Document B5vRp4rBpv56z0xmbLGn1NQNj

a Gop riisa; mo ARaze -- 318 8EHQ -- 0S03_ 00373 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 GEWQ-20-37 2, soy 1.20 iain & epa-ors DuPont Haskell Laboratory 000811854R Attn: A. Michael Kaplan, Ph.D. Director - Regulatory Affairs and Occupational Health Elkton Road, P.O. Box 50 Newark, DE 19714-0050 PREVETNToIONSPUEBSSTTAINOCEESSAND o 2 gL, Na ~oM SUBJECT: TSCA 8(e) Reporting Requirements for PFOA Information Dear Dr. Kaplan: a= Ss " Ina recent report by the Environmental Working Group (EWG) on risks associated with perfluorooctanoic acid (PFOA), posted on the internet (http://www. ew. org/reports/pfeworld)), and ina letter to Administrator Whitman alleging reporting violations ofTSCA Section () (enclosed), there is a reference to a "Personal and Confidential" DuPont document containing information on PFOA blood levels in female workers at a DuPont plant in West Virginia in 1981 (enclosed). This one-page DuPont document also notes that PFOA was found in the umbilical cord blood from one baby and in the bloodof another baby, bothof whom were born to women working in the West Virginia plant. According to this same DuPont document, among the seven individuals listed in the table one gave birth to a child with an unconfirmed eye and tear duct defect and a second individual gave birth to achild with a nostril and eye defect. The ENG rPeFpoOrAt feuxrptohseurrset.ateIsntahdadtitinio1n,98t1heDEuPWoGntrrepeoarstsiaglnseodd5es0crfiebmeasleDuwPoroknetrsstautditehseopflaPnFt OtoAreduce contaminationofdrinking water supplies in areas surrounding the Parkersburg, West Virginia plant. ~ & & o-- TIF == 5> 5533 ~~ = As you know, TSCA section 8(e) states. "Any person who manufactures, processes, or distributes in commerce 2 chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the [EPA] Administratorof such information unless such person has actual knowledge that the Administrator has been adequately informed of such information." Assuming that the information described above is accurate and was in DuPont' possession since 1981, please provide the contemporaneous logic for DuPont's decisions not to submit to EPA under TSCA section 8(e) the reportsof (1) PFOA blood monitoring data on female workers and Recyldecyltie Prt ith VeInteatOAHdBsaesseds(kUsRLo)i 0t% Pntconu6r53m.e3,07ProcessChin Fre Recycled Pps ' their offspring and (2) human developmental effects (a) in 1981 and (b) subsequently as additional data on PFOA's hazards and exposures (including the drinking water data related to its West Virginia plant, the 3M blood monitoring data, the 2-generation reproductive toxicity study, ete.) were accumulated. We are concemed that the blood and umbilical cord monitoring data, together with the known or suspected toxicity of PFOA and other exposure data on PFOA, may present a TSCA 8() reporting obligation. In addition, please provide the drinking water data to the Agency and provide an explanationasto why it was not submitted when Dupont obtained the data. We request a response to this letter within 30 days. Please address your response to: Document Processing Center (7407M) EPA US. EEnavsitr-oRnmoeonmta6l4P2r8otecAttitonn: ASegcetnicoyn 8() Office of Pollution Prevention and Toxics 1200 Pennsylvania Avenue, NW Washington, D.C. 20460-0001 Deliveries: 1201 Constitution