Document gbkrQzYe5xGMeRod3ZgV4oM03

-- IM Speciay Materials i3SUMPCaealneMreNss1e4k1000 AR 236-1349 03JUL 10 R616 31 i VIA HAND DELIVERY July9, 2003 DOfofciucmeoefntPoClolnuttriooln OPfrfeivceent(i7o4n0a7nMd)Toxics (OPPT) Docket AR-226 EPA East, Room 6428 W1a2s01hiCnogntsotni,tuDtiCon2A0v4e6n0ue, NW Phone: 202-564-8930 ORIGI NAL Attention: OPPT Docket No. AR-226 = 8 on = 33 SEE ~ 5s85 2a Re: Information on Perfluorooctane Sulfonate, Perfluorooctanoic Acid, and Related Compounds Dear Si or Madam: `This continues 3M's voluntary submissionsofdata on perfluorooctane sulfonate (PFOS), perfluorooctanoic acid (PFOA), and related compounds, as part of our ongoing dialogue with EPA regarding perfluorochemicals. We are enclosing a numberof studies, which are listed on the enclosed index. As in our past submissions, we have organized the studies by chemical, and within the sections for cach cPhFeOmiAc,ala,ndbyotehnedrpcoionmtpoourntdysp,eoafnsdtuadlys.o inTchliusdessusbtmuidsiseisotnhaitncalduddreesssstmuudliteisprleelactoemdptoounPdFsO.S,Please note that we are submitting a copyof the Protein Binding Study report that s redacted to remove non-responsive confidential business information. We also have included a bibliography of recently published literature, updating the references we have previously provided. We have not included in this bibliography abstracts of presentations to the Societyof Toxicology or the Society of Environmental Toxicology and Chemistry. We enclose paper copiesofdocuments with this letter. We will provide a CD containing our 2002 and 2003 paper submissions in the near future. As T discussed with Ms. Mary Dominiak ofEPA on May 1, 2003, 3M will continue its pvraarcitoiucseorfawsudbamtaitininogurdaptoasswehsesinonfiantalthriespotritmes.areWaevawiillalblceo,ntainnduehetnocseubwmeitarfeinnaoltrperpoorvtisditnogthe AR-226 docket as they are available. CONTAIN NO CBI bg obb I Please feel free to contact me with any questions. Very truly yours, nctuC & Michael A. Santoro SDiarfeecttyoarnodfREengvuilraotnomreyntAaflf,aiHresalth 3M Specialty Materials Building 236-1B-10 3M Center St. Paul, MN 55144 651-733-6374 (phone) E6-5m1a-i7l:33-m1a9s5a8 n(tfaoxr) o@mmm.com cc: Dr. Charles Auer (Room 4146) Dr. Oscar Hernandez 1 AT3TMACFHLMUEONRTOCTHOELMEITCTAELR SOUFBJMUISLSYI9O, N2003 3M FLUOROCHEMICAL SUBMISSION TOXICOLOGY, EPIDEMIOLOGY AND MEDICAL SURVEILLANCE Human Sera/Medical Surveillance/Epidemiology 1. FPienraflluRoerpooorctt,anNeISOuSlfHonHaetael,tNhIHOazSaHrdHEEvTalAua2t0i0o1n0f2o3r5P,eJrufllyuo3r1o,oc2t0a0n1o.ic Acid and 2. OFicncaulpaRteipoonna,l ABsiosleosgsimceLnitmoiftLViaplidu,e HfeorpaPteircflaunodroTohcytraoniodicFuAcnicdt,io3nMinMReedliactailonDteopaarntment, June 9,2003. 3. Final Report, Descriptive Cottage Grove Employee Analysis of Participants Serum of the Fluorochemical Concentrations from 2002 Medical Surveillance Program, 3M Medical Department, June 17, 2003. 