Document rBaGo6L9R5kL6Y8BKyzQRv7eE

TTT a Specialy Materials 3SuMPCaeunlteMrN 55144-1000 S17 0 Ae226-1717 May 11,2004 TSCA Non-Confidential Information Center (7407T) Office of Pollution Prevention and Toxics (OPPT) EDoPcAkeWteAstR-B2u2il6ding, Room B-146 1301 Constitution Ave., N.W. Washington, DC 20460 Phone: 202-566-0280 =S= C93E28 z 55 @ -= Attention: OPPT Docket No. AR:226 Re: Information on Perfluorooctane Sulfonate, Perfluotooctanoic Acid, and Related Compounds Dear Sir or Madam: perfluorTohoicstacnoonitcinauceisd 3(MP'FsOAv)o,luanntdarryelsautbemdicsosmiponosunodfsd,ataas opnarptoerfflouuorroooncgtoainnegsduilaflonoagtuee (wPiFtOhS), EPA regarding perfluorochemicals. collectiWoneofarbierdencsltousdiiensg,faorCtDhoefdeolcekcettropnaipcercocpoipeise.s oTfhaensutmubdieersoafrestiutdeimeisz,eodroinn tthhee ecnacsleoosfeda siencdteixo.nsAsforincoaucrh cpahsetmiscuablm,isbsyioennsd,powienthoarvetyopregoafniszteuddyt.heTshtiusdiseusbbmyiscshieomnicianlc,luadneds wsittudhiiensthe related to PFOS, PFOA, and other compounds, and also includes studies that address multiple compounds. revised WreiptohrtrsesopnectthetoTtehneneesnsveieroRnimveenrtasltusdtyudwihesi,chplsehasoeulndotreeptlhaactetthihsosseubwmeisssuibomnititnecdluidnesJuly <20c0o3t.oxiIcnolaodgdiictailons,twudeiehsacvoerriencctliundgedreipnortthiesdsvuablmuiesssbiaosneaddodnenadnaetwo aannaulymsbiesorfotfhPeFpOuSrityofthe tSeasmtpmlaetemraitaelriaanldutsheuds in the tests. revised the sTahmeplmeopruerirteycesnltigahntalylydsoiwsniwdaerntdi.fieWdeadhdaivtieopnarloviimdpeudritthiees in the pArRo2v2id6indgoackteatblreefseurmemncaerifzorincgacthheofchtahnegsetsudtioescatcohwshtiucdhytrheepsoerta.ddenda pertain. We are also = Docket Office May --, 2004 Page 2 0f2 Consistent with our past practice, we have included a bibliographyofrecently published tliotEerPaAtu,rewien i3nMt'esndptoossdeissscioonnt.inGuievtehne btiheblaimoogruanpthoyfpliusbtlinigsihnefdutluitreersatuubrmeiasnsidointss.ready availability `We will also be providing under separate cover in the near future 3M's CD#6ofits AR- 226 submissions, containing copies of all submissions from February 2002 through this May, 2004 submission. We look forward to continuing our dialogue with the Agency. Please feel free to contact me with any questions. Very truly yours, Mhidosll A. dnSornfy Michael A. Santoro SDiarfeecttyoarnodfREengvuilraotnomreyntAaflfa,iHresalth, 3M Building 236-1B-10 St. Paul, MN 55144. 651-733-6374 (phone) 6E-5m1a-i7l3:3-m1a9s5a8n(tfoaxr)o@mmm.com ce: Dr. Charles Auer Dr. Oscar Hemandez (without enclosures) AT3TMACFHLMUEONRTOCTHOELNEITCTAELRSOUFBMMIaSyS1I1,ON2004 3M FLUOROCHEMICAL SUBMISSION TOXICOLOGY, EPIDEMIOLOGY AND MEDICAL SURVEILLANCE Human Sera/Medical SurveillanceEpidemiology ARE157/ 7/!mPearlfluRoerpaoorctt,inDeessuclrfiopntaitvee (APnaRlOySs)isCoofncSeentrruamtiPoenrsfloufoAronotcwtearnopaEtemp(lPoFyOeAe)Paanrtdicipants from Athuega2s0t0314F,l2u0o0r3o.chemical Medical Surveillance Program, 3M Medical Department, 7 A267;oie Analysis Report fo Protocol EPL0012, Quanitative Determination of PFOS and NReWlBaSte0d0-C0o9m1p,ouNnodvseminbeHrum21a,n20S0e1rum by LC/MS/MS, Northwest Bioanalytical Study No. Ed 