Document MJqOxebLLgZV2NK1YrJY9Vpj7

CL ARI26-1963 me 2ea37/ TFotki.sCopuaatvs To TO arbonmaansteOmFya@saeupalaalUS Corporate MSCorN parste 37P,. 02200O8TISPA Subteine `SEpEhHrOai1m2Y0o0u-ng1l8SS-TCorporate/3MIUS@3M-Corporate Nocsl -- 5 Fepp- sos 14837) am ro espondg ingfo voice messageiatry1a2o0yu01tS4hy83,G.eaanrdyhOpltrsenn2Soefpt3elertbwoedoraydofric0ea0tg,euavleosuoCSmPieEtLerTs,,he n20as t repopn tohp atrstutdy. ou voios message indicate ha you donot have hia na pot he TSCA 86) le fThaeotrea a eamGsanine g you cappAfonh)aSaetineseomosrtsnccawtl5e,odn2Ges0d0tA1nhanfoarlhse0psoe1urrb.meTinItSnceCPdeAadtlSoheecetuceomrorei,nngwnt4aesl)t8baCEdiH3Go0RH5sfvoElhe de hoocupmeenatS sis cilhespehrehaspasteixpnl.ainlsawehsy c1anotan yourolueave any hr Guess ea1 Submission T2SeM2r0eFwie2dc0eikc2MalTPDHoepxt ic&oRelguolagtoyry Services S2Zz = oz SME Admimisvaior 3M TSCA 8(e) Coordinator ~==z 2a35d TFeolx: 6a5g11-517353-A3718723 CONTAIN NO CBI 5 AE A' z2So22.0m MEA --_ Certified Mail April 29,2005 DEoPcAumEeanst-tPrRoocoesmsi6n4g2C8eAnttten:r Section 8(e) No CBI OfficeofPollution Prevention and Toxics U12S0E0PPeAnnsylvania Avenue NW `Washington DC 20460-0001 RDEo:cket NToS.CSAEH8Q(-F)12S0U0P-1P4L8E37MENTAL SUBMISSION: Dear Sirs: pItneherDfaeubcoorevomeab-creterafnoecrfseu2nl0cf0eo0dn,yd3locMfkleustourbnimudimetbt(eerPd.OaSFTd)hr-aebftafsirnceapdlolrrtuepooorrfotcohmfeormttihaacltaislttymuasdnytuuwdfayascotfsuur3biMmnigetmtfaepcdlioliiynteyeusndaetra September of 2001 Wineveastriegnatoewthperofviinddiinnggsaffrionamltrheepporritoornstudfyo.llow-up incidence study that was conducted to Please contact Geary Olsen at 651-737-8569 should you have any questions orifwe can provide additional information. Sincerely, Katherine B, Reed StEanfvifrVoincmeenPtraels,idHeenatlth and Safety Operations Enclosure a2 g= haen 22 3 = IF i of NYoe a6 (f . snmoosaan tom = AR226- |036 MR Bla 3M %EHR 0901 - 37%5sspepeemnpedrs2zo0n 00 ODofcfusmoefntToPxriccesSuibnsgtaCnecens (1407 U.S. Environmental Protection Agency 4`W0aA1sehMinTgSSitroCeneA,t,DSSeCWct.2i0o4n680c) Coordinator DELO- DO-IT ooo (ga 6 Dear Section 8() Docket Coordinator: . Re: TSCA8(c) SupplementalNoticeonSulfonate-basedFluorochemicals `With this letter, 3M is providing final reports and other supplemental information TreeploarttsetpodropvriedviinogusblToSoCd AseSreucmtiaonnd8l(iv)er`nloetivfeilcsaotifotnes.st Mmaatneyroifaltshfeorewnhcliocshetdheitienm-slifaerereapnoalryttical rwehfeerrreitnhgeto8(acd)mniontiisftiecraetdiodnocsoenssihsatsedaolrfepardeylbiemiennasryudbatma,iwttetotaerhedes8u(bem)itdtoicnkgeta. fiInn:alotshteurdycarseepsort. 3 DocketAAlRl-o2f2t6h.e eWneclboesleidevie, htoawreeevaelrmr,etashdayt pilnaEcPinAg'tshepsoessietsesmisoninatnhdea8v(aci)ladbolcekientTmSaCyAallow for more convenient access to information directly related to previous 8(e) notifications by IM. EE The table below lists the enclosed itemsand references. the study ordatawhich already `has been the subjectofar 8() notification by 3M: AD mended Ae lyn Snodr,GfeS2sa0GaiennEnihelryCeaolLndpeioeenvrneuReoaaartnoidRooePncprOtooaSfdnu,FecFtOiSo.n,|||| RCDeEoepWmrvFobeOdliSuonEcpetmdiineoOnRnraaalilTosa(xniG3cdaMivtPyaReegrSf)nteardFeynePcolefoN,Nos.-sT- NAE Sr AnN.se PRoO5A.SAaEnnaadpiEoesFaeOldSRtEeop.EoOFrHOtSTEOt-XhOOH1S.3e.r8n4of ||| ss6uu3pb1rm6ii.et5meeJdunnsFeeeb0ra,uln1y9f9l81i.5n,lg2l00r0ep0ort g LRN02095, June 11,2001 g= : S8 zB= Conia EzoF 3235%8 [eSEro i z= g0za00hs0ud m0Zz/ R end onan NO cg) & OF 3 . Tones3 TSCA Section 8() Docket Coordinator # : Page2 an RelatedStudyData Alrend Filed Under 8(e) ' | 2. BPASneaeelryrmtoiaecnaanalnsnLLdaciCbseovonruecafenotnfoatrnSrcyaatRpeieeopeno(rCotDAf,SePDoNewttueaemrsbymseiirnu:Ramtt2is7on5Eo5xf-pt3oh9se-e3itionthe||| CRDInoeepmavrbteosidl,nuoecApdtirmOoersnanTltRoa(axenGlidsaevePiaeatgrrieSn)taLtuFadelarytPioblofistFoyn,aOraSl RPReOSivnia GParvoagjee,NLo.abo3rMatTorOyXRe3p9o5r.t9N,o.GeUo2b0e06r,27, 1999. | FI1ne0c.b,r1u9Sa6pr9oy,ns1u5ol,rre2sp0S0ot0rutdsyuspuNpbolm.eimtet2ne9td5i9n,g June 3. RTDeoepxvoierclitotAypmmSeeennudadmyloeafnatdPF1P,OeCrSininaoaRlat/msP,osOAtrrbaaglaulsGiRRaeevpsraenogadreuc)chFetieonrdt, | carl fling 6L2i9b5o9r,toArpee,l I1n3,.,2P0o0t0o.sdl 418-008, Sponsor's Study No. CFAononaulcoyertniocroatcliiRaoennpcoosrfut,fPocDfnuyeolratomoiceduear,neMms3ou5lfi6ft,ohnaeasPanerd.etMseSinTc0oeannntdhe || (P1eN3c--fWMloeueoFkrODoSioEect)taarinnycSRualttfusod,ny3amoMfiNdR-oeMfae.ntNhooy.llT- RLievfesNoa.ndUS2e6r3a6,SaTmOpXle-s0,283,MFeEbnrvuiarronym3e,nta2l00L1aboratory |daJ6tu3l1ey4d.21J6,u,Cn2eo0v03a00n,c2e00S0m,adSyecNtoi.on63(2e9)-2l2i5n,g 5. AFonmaelymttivhceialSoLenanbooarfnaPtdoELrGiySvR,eerPopEofOrC,SHADL,eCtPeDrFBmORiSnAaVtAAi,Fon/aoPnfdltsEhRIeaFtOsSE || FEDiehnvyaelllpRoeeprpmfoelnruto,arOloroTacoluxnGiccaisvtuaylgoSent)aumdiydoof)-20- Re ReepforNp to.Noo6,N3oT1.O6EX.L.7s F0,O9S8FE,et b,Lr3aubMaorEryan6tv,oir2ry0o0nR1me.eqnuetsst NLoa.boUr2a4t0o2r,y3M. | 6teo31tS6e.c7ht,iioDanneRca8nteesm)o,bd3eolrMck1Re7et,fp1e9er9e8en,ceseruNboom.fitTe-d `August 21,2000 PrBAneaesleya ntcicealnLdcCoanceo obntrraRatoetepi(oonPrroFtfOoSaPn)otwohtresDnieutooemtrmhrinmaettyiaobnoloifttehoef ||FDEienFvaOellRSoEpmeiennpRtaaOblbroTioatxsr(i,cS3itttoMymSaR,tecufhdeTryeuonbfcee)NN-oQgEbc, NG - '2LE(EanNtbv-FoierOrtaSohtEnyo)alrmpiyeeRnnreaLfqilluvuLeeoarrsbotaoonrcNdatotaS,onereUrys2uuR4lme5fpoS2onp,arem3tciiMdNmooeR)n.-esefT,tOhN3Xao-Mn.o0l9T-7(6.N3-16., tATou-gS63eu1cs6tt.i8o2,n1,J82a(n0)u0da0oryck1e1t,p1e9r99l,etsteurbomfitted'[| 433 February 3, 2001 | 7. EFimnpalloRyeepdort,thAlee3xaMndDeerc,aBt.u,rMFaciolityr, SUtanuidvileesrsoifiWooftrkeyrs Minnesou, Api26,2001 | 8P03)rdoeckelrdianiteatsmeurbomiiftDneedctaeomSbrceriyo15n. 2000 000002 , 24 - TSCA SectionS(e) Docket Coordinator + Page Attached Submi_ss--ic Related StuA dy/DaE ta Already | 8. FininAallbRienpoorRta,tsA,cSuatfeetOyraElvaTlouxaitciiotnyLSacbroereantowriyt,hRTi-k3e2r90CoC | A5c2u9t0eCOorCalinToAlxbiiintoyRSactrse,eSnawfittyh. T- LNaob.or1a.t3o2ri9e0s,(4I0nc%, KPr'oPjeFcOt SNoA.A0i8n832A%R0E3X6O2H,,31M7%RefPeArence|| and 40% H,0, L-6778, F-6873,LotS01), November 5, | LEavbaolruaattoiroinesL,abIonrc.a,toPrryo,jeRctikNeor. 0882AR0362, 3M Reference No. T- w1a98s210(Bbieblmioogvraepdh0yTeSntCrAy 8in(De)ocdokcektetA]R-326,final report | 31279%0 (P4A0%anKd'4P0F%OSFAu0A,iLn637%8,EXFO-H, 6s8u7b3,miLottet5do01S)e,cNtioovne8m(be)rdo5c,k1e9t8i2n, (`Awuhgiucsht e2r1r,o2n0c0ou0slseylfr-efaeurdsitteo treabrbits ratherthan rats) 9. GPieersfyh,uoLrPoo,ctaanndcsKu.lfKoannantaena,ndAcRceulmautledatFilounoroofchemicals in | P8(rce)lidmoicnkaertyMdaatya s26u,bm1i9t9t9ed to Section Fish Tissue, Michigan State University, June 20, 2001. 