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wt 3M | 3MM W GeneralGmemtomsOfices fP3M ErEeCentep r -- AR 226-- 0003 April 21,2000 LoL Dr. Charles Auer URSooEmP7A40He5adquarters Ariel Rios Bldg 1200 Pennsylvania Avenue, N. W. WashingtonD,. C. 20460 Dear Charlie: Mr-- r 257a 33 & OAR = Zn ai! BF Ptourpseurafnltuptroooocutrarneecseunltfocnoamtmeu(nPicFaOtSi)o.nsW,e3aMreispreonvcildoisnigngthaidsdiitnifoonramlatiinofnortmoatyioounornelaating vfloulournotcahreymibsatsriys.asTphairstoifnfoourrmactoinotniniunicnlguddeisscsutsudsiieosnsowniPthFOESPArelraetgianrgditnogthe following asrueravse:ill(ai)ncpeh.arAmalciosktiinngeotfictsh;e(eiin)ctleorsaetdolsotguyd;ieasndha(siib)eeepniadtetmaicohleodgtyoatnhids mleetdtierc,aland isnucmomrarercitelsy aaplpsoliheadvleebgeeendnsprreolvaitdinegdtfoorleegaaclhprciavtielgeogreysofasntdudpiroepsr.ietPalreyasperontoetcetitohnast have bcoeveenrraedmdoitvieodnaflrsotmudcieerstaoinn PdoFcOuSmernetlsa.tinFgitnaolrlye,pryooduucsthiovueltdoxbiecroelcoegiyvithnagtu3ndMerwsilelpaarlasteo: be submitting to the TSCA Section 8(e) docket. 3inMthpelannesartofupturroev.ideInytohuiswrietgharadd,diwteionhaalveinbfeoernmattriyoinngotnoPcFonOtSacatnydooutthoeradfdlrueosrsocshceompiecals `and procedural matters, and we hopteo talk with you the weekofApril 24, 2000. Please do questions. not hesitate 10 call I look forward to me or Dr. Larry talking with you. Zobel, 3M's Medical Director, with any Very truly yours, Holi (A eppprins Contain, NO gg `DWiirlelcitaomroAf.EnWveiprponnemre,ntPahl.,D Health, Safety, and Regulatory Affairs Specialty Materials Markets B3lMdg 236-1B-10 3StMPCaeuln,teMrN 55144 g Z on = 5A SS s E 38 2 438 ==| 000008 PECER I) OD Lo CCoorrppoorraatte HInedaulstthriPahlysHiycsgien&e P3OM BCeonxte3r,32B2u0ilding 220.26:02 : CEorrgpoonroamtiecsOccupations Medicine S6t5.1P7au3l3, M11N10$5133.3220 3CoMrpMoerdaitceaTloDxiecpoalrotgmyent AAbtstoarcphtmieonntsantodAIpnrtirlav2e1n,o2us00P0halretmtaecrotkoiCn.etAiuceSrtfudrioemsWi.n RWaetsp)pner (Radiolabel Oral 3M Technical 1. Synthesis and Characterization of FC-95-''C, November 2, 1979. 2. Extent and Route of Excretion and Tissue Distributionof Total Carbon-14 in Rats after a Single Intravenous Dose of FC-95-'C, December 28, 1979. 3. Absorption of FC-95-'"C in Rats aftear Single Oral Dose, October 26, 1976. 4. J.D. Johnson, et. al., Cholestyramine-Enhanced Fecal Elimination of Carbon-14 in Rats after Administration of Ammonium ['*C]Perfluorooctanoate or Potassium 9[7"C6]P(1e9r8f4l)u,orooctanesulfonate, Fundamental and Applied Toxicology 4, pages 972- Lillo. 000009 : CT MInedutstirinal HHeyaslitehneP,hTsoxiiscology 3M Medical Department 3POM BCoenxte3r3,2B2u0ilding 22026-02 S6t1.2Pa7u3l,3 M11N1055133.3220 Attachments to April 21, 2000 letter to C. Auer from W. and Intravenous Pharmacokinetics in Rabbits) Weppner (Dermal Absorption 3M Technical Reports 1. Single-Dose Intravenous Pharmacokinetic StudyofT-6246 in Rabbits. 3M Environmental Laboratory Study # AMDT-042095.1 2. Single-Dose Dermal Absorption/Toxicity Studyof T-6049 in Rabbits. 