Document 2jpmDBonwKo23w7J6xK3zapbr
AR226-0980
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8EHQ-0101-0373
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FYI-0101-1378
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DErx.ecCultiaverVeiRceefPcrhesident December 15, 2000
YEHQ-4we - 0373 M3aMrkSepecialtyMaterial 3%
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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
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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.