November7,2014

TheMatterofAnArbitrationUndertheRulesoftheUnitedNationsonInternationalTradelaw

ChevronCorporationandTexacoPetroleumCompanyv.TheRepublicofEcuadorPCACase2009‐23

SupplementalOpinionofHarleeStrauss,Ph.D.RegardingHumanHealthRisksandHealthImpactsCausedbyCrudeOilContaminationintheFormerPetroecuador‐TexacoConcession,OrienteRegion,Ecuador

Inresponsetothefollowing:

ExpertOpinionofThomasE.McHugh,Ph.D.,D.A.B.T.,RegardingLackofEvidenceofHealthRisksAssociatedwithPetroleumOperationsintheFormer‐Petroecuador‐

TexacoConcessionArea,OrienteRegion,EcuadorMay2014

ExpertOpinionofSureshH.Moolgavkar,M.D.,Ph.D.May9,2014

ExpertOpinionOfJohnA.Connor,P.E.,P.G.,Bcee,RegardingRemediationActivitiesAndEnvironmentalConditionsInTheFormerPetroecuador‐TexacoConcession,Oriente

Region,EcuadorMay7,2014

Claimants’SupplementalMemorialonTrack2,May9,2014

Preparedattherequestof:Winston&StrawnLLP1700KStreetN.W.

WashingtonDC20006‐3817and

TheLouisBergerGroup,Inc.412MountKembleAvenueMorristown,NJ07962‐1946

Preparedby:

H.StraussAssociates,Inc.30UnionAvenueBoston,MA02130

______________________________________HarleeS.Strauss,PhD.November7,2014

November7,2014 page i

TABLEOFCONTENTS

1.0 Introduction.......................................................................................................................11.1SummaryOfScopeOfRetention.................................................................................................1

1.2SummaryOfPreviousOpinions...................................................................................................1

2.0ResponseToClaimants’CritiquesOfRiskAssessment..........................................32.1Texpet’sContaminationHasResultedInBothCancerRiskAndNon‐CancerHealthHazardsRegardlessOfWhetherTheContaminationIsConsidered“Widespread”...............................................................................................................................................5

2.2ThereAreCurrentExposuresToResiduesOfCrudeOilReleasedByTexpet,AlthoughThisIsNotARequirementForAFindingOfUnacceptableRisk.......................6

2.3ExposureParametersAreAppropriateForTheConcessionArea................................8

2.3.1DrinkingWaterIngestion......................................................................................................................92.3.2SoilAndSedimentIngestionRates.................................................................................................102.3.3FrequencyAndDurationOfBathing..............................................................................................13

2.4TPHCanBeUsedToEvaluateToxicity,EspeciallyOilRelatedToxicity,andThusToShowHealthRisks............................................................................................................................14

2.4.1DevelopmentOfANon‐CancerDoseResponseFactor(ReferenceDose)ForCrudeOilFromTheConcessionArea....................................................................................................................152.4.2MethodsForAnalyzingTPH.............................................................................................................162.4.3RiskCharacterizationBasedOnCrudeOilAsAWhole.........................................................18

2.5ThereAreSubstantialNon‐CancerHealthRisksFromExposureToCrudeOil....19

2.6.ThereAreCancerRisksFromCrudeOilExposure...........................................................21

2.6.1ToxicologyStudiesShowCrudeOilComponentsAreMutagenicAndCarcinogenic.222.6.2RiskOfCancerInTheConcessionAreaUsingHHRAMethodology.................................23

2.7ResponseToAdditionalCritiquesFromClaimants’Experts.......................................24

2.7.1BariumToxicityIsEvaluatedAppropriately.............................................................................242.7.2SurfaceWaterSamplesShouldNotBeFiltered........................................................................252.7.3ExposureIsEvaluatedAtAppropriateLocations.....................................................................252.7.4ExposureToSedimentsAndToSurfaceWaterIsEvaluatedAppropriately................262.7.5Dr.McHugh’sCitationOfHisPersonalExperienceIsCulturallyInappropriateAndAnUnreliableBasisToDevelopExposureParametersInTheConcessionArea...................26

3.0SupplementalOpinion:PetroleumContaminationHasReducedLocalFoodResources,IncludingFarmAnimals,Crops,AndFish.TheReducedAvailabilityOfHome‐ProducedFoodHasHadAnAdverseImpactOnTheHealthOfTheLocalPopulationThatReliesOnTheseResources.....................................................................273.1LossOfLivestock..............................................................................................................................27

3.2ContaminationOfFishPondAtSSF‐13..................................................................................31

3.3ImplicationsOfLivestock,Fish,WildGameAndCropLoss..........................................31

4.0SupplementalOpinion:Dr.MoolgavkarUsedHighlyFlawedDataAsTheBasisOfHisCancerStudy,MakingHisResultsAndConclusionsUnreliableAndUninformative..............................................................................................................................32

November7,2014 page ii

4.1CancerMortalityDataFromTheOrienteAreUnreliable..............................................32

4.2Dr.MoolgavkarUsesAnInappropriateMeasureOfOilExposure............................34

TechnicalAppendix1:DetailsOfTheRiskCalculations...............................................36

TechnicalAppendix2:DevelopmentOfAReferenceDoseForCrudeOil...............37

References.....................................................................................................................................39

November7,2014 page1

1.0  Introduction 

ThisreportrespondstocommentsonmyrejoinderexpertreportdatedDecember16,2013,offeredbyChevron’sexpertsMcHugh,Moolgavkar,andConnorandbyClaimantsintheirSupplementalMemorialofMay2014.IcontinuetoholdtheopinionsexpressedinmyFebruaryandDecember2013reportsandprovideadditionalevidencetosupportthoseopinionsinthisreport,includingquantitativeriskassessmentsofadditionalwellsitesinvestigatedbyLBGin2014.Ialsoprovideopinionsregardingtheadverseimpactofpetroleumcontaminationonlocalfoodproductionandhumanhealth,andtheunreliabilityofdeathcertificatedatawithregardtocancerdeathsintheConcessionArea.

1.1  Summary Of Scope Of Retention 

SinceprovidingmyexpertreportinDecember2013,Ihavebeenfurtherretainedto:1)reviewadditionalreportspreparedbyChevron’sexperts;2)traveltotheConcessionAreatopersonallyviewlocationsofadditionalfieldstudiesandtointerviewresidentsnearwellsitesstudiedbyLBGandhealthcareprovidersintheConcessionArea;3)prepareadditionalbaselinehumanriskassessmentsusingnewlycollecteddata;and4)preparethisreporttorespondtoissuesraisedbyChevron’sexpertsregardingmyDecember2013report.

Myopinionsinthisexpertreportaregiventoareasonabledegreeofscientificprobability.Theyarebasedonmyeducation,training,experience,informationanddataavailableinthescientificliterature,andinformationanddataaboutthislawsuitmadeavailabletomeatthetimetheseopinionswereformulated.TheyarealsobasedonpersonalobservationsduringmyvisitstotheConcessionAreaincludingmymostrecentvisitofapproximately10daysinJune2014.Ifadditionalinformationbecomesavailable,Ireservetherighttosupplementmyopiniontoreflectsuchinformation.

1.2  Summary Of Previous Opinions 

1)TheextractionandtransportofcrudeoilfromtheNapoConcessionAreainEcuador’sOriente(“ConcessionArea”)byTexacoPetroleum(“Texpet”)resultedinthereleaseofcontaminationintotheenvironmentthat,withsufficientexposure,istoxictohumans.

Thisremainsmyexpertopinion.Chevron’sexpertsMcHugh,Moolgavkar,andConnorcommentedonvariousaspectsofmyexpertreportintheirMay2014rebuttalreports.NoneofChevron’sexpertscontestedtheexistenceofcontaminationsourcesrelatedtocrudeoiloritscomponents.TheLBGreportshaveexaminedsourcesandtypesofcontaminantsreleasedduringoilwellinstallationandoperation,includingcontaminationattributablesolelytoTexpetoperations.Theseadditionalanalysesidentifypetroleum‐relatedcontaminantsandelevatedconcentrationsofbarium,ametalassociatedwithdrillingmuds.

November7,2014 page2

2)DuringTexpet’soperations,adultsandchildrenresidingintheConcessionAreawereexposedtocrudeoilanditsresidues,producedwater,drillingmud,hydrogensulfide,dieselemissions,andflaresviaexposurepathwaysthatresultininhalation,ingestion,and/ordermalexposures.SomeexposureisongoingatlocationswhereTexpetreleasedcontaminationremainsinenvironmentalmedia.SeveralofthepathwaysbywhichConcessionArearesidentswereexposedtocontaminantsarenotgenerallyincludedinexposureassessmentsinindustrializedcountries,butarecriticaltoconsiderbasedonthelifestyleandculturalpracticesintheOriente.Thisincludes,butisnotlimitedto,domesticuseofwatervisiblycontaminatedwithoil,walkingonlocalroadsthatwerecoatedwithcrudeoilanditsresidues,andconsumptionoffishfloating(dead)inoilcontaminatedwater.

Thisremainsmyexpertopinion.Chevron’sexpertsMcHughandMoolgavkardidnotdisputethespecificexposurepathwayslistedinmyFebruary2013report,althoughtheydiddisputewhetherthereison‐goingexposurefromthesepathwaysthatisattributabletoTexpetandishighenoughtoconstituteahealthhazard.

MyexpertopinioncontinuestobethatexposuresoriginatingfromTexpetsourcesposearisktothehealthofresidentsintheConcessionArea.Thebasisofthisopinionisthequalitativeassessmentprovidedinmyoriginalreport,strengthenedbythequantitativeriskassessmentinmyDecember2013report,andfurtherstrengthenedbytheadditionaldatacollectedinfieldstudiesconductedin2014.Myanalysisofthenon‐cancerhazardsofthemostrecentdataisdiscussedinSection2.5.MyanalysisofcancerrisksfromcrudeoilissetforthinSection2.6.

3)Adverseeffectsreportedinstudiesofoccupationalandcommunityexposurestocrudeoilincludeskinirritationandotherskinproblems,eyeirritation,throatirritation,headaches,dizziness,psychologicalproblems,perceptionofpoorhealth,leukemiaandothertypesofcancer.TheadverseeffectsreportedbyadultsandchildrenintheConcessionAreafollowingexposuretocrudeoilanditsresiduesarecompletelyconsistentwitheffectsreportedfromdermalandairexposuresinothersettings.Othersymptoms,suchasstomachproblemsanddiarrhea,areconsistentwithsymptomsofpoisoningfollowingingestionofpetroleumproducts.

Thisremainsmyexpertopinion.NoChevronexperthasdisputedthetoxicityofcrudeoilanditscomponents.AlthoughChevronexpertDr.Moolgavkarstatesthatthereareno‘goldstandard’epidemiologicalstudiesprovingadverseeffectsfromexposuretocrudeoil,Dr.McHugh—who(unlikeDr.Moolgavkar)hasatoxicologydegree—doesnotdisputetheclinicalandtoxicologicalevidenceforhealthimpactsfromexposuretocrudeoil.Dr.MoolgavkaralsoclaimsthathisepidemiologicalstudyshowstherearenoexcesscancerrisksintheConcessionArea.AsdiscussedinSection4,however,hisstudyisbasedonunreliabledataandthusisnon‐informative.

Inheropinion,Dr.BlancaLaffondescribesherstudiesoftheimmediateanddelayedimpactsofexposuretofueloilfromthePrestigeoilspilloffthecoastofSpainonworkersandcommunitymembers.Dr.PhilippeGrandjeanaddressestheepidemiologicalissues

November7,2014 page3

raisedbyDr.Moolgavkarinhisopinion.

4)Thepatterns,durations,andintensitiesofexposureintheConcessionAreaaredifferentfromtheseaspectsofexposureinoccupationalsettingsandingeneralpopulationsoftheindustrializedcountriesinwhichmostepidemiologicalstudiesareconducted.Asaresultofthesedifferences,comparableemissionsorcontaminantconcentrationswillresultinhigherexposuresanddosesofthecontaminantstochildrenandadultsintheConcessionArea,which,inturn,resultsinanincreasedlikelihoodandseverityofadverseeffectsintheexposedpopulation.

Thisremainsmyexpertopinion.MyvisitstotheOrienteregionin2014furtherconfirmedmyopinion.

5)ToxiccontaminantsreleasedintotheenvironmentduringTexpet’sexplorationandproductionofcrudeoilresultedinimmediateanddelayedadversehealtheffectsinchildrenandadultslivingintheConcessionArea.Someoftheseexposuresareon‐goingandcontinuetocreateimmediatehealtheffects.Thedelayedhealtheffectsarecontinuingtoharmresidentsfrompreviousexposuresaswellason‐goingexposures.

Thisremainsmyexpertopinion.Thisopinionwasbased,inpart,onmyquantitativeriskassessmentforfoursites,asdescribedinmyDecember2013report,andisfurtherconfirmedbytheadditionalquantitativeassessmentprovidedinthisreportandtheopinionsofDrs.LaffonandGrandjean.

6)EcuadorianandWorldHealthOrganizationdrinkingwaterstandardsareexceededintheConcessionArea

Thisremainsmyexpertopinion.ThebasisforthisopinionwasprovidedinmyDecember2013report.