4. DFiencaaltuRrepEomrtp,loDyeseceriPpatritivceiApannatlsysoifstohef S2e00r2umMeFdliucoarlocShuermviecialllaCnocnecPerntorgartaimo,ns3MfrMoemdical Department, June 17, 2003, Pharmacokinetic Studies 1. PPreortfeliunorBoioncdtiannogaotfePteorPfllauosrmoah(exHaunmeanSu,lfRoanta,taen,dPeMrofnlkueoyr)oo,ctaanndeVSaurlifoounsatHeuamnadn-Derived PNolsa.smTa-6P2r9o5t.e3i3n,FTra-c7t4i8o5n.s,18S,ouTt-h7e5r0n4.R4e,saenardcTh-7I5ns0t7i.t4u,teJSutnuedy3,I2D00939.21.[7C,op3yMfoRrefdeorceknecte redacted to remove non-responsive confidential business information] ATT3AMCFHLMUEONRTOCTHOELMEITCTAELRSOUFBMJIUSLSYI9O,N2003 [Fos [retaromancuitont Repeated-Dose Toxicity I. 4(P-FWOeSe;kTC-a6p2s9u5l)eiTnoxCiycniotmyoSltguudys wMiotnhkPeeyrsf,luCoorvoaonctcaeneStSuudlyfoNnoi.c A63c2i9d-P2o2t2a,s3siMumReSfaletrence No. T-6295.6, April 9, 2002. Pharmacokinetic Studies 1. AMoPnhkaerym,acSookuitnheetrincRSetsuedayrcohf PInosttaistustieuSmtPuedryflIuDor9o9o2c1a.t6a,ne3sMulfRoenfaetreenicnethNeo.CyTn-o62m9o5l,guAspril 22,2003 Reproductive 1. OanndeNGeOnEerLatIinvoenstRiegpartoidouncitnioRantSs,tu3dMy oRfePfeFrOeSnc~e NMoe.vaTl-o6n2i9c5.A2c5i,d/DCehcoelemsbteerro1l6,Ch2a0l0l2e.nge [Fost rertuorscanetons tuoi Acute Toxicity 1 7A0c9u8t.e3,In3haMlaRteifonerLeinmcietNToo.xiTc-i7t0y9S8t.3u,dyOcotfoPbeerrfl1u8o,ro2o0c0t1anesulfonyl Fluoride (POSF) TGenotoxicity 1. `PTeersftliunorHouocmtaanneLsuylmfpohnoy!cyFtleuo(rHiduent(iPnOgSdFo)n ISntuVdiytrNoo.MaMmImNal3i1a5n/0C2h23r5o6m)o,s3oMmeRAebfeerrreantcieon No. T-7661.3, October 22, 2002. 2. SPterufdlyuoNroo.ocMtIanNes3u1l4f1o0n2y2l2F0l8u)o,ri3dMe (RPefOeSre)ncBaectNeor.iaTl-7Re6v1e.r2s,eOMcuttoabteiron23T,e2s0t0(2.Huntingdon w srrsciweTo LETEROP LY0 EE Pharmacokinetic Study 1 A Pharmacokinetic Study of Potassium Perfluorohexanesulfonate in the Cynomolgus Monkey, Southern Research Institute Study ID 9921.5, 3M Reference No. T-7504, April 22,2003. rox Pharmacokinetic Study 1 A Pharmacokinetic Study of Potassium Perfluorooctanoate in the Cynomolgus Monkey, Southern Research Institute Study ID 9921.4, 3M Reference No. T-6889, January 14, 2003. N-EtFOSE N-Ethylperfluorooctane sulfonamidoethanol Reproductive & "Two Generation Rat Reproduction Study a. Report Amendment, Combined Oral (Gavage) Fertility, Developmental and Perinatal/Postnatal Reproduction Toxicity Study of N-EtFOSE in Rats -- CorrectiontoText Figure 1, 3M Reference No. T-6316.5, October 12, 2000. mr ENVIRONMENTAL STUDIES a. Data Area Evaluation, A Survey of - 2002 Sampling, Entrix, Selected Fluorochemicals Inc. Project No. 178401, in the Decatur July 2003. Alabama b. Analytical Laboratory Report, Tennessee River Valley Samples, 3M Environmental Laboratory Study # E02-0443, Revised Report, January 6, 2003. ros remem 1. Incineration Study a Robust Summary, Laboratory-Scale Thermal Degradation of Perfluoro-Octanyl Sulfonate and Related Precursors, July 3, 2003. b. Final Report, Laboratory-Scale Thermal Degradation of Perfluoro-Octanyl Sulfonate and Related Precursors, Environmental Sciences and Engineering Group, University of Dayton Research Institute, June 19, 2003. 