Document V3DDJZKoo3mnVrp29qdD6vxzK

, A226 _ lle 4 `OHIO ENVIRONMENTAL PROTECTION AGENCY | MEETING COLUMBUS, OHIO : July 24,2002 , LITTLE HOCKING WATER COMMENTS : BHoyclkeitntegr WdaatteedrFAesbsroucairatyi2o1n,, 2r0e0q2u,esMtre.d tKheavtitnheHoOphpieorE,nevnivriornomnemnetnatlalPrcootuencsteilofnorAtgheencLyittle enter into aconsent order with DuPont for ofthe contaminationofthe "watersof the the purposeof State" by C-8 establishing thenatureand impacted aquifers in Ohio. scope `The people in this room today represent someofthe Ohio water systems that we kiow C-8 thoasabionfuitltr3a7t,ed0.00COohllieoctciivteilzeyn,s.water systems with C-8 contamination supply drinking water `We are here today 10 request, on behaoflalfl the water systems and citizens affected by the C-8 contamination, that the Ohio Environmental Protection Agency enter into its own ccuosntsoemnetrosr,deburtwditohwDeuPporontte.ctWtehehmavferoamdtuhteyhtaorpmrfoutlecetffoeuctrswoafteCr-8subppylrieelsyainngd our on the 150 pclpabssnaucmtbieonroatfttohreneWyse?st AVirrgeivniieawoCfAtTheTeevaimdeonrcoenitnhdeica0t.e3sptphabtnaunmibnedrepaednvdoecnatterdevbiyetwhaend analysisofthe whole C-8 problem is requiredforthe following reasons: 1. The "Safe Level" Standards for C-8 Keep Escalating g < The "safe level" standard for C-8hasbeen a rather fluid number that periodically = $2 iDnucProenatse'sseixnptoenrennatliCaollmym.unIniittiyalElyx,pothseur"esaGfueildeevleiln"e.waTshsiasindutmobbeer1evpepnbt,uwalhliych was & 23 z2 cexhcaenegdeeddafitt.er Ldaetteerc,titohnesoU.fS.C-E8PinAtChoensLietnttleOHrodcekriwnigthWDautPeronAtsscoictieadt1i4onpwpeblalsstfhare ==X 235 interim "action level" for C-8. The Little Hocking Water Associationhas a ~ `monitoring well which has C-8 levels that are morethantwice 14 ppb. Now, based on the announced CAT Team findings, the "safe level" is 150 ppb. 3thMe waonrdldD.uPTohnetyhhaavveepmraonbuafbalcythuraeddmaonrdeuesxepderiitefnocremwoirteh Cth-a8nt5h0anyeaanrys.onWeiitnh all the knowledge that DuPont had gained from its own lab studies and those of G3uMid,elDiunPeo.ntThseitsagnuiidnetleirnnealbavsalbueeeonfi1n.0plpapcebffoorrmtoherier CthoamnmuandiectaydeE.xpoWsasu.re DuPont really wrong by afactor of 150? cB CONTAIN NO 000083 rage 2 2. Validity of the CAT Team's "Screening Level" of 150 ppb is Highly Questionable a. The "screening level" is calculated froma reference dosage. The . calculationofthe reference dosage is greatly affected by five `uncertainty factors'. Determinationofthese factors appears tobe quite arbitrary. For the six studies considered, one-hoaftlhfe `uncertainty factors' assigned by the CAT Team were the least conservative values that could have been assigned. Therefore, they are also the least protectiveofthe public health. `They even did this for a monkey studyin which a coupleof the monkeys apparently died inexplicably. (Refer to Attachment A) b. The reference dosage usedby the CAT team in the calculationoftheir 150 ppb number is only twice the referenced dosage cited in the ENVIRON report which was the sourceofthe 14 ppb interim level of C-8. Witah reference dosageof only twice the ENVIRON dosage, the CAT Team determined the "screening level" of150 ppb, which is more than ten times the ENVIRON level of 14 ppb. (Refer to Attachment A) c. Inthe ENVIRON RepaoUSrEPtA default valueof 20% was used in the calculationofthe 14 ppb to account for exposureofpersons to C-8 by means other than drinking water. It appearsthat the CAT Teamin their calculation did not utilize this 20% value even though we know that DuPont also emits C-8 into the air from its stacks in addition to discharging it to the Ohio River. This fact is evidenced by the presenceofC-8 in groundwater sources upstream and far inlandfromthe point that DuPont dischargteos the Ohio River. The useofthisvaluealone would reduce the CAT Team "screening level" to 30 ppb. (Referto Attachment B) d. Accordingtothe Conclusionsofthe ENVIRON Report, the best available and most relevant data for deriving a drinking water level for C-8 are those: from the monkey study. The CAT Team used data froma rat study to derive their reference dosage. (Referto Attachment B) e. The CAT Team makes the assumption that C-8 it is not a carcinogen. The USEPA Region 9 formula used by the CAT Team to calculate the screening level" for C- was for pon-carcinogeniccontaminants in water. The recent USEPA "Draft Hazard Assessmentof Perfluorooctanoic Acid and its Salts" States, "As the mechanismsofcarcinogenic action ofAPFO have not been fully elucidated, it is assumed that the tumors induced in rats are relevant to humans." (Refer to Attachment C) 000004 rage 3 `The American Conference of Governmental Industrial Hygienists (ACGIH) has classified C-8 in Group A3. The Group A3 classification means that C-81s aconfirmed animal carcinogen with unknown relevance to humans. C8 shares this Group A3 classification with currently regulated chemicals such as aldrin, chlordane, DDT, Di (2-ethylhexy) phthalate, paraDichlorobenzene, dichloromethane, ethylene dibromide, heptachior, heptachlor epoxide, hexachlorobenzene, and lindane. Therefore, in lightof the preceding information how can the CAT Team assume that C-8 is a non-carcinogen? 