Document QJ53o65Lxb8QdYXQqjRbjjm3v

. CHER - EHSR 25S6pe18y Merit 631 135 19fSr5aosoussisciWon Y 00 15:44 0.398 01/01 74 ff S17 li AR R26 _064-4 AOMPARY SANITIZED September 19, 2000 Ms. Vanessa Williams EUPSAEDnovciruomnemnenttaClonPtrrootlecOtfifoinceA:gency W4a0s1hMingSitroene,t,DSCW.20460-001 FYyT- oo-001373 GGocensos 5 FAX 202:2609555 Dear Ms. Wiliams: iPRneecrglfuladureodrdioionanctntghaenAseuugSbuumlsiftsosn31ai,toen2wa0na0d0sRsceullbaaitmmeiedsdCs2oi5moCtpnoBouELnPdAAsbl"ly,oot3nhMeersespnetciittfliecdae"dnnIdvniifrfooornrcmmmaeatntistioosonnstiundcyjaded in that submiarsecsonsiidoerned benon-CBI by 3M. Best regards, DWiirlelcitaomr A. Wepre, PhD. SEpnevciiraolntmyeMnattaelr,iHaelaMlatrh,keStasfGert&oyupRegulatory Affairs S3tMPCaeual,teMr,NBld5g5.142436-18-10 8o 5, Dg ~3 sEl d 1 : SM 3M General Otics SMtcPeanulerMN 35144-1000 6517331110, FYr.0900- 1378 wm SE ACNEE August 31, 2000 VIA OVERRNIGHT DELIVERY /y, Dr. Charles Auer 5 Director > OCfhfeimciecOafl PCoolnlturtoiolnDPirviesvieonntion And Toxics United States Environmental ProtectionAgency 401 M Street, Southwest Room 403 East Tower (Mail Code 7405) Washington, D. C. 20460 AR 226 O06} WR mon meih 320 EN] g 8TE gz I - 92 = 35 w 3 = Re: SIunlfforomnaattieosnAOnndPReerlfaltueodrCooocmtpanoeunds ` Z 93m8 Dear Charlie: z= 5253 Pursuant to our recent communications, 3M is enclosing additional ~~ liienntfftooerrrmmsaadttaiitooenndsoAunppprpeilref2m1ie,unoMtroasoyicnt4fa,onrMemaastyuilof1n8o,nsaMutbeamsyiat2tn5ed,dratenoldaytJoeuudncperoem2v8pi,oouu2sn0l0dy0s,..inAcTglhaueidnien,gnwcoeulroarsee dpirsovciudsisnigontshiwsiitnhfEorPmAatiroengaorndiangvoflluunotraorcyhebmaissitsrya.s part of our continuing We are enclosing information on perfluorooctane sulfonates and related lcoocmapteodunadsspatrhtatofeiotuhrercopnotsitn-udiantgesfioleursemaorcsht.rTehceentensculbomsiesdsiionfnoorrmahtaisonbienecnludes: > Copiesofpost-1976 studies and certain other information relating to the sdfouolrslveoewitilonlxgaicnhicteeya;altn(hidv)eefppfhieacdrtemsmaiacorolekoaigsny:e.t(iiWc) sea;cuh(tva)evteteorxoiarctgiotalyno;giy(zi;ie)dagnetnhdiost(oviixn)ifcmoiertdmyia;ct(aiioilin) repeated- in labeled file folders for each compound, and provided a detailed index, to aid EPA's `armepivpnieoearwr.coorSnrloeycmtaeisoanbcsiubttloeioesgatrruafpdehiriecsineadnritecreiese.nscloonsetdh,e wihnidelxe.leTshsesiignndifeixcaanltsoacnuotteesstaudfieews Copies of post-1976 studies and certain other information relating to the following environmental science areas: (i) environmental fate andtransport and (ii) environmental monitoring. These