Avenue, NW Washington, DC 20004-3302 Questions regarding this request should be directed to Mr. Terry O*Bryanofmy staff at (202) 564-7656 or email OBRYAN.TERRY@EPA.GOV Richard H. Hefter, Chief High Production Volume Chemicals Branch Enclosures cc: Charles Auer Oscar Hemandez Terry O'Bryan A Emommen wenn aroun Aor 11, 2003 W1a43s6t0ingSnu, eOtC;eeSsteUoon usasz n ATdhmeinHiosntorraatbolre Christine Todd Whitman E--_ Ley tol U.S. Environmental Protection Agency Washington, D.C. Cleve Steen Re: DuPont's failure to submit key health studies under the : requirements of TSCA Susie 1 8(e), 15 U.S.C. 2607(e). zh arlic Dear Administrator Whitman: vase As your Agency moves forward withsits assessment of publiic health rii sks posed by Pu seid la `8t)he, Tweeflownr-itaesstoocinaotteidfycyheomuicofalapkpnaorewnnt avsioPlFaOtAion(speorfflrueoproorotcitnagnoriecquaicirde,meanltsso ucanldleerd ~ 2: | 1114 alSeesacsdteiisnosgnmem8n(aten.)ufWoaefcttruheerqeuTreosxatinctdhSauutsbesyrotuao'nfciPenFvsOeAsC,toingDtarutoPelontAthc,etst(eh"aTptSoCtmAea"n)tyi,abl1e5vhiUio.nlSda.teCir.oinnsg2oy6fo0u7l(raew),by.bya P | cAO as Cd bes) DuPont, allow for aannd`arcecquuriarteefualslsseusbsmmiesnstioonf of the relevant the health risks studies posed to by th ths public record to"! persistent global. 22 Jr opfoltlhuetaonmtistshiaotnwsi,dewleyrceocnotammmiennadtetshahtutmhaenAbgleonocdy. lGeivvyenthtehemanxatiumruemanadllsoewraiboluesness 1p0en1a5ltUy.Su.nCder 2t6h1e5La(wa,). aW$e25a,i0so00a-sfkintehapteryoduayin1v0esatcicgoautnetpfootrenctiiviall vciroilmaitniaolnsvipoulrastuiaonnst sfourbjDeucPtotnth'esckonmopwainnyg and to a mwialxliinmgufmaidlaurielytfoipneroofdu$c2e5t,h0e0s0e. s1tdu.diaets, w2h6i1c5h (wb)o.uld also Ilneve2ls19o8f1PFinOtAerinnalumcboimlipcaanlycosrtdudbylo(oatdtfarcohmedoanse Ebxahbiyb,itaAn)d DtuhePobnltoofdouonfdaqnuoatnhteirfibaabblye, bPoartkherosfbwurhgo,mWewsetreVibrogirnniat.o Twhoismesntudwyorpkrionvgidiendtehveidceonmcpeantyh'ast TPeFfOlAoncprloassnetsitfhe placenta and exposes a fetus in utero, at a time when DuPont had accumulated a significant body of knowledge on the toxicity of PFOA. Tmheeassutrueddy PdFoOcuAmiennttahteiobnl,oodmaodfeeipguhbtlipcrtehgrnoaungthwloimtiegantieomn,plsohyoewdsatthattheDuplPaonnt,t and for fsoeuvennd oqfuatnhteisfeiawbloemelenvelrsecoofrdPeFdOAinifnortmhaetibolnooodnotfhseevbeanb'yo'f eheiaglhtthwaofmteernbitretsht.edD,uPatont ucmobnicleinctarlatcioornds brlaonogdinfgroump otnoe:2b.5abpyaratts apecronmcielnltironat(ipopnmo)f.0.D0uP5o5ntppfmo,unadndPFinOAthien sblhooowds otfhaatnottwtioerofbasbevyaentwaocmoenncengtarvaetiboirntohft0o.0b1ab2iepspwmi.thThbeirstthuddeyfedcotcsu,meonnteaatnion, "unconfirmed" eye and tear duct defect, and one a nostril and eye defect. That same vear, DuPont reassigned 50 women at the plant to reduce PFOA exposure. We have cine . 3 vumvsenraaionserins DTuhePoHnotnoRreapbolretiCnhgriVsitoilnaetiToondsd Witinar 11/03, page 20t3 trehcoorrodugohflythirsevsiteuwdeydi8n(teh)esAugbemnicsys'isonfsilfesr.om DuPont regarding PFOA, and find no "TtShCaAt rreeqausiorneasbtlhyatsuappcoormtspatnhye icnofnocrlmustihoen Atdhmaitnsiuscthrastuobrswtahnecne.i.t.pfirnedssenitnsfoarmation substantial risk of susceptibility of a injury to fetus to health." 