Document 3QvK443aKxdJmYGO5VaYEprYE

- 7 AR226-1327 RECCEIEVEDD PNarer m main FER CoDpionrdrteneaCoV.urBsMe0a!li7nowski geHR -- 060033_ 00373 T W1i0l0m7inMgalroknen ,r DSetleaewtare 19895 BE=Hp-40- 373 Fox 3027744812 email: Andrea.V.Malinowski@usa.dupont.com Mr. Richard H. Hefter, Chief High Production Volume Chemicals Branch USS. Environmental Protection Agency Office of Pollution Prevention and Toxics 1200 Pennsylvania Avenue, NW Washingion, DC 20460-0001 Document Processing Center (7407M) EPA East - Room 6428 At: Section 8(c) USS. Environmental Protection Agency OfficeofPollution Prevention and Toxics 1200 Pennsylvania Avenue, NW Washington, DC 20460-0001 VIA HAND DELIVERY Dear Mr. Hefler g epA-OTS jn 0008118594 June 20,2003 Cony, ny cy TSCA Section8() PFOA Reporting Requirements "This leter is submitted in response to your May 22, 2003 letter to DuPont concerning perfluorooctanoic acid (PFOA) and to address certain unwarranted allegations made in an April 11, 2003 letter to Administrator Whitman conceming PFOA, which you reference in your letter. The April 11" letter claims that information contained in 2 one-page 1981 DuPont document listing PFOA blood sampling results and pregnancy status for eight employes should have been reported to the Environmental Protection Agency (EPA) as information supporting a conclusion of "substantial risk" under Section 8(c)ofthe Toxic Substances Control Act (TSCA), and makes the same unfounded claim for some drinking water sampling data on PFOA that = DuPont collected in the mid-1980s. In your May 22" letter, you asked that DuPont provide the = company's perspective on the 8(c)-reportability ofthis information. go As st forth in more detail below, the information reflected in the one-page 1981 document and ~~ <N1 3i8C3 2067670 ttrhiegdgeertercetpioorntoifngmoibnluitgeattiroancsesun(daerrouTnSd C1A-2 pp8b(c)).ofTPhFeOiAnfionrmdartiinokninign wtahete1r9n8e1ardotcheumpelanntt ddoiedsno~t ~~~ >= 5375 nwoatteirnaalnsyo wdaoeysenvoetnisnuagngyeswtatyhastuPggFeOstAPisFtOhAe ciasutsheeocfaaunseyofadvaenrysaedevfefrecste. efSfiemcitl,aarslys,upthpeordtaetdaboyn ~~ = the fact tha the levels found are more than an order of magnitude below recently established drinking water safety standards. Presence alone,a the levels found for this substance, docs not indicate substantial risk and therefore docs not rigger reporting obligations under TSCA 8(). es hte 5 Mr. Richard H. Hefter June 20P.a2g0e0?3 The 1981 One-page Document Background DuPont uses ammonium perfluorooctanoate (APFO), which converts to PFOA in solution, as a processing aid at ts facility in Parkersburg, West Virginia. In over 50 yearsofuse by DuPont and others, DuPont is not awareofany adverse human health effects that have been shown to be. caused by PFOA. In March 1981, the 3M Company (3M), which was the manufacturer ofAPFO (radenamed FC143) and DuPont's supplier, notified DuPont (and EPA) that inanoral rangefinder study in rats, designed to determine the maximum dosage rate that pregnant females could tolerate, and run in preparation for a full-scale teratology study, researchers observed what appeared to be treatmentlrealbaotreadtodray,ma3gMe, taontdheDuePyoenlte,nsaesswoeflsloamserervaitepwueprss.'frWoimtThihne aNafteiwonmaolnItnhsst,ithutoewoefveNre,urtohleotgeisctailng Diseases and Blindness and the National Institutes of Health, all concluded that PFOA did not cause any developmental lens abnormalities in the fetal rat. This conclusion was based primarily ona determination that the lens damage reported in the 3M study was the result of artifacts from fixation and tissue sectioningfordissecting microscope observations, and was not treatmentrelated. EPA reviewers subsequently concurred with the conclusion that the lens effect was not cuasuinsgedprboypePrFOanAa.l"ysiSshotretclhyniaqfuteerftohuenidnintioalevraindgeenfciendteharttPesFt,OfAoucrrefaultle-dscaanley