72PiFmOpSlAe,APnaFlOySsiAsAR,epPoFrHtS,forPPOrAotAo,coMl5E5lP6I-aPnEdurMoS,7Q0uanintiHtuatmiavenDSeetreurmmibnaytiLoCn/oMfS/PFMOSS.. Northwest Bioanalytical Study No. NWBS99-117, December 9, 1999 22E5G1 17728P92F-OSiAc,APnaElOySsiAsA,RepPoFrHtSf,orPOPrAoAto,coMl3E5P6I-aSnwdedM.7Qu0anitnitHautimvaenDeSteerrumminbaytiLoOnoMfSIPFMOSS.. Northwest Bioanalytical Study No. NWBS99-116, December 9, 1999 Pharmacokinetic Study 22226721177223 report, Xenochemicl Receptor trans-Activation Chemicals, Boston University DepartmentofBiology. 3byM PReerffelrueonrcoeocNtoa.neT--b6a2s9e5d.35, September 12,2001 fr Pharmacokinetic. Mechanism and Other Studies 206124H.iz)h LReevpeorlts,oAfnPeIrnfvleusotriogoacttiaonneosfultfhoenaMteec(hPaFnOiSs)m,o3fMToPxriocjietcytiNno.AdTu-l6t2R9a5t.s31E.xApporsield2t3o. 2004 A6172(P3FiOSR)epCoorntc,enAtnraaltyisoins ionfSLaimveprleEsnzfyrmoemsT,-6G2l9y5c.o2g5e:n,Oanned-GPeenrefrluaotriooonctRaenperoSduulfcotniaotneStudy AT3TMACFHLMUEONRTOCTHOELMEITCTAELRSOUFBMMIaSyS1I1O, N2004 oPfroPjeFcOtSN-o. MTe-v6a2l9o5n.i2c8,AcAipdr/iClh2o3l,es2t0e0r4o.l Challenge and NOEL Investigation in Rats, 3M BE 17722,report, Determination of Possible Interferenceof Perfluorooctane Sulfonic Acid Potassium Salt with Rat Cholesterol, 3M Project No. 6329.263, August 17, 1999 267-67117722,7noronicity, Carcinogenicity, Developmental Effects and Reproductive Effects of perfluorooctanoate: A Perspective from Available Animal and Human Studies." Associationof Plastics ManufactoufEruerorpse and The Society of the Plastics Industry, tDheecdeomcbkeert]12, 2002. [previously submitted to EPA but we have not heen able to locate in POSF Perfluorooctanesulfonyl fluoride Repeat Dose 361728 1 mal Report, Oral Toxicity Rangefinder for Perfluorooctane Sulfonyl Fluoride (POSF) in Rats, 3M Study No. T-7098.2, May 1, 2001 6-172 ) Pharmacokinetic Study bad Ta Report, Acute Inhalation Toxicokinetic Study of Perfluorooctanesulfonyl Fluoride (POSF), 3M Study No. T7098.4, November 9, 2001. Repeat-Dose 2261730 T Final Report, Oral (Gavage) Combined Repeated Dose Toxicity Study of T-7706 with the Reproduction/Developmental Toxicity Screening Test, Argus Research Protocol No. 418-028, 3M Reference No. T-7706, July 31, 2003. - | FOSA Perfluorooctanesulfonamide AT3TMACFHLMUEONRTOCTHOELMIECATL TOSUFEBMMaRIySS1I1O,N2004 Pharmacokinetics and Mechanism Studies RI617-(73]Hina Report, Comparative Molecular BiologyofPerfluorooctanesulfonamide (FOSA. T-7132) in Rats Following Four Consecutive DaysofDosing, Study No. DT15. 3M Reference No. T-7132, February 18, 2004. ENVIRONMENTAL STUDIES Environmental Monitoring I. Revised Tennessee River Study (replaces versions submitted July 2003) SIZ RAerveias-ed20R0e2poSratm,pAliSnug,rvEenytorifx,SeIlnce.ctPerdojFelcutoNroo.che1m7i8c4a0l1s, iNnotvheemDbeecrat2u0r03A.labama (replaces the previously submitted Docket No. AR226-1364) 2671733 Revised Analytical Laboratory Report, Tennesse River Valley Samples, 3M Environmental Laboratory Study # E02-0443, September 12, 2003. (replaces the previously submitted Docket No. AR226-1365) [ PFOS Perfluorooctane sulfonate 1 Avian Inlife Studies a. Mallard Duck Acute Study 221734 Toxicological Summary, PFOS - Dietary Acute Mallard Study, May 5. 2004. 