Document LJZ34NojkJwLNOx3D47gaYjO3

rtlM 3M Specialty Materials VIA OVERNIGHT DELIVERY 3M Center St. Paul, MN 55144-1000 651 733 1100 OY7 9 RECEIVED OPPT CRt 0 61 2BBI JAM I6 AD1 RI NAL^^0101-001^7Sr December 22, 2000 W4(UDO0.oaS1ffcsi.cuhMeEminonSegvftntirPorteonoePn,ltlrmuoDSteci.WoCenns.tasPl2inr0Peg4rvo6Cet0neetcniottieonrna(A7n4dg0eT7no)cxyics FYI-00-001378 'Y I-00-001378 IS ) yz CD --Jirmon O m< up EDO IV> Attention: For Your Information Docket - Docket No. AR-226 Re: SInufolfromnaattieosnaonndPReerlfaluteodrooCcotmanpeounds Dear Sir of Madam: sreuglfaorndaiTntehgsisflaucnoodrnotrcienhluaeetmesdis3tcMroy'.ms pvooulunndtsa,ryassupbamrtisosfioounrs oonfgdoaintagodniaploegrflwuiothroEocPtAane Contents of this Submission toeinhnlfdisoverirsmroudnaboImtnmicoetuinhsnm,isstaiweoslnintusthsburinembthlmatiashtietsesishsoniantoeov,nxe,wht oeafeeanlowalltynrhegmreeewofcfnnieettchnchlottsaslsy.dirnbdegeistieeosnanormalcolhecn.aentWewedwe.heienAaxflolplthreomcfetatfhftteoieocnptinsraofornverdimsdeesaaotarimocnnhe in Analytical Data for Previously Submitted Studies > TasgiFnenehOtranihsSuleeymEsrtaiudctvtbrwaiaoamlolnfutr-iseegrIsnapesiitonotfirsoeanttrrlusaiAtnduhtiscyboesl.munePdTisstFethstesOumeddSrePeyMncFmhtaeOaoynRdSnte4kfnp,imenoo2yaotr0tlnsp,0atkr0tueenh.dvayeyilToyslaahuttiunbecsddoalyayrltanbhrrteaeeeoplpeyrNoyontirrc-ittsessautulhcpbpdoyrmdaolnatvitFtaititnOedeufsidoSnin.ragEgtnhltAiwtevionseotNrue-in-praedidmntiachdatyetled tohtehesresrutumdieasndwillilvebrevfaolruthecsofmorinvgariinoufustusrteudsiuebs.miAsdsidointios.nal revised values for 85010000008 Contain NO CB^ 85010000008 ! DPaegceem2ber 22, 2000 > Tr1eh9ci7se8ns/7tuly9bmlmociosanstikeoednytahsletsusodeiienoscldlwudaitenhsaPlyaFtniOcaalSyltriacenapdlovrNtas-l.eutehsyloFnOliSveEr.aWndeshearuvemofrnolym Additional Copies of Information Submitted to TSCA Section 8(e) Docket > sFuobrmcoisnsvioennisenucned,ewr TeShCaAveSineccltuiodned8(ien).this package copies of three recent > wTexhhceeerfseirssfltourfoeurloarictnehaserymtobicalaandlsudaperdreactapenroocdefurthc(eebdam,seosdhrtoaowlnitiynthgsrteauedsytcaaatsitsetthisce)a. lDlyBeascsiagetnudirfoipcnalanantltl of WtSphleaeecuatasiovribeanlielc8ao(tbhenl)eatintlteutothitxneeicgr,ootbtlohosegeinyrrvveieenpsdfootirergtmxaiscateetsisottihsnlli,srinewfliaepntrdedeisnopgatno,raoafttlniuobdoner.aloiescvhienedmiticiicasatebl