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AR226-0980 has actually been processed as 8EHQ-0101-0373 but is included here in FYI-0101-1378 as well as it was received as an attachment to this FYI. C. if DErx.ecCultiaverVeiRceefPcrhesident December 15, 2000 YEHQ-4we - 0373 M3aMrkSepecialtyMaterial 3% 3SMt. CPean,teM,NBuSilSdHiAng120000 651733 0439 651.575 8001 Fax ARRZE - 0950 - CERTIFIED MAIL Document Processing Center (7407) z3 Cn AOfTfIiNc:eofSPeocltliuotnio8n(6P)reCvoeonrtdiionanatonrd, Toxics = Z= 5283 USEnvironmentalProtection Agency 401 M Street, SW "LEHp-30- 202 5= `Washington, DC 20460 Re: TSCA () Notice for Perfluorooctane Sulfony! Fluoride-based Production Processes Dear Sir: o`fPuarnsuuapndtattoeSoefctairoentr8o(scp)eocfttivheecToohxoirctmSourbtsatlaintycesstuCdonytorfolwoArckt,er3sMatitshreepDoerctaitnugr,thAeldarabfatmraesults DmiavniusfiaocntoufriEnngvifarcoinlimtey.ntTahleasntduOdcycuuppdaattieonwaalsHpeearlftohramnedd ibnyctlhuedUendiwvoerrkseirtsyowiftMhiantnelseaosttao'sne y`eeamrpolofyeceusmuwlaastifvoelleomwpedlofryomme1na9t6t1htehprloaungtphr1i9o9r.toDecember 31, 1997. The cohoof2r,0t83 `Tfhuiosrmoocrhteamliitcyasltpurdoyduwcatsioonriwgoirnaklelrysitnhiattiabteegdaanspianrtthoeflaatneo1n9g70o'is.ngPrmeonviitooursisntgupdryorgersaulmtos f rsahtoiowsfeodraahneyalctahuysweoarkmeorngefffelcutoraoncdhnemoisctaaltipsrtoicdaulcltyisoingnwiofrickaenrtsaeltevDaetciaotnusosf[sMtaannddealr,d1m9o9r5t]a.liItny acdhdeimtiisotnr,ytersetsuilntgsdwointehtDhercoautguhrreemgpullaoryemeesd'icsaelrummonlietvoerlsinfgorhpaesrnfoltuoarsosoocctiaanteedsualbfnoonramtael[Ocllisneinc,al 1999]. Icnattehgeocruirersebnatsuepddaotnejoofbtthiitlsescoinhotrhtemeomrtpalloiyteyes'tsudwyo,rtkhehicsothoroyratnwdaksndoiwvlideeddgienotfotsherreuemePxpOosSure = = levels generally found in employees with thatjob title - no workplace exposure to S 22 t`opePrOfSluFo-rbooacsteadnecshuelmfiosntyrliefsl;uoarniddee(vPeOrShFa)d-bjoabsewditchhehmiigshtrpioetse;ntlioawl pwootreknptilaalcewoerxkppolsaucree etxopPoOsSurFe- =o> "--31C7 beaxpseecdtcehde)maisntdrfireso.mTahlelrceawnecerres f(e3w9evr.th5a4 neexxppeecctteed)didnetahtehsofvreoramlallclohcoaruts.esIn(1t4h5e hvi.g2h3e0st z= = 35 exposedgroup,therewerefewerthanexpectedoveralldeaths(65 v. 93 expecantddeeadth)s 2 fromcancer (18 v. 21 expected). Thebasisofthis sec8(t)irepoortnis that the studydid ind a statistically significantly elevated standard morality ratio (SMR) for bladder cancer (coded as `malignant neoplasmofthebladderand other urinary organs)inthe high exposure group. The SMRforthiscauseinthehighpotentialexposuregroupwas 16.1(3observed, 0.2 expected, 9in5t%hecofancfiilidteyncbeegiinntneirvnagli3n,t3h4e7.119)6,0'sAlalntdhrtehee elamsptrleotyiereesd wbyho19d8i9e.d fOrnoemdbileaddpdreirorcatnoce1r9w9o2raknedd theothertwr died between 1992 and 1998. Contain M0 BY Althoughthestudy shows an association between `workers ever employedin jobs with high exposure to POSF-based fluorochemicalsatDecatur and bladder cancer, existing toxicology data indicate it is unlikely that POSFchemistry exposure is related to these tumors. Perfluorooctane sulfonateand N-ethyl-perfluorooctanesulfomamidoethanol have both been extensively studied. Neither is genotoxic in multiple studies. Two-year bioassays onboth `compounds, in rats,arenearing completion. Preliminary information shows notumorsofthe urinary bladder inthehighdosegroupofeitherstudy. (Final reports pending.) No acute or `subchronicstudy for either compound has shown any blaodrudrienar rytract toxicity. Otherpossible explanationsforthe study finad recihanncge, exposurtoeotherchemicals in thework environmentandpersonal risk factorssuchas smokingor recurrent urinary tract stones or infection. Ingeneral,theexposure stratification used in this study would apply to ceuxrproesnutrlye tionvmeostsitgacthienmgiwchaeltshuesretdheorne thhaessibtee,ennohtisjtuosrticPalOSuFs-eboafsekdnochwenmiosrtrsiuessp.ecWteed abrleadder carcinogens at this location. NTeheethlyilve-rpehrafslbueoernootchteatnaersgueltfoorngamaindoientahnainmoall. studies done with perfluorooctane sulfonate The two-year feeding studyofN-ethyl- and perfluorootanesulfonamidoethanol resulted in a significant increase in benign liver adenomas in high dose female rats. (Supplemental 8(c) notice dated Decembe4r,2000)In this mortality studythereweretwocasesofdeathfromlivercancer -oneinthe lowexposuregroupand one inthehighexpgorosup(uSMrR=e 3.1,observed =2, expecte=d 65, 95%confidenceinterval y=e0a.r4--o1l1d.1m)a.lIenwoanseroeflattheedsteocaapsresi,matrheyreliivserstcilalnucnecrerotraainmteytaassttaotwicheptrhoceerstshetodtehaethloivfetr.hiIsn 8t5h-e roatihseirngcatshee, ptohsesiebmipliltoyyomfeanntodtuhreartciaounswaatsivberieexpfl(aonnaetiyoenar()viraanl)d. the workerwasyoung (36 years), The final report will be forwarded to you when available from the University ofMinnesota. PquleesatsieocnosnctoanccteDrrn.inLgatrhriysZofibleilng,.3M Medical Director at 651-733-5181ifyou have any Sincerely, Rauwe Charles Reich Executive Vice President MReafnedreelncJe,sJ:ohnson R. Mortality study of employees at 3M plant in Decatur, Alabama. DivisionofEnvironmental and Occupational Health, SchoolofPublic Health, University of Minnesota, Minneapolis, Minnesota, 1995. `OalnsdelnipGidWc,liBnuicrarlischJeMm,isMtrayntdeeslsJHi,n fZlouboerlocLhRe.miScealrupmropdeurcftliuoonroeomcptlaonyeeesusl.foJnoautrenaalndofhepatic `Occupational and Environmental Medicine 1999; 41(9): 799-806.