3. C-8 has Similar Characteristics to Perfluorooctane Sulfonate (PFOS) a. PFOSis a chemical, manufactured by 3M, that was used in Scotchgard coatings. In May 2000, 3M, which also manufactured C-8, announced that it was phasing out the production of PFOS. According to a 3M news release, "... our decision was based on principlesofresponsible environmental management." The decision followed negotiations between 3Mand the USEPA. According to an USEPA document, PFOS appears to : `combine Persistence, Bioaccumulation, and Toxicity properties to an extraordinary degree. (Refer to Attachment D) b. 3M was the primary supplierofC-8 to DuPont. 3Mhas also stopped marketing C-8. Therefore DuPontisproducing C-8 at oneofis plants in North Carolina. c. The Risk Assessment Divisionofthe EPA Office of Pollution Prevention andToxics recently released its "Draft Hazard Assessment Of Perfluorooctanoic Acid (PFOA) And Its Salts". Thisdocument states, "Based on the existing data, PFOA may present some concerns similar to those raised by perfluorooctyl sulfonates (PFOS). Like PFOS, it is persistentinthe environment and does not appear to degrade. PFOA also appears to have a half-lifein humansofbetween 1 and 3.5 years, indicating that it may bioaccumulate in humans in the samemanneras PFOS does, remaining in enterohepatic circulation." (Refer to Attachment E) Therefore, C-8 definitely has similar characteristics to PFOS, which is a known health hazard. 000085 Page 4 4. The terms of the West Virginia Consent Order establishing the procedure to determine the Provisional Reference Doses and Screening Levels have been disregarded. These violations call into question the validity both of theprocess + employed and the results obtained. a. Under the provisionsof the West Virginia Consent Ordear non-profit scientific organization, Toxicology Excellence for Risk Assessment (ReTfEeRrAen)cheaDdtohseesprfoirmaCr-y8 raensdpofnosribtihleintyusfionrgthtehedmevaeslaopbmaesinsttoofdPervoevliospional `human health risk-based Screening Levels for C-8 in air, water, and soil. (Refer to Attachment F - Consent Order, pp. C-4 and C-8) After review of WVDEP provided material, TERA was to consult with the toxicologistsontheCAT Team,ascoordinated by Dr. Staats, regarding its proposed approach for this project. Following the consultation, the Order directed TERA to develop the Provisional Reference Doses and calculate [Sc)reening Levels.(Referto Attachment F - Consent Order, pp. C-4, C-5, b. It is apparent from deposition testimony given by Dr. Staats that at the May 6 and 7th meetingofthe CAT team and TERAin Cincinnati that the CAT team, coordinated by Dr. Staats, usurped the responsibility ofTERA and developed its own Provisional Reference Dose for C-8 in water from which the Screening Levelof150 ppb was then calculated. ( Refer to Attachment G - Staats deposition, pp. 122-125) Apparently Dr. Staats unilaterally decided to abandon the terms of the ConsentOrderand fashionher own procedure to determine a reference dose and screening level. She directed TERA to omit the values it derived from tables to encourage the CAT team, which included DuPont representatives, to,inessence, come "up with numbers themselves." (Refer to Attachment G - Staats Deposition p. 123) OTnEcReA,Drt.heSttearatmssaollfotwheedtCohnesCenAtTOrtdeearm wteourseuvripotlhaetedreasnpdotnhseibbeinleiftioitefosfan independent analysis by TERA lost. These actions not only violate the terms of the Consent Order but also call into question the impartial, scientific validity of the process employed and the results obtained from the CAT Team proceedings. 000008 Page 5 5. Citizens in the Community are Concerned about their Water and Air Quality a. In January 2002 a local newspaper ran a poll - Does water wells in Little Hocking, Ohio disturb you? the finding of C-8 in 77.4% answered `Yes' b. IynouMafeyel2s0a0f2erannootwherthpaotll",haefatletrh1p5r0optepcbtiSvcereleenvienlgs"Lheavevlecbaemeen douette=rmiDnoed dfrorinCk-i8nganwdattehro?se l7e1v.e9ls%araensfwaerrheidgh`Neor'tthahnewyhadto wnaotsffeoelunsadfeirn.area c. AHloswoiwnoMrariyed20a0r2e,yaonuotahbeoruptolCl-a8f,tenro1w50thpaptbtShcerWeeensitngViLregvienliacaDmEePouhtasdetermined a "safe" human level? 68% answered "still concerned' or "remain very worried" d. The local salesofbotled local water supplies. water tripled after C-8 was detected in e. Some people are afraid todrinkthe water,or even bathe their babies in i A developer has complainedofdeclining land values. g. Realtors have told me ofpeople moving to get away from C-8. Other `people, who just bought homes, are concerned about the resale value of their property. h. On June 20, 2002, the Marietta Times published a newspaper article that stated that Washington County is the Ohio county with the highest incidence of lung cancer in the state. TEnhveimraognnmeinttuadle PorfottheectCi-o8n pArgoebnlceym. dWeseeravsekstthhaetftuhlel aAtgteenntciyonenotfetrhienOtohiaoconsent aorredesreewkiitnhgDautPhoonrtousoghthraetvainewiannddepaennadlyesnits,anwahleysrieswoef tchaenCh-a8veprsoobmleemdeigsrdeoeneo.f We confidence in the results. Rnoetgabredlloensgsionfowuhratweavteerr tsuhpep"lsiaefse.Olefveall"litshfeorthCi-n8g,sitthiaststhilalvae cboenetnasmaiindaanbtotuhtatC-d8o,esno one has ever said that itis good for us to have it in our drinking water. 0000907 HANDOUT WUDEF PUBLIC MEETING Airman Derivation af th RAD ndRIC Vlas or C8 wpt m oa (9 soaymsnty | p|maetienretre || (oOrpf0Na3mE7ybinn Toran om FUSION | | i whe se iietwyAe dde| 10OieAEiLn | ocr arppmewatythme| 0a5r2M CCertaatoang liwoaveneror,s pe ry ee `but inciofdhyeperntrcophey Som ose || b TSesemipet rs_||| 11m5s70e0oUnD)EDL) peircsmeplopossia | 07o3 GeDL cT(00o1rr2otweyick ||| leDmvelesanmcarlecemynonmoolgtuts ||| (Lw3Oi-e1A0)EiLn 7 ET | a o otpmn ahreonmae eymseaonre ly oe 7) MRY 15, 200 CoTmwpe w | dooom w| x Frm) eepmsoosnce oom oan ooaorn i5 ii > 000008 A HAZARY NARRATIVE FOIC - ee 3 PERFLUOLOOCTANOATE 3 C PFOA) Prepared by ENVIRON #4 component is 1. When the toxicokinetic component (1) is combined with the toxicodynamic " component (1), then the overall value for this factor is 1, but could be as low as 0.3. Combining these factors results in a conservative MOE of 1000, which would be applied to the point of departure dose of 1.4 mgkg/day (LED10) resulting in a risk specific dose of 1.4 pg/kg/day. Using default assumptions about drinking water consumption and body weight, a risk specific drinking water level would be 50 ug/L. This is essentially the same value as obtained from the use of the monkey data. Stated differently, as did the USEPA in their c9h0l0ortoifmoesrmsmraislklearsstehsasnmtehnet l(oUweSsEtPLAE2D01001b)d,ertihveedRfDromdetrhieverdatfbrioomastshaey.moGnikveeyn stthuatdythies aMbOouEt sduaptapowrotuelddbbyetahededqautaateilsy1p0r0o0t,ecatnidvecoofuladll bpeotaesntliaolweafsfec3t0s0., indicates that the use of the monkey 7.0 --C_--ONCLUSIONS The best available and most relevant data for deriving a drinking water level of PFOA that is protectiveof human health are those from the monkey study. Unlike the effects consistently observed in rat studies, neither indicationsof adverse liver effects nor changes in hormone levels occurred in monkeys treated with PFOA. This lack of a response in the monkey (non-human - cparricmiantoeg)enisicciotnysidsatteantarweitohftlhiemiltaecdk roeflseuvacnhceeffteocthsuminanPsF,OeAspewcoiraklelryst(o hhuummaannspriemxaptoes).edT1h0elroawt levels of PFOA. As discussed in detail in Section 5.0, tumors in rats were produced only at high doses and only in tissues responsive to changes initiated by activation of PPARa by modes of action that have a threshold; similar responses are unlikely to occur in humans exposed to PFOA. Thus, the evidence strongly suggests that PFOA would not be a human carcinogen. Ccoannsceeqruedanttal,y,itwshioluetcaoBmeencihs moafrkhiDgohsley/Muanrcegritnaionf Erxelpeovsaunrcee atpoprhouacmhancanhebaeltha,pplainedd tito tihsenroatt recommended asa criterion for human health protection. `The RED derived from the monkey data (2 pg/kg/day), provides a reliable and relevant criterion for human health protection, and should be used to derive a drinking water limit. Using default `assumptions for drinking water consumption and body weight, the RID corresponds to a drinking water of 70pg/L. If the contribution of PFOA in drinking water to the total intake of PFOA by all media is considered, then the final drinking water criterion would be adjusted accordingly. Using the USEPA default of 20%, the resultant drinking water criterion would be 14 pg/L; however, using 2 more realistic contribution of 50% would result in a drinking water criterion of 35 ug/L. 30 -000009 . " _ DRAFT HAZARD ASSessMenT oF PER FLLok00CT AMOIC ACID AWD ITS SALTS userd res zo, 2002 to 50 mg/kg/day APFO. highest dose tested. There was no evidenceof matemal toxicity at 50 mg/kg/day, the A two-generation reproductive toxicity study is currently being conducted. A two-generation mregp/rkogd/udcatyi.veTthoexicriestuyltsstuodfytohfe PAFPOFSOsshtouwdeydwihlilgbhemiormtpaolrittaynotftoFIdeptueprsmiantedwohseesthaesrlaowsiamsil1a.r6. effect is observed. Carcinogenicity studies in Sprague-Dawley (CD) rats show that APFO is weakly carcinogenic, inducing Leydig cell adenomas in following dietary exposure to 300 the male rats and mammary fibroadenomas in the ppm fo2r years (equivalentot 14.2 mg/kg/day in females males and 16.1 mg/kg/day in females). The compound (at 300 ppm) has also been reported to be. carcinogenic toward the liver and pancreasof male CD rats. `The mechanism(s) ofAPFO tumorigenesis is not clearly understood. Available data indicate that rtehceeipntdourcsatinodnopefrttuumrobartsiboynsoAfPtFhOeeinsddouceritonea snyosnt-egme.noTthoxeilcivmeercchaarnciinsomg,eniincviotlyv/tionxgiaccittiyvoatfiAonPoFfO `appear to be related to induction ofperoxisome proliferation following binding to the peroxisome proliferation activation receptor a (PPAR a) in the liver. Available data suggest that tthoehionrdmuocntailoniomfbaLleayndciegrceeslullttiunmgorfsro(mLCacTt)ivaantdiomnoafmtmhaerPyPgAlRan.d neenodpilnadsumcstiboynoAfPthFeOcmyatyocbhreodmuee. P450 enzyme, aromatase. Preliminary data suggest that the pancreatic acinar cell tumors are related to an increase in serum levelofthe growth factor, cholecystokinin. As the inogenic action of APFO have notbeen fully elucidated, it is assumed~ d"rfer uagndcshethmat iinducceLCTainlanismals has led a workshop panel to conclude that all but two modesofinduction of the luteinizing hormone (LH), "dopamine agonism" and "GnRH agonism"", are considered to be relevant to humans, and that the possibility of induction ofLeydig cell adenoma in humans by specific agents with other modesofaction cannot be ruled out despite the LCT by APFO rarity is via otfheL"CdTopianmhiunmeanasg.oniAtsmp"reosrea"tG, nthReHreaigsonnoisemv"idmeoncdeeothfaatctthieoni.ndIutctision of recognized that there are quantitative differencesincertain biological parameters between rats. and humans. However, the principal cell control mechanisms appear similar, andthedifference in carcinogenic response is probably quantitative. As binding to the PPAR appears to be the cirnithiucamlaenvelnitverlseaidsiongwteo htohramnotnhaal iiambraoldaeantceliavenrd, AitPaFppOeatrusmothraitgehnuemsaisn,samnadythbeelleevsesl soefnPsiPtiAveR than rodents in the development of LCT, mammary gland tumors, or liver neoplasms. s 000019 pco p RCEPCPETIVHCEIDC : [ans W0SEP -6 Ph12: 57 FE CSrsaitEeasnh0ue1111 AM ARRIt6of?-- 0629 To SKLaoavbnsendroDnCLDIaUCcSUaEySPnEAaPLxAIDUSCGSUEGSPEEAPP,AAWNaIrSdGEPPA,eManryOGDboUmSieEnPaArVDICSiI@UESPyEAP,AKUaSr@oEnPA, Fark Sbjct. Paseo arprOS oSio Fondby Chats AveIOGISonESPEAZUS 147 Ab reer * oI EP Chas Aver - "08/16/2000 11:08 AM To: 5CI.hU$aCrhEecAshFAnAuGXs@e3mD0e0C1gI+oI6bSE,ECPtHhAAaUrDSesGaCEHiPRgAIl,STobIniO@nNot2niG@ciasKu,o.nJsotaahcncStaikune.fciisxcs&eSEgksSaer3ec3no..4fSoE3c0i18862o9r6:845E"Goucd.o. aIMmGsEAtF@AXb3a0u01s+.SdEIoC.ObNsjOhoMmuOhUtaSnt2see0n.@2jdr0ee.at., hSasEaA@eTnSv.cSzE.3m1ar6k6h3ym1a2nD5e2a.Ggeovc.akuo. s `CgaaIersirrtrieaj@norcircegeiemmnnsueseesn.a@sosmpefa.a@kiraeedl@eaebmvwanarx.roncsom,iRn.mapeionmGreoerd-nnK.ut.drtmGaUKtoMocGohLv.RaKHoa@k,braegysoeaurrH-araTgUHndoeen.sr@TAhoGaNlonSyv,Leaokkae.hTcaunHi1nsT ,ky@ipO h.fogno3vG .0be1,. oVcgeoRrbeErGaUgkmSaanloyea.nGdvei2d0G,.oWvruisk,sHnayGaeam,to,AoYn@uosnugwvnamery.sBemirc@nha,dDehgiira.ankTtoUerRNvaaHn.kEgoIosGgp@oe.wacnsdoryi.m i, & NSaaboneydtueivrssYDAsCSeIUrUD@SAoEGPeGoAceUmciSdGrooEbrPe,rAt,LdePsolenepeyFrOusNl@YeoOreNDcGC.oUuwSiEcmPdSAu0NrI.iSnOQsWEcaPaAyr,ahmneidkmSoaCynRbUdrSeeEscPkDA@CUeSpSEa@nPEaAPiUA4.S5HaHEa0oPlveAn 1523@2w0g0at1ebr.de, Priscila Flaten DCISEPAUSGEPA Subiect PhaseoutofPFOS. 1 would liketodraw your attention to an important development in the US which concems a paebrosuitstseenttt.ibngiouapccaumduilsactuisvsei,onaonpdpotrotxuicnicthyemaitcsaol.meIpwoiilnltbdeuraipnpgrotahechuipncgotmhienOgEmCeeDtiSnegcroetfatrhieatTask. Force on Existing Chemicals. Abrief summaryofthe information follows below and this is `accompanied by a number of documents which provide additional information (EPA's press statement, 3M's press statement, and several reports submitted to EPA by 3M which provide `more detailed background information). The reports from 3M will follow separately as pdffiles andarenot being sent to the cc's. Following negotiations with EPA. 3M Corporation today announced that it will voluntarily phase `out perfluorooctanyl sulfonate (PFOS) chemistry, which is used to manufacture a wide range of products. This announcement is the resultof a successful production stewardship effort between 3Mand Agency EPA. which EPA supports indicated that this effort which began as a resultofdata these chemicals are very persistent in the 3M supplied environment, to the have a strong tendencytoaccumulate in human and animal tissures and, based on recent information, EE -- -- Te000i1 TTT } :: M2T0AfCH3NENT ccooumlpdapnoytepnltainaslltyopexiotawosirslkdetwoidheufmroan hperaoldtuhcatnidontohfetehensve ichremoicnoamlvseerbtnyhtteheloenngdotfertmh.eTyheear PpeFrOflSuo(rpoe-rcfhleumoircoaolcsta(ntcotsaullafnoaniucalacpirdo)diusctaimonem<bSermoilfliaonlakrgges)fawmhiilcyhofasruclufsoendaftoerda wide variety ostfaiian-dursetsriisatla,ntccoomamteirncgisaflo,rafnadbrcicosn,sluematehrera,ppfluimciattuiroen,sa(nidncclaurdpientgs u(suendaesratcheomSpcoontcehngtaorfdsoliinle)a, nidn fsiurref-afcitgahnttinign footahmesr,spceocmimaletrycaipaplliacnadticonosn)s;upmeesrtifcliodoarl aponldisihnedsi,reccltefaoniondgupsreodpurcotdsu,catnsdaaresaal.so made . cfhreommictahliss.teAclhlnoolfotghye.seFicnhaelmifcoramluslhaatvieotnshfeorptotheensteiaulsteosdceognrtaaidne lbeascsktthoanP1FO%SowfhtihechPdFoOeSs not ampapneuaftroacdetgourafrdteehrfeurPtFheOrS(iftaimitlhyuosfhicghhelmyicpaelrssi;st3enMt)a.ls3oMhaCsoarpporroadtuicotniiosntfhaecisloiltye iUnSBelgium. `AavnaditlhaeblReusisnifoarnmFaetdieornatsiuogng,esatlsththoautghth3erMe mapepyeabresptroobdeuctthieodnofmaicinlaintitesprinodIutcaleyr,.Germany, Japan, pPpFbOlSevhealssibneennonf-oeuxnpdowsieddewloyriknehrusmanadn binloboldosoadbmapnlkess(apmppmlesle.vePlsFiOnSmahnausfaalcstoubreienngwfooruknedrsin, `wwaisldldiefteescpteecdiiens naacirvoesst(uhneexUpSos(eeds)pelcaibaolrlaytoinryfirsahtsca(ttihnegPbiFrOdSs)ceonndtaimnitnhaetBiaolntwicasintrSawceeddebna,ckItto fish meal used in the rat chow). PreFpOroSduccatuisveedepfofsetcntsataatl dsetautdhys((NaOndAoEtLhoerfd0e.v1elmogp/mkegn/tdaalyeafnfedctLs)OiAnEoLfofsfpr0i.n4gmiga/kag2/-dgaeyn)e.raAttion hpirgohgeernydforsoesmtinhtehsiescsotunddyg,eanlelrpartoigoennydieidnf.irIstitgsevneerryatuinounsudailedtowhsieleeasutcthheseLcoOnAdEgLenmeraantyioonfthe effects. PyeFaOrsSianchcuumamnusl.atItetosthaushiagphpdeaergsretoeicnomhbuimnaenPsearnsidsatnenicmea,lsB.ioaItcchuamsulaantieosnti,maanteddThoaxlifc-ilitfye of4 properties to an extraordinary degree. SPeFvOerSatloycehaarrsaacgtoe,riizneriesspeonnvsiero1n0mtehnetabllopordesfeinncdei,ngesn,v3irMonlmaeunntcahledanadmahjuomranreesfefaercctsh,eaffnodrt on environmental fate. EPA REVIEW PwriedleismpirneaardyhduatmaainndeixcpaotseudrteoaEnPdAintdhiactatPiFonOsSofisotofxsiicigtnyifiincaant2cgoennecreantioonn trhatesbtausdiys. oIfneavdiddietnicoen,of E(PMAO'EsS)prfeolriwmoirnkaeryrsraisnkdaspsoessssibmleyntthiendgiecnaetreadlppootpeunltaitailloyn.uTnhaeccreepatrabelmeamnayrgaisnssoumfpetxipoonssuarned t`hceonasidderabeleouqrncaecurcauiranatcyycoinfttyhheeseaMrOgEumaennaltyssaensdorawnahleytshees.rt1hesexnpootspuorsesilbelveealst pusreedsiennttothejaubdgoeve ersetqiumeasttieodndsemtaaiylebdeincfoonrsmiadteiroend frreopmre3seMntaantidvaeoflatrhgeebaofdfeycotfeid pnopuflaotiornhsamastblaaeregte.rieEcPoeiAvned but a --& 000012 : 3063 not reviewed. 3M has raised questions regarding the possible relevance to humans ofaproposed mechanism (perfofpecotsseodnmecchohlaensitsermo,l tbhieoscyonmthpeasniys)afrogruePsF,OaSf'fesctlsetrheaplreofdfueccttiivne tohuet2c-ogmeenseriantilointtsetbuedya.ringT,he `animals due to its inhibitory effect on a burstof cholesterol biosynthesis in the critical period just pbreefsoernetbisritghn.ifTihcaentprpoopteonsteidalmceocnhcaenrinssmfowrohuuldm,ainfsdaenmdonesntvriartoendm,enhtaavleobrrgoaandisimmsp.lications for and RECENT DEVELOPMENTS . Folalscriocsowfdiiscunssigons with EPA,andbasedonconcerns aboutthewidespread fprreosmentchiesamnadrlkoentgbeyrtaebromuttrihseksepnrdeosfenttheedyebayr,PFaOSl,t3hMoidtuecagiadhyednetedthiotewaxotuetlnddetxhiet twiomreldpweirdieo:d for rseosmeearccrhiteifcfaolrutssoesn(Pc.Fg.OSfitreopfriogvhitidnegafnoaimn)-.deTphtheucnodmeprsatnayndhiandgporfevthieoupsrloybllaeumncahnedditasmhaujmoarn and deencviisrioonnm.en3tMalhacosnesxepqrueesnsceeds;inttheirserstesienacroclhleafbfoorrattiwvoeuelfdfobretscwointthinEuPedAadosstphiteeytwhietchodmrmaewrcfiraolm the `market and in the development of safer substitutes. A NEXT STEPS FOR EPA EPAisprepacaommruniicantiogns strategyforconveyingclearmessages in response to 3M's `announcement. We will be alertingotherUS Agencies (FDA, CPSC, OSHA, NIOSH), OECD `governments, and international agencies (UNEP, IPCS). We do not believe that PFOS presents aonliemcmuilnaernwteihagrhmtpforloymmuesrcs wihnciocnhsduomenortparpopdeuacrtstdourreisnulgttihneepxhpaosseuoruett(oitPiFsuOsSeddiurninhgignhormal use; residual PFOS contamination occurs a very low levels). At the same time, we agree that ecloinmtiinnauteeddmtaonpurfoatcetcutrheuamnednuhseealotfhPaFnOdSthreeepnrvesieraotnsmaenntunfarcocempptoatbelnetiatlelcyhsneovleorgeyltohantgstheorumld be `consequences. Regulatory action would have been difficult and time consuming at best and, given taken EPA's view thata rapid phase out responsible corporate decision in is necessary and quickly moving appropriate, away rom EPA believes thal this technology. 3M has hEePalAthisacnudrrtehaetelynveixraomnimneiantg. appropriate regulatory steps necessary to easure protectionof human PFOA cPeFrtOaAin(ppoelryfmleuroirzoaotcitoannoriecacatciiodn)s.is cElPosAelhyasrerleaqtueedsstterducitnufraolrlmyattiooPnFfOrSomapnrdoidsucuesresd aansdawsiolllvbeen:t for epxrpeopsaurrieng,aanndarsissekspsimcetnutr.e BcaosmepdaroendptroelPiFmOiSna.ry3iMnhfoarsmaaltisoonc, oPmFmOiAtptretesdoenetnsdsindgifpfreorednutcthiaoznarodf, PFOA. Therearcother producers inthe US and EPA is examining its options regarding action on PFOA. 3 000013 S a 1 ' Sima UNITED STATESWEANSVHIIRNOGNTMOENN,TDA.CL. P2R0O4T6E0CTION AGENCY Dear Interested Party: WAR 28 2002 ommceor PreTvoreensoPsEStTsS io . PerfluorAototcatcahneodiicsAacciodp(yPFinOPA)DFAnfidlelifsoSramlaits,(p3r8ep9aKr)eodfbtyhetheDrRaifstkHAaszsaersdsmAesnstesDsimveisnitoOnoffthe rEoPbAustOfsfuimcmeoafriPeoslolfuttihoen sPtruedvieenstrieovniaenwdedToixnictsh.e aTshseesAsnmennetx,tios tnhoet aaststeascshmeednbte,cwauhsiecohfciotnstavienrsy tlhaergPeFsiOzAe (s7e8c5tiKoBn)o,fbtuhteipsuabvlaiicllayblaeccuepsosinblreeqAudemsitnaisstarsaetpiavreatReecfioler.dBfoiltehAfRi2le2s6h:avPeFObeSe,nPpFlaOcAe,d in a`Tvealiolmaebrlse,asaonfd RJeullyat2e0d01C,hebmuitcadlose.s Tnohtisipnrceorlpiomriantaeryanayssiensfsomremnattiroenvireecwesitvheed sbtyudtiheesAtgheatncweyrea.fter athdadtitdiaotnea.lTshteucduites-owfefrdeatsiellwausndaedrowpatye.dTtohealalsoswestshmeernetlesapseecoiffitchailslyprreelciomginniazreys athsastesadsdmietnitonwahlile udantdae,rpdaretviecluolpamrleynti.ncAlsudtihneg tAhgeefnicnaylrreepcoeirvteosnfuartthweor-sgteundeyraitnifoonrmraetpiroond,ucittiwvilelsbteuidnycilnurdaetsd,ianre sil AR226 and in the Agency's review process. perfluorBoaoscteydlosnutlhfeoenaxtiessti(nPgFOdSa)ta.,LPiFkeOAPFmOaSy, pirtiessepnetrssiostmeentcionntcheemesnvsiirlonametnottahnodsedroaeissendobty 4 ianpdpiecaartitnogdtehgartadite.maPyFbOiAoaaclcsuomauplpaetaersinohuhmaavensa ihnatlhf-elisfeaimnemhaunmnaensroafsbPeFtOwSeednoe1s,anrdem3a.i5nyienagrsi,n etnhtaenroPhFeOpSa.ticPFciOrcAuliastcioanr.ciPnFogOeAnihcaisnbaeneimnaflso.unRdepinrohduumcatinvbelsotouddysadmaptlaeos,n aPlFthOoAugchoamtpalervaebllselotower othnetshteudtiweos-gtehanterraatiiseodntrheeprinoidtuicalticvoenscteumdsy oinnrPatFsOsShoaurlednboet cyeotmpalveaitleadblien,tahletfhiosutghhthaeoffli2n0alf0r2epaonrdt will be included in AR226as soon as it i submitted to the Agency. `The Agency will continue to review data on PFOAas they are received. `phone a1tf2y0o2u-5h6a4v-e76a3n4y,qouresbtyioenmsaiclonactsejerenedinnngitfheerA@sesepsas.mgenotv,.IplfeaysoeucwointsahcttoJreencneiifveer aSeceodpybyof PthheonAennaetx2,02or-5i6fy4-o8u10h4a,vebyanfyaxdiaftfi2c0u2l-ti5e6s4-o4p7e7n5i,ngorthbeyfielmeas,ilplaetadseomcionnitaackt.mMaarry(y@Deopam.ignoiva.k by Sincerely, Charles M. Auer, Director Chemical Control Division Raya riedwi Vaemget r4sBuss (UaR)aRMiod Paap govir 5%Posner) 000014 Tots First Public Meeting, CAT Team members shall familiarize themselves with the available toxicological information concerning C8. A CAT Team meeting shall be held immediately prior to the first public meeting tsou:r(r1o)uncdoinndgucrtesaidseintteiavilsiatretaos;th(e2)thdrieseculsasndtfihlelstoaxnicdittyheofWaCs8hianngdtootnheWroprekrtsinPelnanttd,aatan;d(3) prepare an agenda for the public meeting; (4) coordinate and prepare for the public meeting. Finally, the First Public Meeting will be held and public questions and comments will be recorded by WVDEP. Task A: Public Meetings (two meetings are anticipated) Objective: to inform the local citizens of the following: (in Meeting #1) intent to perform a groundwater and to ask for well their use survey cooperation and analysis for C8; intent to in conducting the water use develop Screening survey; and (in Mee Levels; ting #2) resultsof survey, chemical analysis, and risk assessment. Not that an interim public meetingmayberequiredshouldsixmonthspassfrom thefirstpublicmeetingandthe CPrAiTmaTreyaRm eFinasl Rpepoornt shSasaintobst ib_ee_ln_iis_stu_edy_. _: Task B: Development of Provisional Reference Doses Objective: to develop Provisional References Doses for C8 for the inhalation and ingestion (and dermal,if possible) routesof exposure. Primary Task C: Responsibility: Development of TERA Screening Levels Based on Protection of Human Health Objective: to utilize Screening Levels for the C8 Provisional Reference in air, water, and soil. Doses to develop human health risk-based Note a determinationof the potential carcinogenicityof C8 will be conducted as well. Primary Responsibility: TERA receptors. Task D: Ecological Data Review Objective: to review available information to determine whether sufficient studies have been performed and data have been collected to develop screening criteria for ecological Primary Responsibility: TERA Task E: Draft Report and Final Report Objective: to present and discuss the results of the above tasks. Primary Responsibility: TERA ScreeningLevels, and Risk Assessment After In Phase II, TERA having reviewed the shall conduct toxicological the toxicological and risk information regarding C8 assessment activities. provided by WVDEP, "rTegEaRrAdisnhgaliltscpornosuplotsewditahpptorxoiaccohlofgoirsttshios nprtohjeecCt.ATFoTlelaomwi,nagsscuocohrdcionnsautletdatbiyonD,r.TSEtRaaAts, C4 000015 20f3 shall develop Provisional Reference Doses for C8 for the oral, inhalation, and dermal (if paonsdsiabilreb)arsoeudteosnoftheexpriosskurfea.ctoTrhsetnheTyEhRavAe sehsatlilmactaeldc.ulaTteESRcAresehnailnlgpLeecvfeolrsm foonrewagteenre,rasloil risk the assessment involving three landfills and the comparison Washington of exposure concentrations to Works Plant, and the Lubeck Screening Levels Public Service for District water supply, that focuses on current risk to human healt, including workers and rleasniddeunstes,.suTrhfiasceriwsaktaesrsaesnsdmgernotusnhdawlaltienrcluusdee;: ((21))iiddeennttiiffiiccaattiioonnoforferceeapstoonrasb;ly(3a)nticipated . cidoemnptaifriicsaotinoonfoefxpexopsousruerecopnactehnwtaraytsi;o(n4s)tiodeanptpirfoipcraitaitoen oSfcreexepnoisnugreLecvoenlcse.ntTraEtRioAnss;haalnld (5) w`iglriozuenddwaattaerobCt8aicnoendcfenrtormattihoenosthinerreesfifdoernttsidailsacnudsspeudblaibcovweelslsu;chreassidaeinrtimaoldeglrionugn;dwater : wCeolnlsuulsteatsiuornv(eiyf; atvhaeilUaSblEeP).A'TsEDRraAftalHsaozsahradllArsesveiseswmeanvta;ilaabnldeAiTnfSoDrRma'tsioHneatoltdhetermine wshcreetehneirngsucfrfiitceireinatfsotrupdrioetsehcativoenboefeencpoleorgfiocramlehdeaalntdh,dpaatrathicauvlearbleyeanqucaotlilcecltiefed. toTdEeRvAelop sshuamlml aprriezpearsetahedrdaaftta auntdilaizfeidnaflrdoomcoutmheernteftfhoarttsd.isAcsustshees ttahseksroesfutlthseoCf AthTeiTr eefafmoratns,danodther ievnivdoelnvte,dTphaertsieess"haplrlobgreesisn,clduadteadgianpsTEaRnAd'rSesereaprocrhtraescsoumgmgeensdtaitonisonfsormfauyrthbeercroemseearch to elucidate the toxicity ofC8. Phase Ill Second Public Meeting ofthe efTfhoertspoufrtpohseeGoIfStTheaSnedcConAdTPuTbelaimcsMeienctliundginigs tCo8prceosnecnetnttroatthieoncsitiinzegnrroyutnhdewaretseurlts afsrsoemssrmeesnitd.entAiiarl wmeoldleslianngd rpeusbullitcsowfeltlhsetehfefosrctrseoefniWngVlDeEvePls aanndd Dthuepognentewrialllrbieskdiscussed also. The WVDEP will address any further actions that may be necessary. cs 000018 asians SCOPE OF WORK FOR TERA that appTliEesRsAou(nTdoxtiocxoilcooglyogEixccaelldlaetnacteo for Risk the risk aAsssseessssmmeenntt)prioscaesnsonl-oprfoifnidtcoormgmaoninz.ation gprroovuinddibngetsweerveinceesnvinirtoonxmiecnotlaolg,yianndudstrrisyk, aasnsdesgsomvenetr.meTnEtRgArouspcise.ntTisEtsRwAilwlibllebe: . Gaesvseelsospmienngt rfiosrktfhaect3orlsanadfnidllssc,rLeuebniencgkcPruitbelriica;SaenrdviccoenDdiuscttriicntgwoanteergesnueprpallyraisnkd the - . Washington Works Plant. The specific tasks assigned to TERA are described below. Phase II Tasks B,C, D, and E: Screening Levels, and General Development of Provisional AssessmentofRisk Reference Doses and =% provide`dSutbotbasyk W1 V-DTEEPR.AsNtoaflfiwtielraltufraemisleiaarrcihzeorthdeomcsuemlevenstwriettrhietvhaeltwoixlilcobleogriecquailredda.ta Toxicological following: data o be provided to TERA shall include but is not : limited to the . a 83cMomCpoarcpt(ndoitscesonoflyianfsomramlaltipoorntpironoovifdtehdistoiUnfSoErmPaAtiounndceorncTeSrnCsACb8)y; b. <. UJoSurEnPalAarDtriacfltesHaanzdarodthAesrsiensfsomremnattifoonrsCu8b;mitted to WVDEP by DuPont. Subtask 2 - TERAstaff will: a. diedveentliofpyianlgl RpeofsesirbelnececriDtoiscaelstfooxrictohleogoriacla,lisnthuadliaetsiosnu,itaanbdledeforrmal (if b. pooustsliibnlee)mertouhtoedsoolfogexypfoosrurdee;veloping said Reference Doses and for dReevfeelroepnicnegDSocsreesencionrgreLsepvoenldsinfogrtaoire,awcahtecrri,tiacnadl ssotiuldybaisdeedntoifniesdaiidn . sctuhoebnitvraesfnkien2d-ai3nm;gesetininsgubattatshke2T-2EaRnAd f2a-cbi,liatnydincoCnisnuclitnnwaitti,h OChAioT,Tteoaprmesent 4. tfoixnailciozleogRiesftesraesncceooDrodsienastaedndbyScDrre.eSntianagtsL;evels based on recommendations of the CAT Team toxicologists as coordinated by Dr. Staats. landfillsSuabntdasWkas3h~inTgEtoRnAWsohralklscPolnadnut,ctanodnethgeenLeurbaelcrkisPkuabslsiecsSsemrevnitcefoDristthreitchtrweaeter supply based on current risk {0 human health. This tisk assessment shall include: #) identificationofreasonably anticipated land use, surface water and `groundwater uses; 0000107 cs Teed From DR. STAATS Dersirion 122 1 A They may have the table and not the 2 e-mail. Are you asking == 3 o. Whatever they have. Whatever they have. ` So this was a one-page chact similar to S Exhibit 11 but all the colums are filled in by . 6 TERA? 7 A This is multi-page. Q. What were the numbers TERA picked? 5 A dent recall. 10 Q. bo you recall what their total screening 11 level number was for drinking water? : 12 A Ident recall. Iam not even positive 13 7 had then take it to a screening level, only 14 to the reference of filling in this table. This 15 table, as you see, dossn't have a column for 16 screening levels it stops at RSD. 17 Q. bo you know whether the nusbers were 16 higher or lower than those that the CAT Team 15 cane up with on Nay Sth and Teh? 20 A. I don't recall. 21. You don't recall what generally, even 22 genssally speaking what the range of the numbers 23 were in comparison to what <= 2 A No. I just briefly looked over it, and 000013 123 1 as I thought about it it made more sense to me 2 to -- and I discussed it with TERA. 3 Q. Who at TERA? a A. Andy Maier and Joan Dellrhide probably. 5 Iam positive Andy Maier. Sometimes Joan was . 6 also on the phone and sometimes not 7 But I told them that I wanted them to lead us through the process. 5 And at the meeting I told them that they 10 could make suggestions. And it would more, that 11 that table that was filled would be, not 12 presented in the sense of given to the people at 13 the meeting but that TERA could make 14 suggestions. 15 But as the meeting proceeded it became 16 clear that TERA, we were leading, but 10 17 opinionated toxicologists took the discussion in 18 hand and came up with the numbers themselves. 19 And we were, again, in agreement. And I let it 20 go forward that way. 21 Q. So you don't remember any, even remotely 22 what any of the values were that TERA had come 23 up with on its own? 2 A No. A2TT0A4CHMENT : 000013 12 1 @. Do you know, for example, what they had 2 picked, whether they picked uncertainty factors 3 of 10 for any of the UFLs, UFSs or UFDs on the 4 chare? 5 A. Idon't remember the table at all, I : 6 mean the numbers that are in it at all. As I 7 said, I simply scanned it and thought about how would, how did T want to set this up, would that 9 influence the other people. I wanted mo 10 influence at all. I wanted each and every one 11 of them's opinion. So I didn't want to 12 influence their opinions. So I made the 13 decision -- Of course, TERA would lead us 14 through it. That's their job. If they wanted 15 to make recommendations they could. But quickly 16 the group was very opinionated and made their 17 oun decisions quite quickly. 18 Q. Do you recall whether the opinions that 19 the group came up were different from what TERA 20 had suggested? 2 A. Hou could I recall when I don't remember 22 What TERA suggested. 23 Q. You got this chart from TERA and you 24 golooked at it. Was there something about it ATEACHEAL 3of 4 : 000029 : 125 1 that caught your eye that made you think that we 2 ought to let the CAT Team do this instead of 3 what TERA has come up with? + A. No. Just the fact that those S uncercainty factors were already filled in. And : 6 I didn't want the team to feel like the decision 7 was already made. It should be a time 8 decision. So it implied, Lif I would have sent Sit to them, that the decision had already been 10 made and we were simply reviewing what TERA had 11 already done. 12 I wanted it to be a group decision, so 13 that everyone's opinion mattered, everyone 14 contributed. We reach a consensus. Hopefully, 15 it is not a consensus then majority rules. 16 Q. Did anybody else get the preliminary 17 chart that TERA had prepared and e-mailed to 18 you 19 A No. 20 Q. Did you ask TERA to do anything with 21 that chart or e-mail? 22 A. Just to remove the uncertainty factors 23 and make one without the minute. 2 Q. Did you ask them to destroy that chart AdToTArCsHMENT G : -- 000021 oo