tteerraattoolgoegnyicsteufdfeicetss in rats or rabbits. `When DuPont first received word ofthe eye lens damage in 3M'spreliminary study, as a precautionary measure while the chemical's potential was being studied, DuPont temporarily reassigned womenof childbearing potential from the fluoropolymers unit to other locations `where APFO exposure would be lower. DuPont permitted the women to return to the fluoropolymers unit shortly after the full-scale teratology studies showed no teratogenic effects. At the timeofthe initial report from 3M, DuPont also provided its Parkersburg facility employees, and the public, with information on the situation." DuPont offered blood testing for E" xSpeeeriGmoertnnteNro,.E0G8(01R9R8O1)0IOrSa,l FReabnrgueafriynd1e9r81S.tuEdyPoAfhTa-s2a9c9opCyoofChiinsPrtegun.ant Rats. Riker Laboratories, Ine. P2eSrefeluEorPoAoctParneoliicmiAncairdy RainsdkiAssSsasltssm(eAnptriolft1h0e, 2D0e0v3e)l,oppamgeent2a8l"..T.oxictihteyfAestsaloclieantsefdinwdiitnhg.Ex.powsausrelattoe determinetdo be an arifct ofthe free-hand sectioning technique and therefore was not considered tobe reatment elated") AtAapcrihlmse,nt1928)1 Wall Steet Journal; April, 1981 New York Ties (copies included as Atachment 1 3nd Mr. Richard H. Hefter ; June 20P.a2g0e033 PFOA (referred to as "C8" in the one-page 1981 document) to employees at the plant site.` `Those who volunteered for blood testing included eight women who worked at the plant and who cither were pregnantorhad given birth recently. DuPont staff also inquired about the outcomes. of the employees" pregnancies. This informal collection of information, reflected in a half-page table and some handwritten margin notes, is the "study" that the April 11" leter alleges DuPont should have reported to EPA. In fact, thisdocument does not contain information obtained as the resultofany designed or controlled scientific study. The table in the 1981 document indicates that five of the women gave birth to normal children. One woman was on pregnancy leave at the time the document was prepared. Although it is not noted on the document, this sixth child also was bom normal. With respect to the pregnancies of the remaining two women, one had a child listed as being four months old and having one nostril and eye defect and the other had a child listed as being over two years old and having an "unconfirmed eye and tear duct defect." C- blood concentration for the four-month old child is listed as 0.012 ppm; there is no blood data listed for the two-year old child. 8(c)-Reportabilityof Information in the 1981 One-page Document `The information in the document concerning the child having a nostril and eye defect was not reportable under TSCA 8(e), per the statutory language and guidance issued by EPA. TSCA 8(0) states: "Any person who manufactures, processes, or distributes in commerce a chemical substance . and who obtains information which reasonably supports the conclusion that such substance... presents a substantial risk of injury to health or the environment shall immediately inform the Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information." 15 US.C. 2607(e). Thus, to trigger reporting obligations under TSCA section 8(e), an item of information mustreasonablysupport the conclusion that the substance does presenta substantial risk to health. EPA states in the Agency's 1978 TSCA Section 8(c) StatementofInterpretation and Enforcement Policy (hereafter EPA's 1978 Policy Statement) that to "reasonably support"a conclusionof substantial risk, the information must do more than simply *thInvtahleueonwea-spacgoenvdeorctuemdetnot,ppblmofolduovrailnuefesorrecpoomrpteadriassopnpwmitCh-8teareesaucltusalolfy tpoptaml oflrugorainnie.flPuoFrOinAe (wsansotmheearsmureetdh,odbut dtehvaitahtiaodn.beeTnheusleedvetloomfdeeatseucrteiofonriPsF0O.A0)0.4 pEpsmt;imcaotnecednutnrcaetritoanisntiyn itnhatthreamnegaescuarnenmoetnbteiwepllusquoranmtiantuesd1a0n%d