermit…oratanypointwhichisnotauthorizedaccordingtothischaptershall,uponconvicDon…shallgotojail...

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SanMateoCountyHazardousWasteGeneratorClosurePolicy•  Objec0ve:Provideguidancetocomplywithclosurestandards.

•  Goals:Facilityneedstodemonstratetheproperremovalanddisposalofhazardouswastesandchemicals,theabsenceofvisiblecontaminaDon,andthattherehasbeennoreleasetotheenvironment.

•  Applicability:FullandparDalclosures,andownershipchanges

•  No0fica0onrequirement:30daysbeforebeginningclosureacDviDes.

•  ClosureplanmayberequireddependingonthecomplexityoftheclosureacDviDes.

•  SanMateoCountywillclosethepermitoncealltherequirementshavebeensaDsfied.

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WorkPlan/ClosurePlan•  Historyandbackground

•  Chemicalinventory(currentandprevious)•  Proposedschedule•  DecontaminaDonprocedures•  Allsurfacesandequipmentwherehazardouswasteorchemicalswherestoredorusedneedtobecleanedtoremoveanyliquidorsolidresidues.

•  SurfacesandequipmentwherehazardouswasteordirectchemicalcontactoccurredneedtobedecontaminatedusingasoluDontoeffecDvelyremoveanychemicalresidue.

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WorkPlan/ClosurePlan–Cont.•  Samplingandanalysisplan•  Samplingcouldberequiredtovalidatetheeffec0venessofanyrequired

decontamina0ononequipmentorstructures,andtodemonstratethattherehasbeennoreleasetotheenvironment.

•  ItmustidenDfythesamplelocaDons,analyDcalparameters,applicablestandards,samplingmethods,handlingprocedures,managementandtracking,andthestate-cerDfiedlaboratorythatwillbeusedforsampleanalysis.

•  Projectmanagementteam,andHealthandSafetyPlan•  Managementofclosurederivedhazardouswaste•  IdenDfycharacterizaDonproceduresforwastethatwillbegeneratedduring

closureacDviDes.•  WastecontainerizaDon,storagelocaDons,labeling,transportaDonanddisposal,

inspecDons,etc.Allchemicalproductsmusttoberemovedfromthebuilding,andtheirdisposiDonmustbedocumented.

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CUPAOversight•  InspecDons•  Pre-inspecDon•  SamplinglocaDonsverificaDon•  SamplingobservaDon•  FinalinspecDon-REQUIRED

•  ClosuredocumentaDon •  Finalmanifests•  Samplingreportandanalysisoftheresults•  SummaryofclosureacDviDes

•  ClosureCerDficaDon•  SanMateoCountywillprovideconfirmaDonthattheclosurewasconductedincompliancewithapplicablerequirements.

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ComplianceAssistanceSanMateoCountyHealthDepartment,CUPAProgram2000AlamedadelasPulgas,SanMateoCA94403(650)372-6200hop://www.smchealth.org/hazardous-materials-cupaLilianaMejiaHazardousWasteProgramSpecialist(650)339-9791lmejia@smcgov.org

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Thankyou!

…QUESTIONS

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