15 U.S.C permanent health 2607(e). harms from Given the exposures unique. to industrial . chemicals, the finding of qualifies as "information an industrial chemical in that reasonably supports umbilical cord the conclusion blood inherently that such sturbisgtgaenacre.s.u.bpmriessseinotns a substantial riskof of the study to EPA injury under to the health..." and provisions of therefore TSCA 8(e). should In the acassiegnoiffiDcuaPnotntb'osdy19o8f1knbloowoldedsgteudoy,n hPFoOwAe'vsert,oxtihceitcyotmhpaatnfyuratlhseor psouspspeosrsteedd awthathte tire should have been substantial risk to aheraelatsho.nable conclusion that the blood tests indicated a Acchcemoircdailnsg, taonoat1he9r61doinctuemrenanltcmoamdpeanpyubmliecmtohrraonudguhmLiotingatthieont,ox2icDiutPyoonftCt8oxaincodlorgeilsatt.ed fraotusndattlhoawt "dCos8esa,n"daCnOdafcuidrst.h.e.r hraevceomthmeenadbislitthyattoailnlcroefatsheetsheemsaitzeerioaflst.h.e.bleivheranodfled with extreme care. Between 1961 and Contact with 1981DuPont the and skin.should be strictly its PFOA supplier (3M) avoided" (DuPont 1961). conducted or summarized 32 additional PFOA mice (Bilott 2002). toxicity studies in dogs, rats, monkeys, guinea pigs, rabbits, and aArmeotnhge octohmepransytu'dsiesstutdhiaets DoufPPoFnOtAfcaiolnetdatmoinsautbimointitnodEriPnAkiunngdewratreerqusiurpeplmieenst ionf alraewas s2u0r0r2)o.unUdipnogniitsnfPoarrmkaetrisobnuragn,dWebesltieVfi,rgDiunPioantp'lsan1t9(8s1eestDuudPyoonft PdFoOcAumiennbtasbiaets'EbWlGood, saanfdettyhesitrudfiiensdicnognodfucPtFeOdAbcyonDtuaPmoinntatbieognininnitnagpawtatleears,t are 22 just tio of the health years ago that the and Uc.oSm.pCan.y26f0a7i(leed).to-submit to EPA under the requirements of TSCA Section 8(e). 15 Whoepeapptrhaetcitahtee fyuolulrrepcroormdpotfaPtFtOeAn'tsiotnoxtiocitthyetocohncuemrannsswweillrasioseoninbteh'iasvalieltatberl,e atnodthe public by the and Agency chemical as you proceed with your assessment af human health risks posed Sincerely, . President, Environmental Working Group EWG: THE POWER OF INFORMATION H DTuhepoHnotnfsaebolreinCghiVtioilnaiToonsdd Whitman 4/13/03, page 3 of 3 cSet;evCehaJrolhenss0o.n,HoElPlAi'dsayA,sJsri.staCnhtaiArdmmainni&stCrEaOt,orDfuofroPnrtevention, Pesticides, and Toxic Substances References : BIiRlIoSttS,uRb.mi2s0s0i2o.nLDeetstke.r fIrRIoSm SRuobbmeirstsAi.onBiIlnovtetnotfarTya.ffto,rStPeetrtfilnuiourmo,oc&tanHoolilcisAtceirdL~LP to Ammonium Salt. April 12 2002. OuPont. 1061. Internal memo Re Toxicity of Teflan Dispeising Agents. EDnevciardeosn.meAnvtaaillaWbolrekoinnlginGeroatu.p (EWG). 2002; . DuPont Hid Teflon Pollution for http://uiwuewo.ora/policymemo/20021113/20021213.ghp. December 12 2002. Attachment PExFhOiAbiitnAt,heDubPloonotd. o1f9f81e.maBliertehmsplaonydePersegannadnctiheesi.r b(aDboiceus.m)entation of DuPont st:udy of : EWG: THE: POWER OF INFORMATION oq . | on ~ ( ~hor PE ih ")prPad > w Aad 8 BLOOD' Tc res Birchsand Pregnancies Ctr .J SA PPM C-8 - Status .) : 0.43 TNooarmmsaflerctheidldou-tboofrFJluunoeroc1a9r80h.ens 4/79. 0.28 Normal child - bom April 1981. 0.078 15 0.013 NUomrbmiallicaclhilcdord- bbolronodAp0r.i0l55 1p98p1m,. Five-sonshs--pregnent. Om pugnarsy Love PmaveoncheprTpomfgchiuld-aboni as ugus.t| 2.5% UCnhciolndfi-rm2epdluesyeyeaanrds,tear duct: d-efect. 0.048 Gules bmonena, 21007 WEISFRY Bother Dod Al- epros Gly 199) *Current blood level - in fluorocarbons area only one month before, pregnancy. BETEON\( 005574 SE 5 vg } eros