10. GPMeiirenfsklyu,ao1rn.od.o,RcatiavnnedersKOu.tltfKeoarnna,ntMaeinac,nhAdicgRacelnuamSttueadlteFaltUuniooiroovnfcehresrim,icJaulsnein20, 2001. 11. GRieelsayt,edJ.FPl,ooarnodchKe.mKiacanlnsani,n OPyesrtfelr,uoCrroaosscotsatnreesauVlifrgoinanaintcaed, FStraotemUtnhievGersiutoyf,MJleunxeifc20o,a2n0d01C.hesapeake Bay, Michigan 12. GRieelsayt,edJPF.luaonrdocKh.emKiacnanlasni,nPFeirsfhl-uEoartoioncgtWaanetsesrfBoinradtse,and Michigan State Univesity, June 20, 2001. 13. GPeersfyl,uo1ro.ocatnandeKs.ulKfaonnantaena,nAdccReulmautleadtiFolunoorfochemicals in M20a0r1i.ne Mammals, Michigan State University, June 20, Ifyou have any questions about this subeaission, please contact me at (651)737-4795. Sincerely, Enclosures am `Manager, 3M Corporate Product Responsibility 000003 . Se RECEIVTT) OSHAY 17 m1:27 Final Report QENQ -\200-- HET No CB) Mortality Study of Workers Employed at the 3M Decatur Facility `Submittedby: `Bruce H. Alexander, PhD Division of Environmental andOccupationalHealth School of Public Health University of Minnesota `Mayo Mail Code 807 `Mayo Building 420 Delaware Street SE. `MinneapoliMsN, 55455 April 26,2001 53 = 2 6 Summary TObojedcettievremine whether occupationa(lPOexSpEo.sCu.rFe (0SOfAluFo)robcahseemdicfallvsoreoxcphoesmuircea,lsp,aritsilcualtaerldyt(o0 pmeorrfailuiotryooocftaenmepsluolyfoeneyslofflutohreid3eM facility in Decatur,Alabama. MAlelthwoodrskers with atleast onTehyeceoahoofrctuwmaulsaftoilvleoewmepdltohyromuegnhtDeatctehmebDeerca31t,ur1fa9c9i8liatnydwdeeraetehligible for tinicclautseisonofindetcheedceonhtosrwtere abisined asnubdgcrooduepsd:foHrigahnaelxyspioss.eTd,helojwobesxphoelsdedb,yacnodhonrotnemxepmobsecrd,s ceerne assihgeniedretoxpoonsuroef tthorPeeOSeFx-pobsausreed fluorochermicals `Standardized mortality ratiosse(sSpMeRci)fic pased ont calculated to SHAS the all cause and cau imotrhal9i5typerricseknstacsosnofciiadteendcewiitnhteervmapllsowyemreent a the Deacalieixr-poTsehdewaosrsokceirastiaonndbweotrwkeeernsevxiptohs2ure to P`OmSiEn-ibmuamseodneflyseoarrocohfemXipcOaSlUsTEw.as evaluated among . RAestuoltatlsof 145 deoavtehrsewmeprleoiydeedntiinfiheidgihnetxhpeo2s0e8d3jocbosh.orTth`emeomvbeerralsl. mSoirxttayl-iftiyveradteeasthfsorotchceurcroehodrt anmdontgheweoxrpkoesrusre sub-coohbasretrsveerd einotwheewrtorhkaenrsexwpietchtaetdlienasttheongeenYeer&aol fpohpiulgahtioorn.loTwweoxpdoesautrhes r(oSmMRli=v3er.0c8a,nc9er5%weCrIe=0.37-11.10). Th9e5s%isCIo=f0d.e9a9t-h1f4r.0o6m)b.laAdldethrrceaenbcleardwdaerscealnecveartseodcfcourrtrheed eanmtiornegcowhoorrkte(r3scwbhsoerhveeldd, aSMhRig=h4.ex8p1o,surejob. (SmMaRi=n1i2e.n77n,e9wo5r%keCr1s=2(.26)3a-n3d1.i3n5c)i.neTzhaetor and, eamtplooyweaetserwthroeadtimeedntfrpolamntbloapdedreartocranacnedrpwreorceess operator (1: CWoonrckleurssiocnrployeodfidnejaotbhsfwriotmhbhliagdhdeexrpcoasnucreer,thooPwOeSveFrbiaissedoftlucolreoacrhwehmeitchalesr tatheDseecactasuershacvaen.be +n increased `vibuted to risk fluorochemical exposure or an unknown bladder carcinogen encountered during the course of maintenance Work. 2 7 SE -- Introduction Fluorinated organic compounds have been used for decades in a wide variety of industrial 2nd commercial applications. Perfluorinated compounds are used in applications such as specialty lubricants, semiconductor manufacturing, protective buries of coatings, surfactants. fire retardants, and non-conductive coolants. "The 3M Decatur (Alabama) manufacturing site began production in 1961. The site consists of two plants: Specialty Film (film plant) and Specialty Materials chemical plant). The film plant i located approximately 300 yards west of thechemicalplant The major production buildings in the film plant are polyester and non-polyester films. Logan etal. provide adetailed descriptionofthe chemical plant." The three major product groups (referred to as focus factories) inthe chemical plant are protective chernical, performance chemicals and fluoroelastomers. Therearemorethan 700 different processes with `more than90percentbeingbatch processes. Raw mataendriniteramedliatsesforeach product group may flow through many different production buildings before packaging and shipment. Perfluorooctanesulfonyl fluoride (POSE, CFy7SOZF)i the major sulfonate fluorochemical `manufactured at Decatur andisused as the pretcotuherprosduoctironofa vasiety of perfluorinated amides, alcohols, acrylates and other fluorochemical polymers. POSF is produced via an electrochemical cell process. POSF-based luorochemicals can be absorbed into the body and be metabolically transformed, to an undetermined degree, to perfluorooctanesulfonate (PFOS, CyFSO3). Biological monitoring (serum measurement) of PFOS has been used to assess the employees' exposure experience to POSF-based fluorochemicils at this plantTM 3 8 a Employees may be exposed by one or all routes (i.., inhalation, skin contactabsorption, and ingestion) to these POSF-based fluorochemical materials. The primary route of exposure may be different for each employee and depeonnsevdersal different factors such as: process conditions, job tasks, work location, personal hygiene, personal habits and general work practices. Although POSF-based chemicals are the primary fluorochemicals producedatthis plant, exposure to other fluorochemicals, including perfluorohexanesulfonyl fluoride and perfluoroctancate (PFOA), and exposure to non-fluorochemicals are likely Regarding the toxicologyofPFOS, several repeat dose studies have consistently demonstratedthattheliveris the primarytargetorgan. Livertissueresponsetohighdosesof PFOS included the enlargement of liver and apparent alterations in metabolic processeswiththe reduction in serum cholesterol levels obsereved as the earliest clinical response to PFOS. These effects occurred in cynomolgus primates at serum PFOS levels at 100 ppm. Also at high doses, 'PFOS adversely affected survuval of rat pups in the neonatal period of life as a result of matemal exposure during fetal development. Reduced weight gain, absorptions and resorptions were observedatthehigherdosestested(1.6mg/kg/dayand 3.2mg/kTgher/ewedreanoeyffe)cts.on `post-natal neurological development or on fertility and estrous cycling in offspring in `multigeneration studies. Multiple genotoxicity assays suggested PFOS does not present a hazard from interaction with genetic material. Results from a two-year rat bioassay cancer study are schedulteod be reported in 2001. Medical surveillance findings have not associated abnormal clinical chemistry results with Decatur employees' serum PFOS levels. A previous mortality study of workers employed at the Decplaanttrepuortred an overall lower mortalityratethan expected. This report summarizes the resultsofan update ofthatcohort mortality study with specific emphasis on 4 7 T-- . those jobs which havethe`potential for fluorochemical exposure in employee that may result in elevated serum PFOS levels. 