2.0   Response To Claimants’ Critiques Of Risk Assessment  

Claimantsandtheirconsultantsconfusetheconceptsofhumanhealthriskassessment(“HHRA”)forregulatorypurposessuchascleanupdecisionswithwhetherasubstancecausesanadverseeffectinaspecificindividual(causation).WhileexposureassessmentmethodologycanbeusedtoestimateexposuresforregulatoryHHRAsandtoestimateadosetoaspecifiedindividualtoevaluatecausation,theevaluationshavedifferentobjectivesandthedetailsofthecalculationsdiffer.HHRAs,suchastheonesIhavepreparedforthisandpreviousreports,incorporateconservative(healthprotective)exposureparameterstoevaluateexposuretoahypothetical“reasonablymaximallyexposed”(“RME”)individual,definedas“thehighestexposurethatisreasonablyexpectedtooccuratasite”(USEPA1989,p.6‐4).RegulatoryHHRAsincludeevaluationsofexposuresduetocurrentandreasonablyforeseeablefutureusestoevaluatewhetherremediationisnecessary.ThiswastheobjectiveofmyDecember2013HHRA:todeterminewhetherremediationisnecessary,examiningeachwellsiteindividually.

November7,2014 page4

MyHHRAsarebasedonaconceptualsitemodeloftheConcessionAreaasshowninthediagrambelow.

Thecurrentconditionsscenario,so‐calledbecauseitiscurrentlyavailabletothehypotheticalRMEbeingevaluated,isbasedonresidentialexposuretogroundwater(wheresiteshavedugwells),soil,andsurfacewater,whichincludesdrinking,cooking,bathing,andlaundry.Residentialuseofsurfacewaterincludesexposuretobothwaterandsediment,withintakeofcontaminantsbyingestionanddermalcontact.Thereisfurtherexposurefromresiduesonthelaunderedclothing.Thefutureusescenarioisbasedonthesameexposures,plustheuseofadugwellasadomesticwatersupplyatsiteswherethereisnotcurrentlyadugwell.Similartothecurrentconditionsscenario,thiscouldresultiningestionanddermalexposuretogroundwater.1ConsistentwithUnitedStatesEnvironmentalProtectionAgency(“USEPA”)riskassessmentmethodology,theevaluationisconductedassumingthesameusagepatternaswouldoccurabsentanycontamination.Forthisreason,thereductioninsurfaceorgroundwateruseduetorainwaterusage(collectionbarrelsshownnearthehouse)isnotincludedintheevaluation.Thediagramalsoshowsmanyanimalspresentinthevicinityofthehouse—e.g.,chickens,ducks,cattle,anddogs.Theseanimals(andchildren)getintothecontaminatedsedimentandsurfacesoil,whichisverymuddyespeciallyduringtherainyseason,andthentrackthesoilandsedimentsontoothersurfacesoils.Allbutthecattlealsoentertheresidence,againtrackinginsoilandsedimentwhereitbecomesindoordust.ClaimantscriticizemyDecember2013HHRAshowingthatcrudeoilresiduesatfourwellsitesposesignificantrisksofadversehealtheffectstoresidentsundercurrentandfuture

1Insomegroundwatersamples,therearevolatilecompoundsathighenoughconcentrationsthatinhalationexposurecouldalsoposearisk,butthishasnotbeenquantified.

November7,2014 page5

conditions.Claimantscontendthat:1)contaminationisnot“widespread”andthusposesnorisktothepopulation;2)thereareno“actual”exposures;3)Iusedexposureparametersthataretoohigh,andthusgrosslyoverestimateexposureandrisk;and4)therearenohealthrisksfromTPH.Thesecritiquesareallbaseless,andeachisaddressedinturninsections2.1through2.4.Insection2.5,Iaddressthenon‐cancerhealthrisksofexposuretooil.Insection2.6,Iaddressthecancerriskfromexposuretooil.Andinsection2.7,IaddressmiscellaneousothercriticismsfromClaimants’experts.

2.1  Texpet’s Contamination Has Resulted In Both Cancer Risk And Non‐Cancer Health Hazards Regardless Of Whether The Contamination Is Considered “Widespread” 

InaregulatoryHHRA,humanhealthrisksareevaluatedonanindividual,notapopulation,basis.Thus,whetherornotcontaminationiswidespreadisirrelevanttomyassessmentofwhethercancerrisksandnon‐cancerhazardsexistatthelocationsexamined.AnHHRA,identifieswhetherpeoplecanpotentiallycomeintocontactwiththecontaminationunderpresentorfutureconditions,andthenevaluateshealthrisksbasedonthatcontact.Ofcourse,themore“widespread”thecontamination,thehigherthenumberofchildrenandadultswhomaybeatrisk.Therearesignificantriskstohumanhealthforcurrentand/orfutureexposures,asevaluatedbyacceptedHHRAmethodology,atallfourlocationsevaluatedinmyDecember2013rejoinderreport.Theadditionalsitesevaluatedinthisreportalsoposesignificantrisksofadversehealtheffectsundercurrentand/orfutureconditions.Forexample,additionalsamplingatLA02,apreviouslyevaluatedsite,showsoilcontaminationinthesurfacesoilthatservesasthefrontpatiowherethefamilyspendsmuchofitstime,onthefloorsofthelivingareaandkitchen,andonaplastictoyusedbyyoungchildren.Weatheredresiduesofcrudeoilarealsovisibleadjacenttothebackofthehouse,andadditionalresiduescontinuetosurfaceduetoerosionandlanduse.Thesenewdataprovideadefinitivelinkbetweenenvironmentalcontaminationinsedimentsand/orpitsoils,andeverydaylocationsofhumanexposure.Section2.2includesadditionalinformationregardingtheseexposures.WhilenotevaluatedinmyHHRA,thereisampleevidenceofpastexposurestoTexpet‐releasedpetroleumrelatedcontaminantsattheseandothersites.Theevidenceincludes:1)Chevroninterviews,auditreportsandaerialphotographyshowingtheexistenceofopenpits2andpeoplelivingincloseproximitytothemunderlivingconditionssimilartothoseevaluatedinthecurrentHHRA;2)thedecisionbyresidentstopurchasewaterforalldomesticusesduetopastcontamination(e.g.,AG06,SSF25,SSF43);and3)interviewinformationandsignedaffidavitsregardinglostfarmanimalsatmanyofthesitesevaluated(e.g.,AG02,SSF13,SSF34,SSF43).

2Clickabledatabase;LBGNovember2014ExpertReport,section2;LBG2013ExpertReport,p.23.

November7,2014 page6

2.2  There Are Current Exposures To Residues Of Crude Oil Released By Texpet, Although This Is Not A Requirement For A Finding Of Unacceptable Risk 

TheClaimants’critiquethattherearenoactualexposuresintheConcessionAreaandthusnoriskiswrongfortworeasons:1)thereareresidentswhohavecurrentexposuretopetroleumresidues,includingfrompetroleumresiduesthatcouldhaveoriginatedonlyfromTexpetactivities,and2)thedeterminantforwhetherremediationisnecessaryisbasedonthehighestexposurereasonablyexpectedtooccurgiventhecurrentandfutureexposurepathwaystoanindividual,referredtoinanHHRAasanRMEindividual.3Infact,underASTMguidance4citedbyClaimants’experts,currentexposurewouldbeidentifiedasanimmediatethreatandtriggerresponseactionstoabatetheexposure.Basedondatafromthe2013and2014siteinvestigationsconductedbyLBG,mypersonalobservationsandthoseofLBGfieldpersonnel,andwitnessinterviews,therearecurrent,on‐goingdailyexposuresofchildrenand/oradultstopetroleumcontaminantsatmultiplewellsitesincluding:

AG02–Childrenandadultsfromapproximately6residencesusethecontaminatedstreamfordrinking,cooking,bathing,andwashing5(seephotosection2.3.3).

AG06–Thefarmer/landownerreportsthathisfamilyusesrainwaterandpurchasesmunicipalwaterforalldomesticuses,butheusesthecontaminatedstreamfordrinkingwaterwhileworkinginthefield.Heestimatesthathedrinks4‐5litersofstreamwateronhotdayswhenheisworkinginhisfieldsnearthestream.Hiscowsalsodrinkfromthisstream,comeintocontactwithsediments,andbecomeill.

LA02–Theadultsandchildrenlivinginthehouseadjacenttotheplatformcomeintocontactwithpetroleumcontaminationthroughouttheday,everyday.SamplingconductedinJune2014detectedcrude‐oilrelatedcontaminationonthefloorsinthekitchenareaandlivingarea(separatebuildings),andonachild’splasticsit‐onpony.Thesurfacesoilofthefrontpatiohascrudeoilresiduesasdoesthesoilinthebackofthehousewhereasphaltchunksareembedded.Samplinginthesummerof2013identifiedcontaminatedsedimentandsurfacewaterinthewetlandsareaimmediatelydownhillfromthehouse.Thesurfacewaterisanabandonedwatersupplythatcontinuestobeusedbyfarmanimalssuchasmaturechickensandducksandthathasnobarriertoaccessbyyoungchildren.

3USEPA,1989.RiskAssessmentGuidanceforSuperfund;USEPA1991.RoleofBaselineHHRAinRemediationDecisions.USEPA1989p.6‐4:“ActionsatSuperfundsitesshouldbebasedonanestimateofthereasonablemaximumexposure(RME)expectedtooccurunderbothcurrentandfutureland‐useconditions.Thereasonablemaximumexposureisdefinedhereasthehighestexposurethatisreasonablyexpectedtooccuratasite.RMEsareestimatedforindividualpathways.Ifapopulationisexposedviamorethanonepathway,thecombinationofexposuresacrosspathwaysalsomustrepresentanRME.”

4ASTME1739‐95StandardGuideforRisk‐BasedCorrectiveActionAppliedatPetroleumReleaseSites.,p.7(Table1).ASTMInternationaldevelopsvoluntarystandardsusedglobally.

5SeealsoJoseGuamánwitnessstatement.

November7,2014 page7

LA16–Anextendedfamilylivingintwohousesusespetroleum‐contaminatedwaterfromashallowdugwellfordrinking,cooking,bathing,andlaundry.Thefamilypourswaterovertheiryoungchildrenseveraltimesaday,andmorefrequentlywhenitishot(seephotosection2.3.3).Ahousecompletedinthesummerof2014hasanewshallowdugwellthatappearstobetheirwatersupply.Thiswellisalsocontaminatedwithpetroleum.

SSF13–Theresidentsofthisfarmobtaintheirdrinkingwaterfromastreamcatchmentarea.Asamplecollectedinthesamestreamimmediatelydownstreamfromthedrinkingwaterarearevealedpetroleumcontamination.Thiswaterisusedfordrinking,cooking,bathing,laundry,andwaterforfarmanimalssuchaschickensandducks.Thechickensandducksarecagedtopreventthemfromcomingintocontactwithcontaminatedsedimentsandhighlycontaminatedsurfacesoilinaformerpit,althoughboththesedimentsandsoilarefreelyaccessibletochildren(andadults)andcattleraisedontheproperty.AtilapiapondonthefarmwhichnolongersupportsfishhascrudeoilrelatedcontaminantsinthewatersampletestedbyLBG.

SSF25–Therearetwosetsofresidentslivingnearthiswellsite.Oneresidence,apparentlyarentalfacility,isahouseonstiltsadjacenttoacontaminatedstream.Thereisevidencethattheoccupantsofthisresidenceusedthecontaminatedstreaminthepast.6WhilethereisnowameteredwatersupplypipedinfromthedugwellinLaVictoria,itisnotalwaysavailable.AsofJune2014,thestreamcontinuestoremainreadilyavailableforusebytheoccupants,twochildrenandtwoadults,whenthemunicipalwaterisunavailable.Theownerofthelandlivesinahouseadjacenttotheroadwithhiswifeandthreechildren(withanotheronthewayasofJune2014).ThishouseholdalsoreliesonwaterpipedinfromLaVictoria.Itisnotclearwhattheyusewhenthiswaterisunavailable.ThelandownerreportsthatintheSpringof2014chickens,ducks,andatleastonecowdiedafterwanderingintoacontaminatedswampyareabehindhishouse.

SSF34–Agriculturalworkerswereobservedinandnearanareaofcontaminatedsoil.Cropsarenotgrowingwellinthecontaminatedarea;theownersaidtheywerecuttingdownthepoorlygrowingpapayastotrycacao.

Inadditiontothesecurrentexposures,thereisampleevidence,basedoninterviewsandobservations,thatresidentsintheConcessionAreatrytoavoidexposuretocontaminatedsoil,water,andsedimentandhavehadtoabandonpreviouslyusedresourcestodoso.Examplesinclude:

AG06–Afamilyatthissitereplacedpreviouslyusedsurfacewaterresourceswithrainwaterandadugwell,supplementedwithpurchasedmunicipalwaterdeliveredbytankertruckeveryonetofourweeks.Thefamilynolongerusesthestreamfordrinking,cooking,bathing,swimming,orlaundry.Thefamilyalsoprovideswaterfortheirchickensandpets,whichtheyreportedwereharmedbydrinkingandstandinginthestreamwater.

6ThisusewasdescribedanddocumentedinmyDecember2013report.

