Document 50Dpnjoygz5EzZKkYn85o9wJV

3M 3.NiGeneral Offices April21, 2000 3M Center St.Paul,'vt,\5'5144- 1000 612 733 1110 Dr. CharlesAuer Room 7405 US EPA Headquarters ArielRios Bldg. 1200 PennsylvaniaAvenue, N. W. Washington,D. C. 20460 FE F8[1?71821118191 FedExTrackinNgumber forCustomer Dear Charlie: Pursuantto our recentcommunications,3M isenclosingadditionailnformationrelating toperfluorooctanesulfon(aPtFeOS). We areprovidingthisinformatiotnoyou on a voluntarybasisas partof ourcontinuingdiscussionwsithEPA regarding fluorochemistryT.hisinformationincludestudieson PFOS relatintgothefollowing areas:(i)pharmacokinetics(;iit)eratologayn;d (iiie)pidemiologyand medical surveillanceA. listinogf theenclosedstudieshasbeen attachedtothislettera,nd summaries alsohave been providedforeach categoryof studies.Pleasenote that incorrectlayppliedlegendsrelatintgo legalprivilegeasnd proprietarpyrotectionhsave been removed from certaindocuments. Finallyy,ou shouldbe receivingunder separate coveradditionasltudieson PFOS relatintgo reproductivteoxicologythat3M willalso be submittingtotheTSCA Section8(e)docket. 3M plansto provideyou with additionailnformatioonn PFOS and otherfluorochemicals inthenearfuture.In thisregard,we have been tryingtocontactyou to addressscope and proceduralmatters,and we hope totalkwithyou theweek of April24, 2000. Pleasedo nothesitatteo callme or Dr.Lar7yZobel,3M's MedicalDirector,withany questions.Ilook forwardtotalkingwithyou. Very trulyyours, WilliamA. Weppner, Ph.D DirectorofEnvironmental,Health,Safety,and RegulatoryAffairs SpecialtyMaterialsMarkets 3M Bldg 236-IB-10 3M Center St.Paul,NfN 55144 CorporateHealth Physics CorporateIndustriaHlygiene & Ergonomics CorporateOccupationalMedicine CorporateToxicology 3M MedicalDepartment 3M Center,Building220-2E-02 PO Box 33220 St Paul,MN 55133-3220 651733 1110 AttachmentstoApril21,2000 lettetroC. Auer from W. Weppner (RadiolabeOlral Absorptionand IntravenousPharmacoldneticStudiesinRats) 3M Technical 1. Synthesisand CharacterizatioonfFC-95-14C, November 2, 1979. 2. Extentand Route of Excretionand TissueDistributionf TotalCarbon-14 inRats aftera SingleIntravenousDose of FC_95_14C ,December 28,1979. 3. AbsorptionofFC-95-14C inRats aftera SingleOralDose, October26, 1976 4. J.D. Johnson,et al.,Cholestyramine-EnhanceFdecalEliminationof Carbon-14 in RatsafterAdministrationofAmmonium [14qPerfluorooctanoaotre Potassium [14C]PerfluorooctanesulfonFautned,amentaland AppliedToxicolo 4,pages 972976(1984). NledicintH,ealth Physics IndustriaHlygiene,TomcoloLv 3NI Medical Department 3M Center,Building220-2E-02 PO Box 33220 St.Paul,MN 55133-3220 612733 1110 AttachmentstoApril21,2000 lettetroC.Auer from W. Weppner (DermalAbsorption and IntravenousPharinacokineticisnRabbits) 3M TechnicalReports 1. Single-DoseIntravenousPharmacokineticStudyofT-6246 inRabbits.3M EnvirorunentaLlaboratoryStudy# AMDT-042095.1 2. Single-DoseDeLi alAbsorption/ToxiciSttyudy ofT-6049 inRabbits.3m EnvironmentalLaboratoryStudy# AMDT020895.1 3. Single-DoseIntravenousPharmacokineticStudyofT-6049 inRabbits.3M EnvironmentalLaboratoryStudy#AMDT- 112294.1 Corporate Health Physics Corporate IndustriaHlygiene & Ergonomics Corporate OccupationalNledicine Corporate Toxicology 31NIMedical Department 3M Center,Building220-2E-02 PO Box 337?0 St.Paul,MN 55133-3220 651 733 1110 Attachmentsto April21,2000 lettetro C. Auer from W. Weppner (TeratologyStudiesin Rats and Rabbits) 1. Rat TeratologyStudy T-3351 FinalReport Dec 19, 1983,Hazelton Laboratories America Project#154-160. 