materials are contained in a Fa GYRRfE BlER8A 5, . EBLAchgQeUldIAZRANSEE -| 000010 separate file folder with an index in table form. Oconnefideennctlioalsebduseinnveisrsonimnefnotramlatdiooncu(CmBeIn)t; contains we have einnfcolromsaetdioan stahnaittqiuzaeldifvieerssiaosn of that document, and are submitting the unredacted version in a sealedenvelope. As in our prior submissions, many of the studies refer to the test substance only by a 3M product identification number with a "T", "L" or "FC" prefix. Although analysisofthe test substance has been included where available, it is often not possible to determine from the study report itself the identity of the test substance. Thus, we have 3M's historical records keyed to the 3M product numbetro determine the compositionof the test substance. Where cdaoevamsipclorasibiblteei,dotnihn,epsrioinlodvreesxnutbpcrmooinvstisedixeotsn,sc.soamltPplofesoiartsmieoannnoditnepfutorhriamttyattgihroeantdseeurfcmohr"acnsaormprpeorowcuernnadtnsgen"ortesfoers to a higher purity grade ofa compound. Finally, it should be recognized that product formulations have evolved over the years; composition information may not be contemporaneous with the toxicology studies, and some of thetest substances do not constitute current products. informa3tiMonisacsoanptpirnoupirnigaties.fil3e Mrelvoioekws afnodrwwairlld stuopdpilsecmuessnitntghteheenecnlcolsoesded information with you and other EPA staff. In the meantime, please do not hesitate to contact me with any questions. Very truly yours Enclosures WDiilrlecitaomrAo.f WEenpviprnoenrm,enPtha.l,D Health, SSpaefceitaylAtyndMaRteergiuallastoMrayrkAfeftasirs aM Bldg 236-18-10 3M Center S(t6.51P)au7l3,3M-6N375451(4ph4one) (651) 733-1958 (fax) E-mail: waweppner@mmm.com 00000 | ATTACHMENT TO LSEUPTPTLEERMETNOTACL. ASUUBEMIRSDSIAOTNED AUGUST31, 2000 TOXICOLOGY AND MEDICAL SURVEILLANCE PFOS Perfluorooctane sulfonate Medical Surveillance and Epidemiologic 1. JIuntneeri8,m 2R0e0po0r(tpr#e1,viDoeutselyrmsiunbamtiitotnedoftoSeTrSuCmA H(ael)f-dLoicvkeest,ofinScelvuedreadl hFelrueorfoocrhemicals, convenience) 2. D3aMt'asrEengvairrdoinnmgegnetnaelraLlapbooprualtaotriyoninb1lo9o9d s(anmoprleepsorftrwoamssperveerpaalrecdo)u.ntries analyzed by Acute Toxicity, Tsuhbemifsosliloonw,inbgpurtae-co19p7y6isstnuodwy wbaeisnlgisstuebdmiinttehde bfiorblEiPoAgr'asphcyoonfveanciuetneces:tudies with a prior 1. RIrerpiotarttiobnyanWdAPRrEimaInrsytiEtyutee,IrIrnict.atainodn ainccAolbmipnaonyRianbbgitdso,cuSmaemnptlateiTo-n,11P1r7im(aFrC-y9S5k)i.n November 7, 1974 `Acute Toxicity (Bibliography Only = Copy Not Submited 