November7,2014 page8

LA02–Thisfamilyusesrainwaterandawellsomedistanceawayfromtheirhometoavoidusingthecontaminatedstreamadjacenttotheirhousethathadbeenadrinkingwatersource(andthatthemotherhadusedwhilegrowingupatthislocation).Themotherwashesthelaundryinthestreamdowntheroadnearherparents’houseinsteadofthemoreconvenient,buthighlycontaminated,areaofthestreamadjacenttoherhouse.Thefatherreportsthatheteacheshischildrennottoplayinthecontaminatedsediment,andhehasbuiltacagetopreventveryyoungchickensandducksfromgettingintothecontaminatedsedimentswheremanyhavedied.Thefathercoveredapetroleumcontaminatedpitonhispropertysothathisadultchickens,ducksandgeesewouldstopfallingintoitanddying.

SSF13–Thefamilyonthisfarmcagesitsducksandchickenstopreventthemfromdyingasaresultofcontactwithcontaminatedsedimentandwater.

SSF25–Theresidentsofbothhousesatthissitepurchasemunicipalwatertoreplacepreviouslyusedsurfacewater.However,becausethemunicipalwaterisnotalwaysavailable,theymaycontinuetousesurfacewateraswell.

SSF43–Theresidentsnolongerusetheirdrinkingwaterwell,whichiscontaminatedwithpetroleum,becausetheysaidtheodorofpetroleumwasnoticeable.7Thelossofthisresourcehasforcedthisfamilytopayfortankertruckstodelivercommunitywater.Thisfamilyalsoprohibitstheirchildrenfromhavingpetsbecauseitistoosadwhentheanimalsdieafterenteringthecontaminatedwetlandsarea.Thefamilynolongermaintainslivestockbecauseoftheirinabilitytokeepthemoutofthecontaminatedarea.

2.3 Exposure Parameters Are Appropriate For The Concession Area 

InaregulatoryHHRA,exposureiscalculatedforahypotheticalperson,andisintendedtorepresentanRME.Thecalculationincorporatesseveralparameterssuchas:howfrequentlypeopleareexposed,howlongtheyareexposed,howmuchwaterpeopledrink,andhowmuchsoil/sedimenttheyingest,amongothers.TheexposureparametersIusedinmyDecember2013HHRAareappropriatefortheruralareasoftheConcessionArea,withtheintentionofcalculatinganRMEundercurrentorfutureconditions.Inseveralcases,theexposureparametersarehigherthanareusedbytheUSEPAbecauseofthedifferencesinclimateandinthedailyactivitiesofthesubsistencelifestylemaintainedbytheruralresidentslivingnearConcessionAreawellsites.Theexposureparametersarethereforenotoverlyconservativeandtheydonotoverestimaterisk,asClaimants’consultantsallege.Infact,asIpointedoutinmyDecember2013opinion,manyexposurepathwayswerenotevaluatedduetolackofdata.Asaresult,myHHRAmorelikelyreflectsanunderestimate,ratherthananoverestimate,oftheriskofharmtotheresidents.Theuseofsite‐specificdataoverstandardizedassumptions(defaultvalues)hasbeenpartofUSEPAandotheragencyriskassessmentpoliciesfordecades.Forexample,awidelyusedUSEPAdocumentstates:7ThiswellwastestedbyLBGinJune2014.TheresultscanbefoundintheLBGNovember2014ExpertReport,AppendixASiteInvestigationandDataSummaryReport.

November7,2014 page9

“EPA has made a policy decision to use, wherever appropriate,standardized assumptions, equations, and values in the human healthevaluation to achieve the goal of streamlined assessment.This approachhastheaddedbenefitofmakinghumanhealthevaluationeasiertoreview,easier to understand, andmore consistent from site to site. Developingunique exposure assumptions or non‐standard methods of riskassessmentshouldnotbenecessaryformostsites.Wherejustifiedbysite‐specific data or by changes in knowledge over time, however, non‐standardmethodsandassumptionsmaybeused.”8

Thehotandhumidclimateandsubsistencelifestyleofresidentsexposedtocontaminationatthewellsitesbeingevaluatedprovideclearjustificationfortheuseofnon‐standardexposureparameters.Thesectionsbelowexplainwhatsite‐specificexposureparameterswereusedandwhytheyareappropriatetoevaluateriskintheConcessionArea.

2.3.1 Drinking Water Ingestion 

ThedrinkingwateringestionrateusedinmyHHRAsisappropriatefortheclimateintheOrienteandthedailyactivitiesoftheruralresidentsinthisarea.Thebasisfortheuseof7.5liters/dayintheConcessionAreawasprovidedinAppendixAofmyDecember2013RejoinderReport.ThisdrinkingwaterintakerateisfarmoreappropriatefortheConcessionArearesidentsevaluatedthanthe2liters/dayconsumedbyanofficeworkerintheUS,asadvocatedbytheClaimantsandtheirconsultants.9AdditionalsupportforthiswaterintakelevelisprovidedbyUSguidanceforagriculturalworkersworkinginhotweather,conditionsconsistentwiththoseoftheruralresidentsoftheConcessionArea.TheUSOccupationalSafetyandHealthAdministration(“OSHA”)recommends1liter/hourfluidconsumptionduringworkinghourswhentheheatindexisgreaterthan91oF.10TheheatindexfrequentlyreachesthislevelintheOriente.TheStateofCaliforniaalsorequiresthatemployersprovideatleast1L/hourpotablewaterforeachoutdoorworkertopreventheatstress.11Thesedrinkingwaterratesforoutdoorandagriculturalworkersareconsistentwith,orevensuggestanunderestimationof,the7.5liters/dayintakeusedinmyHHRAs,whichwasbasedon,amongotherthings,USArmyguidanceforwaterintakeforrefugeesinahot8USEPA1989,pp.3‐1to3‐2.

9USEPAincreasedthedefaultdrinkingwaterrateforadultsfrom2to2.5L/dayinFebruary2014.USEPAFeb2014a,bOSWERDirective9200.1‐120.

10OSHA(OccupationalSafetyandAdministration)HeatIndexandProtectiveMeasures(accessedonOSHAwebsiteOct2014).Theheatindexisacombinationoftemperatureandhumidityandreflectsthe“felttemperature.”

11CaliforniaDepartmentofIndustrialRelationsHeatIllnessPreventionStandardTitle8CCR3395:http://www.dir.ca.gov/Title8/3395.html.

November7,2014 page10

climate.Higheractivitylevels,suchasthoseinvolvedinfarming,requirehigherwaterconsumption(separatefrom,andinadditionto,hotclimateconsiderations).InterviewsconductedwithConcessionArearesidentsinJune2014supportwaterintakelevelsofatleast7.5literseachday.Forexample,theownerofthefarmnearAG06saidhedrinks4‐5litersofwater(fromthestream)whileinthefieldonsunnydays,lessondaysthatarenotsunny.Thisintakedoesnotincludewaterconsumptionwhileathomeorwaterusedinfoodpreparation.Iamawareofnodataoroccupationrecommendationsfordrinkingwaterintakeforchildreninahotandhumidclimate.MyHHRAusedavalidmethodologybasedonphysiologytoestimateachild’swaterconsumptionratecomparedtoanadult’sconsumptionrate.Todiscreditthisevaluation,Dr.McHughreferencedanirrelevantcasereportbyBruceandKleigman(1997)thatdescribestwoinfantsinatemperate/chillyclimate(Wisconsin,US)whoseverypoor,youngmothersfedthembottleddrinkingwatertosupplementtheirinfantformula.Theresultwasanelectrolyteimbalance.Asnotedinmyearlierreports,livinginahotclimaterequiresahigherfluidintaketooffsetthelossofwaterthroughsweattoremaincool.Dr.McHugh'scitationprovidesnoinformationregardingappropriatedrinkingwaterintakeforinfantsandyoungchildrenintheConcessionArea.Inaddition,Dr.McHughprovidesnoevidencetosupporthiscontentionthatbreastfeedingisthesourceoffluidsforinfantsandyoungchildren.UNICEFdatafrom2004showthatabout40%ofEcuadorianwomenbreastfeedexclusivelyfor6months,anincreasefrom1999.12TheMinistryofPublicHealth(Ecuador)summarizesdatafrom2008showingthat,inruralzones,theaveragedurationofexclusivebreastfeedingis3.6monthsforthe53.9%ofwomenwhobreastfeedexclusively.13Moreover,evenforbreastfedinfants,hydrophobiccomponentsofoilsuchasPAHsandotherpolycyclicaromaticcompoundsareexcretedinbreastmilkandthuspassedontobreastfeedinginfantsleadingtohigherexposurethanestimatedintheHHRAs.14 

2.3.2 Soil And Sediment Ingestion Rates 

TherehavebeenmanystudiesofhowmuchsoilisingestedduringdailyactivitiesintheUS,Europe,andelsewhere.15Soilistypicallyingestedwhenitgetsonhandsorotherobjectsandtheobjectsgetputintothemouth.Inmostcases,soilingestionishigherinyoungchildrenthanadultsbecausechildrenhavemorehand‐to‐mouthandobject‐to‐mouthactivities.Bothchildrenandadultsingestsoilthatgetsintothehouseandbecomespartofindoordust,settlingonfoodorindoorobjectssuchastoysorglasses.Soilcanalsobeingestedonfruitsorvegetablesthatarenotthoroughlywashed.

12UNICEFdatahttp://www.indexmundi.com/facts/ecuador/exclusive‐breastfeeding.

13MinisteriodeSaludPúblicadelEcuadorFunbbasic/Ibfan.May2009.WorldBreastfeedingTrendsInitiative.NationalReport.

14DelBubbaetal2005.PAHsandfatcontentinbreastmilk.AnnaldiChimica95:629‐642.OEHHA2014.Table5.5p.5‐22.

15USEPA2011.ExposureFactorsHandbook.EPA/600/R‐09/052F.

November7,2014 page11

Theamountofsoilingestedeachday(i.e.,theingestionrate)dependson,amongotherthings,thefrequencyofhandtomouthactivity,andtheamountofdirtonhandswhentheseactivitiesoccur.Theamountofindoordustalsoplaysarole.Sedimentingestionoccursforthesamereasonsassoilingestion,althoughithasbeenlesswellstudied.16TheConcessionArearesidentsareexposedtosedimentinasimilarwayassoil,includingtrackinginandbecomingpartofindoordust.ThecommonpracticeinUSEPA‐typeHHRAsistosetthesedimentingestionratetothesamevalueastheresidentialsoilingestionrate.

ExamplesatLA02ofwhysoilandsedimentingestionoccurs

SoilandsedimentingestionratesarenodoubthigherintheruralpartsoftheConcessionAreathanistypicalintheUSforseveralreasonsincluding:1)wetandoil‐contaminatedsoil17adherestohandsandotherobjectsmorethandrysoil,2)peoplespendmostoftheirdayoutdoors(resultinginahigheringestionrate),18and3)soilandsedimentareregularlytrackedintohomesonadailybasisduetotheoutdoorlifestyleandthepresenceoffarmanimalsindoors.

16Fromthepointofviewofanexposureassessment,thedifferencebetweensoilandsedimentisthelocation(i.e.,sedimentislocatedinwaterwaysorwetlands)andthatsedimentiswet,whichmeansitadherestoskininathickerlayerthandrysoil.

17USEPA2011,ExposureFactorsHandbookEPA/600/R‐09/052Fatpp.7‐20.

18VanWijnenetal.1990.CitedinUSEPA2011ibidatpp.5‐10.

playwithdog,dogtrackssoilandsedimentintohouse

PatioLA02

chickentracksinsoilandsediment

LivingSpaceLA02

dustfromsoilandsedimentonfood(potatosinchair)

KitchenLA02

November7,2014 page12

My2013HHRAevaluatedsedimentingestionbutnotsoilingestionbecausesurfacesoilsamplingwasnotincludedinLBG’s2013samplingprogram.Forthereasonsjustdescribed,Iusedsoilingestionratestoanalyzethesedimentingestion.Foryoungchildren,Iusedarateof200mg/day,whichistheUSEPAhighendingestiondefaultrate.19Foradults,Iusedaningestionrateof100mg/day,basedontheUSEPAhighenddefaultrateforadultresidentialexposuretosoil.20Dr.McHughclaimedthatmy2013HHRAoverstatedtheingestionrateforsediments.ButthemethodologyappliedinmyHHRAisidenticaltothatwhichwouldbeappliedatahazardouswastesiteintheUSwheresoilingestionratesareoftensubstitutedforsedimentingestionrates.Moreover,intheConcessionArea,theindoordustcomponentoftheingestionrateislikelytobederived,inpart,fromsedimenttrackedintothehousebypeopleandanimals.Thus,becausetheconditionsintheConcessionArearesultinahigheringestionofsoilandsedimentthanisanticipatedand/orprovidedforintheUS‐basedstudiesonwhichthisingestionrateisbased,200mg/dayforchildrenand100mg/dayforadultsshouldbeconsideredtobeamoderateestimateofsoilandsedimentingestionintheConcession,notanoverestimate.LBG’s2014samplingprogramincludedbothsedimentandsurface(orshallow)soil.InmycurrentHHRA,Ievaluatedsedimentdatainthesamemannerasmy2013report(200mg/dayforchildrenand100mg/dayforadults)usingthesameHHRAmethodologydescribedinmy2013report.Forsoil,Iusedthesame200mg/dayforchildrenand100mg/dayforadultsforresidentialexposure.Forcertainsites,Iuseda200mg/dayexposurerateforadultsbecausetheirexposureisagriculturalinnature.Theamountofsoilingestedbyadultsinagriculturalandotherhighsoilcontactsettingsishigherthaninresidentialareas,whichiswellknownandacknowledgedbyUSindustry.Forexample,GeneralElectricsuggestedasoilingestionrateof136mg/dayforutilityworkersandagriculturalworkersincommentsona2004HHRApreparedbytheUSEPA.21Morerecently,theCaliforniaEnvironmentalProtectionAgencypublishedahighendsoilingestionestimateforadultsof210mg/day.22Liketheirchildren,adultsintheConcessionAreawillingestmoresoilthananadultofficeorfactoryworkerintheUS,andahighendsoilingestionratebasedondatacollectedintheUSandEuropewillbeclosertoacentraltendencyingestionrateintheConcessionArearesidencesandfarmsnearwellsites.