5 10 Methods CohortEnumeration "The cohort for this study was enumerated using employment records from the Decatur facility. `Workers who accrued at least one yearofcumulative employment at Decatur were eligible for inclusion in the cohort. Work history records were obtained from the plandarenviewted and abstracted into an electronic database. This effort was conducted by 3M staff under the supervision of the 3M Medical Department. The records of all employees were abstracted to record the workers name, Social Security Number, 3M identification number, date of birth, and the dates of any entry on the work history record, including layoffs and leaves of absence. Information about the particularjobs was abstracted wherever available, including thejob department codes,and job title. The abstracted data were entered into a computer database and provided to University of Minnesota investigators. To be eligible for the cohort a worker had to accrue at least 365 days of cumulative employment at the Decatur site by December 31, 1997. The eligibilityofeach cohort member was determined by summing their datesof employment. Periods of absence due to illness, military leave, `matemity leave, or layoff did not contribute to eligibility Currently employed workers were assigned December 31, 1997 as their last dateofemployment. `The newly enumerated cohort was linked to records from the original cohort to update employment information. and to verify names, social security numbers, dates of birth, and dates of death for previously identified decedent. Discrepancies identified in therecordswere resolved using TRW/Experian, a credit reporting agency, and the Social Security Administration 6 1 service for epidemiologicresearchstudies.The latter reports the most recent account activity of an individual and whether they are recordedasdeceased in the Social Security Death Index. FDolleow-tupaendrminaotfViitaloStantus Eligible cohort members were followed from the day they accrued 365 days of cumulative employment till December 31, 1998 or their dateof death. Vital records searches wereperformed forall cohort members whowerenotemployebdy 3MonDecemb3e1r, 1997,or for whom a death certificate was not obtained in the original study. Determinationof vital status was made by searching the National Death Index (NDI) for all workers in theoriginal `study and new `workers included in the cohort. The Social Security Administration data and/or the Social Security Death Index (SSDI) was searchetod verify the vital sta of wtorukes rs who terminated `employment before 1979. "Therecords ofcohort members identified as deceased thr theo NDu Iorg SSh DIwere reviewed by handtoensure a validmatch,and acopy ofthedeathcertificate was requestedfromthestate of record. The death certificates were coded by a licensed nosologist to the International ClassificationofDisease Version 8. A second licensed nosologistcodedthe death certificate using the rules for the ICD version in effect at the ti ofm deate h. This second coding was. used for verification and to enable the use of actual (unadjusted) mortality reference data. [ExposureAssessment The relative differences in serum PFOS by job have been reported elsewhere. In this comprehensive assessment conducted in 1998, a total of 232 Decatur employees were randomly 7 Zz selected for Ser sample serum s were sampling extracted with 80% participation (n = 126 chemical usin an fon-piengxractin procedure plant; 60 and wer = film plant). quantaively analyzed for serum PFOS using high-pressure liquid chromatographylelectrospray tandem mass spectrometry methods. The geometric mean serum PFOS level (95% confidence interval) for chemical plant employees was 0.94 ppm (0.79-1.13) and for film plant employees it was 0.14 ppm (0.11-0.16). The great majorityoffilmplant jobs have no direct workplace exposutreo fluorochemicals. Their serum levels are thought to be due, to a large extent, to environmental exposure in proximity to the chemical plant. Chemical plant jobs were categorized into eight categories: cell operators, chemical operators,maintenanceworkers (primarilymechanicsand electricians), mill operators, waste treatment plant operators, engineers/laboratory workers, supervisors/managers and administrative assistants. The highest geometric mean level of serum PFOS was observed in cell operators (1.97 ppm) followed by the waste operators (1.50), chemical operators (1.48 ppm), and maintenance workers (1.30 ppm). Supervisors/managers (0.89 ppm), mill operators (0.59 ppm), engineer/lab workers (0.39 ppm) and administrative assistants (0.40 ppm) had lower geometric mean serum PFOS levels. Mill operators are entry level positions that usually progtorcheemsicsal operators within a few years of hire. As mentioned previously, exposure to other fluorochemcials, including PFOA, are possible. Until 1998, PFOA was not manufactured at the Decatur facility. Rather, PFOA exposures were. the result of it being produced as a by-producteofthe electrolytic cell production or in its use as an elastomer in fluoropolymer production. The primary route ofPFOA exposure would be dermal contact. Although observed at slightly lower levels, the Decatur employees" serum PFOA levels correlated with their serum PFOS levels." ) 8 13 Because production processes have remained constant over time,a straightforward exposure. `matrix was developedbasedon the work history records of the study cohort. With the knowledge of the majorjob-specific serum PFOS levels, a 3M industrial hygienist and epidemiologist assigned each unique job and department combination in the work history records . 