Document oDboaBvQjR86b65zGpEvNamer

AR R86 1352 ne FINAL REPORT Epidemiology, 220-3W-05 Medical Department 3M Company St. Paul, MN 55144 Date: June 17,2003 CTiottlte:agDeeGsrcroivpetiEvmepAlnoayleyesiPsaorftiSceiprauntmsoFlfutohreoc2h0e0m2icMaeldiCconaclenSutrrvaetiilolnasncferoPmrogram IPrRoBtoAcpoplroNvuamlb:er:N/NA/A PriCnoci-pianlveIsntveisgtaitgoartosr:: JGeefafrreyyWH.. OMlasnedne,lD,.MV.DM..,| Ph.D." Study Director: Jeffrey H. Mandel, M.D." 21.20C-o3rWp-o0ra5t,eSOt.ccPuapual,tiMonNal5M5e1d4i4c.ine, Medical Department, 3M Company, Mail Stop 000057 Pe ABSTRACT InDecember 2002, 38 Cottage Grove employees voluntarily participated in the fluorochemical medical surveillance program. As partofthis program,ablood sample was collected from each participating employee for the determinationoftwo serum fluorochemicals: perfluorooctanoate (PFOA) and perfluorooctanesulfonate (PFOS). The serum PFOA concentrations ranged from 0.07 to 32.6 ppm with a mean (arithmetc) of 4.325 ppm (95% CI 2.025 - 6.624) and a geometric meofa1.6n65 ppm (95% CI 1.0192.720). Eleven participants' serum PFOA concentrations exceeded the Biologic Limit Value of5 ppm for PFOA. Serum PFOS concentrations rangedfrom0.050 to 1.170 ppm with a meanof0.334 ppm (95% CI 0.245 - 0.422) and a geometric meanof0.254 ppm (95% CI0.198 - 0.327). The differences between the employees' 2002 PFOA and PFOS serum concentrations and their most recent prior measurements (collected since 2000) resulted in ameandeclineofapproximately 0.2 ppm for each compound. A cautious interpretation is warrantedofany trend in serum concentrations because potential `occupational exposure information was not incorporatedinthe analyses nor was time since last analysis. 000085 Pues INTRODUCTION In December 2002, the fluorochemical medical surveillance program was offered to employees at the 3M Cottage Grove (Minnesota) chemical manufacturing plan. Results have been reported elsewhere for previous fluorochemical medical surveillance `programs at the Cottage Grove manufacturing plant (Gilliland and Mandel 1996; Olsen et al. 1998; 2000; 20030) as wel as the 3M Decatur (Alabama) (Olsen et al. 1999; 20013; 20032) and the 3M Antwerp (Belgium) fluorochemical manufacturing plants (Olsenetal. 1999; 2001; 20033). There were fewer participantsinthe 2002 Cottage Grove fluorochemical medical surveillance program than in previous examination years (1994, 1997, 2000) at this manufacturing sie. This was likely due to thefact that the 2002 fluorochemical medical program wasofferedafterthe company's announcement to cease `productionofperfluorooctanylrelated materials, including perfluorooctanesulfonate and perfluorooctanoic acid (ammonium salt). The purpose of this study is to report the serum fluorochemical concentrations that were measured in 2002 and compare the participants' results with their most recentprevious serum concentrations. METHODS `The fluorochemical medical surveillance program is offered to employees at the `Decaturmanufacturing site on aperiodic basis. Participation is voluntary. As partofthe 2002 program, a blood sample was collected from each participating employee for determinationoftwo serum fluorochemicals. These fluorochemicals were `perfluorooctanoate (PFOA, C7F1sCO0) and perfluorooctanesulfonate (PFOS, CiFinSOy). 0000Sy Pues `These two fluorochemicals were determined by high performance liquid chromatography electrospray tandem mass spectrometry methods (Hansen et al. 2001). Analyses were conductedat Tandem Labs (Salt Lake City, UT) using validated methods that havebeenreported elsewhere (Tandem Labs 1999; 2001; 2001). Fluorochemical concentrations were measured in ug/ml and reported as parts per million (ppm). RESULTS `The 38 Cottage Grove employee participantsofthe 2002 fluorochemical medical surveillance program had a distributionofserum PFOA and PFOS concentrations comparable to the results obtained fromprior serum fluorochemical assessments for this `manufacturing facility (Olsenetal. 