Document zQpd522mVYvyXqggdL9NE6Jm7

: 331SpectayMteras rSomeite AR296_ S12 3M "VIA HAND DELIVERY July 9, 2003 Document Control Office (7407M) ODfofcikceeotfARP-o2ll2u6tion Prevention and Toxics (OPPT) `EPA East, Room 6428 1201 Constitution Avenue, NW Washington, DC 20460 Phone: 202-564-8930 Attention: ODPPTock No.eAR-t 226 I' 82 om a) [Xt =z o2m8 @ Re: Information on Perfluorooctane Sulfonate, Perfluorooctanoic Acid, and Related Compounds Dear Sir or Madam: `This continues 3M's voluntary submissionsofdata on perfluorooctane sulfonate (PFOS), perfluorooctanoic acid (PFOA), and related compounds, as part ofour ongoing dialogue with EPA regarding perfluorochemicals. Weare enclosing a numofbstuediers, whicharelistedontheenclosed index. Asinour `pastsubmissions,wehaveorganized thestudiesby chemical, andwithinthe sectionsforeach chemical,byendpoint or typeofstudy. This submission includes studies relatedto PFOS, PFOA, andother compounds, and also includesstudies that address multiple compounds. Please `note thatweare submitting acopyof the ProteinBinding Studyreportthat isredacted toremove non-responsive confidential business information. We also have included a bibliography of recently included published literature, in this bibliography updating the references w abstractsofpresentations e have to the previously provided. Societyof Toxicology We have or the not Soc of Einvierontmenytal Toxicology and Chemistry. `We enclosepapercopies ofdocuments with this letter. We will proviadCDe containing `our2002 and 2003paper submissionsinthenearfuture. practiceAosf Idiscussed submitting with data wMhse.nMafirnyalDroempoirntisaakrcoafvEaiPlAabloen, May 1, 2003, and hence we 3M are will continiutes not providing `various rawdatain ourpossession at this time. We will continutoe submit finalreportsto the 'AR-226 docket as they are available. CONTAIN NO oP 1 2bq357 Pleasefeelfreetocontactme withanyquestions. Very truly yours, ce: Dr. ChAauerr(Rloome41s46) Dr. Oscar Hernandez Michael A. DirectorofEnvironmental, Health Safety and Regulatory Affairs 3M Specialty Materials Building 236-1B-10 3M Center St. Paul, MN 55144 651-733-6374 (phone) 6E-5m1a-i7l3:3-m1a95s8a(fnatx)oro@mcmom ba A3MTFLTUORAOTCOHCELMEITHCTAELRMOSUFBE JMUILSN YS5I,O2T N003 3M FLUOROCHEMICAL SUBMISSION TOXICOLOGY, EPIDEMIOLOGY AND MEDICAL SURVEILLANCE Te 1 Final Report, NIOSH HealthHazard Evaluation for Perfluorooctanoic Acid and Perfluorooctane Sulfonate, NIOSH HETA 20010235, July 31, 2001. 2. Final Report, AssessomfLeipnidt, Hepatic and Thyroid Function in Relationtoan Occupational Biologic Limit Value for Perfluorooctanoic Acid, 3M Medical Department, June 9, 2003. 3. FCiontatlagReepGorrotv,eDeEsmcprlipotyievee PAanratliycsiipsanotfsoSfetrhuem 2F0l0uo2rMoecdhiecmailcaSlurCvoeniclelnatnrcaetiPornosgfrraom,m 3M Medical Department, June 17, 2003. 