swtearnedard rpeppmorCte-d8aisn ltehsesdtohcaunm0e,n0t0)7bpypm0F..665.PFOA concentration would be determined by dividing the ppmF value (listed as . Mir. Richard H. Helter June 20F.a2g0e0d3 "suggest" that a chemical might be causing a substantial risk of some adverse effect; to sthhoertc,onttoratrryi,ggtehreairnefpoorrmtaitnigoonbmliugsatti"o.n.,rtehleiraeblmyuasstcrbiebeevtihedeenfcfeecotfatonthaedvcehresmeiceaffle.c"t tIon health and the effect must be reliably ascribed to the substance in issue. Underscoring this point, in response to a comment submitted on a 1977 draftofthe policy statement, the EPA's 1978 Policy Statement provides the following, clarifying that a single incident ofa birth defect is not reportable unless a chemical is "strongly implicated "Comment 12: The reporting of `any instance"of cancer, birth defects, etc. in humans is too broad and such information will be of litle use; chemical workers, like the general population, develop cancers and other ailmentsofuncertain etiology. (EPA] Response: This [1978] policy statement clarifies that the reporting of single occurrences ofhuman cancer or other serious effects wil depend upon evidence strongly implicatingone (or a few) chemicals." Nothing in the 1981 document suggests any link --let alone "reliably ascribes" -- the childs defect, or any other adverse effect, to the presence of PFOA in the mother's blood. The mother andchildsblood concentration samples were taken four months after the child was bon. As such, the data do not provide any reliable information about the presence, level, or absence of PFOA in the blood during the pregnancy. Even ifPFOA was present in the blood during, pregnancy, presence ofa substance alone does not support the conclusion that the substance caused or likely caused an adverse human health effect. As the Centers for Disease Control and Prevention (CDC) stated in its Second National Report on Human Exposure to Environmental Chemicals: "The measurement ofan environmental chemical in a person's blood or urine does not byitself mean that the chemical causes disease. Advances in analytical methods allow us to measure low levels of environmental chemicals in people, but studiesof varying exposure levels and health effects are needed to determine which blood or urine levels result in disease." (CDC Report at p.2)! Further, although DuPont cannot discuss the detailsof confidential employee medical records, the childs eye defect did not involve lens damage, which is the only *16S,ta1t9e7m8e)n(teomfpInhtaesripsraedtdaetdi)o.n and Enforcement Policy; Notification ofSubstantial Risk, 43 Fed. Reg. 11,110 (March 43 Fed. Reg. 1,114 7 TheCDCreportcanbeviewedatwowwcde govincehdisicport Mr. Richard H. Hefter June 20P.a2ge0s03 typeofteratogenic effect ever even suggested (although as stated above, later proven to be incorrect) to have been caused by pre-natal exposure to PFOA. Since 1981 there have been additional full-scale teratology studies on PFOA, noneofwhich produced any birth defects 0(strduacttaurtahlatorwofuunlcdtiroenlailabalbynoasrcmrailbietitehse)cihnitlhdesodfeffsepcrtisngtoofPtFeOstA,anoirmasltsr.o"ngTlhyuism,pilnic1a9t8e1PtFhOerAe waass. the cause, and no study run in the interim has created any such implication. As noted previously, the 1981 one-page document also refers to a child born over two years previously as having unconfirmed "eye and tear duct" defects. Assuming that the defects did exist (and we have not been able to obtain any additional information on the unconfirmed defects), again the information contained in the 1981 documentdoes not provide evidence that any such defects could have been reliably ascribed to PFOA exposure, either then or now. The `mother's blood samples were taken more than two years after the pregnancy. The document indicates that the employee had worked in the fluoropolymer ara for only one month before her pregnancy. Thus, here again, the