Document pmvjdGM2xDrmKOr7vkVKzGMJB

) Hl = aM ped:al Matriats SSMt PCaelen,eMrN $5144.10 ARZ2E- 077% oe RFO53 RECEIVED 0FFT F WIIG 3M VIA OVERNIGHT DELIVERY erences (INA December 22, 2000 Office of Pollution Prevention and Toxics 4U0.1S. MEnSvtirreoentmSenWtal Protection Agency Washington, D.C. 20460 FYI-80-001378 Attention: For Your Information Docket - Docket No. AR-226. c sEZ 333g = 20 2 ~ Re: Information on Perfluorooctane Sulfonates and Related Compounds Dear Sir of Madam: This continues 3M's voluntary submissions of data on perfluorooctane sulfonates and related compounds, as part of our ongoing dialog with EPA regarding fluorochenmistry. Contents of this Submission In this submission, we are enclosing some new information and some older documents that have only recently been located. All of the information in this submission relates to health effects research. We expect to provide an environmental submission, along with additional new health effects research information, within the next few months. Analytical Data for Previously Submitted Studies > This submission includes recent final analytical reports providing liver and gseenreurmatviaolnuerastfsotrudtyh.e PTFhOeSPmFoOnSkemyonskteudyysatnuddytrheepoNr-tetuhpydlaFteOsSEantiwnot-erim aFnOalSyEtictawlo-rgeepnoretrastuibomnitstteuddyMhaayd4,no2t00p0r.eviTohuselyanbaleyetnicsaulbdmiatttaefdo.r thAesN-ientdhicyalted in the draft Initial Assessment Report, the laboratory is continuing to update the serum and liver values for various studies. Additional revised values for other studies will be forthcoming in future submissions. ARORA 85010000008 ) Contain No cB DPaegceem2ber 22, 2000 > T1h9i7s8/s7u9bmmiosnsikoenyasltsuodiiensclwuidtehsPaFnaOlyStiacnald vNa-leutehysloFnOlSivEe.r aWndeshearvuemofnrloym recently located these old analytical reports. Additional Copies of Information Submitted to TSCA Section 8(e) Docket > sFuobrmciosnsvieonnisenucned,erweTShCaAveSiencctliuodned8(ein).this package copiesofthree recent > wThheerfeirsftlureolraotcehsemtiocaanlsupardeatperoodfutcheedm,orsthaolwitiyngsatudsytaatitsttihcealDleycsaitgnuirfipclaanntt tehxeceasvasiolfabulreintaorxyicbollaodgdyeirnfcoarnmcaetrio(nb,awseeddoonntohtrbeeelciaesvees)i.tis Based on all biologically of Wpleausairbelecotnhtaitntuhiengotboseinrvveesdtiegxacteestshisrefliantdeisngt,o afnlduoaroscihnedmiiccaatledexipn otshuere. Section 8(e) letter, the reportis stil in preparation. > TpehretasienscotnodfiSnedcitnigsonfr8(oem)tshuebm1i0s4s-iwoenekrebpirooadsuscaeyduhseirneg fNo-retchoynlveFnOiSeEn.ce That study resulted in a statistically hepatocellular adenomas, and one significant excess of benign hepatocellular carcinoma, in