Document ypz3e5RjQxagx09NzLxxB9aLE

3M General Ofrices 3M Center St.Paul,MN 55144-1000 612733 1110 May 25, 2000 VIA EXPRESS MAIL Dr.Charles Auer Director Chemical ControlDivision OfficeOf PollutionPreventionAnd Toxics UnitedStates EnvironmentalProtectionAgency 401 M Street,Southwest Room 403 East Tower (MailCode 7405) Washington, D. C. 20460 Re: Information On Perfluorooctanoic Acid And Supplemental Information On Perfluorooctane Sulfonates And Related Compounds Dear Charlie: Pursuant toour recentcommunications,3M isenclosinginformationon perfluorooctanoiaccid.We alsoare enclosinginformationon perfluorooctane sulfonatesand relatedcompounds which supplements informationsubmittedtoyou previouslyunder cover ofour April21, 2000, May 4, 2000 and May 18, 2000 letters. We are providingthisinformationon a voluntarybasisas partof our continuing discussionswith EPA regardingfluorochemistry. The enclosed informatioonn perfluorooctanoiaccidincludesthefollowing: Copies of post-1975 studiesand certainotherinformationrelatintgothe following environmentalscienceareas: (i)physicaland chemicalproperties(;ii) environmentalfateand transport(;iiie)nvironmentalmonitoring;and (iv) ecotoxicityF.or each study,3M has prepared a summary inthe HPV"robust summary" format. Copies of post-1975 studiesand certainotherinformationrelatintgothe following healtheffectsareas: (1)acutetoxicit(yi;ig)enotoxicity(;iiir)epeated-dosetoxicity; (iv)pharmacokinefics(;v)teratologya;nd (vi)medicalsurveillancaend epidemiology. 3M has includeda detailedindexofthisinformationsubdividedby Charles Auer May 25, 2000 Page 2 each compound. We also have enclosed summaries forthe medicalsurveillance and epidemiologystudiesand have includedcopies ofcertainpublishedstudies inthisarea inordertoprovideappropriatecontext. =:> Listsofallstudiesinprogressand planned studies,along withstudy protocolsor study plans,where available. A bibliographyofpre-1976 studiessubdividedby each compound. => A bibliographyofacute toxicitsytudiessubdividedby each compound, except thatwe are providingcopiesof key acute studies(withreferenceto the HPV guidance). => A bibliographyofpublishedstudiesin3M's possession. 3M iscontinuingitsfilereviewand m(ilslupplement the enclosed informationon perfluorooctanoiaccidas appropriate.As you reviewthisinformation, we ask thatyou bear severalpointsinmind: => The enclosed informationspans severalboxes. We have organizedthe informationineach box with labeledfilfeoldersand indicesto aidEPA's review. To ensure thatyou and your staffare able toaccess the most pertinent informationw,e alsoare attachingtothislettetrhe indicescoveringstudiesand otherinformation. 3M providedthe Agency witha lisotfallfluorochemical-relatseudbmissions made by 3M tothe TSCA Section8(e)docket under coverof our May 4,2000 letterT.his lisitncludedallsubmissionson perfluorooctanoiaccid. => The enclosed informationincludesstudieson perfluorooctanoiaccidas wellas on aqueous and/orsolventsolutionsof thismaterial.Many ofthe studiesreferto the testsubstance onlyby a 3M productidentificatinounmber witha "-r,"U, "FM" or "FC" prefix.Althoughanalysisofthetestsubstance has been included, where availablei,tisoftennot possibleto determinefrom the study reportitself the identitoyfthe testsubstance. To assistininterpretintghe studies,we have used 3M's historicaplroductnumber recordstoprovidecompositioninformation (e.g.c,ompositionpercentages;solventcontent;puritygrade,etc.)nextto each study name on the index and/oron the study summary. Please note thatsome formulationscontaina smallamount of"perfluorochemicailnerts-" a term which refersto a completelyfluorinatecdarbon chainwithno functionalized components. Finallyi,tshould be recognizedthatproductformulationshave evolved over the years,and thus,some ofthe testsubstances do not constitute currentproducts. Charles Auer May 25, 2000 Page 3 3M understandsthattheAgency has requested informatioonn perfluorooctanoic acidfrom dupont. For thisreason,we are not