101 ofthe following 3 major exposure Categories: 1. no workplace exposure to POSF-based fluorochemicals (encompasses film plantjobs); : 2. low potential workplace exposure to POSF-based fluorochemicals (includes such jobs as engineers, quality control technicians, environmental, health and safety workers, administrative assistants and managers) 3. high potential workplace exposure to POSF-based fluorochemicals (includes cell operators, chemical operators, maintenance workers, mill operators, waste operators and crew supervisors) Hereafterthese three categorics will be referred toasthe non-exposed, low exposedandhigh exposed subcohort. In addition, for the purposeofcumulative exposure for this mortality analysis, these three categories were assignead relative POSF-basedjob exposurevalueof 1,3 and 10 respectively. All exposure assignments were made without knowledgeofthe mortality outcomes. Analysis Themortality experience of the Decatur cohort was compared to thatofthe stateofAlabama. An additional reference population using regional counties was also used to check the results and 14 rule out large variations within the state. The twenty three regional counties, Blount, Calhoun, Cherokee, Colbert, CullmaDne, Kalb, Etowah, Fayette, Franklin, Jackson, Lamar, Lauderdale, Lawerence, Limestone, Marion, Marshall, Morgan, St. Clair, Shelby, Talladege, Tuscaloosa, `Walker, and Winston, were selected for the original study by Mandel and Johnson.' The reference data were obtained from the Mortality Population Data System (MPDS) center at the UniversityofPitisburgh. These data are derived from National Center for Health Statistics data and provide rates for all causes of death combined and deaths due to malignant neoplasms back ! to 1940, and non-malignant cause specific death rates from 1962 forward. These reference data areage (5 year), gender, race,andcalendarperiod (5 year) specific,andarc codedusing therules for the ICD version in effect for the calendar period. `Standardized mortality ratios (SMR) were computed for all cause and specific causeofdeath using the Alabama reference data. The SMRsandappropriate 95% confidence intervalswere computed using the PC Life Table Analysis System (PCLTAS) software developed by the National InstitutesofOccupational Safety and Health (NIOSH)." This program computes age, `gender, and race specific SMR using standard life table methods. Theexpectednumberofdeaths are estimated by multiplying the age, gender, race, and calendar period tabulated person-years of follow-up to the corresponding cause specific reference mortality rates. Race of the workers was not available from the company records, but the population of workers is mostly Caucasian. Therefore, the reference rates for Caucasians were used for this analysis. "The allcausand cause specific SMRs were computed for the entire cohort and the subcohorts of ever high exposure, ever low exposure, and non-exposed. This initial summary analysis was. 10 15 followed by an exposure specific analysis in which the exposed subcohorts were restricted to workers who had at least one year of cumulative employment injobs with high or low exposure. A large number of the workers who ever worked in exposedjobs worked in thosejobs for a short period before being permanently transferred 0 a nonexposedjob. For this analysisth period of follow-up began when the individual reached one year of cumulative exposure, thereby counting person-ime that occurredaferthe minimum exposure was accrued. Causes of death potentially related to fluorochemical exposure were analyzed by duration of employment in the three fluorochemical exposure subgroups. The causes of death of a prior interest were cancersofthe digestive system, in particular liver cancer, and liver cirrhosis, ' because, in animals, PFOS circulates through the enterohepatic circulation and concentratiens theliver.**Othercauses ofdeaththatappearedtobe inexcessin oneormoreofthe. fluorochemicalexposedgroups were also evalbuyadutraetidon of exposure. 1 /b Results Of the 3512 workers identified a total of 2083 workers met the one-year enrollment criteria. OF hese, 47 percent (982) woraktseomde time injobs where exposure to POSF-based Auorochemicals was considered high (Table 1). Approximately 14% (289) worked in low exposure areas, but never held a job in the high exposure areas, and B12 (39%) were considered to have no or minimal workplace exposure to luorochermicals, ic. film plant employees. The high exposure group was modesty younger than the other workers, but had a longer average ! tenure a theplantthantherestofthecohort.Maleworkersmadeup83percentofthe cohortand 84percentofth highexposed sub-cohort,There were total of 145deathsidentifiinethde cohort, 65deaths in the high exposure group, 27 inthe low exposure group, and 53 in the nonexposed group. Death certificates were obtained for 139 (96%) ofthe decedents. The 6 `missing death certificates were in the high exposed group (N=3),th low exposure group (N=2), and the non-exposed group (N=1). A totalof 50,970 person-years offollow up was accrued for the entire cohort. There were 782 workers who woarmiknimeumdof 1yearin highexposurejobs and 1065 workers whoworked aminimoufm1yeari highor low exposujorbes.Thelater subcohort included workers who held high and low exposure jobs for les than one year, but had a combined exposure periodofone year (Table 2). Fifty-three deaths were among those working ne year or more in high expasurejobs, and additional 29 deaths were in the combined high and low exposure group. ) 12 "7 "The all cause and cause specific mortality rates for the entire cohort were lower than expected compared tothe general population of Alabama; 145 observed and 230 expected (SMR=0.63, 95% C1=0.53-0.74). (Table 3) A similar pattem was observed for all deaths from cancer; 39 observed, 54 expected (SMR=0.72, 95% CI = 0.51-0.98). The all cause and all cancer causes of death were fewer than expected for the high exposure (Table 4), low exposure (Table 5), and nonexposed (Table 6) subcohorts. When restricted to workers who accrued at least one year of employment in the high exposure (Table 7), and high or low exposure (Table 8) subgroups, the ` standardizedmoralityratios forall causesofdeathandallmalignant neoplasms were wel below unity. Five deaths from circhosis of liver were identified in the entire cohort, twoof which occurred in the high exposure group; however this did not exceed the numberexpected. Two deaths from liver cancer were observed in the entire cohort, with 1.24 expected (SMR=1.61, 95% CI=0.205.82). One liver cancer was observed in the sub-cohort employed in a high exposurejob for at leasta year (0.50expected,Table 7), and the other held a low exposure job for at least one year. `The SMR forliver canceramongworkers who heldhighor lowexposujorbesforatleast one year was 3.08 (95%C10.37-11.10) (Table 8). "The detailsofthe two livercancercases are as follows. Case 1. Diedatthe ageof 85.The causeofdeath listed onthedeathcertificate was "respiratory arrest" due to "carcinomaofthe liver with metastatic disease". The time from onset of thelivercancer todeathwasrecordedas 4 months. Thedeath certifwiasccaodteed by one nosologist to ICDS 155.0 (primaryhepatocellularcarcinoma), and to ICD9 155.2 (malignaiit neoplasm of the liver not specified as primary or secondary) by the second nosologist. There were no other contributing causes of death entered on the death certificate. 