data in the 1981 document - listing blood levels more than two years after the pregnancy -- do not provide any reliable information about the presence, levels, or absence ofPFOA in the employee's blood during her pregnancy. As such, from the information in this document, it cannot be reasonably concluded - even assuming PFOA exposure during pregnancy ~ that PFOA is "strongly implicated" as the cause ofthe unconfirmed defects. The 1981 one-page document also indicates that oneofthe women, who gave birth a few weeks afte the initial blood tests, permitted DuPontto test for PFOA concentration in the bloodofthe umbilical cord. PFOA was found to be present at a concentration level lower than that found in the mother's blood. In the courseofinvestigating the basis for the information contained in this one-page document, DuPont recently found that the umbilical cord blood of the childofthe fourth employee on the list was tested as well. The level reported was 0.43 ppm, again a lower evel than that reported in the bloodofthe employee. Nothing about his detectionof the presence of PFOA in the umbilical cord blood at lower levels than in the mother's blood is unexpected or would reasonably support a conclusionof substantial risk. Indeed, teratology studies (such as were being run in 1981 on PFOA) are run on the: assumption that the chemical in question will cross the placenta and will be present in the umbilical cord and come in contact with the developing fetus. The levels that DuPont detected in the umbilical cords simply confirm that there was no unexpected accumulationof PFOA at levels above those in the mother's blood. As explained above, and as supported by the CDC, presence alone does not indicate substantial riskofharm. Both children who had PFOA in their umbilical cords were born normal. L#aGboorrtaoteorr,iEesG,.I(n1c.98E1x)peOrirmaentterNtuomlboegry:s0t6ud8y1oTfRTO-12190,98DCeocCeminbears.198S1a;ftGoyrtEnvearl,uaEtGi.on(L1a9b8o2r)aOtroarly taenrdatRoilkoegry study of OTG-B3I1T4B1OC3oSCS,inFreabbbriutas.ryS1a9f8e2t;y ESvtaapllueast,ioRnE;LaBbuorrgaetsosr,yBaAn:d KReirknesr,LaWbDo.rat(orie1s,TIh9nce. c8mEbxrpye4or-ifme)eanlt ntuomxibceirt:yand stetruadtoigeesniicnphoatleanttiioanlaonfdamormaoldnoiseuamdmpienrifslturoartoioocni)a.noste (PFO) inthe rat. Fundam. Appl. Toxicol 4429-440 two. Mr. Richard H. Hefter June 20P.a2g0e0s3 In summary, nothing reported in this 1981 document -- and no data generated to date -- even suggests, much less reasonably supports, a conclusion that PFOA presents a substantial risk of injury to human health. Therefore, the information did not and does not trigger any reporting obligations under TSCA 8(). Drinking Water Monitoring Data -- 8(e) Reportability s`ThhoeulAdprhialv1e1r"epleotrtteerdatnodEaPrAelautneddewreTbsSiCteArep8o(rct) tthhaet pyroeusrenlecteteorfmaepnptriooxnismaaltseolycl1aitom 2thpaatrDtsuPpoernt billion (ppb) PFOA in drinking water from two communities inthe area ofthe Parkersburg facility." As noted above, however, TSCA 8() requires reporting onlyifthe information received reasonably supports the conclusion that the substance presents a substantial risk of injury to health or the environment. There is no evidence that the presenceof those ppb levels of PFOA. in drinking water, or any levels subsequently found in drinking water in that area, presents any riskofinjury, let alone a substantial risk, which would be necessaryto trigger reporting obligations. The detected levels all far below levels that the governing regulatory authorities subsequently have set as screening levels for presence in drinking water. Further, DuPont alerted EPA and other state and local agenciesto the presenceofPFOA traces in groundwater and drinking water near the plant many years ago in reports filed under other regulatory programs. EPA's recently published clarifications to the TSCA 8(e) reporting guidance reflect the Agency's longstanding