providingcopiesofstudieson perfluorooctanoiaccid in3M's filesponsored or conducted by dupont. Consistentwiththe informationpreviouslyprovidedon perfluorooctane sulfonatesand relatedcompounds, 3M has notprovidedallanalyticaclhemistry reportson perfluorooctanoiaccid. Rather,we have enclosed analyticaclhemistry reportswhich may prove usefultoEPA ininterpretincgertainstudies; understandingthe detailsofanalyticaclhemistrymethods; or verifyinhguman and biomonitoringdata. The enclosed informatiodnoes not includea "Use And Exposure Information Profileo"r"UEIP" forperfluorooctanoiacid.Our presentintentioinsto provide you withcompleted a UEIP form forperfluorooctanoiaccid by June 9,2000. => The informationon perfluorooctanesulfonatesunder cover of our May 4,2000 letteirncludeddocuments relatintgo ongoing mechanisticresearchby Dr. Ken Wallace ofthe UniversityofMinnesota. Please note thatthisresearchalso encompasses perfluorooctanoiaccid.The comparativemetabolism researchby Dr.Marion Anders ofthe UniversityofRochester Medical Center alsoincludes perfluorooctanoiaccid;thereare not documents yet availablerelatintgothis research. CharlesAuer May 25,2000 Page 4 3M looksforwardto discussingtheenclosedinformatiownithyou and otherEPA staff.Inthemeantime, pleasedo nothesitatteo contactme withany questions. Very trulyyours Enclosures WilliamA. Weppner, Ph.D DirectorofEnvironmental,Health,Safety And RegulatoryAffairs SpecialtyMaterialsMarkets 3M Bldg 236-1B-10 3M Center St.Paul,MN 55144 (651)733-6374(phone) (651)733-1958(fax) E-mail:waweppnerommm.com PFOA AttachmentstoLettertoC. Auer datedMay 25,2000 ToxicologSytudiesand OtherInformatioonn PFOA AcuteToxicit 1) InhalatioTnoxicityStudy of T-2305 CoC - Rat a) FinalReport,An Acute InhalationToxicityStudy ofT-2305 CoC intheRat, Bio/dynamics,Inc.,Study No. 78-7184, May 3, 1979 b) TechnicalReport Summary, Analysisof ratserum of FC-143, reportedin terms of organicand inorganicfluorineC,entralResearch Laboratories,June 20,1979 2) FinalReport,Acute OralToxicity(LD50) Study in Rats,InternationRaelsearch and Development Corporation,Study No. 137-091,3M ReferenceNo. Fluorade FC- 143, Lot 340, May 5, 1978 3) FinalReport,Acute Oral ToxicityStudy of T-6669 inRats,Coming Hazelton,Inc., Study No. CHW 61001760, 3M Ref FC-1 43, January 10, 1997 4) FinalReport,Primary Skin IrritatioSntudy -Rabbits,Biosearch,Inc.,3M Reference No. T-1395, FC-143, March 4,1976 5) FinalReport,Primary Eye IrritatiSotnudy - Rabbits(Washout Procedure),Biosearch, Inc.,3M ReferenceNo. T-1395, FC-143, March 4,1976 6) FinalReport,Primary Eye IrritatiSotnudy - Rabbits(Not Washed), Biosearch,Inc., 3M ReferenceNo. T-1395, FC-143, March 4,1976 7) FinalReport,Primary Skin IrritatiToenstwith T-3371 in Albino Rabbits,Riker LaboratoriesS,tudy No. 0883EB0079, 3M ReferenceFC-26, Lot 389, July 13, 1983 8) FinalReport,Acute Oral Toxicity- Rats,Biosearch,Inc.,3M ReferenceNo. T- 1585, FC-26 (perfluorooctanoiaccid),September 16,1976 9) FinalReport,Primary Eye IrritatioSntudy - Rabbits,Biosearch,Inc.,3M Reference No. T-1585, FC-26 (perfluorooctanoiaccid),September 16,1976 10)FinalReport,Acute Dermal ToxicityStudy of T-6342 inRabbits,Coming Hazelton, Inc.,Study No. HWI 50800374, 3M Ref No. FC-1 090, Ll 3364, Lot 1,Fl 1426, sodium perfluorooctanoatseolutionO,ctober 24, 1995 1 AttachmentstoLettertoC. Auer datedMay 25,2000 ToxicologyStudiesand OtherInformatioonn PFOA AcuteStudie-sBibliogrgphOynl 1) FinalReport,Acute OralToxicity-Rats,Biosearch,Inc.,3M ReferenceNo. T-1395, FC-143, March 4,1976 2) FinalReport,Primary Skin IrritatioSntudy - Rabbits,Biosearch,Inc.,3M Reference No. T-1585, FC-26 (perfluorooctanoiacid),September 16,1976 3) FinalReport,Acute Oral ToxicityStudy inRats,Hazelton LaboratoriesAmerica, Inc.,3M ReferenceNo. T-3974, Lot 390 (FC-126, approximately88% solid), February 6, 1987 4) FinalReport,Primary Dermal IrritatiSotnudy inRabbits-Method, Summary, Raw Data Appendix, Hazelton LaboratoriesAmerica, Inc.,3M ReferenceNo. T-3974, Lot 390 (FC- 