Document MGmqb9BR9QGzEDwzN5OQEMXQ9

FE 3M Genera Offics MSU PCaeunlteMrN SSL4-1000 sine AR 9ac_ 1303 3M March 13, 2003 ASstseipshteanntLA.dJmoinhinsstornator Office Of Prevention, Pesticides And Toxic Substances United States Environmental Protection Agency W1a2s0h0inPegntnosny,lDv.anCi.a A2v0e0n0u4e, N. W. Re: Environmental, Health And Safety Measures Relating To Perfluorooctanoic Acid And Its Salts (PFOA) =3 oInR Nam 33 = 50 & Dear Assistant Administrator Johnson: 3M Company (3M) understands that your office has been evaluating pcearrfblouxoyrloaotcetasnurofiaccatcaindtsaunsdeidtspsrailmtasri(l"yPFaOsAf"l)u,orwihniactehdaproelypmerefrliuzoartiinoanteadi,ds8 (cFaPrAbSo)n in the menavniurfoancmteunrtealo,f hfelaulotrhopaonlydmesrasf.e'ty T(hEiHsSl)etmteeracsounrfeisrmrsel3aMti'nsginttoenPtFtOoA.conItnipnauretiocunlgaori,ngt.his letter documents past EHS measures by 3M to characterize exposure to PFOA; to cPoFnOduActexhpeoasluthreantdhreonuvgihraonpmreondtuacltifoantepahnadsee-fofuetctasnrdesoetahrecrhmfeoarsPurFeOsA.; aThnidstloetrteerduaclseo `summarizes 3M's plans for ongoing and future EHS measures to develop additional data characterizing exposure to PFOA; to continue to monitor possible PFOA presence in the environment near 3M's former manufacturing facilties; to characterize possible PFOA exposure pathways from 3M's former manufacturing and commercial activities; and to fund additional health and environmental fate and effects research for PFOA. - I PERTINENT BACKGROUND 3M production records reflect that PFOA was produced at various facilties from 1969 to 2002 using electrochemical fluorination (ECF) technology. Between 1992 and 2002, 3M's total PFOA production averaged 250,000 pounds per year. ' CNuhmebmeirc:al VNaarmieo:us,Pienrcflluudoirnogo:ct3a3n6o.i6c7-A1cid(r(ePeFaOcAi)d.); 3Mo6l2e5c-u2l6ar1 f(orammumlao:niCuymHsaFli;s O3a3.5-C95A-S5 (sodium snaulm)bearn.d 2395.00-8 (potassium sal). The perfiuoroocianoate anion hes no specifc CAS CONTAIN NO CBI 1 . : Lo spruronxtiiornmen industrial Approximately 97 percent of the customers and in its own processes PFOA produced by as a fluoropolymer 3M was used by its processing aid. The remaining 3 film coating percent totaled application and roughly 8,000 pounds per in electronics applications year and involving was used in a printed circuit medical boards and precision bearings. population Between and certain 1998 U.S. and 2002, population 3M submitted to EPA serum subgroups. These analyses analyses indicated of the the U.S. presence in mean levels individual and pooled human of 4-6 parts per billion (ppb). serum samplesof Wildiife sampling the also PFOA anion at very low occurred during this period and indicated the presenceof the PFOA anion only in limited circumstances. Toxicological and epidemiology studies on PFOA have been sponsored by 3ThMesase wsetluldiaessoatrheeravmaeilmabbleerstootfheinpduubsltircy aaldodnrgeswsiitnhgotahreranignefoorfmahteiaolnththenrdo-upgohinatsp.ublic docket maintained by EPA OPPTS - AR-226. 