19IntheUS,studiesofsoilingestionrates–whichareusuallyconductedinurbanandsuburbansettingswheremuchtimeisspentindoors–showthatratesvaryamongtheparticipatingindividuals.EPAsummarizeshighendandcentraltendencyestimatesoftheseexposuresc.f.EPA2011op.cit.Table5‐1.p.5‐5,andgenerallyrecommendstheuseofthehighendratesinHHRAcalculationsfortheRME.

20USEPA2014b.

21ExcerptfromaresponsebyGeneralElectrictoaUSEPAriskassessmentfortheHousatonicRiverinMassachusetts.

22CAEPA(OEHHA)DraftHotSpotsProgramGuidanceManual)September2014.

November7,2014 page13

Finally,Dr.McHugh'sunsupportedassertionthatstreamsedimentsareconstantlycoveredwithwatershowshisunfamiliaritywiththeseasonalityofthewaterlevelsintheConcessionArea,andtheextentofsedimentcontamination.Thecontentionthatthecontaminatedsedimentsarealwaysburiedundercleansedimentsisalsofalse.Allofthesedimentsamplescollectedinthe2014samplingprogramandmostofthesedimentscollectedin2013(includingallthesamplesincludedintheriskcalculation)aresurfaceandshallowsediments.Thesesedimentsareoreasilycouldbeencounteredbyresidents,e.g.,astheystandinthestreamstowashclothing,orbyanimalsdrinkingstreamwater,andthentrackedintohouses—andtheyarecontaminatedwithpetroleum.23

2.3.3 Frequency And Duration Of Bathing 

IusedUSEPAdefaultvaluesforbathingfrequencyanddurationinmy2013HHRA.AdditionalinformationwascollectedinJune2014fromobservationandinterviewdataintheConcessionArea.Bathingisusedforbothcleaningandheatrelief.MothersinruralareasrelevanttotheHHRAreportedbathingtheirchildrenatleastonceeachday;severalreportedbathingtheirchildrenmultipletimesperday,includingthemotherofyoungchildrenatLA16.Asshownbelow,bathingatLA16meansusingabuckettopourwateroverthechild.Thisprocessisrepeatedmanytimesperbathingeventaddingtothetotalamountoftimethewaterremainsontheskin.Inotherlocations,childrenareimmersedinwater.Forexample,atAG02(shownbelow),childrenandadultsbatheandwashlaundrywhileimmersedinastream. 

 bathingandwashingatLA16bathingandwashingatAG02Thedurationofbathingisvariableandlesswellknown.MyHHRAreliedonUSEPAguidanceineffectwhentheriskassessmentwasprepared,onehourforyoungchildrenand35minutesforadultsandchildrenover6.InFebruary2014,theUSEPAchangeditsrecommendationfordefaultvaluesbasedonmorerecentdata.24Theyoungchildbathing

23LBGDecember2013RejoinderReport,AppendixBSiteInvestigationandDataSummaryReportandLBGNovember2014ExpertReport,AppendixASiteInvestigationandDataSummaryReport.

24USEPA2014a,bOSWERDirective9200.1‐120datedFebruary6,2014.

November7,2014 page14

durationwasreducedto32minutesandtheolderchildandadultbathingdurationwasincreasedto43minutes.UseofUSdatamayunderestimatethetypicallengthofdermalcontactwithwaterbecauseConcessionArearesidentsusethesamesurfacewaterforbathing,swimming,andlaundry,andtheclimateishotterandmorehumidthantypicalintheUS.InresponsetoChevron’scriticisms,Icalculatedcancerriskandnon‐cancerhazardsbasedonboth30minuteand60minutedurationbathingforyoungchildren.Thedurationofthebathingmadelittletonodifferenceintheriskcalculations,andnodifferenceinconclusionsbasedonexceedanceofabenchmarkbecausedermalexposuretowaterisjustoneofseveralcontributorstotheoverallriskatmostofthewellsites.Fortheriskcalculationsreportedbelow,IusedtherevisedUSEPArecommendations. 

2.4 TPH Can Be Used To Evaluate Toxicity, Especially Oil Related Toxicity, and Thus To Show Health Risks 

ItisundisputedthatDr.McHughdidnotevaluatehealthrisksfromTPHinhisriskassessments.Inpart,hearguedthatitwasimpossibletoevaluaterisksfromTPH.Inthissection,Iprovideamethodology,explainedbelow,toevaluatehealthrisksassociatedwithexposuretocrudeoilanditsresiduesusingTPHasameasureofconcentrationandpetroleumindustrygeneratedtoxicitydataforcrudeoil.IfurthershowthatTPHmeasuredbytotalextractablematerial(TEM)methodprovidesthemostappropriatemeasureofTPHconcentrationtouseinthisevaluation.ThefourstepmethodologyforconductinganHHRA,appliedhere,wasdescribedinbothofmypreviousexpertreports:1)hazardidentification;2)dose‐responseassessment;3)exposureassessment;and4)riskcharacterization.25Thegoalistocharacterizetheriskofhealtheffectstodetermineifcleanupiswarranted.Thefirststeptoachievingthisgoalistoidentifythehazard.IntheConcessionArea,thehazardiscrudeoilanditsresidues,hazardsthathavebeendescribedbasedonclinicalstudies,toxicologystudies,andepidemiologicalstudies.Thedoseresponseassessmentisusuallybasedontoxicity(animal)testing.TheAmericanPetroleumInstitute(“API”)(2011)hassummarizedtoxicitytestsofcrudeoilforanumberofadverseeffects.APIhasalsodevelopedmodelstopredicttheadverseresponsesatparticulardoses(benchmarkdoses)ofdifferentcrudeoils;thesearenecessaryforaquantitativedose‐responseassessment.TheexposureassessmentistheestimationofthedosethatreachesahypotheticalRMEperson.Theexposureassessmentincludestheanalyticaldatacollectedatthelocationbeingevaluated(inthiscasemeasuresofTPHatthevariouswellsites)andvariousexposureparameterssuchasthosediscussedinearliersectionsofthisreport.Informationfromthedose‐responseassessmentandexposureassessmentarecombinedtocharacterizerisk.

25Strauss,Feb2013Section2.3.2pp.12‐17andStraussDec2013AppendixA.

November7,2014 page15

Thenon‐cancerandcancerassessmentsareconductedseparately.Theresultsarecalledthehazardindex(HI)andexcesslifetimecancerrisk(ELCR),respectively.Theseresultsarecomparedwithregulatorybenchmarks,whichareoftenanHIof1andanELCRintherangeof10‐4to10‐6(oneintenthousandtooneinamillion).IftheHIishigherthanone,andtheELCRwithinorhigherthanthecancerriskrange,furtherevaluationandoftenremediationarerequired.

2.4.1 Development Of A Non‐Cancer Dose Response Factor (Reference Dose) For Crude Oil From The Concession Area 

TheAPI,aspartofitssubmissiontotheUSEPAHighProductionVolumeprogramforcrudeoil,providedtheresultsofitstoxicitytestingprogramforvariouscrudeoils.26Thetestingincludedskinpaintingstudiesinwhichtwocrudeoils,oneheavyandonelight,wereappliedtothebacksofratsfor90days,andtheadverseeffectsevaluated.Bothcrudeoilscausedskinchanges(hyperplasiaandhyperkeratosis)associatedwithskincellproliferation(pre‐cancer),irritation,andinflammation.Adverseeffectsoninternalorganswerealsoobserved,whichshowsthattoxiccomponentsoftheoilswereabsorbedthroughtheskinandreachedinternalorgans.Theimmunesystem(thymus),theendocrinesystem(thyroid),theliver,andbonemarrow(manifestingasaberranthematologyincludingreducedredbloodcellsandplateletcounts)werealladverselyaffected.Reducedbodyweightgain,areflectionofslowergrowthoftheyounganimalsusedintheexperimentandageneralindicatoroftoxicity,wasalsoobserved.Skinirritationandthyroideffects(hypertrophyandhyperplasia,potentiallyaprecancerouscondition)wereobservedevenatthelowestdosetested.27

Similarskinpaintingstudieswereconductedusingpregnantratstodeterminetheimpactofcrudeoilonthedevelopingfetusandyoungoffspring.Crudeoilwaspaintedonthebacksofpregnantratsfromzeroto19daysofpregnancy.Eventhisshortdosingperiod(20daysvs.90days,above)resultedintheadverseeffectsjustdescribed–skinirritation,immunesystemeffects,liverchanges–onthepregnantrats.Observedpre‐natalandpost‐nataleffectsincludedincreasedinuterodeath,delayedossification(skeletonformation),decreasedpupbodyweight,anddecreasedpupsurvival.28

Asdiscussedinbothofmypreviousreports,differentcrudeoilshavedifferenttoxicpotencies,andAPIhassummarizeddatashowingthatcrudeoil’s(andthatofotherpetroleumproducts)potencyforcancer,birthdefects,thyroideffects,bloodeffectsandimmuneeffectscanbepredictedbythequantityofthefractionofcrudeoilknownas3‐7

26API2011.Citedandprovidedinmypreviousopinions.

27API2011.p.45.ThesestudieswerealsodiscussedinmyFebruary2013expertopinion(p.41‐42).TheexpertreportofDr.BlancaLaffon,submittedconcurrentlywiththisone,discusseshealtheffectsexperiencedbyoilcleanupworkers.Manyaresimilartothoseobservedinthetoxicitytests.

28API2011pp.51‐54.ThesestudieswerealsodiscussedinmyFebruary2013expertopinion(p.42)andmyDecember2013rejoinderopinion(pp.51‐52).

November7,2014 page16

ringPACs,29althoughthesearenottheonlytoxiccomponentsofcrudeoil.Skinirritationisprimarilyduetoanentirelydifferentcomponentofcrudeoil;andsomearomaticcompoundsincrudeoil,suchasbenzene,isopropylbenzene(cumene),naphthalene,and2‐methylnaphthalenearecarcinogeniceventhoughtheyhave1or2aromaticrings.Basedonthetoxicitydatafromskinpaintingtests,APIcalculateddosesatwhich10%oftheanimalsarepredictedtosufferadverseeffects.30TheseareknownasbenchmarkdosesorBMD10.APIalsodevelopedamethodforextrapolatingthetoxicityofknowncrudeoilstountestedcrudeoilsbasedontheamountof3‐7ringPACsincrudeoilsofuntestedtoxicity.Toquantifythetoxicityoftheuntestedoils,APIcalculatedpredictedbenchmarkdoses,denotedPDR10,usingthe3‐7ringPACconcentrationofeachcrudeoilasthebasisoftheprediction.ThePDR10sofmorethan40untestedcrudeoils,alongwiththeirAPIgravitywereintheirsubmissiontotheUSEPA.BenchmarkdosessuchasthePDR10calculatedbyAPIcanbeconvertedtoreferencedoses(RfDs),whicharethetoxicityfactorusedinthedoseresponseassessment.Theconversionistheapplicationofnumericalfactorstoadjustfortheuncertainty,variability,andinadequaciesofthebenchmarkdose.Thesefactorsinclude:

variabilityinresponses(e.g.,onehumantoanother), uncertaintyofpredictingtoxicityinhumansbasedonanimaldata, conditionsofthetestvs.applicableconditions(e.g.,90dayvs.lifetimeexposure,

oralvs.dermalexposure), whetherthebenchmarkdoseisanoobservedeffectlevel,and qualityandcompletenessofavailabletoxicitydata.

FollowingUSEPAguidancefordevelopmentofreferencedoses31,Iusedafactorof3000toconvertthePDR10toadermalreferencedose.Thedermalreferencedosewasthebasisofanoralreferencedose.Icalculatedadermalreferencedoseof0.03mg/kg‐dayandanoralreferencedoseof0.004mg/kg‐dayforcrudeoilofsimilarAPIgravitytothatintheConcessionArea.TechnicalAppendix2providesdetailsofmyderivationofthesedoses.

2.4.2  Methods For Analyzing TPH 

Measuringtheconcentrationofoilintheenvironmentisadifficulttaskascrudeoilisacomplexmixturewithmanydifferentcompoundswithdifferentchemicalandtoxicologicalproperties.Sensoryapproachessuchasobservationoffloatingoilorsheen,odor,andtasteareindicativeofthepresenceofoil,andtheAPIandASTMrecommendcleanupwhenobservedtoprotectanimalandhumanhealth.32

29PACsarepolycyclicaromaticcompounds.Thisfractionincludespolycyclicaromatichydrocarbons(PAHs)aswellastoxiccompoundsthatalsocontainnitrogen,sulfurandoxygenintheirringsorattachedtotherings.

30API2011p.46.

31USEPA2002.Areviewofthereferencedoseandreferenceconcentrationprocesses.EPA/630/P‐02/002F.

32API2004(Livestock);ASTME1739‐95(humanhealth,sensitiveecologicalreceptors).