13 ) % `This individual worked as ayardclean-up man and general helperfromthe mid-1960s through the mid 1970s. Retired at age 65. Case 2: Died at the age of 36. The causeofdeath listed on the death certificate was "hepatocellular ca" and coded to ICDS 155.0 (primary hepatocellular carcinoma) by both nosologists. The time from disease onset till death was recordeads 2 months. Therewere no other contributing causes of death listed on the death certificate. This individual worked in the mid-1970's as a general helper for 2.5 months, aprocess helper fo7r months, and a `material handler for $ months. He terminated employment at age 20. Medical validation by follow-back to the physician of record on the death certificate was conductedforthe deaths fromlivercantocveerirfy that liver was the primary cancer. Medical recordswereobtained for both liver cancers and they were confirmedasprimary hepatocellular carcinomas. | `Three deaths wereatwibuted tomalignantneoplasmsofthebladder (0.62expectedintheentire: cohort, SMR 4.81, 95% C1=0.99-14.05). The workers who died from bladder cancer were in the. sub-cohortthatworiknjeobdswithhigh exposureforatleastoneyear (0.19 expected, SMR=16.12, 95% C1=3.32-47.41, Table 7). All three cases of bladder cancer were male and ach had worked in high exposurejobs for at least 5 years (Table 9); the SMR for five or more yearsofemployment in a high exposurejob was 24.49 (3 observed, 0.12 expected).Theresults for bladder cancer in relation to fluorochemical exposure did not change when the reference `population was the local counties rather than the entire state of Alabama. `The job classifications of the workers who died from bladder cancer were. 1. Maintenance mechanic, lead man, maintenance foreman,and crew supervisor. Twenty `years employment at Decatur 5.3 years in high exposure jobs. First employed in 1960. 14 17 2. Maintenance mechanic, general maintenance mechanic; Twenty-three years employment at Decatur, 8.5 years in high exposure jobs, and 1.2 years in low exposurejobs. First employed in 1962. 3. General helper, packer, rewinder, process operator, material handler incineratorand utility operator, and incinerator and waste water operator. Twenty-three years of employment at Decatur. Thirteen years in high exposure jobs, 1.3 years in jobs with low exposure. First employed in 1966. 1s M0 L~ Discussion "This study evaluated the morality experience of workers with at least one year of employment at the 3M facility in Decatur, Alabama. The overall mortality rates were below the expected for most causes. An excess ofdeath frombladder cancer was detected and limited to workers who worked inobs with hghexposureto POSF-based flvorochemicals for at least five years, All other causesofdeath were below the expected or occured too infrequentlytoevaluate with confidence. Some limitations must be considered when interpreting the results of this mortality analysis. Although several methods of follow-up were employed to identify decedents in this cohort, there is the possiblitythatsome deaths were not ascertained. Adeath certificate was not obtained for 6ofknown decedent, thus theywerenot included inthe caus specific death analysis, The extent which these limitations would affect the results is unknown, but they would have their largesteffecton the analysisiftheunknownanduncoded cauofsdeeatsh were atributteod relatively rare causesofdeath, including liver, bladder, kidney, and prostate cancer. Another limitation in this study is the lackof employee specific exposure data for PFOS and other fluorochemicals. The employment records were used as surrogates of exposure, The relative exposure estimates were guided with data from a previous exposure assessment, which reduced misclassification,butdid not eliminate it. Finathlelfoycu,s of this study was flouorochemical exposure, therefore exposure to other chemicals in the workplace was not assessed, "The current shady is an update ofa cohort mortality study by Mandel and Johnson'. The main difference in the methods used for this study is the more specific exposure assessment. The 16 --_-- 2 earlier analysis divided the cohort solely into chemical and film processing workers. In this analysis an effort was made to separate the chemical workers in the high and low fluorochemical `exposurejobs; thus theresultsaremore specific to exposures. There are seven more years of follow-up in this study, which added 71 additional deaths to the analysis. Nevertheless, the cohort relatively young and the low cumulative mortality experience limits the powerofthis _ study to evaluate associations between occupational exposures and employment at the Decatur facility. `Thenumberof deaths from bladder cancer was more than expected based on the prevailing rates for Alabama and the regional counties. The report by Mandel and Johnson also showed an excess of bladder cancer, but was only based on one case, and therefore could have been a chance finding. In the current analysis only three cases were observed, however the fact that all three: cases workedforatleast iveyearsin the high exposedjobs warrants further evaluation. There arefourpossible explanations for ths occurrence; 1)thecancers aredue to exposure to fluorochemicals, 2) thecancersare attributable to another, undetermined occupational exposure, 3) the cancers are related to non-occupational factors such as smoking or other personal habits, or 4)thefinding is due to chance.Withonlythreecasesthepossibility that the finding is due to chance cannot entirely