1. FEivnaalluaRteipoonrtL,abAocruatteorOyc,ulRiakreIriLtaabtoiroantoTreisets,wiItnhc.,T-S2tu9d9y7CNoo.C 0i8n8A2lEbBin0o00R9a,bbi3tMs, Safety R1e9f82e.rence No. T-2997 (perfluoroethylcylclohexylsulfonate DEA sal), January 25, Genotoxicity 1. CFionmalpoRuepnodrtT,-r2e8v1is6eCdo,CI,n VSiRtIroInMtiecmraotbiioonlaolg,iScaRlI MSuttuadgyenNioc.iLtSyCA-s8s9a5y8s,of33MMReCfoermepncaen.y No. T-2816CoC (PFOS DEA salt), March 1980. 2. CFionmalpoReupnodrtT,-I2n99Vi7tCrooMCic(rpoebrifolluoogrioceathlyMlcuytlacgleonhiecxiytlysuAlsfsoanaytseoDfE3AM sCalotm),paSnRyI's International, SRI Study No. LSC-8958, January 1981. Teratology CE.orMraercsthiaolnltoJoMhansyo2n5toInWdielxl:iaMmatCe.riMaclCsoprrmoivicdke.d wInedreexisnhcoorurledctrleyadinLdeetxteerd farsoLmetEt.er from aMnasdsehtahlyll JFoOhSnEs,onNtoovDerm.bFerran1k2l,in19D8.2.Griffith, regarding Riker teratology studies on PFOS 000003 ATTACHMENT TO LSEUPTPTLEERMETNOTACL. ASUUBEMIRSDSIAOTNED AUGUST 31, 2000 Repeat Dose 1. AAdcdiidtiPoontaalssDiautma Soanlt2(6P-FWOeSe,k3CMapsRuelfeerTeonxcieciTt-y62S9t5u)dy with Perfluorooctane Sulfonic 4) LDriavfetr iPnatChyonloomgyolRgeuposrMto(nAknceiylsla(rRyeSctouvdeyr),y EAlneicmtarlosn),MiSctruodsycoNpoi.c6E3v2a9l-u2a2t3i,on of Pathology Associates Intemational, PAI Study Number EM 99.76, May 30, 2000. b) rDeaptoartoendTMSaHy a2,nd20L0i0p,idwsitinhCaycncoommopalngyuisnMgocnokreryess,poAnndielnycteicisnIcnlcuodripnogralettetde,r from fArnodmreSawroSjeaRc.aD,asP,h.PDh..Dt.o PteoteArndJ.rTehwomSefaocradt,, PPhh..DD.. ddaatteedd AMparriclh5,6,22000000,reagnadrdlientgter methodology Pharmacokinetic: 1. cTohpeyfnololwowbienigngstsuudbymwitatsedprfeovricoounsvleyniideennctief:ied in the lstof published literature; a PArnotIenivne,stthiegsaitsiosnubomfitthteedEftfoectthseoGfraFdluuaotreocSacrhbooonlsoofnthLeivUenrivFeatrtsyitAycoifd-MBiynpndeisnogta, by Deanna J. Nabbefeld, April 1998. Legend: FFCC2I ==apmermfolnuoiruomocptearnfelsuuolrfoooncitcansacsitde FFCC33 == NN--EeitkhyyllpFeOrfSuEoroocian sulfonamide 2. SFianfaeltyReEpvoarltu,at2i8onDaLayboPreartcourtya,neRoiukserAbLsaoborrpattioornieSst,uIdnyc.w,i3thMFRCe-f9e8reinncAelNboi.noT-R4ab9b8i0t,s, (perfluoroethyleyllohexylsulfonate), Experiment No. 0979AB0630, March 15, 1981. 3. CFionmailnRgepHoarztl,eStionng,lSet-uDdoyseNoI.ntCraHveWno6u3s2P9h-a1r9m9a,co3kMinReetfiecrSetnucdeyNoof.TT--66668844in Rabbits, (didecyldimethyl ammonium salt of PFOS), December 31, 1997. 4. 