4. Final Report, Descriptive Analysis of Serum Fluorochemical Concentrations from Decatur Employee Participants of the 2002 Medical Surveillance Program, 3M Medical Department, June 17, 2003. PharmacokineticStudies L Protein Binding of Perfluorohexane Sulfonate, Perfluorooctane Sulfonate and Perfluorooctanoate to Plasma (Human, Rat, and Monkey), and Various Human-Derived Plasma Protein Fractions, Southern Research Institute StudyID9921.7, 3M Reference Nos. T-6295.33, T-7485.18, T-7504.4, and T-7507.4, June 3, 2003. [Copy for docket redacted to remove non-responsive confidential business information) AT3TMACFHLMUEONRTOCTHOELMEITCTAELRSOUFBMJIUSLSYI9O, N2003 Repeated-Dose Toxicity 1 4-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T6295) in Cynomolgus Monkeys, Covance Study No. 6329-222, 3M Reference No. T-6295.6, April 9, 2002. Pharmacokinetic Studies 1 APharmacokinetic StudyofPotassium Perfluoroocatanesulfonate in the Cynomolgus M22o,n2k0e0y3,. Souther Research Institute Study ID 9921.6, 3M Reference No. T-6295, April Reproductive 1. One Generation Reproduction StoufPdFOyS ~ Mevalonic Acid/Cholesterol Challenge and NOEL Investigation in Rats, 3M Reference No. T-6295.25, December 16, 2002. Perfluorooctanesulfonyl fluoride Acute Toxicity L Acute Inhalation Limit Toxicity Study of Perfluorooctanesulfonyl Fluoride (POSF) T7098.3, 3M Reference No. T-7098.3, October 18, 2001. Genotoxicity 1 Perfluorooctanesulfonyl Fluoride (POSF) In Vitro Mammalian Chromosome Aberration `Test in Human Lymphocyte (Huntingdon Study No. MIN 315/022356), 3M Reference No. T-7661.3, October 22, 2002. 2. Perfluorooctanesulfonyl Fluoride (POSF) Bacterial Reverse Mutation Test (Huntingdon Study No. MIN 314/022208), 3M Reference No. T-7661.2, October 23, 2002. H A3T M PLT UORA OTCOHC ELMEITH CTAELRM OSFUBE JMUILSN YS9I,O2T N003 PharmacokineticStudy 1. `AMoPnhkaerym,acSookuitnehteircRSetsuedayrocfhPIonsttaistustieuSmtPuedryflIuDor9o9h2e1x.a5n,e3suMlfRoenfaetreeinncethNeoC.yTn-o7m5o0l4g,uAspril 22,2003. err PharmacokineticStudy 1. APharmacokinetic Study of Potassium Perfluorooctanoate in the Cynomolgus Monkey, Southern Research Institute Study ID 9921.4, 3M Reference No. T-6889, January 14, 2003. N-Ethylperfiuorooctane sulfonamidoethanol Reproductive L "Two Generation Rat Reproduction Study a RPeerpionrattaAlm/Peonsdtnmaetnalt,ReCpormobduicnteidonOrTaolxi(cGiatvyaSgteu)dFyerotfilNit-yE,CDFevOeSlEopinmeRnattasl--and Correction to Text Figure 1, 3M Reference No. T-6316.5, October 12, 2000. ET? ATTACHMENT TO LETTER OF JULY 9, 2003 ENVIRONMENTAL STUDIES emer] 1. Tennessee River Study a Data Evaluation, A Survey of Selected Fluorochemicals in the Decatur Alabama Area -2002 Sampling, Entrix, Inc. Project No. 178401, July 2003. b. Analytical Laboratory Report, Tennessee River Valley Samples, 3M Environmental Laboratory Study # E02-0443,RevisedReport, January 6, 2003. 1. Incineration Study a Robust Summary, Laboratory-Scale Thermal DegradationofPerfluoro-Octanyl Sulfonate and Related Precursors, July 3, 2003. b. Final Report, Laboratory-Scale Thermal Degradation ofPerfluoro-Octanyl Sulfonate and Related Precursors, Environmental Sciences and Engineering Group, Universityof Dayton Research Institute, June 19, 2003. 