126,approximately88% solid)D,ecember 31, 1986 5) FinalReport,Primary Eye IrritatioSntudy in Rabbits- Method, Summary, Raw Data Appendix, Hazelton LaboratoriesAmerica, Inc.,3M ReferenceNo. T-3974, Lot 390 (FC-126, approximately88% solid)J,anuary 14,1987 6) FinalReport,Primary Eye Irritation/CorrosiSotnudy of T-6564 inRabbits,Coming Hazelton,Inc.,Study No. CHW 60504574,3M Ref.No. FC-1015, Fluorade fluorochemicalemulsifierL,13167, straight-chaiAnPFO solutionS,eptember 5, 1996 7) FinalReport,Primary Dermal Irritation/CorrosSitoundy of T-6564 inRabbits, Coming Hazelton,Inc.,Study No. CHW 60504573, 3M Ref.No. FC-101 5,Fluorad(EfluorochemicalemulsifierL,13167, straight-cliaAiPnFO solutionA,ugust 15,1996 8) FinalReport,Acute Oral ToxicityStudy of T-6564 inRats,Coming Hazelton,Inc., Study No..CHW 60504572,3M Ref.No. FC-1015, Fluorad(Vfluorochemical emulsifierL,13167, straight-chaiAnPFO solutionN,ovember 8, 1996 9) FinalReport,Acute Oral ToxicityStudy of T-6342 inRats,HazeltonWisconsin,Inc., StudyNo. HWI 50800373, 3M Ref No. FC-1090, L13364, Lot 1,Fl 1426,sodium perfluorooctanoatseolutionN,ovember 16, 1995 10)FinalReport,Primary Eye Irritation/CorrosiSotnudy of T-6342 inRabbits,Hazelton Wisconsin,Inc.,Study No. HWI 50800376,3M Ref.No. FC-1090, L13364, Lot 1, Fl 1426,sodium perfluorooctanoatseolutionO,ctober 12, 1995 11)FinalReport,Primary Dermal Irritation/CorrosSitoundy of T-6342 inRabbits, HazeltonWisconsin,Inc.,Study No. HWI 50800375, 3M Ref No. FC-1 090, Ll 3364, Lot 1,Fl 1426, sodium perfluorooctanoatseolution,September 28, 1995 2 AttachmentstoLettertoC.Auer datedMay 25,2000 ToxicologSytudiesand OtherInformatioonn PFOA Genotoxicit 1) An Assay of CellTransformationand Cytotoxicitiyn theC3H IOT 1/2ClonalCell Line forthe Test Chemical T-2942 CoC, EnvironmentalPathology Laboratory,Stone Research LaboratoriesU,niversityof Minnesota,3M Ref.No. FC-143 Lot 340, L138679, March 5, 1981 2) FinalReport,Mutagenic Evaluationof T-2015 CoC in theAmes Salmonella/MicrosomePlateTest,LittonBionetics,Inc.,Study No. 20838, 3M Ref. No. FC-143, February 1978 3) FinalReportM,utageniciTteyston T-6564inanIn VivoMouse MicronucleAusssay, ComingHazeltonI,nc.S,tudyNo. 17750-0-4535M, Ref.No.FC-1015,Ll3167, straight-chaiAnPFO, November 1,1996 4) FinalReport,MutagenicityTeston T-6564 Measuring Chromosomal Aberrationsin Chinese Hamster Ovary (CHO) Cells:with a ConfirmatoryAssay withMultiple Harvests,Coming HazeltonInc.,Study No. 17750-0-437CO, 3M Ref.No. FC- 1015, Ll 3167, straight-chaiAnPFO, September 16,1996 5) FinalReport,MutagenicityTestwith T-6564 intheSalmonella-Escherichia Coli/Mammalian-Microsome ReverseMutationAssay witha ConfirmatoryAssay, Coming HazeltonInc.,Study No. 17750-0-409R,3M Ref.No. FC- 1015,L 13167, straight-chaiAnPFO, September 13,1996 6) FinalReport,MutagenicityTest on T-6342 Measuring Chromosome Aberrationsin Human Whole Blood Lymphocytes with a ConfirmatoryAssay with Multiple Harvests,Coming Hazelton,Inc.,Study No. 17073 -0-449CO, 3M Ref.No. FC- 1090, L 13364,F 11426, Lot 1,sodium perfluorooctanoateN,ovember 1,1996 7) FinalReport,MutagenicityTest on T-6342 Measuring Chromosomal Aberrationsin ChineseHamster Ovary (CHO) Cells:with a ConfirmatoryAssay withMultiple Harvests,Coming Hazelton,Inc.,Study No. 17073 -0-437CO, 3M Ref.No. FC- 1090, L13364, Fl 1426, Lot 1,sodium perfluorooctanoateS,eptember 16, 1996 8) FinalReportM,utageniciTteyston T-6342inanIn VivoMouse MicronucleuAssay, Coming Hazelton,Inc.,Study No. 17073-0-455,3M Ref. No. FC-1 090,L13364, Fl 1426, Lot 1,sodium perfluorooctanoateD,ecember 14, 1995 9) FinalReportM,utageniciTteystwithT-6342intheSalmonell-aEscherichia Coli/Mammalian-MicrosRoemveerseMutatioAnssay,Coming HazeltonI,nc.S,tudy No. 1703073-0-409,3M Ref No. FC-1090, L13364, Fl 1426,Lot 1,sodium perfluorooctanoateD,ecember 14, 1995 3 AttachmentstoLettertoC.Auer datedMay 25,2000 ToxicologSytudiesand OtherInformatioonn PFOA Rgpeated-DosTeoxicit 1) FinalReport,Volumes 1-4,Two Year Oral(Diet)Toxicity/CarcinogenicitSytudyof