position that mere detectionofthe presence oaf chemical in environmental media such as drinking water does not trigger reporting obligations; rather, reporting obligations are triggered only by a findingoflevels that are high enough to support a conclusionof substantial risk.'" To illustrate that point, EPA'sclarification states: "From time to time EPA establishes concentrationsof various substances in different media that riggear regulatory response or establish levels that are presumed to present no risk to human health or the environment. For example, EPA establishes Maximum Contaminant Levels (MCLs) in drinking water, Ambient Water Quality Criteria for receiving bodiesof water, and Reference Doses (RIDs) or Concentrations (RECs). For the, `purposesof section 8(e), information about contamination found at or below these kindsofbenchmarks would not be reportable. Conversely, information about contamination found at or above `benchmarks that trigger regulatory requirements... s to be s* aImnpLliintge iHnoJcuknieng1,98O4h,ioM,aPrcFhOA19w8a7sadnedtMcaceyda198h8edildevnelootfdedtecttcttihoenpr(e0s.6enpcpebo)finPFMOaAr.ch I1n98L4u.becSku,bsWeeqsutenVtirginia, iPnFtOheALwuabsecdketdersitnekdiningtwhaterranagteoppfb0l.e7v1el0s2t.o2 EpPpbAfRreogmio1n98I4 tihnr1ou9g9h0 (19s8e9e.AtDsucPhomnetntre9p)o.rted th presence ofPFOA 1068 Fed Reg. 33129 (June 3, 2003) i Mr. Richard H. Hefter June 20P,a2g0e0?3 considered for possible reporting, based on potential exposure to humans and/or non-human organisms and other relevant factors." In other words,to trigger reporting obligations, detected levels in drinking water must be sufficiently high to supporta finding of substantial risk. Detectionoflevels below safe levels sot by EPA are not reportable. In all of DuPont's water monitoring tests, the levels measured in drinking water have never even remotely approached the 150 ppb screening level (the level requirinag response) set by the C8 Assessmentof Toxicity Team (CATT), whose members include toxicologists from EPA rReepgrieosennItlaltaivneds EfProAmHtehaedWqeuasrtteVrisrgainndiafDreopmatrhtemeAngtesnocfyEfnovriTrooxnimcenDtiasleaPsreotReecgtiisotnry(,"aWsVwDelElPa"s) and Health and Human Resources ("WVDHHR"). The highest levels DuPont has detected have. been more than an orderofmagnitude lower than this 150 ppb screening level. In fact, the highest levels DuPont has detected do not even approach the far more conservative interim screening level of 14 ppb proposed by ENVIRON Intemational Corporation and used by EPA Region ll in a Safe Drinking Water Act consent order executed with DuPont, which govems the sscarmeeengienoggrlaevpehlischaarveeasonalnyd rtehceenstalmyebederinneksitnagblwiastheerd,subpuptltiheesy.'arIet iinsdrieccaotigvneiozfedwthhaatt athteesaem of experts believes is a safe level for PFOA in drinking water. Therefore, the screening levels set by these expert teams strongly support the conclusion that the levels DuPont found previously `which are a tiny fractionofthe level that the agencies have declared to be safe -- never were reportable under TSCA 8(e), because they could not reasonably support any conclusion ofa substantial riskof harm to human health Although the drinking water data did not rigger reporting requirements under TSCA 8(c), on a `numberofoccasions as far back as 1981, DuPont apprised EPAof the presence ofPFOA in `water (surface water, ground water and drinking water) in the area in question in reports filed pursuant to Clean Water Act or Resource Conservation and Recovery Act requirements. As examples, the following submissions are noted: DuPont's June 9, 1981 letter to West Virginia Division of Water Resources (WVDWR), with copy to EPA Region II, stating that PFOA (referred to by the 3M trade name "FC-143" in the letter) is present in an outfal that dischargteos the Ohio River. Information on the toxicology of PFOA, including reference to the abovediscussed 3M study, also was provided. This letter is enclosed as Attachment 3. 