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)[email protected]
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Thankyou!
…QUESTIONS
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