Document qk97LjN1eyd6wvgEOnw4aba4R

Dr.ChadesReich ExecutiveVice President December 15,2000 3M SpecialNtbyterial Mw*ets 3M CenterB,uilding220 St.Paul,MN 55144-1000 6517330439 651575 8001 Fax CERTIFEED NUIL Document ProcessingCenter(7407) ATTN: Section8(e)Coordinator OfficeofPollufioPnrevenfionand Toxics US EnvironmentalProtecfioAngency 401 M Strea@SW_ Washington,DC 20460 Re: TSCA 8(e)NoticeforPerfluorooctanSeulfonylFluoride-basePdroductionProcesses Dear Sir: PursuanttoSection8(e)oftheToxic SubstancesControlAc@ 3M isreportingthedraftresults of an updateof a retrospecticvoehortmortalitsytudyofworkersattheDecatur,Alabama manufacturingfacilityT.he studyupdatewas performedby theUniversityof Mnnesota!s DivisionofEnvironmentaland OccupationalHealthand i@cludedworkerswithatleastone yearof cumulativeemployment attheplantpriortoDecember 31,1997. The cohortof2,083 employees was followedfrom 1961 through1998. Thismortalitsytudywas originalliynitiataesdpartof an ongoingmonitoringprogram of fluorochemicalproductionworkersthatbegan inthelate1970's.Previousstudyresults showed a healthyworker effectand no statisticaslilgynificaenltevationosf standardmortality ratiosforany causeamong tluorochernicparloductionworkersatDecatur[Mandel,1995].In additiont,estingdone throughregularmedicalmonitoringhasnotassociateadbnormal clinical chemistryresultswithDecaturemployees'serum levelsforper:fluorooctasnuelfonate[Olsen, 1999]. Inthecurrentupdateofthiscohortmortalitsytudy,thecohoitwas dividedintothreeexposure categoriebsasedon jobtitleisntheemployee'sWork historyand knowledge ofserum PFOS levelsgenerallyfound inemployeeswiththatjobtitl-eno workplaceexposureto perfluorooctanesulfonfylluorid(ePOSF)-basedchemistriesl;ow potentiawlorkplaceexposure toPOSF-based chemistriesa;nd everhadjob withhighpotentiawlorkplaceexposuretoPOSFbased chemistriesT.herewere fewerthanexpecteddeathsfrom allcauses(145 v.230 expected)and from allcancers(39v.54 expected)intheoveralclohort.In thehighest exposed group,therewere fewerthanexpectedoveralldeaths(65v.93 expected)and deaths from cancer(18v.21 expected).The basisofthissectiong(e)reportisthatthestudydidfind a statisticaslilgynificantellyevatesdtandardmoralityratio(SMR) forbladdercancer(codedas malignantneoplasm ofthebladderand otherurinaryorgans)inthehigh exposuregroup. The SMR forthiscauseinthehighpotentiaelxposuregroupwas 16.1(3 observed,0.2expected, 95% confidenceinterva3l.347.1).Allthreeemployeeswho diedfrom bladdercancerworked inthefacilitbyeginninginthe1960'sand thelastretirebdy 1989. One diedpriorto 1992 and theothertwo diedbetween 1992 and 1998. -2- Although the studyshows an associatiobnetween workerseveremployed injobswith high exposure to POSF-based flUOTOChemicalsatDecatur and bladdercancer,existingtoxicology dataindicateitisunlikelythatPOSF'chemistry exposureisrelatedtothesetumors. Perfluorooctanesulfonateand N-ethyl-perfluorooctanesulfomaniidoethhaanvoel bothbeen extensivelystudied.Neitherisgenotoxicinmultiplestudies.Two-year bloassayson both compounds, inrats,arenearingcompletion.Preliminaryinfbnnationshows no tumors of the urinarybladderin thehigh dosegroup of eithesrtudy.(Finalreportspending.)No acuteor subchronicstudy foreithercompound has shown any bladderorurinarytractoxicity. Other possibleexplanationsforthestudyfindingarechance,exposureto otherchemicals in thework environment and personalriskfactorssuchas smoking orrecurrenturinarytract stonesor infection.ingeneral,theexposurestrafificatuisoend inthisstudywould apply to exposureto most chemicalsused on thesite,notjustPOSF-based chemistries.We are currentlyinvestigatinwghether therehas been historicaulse of known orsuspectedbladder carcinogensatthislocation. Ile liverhas been thetargetorgan inanimalstudiesdone withperfluorooctanesulfonateand N-ethyl-perfluorooctanesulfonamidoethanTohle.two-yearfeedingstudyof N-ethylperfluorooctanesuffonamidoethanroelsultedina significanitncreaseinbenign liveradenomas inhigh dose female rats(.Supplemental8(e)noticedatedDecember 4,2000) In thismortality studytherewere two casesof deathfrom livercancer- one in thelow exposuregroup and one inthe high exposure group (SMR = 3.1,observed= 2,expected=.65, 95% confidenceinterval = 0.4-11.1).Inone ofthesecases,thereisstilulncertaintays towhetherthe deathofthis85year-oldmale was relatedtoa primarylivercancerora metastatipcrocesstotheliver.Inthe othercase,theemployment durationwas brief(oneyear)and theworker was young (36 years), raisingthe possibilitoyf anothercausativexplanation(viral). The finalreportwillbe forwardedtoyou when availablferom theUniversityofMirmesot& Please contactDr. Larry Zobel,3M Medical Directorat651-733-5181 ifyou have any quesfionsconceming thisfiling. Sincerely, ExecutiveVice President References: Mandel J,Johnson P, Mortalitystudyof employees at3M plantinDecatur,AlabamaDivisionofEnvironmentaland OccupationalHealth,School ofPublicHeaiti4Universityof Mnnesota, Minneapolis,Mnnesota, 1995. Olsen GW, BuffisJK Mandel JK ZobelLR. Serum perfluorooctanseulfonateand hepatic and lipidclinicaclhemistrytestsinfluorochemicaplroductionemployees. Journalof Occupationaland EnvironmentalMedicine 1999;41(9):799-806.