168 Fed. Reg, 33,138 ("2NoBvPeAmbReergi1o5n,s2I001a)nd VOrderon Consent Docket Numbers SDWA-03.2002-0019 and SDWA-05-2002-0002 Mr. Richard H. Hefter June 20P,a2ge0s03 hDaudPobnete'nsdJeutneect5e,d 1i9n8t5helegtrteorutnodwEaPtAerRaeqguiifoenr.IIIE,xicnewrphtischfritomwatshisrelpeotrtetredartchaetncFlCo-s1e4d3 as Attachment 4. DuPont's February 9, 1990 letter to EPA Region III, in which it was reported that the eLnucbleocskedpuabslAicttsaucphpmleynwtel5.ls contained ppb levelsof C-8. Excerpts from this letter are DuwPiothntW'VsDgErPouanndwdaWteVrHaHnRd ,drwiintkihncgowpiaetsertomoEnPitAorRienggiodantaII,I,fisliendceonthae rseiggunlianrgboasfais consent order with WVDEP, effective November 14. eFinnvailrloy,nmiennats,sietsmsiunsgtrbeeporrteacboiglniitzyeodfitnhfaotrtmhaetreiownascosnuccehmcionngsipdreersaebnlceedoebfaatseucbosntcaenrcneiinngtthhee reportability of that typeofinformation that EPA announced tht the Agency was suspending the applicabilityofthe portion ofEPA's 1978 Policy Statement which outlined TSCA section 8() urnetpiolrttahbeilAigtyeonfcdyatisasuoenddaidsdtirtiibountaiolncolfasruifbysitnagngcueisdainnceen,vtihreornemgeunltaatledmecdoimam.u"niEtPyAwasstatteodfothcauts on cthoentsatmaitnuatotriyonl,anbgoutahgfeoorf speucrptoisoenso8(feo)ntgoodientgercmoimnpelireapnocretawbiiltihtyTofSiCnAfo8r(mca)trieopnorotninegnavnidrofnomrental complying with the TSCA section 8() Compliance Audit Program (CAP). r`Tehfiesraedndcietdioanbaolvec,laornilfyyijnugstguiisdsaunecdeoonnJtuhnees3t,a2nd0a0r3d.s DfuorPorenptorhtaidngatlhwiasytsypienotfeindnefdotromarteivoinewwatsh,e as pdautbaliosnhepdreits.enUcnetiolftPhaFtOtiAmei,n rderpionrktianbgilwiatytewrasinalsisgehtssoefdtbhye nfeocwusEiPngAognuithdeanscteataustosroyolnanasguEaPgeAof tsheacttitohne 8d(rci).nkiAnsg nwoatteedr atbesotvien,g iEnPfAo'rsmanteiwonJduonees3n,o2t0t0r3igggueridaannycerecpoonrtfiinrgmsobDluigPaotnito'nsucnodnecrlusion section 8(e). 1356 Fed. Reg 28,458 (June 20, 1991) intTerhpereCtaAtPionwsabseatnweiennduEsPrAy.-wainddeinTdSusCtArysreecgtairodni8n(g)TcSoCmApl(iean)creepaourdtiitnpgrroegqruaimembeengtusn.beAcauthseeoofudsiftf,ertihengCAP was imnefaonrtmaoticoonvoenr tbohthrehleeaaslehofefsfuecbtsstarnepcoerstionga(nPdhdaesteec1t)iaonndinenevnivriornomnemnetnatlalefmfeedctisar(ePpohratsieng2,).whEiPcAhwaisss1ue0d dinrcaltude rseepaosrotnianbglcguainddanecqeuiotnableenvtioreonnfmoernctealthreepfoirntainrgeavnids,dafrteeprorrteicnegivgiunigdaenxcteenosinvae pcroomsmpeencttisv,e dbeacsiidseodlyth.atTh.e.rtef5or, emienndffiooarr.mcaetmieotnnattoancptrtiehdoeanrt"eeletSaheseeeoeAfftfecachctehimvmieecdnatalt6os,ufebtstteearngcrueosidm0anEacPnedAwitDlhlietodcetetoebrcetTitoohxnoisfcuscbjhaeencmdtiPocefasaltniscuiEbdPsetsAaEnTncSfesoCriAcneeSmneevcnittirooDnnimvSeicns)tiaoln to DuPont (May 15, 1996) Mr. Richard H. Hefter June 20P,a2g0e0s3 h`YaosurrelceetitveredalssoomreeqduaetsatsoncotphieesroesfudlrtsinokfiDnugPwoantte'rssdarmipnlkiinnggwdaattae.r sAasmpnloitnegd. abHoovwee,vEerP,ADaulProeandty will compile and forward drinking water data to you under separate cover. Contact Information We trust that the information provided in this letter will dispel any concerns about TSCA () srteapfofrttoincgontthaatctmmaye phraovmepbieleyniftrEiPggAerheadsbayntyhereAmpariinli1n1g"quleetstetri.onPslreeagsaeradsikngstohmies oisnseuef.rom your Attachments "Andrea Malinowski, Counsel EL du Pont de Nemours and Company . Mr. Richard H. Hefter Attachment No. 1 2 3 4 5 6 ATTACHMENTS Title April 8, 1981 Wall Street Journal April 8, 1981 New York Times JDuenpear9t,m1e9n8t1olfeWttaetrefrroRmesDouuProcenst, twoiWthesctopVyirtgoinia EPA Region Ill Excerpt from June 5, 1985 DuPont letter to EPA Region Ill Excerpt from February EPA Region Il 9, 1990 DuPont letter to May 15, 1996 letter from EPA to DuPont June 2P0a.g2e00130 No. of Pages 1 1 1 3 2 5