FluorochemicalFC-143 inRats,Riker Laboratories,Inc.,Study No. 0281 CROO12, conducted duringApril1981 - May 1983,August 29, 1987,with Study Report Amendment No. 1,dated November 2, 1987 2) NinetyDay SubacuteRat ToxicityStudy on FluoradeFluorochemicalFC-143 a) FinalReport,Ninety Day SubacuteRat ToxicityStudy on Fluorade FluorochemicalFC-143, InternationaRlesearch and Development Corporation, Study No. 137-089,3M Reference No. T-314 1,November 6, 1978 b) 3M InternalCorrespondence re FC- 143 analysisof serum samples from ratsof 90-day subacutestudy,from Jon BelisletoJE Long, dated March 20, 1978 c) 3M InternalCorrespondence reFC-143 analysisof liversamples from ratsof 90day subacutestudy,from Jon Belisleto JE Long, dated March 31, 1978 3) FinalReport,28-Day OralToxicityStudy withFC-143 inAlbino Mice, Industrial Bio-TestLaboratoriesI,nc.,Study No. 8532-10655, 3M Reference No. T-1742CoC, Lot 269, Undated [1977] 4) FinalReport,28-Day Oral ToxicityStudy with FC- 143 inAlbino Rats,Industrial Bio-TestLaboratoriesI,nc.,Study No. 8532-10654,3M Reference No. T-1742CoC, Lot 269, September 29, 1977 5) FinalReport,Repeat Application28 Day PereutaneousAbsorption Study with T2618CoC in Albino Rabbits,SafetyEvaluationLaboratory,RikerLaboratoriesI,nc., Study No. 09790ABO485, 3M Ref.No. FC- 143,March 15, 1981 6) Ninety Day Subacute Rhesus Monkey ToxicityStudy a) FinalReport,Ninety Day SubacuteRhesus Monkey ToxicityStudy,International Research and Development Corporation,Study No. 137-090,November 10,1978 b) Analyticaldata,FC-143 Analysisof IRDC 137-090 Samples [monkey serum and liversamples],3M CentralResearch LaboratoriesM,ay 16, 1978 7) FinalReport,Vol.I-II,13-Week DietaryToxicityStudy withT-5180,Ammonium Perfluorooctanoat(eCAS No. 3825-26-1)inMale Rats,Hazelton Wisconsin,Inc., StudyNo. HWI 6329-100, May 17, 1993 8) FinalReport,5 Daily Dose OralToxicityStudy with T-6669 (FC- 143) inRats, Coming Hazelton,Inc.,Study No. CHW 6329-197,April30, 1997 4 AttachmentstoLettertoC.Auer datedMay 25,2000 ToxicologSytudiesand OtherInformatioonn PFOA Ongoin : 26-Week CapsuleToxicityStudy withAmmonium Perfluorooctanoat(eAPFO) in Cynomolgus Monkeys, Covance LaboratoriesInc.,No. 6329-231,3M Ref No. T-6889.3. In progress.Protocolprovided. Note: The studyissponsoredby the Associationof PlasticManufacturersof Europe, APFO Toxicology Working Group. 3M has submitteda noticeunder TSCA Section8(e) regardingpreliminarydatafrom thisstudy. 3M and otherWorking Group members have received draftreportson the4-week range-findingstudy and the fullstudy,but these draftsarenow obsolete.Finalreportsareinpreparationand willbe provided tothe docketwhen available.In additiont,heWorking Group isstilalwaitingthehormonal measurements reportcoveringcholecystokinindata;serum,urine,fecesand liverAPFO levels;palmitoylCoA oxidasedeterminationsc;ellproliferatioenvaluationsa;nd bileacid and receptorleveldeterminations. 5 AttachmentstoLettertoC. Auer datedMay 25,2000 ToxicologSytudiesand OtherInformatioonn PFOA PharmacokinetSit.ucdies 1) FinalReport,AnalyticalStudy,Single-DoseIntravenousPharinacokinetiSctudy of T-6067 inRabbits,3M Ref No. L13492 (45% perfluorooctanoiaccid tetrabutylammoniumsaltinwaterand isopropylalcohol)S,tudy No. AMDT120694.1,November 28, 1995; reportincludesFinalReport,Single-DoseIntravenous PharmacokineticStudy of T-6067 inRabbits,Hazelton Wisconsin,Inc.,Study No. HWI 6329-151, February 1,1995 2) FinalReport,AnalyticalStudy,Single-DoseAbsorption/ToxicitSytudy of T-6067 T6068, and T-6069 inRabbits,3M Environmental Technology & Services,Study No. AMDT-0 11095.1,November 28, 1995; reportincludesFinalReport,Single-Dose Absorption/ToxicitSytudy of T-6067, T-6068, and T-6069 inRabbits,Hazelton Wisconsin,Inc.,Study No. HWI 6329-152,May 26,1995; T-6067 isL13492, 45% perfluorooctanoatteetrabutyalnnnonium saltinwater and isopropylalcohol; T-6068 isfabrictreatedwith high levelof L13492, 45% perfluorooetanoate tetrabutyalnimonium saltinwater and isopropylalcohol; T-6069 