3M Environmental Laboratory Study # AMDT020895.1 3. Single-Dose Intravenous Pharmacokinetic Studyof T-6049 in Rabbits. 3M Environmental Laboratory Study #AMDT-112294.1 000010 te . CCoorrppoorraattee IHenadlutshtrPihaysHiycsgien&e 3PMO CBeonxte3r3,2B2u0ilding 220-2602 . CEorrgpoonroamtiecsOccupational Medicine 6St51P7a3ul3 1M1N0331333220 3CoMrpMoerdaitcealToDxeicpualrotgmyent Attachments to April Rats and Rabbits) 21, 2000 letter to C. Auer from W. Weppner (Teratology Studies in 1. Rat Teratology Study T-3351 America Project #154-160. Final Report Dec 19, 1983, Hazelton Laboratories 2. December 7, 1983Letterto Mr. William C. Johnson, Ph.D., reviewing draftofabove. McCormick, 11 from E. Marshall 3. Oral Teratology StudyofFC-95 068TR0008, December, 1980. in Rats, Riker Laboratory, Experiment # 4. November 12, 1982, Ph.D. reviewing the Letter above. to Franklin D. Griffith, Ph.D. from E. Marshall Johnson, 5. #Or4a1l8-(0S1t2o,maJcahnuTaurbye)11D,e1v9e9l9o,pAmrengtuaslLaTbooxriactiotryieSst.udyof PFOS in Rabbits, Study 000011 : PT | SCCo oommmeer i ScR e April 21, 2000 Attachments To April 21, 2000 Letter to C. Auer from W. Weppner (Medical Surveillance and Epidemiology) 1. An Epidemiologic InvestigationofClinical Chemistries, Hematology and Hormones in Relation to Production ESmeprluomyeLeesv.els[oIfncPleurdfelduoirs oaoc3tManreespuolrftoonfamteediincMaallseurFvleuiolrloacnhceemdiatcaa.l Also included is a published paper from this 3M report. 1 2. Fluorochemical Plant Employees. Exposure (Serum) Assessment of (3M) Decatur [Included are a 3M study protocol and report] Chemical and Film 3. Mortality Study of Employees at 3M Plant in Decatur, Alabama [Included is a Universityof Minnesota final report. ] 4. Determination of Serum Fluorochemical Levels in Sumitomo 3M Employees [Included are a 3M study protocol and final report ] 5. Analysis of Selected Decatur Employee Serum for Sulfonic and Carboxylic Fluorochemicals [Included is a 3M technical report] 6. Fluorochemical Control Study [Included is a 3M report of medical surveillance data. ] 7. Working Laboratory Memorandum on Data Quality Assessment memorandum regarding the mean and range [Included is a Battelle ofperfluorooctanesulfonate sera sample data collected by 3M from current and historical human populations.) Ks Doi ECEIVEl)l 000012 AAtnatlaycshimseMnettshtoodAsp)ril 21, 2000letter to C. AuerfromW. Weppner(TissueExtraction and 1 3M Environmental Laboratory Method. ExtractionofPotassium Perfluorooctanesulfonate or Other Fluorochemical Compounds from Serum for Analysis Using HPLC-Electrospray/Mass Spectrometry. Method Number: ETS-8-4.1. Adoption Date: 03/01/99. 2 3M Environmental Laboratory Method. Analysis of Potassium Perfluorooctanesulfonate or Other Fluorochemicals in Serum Extracts Using HPLC-Electrospray/Mass Spectrometry. Method Number: ETS-8-5.1. Adoption Date: 03/01/99. 3. 3M Environmental Laboratory Method. ExtractionofPotassium Perfluorooctanesulfonate or Other Fiuorochemical Compounds from Liver for Analysis DUastien:g0H7P/L2C2/-9E9l.ectrospray/Mass Spectrometry. Method Number: ETS-8-6.0. Adoption 4. 