2. "Terrestrial Plant Toxicity Study a Robust Summary, Toxicity to Terrestrial Plants, June 3, 2003. b. Final Report, `Substanocne PFOS: A Seedling Toxicity Test Emergence of to Determine the Effects Seven Species of Plants, of the Test Wildlife International, Ltd. Project No. 454-110, May 30, 2003. c Analytical Laboratory Report, Analytical Method Validation for the Determination of Perfluorooctanesulfonate, Potassium Salt (PFOS) in Artificial Soil, Wildlife Intemational, Ltd. Project No. 454C-120, May 27, 2003. d. Analytical Laboratory Report, Analytical Method Validation for the Determination of Perfluorooctanesulfonate, Potassium Salt (PFOS) in Plant `Tissues, Wildlife International, Ltd. Project No. 454C-125, October 22, 2001. 6 . AT3TMAFCLHUOMREONTCOTHELMEITCTAELR SOUFBJMUISLSYI9O, N2003 BIBLIOGRAPHY OF PUBLISHED LITERATURE TOXICOLOGY, EPIDEMIOLOGY AND MEDICAL SURVEILLANCE Austin ME, Badrinarayanan SK, Barber M, Kannan K, MohanKurmar PS, and MohanKurmar SMI (2003). Neuroendocrine Effects of Perfluorooctane Sulfonate in Rats. Environ. Health Persp. doi: 10.1289/ehp.6128 (available at hutp:/dx.doi.org) online April 3, 2003. Berthiaume J, Wallace KB (2002). Perfluorooctanoate, Perfluorooctanesulfoante, and N-ethyl Perfluorooctanesulfonamido Ethanol; Peroxisome Proliferation and Mitochondrial Biogenesis. Toxicol. Letters 129:23-32. ButenhofJf,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, Butenhoff JL, and Seacat AM (2002). Interactions of Fluorochemicals with Rat Liver Fatty Acid-Binding Protein. Toxicol. 176:175-85. Masunaga S, Kanan K, Doi R, Nakanishi J, Giesy JP (2002). Levels of Perfluorooctane 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 Assessment of Worker Serum Perfluorooctanesulfoante (PFOS) and Perfluorooctanoate (PFOA) Concentrations and Medical Surveillance Examinations. JOEM 45:260-270. Olsen GW, Hansen KJ, Stevenson LA, Burris JM, and Mandel JH (2003). Human Donor Liver and Serum Concentrations of Perfluorooctanesulfonate and Other Perfluorochemical, Environ. Sci. & Technol. 37(5):888-91 Seacat AM, Thomford PJ, Hansen KJ, Olsen GW, Case MT, Butenhoff JL. (2002). Subchronic Toxicity Studies on Perfluorooctanesulfonate Potassium Salt in Cynomolgus Monkeys. Toxicol Sci. 68:249-264, Seacat AM, Thomford PJ, Hansen KJ, Clemen LA, Eldridge SR, Elcombe CR, and Butenhoff JL. (2003). Sub-chronic Dietary Toxicity of Potassium Perfluorooctanesulfonate in Rats. Toxicol. 