be ruled out. However, given the magnitude of the risk estimate it would take many yearsofadditional follow-up with no further deaths from bladder cancer for this excess to fully attenuate to null. Preliminary Ramination of a two yea feeding bioassay of with either N-cthylperfluorooctane sulfonamide alcohol or PFOS has not shown an increased risk of bladder tumors, The former i 1" QL compoundcan metabolize to an undetermined, toPFOS.There are no lifetime inhalation bioassay studies for POSF. A known risk factor for bladder cancer is tobacco smoking." However, i this cohort, the rates of other smoking related cancers, including lung cancer, were not elevated, suggesting that the. cohort as a whole did not smoke appreciably more than the general population. Although conceivable, it is unlikely that smoking alone could account for a thirteen-fold increase in the rate of bladder cancer among employees who ever held ajob with high exposure. In addition to smoking, bladder cancer has been associated with several occupational exposures. `Employment in the textile industry in particular hasJong been associated with risk of bladder cancer due to the use of aniline dyes and other agents. Several chemicals currentlyorhistorically used in the textile industry have been classified by the Intemational Agency for Research on Cancer (IARC) as Class 1 (carcinogenic), Class 2A (probably carcinogenic) andClass2B. (possibly carcinogenic). The majority of the chemicals evaluated fall into the 2B category including plasticizers such as acetamideanddi(2-ethyl hexyl)-pthalate, flame retardantssuchas thiourea, tris (2,3-dibromo propyl phosphate), and antimony trioxide." Occupational exposure to aromatic amines in the textile andother industries are possibly responsible for up to 25 percent of bladder cancer in some countries. "! Exposure to polycyclic aromatic hydrocarbons (PAHS) hasalsobeen linkedtobladder cancer." These associationshavebeen reported in the aluminum industry, and occupations where exposure to coal tar itch is common. Other occupational exposures possibly related tobladder cancer that are less industry specific, include exposure to 18 2% metal cutting fluids, diesel exhaust, polybrominated biphenyls, and perchlorocthylene and other solvents. 1%, Althoughthebladdercancercases in ths cohort occurred among workers who held high POSFbased exposedjobs, the specificobs of the cases suggest that other exposures could have occurred. The bladder cancer cases worked mostly in maintenance or at the incinerator and waste watertrepalantt.Tmheeexponsurtes i thesejobsarenotlimitedtothoseencounteriedn a specific chemicalproductionprocess.Maintenanceworkersmay work in many areasofthe plan.Thewastewatertreatmentandincineratorworkersareonthereceivingendofthe waste stream, thus they too may have encountered a number of chemical exposures. Mortality from bladder cancer is relatively low with annual incidence rates are five to ten times greater than mortality rates, dependionng age and gender, Clearly this mortality study did not ascertain all cases of bladder cancer in this population. Based on ratesof bladder cancer in the USS. from the Surveillance Epidemiology and End Results (SEER) cancer registry data, 6.9 incident cases of bladder cancer in this population during the follow-up period. Because the `population understudy is not covered by a cancer registry ascertaining these cases would require direct surveys with living cohort members. `Death from liver cancer and cirrhosisofthe liver were a priori outcomes of interest for this study because PFOS is concentrated in the liver. The occurrence of cirrhosisofthe liver did not exceed the expected. There were two deaths rom liver cancer in th fluorochemical-exposed subcohort; approximatelythree timesthat expected. Both cases were verifiedasprimary cancers 19 24 by medical record follow-back. Though more than expected, these results are difficult to interpret because they are based on only two cases. The case with the highest fluorochemcial exposure held a high PFOS exposedjob for nly 14months. The other case occurredi an older man who workedas a general helper in departments with low exposure for eleven years. There were no liver cancer cases among the workers with much longer durationofemployment in high exposurejobs, thus a dose response relationship could not be evaluated. `Both PFOS and PFOA are hepatic peroxisome proliferators in the rat.'*2" A two-year bioassay of "PFOA in the dict caused an increaseofhepatic, pancreas, and Leydig cell adenomas. Two-year bioassays of fecding studies of PFOS in rats are near completion. * It is unlikely that peroxisome proliferators are carcinogenic to humans under anticipated conditions and levelsof human exposure? `Known causes of primary hepatocelluar carcinoma include the hepatitis B and C viruses and aflatoxins produced by Aspergillusflavus and Aspergillus parasiticus primarily in foodstuffs HepatitisB virusisthoughttoberesponsiblefor up to 85%of livercancers inendemicareas, however the prevalence of infection in the U.S. is relatively low. Other contributing causes may include cirthosis due to excessive alcohol consumption. Exposure to high concentrations of vinyl chloride is associated with angiosarcoma of the liver; a very rare cancer. However, there are no clear occupational causes of primary hepatocellular carcinoma. While the possibility exists that this finding is notdueto chance, the results should be interpreted with caution. 20 25 Recommendations Duetothe apparent excess risk of bladder cancer in this population areview of potential exposure to known occupational bladder carcinogens attheDecatursiteiswarranted. The relatively young age and small sizeofthecohort currently precludes detailed analysis by exposure, particularly for less common diseases. To further evaluate the healthoftis cohort in reference to the risk of liver and bladder cancer, and continue to develop the understanding of the toxicology of fluorochemicals, continued follow-up and monitoring of this cohort is recommended. ) 2 26 References I. eLxopgoasnurPeWa,ssJeoshsnmseonntoTfM,a OfllusoernocGhWe,micRaelagmaannuWfaKc,tuMruilnghapulasnetn. AJRm. AInnduinsdtuHstyrigalAshsyogiceJn.e 2001;Submitted. 2. OhelpsaetnicGaWn,d BluiprirdisclJinMi,caMlacnhdeemlisJtHr,yZtoebsteslinLRf.luSoerorcuhmempiecraflluporroodouccttainoenseumlpflonoayteeesa.ndJournal of Occupational & Environmental Medicine 1999;41(9):799-806. 