226-1736. Final Report, PFOS: A Dietary LCS0 Study with the Mallard, Wildlife International, Ltd. Projet No. 454-102. March 24. 2004. 2-/73ii. Analytical Report, Laboratory Report Revision 1: Analytical ReportofData for 2 PFOS Dietary LCS0 Study with Mallards (Sera and Liver), 3M Environmental Laboratory No. FACT-TOX-130, March 23, 2001 AT3TMACFHLMUEONRTOCTHOELMEITCTAELRSOUFBMMIaSyS1I1O.N2004 b. Mallard Duck Pilot Study 226173]. ToxicoloMgailclaalrdS,uMmamayr5y,,20P0F4.OS - Dietary Chronic Pilot Reproductive Study: D201738ji. Final ReIpnotretr,naPtiFoOnSal:, LAtd.PilPortojReecptrNood.uc4t5i4o-n10S5t.udMyawricthh 2t4h,e 2M0a0l4l.ard, Wildlife L%7/737 i. natytic`aSlerRuempoarntd, MEaxtlrlaacrtdioLnivoefrPfootraAsnsailuymsiPserUfsliunogroHoPctLaCn-cEsluelcftonraotseprfaryo/mMMaaslslard `Spectrometry (Mallard Pilot Study Samples), Centre Study No. 023-042, September 10, 2001 726 4piv. Analytic`aMlemRbeproarnte,, EAxltbruacmteino,n oafndPoYtoalsksifuorm APnearlfylsuiosroUosctianngesulfonate from Egg HPLC-Electrospray/Mass Spectrometry (Quail and Mallard Pilot Studies samples), Centre Study No. 023-063, September 10, 2001. Mallard Duck Definitive Study 2&1 71 i. SOG/T4E. i. SRU/743 ii. AA 74. D265. d& 221 74+ 994-17]. 1 ToxicoloMgailclaalrdS,uMmamyar5y.,20P0F4.OS- Dietary Chronic Definitive Reproductive Study: Final Report, PFOS: A Reproduction Study with the Mallard, Wildlife International, Ltd. Project No. 454-109, March 24, 2004. Analytical the Report, Mallard Analytical Phase Report for PFOS: (Mallard Definitive Study Sera and A Reproduction Study Liver Analyses), 3M with Environmental Laboratory Study # EO1-1256, January 22, 2003 AnalyticBallooRedpoCretl,lsEaxtnrdacSteirounmoffoProAtnaaslsyisuimsPUesrifnlugorHoPoLcCt-aEnleescultfroonsaptreafyr/oMmasRsed Spectrometry (Samples Studies), Exygen Study Nfor.om0D2e3f-i0n6i6t,ivJeunMeal1l2a,rd20a0n3.d Quail Reproduction Analytic`aYlolRke(pMoratl,laArndalaynsdisQouafiPlerDfelfuionritoiovcetaRneepsruoldfuocntaitoeninStMuadlylaErgdgsa)n.dEQxuyagielnEgg. Study No. 023-070, July 5, 2002. Norther Bobwhite Quail Acute Study Toxicological Summary. PFOS- Dictary Acute Northern Bobwhite Study, May 5, 2004. Final Report, PROS: Intemational, A Dictary LCS0 Ltd. Project No. 4S5t4u-d1y03w.itMhatrhcehN2o4r,th2e0r0n4.Bobwhite, Wildlife AT3TMAFCLHUOMREOTNCOHTELMEITCTAELRSOUFBMMIaSyS1I1O.N2004 702-6Yog 61 748 i. Analytical Report, Laboratory Report Revision 1: Analytica Report of Dat for PFOS Dietary Environmental LCS0 Study Laboratory in No. Northern Bobwhite FACT-TOX-129, (Sera and March 23, Liver), 2001 3M Norther Bobwhite Quail Pilot Study S261 749 i. ToxicoloNgoirctahleSrumBombawrhyi,teP,FMOaS-y SD.i2e0t0a4r.y Chronic Pilot Reproductive Study: 2.24-(750 i. Final Report, PFOS: A Pilot `Wildlife Intemational, RLeipd.roPdruocjteicotnNSot.ud4y54w-i1t0h4,thMeaNrocrhth2e4r,n20B0o4b.white. 22.6=175) iii. AnalyticSaelrRuempoarntd, QEuxatirlacLtiivoneorffoProAtnaaslsyisuims PUesrifnlguoHrPoLoCct-aEnleescutlrfoonsaptreayf/rMoamsQsuail Spectrometry (Quail September 10,2001 Pilot Study Samples), Centre Study No. 023-041, f Norther Bobwhite Quail Definitive Study 206 )752). i. Toxicological Summary, PFOS- Dietary Chronic Definitive Reproductive Study: > Norther Bobwhite, May 5. 