18311731. Starkov AA, Wallace KB (2002). Structural Determinants of Fluorochemical-Induced Mitochondrial Function. Toxicol. Sci. 66:244-252. ENVIRONMENTAL Bonifacio RP, Padua A, and Costa-Gomes MF (2001). Perfluoroalkanes in Water: Experimental THeetnrrayf'lsuLoraowmeCtoheafnfeicainendtHsefxoarflHueoxraofeltuhoarnoee.thJa.nPehyasn.d CCohmepmu.t1e0r5S:i8m4u0l3a-t0i3ons for . ATT3MACFHLMUEONRTOCTHOELMEITCTAELRSOFUJBMUILSYSI5O,N2003 Giesy JP, Kannan K, and Jones PD (2001). Global Biomonitoring of Perfluorinated Organics. Scientific World 1:627-29. Golovanov IB and Tsygankova IG (2001). Structure-Property Correlation Equation: VII. Some Properties of Perfluorinated Organic Compounds. Russian J. of Gen. Chem. 71(6):839-44. Hansen KJ, Johnson HO, Eldridge JS, Butenhoff JL, and Dick LA (2002). Quantitative Characterization of Trace Levels of PFOS and PFOA in the Tennessee River. Environ. Sci. & Technol. 36:1681-85. Hebert GN, Odom MA, Craig PS, Dick DL, and Straus SH (2002). Method for the determination of sub-ppm concentrations of perfluoroalkylsulfonate anions in water. Department of Chemistry, Colorado State University, Fort Collins, CO 80523. Hoff PT, Vijver K, Dongen W, Esmans EL, Blut R, and Coen WM (2003). Perfluorooctane Sulfonic Acid in Bib (Trisopterus luscus) and Plaice (Pleuronectes platessa) from the Westem Scheldt and the 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, and Giesy JP (2002). Inhibition of Gap Junctional Intercellular Communication by Perfluorinated Compounds in Kidney Epithelial Cell Lines in Vitro and Sprague-Dawley Rats in Vivo. RToaxticLoilv.erSacin.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 49:22531. mKaarninnaenmKa,mmetaall.s,(2f0i0s2h)e.s, PaenrdflbuirodrsoofcrtoamnecosausltfsonoaftethaenBdalrteilcataenddfltuhoeriMneadtietderhryadnreoacnarSbeoanss. in Environ. Sci. & Technol. 15:3210-16. Kannan K, etal. (2002) Perfluorooctane sulfonate in oysters, Crassostrea virginica, from the `Gulf of Mexico and the Chesapeake Bay, USA. Archives of Environmental Contamination and Toxicology 42313318. Lewis, Pryce HG, Caulfield JA, and Gleason KK (2001). Perfluorooctane Sulfonyl Fluoride as an Initiator in Hot Filament Chemical Vapor Deposition of 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. . AT3TMACFHLMUEONRTOCTHOELMEITCTAELR SOUFBJMUISLSYI9O, N2003 Martin JW, Mabury SA, Solomon KR, and MuiDr (2003). Dietary Accumulation of Perfluorinated Acids in Juvenile Rainbow Trout (Oncorhynchus mykiss). Environ. Toxicol. and Chem. 22(1):189-95. Martin JW, Muir D, Moody CA, Ellis DA, Kwan WC, Solomon KR, and Mabury SA (2002). Collection of Airbome Fluorinated Organics and Analysis by Gas Chromatography/Chemical Tonization Mass Spectrometry. Analytical Chem. 74:584-90. Nakano T, Sugihara G, Nakashima T, Yu $ (2002). Thermodynamic Study of Mixed Hydrocarbon/Fluorocarbon Surfactant System by Conductometric and Fluorimetric Techniques. Languir 18:6777-85. Sanderson H, Boudreau TM, Mabury SA, Cheong WJ, and Solomon KR (2002). Ecological Impact and Environmental Fate of Perfluorooctane Sulfonate on the Zooplankton Community in Indoor Microcosms. Environ. Toxicol. and Chem. 21-7:1490-96.