November7,2014 page17

Therearemanymethodstoquantifyhowmuchoil,orwhichcomponentsofoil,arepresent.Eachgivesadifferentresultfromthesameinitialsample,dependingonfactorsthatincludetheportionoftheoilmixturetargetedforanalysis,samplepreparation,detectionmethodology,potentialinterferences,andmanyothers.LBGutilizedseveralmethodstoquantifyoilresidues,commonlyreferredtoasTPH(totalpetroleumhydrocarbons),intheJune2014fieldprogram:33

Method8015M:ThismethodyieldsfractionslabeledasGasolineRangeOrganics(GRO),DieselRangeOrganics(DRO),extendedDRO,andheavyDRO.Eachfractionhasacharacteristiccarbonrange,andaromaticandaliphatichydrocarbonsaremeasuredtogether.TheDROandextendedDROfractionsincludethetoxic3‐7ringPACfraction,althoughsomewouldbelostduetothesolventusedinsamplepreparation.TheGROfractionhasthe1‐2ringcompoundsandisappropriatelyevaluatedbycomparisontogasoline.

MassachusettsMethodVPH/EPH:Thismethodyieldsfractionswithspecifiedcarbonranges;aromaticandaliphatichydrocarbonsarereportedseparately.ThearomaticfractionsC11‐C22includethetoxic3‐7ringPACfraction,althoughsomewouldbelostduetothesolventusedforsamplepreparation.TheVPHaromaticfractioncontainsthecarcinogenic1‐2ringcompounds.

TexasMethodTX1005:Thismethodyieldsvariousfractionsofcharacteristiccarbonrangewiththearomaticandaliphaticcombined.Someofthetoxic3‐7ringPACfractionwouldbelostduetothesolventusedforsamplepreparation.

TotalExtractableMaterial(TEM)Method:Thismethodmeasurestheentiremassofmaterialsusingasolvent(dichloromethane)thatdissolvesthetoxic3‐7ringPACfraction,allowingittobemeasured.Theresultscombineallcarbonrangesandaromaticandaliphatichydrocarbons.

Thefollowingchartshowsgraphicallytherangesofcrudeoilcapturedbyeachanalyticalmethod.Ascanbeseen,theTEMmethodisthemostcomplete,capturingthemostfractionsofoil.

33LBGNovember2014ExpertReport.ShortNovember72014,SupplementaryMemorialExpertReport.

November7,2014 page18

ThefractionsdetectedbythefirstthreemethodscanbesummedtogiveasingleTPHnumberforeachsampleanalyzed,althoughasnotedabove,thesesummationsstillmisspartoftheoilcomponentsintheoriginalmixtureincludingsomeofthetoxic3‐7ringPACsandheaviercomponents.MostofthecrudeoilcomponentsmissedinthesummationarecapturedintheTEMMethod.Asaresult,TPHmeasuredbytheTEMmethodalwaysgivesamorecomplete,andthushigher,resultthantheotherthree.DetailedcomparisonsofTPHconcentrationsfromTEMandMethod8015showthatTEMconcentrationsareapproximatelyfivetimeshigher.34

2.4.3  Risk Characterization Based On Crude Oil As A Whole 

Thehealthriskfromcrudeoilcanbeevaluatedseveralways.USEPAguidancefortheevaluationofmixtures35presentsahierarchyofapproaches,withthepreferredapproachesbeingevaluatedbasedonthemixtureitselforasufficientlysimilarmixture.Theoilandgasindustryalsorecommendsthisapproach.36Becausetoxicitydataforwholemixturesareusuallylacking,alesspreferredbutmorecommonlyusedapproachistoevaluatefractionsofthemixtureseparatelyusingatoxicityvalueforeachfractionbasedononeindividualcomponentofthatfraction.ThismethodwasusedinmypreviousHHRAbasedonMethod8015MdataandMassachusettsVPH/EPHdata.

34ShortExpertReportNovember2014section4.1;LBGExpertReportNovember2014AppendixC2.

35USEPA1986.GuidelinesfortheHealthRiskAssessmentofChemicalMixtures.EPA/630/R‐98/002.;USEPA2000.SupplementaryGuidanceforConductingHealthRiskAssessmentofChemicalMixtures.EPA/630/R‐00/002.

36c.f.,IPIECA2010GloballyHarmonizedSystemforPetroleumSubstances.Version1.

November7,2014 page19

Forcrudeoil,thenon‐cancerhazardcanbeevaluatedusingthemorepreferredwholemixturesapproachbasedonthequantitativedoseresponsefactordescribedinSection2.1.4andananalysisofTPH.Inmyopinion,theTEMmethodisthebestbasisforthiswholeoilTPHanalysisbecauseitincludesalmostallofthecomponentsincrudeoil,andmostcloselyapproximatesthemeasurementusedinthetoxicitytests(massofcrudeoil).Inotherwords,TEMisthebestmeasureforan“applestoapples”comparisonofthedose.

2.5 There Are Substantial Non‐Cancer Health Risks From Exposure To Crude Oil 

ForthisHHRA,Icalculatednon‐cancerhazardindices(HIs)usingboththefractionapproachusedinmyDecember2013HHRAandthewholemixtureapproachdescribedabove(section2.4).IcalculatedexposureusingthesameequationsasinmypreviousHHRA,althoughthedurationofbathingwaschanged,asdescribedinsection2.3.3above.Inaddition,mynewHHRAincludesexposurestosurfacesoil,asthesedataareavailablefromLBG’s2014testingbutwerenotavailablefromLBG’s2013testing.Soilingestionratesweredescribedinsection2.3.2.AdditionaldetailsoftheexposurecalculationsareprovidedinTechnicalAppendix1.ThecalculationofareferencedosefromtheAPIderivedbenchmarkdosesisprovidedinTechnicalAppendix2.Thechartbelowsummarizesthenon‐cancerhazards(HIs)atsixofthewellsitesinvestigatedbyLBGin2014:AG06,LA02,LA16,SSF13,SSF34,andSSF43.Ievaluatedseveralexposurepathwaysatfiveofthesitesandonlyaformerusepathwayatthesixth(SSF43).Thesecondcolumnliststhetypeofexposurepathwayandwhethertheexposureisapast,current,orfutureuse.ThecolumnslabeledVPH/EPHfractionand8015MfractiongivetheHIsbasedonanevaluationofthetoxicityofeachfraction,themethodusedinmyDecember2013HHRA.ThenextthreecolumnsprovidetheHIsusingthewholemixtureapproach,namelytheconcentrationsinallthefractionsobtainedusingVPH/EPH,8015M,orTX1005aresummedtoobtaintheconcentrationofpetroleumhydrocarbonsforthatspecificmethod.ThistotalisthenusedinconjunctionwiththeRfDforOrientecrudeoildescribedinSection2.4.1andTechnicalAppendix2.ThefinalcolumnofthechartbelowprovidestheHIcalculatedbywhatis,inmyopinion,themostappropriatemethodforevaluatingtherisk,namelyusingoilconcentrationsmeasuredbyTEMandtheRfDforOrientecrude.

November7,2014 page20

ThecharthighlightstheHIsabove1,thepointatwhichharmmayoccur.HIsabove1butlessthan10arehighlightedinpink,thosebetween10and99arehighlightedinorange,andthoseabove100inred.TheTEM‐basedwholemixtureanalysisresultsinthehighestHIs,asexpected.AllmethodsresultinanHIabove1foratleastthreewellsites.Non‐cancerhazardwasidentifiedatallsixsiteexamined.ExposurepathwaysatAG06,LA02,andSSF34hadHIsgreaterthan100,

November7,2014 page21

whichmeansthatthedosesareapproachingtherangeinwhichadverseeffectswereobservedinthetoxicologystudies.

2.6. There Are Cancer Risks From Crude Oil Exposure 

Dr.Moolgavkarcontinuestostatethatthereisnoevidencethatexposuretooilhascausedanyharm,includingspecifically,cancer.However,Dr.BlancaLaffonhasfiledconcurrentlywiththisreportareportdetailingherfindingsregardingoil’sgenotoxiceffects,whichshowthecancerriskofoil.Inaddition,Dr.Moolgavkar’sopinioncontradictspetroleumindustryfindingsandreportsthatindicatethatdermalcontactwithcrudeoilisassociatedwith,amongotherthings,skincancer,andimmunedysfunction. TheworldwidepetroleumindustryhascompiledtoxicitydataoncrudeoiltoprovidetoUSandEuropeanregulatoryprograms,suchastheHighProductionVolumeprogramintheUSandtheREACHprogramintheEU.Thefocusofindustrystudiesisondermalexposure.Thediagrambelow,takenfromareportpublishedbyCONCAWE37,anindustryorganization,showsthatrepeatedexposures,suchasthoseexperiencedbypeopleintheConcessionArea,canresultindermatitis,andskintumors(cancer),andotherhealtheffectsthatrequirequantitativeriskassessment,suchasthatpresentedinsection2.5.

 

37CONCAWE(ConservationofCleanAirandWaterinEurope,)istheoilandgascompanies’Europeanassociationforenvironment,healthandsafety2010.Reviewofdermaleffectsanduptakeofpetroleumhydrocarbons.Reportno.5/10.

Figure 6 Health risk assessment of dermal exposure to petroleum hydrocarbons

November7,2014 page22

Source:CONCAWE2010,p.60 CONCAWE382010(p.59)alsopointsoutonereasonwhytheharmincreaseswithrepeatedexposuresandmayproduceskincancer:

“In addition to the irritationeffectsofpetroleumhydrocarbons, the skinbarrier functionmay be affected following repeated contact,making theskinmore susceptible to other irritants, sensitizing agents, and bacteriaand also enhance the dermal penetration of other substances.Furthermore, there is increasing evidence that severe, dermal irritationinducedby long‐termor repeated exposure to certainhydrocarbons cancontribute to the progression‐promotion effect and the development ofskintumours.”

2.6.1 Toxicology Studies Show Crude Oil Components Are Mutagenic And Carcinogenic 

ThePACfractionofoil(whichincludesPAHs)ismutagenicinstandardtoxicitytestsincludingthewell‐knownAmesassay;crudeoilsarecarcinogenicafterdermalapplicationtoskin(mousebioassays).

AssummarizedbytheAPI39:

“A number of crude oil samples, representing a range of compositions,havebeen investigated for theirpotential to cause skin cancer inmouseskin‐painting studies of 104‐110 week duration. All four crude oilsincluding some distillation fractions of API Crude C and D (See below),producedskintumors in33‐100%ofmicewith latencyperiodsof40‐76weeks, and were considered dermal carcinogens. Tumor incidence andlatency depended on crude oil source and dose (Table 18). Numerousstudies have shown that the mutagenic and carcinogenic potential ofcomplex petroleum‐related substances, all of which are derived fromcrudeoil, correlateswith thepresenceof 3‐7 ringPAC.Furtherstudieshaveshown thesePACcanbeabsorbed through the skinandenterthegeneralcirculation.”(referencesdeleted,emphasisadded)

ThisassessmentofthepotentialcarcinogenicityofcrudeoilissupportedbytheInternationalPetroleumIndustryEnvironmentalConservationAssociation(IPIECA):40

“For petroleum substances containing PAHs, the skin carcinogenicpotential is related to the level of specific 3‐7 fused‐ring PAHs. While

38ibid.p.59.

39API2011.p.58.

40IPIECA,June17,2010.Version1.GuidanceontheapplicationofGloaballyHarmonizedSystem(GHS)criteratopetroleumsubstances,atp.10.

November7,2014 page23

concentrationsofspecificPAHscanbedetermined,andcertainPAHsareclassifiedascarcinogenic(e.g.,byIARC),theskincarcinogenicpotentialofpetroleum substances should normally be assessed based on the wholesubstance, taking into account the total PAH content. This is becauseindividual PAHs may occur at toxicologically insignificantconcentrations, but the total PAH‐content may be toxicologicallyimportant.”[emphasisadded]

Formostpeopleexposedtocrudeoilindevelopedcountries,dermalcontactandinhalationofvolatilecomponentsareconsideredtheprimaryroutesofexposure.However,intheConcessionArea,ingestionexposure–viadrinkingwater,soils,andsediments–isalsoanimportantconsideration.OralexposurewasrelegatedtoAppendix5intheAPIsubmissiontotheUSEPAbecauseitwasdeemedan“unrealistic”routeofexposure.However,theAPIsummaryandtheunderlyingdata41showthatdermalandoralexposureresultinthesamehealtheffects,stronglysuggestingthatingestionofcrudeoilalsoresultsincancer,includinginparticular,cancersinthegastrointestinalsystem.Moreover,becausethecarcinogenic3‐7ringPACsareabsorbedintothebody,theymaycausecancerwherevertheybecomelocatedinthebody.