2000; 2003c). Several subjects have contributed to multiple reports. Serum PFOA concentrations ranged from0.070to 32.6 ppm (Figure 1) with a `mean (arithmetic) of 4.325 ppm (95% CI 2.025 - 6.624). Because the concentrations were skewed, a geometric mean wasalso calculated for PFOA (1.665 ppm, 95% CI 1.019 - 2.720) which was comparable to the median value of 1.6 ppm. Twenty-six participants had a prior serum PFOA concentration (analyzed since 2000) whose mean was 6.255 ppm (95% C1 2.965 - 9.545)and median 3.345 ppm (Figure 2). Their mean 2002 serum PFOA concentration was 6.056 ppm (95% CI 2.87- 9.249) and median was3.180ppm. `The mean difference was a declineof (-) 0.199 ppm PFOA [95% CI (-0.629) - 0.231, p < 18). `The38participants had serum PFOS concentrations ranging from 0.050 to 1.170 ppm (Figure 3) witah meanof0.334 ppm (95% CI 0.245 - 0.422)and a geometric mean 000060 Pees 0f0.254 ppm (95% C1 0.198 - 0.327). The median PFOS value was 0.280 ppm. Twenty. two participants had a recent,prior serum PFOS concentration (analyzed since 2000) (Figure 4) whose mean was 0.616 ppm (95% CI 0.352 - 0.880)and median was 0.390 ppm. These 22 employees' mean 2002 serum PFOA concentration was 0.423 ppm (95% C10.287 - 0.559) with a median valueof 0.310 ppm. The mean difference between these 22 employees' 2002 PFOS concentration and their most recent prior PFOS concentration waadeclsineof(-) 0.193 ppm PFOS [95% CI (-0.351-) (-0.034),p < 01], DISCUSSION Because potential exposure to PFOA as well as perfluorooctanesulfony] fluoride (POSF)-related materials occurred between the prior fluorochemical medical surveillance program (2000) and the present one, it is not possible to determine whetherthe modest decline in serum PFOA and PFOS concentrations is the resultofserum elimination `and/or reduced opportunity for potential workplace exposure. An ongoing study is `examining the serumhalf lifeofelimination for PFOA and PFOS among 27 retirees followed for $ yearsatthe Decatur and Cottage Grove manufacturing sites. Results from this investigation should be available in 2004. Presently, the estimated serumhalflifeof elimination for PFOA and PFOSare 4.4years (SD = 3.5)and8.7years (SD = 6.1) respectively (Burris et al. 2002). These estimates, however, re based on on9oflthyese retirees followed for 18 months. Eleven participants hadserum PFOA concentrationsthatweregreaterthan the Biologic Limit Value (BLY). The purposeforthe PFOA BLV program is explained, in detail, elsewhere (3M Company 2001). Basically, 3M established the BLY (5 ppm serum 000061 Pages PFOA) to represent the best estimateofa level ofa chemical substance or its metabolite inabiological fluid thatifpresent, even on a chronic basis, would not be expectetdo `pose,or correlate with, a significant riskof adverse healtheffectsto the worker(s). By establishing this BLV at S ppm for PFOA, the 3M exposure guideline committee did not intend to imply that serum levelsofPFOAgreaterthan the BLV immediately impose a significant riskofadverse health effects. However,ifan employee's serum PFOA level either meets or exceeds the BLV, it should be understood that corrective actions (which `mayincludetemporaryremoval fromtheimmediate workarea)mayneedtobeapplied, ona case-by-case basis, at the direction of 3M Corporate Occupational Medicine. Implementationofthe BLV program by 3M Corporate Occupational Medicine did not allow for employees with serum PFOA concentrations > 10 ppm to be directly engaged in the productionofPFOA (Olsenetal. 2003). Cottage Grove employees' serum PFOA `concentrations have not been associated with adverse hepatic clinical chemistry enzymes, cholesterol, lipoproteins, plasma cholecystokinin, reproductive hormones or thyroid hormones (Gilliland and Mandel 1996; Olsenetal. 