2. December 7,1983 Letterto Mr. William C. McCormick, IIIfrom E. Marshall Johnson,Ph.D.,reviewing draftofabove. 3. Oral TeratologyStudy of FC-95 inRats,RikerLaboratory,Experiment 068TROO08, December, 1980. 4. November 12,1982,LettertoFranklinD. GriffithP,h.D. from E. MarshallJohnson, Ph.D.,reviewing theabove. 5. Oral (Stomach Tube) Developmental ToxicityStudy ofPFOS inRabbits,Study #418-012, January 11, 1999,Argus Laboratories. 3M Corporate flealthPhysic3 @,.,ej.lua.AA vieuiciae Corporate Product Re-qnontihilit-y Corporate Toxicology 31N(Medical Department 3t',Cfenter. eu t3oyjj2 )o 3 651 733 [ttO April21, 2000 Attachments To April21, 2000 Letterto C. Auer from W. Weppner (MedicalSurveillanceand Epidemiology) FinalReports I.An Epidemiologic Investigatioonf ClinicalChemistries,Hematology and Hormones in Relationto Serum Levels of PerfluorooctanesulfonatienMale Fluorochenlical ProductionEmployees. [Includedisa 3M reportof medicalsurveillancdeata. Also includedisa publishedpaper from this3M report.] 2.FluorochemicalExposure (Serum) Assessment of(3K Decatur Chemical and Film PlantEmployees. [Includedarea 3M study protocoland report.] 3. MortalityStudy of Employees at3M PlantinDecatur,Alabama [Includedisa Universityof Mnnesota finalreport.] 4. Determinationof Serum FluorochemicalLevelsin Sumitomo 3M Employees [Includedarea 3M study protocoland finalreport.] 5.Analysis of SelectedDecatur Employee Serum forSulfonicand Carboxylic Fluorochemicals [Includedisa 3M technicalreport.] 6.Fluorochemical Control Study [Includedisa 3M reportof medical surveillancdeata.] 7.Working Memorandum on Data QualityAssessment [Includedisa Battelle Laboratory memorandum regardingthe mean and rangeof perfluorooctanesulfonastera sample datacollectedby ')M from currentand historicahluman populations.) Study Protocols/Prol2osaolfsonggin R@e earch 1. IdentificatioofnFluorochemicalsinSeraof ChildrenintheUnitedStates.(Included isa 3M studyprotocol.Study ison-going.Finalreportdue January1,2001] 2. Serum fluorochemicatlrendsofout-of-countryesidentisnCLUE 1 (1974)and Clue II (1989)epidemiologicinvestigation(sI.ncludedisa JohnsHopkinsUniversitystudy protocol.Study ison-going.Joint3NVJohns Hopkins Universityfinalreportisdue January 1,2001.] 3. IdentificatioofnFluorochemicalsinHuman Tissue.Uncludedis3M studyprotocol. Suty ison-going.Finalreportisdue January1,2001.] 4.An EpidemiologicAnalysisoftheInpatienatnd OutpatientClaimsEvent and Episode Experienceof3M-Decatur Employees, 1993-1998. [Includedisa 3M studyprotocol. The studyison-going. Finalreportisdue September 15,2000.] 5. Determinationof Serum EliminationHalf-LivesofAmmonium Perfluorooctanoate, PerfluorooctanSeulfonicAcid,PerfluorohexaneSulfonicAcid and TotalOrganic FluorineinDecatur ChemicalPlantRetirees.[Includedisa 3M studyprotocol.The studyisor.-going.Finalreportisdue June 1,2004. Interimdraftreportswillbe issued.]