2.6.2  Risk Of Cancer In The Concession Area Using HHRA Methodology 

Liketheriskassessmentfornon‐cancerhazardsdescribedinsections2.4and2.5,cancerriskfromcrudeoilismostappropriatelyevaluatedusingawholemixtureapproachwithcarcinogenicitydatabasedontestsusingcrudeoilandexposuremeasuredbytheTEMmethod.APIandotherindustrygroupshavereportedtheresultsofcancerbioassaysofcrudeoil,but,unlikeforthenon‐cancerbenchmarkdose,havenotquantifiedacancerpotencyfactor.InmyDecember2013HHRA,thecancerriskcalculationincorporatedthepublishedcancerslopefactorsforsixPAHswhichcompriseaverysmallportionof3‐7ringPACs,plus1‐methylnaphthalene,a2ringcompound.However,manymore3‐7ringPACsareknowntobecarcinogenicbasedontoxicitytesting,asdiscussedinsection2.6.1.SomeofthealkylatedPAHs,suchas5‐methylchrysene,are100timesmorecarcinogenicthantheirparentcompound,inthiscasechrysene,42yetonlychryseneiscurrentlyincludedinUSEPA’sriskassessmentmethodology.BothareincludedinmethodologyrecentlyproposedbytheStateofCalifornia.43Carcinogensthatarenotpartofthe3‐7ringPACfractionhavealsobeenleftoutofthecancerriskestimate.Forexample,carcinogenswithfewerthan3rings,suchas

41API2011andAPI2003HighProductionVolumeChemicalChallengeProgram.Testplancrudeoilcategory.SubmittedtoUSEPAbyAPIpetroleumHPVtestinggroup.November21,2003.

42CAEPA(OHHEA)2009.AppendixB(updated2011)pB‐91.

43CAEPA(OHHEA)2014opcit.

November7,2014 page24

naphthaleneandcumene(isopropylbenzene)havebeendetectedinmanyConcessionAreasamples,butarenotincludedinthecancerriskcalculationbecauseUSEPAhasnotpublishedacancertoxicityfactor.Cumenewasfirstlistedasacarcinogenthisyear(2014)andmorecarcinogensmaybeidentifiedastoxicitytestingcontinues.44Obviously,theUSEPAmethodologybasedononlyafewparentPAH(asubsetofPAC)compoundssubstantiallyunderestimatescarcinogenicriskofcrudeoil.Thecarcinogenic3‐7ringPACfractionisobtainedusingananalyticalmethodologythatwasnotusedinanyofthefieldsamplesintheConcessionArea.However,theLBGdatasetprovidesthemassofalkylsubstitutedandparentPAHsforspecified3‐5ringPAHsandafewsulfurcontainingPACs(dibenzothiophenes).Theseareaportionofthe3‐7ringPACfraction.Thus,whilestillanunderestimate,thesumofthetotalamountofidentified3‐5ringPAHsplussulfurcontainingdibenzothiophenes,whichrangesfrom0.2‐5%,providesaminimummeasureofhowsmallafractionofpotentialcarcinogenicityisevaluatedbycurrentlyavailablecancerslopefactors.Despitethesubstantialunderestimateofcancerrisk,myDecember2013HHRAresultedinsignificantcancerrisksforseveralwellsite/exposurepathwaycombinations.AtLA02,useofthenearbystreamasadomesticwatersupply(aknownformeruse)resultedinanexcesslifetimecancerriskof1x10‐3(oneinathousand).Thisestimateevaluates0.5%and4%ofthe3‐7ringPACfractionforsedimentandsurfacewater,respectively.Whilethisisaformeruse,samplescollectedin2014frominsidethehouseshowsongoingcontamination.45

2.7  Response To Additional Critiques From Claimants’ Experts 

2.7.1  Barium Toxicity Is Evaluated Appropriately 

Dr.McHughsuggeststhatIusedaninappropriatemeasureforthetoxicityofbarium.46Accordingtohim,IshouldhaveusedtoxicitybasedonbariumsulfatebecausetheelevatedbariumconcentrationsarefromTexpet’suseofbarite‐containingdrillingmuds.Hisargumentassumesthat:1)bariumsulfateislesstoxicthanotherbariumsaltsbecauseitisinsolubleandthereforenotwellabsorbed,and2)bariumsulfateisnotconvertedtomoresolublebariumsaltswhileintheenvironment.Neitherassumptionistrue.AccordingtotheUSEPAtoxicologicalprofileforbarium,47somestudiesshowthatbariumoriginatingfrombothsolubleandrelativelyinsolublebariumsaltsisabsorbedfromthe44USNationalToxicologyProgramOctober2014.ReportonCarcinogens,13thedition,MonographonCumene,(monographdatedSeptember25,2013).

45Theinteriorsampleswerewipesamples.Theywerecollectedusingindividuallypackagedalcoholwipesrubbedagainstthesurface.Onewipewasusedforthechildren’stoy.Forthefloorsamples,eachsamplewascomposedof5individualwipes.Eachwipewasrubbedinsidea200cm2template.

46ExpertopinionofThomasE.McHugh,May2014.pp.3and4.

47USEPA2005.Toxicologicalreviewofbariumandcompounds.EPA/635/R‐05/001.

November7,2014 page25

gastrointestinaltracttoasimilarextent,likelyduetotheacidicenvironmentofthestomach.Inaddition,Chevronhasnotprovidedanydatashowingthatbariumsulfateistheformfoundintheenvironmentalsamples.Infact,LBGhasconductedananalysisofbariumconcentrationsinwaterandhasconcludedthat,incertainsamples,thebariumisnolongerpartofbariumsulfate;ithasbeenconvertedintoasolublesalt.48Inmyopinion,theUSEPAreferencedoseisthemostappropriatemeasureoftoxicityofbariuminthewaters,soils,andsedimentsintheConcessionArea.Ialsonote,however,thatbarium,evenusingtheUSEPAreferencedose,doesnotmeaningfullycontributetothenon‐cancerhazardsintheConcessionArea.Thevastmajorityoftheestimatedhazardisfromthecrudeoil,measuredasTPH.

2.7.2 Surface Water Samples Should Not Be Filtered 

Drinkingwaterexposureshouldbebasedonunfilteredwatersamples(i.e.,includingsedimenttotheextentitissuspendedinthewater)becausethatiswhatresidentsconsumeandbathein.49Dr.McHugh’sstatementthat"theuserswouldminimizetheamountofsedimentintheirdrinkingwatertotheextentpossible"isyetanotherculturallyinappropriateandunfoundedassertion.HHRAsassessexposureasasitewouldbeusedifitwerenotcontaminated.IntheformerConcessionArea,watergenerallyisconsumedascollected,sometimesinplasticbottlesfromstreamsnearafarmer’sfield(c.f.,thefarmeratAG06),sometimesfrombucketsatwellsorfrombridges(c.f.,LA16,SSF25),sometimesincollectionboxes(SSF13).In2013,theLBGsamplingteamcollectedwatersamplesinamannersimilartothatusedbytheresidents.Inthe2014samplingprogram,LBGcollectedsurfacewatersamplesbyperistalticpumpwhichhadtheconsequenceofminimizingtheinclusionofsediments.Datafromsamplescollectedinthismannermayleadtoanunderestimateofriskfromwaterconsumption.

2.7.3 Exposure Is Evaluated At Appropriate Locations 

MyDecember2013HHRA(aswellastheHHRAincludedinthisreport)evaluatedlocationswheretherewasbothvisibleandanalyticallymeasuredcontamination.Real,livepeopleliveintheseareas,althoughthesiteswereevaluatedusingriskassessmentmethodologyandexposureparametersappropriateforanRMEreceptor.Dr.McHugh,liketherestofClaimants’consultants,istryingtoaveragethepetroleumcontaminationoverbothcleananddirtyareas,thusdilutingtheexposureandsubsequentriskthatisexperiencedbyindividualslivingnearcontaminatedwellsites.

48LBGExpertreportNovember2014Section3.4.3.1.

49USEPA1989,p.6‐34.

November7,2014 page26

Thepopulationintheseruralareasisincreasing,50whichmeansthatevenmorepeoplewilllivenearcontaminatedwellsitesandabandonedpitsinthefuture.Riskassessmentmethodologyrequiresevaluatingriskatfuturepotentialdrinkingwatersourcesandotherexposuremedia.Bothcurrentandfutureexposurelocationsweresampledandevaluated,andtheyareappropriate.

2.7.4 Exposure To Sediments And To Surface Water Is Evaluated Appropriately 

ClaimantscontendthatIevaluatedthedermaluptakeofcontaminantsinsedimentinappropriately.AccordingtoDr.McHugh:“TPHmeasuredinthesurfacewatersampleswasnotdissolved,butratherwasassociatedwithsedimentpresentinthewatersamples,assuminguptakefrombothsedimentandsurfacewaterdouble‐countstheexposureresultinginanoverestimationofriskfromdermaluptake.”51

Dr.McHugh’spremisethattheTPHmeasuredinwaterisassociatedwithsedimentisnotsubstantiated.LBGhasshownthatoil(measuredasTPH)inwatersamplescanbeintheformofanemulsion,i.e.,amixtureofwaterandoil,likeshakenupsaladdressing.Inothercases,itisasheen,aseparatephaseinthewater,orasoildropletsasshowninphotographsintheLBGopinion.52Thus,theTPHmeasuredinwaterisnotnecessarilysedimentassociated.AndeveniftheTPHweresediment‐associated,exposuretosedimentoccursviatwodifferentandindependentexposurepathways(dermalexposuretowateranddermalexposuretosediment).USEPAmethodologycallsforevaluatingtheseexposurepathwaysseparatelyandcombiningtheresultstocalculatethecumulativerisksofexposurefromallpathways.53

2.7.5  Dr. McHugh’s Citation Of His Personal Experience Is Culturally Inappropriate And An Unreliable Basis To Develop Exposure Parameters In The Concession Area 

Claimantsandtheirconsultantsclaimthatmyuseofdatacollectedusingvalidsocialsciencemethodologyis“anecdotal”andthusunreliable.YetDr.McHughoffersopinionsbasedonhispersonalexperienceinadifferentclimate,lifestyle,andculture.Forexample,Dr.McHugh’sstatement–“Inmyexperience,parentstrytominimizethetimerequiredtobathetheirinfants”–doesnotprovideabasisforassessingbathinghabitsintheConcessionArea.AsIdeterminedfrommyinterviewswithpeoplelivingnearthecontaminatedwellsites,bathingisforbothcleaningandrelieffromtheheat.

50Observationsofnewhousingconstruction,conversionofforestedlandtofarmuse,andrapidgrowthofsmallertowns(suchasShushufindi)reportedbyLBG,andINECdataforConcessionAreacantonsshowthatbothurbanandruralpopulationsaregrowing.

51ExpertopinionofThomasE.McHugh,May2014.p.5.

52LBGExpertReportNovember2014.Section3.4.1.

53USEPA1989,pp.8‐15ff.

November7,2014 page27

Dr.McHughsuggeststhatIhadnotaddressedhispreviouscriticismregardingmyuseof“anecdotaldata”54principallytheBeristainetal.studywiththeEnglishtitle“WordsfromtheRainforest.”55Onthecontrary,IdidaddresshiscriticisminmyDecember2013opinion.Inanyevent,theinformationintheBeristainreportisconsistentwiththeinterviewreportspreparedbyClaimants’consultantsoftheresidentssurroundingwellsduringtheirPre‐inspectionInvestigations,interviewswithsomeofthesameresidentswhomIspokewith,observationsofhealtheffectsofoilspillsoutsideoftheConcessionArea(andoutsideofEcuador)56,andinformationonindigenousculturedocumentedbyanthropologyandotherstudies.57

3.0  Supplemental Opinion: Petroleum Contamination Has Reduced Local Food Resources, Including Farm Animals, Crops, And Fish.   The Reduced Availability Of Home‐Produced Food Has Had An Adverse Impact On The Health Of The Local Population That Relies On These Resources. 

Farmanimalsintendedforfooduse,includingcows,chickens,ducks,andpigscomeintocontactwithsoil,sediment,andsurfacewater.Terrestrialwildlifethatarehuntedforgameaswellasdomesticanimalssuchashorsesandpetsalsocomeintocontactwithsoil,sediment,andsurfacewater.Bothwildfishandthoseraisedinfarmpondscomeintocontactwithsedimentandsurfacewater.Crudeoil‐relatedcontaminationhasbeendetectedaboveconcentrationsknowntoaffectfarmanimalsandfishatmanyofthewellsites.

3.1 Loss Of Livestock 

TheAPIdevelopedguidanceforcleaningupcrudeoiltoprotectlivestockoncontaminatedlands,specificallyincludinglandcontaminatedbyclosedoilpitsthatweredugaspartofthewellinstallation.58TheAPIguidanceassumesthattherearenoopenpitsorotherfreeoilaccumulationsontheground,consistentwithindustryandregulatoryguidancedatingbacktoatleastthe1990s.

54ExpertopinionofThomasE.McHugh,May2014.p.6.(insection3).

55Beristain,CM,DPRovira,andIFernadez.2009.WordsfromtheRainforest.ApsychosocialstudyoftheimpactofTexaco’spetroleumoperationsonthecommunitiesofEcuador’sAmazon.EnglishtranslationofLasPalabrasdelaSelva.

56LaffonExpertReport2014;StraussRejoinderReportDecember2013;StraussexpertopinionFebruary2013.

57c.f.Martínezetal.2007ImpactsofPetroleumActivitiesfortheAchuarPeople.ofthePeruvianAmazon:SummaryofExistingEvidenceandResearchGaps.Env.Res.Lett.2:1‐10.Sirén,A.;J.Machoa2008.Fish,wildlifeandhumannutritionintropicalforests:Afatgap?Interciencia33(3)pp.186‐193.

58API2004.RiskBasedScreeningLevelsfortheProtectionofLivestockExposedtoPetroleumHydrocarbons.Publicationno.4733.