1998; 2000; 2003c). Thareeservereallimitationstotheanalysespresentedinthisreport. Theresults arise from a small subsetofemployees who voluntarily participated in the 2002 Cottage Grove fluorochemical medical surveillance program. The numberofemployees in the 2002 fluorochemical medical surveillance program is 75 percent less than those who participatedinthe 2000 fluorochemical medical surveillance program. Attrition of employees due to production cessation ofPFOA and POSF-related materials occurred between2000and 2002. Unlike the 2000 Cottage Grove fluorochemical medical surveillance program, employe interview data were not collected in 2002 to provide an 000062 Pe? estimateofexposure to POSF-related production areas for these workers. Therefore, it was not possible to associate serum fluorochemical concentrations to potential workplace exposures in the 2000-2002 time period. Knowledge regarding the serum elimination half-lifeofthese fluorochemicals remains sparse. Actual time wasnot taken into account in the comparisonofthe mast recent prio test results compared to the 2002 serum fluorochemical measurements. As a consequenceofthese limitations, there needs to be cautious interpretationofanytrendanalysis of the serum fluorochemical concentrations ofthe 38 Cottage Grove employees who participated in the 2002 fluorochemical medical surveillance program. 000063 Pt REFERENCES h`BaulrfrliisvJeMs,ofLusnevdebrearlgflJuKo,roOclhseemnicGal,sS.imSpt.soPnauCl,(MMaNn)d:e3lMJ.Co20m0p2a.nyD.eteU.rSm.inEantviiornoonfmesnetraulm Protection Agency docket AR-226-1086. lGiiplolpirloatnediFnsD,,aMnadncdheollesJtSe.rol1:99a6.stSudeyroufmopcecrufplautoiroonoacltlaynoeixcpaocsieddamnednh.epAatmicJeInnzdymMeesd, 29:560-568. qHuaannstietnatKiJv,e CclhaermaectnerLiAz,atEilolneoffsoorngMaEni,cJfolhunosroonchHeOm.ica2l0s01in.biCoolmopgoiucanld-msaptericciefsi.c,Environ Sci Technol 35:766-770. etOpolispdeeenrmfGilouWlo,orogGoiiccltliainnlvoaeinscdtiaFgcDai,dt.iBonuJroOlfcecrweupMprMoEd,nuvciBturirovrneiMshoeJrdMm,o4nM0e:a6sn1di4en-l6m2eJ1Sn, MwiatnhdeoclcuJpHa.ti1o9n9a8l. exApnosure aOlnsdehnepGaWti,caBnurdrilsipJidM,clMinaincdalelchJeHm,isZtorbyetlesLtRs.in19f9l9u.orSoecrhuemmipcealrfplruoodruocotcitoanneempsullofyoeneast.e J Occup Environ Med 41:799-806. hOelpsaetnicGeWn,zyBmuersr,ischJoMl,esBteurrollewanMdMl,ipoMparnotdeeilnsiJHn.am20m0o0.niPulmaspmearfclhuoolreocoycsttaonkoiantien and production workers. 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J Occup Environ Med 45:260270. 000064 Pes OflunscetnioGnWi,n rBeultateinohnotfofJaLn,oMccaunpdaetlioJnHa.l b2i0o0lo3gbi.c Alismsietsvsamleunetfoorfpleiprifdl,uohreopoacttiacnoaantde.thySrt.oid Paul (MN):3M Company. U.S. Environmental Protection Agency docket AR-226. aVOselsnsekesanstGmeeWsnw,taroLlfougaPap,neSrPfclWhu,uomrHpoaeoncrsttaeJnneCs,KuJMl,faonSndiyem!lpfsJlouHno.rCi2dA0e,0p3Brcuo.rdruAicsntiJooMcn,cusiBptuae.trilBoeinwoamMloMneix,tpooVrsoiurnrager.athAmPP, Ind Hyg Assoc J. (in press). PTaFnOdSeAm, LPaFbsO.SA1A99,9.N-AMsesFaOySvEal-iOdaHt,ioNn-rEep(oFrtO.SEQ,uaPnOtiAtAa,tivaenddePtFerHmSiniantihounmoafnPsFeOrSu,m by CLiCt/yM,SU/TM.S,.U.SS.tEundvyiNroo.nmNeWnBtSal98P-ro0t8e2ct,ioRnepAogretnNcoy.dNocWkBeRt9A9R--020265-.12N08W.T Inc, Salt Lake `PTFaHnSd,emM5La5b6s.an2d00M15a7. 0QuinanhtuitmaatnivseedreutmerbmyinLaCti/oMnSo/fMPSF.OSA,ssPaFyOreSvAa,liPdaFtOiSonArAep,orPtO.AA, UStSu.dyEnNvoi.rNonWmBeSn0ta0l-0P4ro0t,ecRteipoonrAtgNeon.cyNWdBocRk0e0t-A1R0-82.26-N1W20T9.Inc, Salt Lake City, UT, `PTFaHnSd,emM5La5b6s.an2d00M15b7.0iQunanhtuitmaatnivseedreutmerbmyinLaCti/oMnSo/fMPSF.OSA,ssPaFyOrSeAva,liPdFatOiSonAAad,dPeOnAduAm, UreTp,o,rt.USStuEdnyviNroo.nmNeWnBtSal00P-ro0t4e0ct,iRonepAogretnNcoy.doNcWkBetROARO--212262-.1N21W0T. Inc,, SaltLakeCity, f3oMr PCeormflpuaonryoo.ct2a0n0o1a.teD[oCcFu3m(eCnFt2)aitCiOozn]o.faSnt. OPcacuulpa(tMiNo)na:l3MBioCloomgpiacanly.LimUiStS.Value (BLV) Environmental Protection Agency docket AR-226. 000065 | | 385 EH i3| s5 23 iHEz3 HE] HZSuz osFf il gk-< E8 02 OR Ra 3 2 | 3 | g|| | | : : 3 _ : s  = 5 " 33 " ti = 3 2 i: : BE o" 58 3g%e " i: iy 5%3 gZ nugg 5 g wi 5208 S2 a"o EE of . oEyc 3 2 . og ee | : w i3 5 a0=| v. : ' 3a e38o a58 b]38 a&5 8eo a3 a2 (wdd) vodd 000067 . : ia] :51: !i : Ez c: g : & : i RoR 2 os 3 os 000068 } 32 92g|] 8 28 28 33 gZaz iHqH i:3 Ez 24 =o se 2 314 8 oE3e8 is TE 3g532 . :5 & TTT wedsos x s& 2 ? :: iiifts - -. N . - 000VES