2. `Terrestrial Plant Toxicity Study a Robust Summary, Toxicity to Terrestrial Plants, June 3, 2003. b. Final Report, PROS: A Toxicity Test toDeterminethe Effects of the Test Substance on Seedling Emergence of Seven Species of Plants, Wildlife International, Ltd. Project No. 454-110, May 30, 2003. c. Analytical Laboratory Report, Analytical Method Validation for the. DeterminationofPerfluorooctanesulfonate, Potassium Salt (PFOS) in Artificial Soil, Wildlife International, Ltd. Project No. 454C-120, May 27, 2003. d. Analytical Laboratory Report, Analytical Method Validationforthe Determination of Perfluorooctanesulfonate, Potassium Salt (PFOS) in Plant `Tissues, Wildlife International, Ltd. Project No. 454C-125,October22, 2001. A3T MFLT UORA OTCHOC ELMEITHCTAELRMSOUFBE JMUILSN SYI5O,2NT003 BIBLIOGRAPHY OF PUBLISHED LITERATURE TOXICOLOGY, EPIDEMIOLOGY AND MEDICAL SURVEILLANCE Austin ME, Badrinarayanan SK, Barber M, Kannan K, MohanKumar PS, and MohanKumar 'SMJ (2003). Neuroendocrine EffectsofPerfluorooctane Sulfonate in Rats. Environ. Health Persp. doi: 10.1289/chp.6128 (available at hitp://d.doi.org) online April 3, 2003. `Berthiaume J, WallaceKB (2002). Perfluorooctanoate, Perfluorooctanesulfoante, and N-cthyl Perflucrooctanesulfonamido Ethanol; Peroxisome Proliferation and Mitochondrial Biogenesis. Toxicol. Letters 129:23-32. Butenhoff J, Costa G, Elcombe C, Farrar D, Hansen K, Iwai H, Jung R, Kennedy G, Lieder P, Olsen G, and Thomford P (2002). Toxicity of Ammonium Perfluorooctanoate in Male Cynomolgus Monkeys after Oral Dosing for 6 Months. Toxicol. Sci. 69:244-57. Luebker DJ, Hansen KJ, Bass NM, ButenhoffJL, and Seacat AM (2002). Interactions of Fluorochemicals with Rat Liver Fatty Acid-Binding Protein. Toxicol. 176:175-85. Masunaga S, KananK,Doi R, Nakanishi J, GiesyJP (2002). LevelsofPerfluorooctane Sulfonate (PFOS) and Other Related Compounds in the Bloodof Japanese People. Organohalogen Compounds 59:319-322. Olsen GW, Burris JM, Burlew MM, Mandel JH (2003). Epidemiologic AssessmentofWorker MSeedriucmalPeSrufrlvueoirloloacntcaeneEsxualmfionaanttieon(sP.FOJSO)EanMd4P5e:r2f6l0u-o2r7o0o.ctanoate (PFOA) Concentrations and aOnldseSneGruWm,CHoanncseentnrKatJi,oSntsoevfePnesrofnluLoAr,ooBcutrarniessJulMf,onaantdeMaannddOetlhJerHP(e2r0f0l3u)o.roHcuhemmaicnalD,onEnovrirLoinv.er Sci. & Technol. 37(5):888-91. TSoexaiccaittAyMS,tudTiheosmofnorPedrPfJl,uoHraonoscteanneKsJu,lOflonsaetneGPWot,asCsaisuemMSTal,t BinuCtyennohmooJlfLgfu(s20M0o2n)k.eSyusb.chTrooxniiccol. Sci. 68:249-264. (S2e0a0c3a)t.ASMu,b-TchhormonfiocrdDiPeJt,aHryanTsoxeinciKtJy, oCflPeomteanssLiAu,mEPledrrfildugoeroSoRc,taEnlescuolmfboenaCteR,inaRnadtsB.utToexnichoolJ.fLf 183:117-31. SMittaorckhoovnAdAri,alWaFlulnacctieoKn.BT(o2x0i0c2o)l.. SSctir.uc6t6u:ra2l44D-e2t5e2r.minantsof Fluorochemical-Induced ENVIRONMENTAL HBoennirfya'csiLoaRwP,CoPeafdfuiaciAe,ntasnfdorCoHesxtaaf-lGuoomreosetMhaFne(2a0n0d1)C.omPperuftleurorSoiamluklaanteisonisn Water: for Experimental Tetrafluoromethane and Hexafluoroethane. J. Phys. Chem. 105:8403.03. . AT`T3MAFCLHUOMREONTCOTHELMICEAL TOSUFBJT MUILSYSEI9,ON2R003 Giesy JP, Kannan K, and Jones PD (2001). Global BiomonitoringofPerfluorinated Organics. Scientific World 1:627-29. Golovanov IB and Tsygankova IG (2001). Structure-Property Correlation Equation: VII Some PropertiesofPerfluorinated Organic Compounds. Russian J. ofGen. Che. 71(6):839-44. `Hansen KJ, Johnson HO, Eldridge JS, Butenhoff JL, and Dick LA (2002). Quantitative CharacterizationofTrace Levels of PFOS and PFOA in the Tennessee River. Environ. Sci. & `Technol. 