Document 2zvZKMZBbZyBERagXReVaGGR

J . or 3M Specialty Materials. 6S3M51C7en3ite1r100ns FY1-0600A-R1578 0587 . 3M May 26,2000 Dr. Charles Auer, Director Chemical Control Division OUfnfiitceedoSftaPtoelsluEtnivoinrPornemveennttailonPraontdecTtoixoincAsgency 401 M Room Street, Southwest 403, East Tower (Mail Code 7405) `Washington, D.C. 20460 MR F-ee) FYI-00-001378 Dear Charlie: 0T wparnotveiddetoEfPoAllwoiwt-hupionnforremcaetnitondiosncupsesrifolnusorroeogcatradniengsu3lMf'osnavtoelsuanntadrryelefaftoerdt aclormepaoduynhdass.prIonivtiidaleldy,inittmheaylasbtemuosnetfhul: to review the information that 3M material*sAprreilalti2n0g,t2o00t0h:e twLoet-tgeernetroaOtsicoanrrHeperrondauncdteivzeesntculdoysianngdadrdeilattieodnal studies on perfluorooctane sulfonates. (Materials also submitted separately to the TSCA Section 8() docket) Ce studies +oAnprpielrf2l1u,or2o0o0c0t:anLeetsuelrftonoatCehsarrleileatAinugetoetnhcelofsoilnlgowhienagltahreeafsf:ect(is) pharmacokinetics; (i) teratology; and ii) epidemiology and medical surveillance. Informat*AiporniPlro2f8i,le20(0U0:EIPL)etftoerrpteorfOlsucoarrooHcetmanaendsuelzfoennactelso.sing Use Exposure "May 3, 2000: Letter to Dr. Jennifer Seed from John Butenhoff conveying analyses of PFOS in serum from two pharmacokinetic studies. perfluor*oMoacytan4e,2s0ul0f0o:naLteetstaesr ftoolClhoawrsl:ie(iA)uCeorpieenscloofsipnogsti-n1f9o7r5mation on eexncveiurtoinvmeenstuamlmascriieenscefosrtucdaicehs eanlvoinrgownimtehnatalrosbcuisetnscuemsmuab-rayrefaorancdacahdsettuadiyl:ed iinnddeexx;; ((iiii))CLoipsitsesofofalploPsFt-O1S97s5tuhdeiaelsthpleaffnencetds osrtuidniepsroaglroensgswailtohnga wdeittahiled Sptruodtioecsolasn/dstnuodny-pkleaynsa,cwutheerteoxaivcaiitlyasbtlued;ie(siv;)aBnidbl(ivo)gAranphiinedseoxfporfeal-l1976 perfluorochemical-related submissions to the TSCA Section 8(e) docket. ll 85000000017 / op)/ . "=~ Smo : BH = = = g== 93=78a LEE 3Zs 88 93 Lo Page2 Dr. Charles Auer, Director different*Mapapyli1c1at,i2o0n0s0:forLpeetrtefrlutoorCohoacrtlainee Asuulefroneantcelsosainndgoinnfcoormmpaotsiiotnioonn tohfe certain perfluorooctane sulfonates-containing products. *May 12, 2000: Letter to Charlie Auer enclosing additional data on wildlife measurements of perfluorooctane sulfonates and related compounds. certain *May 15,2000: studies included Letter to Charlie Auer providing summaries in the May 4, 2000 package of materials for perfluor*oMoactyan1e8s,u2l0f0o0n:ateLsetstteurditoesChloacraltieedAsuuebrseeqnucelnotsitnogtahdediMtaioyna4l, 2000 pstaucdkiaegseoonf1m3atreerliaatelds casomwpelolunasdshelailstthedefifneTctasblaend1 eonfvtihreondmoecnutmaelnstcienetnicteled: "FSautlefAonnadteEdffPeectrsf"l,uoarto1c2he(mMiacraclsh I1n, T20h0e0)E.nvTihroenMmeanyt:18S,o2u0r0ce0sp,aDciksapgeersoifon, materials included robust summaries and detailed indices similar to the May 4,2000 package. a*nMdaoyth2e6r,2i0n0f0o:rmaLteitotnerontopCehrafrlluioeroAoucetraneonicclaocsiidng(ePnFvOiAr)onamsenwtelall assciseunpcpelaenmednhteaalltihnfeoffremcattsiosntuodnies perfluorooctane sulfonates and related compounds. 3M fle review covered in these is continuing, and previous packages we of will supplement the areas materials as appropriate. already What I'am hionpfoirnmgattoiocnlaornifoytwhietrharyeoaus, whhoewreeveEr,PAishtahse epxapthrefsosrewdaarnd ifnotrerpersotv.idTiongthis end, 3M would propose the following schedule: #May 31,2000: UEIPs for the 13 perfluorooctane sulfonates-related cPeormfplouuornodcshelmisitceadlisnITnaTbhlee 1Eonfvitrhoenmdeonctu:meSnoutrecnetsi,tlDeids:pe"rSsuilofno,naFtaetde And Effects", at 12 (March 1, 2000) and *June 9, 2000: other information UonEImPixftourrPesFcOoAntaanidnienngvPiFroOnSm.enFtoarl science and purposesof health effects studies this submittal, we: are applying a definitionof"mixtures" where PFOS is an intentional componentofthe mixture. - . Page 3 Dr. Charles Auer, Director `We continue to work diligently to provide EPA with the information requested in as timely a `manner use our as possible and best judgement in in a format that is effective for the agency's review. We will continue providing this information to EPA, including considerationofthe to `human effort involved in completing this task. 3M has discussed with you the question of environmental science and health effects studies on mixtures containing the 13 PFOS-related `compounds. It is 3M's recommendation that such studies not be provided to EPA at this time for several reasons. First, the vast majority of these studies do not involve products in current (or even recent) commercialization. Second, manyofthese studies are acute studies and would not qualify as "key studies". Third, being mixtures, it is difficult to determine the contributionofthe fluorochemical on toxicity in any given study. Finally, the processof identifying, reviewing, cataloguing and copying all effort at a time when weare such very mixture studies in 3M's files would involve involved in executing our business decision an extraordinar regarding the y manufactureofperfluorooctanyl chemistry. Iwould like to suggest that 3M focus specifically on cPoFmOpAl.eti3nMg twhiellsutbhmeinsssuibomniotfdtoatEaPoAniPnfFoOrSm,attihoeniodnensttiufideideschreemgiasrtdriinegsmmiaxtduerefsrocmonPtaOiSnFi,nganPdFOS specifically before the endof June. 3M would like the agency to first review the data on mixtures containing PFOS and assess the utilityof such information before requesting the submission of data on mixtures containing the 13 PFOS-related compounds. At that time we would be pleased to discuss approaches and a timetable for providing such information. Please give me or Mike Nashof 3M (651-733-0134) or Julie Hatcher of Latham & Watkins (202637-2238)a call to discuss this matter. In the meantime, 3M will proceed in accordance with the. foregoing schedule. Best regards, Ais Q. Hefprrans William A. Weppner, Ph.D. Director Environmental, Health, Safety & Regulatory Affairs Specialty Material Markets Group 3M Center, Building 236-1B-10 St. Paul, MN 55144-1000