isfabrictreatedwith low levelof L 13492,45% perfluorooctanoate tetrabutyalmmonium saltinwater and isopropylalcohol 3) ADME studieswith FC-143-14C a) FinalReport,Absorptionof FC-143-14C inRats Aftera SingleOral Dose, Riker Laboratories,Inc.,January 14, 1980 b) FinalReport,Synthesisand Characterizatioonf FC-143_14C, Commercial Chemicals Divisionand Riker LaboratoriesI,nc.,January23, 1980 c) FinalReport,Extentand Route ofExcretionand TissueDistributioonf Total Carbon-14 in Male and Female Rats Aftera SingleIV Dose 14C, of FC-143- Riker Laboratories,Inc.,February7, 1980 d) FinalReport,Extentand Route of ExcretionofTotalCarbon-14 inPregnant Rats Aftera SingleOral Dose ofAmmonium 14C-PerfluorooctanoateR,iker Laboratories,Inc.,July 1,1983 e) FinalReport,Enhanced EliminationofFC-95_14C and FC-143_ '4C inRats with CholestyramineTreatment,RikerLaboratoriesI,nc.,March 14, 1980 4) FinalReport,Single-DoseIntravenousPharmacokineticStudy of T-6564 inRabbits, Coming Hazelton Inc.,Study No. CHW 6329-186,April18,1997 5) FinalReport,5-DailyDose Dermal Absorption/ToxicitSytudy of T-6564 inRabbits, Coming Hazelton,Inc.,Study No. CHW 6329-18 5,April28, 1997 6 AttachmentstoLettertoC. Auer datedMay 25,2000 ToxicologSytudiesand OtherInformatioonn PFOA Teratolog 1) TeratologyStudy of T-2998CoC inRats a) Oral RangefinderStudy of T-2998CoC inPregnantRats,RikerLaboratoriesI,nc., Study No. 068ORROO 18,February 25, 1981 b) FinalReport,Oral TeratologyStudy of T-2998 CoC inRats,RikerLaboratories, Inc.,Study No. 068 1TRO I10,December 15, 198 1,with Amendment to Final Report,December 22, 1981 and Protocol 2) TeratologyStudy of T-314ICoC in Rabbits a) Oral RangefinderStudy of T-3141 CoC inPregnantRabbits,RikerLaboratories, Inc.,Study No. 068 1RB0331, November 18, 1981 b) FinalReport,OralTeratologyStudy of T-314ICoC inRabbits,Riker LaboratoriesI,nc.,Study No. 068 1TB0398, February 23, 1982 c) 3M InternaClorrespondencere analyticaalnalysesofT-314ICoC, from LD Winter toDR Ricker,datedFebruary 5, 1982 3) Letterrefurthertestingfrom E. MarshallJohnson,JeffersonMedical CollegetoDr. FranklinD. Griffithd,atedNovember 19,1982 4) 3M Memo reFC 95 and 143 Teratology,from Marv Case to Geo@ean Adams, dated May 26, 1998, enclosingan analysisof the eye lensdefect 7 AttachmentstoLettertoC.Auer datedMay 25,2000 ToxicologSytudiesand OtherInformatioonn PFOA Human Sera/MedicaSlurveillance/Epidemiolog 1) F.A.Ubel,etal.HealthStatuosfplantWorkersExposedtoFluorochemicalAsPreliminarRyeport4,1 Am. Ind.Hyg.Assoc.J.584-589(August1980)W,ith Summary. 2) Leonard M. Schuman & Jack S.Mandel, An Epidemiologic MortalityStudy of Employees atthe Chemolite Plant (February 1980),with Summary of study. 3) JackS.Mandel& LeonardM. Schuman,"MortaliSttyudyatthe3M Chemolite Plant"(Januar1y989)w,ithSummary ofstudy. 4) FrankD.Gillila&ndJackS.Mandel,MortaliAtmyong Employeeosfa PerfluorooctaAncoidcProductioPnlant3,5JOM 950-954(Septembe1r993)w,ith Summary of study. 5) Frank Davis GillilandF,luorocarbonsand Human Health:Studiesin an Occupational Cohort (October1992)(unpublishedPh.D. thesisU,niversityof Minnesota),with Summary. 6) GearyW. Olsene,tal.A,n EpidemiologiIcnavlestigatoiforneproductiHvoermones inMen withOccupationEaxlposurteoPerj7uorooctanAocicd,40 JOEM 614-6-19 (July1,1998),withSummary of study. 7) FrankD. Gillila&ndJackS.Mandel,SerumPerfluorooctanAociicdandHepatic EnzymesL,ipoproteiannsd,CholesteroAlS:tudyofOccupationalElxyposedMen,29 American Journalof IndustriaMledicine 560-568 (1996),with Summary of study. 8) GearyW. Olsene,tal.A,n EpidemiologIincvestigatoifopnlasmaCholecystokinin andHepatiFcunctioinnPerj7uorooctanAocicdProductioWnorkers3,M Final ReportEPI-0003,(1997),with Summary of study,Protocol,and Manuscript accepted forpublicationin 2000,Drug & Chemical Toxicology. 