36:1681-85. dHeetbeerrmtinGaNt,ioOnodfosmuMb-Ap,pCmrcaoingcPeSn,trDaiticoknDsLo,f paenrdflSutorraouaslkSyHls(u2l0f0o2n)a.teMaentihoondsfion rwattheer. `DepartmentofChemistry, Colorado State University, Fort Collins, CO 80523. HoffPT, Vijver K, Dongen W, Esmans EL, Blust R,and CoenWM (2003). Perfluorooctane Sulfonic Acid in Bib (Trisopterus luscus) and Plaice (Pleuronectes platessa) from the Western Scheldtandthe Belgian North Sea: Distribution and Biochemical Effects. Environ. Toxicol. and Chem. 22(3):608-14. `Hu W, Jones PD, Upham BL, Trosko JE, Lau C, andGiesyJP (2002). Inhibition of Gap JKuindcnteioynEapliItnhteelricaelllCuellalrLCionmemsuinniVciattriooanndbySpPrerafgluueo-rDinaawtleedyCRoamtpsoiunnVdisvoi.n RTaoxtiLciovle.rScain.d6D8o:l4p2h9i-n 36. Kannan K, Choi JW, Iseki N, Senthilkumar K, Kim DH, Masunaga S, and Giesy JP (2002). Concentrations of perfluorinated acids in livers of birds from Japan and Korea. Chemosphere. 49:225-31. Kannan K, et al. (2002). Perfluorooctane sulfonate and related fluorinated hydrocarbons in E`mnavriirnoen.maScmim.a&lsT,ecfihsnhoels., a1n5d:3b2i1r0d-s1f6r.omcoasts of the Baltic and the Mediterranean Seas. Kannan K, et al. (2002) Perfluorooctane sulfonate in oysters, Crassostrea virginica, from the `Gulf of Mexico andtheChesapeake Bay, USA. ArchivesofEnvironmental Contamination and `Toxicology 42:313-318. Lewis, Pryce HG, Caulfield JA, and Gleason KX (2001). Perfluorooctane Sulfonyl Fluoride as an Initiator inHotFilament Chemical Vapor Depositionof Fluorocarbon Thin Films. Langmuir 17:7652-55. Martin JW, Mabury SA, Solomon KR, and Muir D (2003). Bioconcentration and Tissue Distribution of Perfluorinated Acids in Rainbow Trout (Oncorhynchus mykiss). Environ. `Toxicol. and Chem. 22(1):196-204. 2 Lo . A3T M FLTUORAOTCOHCELMEITHCTAELRMSOUFBE JMUILSN YSI9O,NT 2003 Martin JW,Mabury SA, Solomon KR,and Muir D (2003). Dietary Accumulation of PCehrefmlu.or2i2n(a1t)e:d18A9c-i9d5s. in JuvenileRainbow Trout (Oncorhynchus mykiss). Environ. Toxicol. and MCoalrlteicntiJoWn,oMfuAiirrbDo,rMneooFlduyorCiAn,atEeldlOirsgDaAni,cKswaandnAWnCal,ysSioslboymoGnasKRC,hraonmdatMoagbruarpyhyS/ACh(e2m0i0c2a).l Ionization Mass Spectrometry. Analytical Chem. 74:584-90. NHaydkraoncoarTb,oSnu/gFilhuaorraocGa,rNbaonkaSsuhrfiamcataTn,tYSuysSte(m20b0y2)C.onTdhuecrtmoomdeytrniacmiacndSFtluudoyroifmeMtirixceTdechniques. Languir 18:8777-85. `Sanderson H, BoudreauTM, Mabury SA, Cheong WJ, and SolomonKR(2002). Ecological Impact and Environmental Fate ofPerfluorooctane Sulfonate on the Zooplankton Community in Indoor Microcosms. Environ. Toxicol. and Chem. 21-7:1490-96. 9