dieoxlionpgotihcseualrley. > faeTTedhrbDpianxtenelehheatadlspraseacadtmiunataanydosrytisetgienenoenutdsrdlsucceryt.ooethdd,omtissonlayflGaeustodtnnhfru.ilritevaodenthSeaesrtdWeeeoulunoaiir.cntnrleeyfdttitgelnhiyeaHoessidaeslnntlxoarufoipynwarrtnd8meoeonteby(hcmacieav,lmaeeat)seswbntdta,trhshhntaed,luiaesiofgtsewibinhnrhsri1mmdwenasdt0idvcioaitohon4sohearlnagfs-skelwpelaviheyoomaessei.nghfstkteahuaheieaTkrgydos-pnedhdnyklbapdoeoi.eetiftreghoisodxofcyleTiaeaccdnafsheeypuaonlaaseslrclrtlniabeusserteldyoslhasedaxoeruebpcurcafnahooosectabtneorrnisandltarciartsnregdrytoecdooinotifttdlrNhnoioofyoetaoef-rhbnerrnhmtcaeeahutciahomntavleradiynii,swnaenglfvtaaiilwncounnseFlrerrda,ynOekfurylewiaerSbitmrinwoidnnelEtahyaiacpt.ldhlleroendyebroeters toerrinheenxcesgplutauehclrdtchedsetrioncdtohhngftarihtcoahtendebsidtSicuociethdaNiocyrs-tonseitonaaotnhilycybt8iilesPn(sFeFdtuOh)OeeilSlsSeaeEtyptsxeeatasdurctmduckpyodaine.ngyantetWbadi.oyiinnen(isgnWehigncvaeoevtthhmheraeaapmltvslmeesaigttdouinonendoniftytihtc,hoysaeaef.nntastWddraeidnmaeciftceoeihocirvamonreevraaddeqltiuinwttohhegnoeselrytrfk,re.o)faomlsreo > WTPSeerCfhlAuaovdreooocakclsetaotnbienysculleulftdoteenrdadmaaitrdeeodpoJErutthlyoann2o4al, 1(2N30--0Mw0ee.ethkydl iFeOtaSryEs)tsuudbymoifttNed-Mtoetthhyel Jb PDaegceem3ber 22, 2000 Mixtures > AesalssaPHOoupanvFFecusbaleFaOtrurismlcnntuFbsSeiatfaiameetid.npettsrneidiirdosaAetdooeinsoss.ndffzilenoueuaoIaowno,cnfdlftrdwd,ioaiisEnnaekdccrPgtirnJhdusaerAuoeiksetn,swimscdoaueteoninhisebcdva2esnmaaeel0tislrnu.si0ssestsLu0daisT(lmcii1igthorrihy3neheeanogtncstcstwheattfhmuaehntreihdsdtiatmxedieivetlntrioesuiemsgccelr,eaei,putmwplmewrsmshodie,xihuevox.tcibaitnuncdoumAgrteheurercsedinesccscuteoosstoibinodinntnromugdvtnywtdaeiihosnPiihreneasugsFisssticlaoOysshtftsnh,teoiSuomsePanrdn)slataFt.tiieoehalcwOlxsoWilndilaSityucheamegoacedisnhloDoadomduvlprg3s.ninernioMiceOottrisseasstpstdhlevborecaoanefarosvirtnruiioadgrsuesd > vwfsoelusclmlDielimuetmhuxsriuevitropeebxwhieidrstttrefmmmeeluiuuhoterdhdsrlisiaeicsncsemeuhlt.aseiumhrneeotilAtsvoeofinmerlosseFnrittttuiryaayihsnFtomchc,bl.teoFfahreaorhatfltahtsloWeavetpiitsoeotewsshxrumnseentpedetPeseo.sorivineesFspustemoshntMOeusartaci.aecrovxSaaeennitanentTubihiiosmpycnlhrsmaae,oofoeaobttiamtahrxselfltpssnneehtttnmtutudhyeuihtaoardieerdeaaftsnnielrheisulvcpe.item,seosaoirsan,otraTlausalotwdwnhhlmodlpc.urdeeeeiehreeceroyTeapetcasaxdshmdadorsiutsieeyormnuhaicttctridandbtcepsneasmtaoeutnoodl,uatteldstiaardandtnpeieihrtniinmeifrlssdoeyrdsodutsoineuvitnglpcmiottrpinieidharoesvpedbitatdfsetnelesheiottnegfehrtermtaoedoohenstcddhnmeecetoimthenleeypacrseisaaiolnoateaictubmtauisfseosdsmsneraivtoticooeiseepaemrrcfrfsdrptreoeoeeteaathendvirivdlbsosnieeliaysonaisorlnwou.eefgresdp-Artesion Compact Discs and eaWrlyeMhaayvesupbremviisosuiosnlys.prWoveidaerdeynoouwweitnhcaloscionmgptwacot addisdciticoonnatlaCinDinsg: our April > Disc 2 covers the submissions dated May 23, 2000 through June 2000. > Disc 3 covers the August submission and this submission. tTchhhaeutmse,iacycaohlus.owfitlhl