November7,2014 page28

Guidancewasneededbecause:

“Consumptionofpetroleumhydrocarbonsbylivestockhasbeenfoundtolead toa rangeofhealthproblems, includingneurotoxicity, fetal toxicity,damagetothegastrointestinaltract,respiratorysystem,kidney,andliver.Petroleum ingestionhas alsobeen linked to anorexia, lethargy, and fatalpoisoningincattle.”59(referencesdeleted).

APIdevelopedriskbasedsoilandwaterscreeningvaluesforlivestocksuchascowsandhorsesthatarepastured,butnotchickensandducks,whichitassumedareraisedinenclosedareas.However,intheConcessionArea,chickenandducksgenerallyroamfreely,andthusarealsosubjecttoinjurybyoil.

Becauseitassumedtherearenoopenpits,API’slivestockguidanceisbasedontheconceptualmodeldepictedbelowinwhichaclosedpitreleasespetroleumcontaminationtosoilandtosurfacewater(eitherbyoverlandfloworthroughgroundwater).Inthismodel,livestockareexposedwhenconsumingsoilalongwithplantmaterialsduringgrazing,andbyingestionofcontaminateddrinkingwater.

Source(API,2006)60 

59Ibid.p.2‐1.60AmericanPetroleumInstitute(API)2006.LivestockExposureBrochure.APICreativeServices|2006‐059|06.06|300.

November7,2014 page29

ChevronemployeesSaraMcMillenandRenaeMagawweremembersoftheworkgroupandreviewcommitteethatdevelopedtheAPIlivestockguidance.GSIhasusedlivestockriskbasedscreeninglevelsinthepast,61andpreparedanissuepaperonlivestockexposureintheOriente,includingdevelopmentofrisk‐basedscreeninglevelsforpigs,ducks,andchickens.62Unfortunately,documentationofhowtheselevelswerederivedwasnotprovidedinthepaper.Thechartbelowhighlightsthesixwellsitesthatviolatetheindustrystandardofnosurfaceaccumulationsofoilinagriculturalareas.Italsocomparesriskbasedscreeninglevelsprotectiveoffarmanimalssuchascows,horses,goats,andsheepwithTPHconcentrationsfoundincertainsurfacesoilsnearthewellsitesinvestigatedbyLBGin2014.63SurfaceandshallowsedimentdatawerecomparedwithAPI’sriskbasedscreeninglevelsatallwellsitesfromwhichdatawerecollected.ThesiteswhereatleastonesoilorsedimentsampleexceededtheAPIscreeninglevelsaremarkedwitharedoval(soil)ortriangle(sediment).Thechartalsosummarizesreportsofharmtocropsoranimalsbasedoninterviewsintheclickabledatabaseorbyinterviewsconductedwithlandowners/tenantsduringmysitevisitinJune2014.

61GSI0520535.

62GSI0769161.

63Nosurfacesoilsampleswerecollectedinthe2013siteinvestigation.

November7,2014 page30

November7,2014 page31

Elevenofthe13wellsitesexaminedhadobservablesurfaceaccumulationsofpetroleum,oratleastoneexceedanceofariskbasedlivestockscreeninglevelorcropscreeninglevel.LBGconductedonlylimitedsiteinvestigationsatthevariouswellsites.NosurfacesoilsampleswerecollectedinthecropareaatLA16norinthewetlandsareaatSSF43whereanimalsreportedlycontactedcontaminationanddied.Thus,absenceofanexceedanceshouldnotbeinterpretedasabsenceofcontamination.Asseeninthefinalcolumn,thepetroleumcontaminationcausesobservableharmstofarmanimals,oftenresultinginthelossoftheanimalandthefoodorcashincomeitwouldprovide.

3.2 Contamination Of Fish Pond At SSF‐13 

ThefarmatSSF13hasafishpondsimilartomanyintheregion,wherefishsuchastilapiaareraisedforpersonalconsumptionandpossiblyalsoforsale.However,nofishwereobservedinthispondduringtheLBGfieldworkinJune2014.AsedimentsamplecollectedfromthepondhadaTPHTEMconcentrationof320mg/kg.ThesurfacewaterhadTPH8015of153ug/L;naphthenicacids,whichcouldonlyhavecomefromcrudeoil,werepresentat3.7ug/L.64Inotherwords,residuesofcrudeoilhavereachedandcontaminatedthesurfacewaterandsedimentofthisfishpond.

3.3 Implications Of Livestock, Fish, Wild Game And Crop Loss 

Thelossoflivestockandcrops,chickens,ducks,eggs,andtilapiaponds,representsthelossofbothfoodforresidentsandcashincome.Thelossoffishinstreamsandwildgame65alsorepresentsalossoffoodforthesubsistencefarmersandindigenouspeople.66Thelossoffoodhasimportanteffectsonnutrition,includinglossofbothcaloriesandabalanceddietincludingfatandprotein.67TheselossesareparticularlyimportantintheConcessionAreabecausethechildrenarealreadynutritionallydeficientasevidencedbyanapproximately50%rateofanemiainchildrenunder5.68Most,butnotall,oftheanemiarespondstotreatmentwithsupplementalvitaminsandiron,whichmeansthattheanemiaisduetoundernourishment.Thislocalestimateofnutrition‐relatedanemiaisconsistentwiththeWorldHealthOrganization’sstatisticsonchronicmalnutritioninruralareasofEcuador.69

64LBGExpertReport2014.Section3.4.3.2.

65Beristainetal.2009opcit;JoséGuamánwitnessstatement(alsointerviewJuly2013).

66Martínezetal.2007op.cit.

67SirénandMachoa2008opcit.

68EstimatebasedoninterviewwithDr.AngelJaraPinto,SubCentrodeSaludLaVictoriaon6/13/14.69TheWorldHealthOrganization(WHO)2013reportsthatchronicmalnutritioninruralareasofEcuadordecreasedfrom42.8%in1999to35.5%in2006,althoughtherateistwicethatamongindigenouspopulations.

November7,2014 page32

Thehealthimpactsofundernourishmentandmalnutritionarewellknown.TheWorldBank70,initssummaryofEcuador,providesageneral,laysummaryofthehealthimpactofundernourishment:

Undernourishedchildrenhaveanincreasedriskoffallingsickandgreaterseverityofdisease.

Undernourishedchildrenwhofallsickaremuchmorelikelytodiefromillnessthanwell‐nourishedchildren.

Inthelanguageofriskassessment,thelossoffoodanimalsandcropsmakestheresidentsoftheConcessionAreaasusceptiblepopulationandthusmoresensitivetothetoxiceffectsoftheoilpollution.

4.0  Supplemental Opinion:  Dr. Moolgavkar Used Highly Flawed Data As The Basis Of His Cancer Study, Making His Results And Conclusions Unreliable And Uninformative 

Dr.MoolgavkarcitedanopinionpiecebyJ.P.A.Ioannidistitled“WhyMostPublishedResearchFindingsareFalse”71inhisMay2014expertopinion.Ironically,hisrecentlypublishedpapertitled“CancermortalityandquantitativeoilproductionintheAmazonregionofEcuador,1990‐2010”72mostcertainlyfallsintothecategoryoffalseresearchfindings.

4.1  Cancer Mortality Data From The Oriente Are Unreliable 

Dr.Moolgavkar’sanalysishasafundamentalflaw:themortalitydataonwhichhebaseshisanalysis,deathcertificatedatafromtheAmazonregion,areunreliablewithrespecttocancerdeaths.Obviously,theuseofunreliabledatayieldsresultsthatarenon‐informativeatbest,anditcanleadtofalseandmisleadingconclusions.Dr.MoolgavkarandcolleaguesobtainedalloftheirunderlyingcancermortalitydatafromtheInstitutoNacionaldeEstadisticayCensos(INEC),whichinturnderivesitsdatafromdeathcertificatedatasubmittedbyhealthcareworkersthroughoutEcuador.InterviewswithseveralhealthcareprovidersintheConcessionArea,includingphysicianswhowritedeathcertificates,revealedseveralreasonswhydeathcertificatedatafromtheConcessionAreaareunreliableandmaysubstantiallyunderreporttheexistenceofcancer.

70WorldBank(undated).EcuadorNutritionataGlance.(downloadedfromtheWorldBankwebsiteinOctober2014).TheWorldBankgoesontoprovideitssummaryoftheeconomicimpactofundernourishment,butthatisbeyondthescopeofmyopinion.

71Ioannidis,JohnP.A.2005.WhyMostPublishedResearchFindingsareFalse.PLoSMedicine,2(8)e124.

72Moolgavkar,SH,Change,ET,Watson,H,Lau,EC.2014.CancerCausesControl25:59‐72.

November7,2014 page33

ThedirectorofHospitalProvincialMarcoVinicioIzaLagoAgriotoldmethatdeathcertificatesarenotoriouslyinaccurateintermsofactualcauseofdeath.Henotedthattheyoftencitetheimmediatecauseofdeath(e.g.,cardiacarrestormulti‐organfailure)ratherthantheunderlyingcauseofdeath(e.g.,cancer,heartdisease,diabetes).Similarly,adoctoratShushufindiHospitaltoldmethateveryonegetsadeathcertificateandconfirmedthatcancerwouldrarelyifeverbelistedasacauseofdeathonadeathcertificate.Further,anunknownbutpotentiallylargepercentageofcancersintheConcessionAreaarenotdiagnosedformally,73whichcanbedoneonlyatcertainhospitalsrunbytheSociedaddeLuchaContraelCáncer(SOLCAhospitals)thatspecializeincancer.74ResidentsintheConcessionAreaareusuallyreferredtotheSOLCAhospitalinQuito.ManyhealthcareprovidersintheConcessionAreapointedoutthatpoorpeoplerarelyseekformaldiagnosisortreatmentbecauseofthemanybarrierstheyfaceingettingtoQuito.Theresidentslivingnearesttothewellsites,thosemostexposedtooil,areamongthepoorestoftheConcessionArea(basedonhousingtype,accesstocleanwater,electricity,sanitarywastedisposal,andothermeasures).Theyaremostatriskofcancerfromoilexposuresandyetleastlikelytobecountedincancerincidenceandcancermortalitystudies.Onedoctorestimatedthat90%ofthechildrenreferredtoQuitofortreatmentdon’tgo.Significantly,hisestimateisbasedononlythoseresidentswhovisitShushufindiHospital;theremaybealargenumberofsickpeoplewhodonotevenmaketheinitialvisittothelocalhospital.Thehealthcareworkersinterviewedataprimarycareclinic,18thdeNoviembreCentrodeSalud,whichreferspatientstoShushufindiHospital,reportedbarrierstoaccess,suchaslackoftransportation,toeventhislocalhospital.AnotherdoctorattheProvincialHospitalinLagoAgrioalsoreportedthatnotallpatientsgotoQuitofordiagnosisandtreatment,andhispatientsincludethosewhohavethemeanstogettothemainprovincialhospital.TheinadequacyofdeathcertificatedatafromtheOrienteiswell‐knownandtakenintoaccountineconomicdevelopmentplansforprovinces.Forexample,the2011DevelopmentPlanforOrellana,referringtothetwonationalregistriesfortheprincipalcausesofdeath,pointsoutthat“[i]tisimportanttotakeintoaccountthattheinformationfrombothsourcesisnotalwayscompletegiventhat,inmanycases,deathstakeplaceinremoteplacesintheregionwithoutobtainingmedicalassistanceorevaluation.”75 Itisunknowablehowmanyofthesedeathsmayhavebeenduetocancer.

73Theyarestronglysuspectedtohavecancerbasedonclinicalindications,whichiswhytheyarereferredtoQuito.

74TheexceptiontothismaybecervicalcancerthatcanbediagnosedatthehospitalinLagoAgrio.However,thiscapabilityonlybecameavailable4yearsago(2010);attheveryendofthetimeperiodstudiedbyMoolgavkaretal.

75GobiernoAutónomoProvincialdeOrellana2011.PlandeDesarrollodelaProvinciadeOrellana.CaracterizaciónProvincial.P.177.TheoriginalSpanishis:“esimportantetenerencuentaquelainformacióndeambasfuentesnosiempreescompletayaque,enmuchoscasos,lasmuertessucedenenlugaresapartadosdelaregiónsinqueselogrecontarconasistenciaoevaluaciónmédica.”

November7,2014 page34

BecausethemortalitydataunderlyingMoolgavkar’scancerstudyareinaccurate,theonlypossibleconclusionisthatthestudyisnon‐informativeregardingcancerdeathsinoilproducingareas;anyconclusionsdrawnfromthestudyareunsubstantiated.

4.2  Dr. Moolgavkar Uses An Inappropriate Measure Of Oil Exposure  

Dr.Moolgavkarclaimsthathisnewstudyimprovesupontheexposurecomponent(andothercomponents)ofthestudypublishedin2009byKelshandco‐workers.76Bydoingso,healsoimplicitlyclaimsthatitisbetterthantheexposuremetricusedbyHurtigandSanSebastianintheirpublication.77IdisagreethatMoolgavkar’smeasureofexposureisbetterthanpriorstudies,andIcontinuetoholdtheopinionthattheexposuremetricusedbyHurtigandSanSebastianismoreappropriatefortwoimportantreasons:

HurtigandSanSebastianfocusedtheirstudyontheConcessionAreawhereTexpetoperated.Incontrast,MoolgavkarandKelshincludedalloil‐producingareas(Cascales,Cuyabeno)whereotheroilcompaniesweretheoperators.OnlyTexpet’spracticesarerelevanttothequestionofhealtheffectscausedbyTexpet.