3. MOlasnednelGWJH,.LFolguoarnoPchWe,miSciamlpesxopnosCuAr,eHaasnsessesnmeKnJt,oBfuDrreicsaJtMur,cBhuermliecwalMa,ndScfhiulmmppelratntJC, employees. Am Indust Hyg Assoc J. 2001;Submitied. 4. SIDS. SIDS initial assessment report: perfluorooctane sulfonic acid and its sals. Saint Paul: 3M Company, 2000. 5. MMinaneanpoJl,diJso:ehnDsilovinsiRo.noMofrEtanlviitryosntmuednytoalfeanmd Opcclupoaattiyo3nMeaplelHaensalttihn,DSecchaotoulro,fAPluabblaimca. Health, UniversityofMinnesota, 1995. 6. OMlasnednelGWJH,.LFolguaornoPchWe,miSciamlpesxopnosCuAr,eHaasnsessesqmeKnJt,oBfuDrreicsatJuMr,cBhuermliecwalMa,ndScfhilulmmpeprltanJtC, employees. Saint Paul: 3M, 1999. 7. NsaytsitoenmaflorIunssteituotnetshfeorPCOc.cuCpiantciinonnaatli:SaUf.eSt.yDaenpdarHetamletnht. oPfCHeLaTlAtSh:anLdifHeutmabalne aSnearlvyisciess, 1998. 8. `JofohTnotsaoln CJaDr,bGoinb-s1o4niSnJR,aOtbseArftReEr.aESxitnegnlteain.vd.RDoousteeooffFExCc-r9e4t-i-oCn.anPdroTjiescstu8e9D0i0s3tr1i0b2u0t0i.on `Saint Paul, MN.: Riker Laboratories Inc., 1979. 9. SJFi,lveedsr.maCnanDcTe,rMEoprirdiesmoinolAoSg,yDaenvdesPraeSvSe.ntBiloan.ddSeercCoanndceerd.. NIne: wScYhoorttke:nOfexlfdoDrd,UFnriavuemresnitiy Press, 1996;1156-1179. 10. cIanrtceimnaotgieonniacl rAigseksnctoyhfuomraRness:eaSrocmheonflCaamnecerre.taIrAdaRnCtsmoanndogtrexatpilheschoenmitchaelesvaalnudateixopnosoufres in the textile manufacturing industry. Vol. 48. Lyon: IARC, 1990. IL. Vineis P, Pirastu R. Aromatic amines and cancer. Cancer Causes & Control 1997:8(3):346-55. 12. Boffetta P, Jourenkova N, environmental exposureto Gustavsson polycyclic P. Cancer risk from occupational and aromatic hydrocarbons. Cancer Causes & Control 1997:803):444-72. 13. Ward EM, Bumett CA, Ruder A, Davis-King K. Industries and cancer. CancerCauses & Control 1997:8(3):356-70. 2 14. pBoolnyacsysciliSc,aMreormlaotiFc, hPyedarroczeaNrb,oPnusn.tIonntieRm.atBiloandadleJrocuannaclerofanCdanoccecrup1a9t8i9o;n4al4(e4x)p:o6s48u-r5e1t.o 15. PH.ouFrasbrMy,J.DBalnaadndcehrecaBn,cFeervaontdtoJec,cBuepragteiroentalAe,xApyoszuarcesL.,SCcaarnddiisnEa,vEitaanrJdoJuFn,aPlaolfleWnoCr,k,Roy Environment & Health 1994;20(5):322-30. 16. cShteemiinceaclksG:,aPnleavtaolNu,atNioornelolf tShEe,eHpoigdsetmeidotloCg.icUrloittheerlaituarle.caAnmceerriacnadnsJooumrenailndoufstIrnyd-ursetlriaatled Medicine 1990;173):371-91. 17. AAnmteorni-cCaunlJvoeurrnHa,loLefeE-pFeilddesmtieionloAg,yT1a9y9l2o;r1T3H6(.1)O:c8c9u-p9a4t.ion and bladder cancer risk. : 18. CWaeuissessN&S.CCoantnrcoelr i1n99r5e;l6a(t3i)on:t25o7o-c6c6u.pational exposure to perchloroethylene. Cancer 19. BlPaoddme,rcAaunlceenrtianVd, oDcocnuaptatoiFo,n:Boaffceatsiea-cPo,ntFarzoilosltiuRd,y CinosncoiratnhierCnurlailcyo.SO,ccAluepsastiioonLa.l & Environmental Medicine 1996:53(1):6-10. 20. `HpaeurfglhuoormooBc,taSnpoyicdeavciodl,dpOe.rfTlhuoeromoeccthaanenissulmouhnodneirclayciindg(tPheFOhySpAo)liapnedmiclcofeifbfreicct aocfid. Biochimica et Biophysicia Acta 1992;1128(1):65-72. 21. rSaitbsi.nSsakiinLtIP.Tauwlo:-RyikereLaarboorralat(odrieite)st,ox1i9i8t7y.caicinogenicityof flurochemical FC-143 in 22. PCaotplpeJyAR,CR,obDienLsuocnaDJE,,ElSccahnwbeetEx, BF,eaTnuegr-wCoroidspJ,P,WLaalkieWB.G,DMoapresrmoaxnisDoSm,e PparosltiofoerraTtAi,ng P`choamrpmuancdoslopgosye1a99h8e;p2a7t:o4c7a-r6c0i.ongenic hazard to humans. Regulatory Toxicology & 23. London Second eWdT. ,NeMwcGYloyrnk:n OKxAf,oreddsU.nLiivveersriCtayncPreers.s,Ca1n9c9e6r. Epidemiology and Prevention. : 2 ---------------- T. ------ C-- aTtatbhleeDe1.cCahtaurracftaecriilsittyi.cs of3M employees with & minimum of | year of cumulative employment High Low Toul 982 289 812 2083 Gender M 826(84%) 204(71%) T00(86%) 1730 83%) F 1S6(16%) 8SQY%) 203%) 337%) Meanageatfollow-up 49.9 536 sis SLL Median age at follow-up 49.7 529 se 509 | Mean yearof birth 1948 1944 1946 1947 Medion yearatbirts 1948 1945 47 ea Mean years at Decatur 16.4 133 137 149 Median yearsatDecatur 16.7 104 29 1532 Person-years of follow-up 21867 523 20304 50970 Deaths 6s 27 5 45 :ba:: NEEvvoeerorreemmmippnllioomyyaeelddwiionnrhlkiopgwlhaecexexppofolssuuuorrreoecjjhooebbsrs,miibcnuatltnheeexvcpehorseumariehc,iaglihp.elaxfnpitlo.msuprleanjtoebmipnltohyeeecsh.emical plant. _ --= 29 Teaxbploesu2r.eCahanrdachtiegrhisotrilcsowofeDxepcoastuurre jwoobrsk.ers with a minimum of one year employment in high High High or Low Toul op78e2 d expo1s0e65d Deaths 5 8 Person years 17108 2031 Gender M 668 (85%) 867 @1%) F 114 (15%) 198 (19%) Mean age at follow-up 50 st Mean year of birth 1948 1947 : Mean years at Decatur 166 158 Mean vearsofexposure 05 8 ab:: EEmmppllooyyeedd iinn hhiigghhoerxplooswureexjpoobssurienjtohbescihnemtihceaclhepmlainctalfoprlaatnltefaosrtata yleeara.sat year. 25 30 TalalbDleec3a.tCuaruesmeplsopeyceiefisc(dcehaetmhiscaalndansdtafnidlamrpdliaznetdsmcoormtbaliinteyd)r.atiosforselected causesofdeath for C`aAllsDeeaths Obse1r45ved E2x3p0e0c9ted SM06R3 905.5%3C074 `CAalnlcMearlsignant Neoplasms Digestive OrgansandPeritoneum 39 s ESstoopmhaacghus 02 Large Intestine Rectum 1 0 PaBnilciraeryasPasansd Laivegr Preimasry 2 0 ReLsapriryantoxry System 1s 0 Bronchus, Trachea, Lung Breast 15 2 PrToessttiastaend Other Male reproductive Organs 0 0 Urinary Organs, Kidney 3 0 MalBilgandadnetrMaenldOatnhoemraUorfinSakriyn 3 3 TAhliyrLoyimdphaantdiOcthaenrd EHnedmoactroipnoeieGtliacnTdisssue 0 4 5947286 005712 001571--101998 110174 010706 002010633456 335 063 030 000 00I-166 000-58 124 218 161 000 020582 000-169 2101 051 071 000 040-118 000725 2033 128 074 157 041122 019-566 144 034 000 000 000257 000-1096 189 126 159 000 033465 000292 062 180 481 167 0991406 034488 019 568 000 070 000-1901 019-180 NoCner-embarloivgasncaunltarcaDuisseeasse: `ANllonHmeaalritgnDainsteaRseespiratory Disease: Cirrhosis of Liver AccMiodteontrsVehicle Accidents VioAllelnOcteher Accidents Suicides Homicides 5 35 713 6253 070 056 023-164 039078 1 5 1060 589 009 085 000-052 027-198 27 1s 3665 2205 074 049-107 068 038-12 2 10 1461 1927 082 052 042144 025095 5 5 142 785 044 064 014102 021-149 2 2/ TDaebclateu4r. eCmapulsoeysepeesciefviecrdeematphlsoaynedd sintaandhairgdhiezexdpomsourrtealjiotby.ratios for selected causes of death for CAalwl sDeeaths Obs6e5rved Ex9p3e.c5t6ed S0M6R9 OS0.H54C0I89_ C`AalnlcMearlsignant Neoplasms Digestive Organs and Peritoneum ESstoopmhaacghus Large Intestine: ReBiclitaurymPassages and Liver Primary RePsapnicrarteoarsy System LBarroynnchxus, Trachea, Lung Breast PrToessttiastaend Other Male Reproductive Urinary Organs KiBldandedyer and Other Urinary Organs MCeanltirganlaNnetrMveoluasnSoymsateomf Skin TAlhlyrLoyimdphaantdiOcthaenrdEHnedmoactroipnoeieGtliacnTdisssue 18 2 21.54 391 084 050-132 051 006-185 1 0 046 042 216 000 005-1202 000875 0 0 133 026 000 000277 000 000-1432 1 0 050 086 200 005-1110 000 000430 7 0 824 020 085 034-175 000 000-1851 7 0 7.97 048 088 035-181 000 0007.71 0 0 049 015 000 0007.53 000 0002534 3 075 402 083-1175 0 3 051 023 000 0007.21 1277 2633135 2 0 007969 206020 000302397436 0 1 008 231 000 0004623 043 001240 NoCne-rembarloivganscaunltacraDuissecsase ANlolnmHaelaritgnDainsteaRseespiratory Disease Cirthosis of Liver AccMiodtenotrsVehicle Accidents All Other Accidents Violence SHuoimciicdiedses 2 1 276 2478 072 009262 056 031-095 0 2 4.00 2.46 000 000092 081 01029 17 9 15.87 9.60 107 062-172 094 043-178 8 3 626 838 128 055252 036 007-L05 1 2 497 342 020 00I-L12 059 0072. 