enodwochuamveenatllsoufbtmheisdsiaotnassmubamyiisnsciolundseininfeolermctarotinoinc ofonrmmautl.tipNleote tahnedseinedAleesxcwtfroiotrhneictahcdehofcisrusumtbCmeDnist,sstihoaenre,effnooclrlloorwesaeeddd-oCbnyDlytshpeinudcrplauotdase.esaAlacsnoodpayasorewf tinthhoetthctooevbfeierrstleCttDer, 3 PDaegceem4ber 22, 2000 va3meMnorysdpiiionfainefpodero.mrf c3aaoMntipoyinwecsiosllnuwmfbiildmlaeibinntettteaiacdinol unipnnsafidodpereemrrrecacdltaoioipcmnoie;nosEt,frPocalAonlinndsgfhiid.noeutnhTldtehiaereleitvCfyee.Dnrsttoointfhcaleundypeadpiosencrlryecotphpaeinecpsyuf,botlrhice fSarveaaenitltaoobroWcleo(.eanttwIatwihclleitlclmsobaenemtuirneenuttiiperlihntthoogenpfnerr,oonmovuridm3aeMbfteeinerrffotsfherhmacottwa,ivtpnieolenbJaeaoslnoenuwaca)orrwyneitg1tah0uc,ltaa2mnr0yby0aq1ssu.uiescYscatoeisousnistmsob.raeyMcofiecmheeal sel Very truly yours, William A. Weppner, Ph.D. 363S6SSBEDMM55t-apui.mr11iefeleP--dCacc77taiiiytena3l3ou:ngl33arlt,ty-w-neo216MdraMf393NwE657Ra-n84ete15evpgB5((ripfpriu1-aaon1hl4xlanes0o4)tmrnoM@ereya)nmrAtkamfelf,amtsHir.sceoamlth cc: DDrr..(COwhsitachraliernsdHeAexrunebaruntdweizthout other enclosures) ATTACHMENT TO LETTER OF DECEMBER 22, 2000 SUPPLEMENTAL SUBMISSION TOXICOLOGY AND MEDICAL SURVEILLANCE ^ PFOS Perfluorooctane sulfonate 3*: Medical Surveillance Cl 1. Letter submitted under TSCA Section 8(e) regarding update of Decatur plant mortality study, December 15, 2000. Repeat Dose 1. Analytical Laboratory Report, September 19, 2000, "26-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (T-6295) in Cynomolgus Monkeys, Determination of the Presence and Concentration of Perfluorooctanesulfonate (PFOS) in Liver and Serum Samples," to accompany Covance Laboratories Inc., Study No. 6329-223, 3M Medical Department Study No. T-6295.7, Report No. FACT TOX-030 [unaudited draft of in-life report and interim report of preliminary analytical data were submitted May 4, 2000]. [Note: This report contains revised analytical data updating that in the October 2000 draft Initial Assessment Report. The draft Initial Assessment Report contained data available as of July 2000 and noted that revisions would be forthcoming.] 2. Technical Report Summary and Central Analytical Laboratory Report No. 6967, providing analytical data for Ninety-Day Subacute Rhesus Monkey Toxicity Study, with Fluorad Fluorochemical Surfactant FC-95, International Research and Development Corporation, Project No. 137-092, 3M Reference No. T-3351, August 4, 1978 [final in-life report was submitted May 4, 2000]. Contain NO OB! ATTACHMENT TO LETTER OF DECEMBER 22, 2000 SUPPLEMENTAL SUBMISSION N-EtFOSE alcohol N-ethyl perfluorooctane sulfonamidoethanol Genotoxicitv 1. Final Report, L5178Y TK +/- Mouse Lymphoma Forward Mutation Assay with a Confirmatory