3M does not believe that the PFOA levels measured in workers, the U.S. Vpoolpuunltaatriyonbaosritshetoednevvierloonpmeanddtictiaounsael aPdFvOeArsheeeaflftehctasndinehnuvmiarnonsm,enbtuatlisfaatcetianngdoneffaects data; to provide additional characterization agree to undertake additional measures to of potential PFOA reduce or prevent routes PFOA of exposure; and to exposure whenever practicable. The details of these EHS commitments by 3M are described in Section II. below. I. EHS COMMITMENTS BY 3M A. Past 3M EHS Measures For PFOA the exposure Oavnedrtotxhiecoyleoagrisc,al3pMrohfialse uonfdPeFrOtAa.kenTahewiedleemreanntgseboeflmoewadseusrcersibteo 3aMs'ssess major past actions, but are not an exhaustive list of 3's past EHS measures. dating back 1. to 1978. 3M has monitored the health of More recently, this monitoring fluorochemical production workers program has involved periodically wmoerakseurrsinrgegPaFrdOiAngltehveelsseirnessuelrtus;m,untdrearctkiankgincgliinincdaulstcrhiealmihsytgriieesneanmdeacsoumrmeusnitcoamtoinnigtowrith and reduce workplace exposures; and conducting medical surveillance, epidemiological and other forms of pertinent study. address 2. whether 3M PFOA has has both engaged in and supported toxicological research the potential to cause any health effects for a range of to end- points, effects including developmental and cancer. These data toxicity, mutagenicity, chronic toxicity, are available to the public, along with reproductive other information, through the EPA-maintained OPPTS AR-226 docket. 2 .- PfE r rst 3. 3M has performed extensive analytical work to determine PFOA exposure levels in the U.S. population and the environment. For this work, 3M engaged in state-of-the art methods development and refinement to lower limits of detection and quantification. 3M also qualified independent laboratories to apply these methods. Analyses were performed of pooled blood samples from U.S. blood banks as well as of individual blood samples from various population subgroups. A study also examined livertissue. With respect to environmental monitoring, 3M conducted monitoring in the vicinity of ts now former PFOA production facilties; analyzed serum and liver samples from fish, birds and other wildiife for the presence of PFOA; and sponsored a Multi-City Study in which a variety of environmental compartments were analyzed. These data also are available to the public through the OPPTS AR-226 docket. 4. Overthe years, 3M also has undertaken steps to limit PFOA exposures in the workplace. These steps have included implementation of industrial hygiene controls at 3M fluorochemical production facilties, including adoption of exposure guidelines. 3M also has taken various actions to reduce environmental releases of PFOA at these facilities, including capture and incineration of PFOAcontaining waste streams and the implementation in 1998 of activated carbon systems to improve the removal of PFOA from wastewaters. 5. In 1997, 3M obtained new analytical data on PFOA and perfluorooctane sulfonate (PFOS) serum levels in the general population and promptly shared these data with EPA. Thereafter, 3M shared additional data and exposure information with EPA on perfluorooctanyi chemicals, including PFOA, and cooperated with EPA in evaluating hazard and exposure issues associated with these chemicals. 6. Subsequent to obtaining the new analytical data on PFOA and PFOS serum levels in the general population, 3M decided to phase-out its perfluorooctanyl chemistry substantially by the end of 2000. This phase-out included terminating all PFOA production for commercial sale by the end of 2002. 