female rats only, delayed. and only at the high dose. Given the recent finding of aTnheexficneasl sreopforbtlaodndetrhactasntcuedryiwnitlhebe Dbleacdadteurrtmiosrstuaeliotfyaslltuadnyi,mwaleshianvteheasstkueddy.thTehleabloarbaotroartyortoy hreavdieawlrueraidnyary examined the urinary bladders findings of note. However, we ohfavheigahs-kdeodsefoarntdhecoandtdriotlioannailmawlosr,kwtioth no aetnsaunryedtohsaet.thWeree eisxpneoctabtnhiosrwmoarlkpamtahyoldoeglyaypriessseunatnicnetohfetuhreinfianraylbrleapdodrters ionnctluhdeecdhrtoheniSceNc-teitohnyl8(Fe)OlSeEttesrtcuodnytabiynisnegvetrhael smiognntihfisc.antWienfohramvaetitohnerferfoomre trehseulcthsroonfitchbeicoharsosnaiyc iPnFthOiSs psatcukdya.ge.We(Whaevheamvaedneottyheetsraemceeivreedqutehset reexgpaercdtitnhgatadsdtiutdiyontaol btiesdsueelaeyxeadmipneantdiionngicnotmhpaltesttiuodny,ofanadddiatcicoonradlinwgolryk,.)also > WPeerfhlauovreoaolcstoanienscullufdoendaamirdeopoErtthoannoal 1(3N--MweetehkyldiFeOtaSrEy)stsuudbymiotftNe-dMetothtyhle TSCA docket by letter dated July 24, 2000. 2 PDaegcee3mber 22, 2000 Mixtures > sOpuercisfeireidesfolfuodraocthaesmuibcmalisss(i1o3ncshhemaivcealpsr,ovcioduendtitnogyPouFOstSudaiceisdaadnmidniitsstvearriinogus asalstusbmaissosnieo,nwienrJeunceov2e0r0e0d rinegtahreddinogcummixetnutressubimniwshsiicohnsP).FOWSeisalpsroespernotviadsed AanFFiFntepnrtoidouncatl,ikngnroewdinenats. That mixture Lightwater, wshuibcmhiscsointoaniensssesnmtailalllaymcoouvnetrsedofour HPFeOmSa.ndAesz |ofdiEsPcAu,sstehdeiuntiaitryeocfentthetseelempihxotnuerecosntvudeiressatfioorntowxiitcholDorg.icOaslcar l`eovcaaltueadtiaonfaewndadrdiistkiaonsaslessuscmhensttuidsielsi,miwteed.agArcceoerdditnhgaltyt,heaslethnoeugehd 3noMthbaes submitted. > fDleuromraolchoermiicnatlratvoetneosutsaanbismoarlpstihoanvestauldrieeasdtyhabteaednmisnuipspltieerdedinaocuorveprreevdious msuibxmtiusrsei{oonst.he tWeset snpoetceietsh,atatnhderteheanlsmoeeaxsisutrestdudtiheesptrheatseandcmeinoifsatecroevdeared lcihmeimtiedcaultiistuyc, hhoawsevPeFr.OSTihnethsetuadniiemsalw.erTehiendtaetnadefdrtoombteheosnelystaudsicerseeinsionfg- olervwehletshuerrvetyhoef perxepsoesnucree opfotaenntyialf.luoTrhoechyedmiocanlotreinsduilctaetdeftrhoemraabtseoorfptaibosnorption evxepresruismmeenttaablorlaitshme.r tMhaannycoomfmtehreciparlodpurcotdsucatdsm,inainsdteirnesdotmoethceaasneismoanllsy.were wliitmihtetdheinAfFoFrmFatsitoundiisesavoanilmaibxlteuraess,toatnhde pcaormtpicousliatrilyongiovfetnhethteesltimmiatteedrial. As usefulnessof studies. these mixture studies, we are not providing copies of these Compact Discs and earWlyeMhaayvesupbrmeivsisoiuosnlsy. provided We are you with a compact now enclosing two disc containing