Assay with N-EtFOSE T-6316, Covance Laboratories, Inc., Study No. 20785-0-431 ICH, 3M Reference No. T-6316.12, September 5, 2000 [Note: This is a repeat of Final Report, Evaluation of the Mutagenic Activity of T-6906 in an In Vitro Mammalian Cell Gene Mutation Test with L5178Y Mouse Lymphoma Cells, NOTOX Study No. 223458, 3M Reference No. FM-3923, December 22, 1998, submitted May 18, 2000, with a letter from Covance Laboratories (reviewing the NOTOX study and concluding it was technically inadequate and should be repeated)]. Repeat Dose 1. Letter submitted under TSCA Section 8(e) regarding results of 104-week chronic study, December 4, 2000. 2. Technical Report Summary and Central Analytical Laboratory Report No. 6995, providing analytical data to accompany Ninety Day Subacute Rhesus Monkey Toxicity Study on FM-3422, International Research and Development Corporation, Study No. 137-088, August 16,1978 [final in life report submitted May 18, 2000], Teratology & Reproductive 1. Combined Oral (Gavage) Fertility, Developmental and Perinatal/Postnatal Reproduction Toxicity Study of N-EtFOSE in Rats, 3M Reference No. T6316.5, Argus Protocol No. 418-009, FACT-TOX-013, June 30, 1999 ["twogeneration study" previously reported to TSCA 8e docket] a. Report Amendment 1, October 12,2000, amending figure. b. Analytical Laboratory Report, October 9,2000, "Determination of the Presence and Concentration of PFOS, M556, PFOSAA, and PFOSA in the Liver and PFOS, M556, PFOSA, and EtFOSE-OH in the Sera of Crl:CDBR VAF/Plus Rats Exposed to Et-FOSE-OH" ATTACHMENT TO LETTER OF DECEMBER 22, 2000 SUPPLEMENTAL SUBMISSION N-MeFOSE alcohol N-methyl perfluorooctane sulfonamido ethanol Repeat Dose 1. Covance Laboratory, 13-Week Dietary Study of N-Methyl Perfluorooctansulfonamide Ethanol (N-MeFOSE) in Rats, and 4-week Range-Finding Study, 3M Reference No. T-6314, along with letter dated July 24, 2000 submitting reports to TSCA Section 8(e) docket. PFOA Perfluorooctanoic acid Genotoxicitv 1. Report to 3M Company, Reverse Mutation Studies with T-1485 in Five Salmonella Strains and One Saccharomyces Strain, Industrial Bio-Test Laboratories, Inc., IBTNo. 8540-09238, August 10, 1976. Published Literature (Bibliography Only-) 1. Olsen, GW, Burris, JM, Burlew, MM, and Mandel, JH, Plasma Cholecystokinin and Hepatic Enzymes, Cholesterol and Lipoproteins in Ammonium Perfluorooctanoate Production Workers, Drug and Chemical Toxicology 23(4): 603-620 (2000). 2. Reo, NV, Adinehzadeh, NMR Spectroscopic Analyses of Liver Phosphatidylcholine and Phosphatidylethamine Biosynthesis in Rats Exposed to Peroxisome Proliferators - A Class of Nongenotoxic Hepatocarcinogens, Toxicology and Applied Pharmacology 2000; 164: 113126. 7