3M's Dyneon subsidiary continues to manufacture small quantities of PFOA at fs facity in Gondor Germany for its own intemal use as a fluoropolymer manufacturing aid at its two facilities. In this connection, Dyneon has made process changes that reduce the quantity of PFOA required and has developed a "capture for recycle" technology that reduces the need for new PFOA. As described in Section I1.C.6. below, Dyneon will be engaging in its own EHS measures in connection with this limited production and use, including further reduction of PFOA use. * Dfaycnielloense--ngoanegeisn tinhethUenimtaendufSatcatteusreanodf founoeroinpoGleyrmmearnsy.andFofrlmueorroleylaasotionmtervsenatnudreopbeertawteeesntSwoM and Hoechst AG, Dyneon now is a wholly-owned subsidiary of SM. 3 `- ra)ace B. Characterization Of Other Potential Routes Of Exposure related to A qualitative discussion more fully characterizing possible exposure routes non-fluoropolymer PFOA uses and discontinued perflucrooctanesulfonyl fluoride (i) 3M's c(oPmOmSeFr)c-ibaalsePdFpOrAodpurcotdsucftoilolnowfsorbenloonw-.flTuhoirsopdoilsycmuesrsiuosnesreoflceccutrsrtewdookneay points: limited bapapsliiscaattiaonlsevweiltohfloonwlyex8p0o0s0urpeoupontdesntpiaelr;yaenadr (fio)r PmOedSiFc-ablafsiemdapnrdodeulcetctsrdoindicnsot likely provide a route of measurable PFOA exposure. 1. Production Of PFOA For Non-Fluoropolymer Uses 3M produced limited quantities of PFOA -- approximately 8,000 pounds per use year in recent occurred in a years medical for film non-fluoropolymer application where uses. PFOA The principal served as an non-fluoropolymer antistatic additive in coatings sandwiched patient exposure would between multi-layer medical films. be expected from this application. No consumer or medical Worker exposure should have been 30 percent minimal given that the aqueous solution and PFOA sold for this the MSDS advised application in recent protective measures years was during in a handling and use. A small amount of PFOA -- less than 500 pounds per year -- was daeprpilviactaitzieodnsatsoapnroevsitdeer atohfuomrimdiatymbeatrhraicerryolnatpericnot-epdocliyrmcueirt cbooaatridnsg aunsdedtoinseelceucrterosniilciscone soitlatoinonsp.recTihsieosnebaepaprliincgast,iofnors eixnavomlpvleed,PinFgOyArodserciovpaetsizaenddintteolaecsotmambulenipcoaltyimoenrs, smwaikticnhigng PFOA exposure to workers, the consumer or the environment highly unlikely. 2. Transformation Of POSF-Based Substances 3M has submitted two biodegradation studies to EPA on N-Et FOSE aplrooodhuoclt.i>onN-oEftmFanOySEPOaSlcFo-hboalsweads pbrootdhucatsbuailnddinognbeolofckthientperremveadlieanttefulsuoerdocinhetmhei.cal irnesaicdcuoalrsdafnocuendwiitnhPEOPSFA-ObPasPeTdSpGruoidduectlsi.nesThate4b0ioCd.eFg.rRe.da8t3i5o.n3s2t0u0di--es32w1e0re&p-e5r0f4o5r.med NBo-tEht-sFtuOdSiEesalicnodhiocla,tebtuhtatthPatFPOFSOwAouclodulbdebgeefnoerramteedditnhsrteoaudghofthPeFbOioStiocndleygruanddaetriaonn of dabiiaogtricamorbheyldorwoldyetpicicctosndtihteiodnegdruardiantgitohneplaatsthwsateypionfditchaeteddegbryadtahteisoenstpuadtihewsa.y. The > 3OMPTEOS1.A0R4-1252d6atdeocdkeFte.bruary 23, 2001; 3M EOO-2252 dated October 1, 2000, available in MH So mee Pages N-Et FOSE Alcohol Biodegradation Pathway N-ETFOSE "T (STARTING SUBSTANCE) N-ETFOSE ALDEHYDE N-ETFOSAA N-ETFOSA