HurtigandSanSebastianrequiredthatexposuretakeplaceoveralongperiodoftime(20years),consistentwiththecommonunderstandingthatcancerdevelops(inadults)followingprolongedexposure.Incontrast,Moolgavkarquantifiedoilexposureby“well‐year”,thecumulativenumberofoilwellsandtotalyearsoftheirexistence,modifiedbyoilproductionvolumeasifitwereequallydistributedforeachwell.Moolgavkerdoesnotrequireanextendedperiodofexposure.IntheMoolgavkar(andKelsh)exposuresystem,anewlyinstalledhighproducingwellcancountasmuchasanolder,lowerproducingwell,althoughtheolderwellcouldeasilyposemorerisk.Moreover,exposurefromabandonedwells,severalofwhichwereevaluatedinmyHHRAintheprevioussection,arenotincludedintheMoolgavkar/Kelshexposuresystem.GiventhatexposureintheOrienteislargelythroughunremediatedpitsandspills,neitherofwhichgoawaywhenawellisabandoned,itisunreasonabletoexcludethem.

AnadditionalproblemwithDr.Moolgavkar’smethodologyisthathesortedoil‐exposedandunexposedcantonsbasedonoilactivityasof1990.However,someofhisunexposedcantonshavehadsubstantialoildevelopmentpost‐1990,asindicatedinhisTable1.Thisposesaproblembecauseheevaluatedthisexposed/non‐exposedgroupingusingmortalitydatafrom1990‐2010.Thus,someofthepopulationshedesignatesasunexposedhaveactuallybeenexposedduringtheperiodheisevaluating.Healsoignorescompletelythetimeperiodbetween1970‐1990.

76IopinedonKelsh’sworkinmyfirstExpertOpiniondated2‐18‐13atpp.39‐40.

77HurtigAK,SanSebastianM.2002.GeographicaldifferencesincancerincidenceintheAmazonbasinofEcuadorinrelationtoresidencenearoilfields.IntJEpidemiol,31:1021‐7.

November7,2014 page35

ThemanyinadequaciesrelatedtoepidemiologicalaspectsofDr.Moolgavkar’smethodologieswereaddressedinDr.Grandjean’sexpertopinionofDecember2013.   

November7,2014 page36

Technical Appendix 1: Details Of The Risk Calculations  

IevaluatedthedatacollectedinLBG’sJune/July2014fieldsamplingprogramtoevaluatetheriskofpotentialadversehealtheffectstocurrentandfutureresidentsoftheConcessionAreawhomightbeexposedtotheoilcontamination.IusedthesameexposureassessmentmethodologyandparametersdescribedinmyDecember2013Rejoinderreportforexposuretosurfacewater,groundwater,andsediment,withtheexceptionofthemodifiedbathingtimesdescribedinSection2.3.3.Additionalexplanationfortheexposureparametersappearsinsection2ofthisreport.Iaddedexposurescenariostosurfacesoil(childresidentialandadultfarmerexposures)becausesurfaceandshallowsoildatawerecollectedinthesampling2014program.Inaddition,asdescribedinsection2.4.1ofmyreport,Ievaluatednon‐cancerhazardusingthepreferredwholemixtureapproachinadditiontothecommonlyusedfractionapproach.Thesurfacesoilexposurescenarioisverysimilartothesedimentexposurescenario:itincludessoilingestionanddermalcontact,andrequiresexposureparametersfortheevaluation.Forachild,surfacesoilnon‐cancerhazardisbasedondailyexposureforchildrenwhoingest200mgofsoil,andwhogetdirtontheirheads,hands,feet,forearms,andlowerlegs.Theaverageadherencefactor(AF)forthedirtontheirbodiesis0.2mg/cm2.Thesechildexposureparametersarethe‘default’valuesusedinaresidentialsoilscenarioinaUSEPAriskassessment.78Foradultfarmers,theexposurescenarioisbasedondailycontactwithsoilinanagriculturalsetting,butwithoutmachinesandthedustgeneratedbythem.Thescenarioincorporatesasoilingestionrateof200mg/daybasedontheupperboundestimatesofsoilingestionfromtheStateofCaliforniaasdescribedinsection2.3.2.Itassumesthesameareacoveredwithdirtasthesedimentscenario,namelyface,hands,forearms,lowerlegs,andfeetwithatotalexposedsurfacearea(SA)of6275cm2.Theadherencefactor(AF)is0.13mg/cm2‐event.ItisaweightedaverageofthemeasuredAFsforthesebodypartsinthearcheologistactivityprovidedintheUSEPA’sexposurefactorshandbook,asthesearethemostsimilartotheConcessionAreafarmer.79Theseexposurescenariosrepresentahighend,butnotextreme,exposureunderconditionsintheUS.ForresidentslivingnearwellsitesintheConcessionArea,itismorelikelytobeclosertoacentraltendencyoraverageexposure.

 

78USEPAFebruary2014a,bop.cit.

79USEPA2011(ExposureFactorsHandbook)op.cit.

November7,2014 page37

Technical Appendix 2: Development Of A Reference Dose For Crude Oil   

AnRfDisanestimate(withuncertaintyspanningperhapsanorderofmagnitude)ofadailyoralexposuretothehumanpopulation(includingsensitivegroups,suchasasthmatics,orlifestages,suchaschildrenortheelderly)thatislikelytobewithoutanappreciableriskofdeleteriouseffectsduringalifetime.AnRfDisgenerallyexpressedinunitsofmilligramsperkilogramofbodyweightperday:mg/kg/day.AnRfDisdeterminedbyuseofthefollowingequation:RfD=(experimentalorbenchmarkdose)/uncertaintyfactorsThedosecanbeanexperimentallydeterminednoobservedadverseeffectlevel(NOAEL)orlowestobservedadverseeffectlevel(LOAEL),orabenchmarkdosethatiscalculatedfromtheexperimentaldataandprovidesanestimateofthepopulationthatwouldbeaffected(e.g.,10%)ataspecifieddose.Uncertaintyfactors(UFs)takeintoaccountthevariabilityanduncertaintythatarereflectedinpossibledifferencesbetweentestanimalsandhumans(generally10‐foldor10x)andvariabilitywithinthehumanpopulation(generallyanother10x);theUFsaremultipliedtogether:10x10=100x.IfaLOAELisused,anotheruncertaintyfactor,generally10x,isalsoused.Intheabsenceofkeytoxicitydata(durationorkeyeffects),anextrauncertaintyfactor(s)mayalsobeemployed.SometimesapartialUFisappliedinsteadofthedefaultvalueof10x,andthisvaluecanbelessthanorgreaterthanthedefault.Oftenthepartialvalueis½logunit(thesquarerootof10)or3.16(roundedto3‐foldinriskassessment).Note,thatwhentwoUFsderivedfrom½logunitsaremultipliedtogether(3x3)theresultisa10(equaltothefullUFfromwhichthetwopartialfactorswerederived).Iusedapredictedbenchmarkdose,specificallyaPDR10fromarepeateddoseexperiment,asthebasisforthereferencedosecalculation.80Becausedifferentcrudeoilshavedifferenttoxicities,IusedthelowerendofthedosesofthefourcrudeoilswithAPIgravitieswithin1oofConcessionAreacrude(thenearestPDR10sare:93,202,130,305),specificallyaPDR10of100mg/kg‐d.Iappliedatotaluncertaintyfactorof3000,whichwasacombinationofthefollowingfactors:10xvariabilityinthehumanpopulation10xdifferencesbetweentestanimalsandhumans10xuseofaLOAELratherthanaNOAEL.Afactorof10wasusedfortworeasons:1)thebenchmarkdoseisforaneffectof10%ofthepopulationand2)thebenchmarkdose(orthepredictedbenchmarkdose,orPDR10)isthebestestimate,notthelowerbound

80ThePDR10issimilartoaBMD10exceptitisapredicteddosebasedonAPI’speerreviewedmodel.

November7,2014 page38

estimate(BMDL10)thatUSEPAwouldtypicallyuse.3xuseofarepeateddose(90day)ratherthanlifetimetest.RfD(dermal)=100/3000=0.03mg/kg‐dayIconvertedtheRfD(dermal)toanRfD(oral)usingadermalabsorptionfactorof0.13,USEPA’sdefaultdermalabsorptionfactorforallPAHs.Inotherwords,only13%ofthePACsapplieddermallyreachtargetorgansinsidethebodycomparedtothosetakeninorally.AccountingforthisreductionintoxicitybythedermalrouteleadstoanRfD(oral)of0.004mg/kg‐d.

November7,2014 page39

References 

AlreadyInTheRecordUnitedStatesEnvironmentalProtectionAgency(EPA).1989.RiskAssessmentGuidanceforSuperfundPartA.UnitedStatesEnvironmentalProtectionAgency(EPA).1991.RoleoftheBaselineRiskAssessmentinSuperfundRemedySelectionDecisions.OSWERDirective9355.0‐30.USEPA.1986.GuidelinesfortheHealthRiskAssessmentofChemicalMixtures.EPA/630/R‐98/002.USEPA.2000.SupplementaryGuidanceforConductingHealthRiskAssessmentofChemicalMixtures.EPA/630/R‐00/002.ASTM1739‐95StandardGuideforRisk‐BasedCorrectiveActionAppliedatPetroleumReleaseSites.JoseGuamánWitnessStatement.AmericanPetroleumInstitute(API),“HighProductionVolume(HPV)ChemicalChallengeProgramCrudeOilCategoryAssessmentDocument,”submittedtotheUSEPAbyAmericanPetroleumInstitutePetroleumHPVTestingGroup,January14,2011.Beristain,CM,DPRovira,andIFernadez.2009.WordsfromtheRainforest.ApsychosocialstudyoftheimpactofTexaco’spetroleumoperationsonthecommunitiesofEcuador’sAmazon.EnglishtranslationofLasPalabrasdelaSelva.Ioannidis,JohnP.A.2005.WhyMostPublishedResearchFindingsareFalse.PLoSMedicine,2(8)e124.Moolgavkar,SH,Change,ET,Watson,H,Lau,EC.2014.CancerCausesControl25:59‐72.HurtigAK,SanSebastianM.GeographicaldifferencesincancerincidenceintheAmazonbasinofEcuadorinrelationtoresidencenearoilfields.IntJEpidemiol2002;31:1021‐7.

ExpertreportsofLBG,Short,GrandjeanandLaffon,2014.

NewReferencesEPA.Feb2014a,bOSWERDirective9200.1‐120.EPA.2011.ExposureFactorsHandbook.EPA/600/R‐09/052F.

November7,2014 page40

OSHA(OccupationalSafetyandHealthAdministration)HeatIndexandProtectiveMeasures(accessedonOSHAwebsiteOct2014).CaliforniaDepartmentofIndustrialRelationsHeatIllnessPreventionStandardTitle8CCR3395:http://www.dir.ca.gov/Title8/3395.html.UNICEFdatahttp://www.indexmundi.com/facts/ecuador/exclusive‐breastfeedingMinisteriodeSaludPúblicadelEcuadorFunbbasic/Ibfan.May2009.Iniciativamundialsobretendenciasenlactanciamaternainformenacional.DelBubbaetal2005.PAHsandfatcontentinbreastmilk.AnnaldiChimica95:629‐642.GeneralElectric.2004.ResponsetoaUSEPAriskassessmentfortheHousatonicRiverinMassachusetts.AttachmentE.SelectionofSoilIngestionRates.CAEPA(OEHHA).DraftHotSpotsProgramGuidanceManual.September2014.CAEPA(OHHEA).2009.AppendixB(updated2011).EPA2002.Areviewofthereferencedoseandreferenceconcentrationprocesses.EPA/630/P‐02/002F.API.2004.RiskBasedScreeningLevelsfortheProtectionofLivestockExposedtoPetroleumHydrocarbons.Publicationno.4733.EPA.2005.Toxicologicalreviewofbariumandcompounds.EPA/635/R‐05/001.IPIECA.2010.GloballyHarmonizedSystemforPetroleumSubstances.Version1.CONCAWE(ConservationofCleanAirandWaterinEurope)istheoilandgascompanies’Europeanassociationforenvironment,healthandsafety.2010.Reviewofdermaleffectsanduptakeofpetroleumhydrocarbons.Reportno.5/10.API.2003.HighProductionVolumeChemicalChallengeProgram.Testplancrudeoilcategory.SubmittedtoUSEPAbyAPIpetroleumHPVtestinggroup.November21,2003.USNationalToxicologyProgram.October2014.ReportonCarcinogens,13thedition,MonographonCumene(monographdatedSeptember25,2013).Sirén,A.;J.Machoa.2008.Fish,wildlifeandhumannutritionintropicalforests:Afatgap?Interciencia33(3)pp.186‐193.Martinezetal.2007.ImpactsofPetroleumActivitiesfortheAchuarPeopleofthePeruvianAmazon:SummaryofExistingEvidenceandResearchGaps.Env.Res.Lett.2:1‐10.

November7,2014 page41

WorldHealthOrganization(WHO).2013.CountryCooperationStrategyataGlance.http://www.who.int/countryfocus.

WorldBank(undated).EcuadorNutritionataGlance.(downloadedfromtheWorldBankwebsiteinOctober2014).GobiernoAutónomoProvincialdeOrellana2011.PlandeDesarrollodelaProvinciadeOrellana.CaracterizaciónProvincial.AmericanPetroleumInstitute(API).2006.LivestockExposureBrochure.APICreativeServices|2006‐059|06.06|300.