3M Environmental Laboratory Method. Analysisof Potassium Perfluorooctanesulfonate or Other Fluorochemicals in Liver Extracts Using HPLC-Electrospray/Mass Spectrometry. Method Number: ETS-8-7.0. Adoption Date: 07/22/99. 5. P3eMrfElunovrioroocntmaennetsaullfLoanbaotreoatroOrtyhMeerthFoldu.oroEcxhtermaicctailonCoofmPpootuansdsisufmrom Urine for Analysis Using HPLC-Electrospray/Mass Spectrometry. Method Number: ETS-8-96.0. Adoption Date: 07/28/99. 6. 3M Environmental Laboratory Method. Analysis ofPotassium Perfluorooctanesulfonate or Other Fluorochemicals in Urine Extracts Using HPLC-Electrospray/Mass Spectrometry. Method Number: ETS-8-97.0. Adoption Date: 07/28/99. 000013 Protocol Is of h 1. is aI3deMntisftiucdaytipornootofcFoll.uorSotcuhdeymiiscaonl-sgoiinnSge.raFoifnaClhirlepdorretndiunethJeanUunairtyed1,S2ta0t0e1s]. [Included (2.19S89e)ruempifdleumoiroolcohgeimcicianvlesttriegnadtsioonfs.out(-Ionfc-lcuoduendtyisraesJiodhennstsHionpCkiLnUsEUnIi(v1e9rs7i4t)yasntdudCylue II protocol. Study is on-going. January 1, 2001] Joint 3M/Johns Hopkins University final report is due S3.utyIdeisntoinf-igcoaitnigo.nofFFilnuaolrroecphoertmiiscadluse JinanHuuarmyan1,T2i0s0s1ue..] [Included is 3M study protocol E4.xpAenriEepnicdeeomfio3lMogiDcecAantaulrysEimspolfoyteheesI,np1a9t9i3e-nt19a9n8d. Ou[tIpnactliuednetd Cislaai3msMEsvteundty aprnodtoEcpoil.sode The study is on-going. Final report is due September 15, 2000] P5.erDfeltuoerromoicntaatnieonSuolffoSneircuAmciEdl,imPienraftliuoonrHoahlefx-aLnievSeusloffonAicmmAocindiaunmd PTeortfalluoOrrogoacntiacnoate, sFltuuodryiinseoinn-gDoeicnagt.urFiCnhaelmriecpaolrtPlisandtuReeJtiurneees.1, [Included is a 2004. Interim 3M study protocol. draft reports will be The issued] 000014 E- e -- ri Sh tBBmoeSeFemeSsm--aiooore,e rn BE Ne "ot =M 5% - om S07 621 8151 Foctze, p Cpe? e e211 pig | a1)lyHoHg--0e0i 21n oi . J bu TB od a 1722 22m PRIRITY a OUERNIGHT L MON _ ER ye an ri & a oi Bh R Sie 3 7 , EEed 1) 2 o8o077 8211 8191 =r we es 1 Q 1 apHE|ALpOdPmAmHeusddqusaes WASA [I|n 1200Pe essnnesylrvaenia20A"venue, i -- Jl, ~~ Dligii JI | ! Dfuobeamirn rbea] _-- 0 y . a + CCoorrppoorraattee IHnedaulstthriPahlysHiycgsiene & Er`gCoornpoormaitcesOccupational Medicine 3CoMrpMoerdaitcealToDxeipcualrotgmyent P3OMBCeonxte3r3,2B2u0ilding 220.28:02 6Si51P7a3ul3, 1M1N0551333220 AAbtstoarcphtmieonntsatnodAIpnrtirlav2e1n,o2u0s 0P0halretmtaecrtookiCn.etAiuceSrtfudrioems Wi.n Weppner Rats) (Radiolabel Oral 3M Technical 1. Synthesis and Characterizationof FC-95-1C, November 2, 1979. 2. Extent and RouteofExcretion and Tissue Distributionof TotalCarbon-14 in Rats after a Single Intravenous Doseof FC-95-'C, December 28, 1979. 3. Absorption of FC-95-'C in Rats aftera Single Oral Dose, October 26, 1976 4. J.D. Johnson, et. al., Cholestyramine-Enhanced Fecal Elimination of Carbon-14 in Rats after Administration of Ammonium ['*C]Perfluorooctanoate or Potassium 9[C7J6P(e1r9f8l4u)o.rooctanesulfonate, Fundamental and Applied Toxicology 4, pages 972- 000016