N-(2) HYDROXYETHYL dene SULFONAMIDE PERFLUOROOCTANE SULFONAMIDE ACETALDEHYDE "1 FOSA iBiioticn/ on\OnlyCUnodenr s rod Proa Fee" the N-EX As the diagram depicts, these studies indicate that under FOSE alcohol wil follow a stepwise degradation pathway that biotic conditions, results in PFOS as the ultimate degradation product. Prior to the final degradation step to PFOS, the paesnpuelrtfilmuaotreoioncttearnmeesduilaftienadtee.grTadhaetipornotsotceopl fionrvotlhveessedsetgurdaideastrieoqnutioreas caodmepgoraudnadtikonnown control test to be run under abiotic conditions for each step in the pathway. In this scouncthrodletgersat,datthieopnetroflPuFoOrAoo,cthaonweevsuelrf,indaitde ndoidt sochcouwr suondmeerdbeigotriacdacotnidointitoonPs,FObuAt.inAsnteyad only in the abiotic control test mode and only during the last step. Several factors indicate that PFOA is not the expected biological degradation end-product of theotherfluorochenical residuals present in POSF-based products. First, while some degree of abiotic degradation can occur in a biotic system, the particular biodegradation pathway described above suggests that PFOS formation would be the expected degradation route. Hence, evenifthe other fluorochemical risesuindluikaellsyptroesbeenftoirnmPeOdSaFs-baamseetadboplriotdeu.ctSsewceorned,atbosothrebeedxtbeynthPumFaOnAscoorulwidldbleifef,orPmFeOdAin abne aebxipoetcicteednvbiercoanumseen,taalscsotmupdairestmheanvte, snhoowPnF,OPAFuOpAtadkoeefsronmotthbaitoccoonmcepnatrrtamtee.n*t wTohiurldd, finrotmheahnigahbliyotsipceecnivaliirzoendmeanntdallicmoitmepdacritrmceunmtsttaonwcaetserw,htehreePPFFOOAAschoouullddfboermimamnedditartaenslfyer dpielruftleudodrouoecttaoniotas twea)t,eransdoluhbeinlictey,(s>h1o0u0l,d00r0emmagi/nLporres1e0ntpeirnctehnetwbaytewre,igifhattfaollr, aamt monium miniscule levels. Finally, although studies have been done only on the N-Et FOSE alcohol, this degradation pathway should be representative of the other major building blocks for POSF-based products. 3. PEOA As An Impurity In POSF-Based Products 3M analytical studies of eight POSF-based product samples have identified the presence of PFOA at very low concentrations ranging from 200-1600 ppm as a manufacturing impurity. Based on 1997 production information, the estimated + `See Kurume Laboratory, 2001. Bioaccumulation Testof Perfluoroalkylcarboxylic acid (C=7-13), T(BehOseFtcoNafor.<p55e.1x151-p980.1s,)e;Cdhsteeome5ia*clasloiLsRerEevvsiauslleutadetdiDroinanfaatnBHdaCzRFaerosdfea3A.rs1c,shewshInsislmteietncutater,OpfJeaPxpeparonfsleu(dDoercto.ooc5t108a,n*o2gi0cL01As)c,hidoatwAen1d-d2a6Its Salts, U.S. EPA (Nov. 4, 2002), at 1, 14. $ STeCRe-C8h9a0r3ac0t-e0r3i0zaPtihoanseS:tuSdoyluofbiPltFyODAet(eLromti#na3t3i2o)n,PraivmaairlyabSlteainndOaPrdP--TSTeDsotcCkoenttrAoRl-2R2e6f.erenc#e . `hbTaahvseeeNda-pEcrtoomdFupOcaStrsEa.balTlechodeheoogltrhasederartvkieeodynaaplsactothhreowlakybeuyidlbudueiinlogdibniigsocbsklt,roucNckt-fuoMrreatlhFseOimSviaEasrtaiylmacojooortilhteywoNouf-l3EdM'FbsOeSPeOExpSseFlc-ctoshdolto aMoMr'esoPvOerS,F-Nb-Ea{seFdOSprEodaulcctosh,olanwdasheancper,ecduergsroardatotitohne potahleriwkaeyys fbouriltdhiensgeblbouiclkdcinogmbplooucnkdssalfroerady are capiured by the N-Et FOSE alcohol degradation studies. ' - C[ hE yr-- aenxncueaeldeledve6l0s0o0f