2 `Table 5. Decatur Cause specific deaths and employees ever employed sitnaandlaorwdiezxepdosmourrteajloibt,y bruattionsevfeorr saehliecgtheedxcpaoussuersoe fjodbe.ath for Cause `All Deaths Observed Expected SMR 95% CI 27 4243 064 042093 `CAallncMearlsignant Neoplasms 6 1147 052 019-114 Digestive Organs and Peritoneum 2 202 099 012357 ESstoopmhaacghus 0 022 000 000-1691 0 02 000 000-1664 Large Intestine Recum 1 070 143 004794 0 012 000 0.003004 Biliary Passages and Liver Primary Pancreas 1 025 394 0.102188 0 047 000 000-785 Respiratory System Larynx 4 460 087 020222 o oll 000 000-3325 Bronchus, Trachea, Lung Breast 4 446 090 024229 0 040 000 000-933 Prostate `Testis and Other Male Reproductive 0 046 000 0007.97 0 004 000 000-102.57 Urinary Organs, Kidney 040 000 000925 0 024 000 000-1513 Bladder and Other Urinary Organs Malignant Melanoma of Skin 0 016 000 0002378 0 027 000 000-1371 `Thyroid and Other Endocrine Glands All Lymphatic and Hematopoietic Tissue 0 0 003 000 0.00-109.79 105 000 000-352 NCoenr-embarloivagsncaunltacraDuisseesase All HeartDisease. CNiornrmhaolsiisgonfanLtivReerspiratory Disease Accidents `Motor Vehicle Accidents All Other Accidents Violence Suicides Homicides 2 7 161 12.85 125 0.15450 054 022-112 0 1 264 000 000-140 093 107 003-595 1 0 433 023 001-128 250 000 000-147 1 3 182 055 001-305 234 128 026374 1 2 145 069 002383 089 224 027.808 28 `Table 6. Cause specific deaths and standardized mortality ratios for selected causesofdeath for `nonexposed Decatur employees, i. only worked in film plant. Cause All Deaths Observed Expected SMR 95% Cl 53 831 060 045079 CAallncMearlsignant Neoplasms Di`gEessotpihveagOursgans and Peritoneum Stomach Large Intestine Rectum PaBinlciraeryasPassagesandLiver Primary Respiratory System Larynx Bronchus, Trachea, Lung Breast PrTosetastaentdOithser Male Reproductive: Urinary Organs Kidney Bladder andOtherUrinary Organs Malignant Melanoma of Skin `ThyroidandOtherEndocrine Glands, All Lymphatic and Hematopoietic Tissue NCoenr-embarolviagsncaunlatcrDaiusseeass:e: All Heart Disease. Nonmalignant Respiratory Disease. UlofcSteomarch and Duodenum Cirthosis of Liver Accidents AMloltoOtrhVeerhAicclceidAecnctisdents Violence Suicides Homicides 15 11 0 0 0 00 4 0 La 2 00 `0 0 0 1 0 3 1 141 0 2 9 6 a3 3 045 073 o0aLl2l 03742 022275 000016-1124591 040 000 0009.7 127 000 000292 024 000 000-1524 004872 000000 00000074.5709 79 051 014130 019 000 000.1921 764 052 014134 039 SII 0621845 004184 000000 00000072.77243 072 000 000.513 049 000 0007.49 023 000 000-1629 02 138 0037.67 008 000 0004841 219 137 028400 262 038 001212 237821 005296 000312-019496 016 000 0002290 237 084 010305 1467 061 028117 882 068 025-148 57789 005511 O0l114l1-L3510 459 065 013-191 320 031 00L-174 29 Tinabalehi7g.hCeaxupsoesusrpeecjiofbi.c standardized mortality ratios for workers employed forat least one year CAalul sDeeath~s Obse5rved C`AalnlcMearlsignant Neoplasms 1 DigEesstoipvheaOgrugsans and Peritoneum 21 SLatrogmeacIhntestine: 00 ReBiclitaurymPassages andLiverPrimary 01 PaAnllcOrtehaesrDigestive 00 RespBirroantcohruysS,yTsrtaecmhea, Lung 66 BPrroesatsatte 00 UrKiniadrnyeOyrgans 30 MalBilgandandterMaenldanOothmearoUfrSiknianry Organs 31 0 TAhllyrLoyimdphaantdiOcthaenrdEHnedmoactroipnoeieGtliacnTdisssue 01 Fx7p3ec.t6ed 1636075 003373 012030 006379 060465 602247 004509 00.1490 006006 180 SM07R2 008646 020703 000000 205070 009030 009060 0S0110 1060002 167 000506 9055m4C08L5 004068-213471 000070-11L51156 000000-31.85274 000060--1545226 000304--6260435 000305-2103067 010005.-1942963 030302-4972004 004925 0000015390688 NoCner-embarloivgasncaunltacraDuisseesase ANlolnmHaealnitgnDainsteaRseespiratory Discase CNierpthhroistiiss oafndLiNveeprhrosis AccidMeonttosr Vehicle Accidents VioleAlnlceOther Accidents Suicides Homicides 22 192.5124 006913 003121.313077 02 31923 010030 00.0103-317138 30 1204369 010040 000506--913788 67 74.9533 018420 002597-219724 31 63693 004255 000019-.114312 2 271 074009267 30 ``oTnaeblyee8a.rCinauhsieghspoercilfoiwc estxapnodsaurrdeijzoebds,moir.t.alcihteymiractailospfloarntweomrpkleoryseeemsp.loyed for a minimum of C`aAllsDeeaths Cancers DAilgleMsatliivegnOarngtaNnesoapnldasPemrsitoneum Esophagus SLtaormgaecIhntestine Rectum PBailnicarreyaPsassages and Liver Primary RespAilrlatOotrhyerSyDsitgeesmtive BreaBsrtonchus, Trachea, Lung Prostate Urinary Organs KiBldandedyer and Other Urinary Organs `MTahlyirgoniadnatnMdOetlhaenroEmnadoofcrSiknien Glands All Lymphatic and Hematopoietic Tissue Obs8e2rved 19 3 1 0 0 0 2 0 0 10 10 0 0 3 0 3 1 0 1 NoCenr-embarloivagsncaunltacraDuisseesase 4 NAlolnmHaelaritgnDainsetaRsee.spiratory Disease 190 ACicrcrihdoesnitssof Liver 153 AMloltOotrhVeerhAicccliedAecnctisdents 7 8 Violence Suicides 6 2 Homicides a Ex1p17e.c0t8 ed 2845 5.13 059 056 175 033 0L6I5S 0.10 1120 1084 066 088 100 030655 088 010 288 379 257833 172.8097 1020 687 9.09 544 365 SM07R0 067 059 169 000 000 000 300080 000 089 092 000 000 301 000 868 114 000 035 o0s5m6c08r7 0.40-L04 0.12471 0049.41 000660 0002.10 000-1124 003070-3121110 000-3881 043.164 044170 000-563 000421 062875 000566 179.2539 003632 0003795 001-153 105 058 029270 035091 000 000063 018084 004291-310435 069 116 027-141 050-229 066 037 024-144 004133 10 030280 3 Tevaebrleex9p.oBsleadddteorPcFaOncSerbsy(yoebasresrovfedexapnodseuxrpeeacnteddg)ewndietrh.SMRs and 95% CI for Decatur workers EYxeaprosseidn Hjiobgsh PFOS <1 1s 5<i0 10 Observed 0 0 2 1 Expected 005 0.06 00s 007 SMR 000 0.00 4146 1345 95% CI. 075.56 0-58.13 4.66-149.81 0.18-74.88 32