9) PhysicianPlantSummary Reports Regarding Medical SurveillanceProgram at CottageGrove (1978-1991) a) Summary ofProgram Reports b) Blood Levels of RF/F inSelectedEmployees, dated June 20, 1978 c) 3M InternalCorrespondence re 1981 Chemical DivisionHealth Evaluationsfrom DE Roach to PF Riehle,dated February 16, 1982 d) 3M InternalCorrespondence re 1981 Chemolite Health Evaluations,from DE Roach toPF Riehle,dated August 12, 1982 8 AttachmentstoLettertoC.Auer datedMay 25,2000 ToxicologSytudiesand OtherInformatioonn PFOA e) 3M InternCaolrrespondencreeInorganiFcluoridDeeterminationfsr,omDE Roach toPF Riehle,datedApril9, 1984 f)3M InternaClorrespondence reOrganic FluorineLevels,from DE Roach toPF Riehle,dated August 31, 1984 g) 3M InternaClorrespondence reMedical Examinations,from L Zobel toDW Dworak, datedMarch 20, 1987 h) 3M InternaClorrespondence reChemolite Evaluations,Fall,1990,from LarryR Zobel toClairMurphy, etal.,datedMay 10, 1991 Previouslysubmittedwith April21,2000 lettetroCharlieAuer, Fluorochemical Exposure (Serum) Assessment of (3M) Decatur Chemical and Film PlantEmployees. Ongoini@ Studies See listof planned studiessubmittedwith letteorfApril21,2000, which willaddress perfluorooctanoiaccidaswell as perfluorooctanesulfonate. 9 AttachmentstoLettertoC. Auer datedMay 25,2000 ToxicologSytudiesand OtherInformatioonn PFOA Update toSubmissionofMa-v18Ih 13. PFOS PerfluorooetaSnuelfonate I 1) LettefrromE.MarshalJlohnsontoWilliamC.McCorrnickI,IIr,eHazleton teratologystudies,datedDecember 7, 1983. 2) Letterfrom E. MarshallJohnson toWilliam C. McCorrnick,IIIre Rikerteratology studieson PFOS and ethylFOSE, dated November 12, 1982. [8- N-ETFOSE alcohol N-ethyl perfluorooctane sulfonamidoethanol I 1) Letterfrom E. MarshallJohnson to William C. McCorrnick, HI reRikerteratology studieson PFOS and ethylFOSE, datedNovember 12, 1982. 2) FinalReport,BiologicalPhase,Metabolism ofN-Ethyl PerfluorooctaneSulfanomido Ethanol(Net-Fose;T-6316) In Cynomolgus Monkeys FollowingAdministrationof a SingleCapsule Dose, Covance, Study No. 6329-226, June 9, 1999 Note: Analyticalwork associatedwith thisstudyisongoing. 10 AttachmentstoLettertoC. Auer DatedMay 25,2000 PublishedLiteraturien3M's Possession AbdellatiAf.,G.,V. Pr6atH,.S.Taper,andM. RoberfroidT.he modulatioonfrat livercarcinogenesisby perfluorooctanoiaccid, a peroxisome proliferator. Toxicology& AppliedPharmacology 111 (1991)530-537. AbdellatifA,.G., V. Prdat,J. Vamecq, R. Nilsson,and M. Roberfroid. Peroxisome proliferatioannd modulation of rat livercarcinogenesibsy 2,3dichlorophenoxyaceticacid,2,4,5-trichlorophenoxyacetaiccid,perfluorooctanoic acidand nafenopin. Carcinogenesis11 (1990) 1899-1902. BelisleJ,.,and D. Hagen. A method fordeterminationof perfluorooctanoiaccid inblood and otherbiologicalsamples. AnalyticalBiochemistry101 (1980) 369376. Biegel, L.B., M.E. Hurtt, and J.C. Cook. Effects of ammonium perfluorooctanoat(eC8) on Leydig cellfimction:In vivo,ex vivo,and in vitro studies.Yhe Toxicologis1t3[l](1993)399. Biegel,L.B.,R.C.M. Liu, M.E. Hurtt,and J.C. Cook. Effectsof annnonium perfluorooctanoatoen Leydig cellfunction:In vivo,ex vivo,and in vitrostudies. Toxicology& AppliedPhannacology 134 (1995)18-25. Bo@es, H.K. and R.G. Thurman. Peroxisomal proliferatorisnhibitAcyl CoA synthesisand stimulateproteinkinase C in vivo. Toxicology& Applied Pharmacology 126 (1994)233-239. Clapperton,R.M., B.T. Ingram, R.H. Ottewill,and A.R. Rennie. NMR spectroscopicand neutron scatterinsgtudieson ammonium decanoate-ainmonium perfluorooctanoatemixtures. In: Mixed Surfactant Systems. ACS Symposium Series501, Eds.: P.M. Holland and D.N. Rubingh, American Chemical Society: Washington, DC, 1992,268-277. Clegg, E.D.,J.C.Cook, R.E. Chapin, P. Foster,and G.P. Daston. Leydig cell hyperplasiaand adenoma formation:Mechanisms and relevanceto humans (abstract)R.eproductiveToxicology11(l)(1997) 107-121. Cook, J.C.,S.M. Murray, S.R- Frame, and M.E. Hurtt.Inductionof Leydig cell adenomas by ammonium perfluorooctanoateA: possibleendocrine related mechanism. Toxicology& AppliedPharmacology 113 (1991)209-217. Cook, J.C.,M.E. Hurtt,S.R.Frame, L.B. Biegel.Effectsof Wyeth-14,643 (Vry) and ammonium perfluorooctanoa(tCe8) in Crl:CD BR (CD) rats. The Toxicologi1s3t[11(1993)399. Cook, J.C.,M.E. Hurtt,S.R. Frame, L.B. Biegel. Mechanisms of extrahepatic tumor inductionby peroxisome proliferatorisn Crl:CD BR (CD) rats. The Toxicologis1t4[l](1994)301. Feller,D.R. and U. Intrasuksri.Mechanism of peroxisome proliferatiobny perfluorinatefdattyacids in primary culturesof rat hepatocytes(abstract). Toxicologis1t3 (1993)395. GillilandF,.D. 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ExtraperoxisomalTargetsof Peroxisome Proliferators: MitochondrialM,icrosomal, and CytosolicEffects.ImplicationsforHealth and Disease.CriticaRleviews in Toxicology28[l](1998) 1-33. -9- PFOA and Associated Salts Synonyms: FC-26, FX-1001, PFO, FC-143,78.03, FC126, N-2803-3. FX-1003, Fr-,118,FC-1015, FC-1015-X PhysicaUChemical Properties Title Laboratoryor Author Date Type Completed ,Water,acetone and toluenesolubiliteisytimates-FC,143 3M Env. Lab Robust summary, 11/17/81 copy of data sheet EnvironmentalFateand Transport Title Ready biodegradatioonfFC-143 (BOD/COD/TOC) Laboratoryor Author 3M Env. Lab Completion Type Date 7/14177 Robust summary, copy oflaboratory TechnicalReportSummary - AdsorptionofFC 95 and FC 143 on Soil,and a critiquferomDr.S. Boyd,MichiganStateUniversity 3M Env. Lab 2/27/78, 5/19/93 data summary Robust summary, technicalreport, critiqubey S. Boyd TechnicalReportSummary -BiodegradationStudiesof Fluorocarbons- III(FC-143) 3M Env. Lab 7/19/78 (MSU.) Robust summary, technicalreport TechnicalReportSummary -FC-143 PhotolysisStudy Using SimulatedSunlight TechnicalReportSummary -AnalysisforFluorochemicalsin BIuegillFish,and a critiqubey J.W. Gilletotf Comell University 3M Agdchomical Lab 3M Env. Lab 2/2f79 B/l/1979, 3iM3 Robust summary, technicalreport. Robust summary, technicalreport, critiqubey J.Gillett Ready biodegradatio-nofFC-143 (BOD/COD) 3M Env. Lab 615/80 (Comell) Robust summary,,copiesof data sheets. Calculatedoctanolwaterpartitiocnoefficien-tFO-143 3M Env. Lab 1217/81 Robust summary, copy of calculations Robust summary, compldergenerated final report,copiesof Ready biodegradationofFX-1001 (BOD/COD) 3M Env. Lab 217/85 raw data sheets. Robust summary, computer- Pace Analytical, generated final report,copy of ,Ready biodegradationofFC-126 (BOD/COD) Minneapolis,MN 5/20/87 finalreport PFOA and AssociatedSalts EnvironmentalFateand Transport Title Technical Report Summary - Assessment Bioaccumulative ProperUes of Amnionium Perfluomoctan2te:Static(fishtest) of the Laboratoryor Author 3M Env. Lab Completion Type Date Robust SUMM2ry, technicalreport, critiqueby J. Giesy 5/31/95 .(MSU) EcoioxicitEylements Title 96-houracutestatitcoxicittoyfatheadrrdnhow-FC-143 Laboratoroyr Author 3M Env.Lab Comp@etionType Date 6/29174 Robust summary, copy of data sheet 96-hour acute statictoxicittyo fathead minnow - FC-26 3M Env. Lab 11/10174 Robust summary, copy of data sheet. 96-hour acute statictoxicittyo bluegilslunfish- FC-143 3M Env. Lab 4/8178 Robust summary, copy of data sheet 96-hour acute statictoxicittyo bluegilslunfish- FC- 143 Two reports: "The Effectsof Continuous Aqueous Exposure to 78.03 on Hatchabilitoyf Eggs and Growth and survivalof Fry of Fathead Minnow (Pimephales r)romelas)"and "Summary of Histopathological Examinations of Fathead Minnow (P!rTiephalepsromelas Exposed to 78.03 for30 Days". Technical Report Summary - Aquatic ToxicityTesting: FC143 (Lot-37)L.R.5625 S Toxicityto activatedsludge - FC-143 Technical Report Summary - Mufti-Phase ExposuretRecovery AlgalAssay Test method (FC-143) 48-hour acute statictoxicittyo Daphnia magna - FC-143 (3studieson diet) Chronic Toxicityof Fluorochemicals to Daphnia manna (Water Flea)- FC-143, and statisticaanlalysisof data pmvided by ASci Corp.,Duluth,MN 3M Env. Lab EG&G Bionomics, Wareham, MA 3M Env. Lab 3M Env. Lab 3M Env. Lab 3M Env. Lab 3M Env. Lab 6/27/78 June 1978 and Sept. 1978 5/8/80 614/80 11/16/81 5/5182, 5/6182, 6/2/82 8/31/1984, 8/10/98 Robust summary, copy of data sheet Robust summary, copies of two final reports. Robust summary, technicalreport Robust summary, copies ofdata sheets Robust summa technicalreport Robust summary, copies of data sheets Robust summary, i summary report, :4 letterreport 196-hour acute statictoxicityto fathead minnow - FX-1 001 3M Env. Lab 2/2/85 Robust summa@y, copy of data sheet., PFOA and Associated Salts EcotoxicityElements Title Acfivatedsludge respiratioinnhibitio(nOECD 209) - FC126 Microtox test- FC- 126 48-hour acute statict.oxicittyo Daphnia magna - FC-126 96-hour acute statictoxic* to fathead minnow - FC- 126 Activatedsludge respiratioinnhibitio(nOECD 209) - FX1003 Microtox test- FX-1 003 StaticAcute Toxicityof FX- 1003 to the Fathead Minnow, Pimephales promelas StaticAcute Toxicityof FX- 1003 to the Daphnid, Daphnia magna Growth and Reproduction ToxicityTesi with N2803-3 and the Freshwater Alga, Selenastrum capdcomutum Acute Toxicityof N2803-3 to the Fathead Minnow, Pimephales prornelas Acute Toxicityof N2803-3 tD the Daphnid, Daphnia magna Microtox test- FC-1 43 Microtox test7 FC-1 18 Microtox test- FC-1 015-X Laboratoryor Completion Type Author Date Robust summary,,-- copy of data 3M Env. Lab 4/20/87 sheets. Robust summary, copy of data 3M Env.Lab 4/29/87 sheets. Robust summa copy of data 3M Env. Lab 4/30/87 sheets. Robust summary, copy ofdata 3M Env. Lab 5/l/87 sheets. Robust summary, copies of data 3M Env. Lab 2/16/90 sheets Robust summary, copies of data 3M Env. Lab 3/7/90 sheets EnviroSystems, Robust summary,-.- HamptDn, New finalreport, Hampshire 3/15/90 protocol EnviroSystems, Robust summary, Hampton, New Hampshire 4/g/90 finalreport, protocol T.R. Wilbury Laboratories,Inc, Marblehead, MA 1/24/96 Robust summary, finalreport T.R. Wilbury Laboratodes, Inc, Robust summary, Marblehead, MA 1/24/96 finalreport T.R. Wilbury Laboratories,Inc, Robust summary, Marblehead, MA 3/7/96 finalreport Robust summary, copies of data 3M Env.Lab 4/24/96 sheets Robust summary,-. copies ofdata 3M Env. Lab 4/24/96 sheets Robust summary, - copies of data 3M Env. Lab 4/24/96 sheets PFOA and Associated Salts EcotoxicitEylements Title AcUvated Sludge RespirationInhibitiToenst - FC-1 015-X Acute Toxicitoyf FC-1015 tothe Fathead Minnow, Pimephales promelas Gmwth and ReproductionToxicitTyestwithEC-1015 and the FreshwaterAigp,Selenastrumcapilcomutum Acute ToxicitoyfFC-1015 to theDaphnd, Daphnia magna Laboratory or Author Completion Date 3M Env. Lab T.R.Wilbury LaboratoriesI,nc, Marblehead,MA T.R.Wilbury LaboratoriesI,nc, Marblehead,MA T.R.Wilbury LaboratoriesI,nc, Marblehead,MA 4/25/96 5/15/96 5/15/96 5/15/96 Type Robustsummary, copiesofdata sheets Robust summary, finarleport Robust summary, finarleport Robust summary, finarleport Summary Reports Title TechnicalReportSummary -FinalComprehensive IReport:FC 143 Laboratoryor Author 3M Env. Lab Completion Date 3/23f7g Tylpe Robust summary, technicarleport -7 PFOS didecyidimethylammoniusmalt Synonyms:P3025,L-14394 Physical/ChemiPcraolperties ride None Laboratoroyr Author Date Completed Type EnvironmentFaalteandTransport riua Determinatioofnthe28-(IaCyarbonaceousBiochemical Oxygen Demand (CBOD) forP3025 Laboratoroyr Author 3M Env.Lab Compi&Uon Date Type Robust summary, 5/2Qt97 finalreport EcotoxicitEylements Tide Acute Toxicityof P3025 Developmental Materialto FaffieadMinnow (Pimphalespromelas) Acute Toxicityof P3025 DeveJopmental Materialto Dephnia magna Growth Inhibitioonf P3025 Green Alga (Selenastrum capricamutum) Growth Inhibitioonf P3025 toGreen Alga (Selenastrum c4pficomutum) InhibitorEyffectsof P3025 on Microtox InhibitorEyffectsof P3025 on ActivatedSludge Respiration Laboratoryor Author CompleUon Date ASci Corporation, Duluth,MN 1/2/97 AScl Corporation, Duluth,MN 1/10197 ASci Corporation, Duluth,MN 1/29/97 ASci Corporation, Duluth,MN 2/21/97 3M Env.Lab 5112/97 3M Env.Lab 5/12/97 Type Robust summary, finalreport Robust summary, finalreport Robust summary, finalreport Robust summary, finalreport Robust summary, finalreport Robust summary, finalreport