pPoFunOdAs.resNiedaurallyp9r5espeenrtcienntPOofSFP-ObSaFs-ebdasperdodpurcotdsuwcotusl-d- annotd hhaevnece nearly all of the 6000 annual pounds of PFOA residual present in such products -- were ucosmemoefrchiigahlimzoeldeciuntloarinwdeusitgrhitalpaoplpylmiecartsioonrso."theAr nfuormmbuelratoefdthPeOsSeFa-pbpalsiceadtipornosdiuncvtoslvfoerd surface treatment of carpets and fabrics or for coating on paper and packaging. Due to the nature of these applications, only a minute amouofnthte PFOA residual, at most, wapopullidcahtaiovnesefnordePdOSuFp-ibnatsheedfipnriosdhuedctasrtiicnlveo.lvMeodrtehoeveurs,e aofnauqmubeeoruosfwtahsehiinndgustorrifalinishing steps. In view of PFOA's water solubility, a washing or finishing step most likely rinedmusotvreiadl trheelevaesrey osfmaPlFlOaAmoruesnitduoaflPiFntOoAthreeseindvuiarlopnrmeesnetntfrionmstuhcehspersodouucrtc.esAwnoyuld likely hnoatveharveesulptreodviidneedxatrseomuerlcyeloofwmceoanscuenrtarbalteioPnFsOinAleoxcaploiszuerdea.quatic systems and would C. FuEt HSu Mear sure es measures In addition undertaken to to the PFOA production date as detailed above, p3hMaspel-aonusttaonedngthaegenuimn eornoguoisnogthaenrd feuxtpuerdeitEiHouSs mmeaansnuerresanidtemmaizyedunbdeelrotwa.ke3aMddpiltaionnsatloEuHndSermteaakseutrheessenomtedaessucrreibseidn iannthis letter, as warranted, under 3M's existing safety, health and environmental programs. 1. 3Mwill not resume the manufacture of PFOA for commercial sale. fluorochemical2.produ3ctMiownillwocroknetrisnuaenwditwhillitpsrmoevdiidcearlempoorntistotroinEgPeAffoonrtsa for bi-annual basis oprnetsheencreesuolftPs FoOf Ath.is Ipnroadgdriatmi.on,T3heMsweillefcfoornttsiwniulel ctoonttriancukethtoe imnocrtlauldietymoenxipteorriienngcfeorofthtehe frelpuoorrtoschteomiEcPaAl pervoedruycftiivoenyweaorrsk.er cohort and will submit updated epidemiological study production 3. facilities. 3M will continue This monitoring to monitor in the vicinity of its former PFOA will include groundwater, surface water and other environmental media and will be part of ongoing requirements and/orvoluntary commitments established with local regulatory agencies. 3M will provide an initial summary report to periodic additional EPA for this monitoring within two years of reports at appropriate intervals thereafter. the dateof this letter and validation of 4. the PFO3AMsweilrluwmoarnkalwyittihcaolthmeertmhoedmbaenrdssoafmpilndiunsgtrpyrottooccooln;dpuucbtliasdhditthieonal analytical method in a peer reviewed journal; and continue to qualify independent * SDoecekeFtluAoRr.o2c2he6m.ical Use, Distribution And Release Overview (May 26, 1999), available in OPPTS 2 wa lFaobrorDaitsoeraiesse tCoonpterroflor(mCDthCe)vaanliddaEtPedAmteotdheovde.lo3pMa wmilolrseupcpoomrptletthee eufnfdoertrsstoafntdhiengCeonfttehres PasFsOeAssltehveelasppprreospernitatienntehsesogefnuenrdaelrtpoapkuilnagtiaodndiatniodnatlhereesnevairrcohnmaenndt.ot3heMr waicltlicoonnstiinnue to coordination with CDC and EPA. 5. 