6Fi6n8a4l iRnepRoarbtb,it5s-,DCaoivlayrDiocseeLaDbeorrmaatolrAyb,sSotrupdtyioNno.To6x3i2c9i-t2y0P0h,ar3mMacRoekfienreetnicceSNtou.dyT-of Tr6e6p8o4rt(wdiadsecsyulbdmiimtettehdytloaEmPmAonwiituhmlseatletrodfaPtFeOdSM)a,yDe18c,e2m0b0e0r.)31, 1997. [Draftofthis 2 000004 ATTACHMENT TO LSEUPTPTLEERMETNOTACL. ASUUBEMIRSSDIAOTNED AUGUST 31, 2000 Acute Toxicity (Bibliography Only) 1. Final Report, America, Inc. P3riMmaRreyfeEryeencIeriNtoa.tioTn-4S0t1u6d,y JiannRuaabrbyit2s8,, H1a9z8e7l.ton Laboratories 2. Final Inc., 3RMepoRretf,erAecnuctee NOor.alT-T4o0xi1c6i,tFyeSbtruudayryin9,Ra1t9s8,7.Hazelton Laboratories America, 3. FAimnearlicRaep,orIntc,.,P3riMmaRreyfeDreernmcaelNIor.riTt-at4i0o1n6S,tuFdeybriunaRraybb2i7t,s,19H8a7z.elton Laboratories [Post [rerursonsncmony aoe Ongoing Studies 1. SPhtaurdmyaOcuotkliinneetidcatSed tJunouef2Pd2O,Sy2F000inaRnadtsP,r3otMocRolefdearteendceDeNcoe.mTb-e70r983.01,.1998 for N-E(FOSE alcohol | N-ethyl perfluorooctane sulfonamidoethanol Acute Toxicity 1. FRiensaelarRcephoartn,d ADceuvteeloOprmalenTtoxCiocriptoyra(tLiDosno,)3StMudRyefienrReantcse,NFoM.-3T4-22225,3,InStteumadtyiNonoa.l137084, June 7, 1978 Pharmacokinetic 1. BOinoetrWaeneskfo,rmRaitkieornLoabfo1ra4tCo-rNi-eEst,hIynlc.F, OJaSnEuairnyR2a8t,s After 1983. Administration in Feed for The copyofthe following item is submitted under PFOS: APrnotIenivne,stthiegsaitsiosnuobfmitthteedEftfoectthseoGfrFalduuoartoecSacrhbooonlsofotnhLeivUenrivFearttsyitAyciofd-MBiinnndeisnogta, by Deanna J. Nabbefeld, April 1998. 3 000005 ATTACHMENT TO LSEUPTPTLEERMETNOTACL. ASUUBEMRISDSIAOTNED AUGUST 31, 2000 Teratology 1. Teratology Studies on FM 3422, 3M Reference T-3352: a) AFimnearlicRaep,orItn,c,PiPlrootjeRcattNToe.ra1t5o4l-o1g5y9,StMuadyy, T11-,3315928,3.Hazleton Laboratories b) FPrionjaelcRteNpoo.rt,15R4a-t16T1e,raMtaorlcoghy21S,tud1y9,84T.-3352, Hazleton Laboratories America, Inc.. ) PArmoetroiccoal,, RIanct,TJeurnateo2l,og1y98S3t.udy (Segment I, T-3352, Hazleton Laboratories CforrormecE.tiMoanrTshoalMlaJyo2h5nsIonndetxo:WiMlaltiearmiaCl.s pMrcoCvoirdmeidcwke.reIinndceoxrrsehcotullydirnedaedxeLdeatsterLeftrtoerm E. Maanrdsehtahlyll JFoOhSnEs,onNtoovDerm.bFerran1k2l,in19D8.2Griffith, regarding Riker teratology studies on PFOS Ongoing Nisotoen:goMiencghaatnithsetiUcnirveesresairtcyhoofnMNi-nentehsylotFaOuSnEd,er3tMheRdeifreercetniocneoNfosK.enTd-a3l6l16W.a1l0l,acFe.M 3923, DPoFcOuSme(nsetesMreecghaarndiisntgicthi1s)(rae)s-e(a9r)cbhuwtewreerseunbomtititneddexweidthutnhdeerMNa-yct4h,y2l0F0O0SsEu.bmission on N-EtFOSA | N-ethyl perfluorooctanesulfonamide Acute Toxicity, 1. FEivnaalluaRteipoonrtL,abAocruatteorOyr,alRiTkoexricLiatbyorSactroereinesw,iItnh.T,-E3x0p6er7iCmoeCntinNAol.b0i9n8o1RAatRsO,1S4a7f,et3yM Reference No. T-3067 (narrow range ethyl FOSA), May 15, 1987. C6o1r1r0e1c1t4i9o,n CtoHMWay611180S1u1b5m0i,ssainodnC: HTWhre6e11s0tu1d1i5e1s)cwonedruecetrerdobneyouCsolrynilnisgteHdaozenltthoenM(aCyHW `1T8h,e2se00s0tubdiiebslisohgorualpdhynoutndhearveN-beEe{nFlOiSstAed(tAhceurte.e TTohxeicyitdiydbciobrlrieocgtrlaypahpypoenalryointetmhse 1 - 3). May 18 bibliography under PFOS and were provided under PFOS Acute Toxicity 1(2)-). s 000006 ATTACHMENT TO LSEUTPPTLEERMETNOTACL. ASUUBEMIRSSDIAOTNED AUGUST 31, 2000 Pharmacokinetic 1. FHianzalletRoenpoWrits,cSoinnsgilne,-3DoMseReIfnetrreavnecneoNuos.PhTa-r5m9a0c4ok(i9n5e-t9i9c%)S,tuSdtyuodfy TN-o5.9H0W4Iin6R3a2b9b-i1ts1,7, October 14, 1994. Submitted above under PFOS: APrnotIenivn,estthiegsaitsiosnuobfmitthteedEftfoectthseofGFralduuoartoecaScrhbooonlsofotnhLeivUenrivFeatrtsyitAycoifd-MBiinnndeisnogta, by Deanna J. Nabbefeld, April 1998. Ongoing MWeaclhlaanciestinicclruedseesaNr-chEtatFtOhSeAU,ni3veMrsRietfyoerfenMciennNeos.otT-a6u8n6d8e.r1.theDodciruemcetniotnsofreKgearnddianlgl this research have been previously submitted with the May 4, 2000 submission on PFOS (see Mechanistic 1)(a)-(6)). prs Perfluorohexane sulfonate Medical Surveillance and Epidemiologic See item 1 under PFOS: Interim Report Several Fluorochemicals, June 8, 2000. #1, Determination of Serum Half-Lives of FOSA or PFOSA| Perfluorooctanesulfonamide Medical Surveillance and Epidemiologic Secitem 1 under PFOS: Interim Report Several Fluorochemicals, June 8, 2000. #1, Determination of Serum Half-Lives of Ong - Pho armi acokn ineg tic 1. PSruoltfoocnoalmfiodreSitnuRdaytsN,o.3MT-7M1e3d2i.c2a;lSDTe-p3a9r,tmPehnatr,maCcoorkpionreattiecTSotxuidcyoolfogPyerLfalbuoorraotoocrtya,ne In-Life End Date November 2, 1999, report on in-life study pending. We are providing a copyofthe Laboratory Report, Analytical Report of Data for PFOSA LPahbaorrmaatcoorkyinReetpiocrtStNuod.y FinACRaTt-sT(OSXe-ra14an5d(LWi2v8er1)4,)3, M3MEnRveifreornemnecnetaNlo.LaTb-o7r1a3t2o.r2y,, December 6, 1999. 000007 s ATTACHMENT TO LETTER TO C. AUER DATED AUGUST 31,2000 Medical Surveillance and Epidemiologic See item 1 under PFOS: Interim Report #1, Determination of Serum Half-Lives of Several Fluorochemicals, June 8, 2000. Acute Toxicity (Bibliography Only) 1. Final Report, Acute Oral Toxicity Study in Rats, Hazleton Laboratories America, Inc., Study No. 70905392, 3M Reference No. T-4101, FC-109 (19-23% PFOSAA Potassium salt in water), January 21, 1988. 2. Final Report, Acute Dermal Toxicity Study in Rabbits (OECD Guidelines), Hazleton Laboratories America, Inc., Study No. 70905393, 3M Reference No. T-4101, FC-109 (19-23% PFOSAA Potassium salt in water), January 18, 1988. 3. Final Report, Primary Dermal Irritation/Corrosion Study in Rabbits, Hazleton Laboratories America, Inc., Study No. 70905394, 3M Reference No. T-4101, FC-109 (19-23% PFOSAA Potassium salt in water), January 18, 1988. 4. Final Report, Primary Eye Irritation/Corrosion Study in Rabbits, Hazleton Laboratories America, Inc., Study No. 70905395, 3M Reference No. T-4101, FC-109 (19-23% PFOSAA Potassium salt in water), January 18, 1988. Ongoing Mechanistic research at the University of Minnesota under the direction of Kendall Wallace includes PFOSAA, 3M Reference No. T-6896.1. Documents regarding this research have been previously submitted with the May 4, 2000 submission on PFOS (see Mechanistic 1)(a)-(f). Medical Surveillance and Epidemiologic See item 1 under PFOS: Interim Report #1, Determinationof Serum Half-Lives of Several Fluorochemicals, June 8, 2000. ` 000008 ATTACHMENT TO LSEUPTPTLEERMETNOTACL. ASUUBEMIRSDSIAOTNED AUGUST 31, 2000 Acute Toxicity 1. SFitnuadlyRNeop.orHt,LAAcu9t1e20O1r7a3l9T,ox3iMcitRyefSetruednyceinNoR.atsT,-4Ha4z1l6e(taopnpLraobxoirmaattoerliyes4A5m%erFiCc-a1,43 solids -- C;H,sCOO-NH,", 2.2% homologs, 50% water, 2.5% inerts), April 2, 1990. 2. GFuiinadlelRienpeosr)t,,HParzilmeatroyn DLaebromraaltoIrrireistaAtmieorni/cCoar,roSstiuodnyStNou.dyHiLn ARab9b1i2t0s17(4O0E,C3DM Reference No. T-4416, February 14, 1990. 3. FHianzalletRoepnoLratb,orPartiomraireys EAymeerIirciat,atSitound/CyoNroro.siHoLnASt9u1d2y0i1n74Ra0b,b3itMs (ReOfEeCreDncGeuiNdoe.liTne-s), 4416, February 28, 1990. Genotoxicity 1. CFihnianlesReepHoartm,stMeurtaOgveanricyi(tCyHTOes)tCoenllTs,-6C3o5m8iMnegasHuarzeilntgoCnhIrnco.m,oSstoumdaylNoA.ber1r7a3t8i8o-n0s-in 437, 3M Reference No. T-6358, FC-143, Lot 332, April 25, 1996, with protocol, 2. CFionmalinRgepHoartz,leMtuotnagIennci.cSittuydTyesNto.on17T3-8683-508-4i5n5a,n3/Mn VRievfoerMeonucseeNoM.icTr-o6n3u5c8l,euFsC-A1s4s3a,y, Lot 332, May 14, 1996, with protocol and protocol amendments. Pharmacokinetics `Submitted above under PFOS: PArnotIenivne,stthiegsaitsiosnuobfmtithteedEftfoectthse oGfraFdluuaotreocSacrhbooonlsofotnhLeivUenriFvaetrtsyitAycoifd-MBiinnndeisnogta, by Deanna J. Nabbefeld, April 1998 Ongoing 1. WMeaclhlaanciesitnicclruedseesaPrcFhOaAt,th3eMUnRievfeerrseintycoefNoM.inTn-e6s8o8t9.a1u.ndDeorctuhmeednitrsecrteigonarodfinKgentdhiasll research have been previously (see Mechanistic 1)(a)-(f)). submitted with the May 4, 2000 submission on PFOS LU000Y 7 ATTACHMENT TO LETTER TO C. AUER DATED AUGUST 31, 2000 re ENVIRONMENTAL Em r rr er r ---- frre tre e Ee e er its ce errr mr [mr fo a Si L EA ,MLmiI5h e af w o Tn ri255 ras 000010