additional CDs: our April > Disc 2 covers the submissions dated May 23, 2000 through June 2000. > Disc 3 covers the August submission and this submission. tThhautse,aycohuofwiltlhenodwochuamveenatllosufbtmhiessdiaotnassmubamyisisnicolundseiinnefloercmtartoinoinc ofnormmautl.tipNloete chemicals. and As index wfiotrhetahcehfisrusbt mCiDs,sitohne,efnocllloosweedd CDs include by the data. aAlcsoopaysofwitthhetchoevfeirrstleCttDe,r these electronic documents are for read-only purposes and are not to be 3 PDeecgeemsber 2, 2060 modified. 3M will maintain paper copies, and in the event of any discrepancy, the v3eMrspiaonpeorf caonpyiecsonwfiildlenbteiaclonisnifodremraetdiocno;ntEroPlAlinsgh.oulTdhreefCerDstoitnchleupdeapoenrlycotphiepeusbfloirc any information submitted under claim of confidentiality. We available. will continue to | will be retiring provide information on a regular basis as it becomes from 3M effective January 10, 2001. You may feel free to contact me until then, or after that, please contact my successor Michael Santoro (at the same phone number shown below) with any questions. Very truly yours, Hotlines 0 Happpran William A. Weppner, Ph.D. Director of Environmental, Health SSpaefceitayltayndMaRteegruiallastoMrayrkAfeftasirs 3m Building 236-1B-10 3M Center St. Paul, MN 55144 651-733-6374 (phone) 651-733-1958 (fax) E-mail: waweppner@mmm.com cc: Dr. Charles Auer Dr. Oscar Hemnandez (with index but without other enclosures) - ATTACHMENSTUPTPOLELMEETNTTAELRSOUFBMDISESCIEONMBER 22, 2000 TOXICOLOGY AND MEDICAL SURVEILLANCE = BSR Medical Surveillance & 1. Lmeotrttearlistuybsmtiutdtye,dDuencdeemrbTeSrC1A5,S2e0c0t0i.on 8(e) regarding update ofDecatur plant Repeat Dose 1. ATnoaxliyctiitcyaSltLuadbyorwaitthorPyerRfelpuoorrto,oScetapnteemSbuelfron19i,c2A0c0i0d,P"o2t6a-sWsieuemkSCaalpts(uTl-e6295) oifnPCeyrfnloumcorlogocutsanMeosnuklefyosna,tDee(tPerFmOiSn)atiinoLnivoeftrhaendPrSeesreuncmeSaanmdplCeosn,c"enttoration DaecpcaormtpmaennytCSotvuadnycNeo.LaTb-o6r2a9t5o.r7i,esRIenpco.rtStNuod.yFNAo.CT63T29O-X2-2033,03[MunMaeuddiictaedl dsruabfmtiotftiend-Mifaeyr4e,po2r0t0a0n]d interim reportofpreliminary analytical data were [ONcottoeb:erTh2i0s0r0epdorratftcIonnittaiailnsAsrseveisssemdeanntalRyetpiocratl.daTthaeupdrdaafttinIngittihaalt in the AthsastersesvmiesinotnsRewpoourltdcboentfaoirntehdcdoamtianga.v]ailable asofJuly 2000 and noted 2. T6e9c6h7n,ipcraolviRdeipnogrtanSaulymtmicaarlydaatnadfCoernNtirnaeltAyn-aDlyatyicSaulbaLcaubtoeraRthoersyuRseMpoorntkNeoy. TInotxeimcaittiyoSntauldyR,esweiatrhcFhlaunodraDdeveFlloupomroecnhteCmoircpaolraStuirfoanc,tParnotjeFcCt.9N5o,. 