2004. RARE1753 ii. Final ReIpnotretr,naPtiFoOnSa:l, LAid.RePprroojdeuctctNioo.n 4S5t4u-d1y08w,itMhatrhcehNo2r4,th2e0r0n4.Bobwhite, Wildlife 26-1757 ii. Anatytical the Report, Analytical Phase Report for PFOS: Norther Bobwhite (Quail Definitive Study A Reproduction Study with Sera and Liver Analyses), 3M Environmental Laboratory Study # EO1-1245, April 18, 2003. 2 Bluegill Study ARE115S a. Robust Summary, Acute Toxicity to Bluegill Sunfish, 3M, April 14, 2004. A |75,b% Analytical Report, 96-Hour Static Bluegill Toxicity Test: Sheet (FC-95), 3M, May 27, 1978. Aquatic Toxicity Data Analytical Purity Revisions to Ecotox Studies 226-1757. CSounmcmenatrryatTiaobnlse,CaPlFcuOlSatEecdoUtsoiicnoglDoigfifcearlenTteSstaimnpgleRePsuurlittsy,CoMmapyar2i0s0o4nofEffect 2. Addenda to Previously Purity Analyses Submitted Reports Revised to Reflect the Most Recent PFOS 226/775 a. Addendum, PFOS: A 96-Hour Static Acute Toxicity Test with the Saltwater Mysi(d AT3TMAFCLHUOMREONTCOHTELMEITCTAELROSUFBMMIaSySI11O.N2004 M2y0s0i0do[pAsdidsebnadhuiam),toWiAlRd2l2i6f-e0I0n9t5er]n.ational, Lid. Project No. 454A-101, September 27, SR25~/757 b. APidmdeepnhdaulme,s pPrFoOmSe:lasA),9W6i-lHdoluifreSItanttiecmaAtciuotnaelT,oLxiidc.itPyroTjeesctt wNiot.h 4t5h4eAF-a1t0h2e,adSeMpitnemnboew(r 27,2000 [Addendum to AR226-0083]. A 1760 c. Addendum, PFOS: A 96-Hour Toxicity Test with the Freshwater Alga (Selenastrum c2a0p0r0ic[oArdnduteunmd)u,mWitlodAlRif2e26I-nt0e0m8a5ti)onal, Lid. Project No. 454A-103A, September 27. 247176) 4 (ADdadpehnndiuamm,agPnFaO)S.:WiAld4li8f-eHoIuntremSatattiiocnaAlc,utLted.ToPsriocjietcyt TNeos.t4w5i4thA-t1h0e4C,laSdeopcteermabner 27, 2000 [Addendum to AR226-0087). D762 AddeUnnidoumc,omPpFlOaSm:atuAs)9,6W-iHlodulirfSetaItnitcemAactuitoenaTlo,xiLicdi.tyPrToejsetctwiNtoh. t4h5e4FAr-e1s0h5w,atSeerptMeusmsbeelr 27.2000 [Addendum to AR226-0091 2267763 1. Addendum, PFOS: A 96-Hour Shell Deposition Test with the Eastern Oyster C2r7a,s2s0o0s0tr[eAadvdiergnidniucma)t,oWAiRl2dl2i6f-e00In8t9e]r.national, Lid. Project No. 454A-106, September 2067/764/ + 2 67/765 1, AMydsdiednd(uMmys,idPoFpOsSi,s AbahFilao),w-WTihlrdloiufgehILnitfemea-tCiyocnlael,ToLxiidc.itPyroTjeesctt wNio.th4t5h4eAS-a1l0t7w,ater September 27, 2000 [Addendum to AR226-0101] PAidmdeepnhdaulmes, pPrRoOmSe:lasA)n, WFiladylifLeifIen-tSetmaagteioTnoaxli,ciLtidy.TePsrtojweictthNot.he4F5a4tAh-e1a0d8M, iSenptoew(mber 27,2000 [Addendum to AR226-0097] ey 764 i. Addendum, PFOS: A (Daphnia magna), WSielmdil-iSfteatIincteLmiaftei-oCnaylc.leLiTdo.xiPcriotjyecTtesNto.wi4t5h4Ath-e10C9l,adSoecpetreanmber 27. 2000 [Addendum to AR226-0099). 267/76 7. AddIenntderunma,tioNnoaln,-LGiLd.PFSrteusdhy:watDeert,eFrrmeisnhawtaitoenrofAltghaelSMoleudbiiulimt,y oanfdPSFaOltSwaitnerW,ilWdillidfleife sIuntbemrintatteiodnatlo,thLiedA.RP2ro2j6ecdtoNckoe.t]4.54C-101-1, November 27, 2000 [Not previously 2261768 x. MAedtdheondd,umWi,ldDleitfeermInitneartniaotinoonfatlh, eLidW.atPerrojSeocltubNiol.it4y5o4f-P10F7O.S NboyvtehmebSehrak2e7,F2la0s0k0 [Addendum to AR226-0052]. S261 765 1. Addendum, PFOS: An Activated Intemational, Lid. Project No. S4l5u4dEg-e1,01R,espDiercaetmiobnerInh1,ib2i0t0io0n [ TAedstd,eWnidludlmifteo AR226-0093],