3M vil participate in certain human health and environmental fate. and effects studies of PFOA. These studies will occur under the auspices of the A(is)scohcrioantiicontooxficiPtlyasitnidcsapMhanniuaf;ac(it)ucrherrosniocf tEouxricoiptey i(nAtProMuEt;)(aiin)dAwDilEl (iv) protein binding -- ratthuman; (v) physiologically based kinetic imnacslusdebatlhaenfcoellionwirnatgs:; modeling; (vi a(idxs)oarlpgtailognr/odwetsho;rpatniodn(sxt)umdeicesh;an(ivislt)iaccustteudtioexsicoiftypianncdraepahtniica;tu(mvioir) aicnduutcetitooxniciintyratisn.trTouhte; rEePsuAltisn otfhethfeosremsotfudfiineasl, raepnodrtasn.y Tahddeitiinodnuasltrsytupdairetsi,ciwpilalntbsewiplrlocmopntsluyltcowimtmhunEiPcAatoendwthoat additional studies would be beneficial. amounts of PF6.OA forAsindteirsncaulsusseed aanbodvwei,llDcyonnteionnuewitllo cuosnetiPnFuOeAt.oipnrfolduuocreopsomlaylmler production. In connection EHS measures, including: with this production and use, Dyneon will engage in various. its facility in the a. United StatDeysnoefoPnFwOilAl continue imported tforroemdDuycneefounr'thserGetnhdeonrfo,w small use Germany at facility. technology for b. PFOA and hDaysnmeaodnehtahsatdetveechlnoopleodgaynadvaiisluabsliengfoar "capture for recycle" license by other PFOA users. This technology, which allows for a recapture and reuse of PFOA, has and will continue to result in a significant reduction of PFOA emissions and production demands for Dyneon. part of the 3M progrca.m for meDdyniecoanl'smoenmiptolroiynegeosfifnltuhoeroUcnhietmeidcaSltaptreosduwciltliocnonwtoirnkueertsoabned will this bperoignrcalmu.dedThiinsthperoagbroavme-wrilelfecroentnicneuderteopoirntcslutdoebmeosniutbomriitntgedfobryth3eMpornestehnecereosfults of PcoFnOtAin.ueDtyoneboens'usbjeemcptltooyaeneseqautitvhaeleGnetndporrofg,raGmerthmaatnfyolflaocwilsit3yMh'asvmeonbieteonrianngdprwioltlocols. d. ~~ Dyneon's fiuoropolymer manufacturing facility in the United Sptraotgersamw.illTchoinstimnouneittooribnegpwairltloifntchluedeabgorvoeu-nrdewfaetreern,cseudr3faMceenwvaitreornamenndtoatlhmeornitoring environmental media and will be part of ongoing requirements and/or voluntary commitments established with local regulatory agencies. Periodic reporting of the results of this monitoring program will begin within two years from the date of this letter and occur at appropriate intervals thereafter. g A . a r m Ho ee intent among PFOAe.users iDnytnheeofnluwoilrlopcoolmymmietr, iansduastsryi,gntaotopreyrftoortmhethseepeaxrpaotseurleetter of assessment and testing specified therein. importance ofIEnPcAo'nsnercetcieonntlwyi-tihsstuheedfgouriedgeoliinngesEHpuSrsmueaanstutroest,he3DMatraecQouganliitzyesActth.e We will continue -- as we procedures designed thoaveensiunrtehethpaatsdtat--atomeeemtpilnogyrsecaisenotniafbiclypraapcptriocpers,iaptreotboecnoclshmaanrdks for objectivity, utility and integrity are developed and provided to theAgency. future EHS 3M appreciates this measures for PFOA. WopepolrotoukniftoyrwtoarmdetmoordiiaalliozgeueouwritphriEorP,Aonrgeogiarndgiangndthe content of this letter. Very truly yours, DJ Wonlhing wr VDri.ceLaPrrreysideWenntdling ) Performance Materials Division 3M Company ce: Charles Auer, Director Office Of Pollution Prevention And Toxics v* passe 3 S5Ien6ef5o8Gr,umiadti5eo1ln5i(nDaei)ss(sf2eo0mr0i1En)na;stuGerudibindygetlahinnedesEMnafovxriirmEoinnzsmuiernnigtntaghleaPnQrduoatMleiactxtyii,monOibzAjiegncetgnicvtihyte;y,QPuuUatblililiittcyy,,LOaanbwdje1Ic0n6tt-eig5yr5,i4t;yUoHtf.R,. and a(IlnMtsaeoygrEi5tP,yA2o0fO00rI)ndf;eorrEm5Pa3tAi6o0Qn.u,1aDlAii2tsy"sPeMomaliinncuayatAlendFdobryPrEFonevgdirrraaomnlmRAeegnqeiunaiclriPeermso,egnOrtMasmSFs,o,r6A573g6eFe0ndAc.1yRW(eiMgda.ye854Q,5u22a0l0(t03)y0.0S2y)s.t3e6m6: