Document g3902w8NXpVQDoY1O5aoXemL
opaoz size BossLOS
Tsk CINCINNATI
@oor/019
-19f
TAFT,
STETTINIUS & HOLLISTER
wormemaronen
LLP
AR
226
1098
425 WALNUT STREET
romanFREgeTonros
CINGINNAT, OHIO 462023957
ERE os
cEomRmangreen Ei
coma WATE,
wonstonon
FREE,
wk sa49H q
.
EERE
FAX TRANSMISSION
Date: June 10, 2002
From: Robert A. Bilott, Esq.
Direct Line: 513/357-9638
To: Christopher Jones,Esq.
FAX #: 614/644-3184 Confirmation #: 614/644-2782 To Lilian Pinzon, Esq.
FCoAnXfi#r:mat3i1o2n/8#8:6-0371427/886-0664 To:
FAX #:
orConfirmation #:
FAX #: Confirmation #:
[To: Greg Smith, Esq. FAX #: (614) 728-1803 Confirmation #: (614) 644-3037
0: Mary Dominiak |FCoAnXfi#r:mat2i0o2n/5#6:4-240724/5564-8104
To:
orFAX #:
|Confirmation #:
FAX #: Confirmation #:
=
=
g=
5 33
2 3--58i3m
o =
ETR--EaOSaEdNEect ([1T32)PC9R81a-020ea 5 ,Tax. 17C3o.veToBsaend tToow forrTo aEo| reici7g2neh 19
eT e e rT e TbyomayS Deoinsmetan pe whe 0 2 0
Seontr1o
TiTM:me: gorON NIVINOD
XX
EDBYFIX OPERATOR
CMR:
67236
\ ConRm
} 00/1002 18:20 Bassi0z08
TSG CIversaTL
i
ee
cometsures ra
J
Rsoiosroen3xg6ra7A.n.5aB0m3ei8ano
TAFT, STETTINIUS & HOLLISTER LLP 1800 FIRSTAR TOWER
425 WALNUT STREET
CINCINNATI, OHIO 45202-3957 oa s13$3185132081300205 P--
June 10, 2002
@oozvo10
c noE n
El
SEER
ire
TELECOPY
Chris Negley, Esq.
WeEsntviVriorngmieninataDlepParorttemcetnitonOf
Office Of Legal Services
C1h3a5r6leHsatnosn,foWrdVStr2e5e3t01
EPnavmirNoinxmoenntal Advocate PrWoetsetctViirogninia DepartmentofEnvironmental
1356 Hansford Strect
Charleston, WV 25301
James Becker, M.D.
MCaernsthearlflorUnRiuvrearlsaitnyd Environmental Health S1u6i0t0e M1e5d0i0cal Center Drive.
Huntington, WV 25701
`MWainlaligaemroTfooSmoeuyrce Water Assessment PWreosgtraVimrginia DepartmentofHealth and Human Resources
Bureaufor Public Health
8Ch1a5rlQeusatrorni,erWSVtree2t5,3S0u1ite 418
Dr. Dee Ann Staats
`WEenstviVriorngmineinataDlepParorttemcetnitonof
1356 Hansford Street Charleston, WV 25301
JNaatniRo.naTlayIlnosrt,itPuhe.Dfo.r Chemical Studies 2Ch3a0r0leMsatconC,orWkVlc A2v5e3n0u4e, SE.
Joan Dollarhide, Ph.D.
MToixcihcaoelloDgoyurExscoenl,lPehn.cDe.for Risk Assessment C1i7n5c7inCnhatais,eOAHven4u5e223
BDiarrebcatroar,TaOfyfliocreofEnvironmental Health SWeersvticVeisrginia DepartmentofHealth and Human Resources - Bureau for Public Health
815QuartierStreet, Suite 418 Charleston, WV 25301
06/10/02 18:25 Bossio20s
TSH CINCINNATI
@o03/019
June 10,2002 Page2
Jennifer Seed
US. Environmental 4M1Str0 eet, S.W.
Protection
Agency
Washington, DC 20460
Samuel Rotenberg, Ph.D. (3WC11) U.S. Environmental Protection Agency 1650 Arch Street Philadelphia, PA 19103-2029 RUSoSg.erEnRveiirnohnamretntal Protection Agency Region Ill 1650 Arch Street Philadelphia, PA 19103-2029 John Wheeler, Ph.D. (E-29) ATSDR 1600 Clifton Road, N.E. Atlanta, GA 30333
Christopher Jones, Esq. Director Ohio Environmental Protection Agency 122 South Front Street Columbus, OH 43215 Lillian Pinzon, Esq. (C-141) UR.eSg.ioEnnvVironmental Protection Agency 77 West Jackson Blvd. Chicago, IL 60604-3590
Janet E. Sharke, Esq. (3EC00) ReUSgSi.oEnnIvlilronmental Protection Agency Office OFEnforcement, Compliance
and Environmental Justice: 1650 Arch Street Philadelphia, PA 19103-2029 Garth Connor RUSeSg.ioEnnvIillronmental Protection Agency 1650ArchStreet Philadelphia, PA 19103-2029 John Cicmanec, DVM U.S. Environmental Protection Agency 2Ci6ncWiensntatMi,arOtHin L4u5t2h2e0r King Drive
Laura Werner (3HS00) ATSDR U.S. Environmental Protection Agency Region Ill 1650 Arch Street Philadelphia, PA 19103-2029 Greg Smith, Esq. Officeof Legal Services O1h2i2oSoEuntvhirFornomnetnSttarleePtrotection Agency P.O. Box 1049 Columbus, OH 43216-1049 Mary Dominiak OIUniRtNed CStatLes EUnviSrIonNImeAnROt-a2lN2P6rotection Agency OCfhfeimciecoaflPoClolnuttriooln,DiPvriesvieonntion and Toxics M1a2i0l1 CCoondseti7t4ut0i5onMAvenue, N.W.
rashington, DC 20004-001
oom nz messin
TSGH CINCINNATI
@oos/o1o
June 10,2002 Page3
Re: C-8 AssessmentOfToxicity Team Work Under November 14, 2001 Consent OderBetween DuPontAndStateOf WestVirginia(OrderNo.GRW-2001-019)
Ladies and Gentlemen: and co-cAosunisnedlicianteCdhairnloeustropnr,ioWrecsotrVriersgpionnidae,nhcaevteobteheenScteartteifainedd bFeydaerSatlataegeCnocuirets,inouWrelsatw firm Virginia to serve as counsel for a classofal persons whose drinking water i or has been contaminated vith ammonium perflucrooctanoate ("C8") attributable to releases from E.I. VdiurPgoinntiad.eANsemcolausrsscoaunndseClo,mwpeasneyeksc(l"aDruifPiocnatt'iosn")frWoamshtihengatgoenncWioesrwkistihnreWsopeocdt Ctoouantsyit,uaWteisont sineveoklcvlianrgifaictahtrieoanot ftotthheemhaeanlntehorfitnhwehimcehmtbheerCso-8ftAhsesecslsasmsenwteofreTporxeisecnitt.y TMoeraems(p"ecCiAfiTcaTlelya,m"w)e established under the referenced Consent Order selected 150 parts per billion (ppb) as a "screening level" for C-8 in drinking water in West Virginia, which membersofthe class are udrsinokidnagteoinndaidcaaitleys btahsaitst.heACsAexTplTaeianme'dsbealnoawly,stihseisinffuonrdmaamteinotnalthlaytihnacsonbseiesntemntadwietahvtahielafbalcetsto `and agency guidanceforinterpreting those facts with respect to the calculation of "screening. `laenvdelpsu"bloirc"mleifeettiinmgesdsrpinoknisnogrewdatbeyrthheeatChAaTdvTiseoarimesr"eg(a"rDdiWnHgASth"e).150Bpapsbednounmtbhere,ptrheessclraeslseases `members are being ledto believe that drinking water with up to 150 ppb C-8 presents no risk of any kind to their long-term health. We do not believe thatiscorrect. Available facts and guidance do not support eiat"shcreeenirng level"or DWHA above even | ppb, let alone 150 ppb.
Although we requested an opportunity to designate a representativeofthe class members to sit on the CAT Team for purposes ofdetermining an appropriate screening level for C-8 in drinking water, that request was refused. We did not, therefore, have a representative present during the CAT Team's meeting on May 6-7, 2002, norhavewe received any minutes or written reports clarifying the detailsofthe analysis used by the CAT Team in selecting the C-8 screening level during that meeting. Although we understand that a formal report summarizing the CAT Team's screening level analysis most likely will not be available for another several months, the information that has been made available to date by the CAT Team through its public meetings in West Virginia and Ohio on May 15, and May 16, 2002, and during our deposition last `Thursday end Fridayofthe CAT Team's Leader, Dr. Dee AnnStaats,is sufficient to raise serious concerns with respect to the manner in which the CAT Team performed its analysis. Because of the public health threat involved, we are compelled to raise these concerns with you now for prompt resolution.
Based upon the information made available to date, we understand that the CAT Team understood that its purposewasto derive a "screening level" for C-8 in waterofthe nature often used as simply the threshold for triggering a cleanup or remediation ofa Superfund or other
08/10/02 15:25 @easiozos
TSG CINCINNATI
@o0s/010
June 10,2002 Paged
hhauzmaarndohuesalwtahstferosmite,xapsosouprpeostoedC-toiandDrWinHkAingdewsaitgern.ed WspeeciffuirctahlelryutnodecrosntsaenrvdatthiavtelthyepCroAteTct
Tfievae-mstceaplcpruolcaetsesd:if(s1)"sScerleeecntiinognloefve"lkefyo"r Cto-x8iciintydrsitnukdiinegs woantCe-r8t;h(r2o)ugIdhenutsiefoifcatthieonfooflltohwei"ncgribtaiscialc
edfofseicntg" lfervoeml aCt-w8heixcphostuhere"cirnidtiiccaalteedffiencte"aocchocufrtrheed "iknecya"chstoufdtihese; "(k3)eyI"desnttuidfiiecsat(itohneo"fcrtihteicCal-8effect
l"eervietli"c)a;l(e4f)feCcatlcluelvealt"iobnyofthae rperfoedruecntceoftdohseeIonrtr"aRsApDec/iReIsCE"xtfroarpeoalcahti"okneyUn"csetrutadiynbtyy dFiavcitdoirn(gUtFh,e).
tEhxetrIanptoelrastpieocnieFsaEcxttorra(poUlFa)t,iotnheUnLcOeArtEaLin-tty0F-aNctOoArE(LUFE,x)t,ratphoelSautbieohnrUonnciecr-ttaoi-nCthyroFnaicctoErx(poUsFu),r,ethe
DRaItDa/bRaIsCe Qduearliivteyd afonrdeCaocmhoplfettheene"skseyU"ncsetrutdaiiesntbyyF"acUtSoErP(AUFR)e;giaonnd I(5X)SMcurleteinpilnigcaLteivoenolsf"the
apsrsoupmopsteidodnrsinrkeignargdwiantgeardsuclrtebeondinygwleeiveglh.t aEnvdendraisnskuinmginwgatseorlecloynfsourmpputripoonselseoveflatrogduemreinvettthheat the
tChAeT"kTeye"amstuiddieenst,ifainedd tthheeaapppprroopprriiaattee ""ckreiytisctauldeifefse,c"ttlheevealpsp"rofporricaatceh"ocfrittihceal"ekfefye"ctsst"udfioers,each of
acvoarirleasbploenidnifnogrRmaEtDi/oRnIaCnsdogtutihdeanucletidmoatneostcsruepepnoirntg ltehveelCAseTleTceteadmf'osrcCa-l8cuilnathiuonmsaonfdrinking
water, let alone useofthe summarized below.
150
ppb
numberas
a
DHWA
for C-8.
The
bases
for
our
concerns
are
L The CATTeamDidNotAssignAppropriateUncertainty Factor Values.
CAT TeIanmc,alCcuAlTatiTnegatmherRepIrDeSs/enRtIaCtsivfeosrheaavcehosfttatheed tshtautdeieaschidUenncteifriteadinatsytFheac"tkoeryissttuydpiiecsa"llbyy the aesvseingnleesdsac"odnesfearuvlatt"ivvealvuaeloufe o1f0,1w,ihfitchherceanisosnulffyicbieenrtediuncfeodrmtaotiaolnesosrcdoantsaertovactoinvfeivramltuheatotf3heor basis for the standard default valueof10 is not appropriate. Althoughthe calculations provided by the CAT Team indicatethatthe standard, conservative default value of 10 was used by the aCpApeTarTsetahmatftohretCheAUTFT,eaanmd UgenFerfaalcltyorsselienctceadlctuhleatlienagstRcEoDnSs/erRvIaCtsifvoerveaalcuheosffotrheea"chkoeyf"thsteudies. it remaining Uncertainty Factors. As explained below, it is not clear how the CAT Team can j`uasntdiafygetnhceyusgeuoidfatnhcoes.e(lSeeses,ceo.ngs.,erEvxahtiibvietUCnc(eUrStaEiPnAt'ysFa1c/t1o7r/s9,2gi"vBeanckagvarioluanbdleDioncfuomrmeanttio3;n oOnffCi-ce8 of Drinking Water Health Advisories") )
A. The CAT Team Did Not Apply The Correct "LOAEL-To-NOAEL
Available data and guidance does not support the LOAELt0-NOAEL Extrapolation. Uncertainty Factor (UF) values used by the CAT Team in developing its screening level for C-8 in drinking water. Available guidance confirms that the UF, factor, whichaddressesthe
06/10/02 15:26 @aasiozos
TSU CINCINATI
@oos/010
June 10, 2002 Page 5
(un"cLeOrAtaEiLn"t)y,inshheoruelndtbien kexetprtapatoltahteindegfdaautlat vfarluoaemoLfo1w0e,sutnlOebsssearvNaoblOebsAedrvvearbsleeEAfdfevcetrsLeevEeflfect
pLoesvietlio(n"iNnOsAeEveLr"a)l owtahseracitsukalalsysiedsesnmteinftise,d sfourchthaessUtSudEyPiAn'qsuersitsikona.sseUssSmEenPtAfhoras1,ta3k-ebnuttahdeiene.
NthOatAaEbLenocrhLmOaArkELdo,ssehloeuvledl b(e"BvMiDeLwe"d),asaltthheoeuqguhivnaoltednetfoinfeadLaOsAbEeLi.ngItfhetheequBivMaDleLntoisfccliothseertot2he
NLOOAAEELL, iistnisotpairdteinctuilfaireldyfaoprparosptruidayt,estioncreenedfefrecittstmheayeqtuhiveanloecnctuorfmthuechLbOeAlEoLw,theespeLcOiaAlElyLiofar
TBeMaDmLa.ndFtohretBheMCD-8L2(-0g.e4n2ermagt/ikogn/rdeapyr)odiudcetntiivfeierdatbsytutdhye,CnAoTNOTAeaEmLiswaclsosideetnotitfhieedLbOyAtEhLe C(1AT
emfgf/ekcgt/ldeavye)l.foIrntahdedi3tiMon,19t8h3e tCwAo-TyeTaerarmatisntcuordryecatslay NviOeAwEeLd,theev1e.n6tBhMouDgLh 1r.e6fewraesncieddenatsifaiecdribtyical
ctahlecCulAaTtedTebyamthaesCaALTOTAeEaLmfowratshethestsuadmyemaaskitnheg LitOiAmEpLo.ssTihbetloeCAdiTsTpuetaetmhaaltstoheerBreMdDinLlabeling
NthOeA0E4L7,crgiitviceanlthefafteUctSlEePveAl ihdeandtijfuisetdcboyntfhierCmAieTnd Titesdarmafftohretahleth19a9s3sePsaslmaeznztolfoor9C0--8datyhasttuthdey aso
P0.e4r7fleufofreocotclteavneolatweasAcaiLdOaAndEiLts-Sn altsa(oNUSOEAt PEAL,.O(PSPeTe D(r2a/f2t0/H0a2z)a(rads Aasmseensdsemden4t/1o5f/02) ("USEPA
Report"), at 47.) The existence ofa 90-day LOAEL essentiallyatthe chronic BMDL (0.47
a`vpeprrsoupsri0a.t4e2. mNge/vkegr/tdhaeyl)esisn,diictaatpepsetahrastetfhfatectthse pCrAobTabTleyaomcciunrapbperlooprwitahteelByMseDleLctaedndfa2rUlFes,s of 10 is
conservative Of NOAELS.
UF,
values
of
|
and
3forstudies
in
which
LOAELS
or
BMDLSwereused,
instead
than NOEAvEeLniSftjuhsetriefywuesreeoafadisdpefuatuelatsvtaoluweheltohweerrctrhiatinca1l0effofrecttheleUveFls,btahseeCd AonTaTneytahrinhgasotnhoetr
hexupmlaainnheedawlthhyasitpdoisdsinbolte,chwohoiscehtwooeurlrdonhatvhee rsiedqeuiorfedbesienlgecatsiocnoonfsterhveatdievfeaualntvdaalsueprooftec1t0ivase tohfe
eaxpipsrtoepnrcieaotef UaPn,NVOaAlEueLf.oraInn yootfhetrhweorsdtsud,iiefsthwehreerewtahse acnryitricoalomefffoerctalregvuemlewnatsansotto bwahsiecdhoUnFt,he
bveailnuge ctahenmboesjtusptrioftieecdtfiovreoafnyhoufmtahne h"ekaelyt"hs--tudnioets,thwehlyeasdtidprtohteecCtAivTe?TeMoarmeonvotere,rritosnetehmessisdteraonfge
pthraottetchteinCgAhTumTaenamhe(ailntchlaundidntghmeeemnbvierrosnomfegnot)veorpntmeednttoaslelreecgtuflaartolreyssagceonnsceirevsacthiaverg(eadnwditthhereby
alepspsropprroitaetcet.ivMe)orvaelusepsecfiofrictahlelyU,Fi,n Jfaanctuoarrythoafn2e0v0e2n,tthheemmaannuuffaaccttuurreerrooffCC--88,bethleie3veMdCwoamspany
('3M"), submitted Report") in which
to USEPA a Lifetime Drinking Water Health 3M stated that the UF, factor for the 26-week
Advisory for C-8 (the "3M monkey study reviewed by
the
aCnAevTenTealemssschoonusledrbvaetaisvse,iglnesesdparovtaelcuteivoefU6.F,(Sveaelu3eoMfR3epfoorrtt,haete8x)actYesta,mtehemConAkTeyTesatumdys.eleTchtiesd
simply does not `Team meeting.
make
sense,
particularly
when
3M'
lead
toxicologist
for
C-8
was
at
the
CAT
08/10/02 18:26 Beasiozos
TSE CINCINNATI
@oor/oe
June 10,2002 Page6
B.
The CAT Team Did Not Apply Extrapolation Factor" (UF).
The
Correct
"Subchronic-To-Chronic
Exposure
ExtrapolAavtaiiolnabUlnecedrattaaianntyd Fgaucitdoarnc(eUFal)sovadloueessnsoetlescutpepdorbtytthheeSCuAbcThrToenaicm-tfoor-CthhreovnaircioEuxspo"skuerye satsusdiigense"draevdeifeawueldt bvaytluheeoTf1ea0m,.unAlcecssortdhiensgtutdoyCaAtTissTueeaims are"pcrhersoennitca"t(iivefse,titmhee)UstFudfya.ctIonr ais Jwahniucahrywa2s00s2u,brmeiptotretdpbryeDpuaPreodntb'ysDatutPoornnte'yssctoonstuhletaWntV,DEENPVILeRaOdNero(tfhteh"eECNAVTIRTOeNamR,epDorr.t"D)e,e A2-nyneaSrtaraattss,tEudNyVcIoRndOuNctsetdatoend bthaet hthoearfel3hfMadfbreoemn1o9n8l3y 2(tchher"oSniibcin(lsikfyetsitmued)y"st)uadinedsoaf2-Cy-e8ar ratthe asltsuodystfarteodmt2h0a0t1threeoftehreerncsetdudaisestthhea"tBhiaedgebleSetnucdoyn.d"uc(tEeNdVwIitRhOCN-8Re(pionrctl,udatin6gatnhde 89.0)-dEaNy VraItRstOuNdy b"syuPbaclharzoznoilco" fstruodmies1,99r3eqauinrdinthgeu2s6e-owfetehkemdeofnakuletyvsatluudeyobfy1T0hfoormftoherdUfFrovmal2u0e01w)hewnercealacllulating satnuRdyEDa/sRaI"Csufbrcohmrosnuicchfseteuddiiensg.st(uSdeye"E) NanVdIaRtO7,N2R6ep(orretf,eraetnc5in(grtefheere2n6c-iwngeetkhem1o9n9k3ePyalsatzuzdoylcoosvaplounesoorfe1d0biys DthuePoapnptroapnrdia3tMeaUsF;af"ascutbocrhfroornuiscetionxiccailtcyulsattuidnyg"a).n3RMEDa/lsRoCfargoremetdthheat2t6h-ewedeekfault mReopnokrte,yastt7u.d)y,UbSaEsePdAonalrseocroegcnoigtniioznetdhtahtatthtehsetu1d9y93wa9s0-"dsaigynirafticsatnutdlyy lbeyssPatlhaaznzcohlroonwiacs."a(3M "insuMbacrhcrohnoifc"thsitsuydeyari.n t(hSeederUaStEHPazAarRdepAosrts,esastm4e,n4t1.)forTCh-is itshnatotthseurapgreisnicnyg,rgeilveeansetdhatottUhSe EpuPbAlic dDerfiinnkeisngchWroantiecraHselailftehtiAmdevoirsonroitessuWbsetbantsiitael;lyUSdiEffPeArenRtisfkroAmssliefsestmimeen.t (GuUiSdeElPiAncOsf,fPicaeroAtf (U1S98E9P))A. pIrtesse,ntth,earsefsoirgen,ednovtalclueeasrlhesoswthtahen C10A,iTncTleuadmi,ngwtihteh rleeapsrtesceonntsaetrivvaetsiovfe DvualPuoenotf,13,Mt,o atnhed e3xMa,ctasndamUeSPEaPlaAzzaolllopr9e0v-idoauyslryatasgtruedeydawnedrethseubTchhormonfiocr.d 26-week monkeystudythatENVIRON.
2002 asItaa"lcshoroisninco"tsctluedayr,hwohwetnhethCeApeTriToedfarmovmitehweedfitrshted2o-sgienngeroafttihoenpatartensttuadlygbeyneYraotrikonfrtoomthe sshaocrritfeirctehoafnth2eyesaercso.ndIngfeancetr,aetaicohnogfenraetraptuiposnowfatshoernaltysawpapsroxdiomsaetdelfoyr8onmloyntahpser-i-ocdonosfiderably approximately 4 months, which is only approximately 10%ofthe 2-3 year lifespanof a at. USEPA specifically defines such exposures of approximately 10%ofthe experimental animal's lifespan as "subchronic." (See, e.g., Exh. C.) Its not clear, therefore,howthe CAT Team jwuhsteinfideadtsaelfercotmioanocfhrtohneicle(alsitfectoinmsee)rvsattuidyveisvaulsueed.of| for the UF value, which isjustified only
Tus not clear at ths pointwhetherthe Cat Team even reviewed the Biegel Study.
06/10/02 18:27 Bo3si0z05
TSA CINCINGATI
@oos/019
June 10,2002 Page 7
C. The CAT Team Did Not Apply The Correct "Database Quality And
CompUncl erte aintt yFace torn(Ue F).ss
selectioCnoufrrtehntelyl-eaasvtaicloanbsleervdaattiavaenvdalaugeenocf1y gfuoirdtahneceDaatlasboadsoenQoutalsiutpypoarntdtChoemCpAleTteTneeasms's
`Umnecmebretrasi,nttyheFaUcFto,rf(aUctFor)iisntchaelvcaullauteiunsgeadntRoAaDc/cRoEuCn.t fAocrcpoortednitnigaltounscteartteamiennttysabriysiCnAg TfrToema2mless
than complete database ENVIRON, stated in its
for the particular chemical at issue. January, 2002, report submitted to
tDhuePCoAntT'sTeoawmn'scoLnesaudletarn,tD,r.
Staats,
tvahlauateodfa1t0abafsoer itshenoUtFcoo,nusnildeesrsedal"lcooftmphleetfeo"llfoowripnugrdpaotsaesexoisftds:evi"a(t1i)ncghfrornoimctthoexisctiatnydsatruddideefsaiunlt2
sstpuedciieessi(n1 2nosnp-ercoideesn."t),((E2N)VaImRulOtNi-Rgeepnoerrta,tiaotn2r5e.p)roAdcuccotridoinnsgtutdoyE,NaVndIR(3O)Nd,evtehleodpamteanbtaasletfooxricCi-ty
`cannot be viewed as complete, developmental toxicity studies
even though in 2 species
"the available database for [C-] includes (rat and rabbit)" and "[plreliminary results
ofa
2-
tgheinsetraitmieoannroenp-rroodudcetnitocnhsrtoundiyc asrteudny.o"w(aJvda)ilaTbhlues,," abceccoarudsientghteoaDvuaiPloanbtl'esCo-8wndactoanbsausleta"nlta,cks at
vEiNeVwIeRdOasN,"ctohmeplCe-t8e.d"ataCboanssee,queevnetnlyw,itthist,heaegxaiins,tennocteocfletahreh2o-wgetnheeraCtAioTnTraetasmtucdya,ncjuasntniofty ubsee of
tahpeprloeparsitactoenUseFr,vavtailvuee,anwdhelenasetvpernoDtuecPtoinvet'vsalcuoensouflt1afnotrbaelllioeftvehsethaavtaitlhaebdleatCa-b8assetufdoireCs-a8s itshenot
complete and could notjustify a UF value of 1.
sponsor`eTdheby"cWomVpDleEtePneosns"Moafyth1e5,a2v0ai0l2a,blienwCh-i8cdhatthaebaCseAwTaTsedaimscursespreedsdeunrtaitnigvaespwubelriecnmoeteatbilneg ttohei2de6n-twifeyewkhmaotnakcetuyalsltyudcya,uasnedd tsheeedmeeadthtoofsaugngyeostftthhaetmsoonmkeeoyfstahteaenffyeocfttshoebsdeorsveedleivneltshedurrating sutnucdeiretsaimnatyywnooutlcdorarpepleataer wtiotrhaiesfefescetrsiooubssecrovnecderinnspwriitmhatreesspoercthutmoatnhse."cSoumcphleatpepnaersesn"tofthe `daaptpaebaarsteoosnupCp-o8rtwimtulhtriepslpieccattitoonporftimhaetesaunmdofhtuhmeanfihveeaUltnhc.ertSauicnhtyunFcaecrttoarisntbyyawonuladd,diitniofnaaclt, ""eMxopdriefsysiinngg Freascitdoural(MunFc)e"rttahiatn,tyacacsosrodciinagtetdowDiutPhotnhte'sstcuodnysualntdandta,taEbNaVseIRnoOtNe,xpilijciutsltyiftireedatfeodr by tehxeamsitnaendd)a.r'd UF(;EN(eV.Ig,ROcoNmpRleeptoernteastso2f1)the"oAvsewrialtlhdtahteabUaFs,e otrhethvealnuuemobfetrhoefMspFecmiaesy be up to e1v0a."lua(tiidn)g ICt-w8osutluddiaepsp,egairvtehnatinudsiceaotfioansMofdriofmytihnegrFeaccetntor2-wgoeunledrabteiopnarrtaitcsutlaurdlyytahpaptrCo-pr8icaatuesiens tdheevmesleolpvmeesntdaulrienffgetcthse.puYbelti,cdmeespeittiengcoemxmpreenstssinmgaudnecebrtyatihnetyCwAiTthTeextarmaproelparteisoenontfattihveesexisting ditadtoabeassneottoahpupemaarnthhaetaltthheaCnAdTagTaeinadmurcoinnsgitdheereddepuosseitoifonaonfytMhoediCfAyTinTgeFaamc'tosrolefadaenry, Dvra.luSetaiants, calculating its REDS/RECs
06/10/02 15:27 @easiozos
TSG CINCINNATI
@ooss01s
June 10,2002 Page8
I. The CAT Team Ignored Potential C-8 Exposures From Non-Drinking Water
Sowpess.
`CAT TeIatims ncootnvcelretaerfdriotsmtREhDeSi/nRfoErCmaitnitoonitmsa1d5e0 apvpabilnaublmebteordfaotreCb-y8tihnedCriAnTkiTngeawamtehro,worthe
exactly what the purposeofsuch Dr. Staats, has explained that the
a "screening level" isinthis case. REDS/RACs were converted into a
The CAT Team's 150 ppb screening
Leader, level by
ucaslicnugla"tUioSnEsPwAerReehgaisonnoItXyeStcrbeeeenninegxpLleavienle"d,cailtcauplpaetairosnst.haAtltthheocuaglhcuelxaatcitolnyswihncaotrtphoorsaeted the
sfoarmuesestianndcaalrcduUlaStEinPgAa dDeWfaHuAlt,vawlhuiecshfoarscsaulmceulaatsitnagnadadrrdihnkuimnagnwabtoedryewxepiogshutroefli7m0itk(g"aDnWdEL")
sitnacnordpaorrdahtiuomnaonftdhreinCkiAnTg wTaetaemr'rsat0e.o00f242liRtAerDs/pReIrCdaiyn:toDthWisEsLam=e(sRtIanDd/aRrIdCDxW7E0L/2)f.ormAufltearyialell,ds
147 ppb,whichwe understandwasthen =147ppb). The CAT Team apparently
rounded used this
up by the CAT Team to 150 ppb (0.0042 DWEL as its "screening level" under the
x
70/2
r1e5f0erpepnbceDdWCEonLseinnttoOradDerW,HiAn.steaIdnofffto,llwoewiunngdetrhsetsatnadntdhaartdtahgeeCnAcyTgTueiadamn'cselfeoardecro,nDvre.rtSitnagattshe
odfitdhneottyvpieeowft"hsectraeseknoinftghleevCelA"TtyTpiecaalmlyasusdeerditvointgriaggleirfectliemaenDupWoHblAiga(taisonosp)p,oasnedd tthoedreerfiovraetdiiodn
not consider the available agency guidance for deriving lifetime DHWAs. Ifthis is the
"ssocurreceencionngtrliebvuetli"oanpfparcotaocrh(a"cRtSuCa"ll)yruesqeudirbeyd tuhnedeCrAaTgeTnecaymg,utihdeanCcAeTforTecoanmviegrntoirneagd tDhWe EreLlatiinvteo
alifetime DWHA, which both 3M and DuPont's consultant, ENVIRON, stated should be used in
ccaolucludlabteinegxpaonsyeCd-t8odCr-inkfirnogmwasotuerrcsetsaontdhaerrdtthoaanctchoeuinrtdrfoirnktihnegpwoatteenrti.al that community members.
Asrequiredunderagency guidance forcalculating lifetimeDWHAS, Both 3Mand ENVIRON have stated that a DWEL should be multiplied by the standard RSC default value of e0x.2p(os2u0r%e)'tsoucahcacsoun"tffooodrtahned "arire.l"at(i3veMcRoenptroirbtu,taiton4o. fSveaeriaolusos pEoNteVntIiRalOpNatRhewpaoyrstatott2o6t.a)l (ICn-o8t)her words, the more conservative DWHA process for identifying a "safe" level oaf chemical in dtyrpiinckailnlgy wmaatyer,bereeqxupioressedusteoofatchheemRicSaCl tforotmakneoinn-tdorianckcionugntwattheerfascoturtcheats,csoumcmhunasitaiyrmpoelmlbuetirosn containing the chemical, soils contaminated with the chemical, food contaminated with the chemical, efc., which,ifignored when determining an exposure level for drinking water, could result in too highof atotal daily doseofthe chemical from ail sources, combined. Conversion of the CAT Team's 150 ppb number into a more protective DWHA by using the standard RSC factor advocated by both 3M and DuPont's consultant, ENVIRON, would require the CAT Team to multiply its 150 ppb number by 0.2 (a reductionofthe 150 ppb number by 80 %)totake into accountthe potential that membersofthe community may be exposed to C-8 from sources other thandrinking water, such as air pollution. That step alone would reduce the CAT Team's `umber from 150ppbto 30 ppb. Useofthe DWHA RSC would appetoabre particularly
06/10/02 13:25 Baasiozos
TSaH CINCINATI
@ot0/018
PJuangee 10,2002
iatpsprWoapsrhiiantegtionnthWiosrskitsuaptlainotn.when DuPonti discharging C- directly into the air from stacks at
factor, tIhneaCddAiTtioTne,awmhemneamsbkeerdssspteactiefdicdaulrliynwghtyhetrheeceCnAtTpuTbleiacmmedeitdinnogtsutsheatthtehe00..22((2200%%))RRSSCC Cw-a8si"snontotapaplvioclaabtliel,e"" bcehceamuiscealthaendC,AtTheTreefaorme,mceomubledrnsotalploesgseidbllyy heesdca"puenafnriommotuhselyd"riangkrienegdwtahtaetr stotactreemaetnetasniyn iintsharleacteinotndrriasfkt fHraozmartdheAdsrsiensksimnegnwtatfoerr Cit-s8elft.hatTh"iqsuasneteitmastisvteracnognec,lguisvioennsUrSeEgParAd'isng PraFteOsoSfarveolcaatpialbizlaeotifontfrarnosmpowrattoeurtoorfHweantreyr'.s" L(aUwScEoPnAstRaentpoarrte,naott1p1o-s1s2i.b)le.MorHeoowveevre,r,evAePniFfOthaend iexnihsatliantgiodnartiaskp,rothveedCtAhTatTiteaismn'ostrpeojsescitbiloenfoofrtahneyRCS-C8 btaoseesdcaopnetfhreoimnhdarliantkiionngriwsaktefrrotmo ptohese any 0dritnakkienignwtoataecrictosuenltfpcootmepnlteiatleleyxpiogsnuorreestothCe-8pufrrpoomsesofuorrcwehsoitchhetrhtehRanSCdrfiancktionrgiswautseerd, ~suncahmaeslyC.`8TienamaircaenmijsusstiiofnysnfortuosmitnhgetDhuePoRnStC'sfaWcatsohr ifnogr tpounrpWoosreksso.fcaIlticsunloatt, itnhaegredfroirnek,icnlgeawratheorwstthaendCarAdT RfoSrCC-s8h,opualrdtibceuluasreldy,wahnednitbiosthno3tMcleaanrdthDautPCon-t8'wsilolwnnotcoensscualpteafnrt,omENdrViInRkiOnNg,waatgerre.e that the
I. TheCATTeamDid NotIncludeCancerDataInItsScreeningLevelCalculations.
cancer
eIntdsponionttsc.leaRrecwohgynitzhienCgAthTatTCe-amedxipdosnuortephearsfobremena
dose-response analysis for confirmed to cause Leydig
C-8 cell
using
atunmiomrasl,mhoedpeatloucesleldutloaritdeunmtoirfsy,parnodbapbalnecrheuatmiacnaccairncarincoegllentsu,mDourPsoinntr'osdeonwtsn,ctohnesumlotsatntc, ommon
rEeNpVorItRitOsNu,bmiintctleuddetdo tahdeoCseA-TreTspeoanms'esanLaelaydseirs,fDorr. cSatnacaetsr,einndpJoainnutasryionfth2e00o2ri,gitnhaalt avedrvsoicoanteodf athe
C1o0npspebntleOvredlefrorbeCt-wieenndrDiunPkoinntg awnatdert.he(SSteaeteEoNfVWIesRtOVNirRgeipnoirat,reaqtu2i6r-e3s0t.h)e CInAaTddTiteiaonm, ttohe
wpheernfoarsakmed"dheotewrtmhineatCiAonToTftehaempiontecnotiraplocraarctiehndeogeCn-i8cictayncoefrCd-a8t.a" in(tCoonitssecnatlcOurldaetri,onast fC4o.ar)C-Yet.
screening level for drinking water, CAT Team representatives have stated that the triad of
cancers atributable to C-8 exposure had somehow been determined by the CAT Team to be
totally "irrelevant" to humans. Any such conclusion would, however, be completely inconsistent
`with the conclusion recently reached by USEPA in its draft Hazard AssessmentforC-8 released
j(uCs-t8]2 hmaovnethnsotagboe,eninfuwlhliycehluUciSdEatPeAd,isttasteadstshuatme"dasthtahtetmheechtaumnoirssmisnodfucceadrciinnroagtesnaircearcetlieovnaonftto
humans" (USEPA Report, at 9 (emphasis added) (Report also refers to 1997 Clegg panel
wfihnednintghsetmhaetcLheayndiesgmscoelflatcutmioornsiarne rnoodtecnotmspalreeteallyeguintdiemrasttoeode.n)d poTitntis,fotrhecraenfcoerre,rinsoktacslseaersshmoewnt
the CAT Team, with USEPA participants, could support a totally contradictory conclusion.
0310/02 1828 massioaos
san crvcaans
Boos
JPuangee 1100, 2002
guidanc`eThgeenienrhaetreensttuinncnoinnsgisdtiefnfecrieenscbeestwbeeetnwetehnetCheA"TscTreeaemni'nsgalneavleylsi/sclaenadnuapvaniulmabbleerfsacgtesnaenradted
`using the CAT Team anelysis and the levels that would be generated using an analysis that is
m`moarnenecronrseiqsutiernetdwtiotehnasvuarielaabdleeqduaattae apnrdotaecgteinocnyogfuhiudamnacne hienatletrhprfertionmgetxhpatosduartea itno tchheemciocnaslersviantive
drinking water. The nature of someofthose differences is `highlighted in the attached charts
(`EwxohuilbdiatpspAeaarntdo Bb)e smhoorweisnugptphoertneudmbbyerasvaailllaebgleeddlaytuasaenddbaygtehnecyCAguTidTaencaem, aansdsutmhienngumfobrers that
purposesofargument only that one does not dispute the "key" studies, "ortial effects" and
"icnrdiitciactale
defifnetctholseevealtst"ascehleedcctheadrtbsy,
tuhsee
CoAf TavaTielaabmleadnadtathaantdnoagMeondciyf
yguiindgaFnaccetworouisldwanroratntseudp.p.or
As
t
useofan exposure level for C-8 in drinking water above even 1 ppb, which also `happens to be
the "safe" level for C-8indrinking water that DuPont has used. internally since at least 1991.
`Thus, given thefact that availabledata and guidance does not support the CAT Team's 150 ppb
Stleevpesl ftoocrlCa-ri8fyinhdorwinaknindgwwhaytetrh,ewCeArTequTeestamthcaatmteheuSptwatietahnad nFuedmebrearltahgaetnicsimeosrteaktehiamnm1ed0i1a5te
times higher than the numbers calculatedjust several months ago by both 3M and DuPont's
consultant, and more than 150 times higher than any number that would be possible when
viewing the available facts and available agency guidance in the light most protective of human
`ahlesaoltbh,eepnarrteicvuileawrelyd wbhyeDnuPthoenCt AanTdT3eMa.m Wdied anlostorreevqiueewsttpheroremsputltcsolafrainfiycsattuitdoionesthtehaptuhbalidcntohtat
tDhWeH"ascsr.eenWineg allesvoelr"eqnuuemsbtethrasttbheiengStdaetevealnodpeFdedbeyratlheagCenAcTieTseiammmareenodtithtaeaskteaetmhelosytehisntgepass
necessary to abate and remediate this on-going threat to public health. Thank you.
Very ml yous,
bobert bo. Bile? 7 fhidone
Robert A. Bilott
;
RAB/mdm
cAet:tachmRentEsdison Hill, Esq, (wlo attachments) Lary A. Winter, Esq. (W/o attachments) Gerald J. Rapien, Esq. (w/o attachments)
06/10/02 13:25 Boasiozos
:
S&H CINCINATE
@orz/01s
A
5
EXHIT A CAT TEAM REGION IXSCREENING LEVEL ANALYSIS
Amato bratsah A nd CV or 1 seCoitn
CoWmwpe| wre| saTvoe
Portes (oy . ost
orNrem yin artim
`5 | r[eenvoonay[|rEoarmirdeay omey
5
3i
fif r rncreiasesdo litverwt ee igehtnincs aee, Be 042(BMDLin
T rhiaetorweoot
2|
Wo sors
||maormeveserenssis||
Sr3eihg)ho
:i
e-nemeptooimte| 0p7anyo.
&
05 |
oTGhoromwomnyedecasml. ||r [DNeAcSrs emoiadsbds oooenmedrs ||
G"Soo10en
i u
s e Citn tamaro n te
swiors
150m
wo ofoedn
08/10/02 13:20 To3s10205
TSH CINCINGTI
@orss010 B
3
EXHIBIT I - LIFETIME DRINKING WATER ANALYSIS
:| --Co=iC E =-- = ET--mi [MR i
Emme|
EEEEE [ahead
EEEEE E EJEE oEEEeEElSsE0 8 Thontatl |Desrrowihoeemodne.
: Ei, a
(Goldeontas. 1978)
[= eo
|
om_ llI
oa
--
i
2
|
06/10/02 18:29 B93810205
TSE CINCINWATI
@o1s/019 c
ovi00z size Bessioaos
Toen crvcnwatt
- EPA's IRIS Site- Drinking Water Health Advisories
@oir0
Pagedofs
SaEUrPredAtoe
BgeerSeySoest potaton
i
RD
5A 9
4
B&s)
Tesit ion Syn
01/17/52 BACKGROUND DOCUMENT 3 OFFICE OF DRINKING WATER HEALTH ADVISORIES
"fTohreiUn.dSi.vidEuPaAl 'csonOtfafimcienaonftDsrirnepkriensgenWtaitneg rle(sOsD-tWh)andiefveeilmoepsexHpeoaslutrhesAdovfisOonrei-edsay(,HATse)r-
day, Longer-term (an exposureofseveral months up to 7 years), and for Lifetime exposures. The HAs are developed from data describing noncarcinogenic endpoints of toxicity. HAs developed for Lifetime exposures are based on the chemical's oral
Reference Dose (RID) (described in Background Document 1A1). HAs serve as.
ispniflolrsmoarl ctoencthnaimcianlatgiuoindasnictuealteivoenlssotcocuars.siTsthepuyblairce hneoatltlehgoaflfliycieanlfsowrhceeanbleemzenrdgeanrcey Subject to change asnew information becomes available.
The HAs represent guidance levels for drinking water exposures. The values for the Oenxep-odsauyr,e Tsuecnh-adsafyoaondd Loornagire.rF-otreremacehx,ptohseurreespueltriinogdsvadlouen,oitncmogn/sLi,dearsostuhmeerssothuartce1s0o0f%
ooefnxlapyonsfuionrrdeiabvnyidaaudpaulpl'ltsyfeirxnopgmoasaurrcehelractoionvimecesssotufurdrcyoe,mcddoorneitsnrkitibanukgteiwoianntte(orR.cSoCTn)hs.iedIelnirfatetthiiomaneboHsteAhn,ecrecosaoflucruclchaeetsmeidocfal
specific data,anRSC of 10 is used for inorganic contaminaanntds an RSCof20 is used for organic contaminants (NAS, 1977)
TheHAs ae derived employing an approach similar to that used to deve REDs in that
a NOAEL (or LOAEL) is divided byanuncertainty factor (UF). This value is adjusted
for the body weightofthe protected individual and assumed daily water consumption
The study selected for deriving a HA ideally employs an oral routeof exposure. Tuhseirnegfdoireet,aray sotrudgyawvhaegereetxhpeoscuhreemiarcealalesxopaocscuerpetaibsleb.y dInrhianlkaitnigownadtaetra iasriedeoanl.lySutsuedideisn instances where oral data are not available and by applying specific assumptions used
in route-to-route extrapolation.
TthheeHdAattaiumseedpfeoriroHdAbeidnegricvaaltciuolnasteadr.e FgoernearaOlnlye-fdraoym HaAs,tutdhyeosftcuodmyptairmaebpleeridoudrasthioounldto
iidfetahlelydabteafbraosme aisliinmgilteede.xpTohseurTee.nH-doawyevHeArm,aloyngbeer scatlucduyladtuerdatSioonms masytubdey aocfcleepstsatbhlaen
or equal to 30 days. Developmental studies involving maternal exposure during part of
the gestational period have also been used.Longer-termHAs are derived from subchronic studies where animals are exposed for approximately 10%oftheir lifetime
hitp-//srww pa goviiriswehpliris/dwater. html
05/31/2002
08/10/02 18:30 Bessios
TSG CINCINNATI
* EPA's IRIS Site - Drinking Water Health Advisories
Page@2o01fs3/o1s
(for example, 90 days for rodents). `tTahregeNtOoArEgaLnSsaffoerctLeOd.AEALsStuadryetihdaetntdiefmieodnsftrroamtesstuadideossteh-artepsrpoovnisdeerielnaftoiromnasthiiopnison the pnroetfcerornesdidoevreerdafosrtuHdAy wdhereirveatoinoln.y a single dose has been tested. Lethality studies zre H`TAesn-daarye HdeArsi,vetdhetoprportoetcetctedseinnsdiitviivdeuamleimsbaesrssuomfedthteobpeopualachtiilod.n.TFhoercthhieldOnisea-sdsauymaendd otfowwaetiegrh/d1a0y.kgFournlaesLsonogtehre-rwtiesremneoxtpeods.urIet,isHaAlsSo aarsesucamlecdultahtaetdtfhoercbhoitldh caocnhsiludmeansd|aLn adult, It is assumed that an adult weighs 70 kg and consumes 2 Lofwater/day. For 2 tLhiifseteixmpeoseuxrpeoscuartee,gtohreyHfoAraliisfoentliymec.alculated for an adult, since the child will not be in HAS are calculated according to the equation HA = (NOAEL or LOAEL) (BW)/(UF)(__L/day) = _ mg/L `(wthheeree:xpNoOsuArEe Lin =mgN/ok-gObbswe/rdvaeyd)-Adverse-Effect Level or LOAEL = Lowest-Observed-Adverse Effect Level (the exposure dose in mg/kg bw/day) BW = assumed body weight ofprotected individual (10 kg child or 70 kg adult) UF = uncertainty factors, based on quality and natureofdata __ Liday = assumed water consumption TT Liday for child or 2 Liday for adult)
`The uncertainty factor accounts for the inherent variability within the human
``pgoopoudlaatciuotneanordcbhreotnwiecenhutmheanandiamtaaltshpaetciiedse.ntAifny uanNceOriAaEinLtayrfeatcthoerobfas1i0sifsorutshede wHhAe.nIf
the human data areofgood quality, but identify a LOAEL rather than a NOAEL, then
NanOuAncEeLrtafirnotmy
factorof100 is used. An a well-conducted animal
unces- tainty study serves
afsactthoerobafs1i0so0fits haelsHo Au.seIdfawnhen
a
aonfitmhaelHsAt,udtyhtehnataniduenntciefriteasinatLyOfAacEtLor,oofr10a0n0anisimeamlplsotyueddy.ofUlsiemoiftetdhqeuuanlciteyrtiasitnhtey basis
factor is largely judgmental, and may take into account the qualityof the toxicological
data base, the significanceofthe adverse effect or the counterbalancingof possible
beneficial effects.
Lifetime HAs (noncarcinogens only) are calculated from the Drinking Water
utp: epa.goviiriswebpliris dwater html
05312002
os/t0/02 18:30 moasions
tov crvemne
~ EPA'S IRIS Site - Drinking Water Health Advisories
w
rage T0108
-
EcqaulciuvlaalteendtfLreovmelth(eDeWquEaLt)ionw:hich, in turn, is basedonthe unrounded RED. DWELSs are
DWEL = (RID) (BW)/ (_ Liday)
B`cwohWnesreua:mnpdRlE_ioDnL,is/rdteahseypeuacnrteirvoteuhlyne.daedLduiolfrtcartliemfReerDHenAcdSeervaiasvlseuudemsienfotSrheacbttoiodonynlyw1oeaifggtihvhteeancnphdeerwmcaietcneatrlagfieloe,fantdh,e total compound intake is by drinking water and are derived by the equation:
Lifetime HA = DWEL x RSC
wwhaetreer: RSC =relative source contribution; the essumed exposure from drinking
and noncarcinogenic effects. Lifetime HAs are not derived for compounds potentially carcinogenic for`humans
becauseofthe difference in assumptions. `concerning toxic thresholds forcarcinogenic
In situations where data are not available to calculate Longer-term HAs, the DWEL. `may be recommended for the Longer-term HA. For the child Longer-term HA, the DWEL may be recalculated using the child's weight and water consumption.
`For more information about Health Advisories, call the Office ofDrinking Water at (202)382-7571 or FTS 382-7571.
`Reference: NAS (National Academy of Sciencies). 1977. Drinking Water andHealth, Vol. 1. Washington, DC.
sm
j seancH wis
i
F0 oy
comomneants
o"ceea page Homk Page HoTmeeaFags
URLLpast upodatedC:r20 February 1998 hm
hitpiwww.epa.govliriswebpliris/dwater hurl
05/31/2002