137-02, 3M Reference No. T-3351, submitted May 4, 2000]. August 4, 1978 [final in-lifereport was Contain NO CBI Fe eos na ATTACHMENSTUPTPOLELMEETNTTAELRSOUFBMDISESCIEONMBER 22, 2000 N-E(FOSE alcohol | N-ethyl perfluorooctane sulfonamidoethanol Genotoxicity 1. wIFiinntcah.laSRtCeuopdonyrftiN,rom.LaS2t10o77r8y85YA-s0Ts-Ka4y3+1/w-iItMChHoN,u-s3EeM(LFRyOemSfpEerhTeo-nm6c3ae1NF6o,o.rCwToa-vr6ad3n1Mc6ue.t1aL2ta,bioSorneaptAtosersimaebsye,r 5,2000 A(cNtoitvei:tTyhoifsTi-s6a9r0e6peiantaonfFIinnVailtrRoepMoarmt,maElvialaunatCieolnloGfetnhee MMuuttaatgieonnicTest RweiftherLeSnc1e78NoY.MFoMu-s3e92L3y,mDpehcoemmabeCerll2s2,, N1O99T8,OsXubSmtiutdtyedNoM.ay223184,582,0030,M waintdhaconlcetltuedrifnrgoimt CwoavsatneccheniLcaablolryationraideesqu(arteeviaenwdinsghotuhledNbOeTreOpXeatsetdu)d).y RepeatDose: 1. cLherttoenricsusbtmuidyt,teDdeucnedmebreTrS4C, A200S0e.ction 8(c) regarding results of 104-week 2. T6e9c9h5n,ipcraolviRdeipnogrtanSaulymtmicaarlydaatnadtCoeanctrcaolmApnaanlyytNiicnaeltLyaDboaryatSourbyacRuetpeorRthNeos.us MDeovnekleoypmTeonxticCiotrypSotrautdiyoon,nSFtMu-d3y4N2o2., I1n3t7e-m0a8t8i,oAnaulguRsetse1a6r,c1h9a7n8d [final inlife report submitted May 18, 2000]. Teratology & Reproductive 1. RCeopmrboidnuectdiOornaTlo(xGiacivtaygeS)tuFderytoiflitNy-,ED(evFeOlSoEpmiennRtaatls,a3ndMPRereifnearteanlc/PeoNston.atTa-l `6g3e1n6e.r5a,tiAorngsutsudPyr"otporceovlioNuos.ly41r8ep-o0r0t9e,dFtAoCTTS-CTAOX8-0d1o3c,keJtu]ne 30, 1999 ["two- a Report Amendment 1, October 12, 2000, amending figure. b. ofAntahlyetiPcraelseLnacbeoraantdorCyonRceepnotrrta,tOicotnoobfePrF9O,S2,00M05,5"6D,etPeFrmOiSnAaAti,on aEn(dFOPSFEO-SOAHiinntthheeLSievrear oafndCrPlF:OCS,DMB5R56V,AFP/FPOlSuAs,aRnadts Exposed to Et-FOSE-OH" re 6 ATTACHMENSTUPTPOLELMEETNTTAELRSOUFBMDISESCIEONMBER 22, 2000 N-MFOSE alcohol | N-methyl perfluorooctane sulfonamido ethanol Repeat Dose 1. PCeorvfalnucceroLoacbtoarnastuolrfyo,na1m3i-dWeeEetkhaDnioelta(rNy-SMteuFdyOoSfE)N-iMneRtahtsy,land 4-week JRualnyge24-,Fi2n0d0i0ngsuSbtmuidtyt,in3gMreRpeofretsretnocTeSNCo.ATS-e6c3t1i4o,n l8(ocn)gdowcikteht,letter dated Genotoxicity 1. SLRaaeblpomororantteotlroliea3sMS,trICnaoci.nm,spIaaBnnTdy,NOonR.eev8Se5ar4sc0ec-h0Ma9ur2to3am8ty,icoAenusgStSutusrdtaiien1s,0,wIin1dt9uh7s6tT.r-i1a4l8B5ioi-nTFeisvte Published Literature (Bibliography Only) 1. COhlosleen,cyGstWo,kiBnuirnriasn,dIHMe,pBautricleEwn,zMymMe,s,anCdhoMlaesntdeerlo,l JH, and Plasma Lipoproteins in ATomxmioconlioguym23P(e4r)f:lu6o0r3o-o6c2ta0n(o2a0t0e0)P,roduction Workers, Drug and Chemical 2. PRheoos,pNhaVt,idAydlicnhcohlziandeeahn,dNPhMoRsphSapteicdtryolsectohpaimcinAenaBliyosseynstohfesLiisveirn Rats EHexppaotsoecdartcoinPoegreonxsi,soTmoexiPcroolliofgeyraantodrsAp- pAliCeldasPshoafrmNaocnogleonogtyo2x0i0c0; 126 164: 113- Pa 7 .