Document r6NevpEbrxq4eQR3NQJ0m07rE
on
:
con
LE,
RkoCsoerer oA,sareios r
TELECOPY
TAF' T, STET.TINIUS & HOLLISTERALLRPR26
1800 FIRSTAR TOWER
425 WALNUT STREET
CINCINNATI, OHIO 45202-3957 wo 13T380E2000 --
June 10.2002
-- 1182
PB
wd
Sn
Ee
=g
Z a3n3
= 55
Chris Negley, Esq. West Virginia Department Of
Environmental Protection Office OfLegal Services 1356 Hansford Street Charleston, WV 25301
Dr. Dee Ann Staats
=
West Virginia Department of @
Environmental Protection'
1356 Hansford Street
Charleston, WV 25301
Pam Nixon
WEnevsitroVinrmgeinntiaalDAedpvaorctamteent of Environmental Protection
1356 Hansford Street Charleston. WV 25301
Jan R. Taylor, Ph.D.
N2a3t0i0onMaalc[Cnosrtiktluete AfvoreCnhee,miSc.Ea.l Studies Charleston, WV 25304
James Becker, M.D. Marshall University Center for Rural and Environmental Health
S1u6i0t0e M1e5d0i0cal Center Drive
Huntington, WV 25701
William Toomey
`Manager of Source Water Assessment Program
West Virginia Department of Health and
Human Resources Bureau for Public Health
C8h1a5rlQeusatrorni,erWSVtree2t5,3S0u1ite 418
Joan Dollarhide. Ph.D. Michael Dourson. Ph.D. Toxicology Excellence for Risk Assessment
C1i7n5c7inCnhaatis,eOAHven4u5e223
Barbara Taylor
Director, Office of Environmental Health
Services
West Virginia
Department
of
Health
and
Human Resources - Bureau for Public Healt
815 Quarrier Street, Suite 418
Charleston, WV 25301
CONTAIN NO CBI
000123
June 10. 2002 Page
Jennifer Seed U.S. Environmental Protection Agency 410 M Street. S.W. Washington. DC 20460
Janet . Sharke. Esq. (FEC00) US. Environmenial Protection Agency Region [Il OfficeOf Enforcement, Compliance and Environmental Justice 1650 Arch Street Philadelphia. PA 19103-2029
SU.aSm.ueElnvRiortoennmbeenrtga,lPPhr.oDt.ec(t3ioWnCA1g1e)ncy 1630 Arch Street Philadelphia. PA 19103-2029
Garth Connor U.S. Environmental Protection Agency Region [Il 1650 Arch Street Philadelphia. PA 19103-2029
Roger Reinhart
John Cicmanee. DVM
USS. Environmental Protection Agency
USS. Environmental Protection Agency
Region [Il
26 West Martin Luther King Drive
1650 Arch Street Philadelphia, PA 19103-2029
Cincinnati, OH 45220
:
John Wheeler, Ph.D. (E-29) ATSDR 1600 Clifton Road. N.E. Atlanta. GA 30333
Laura Wemer (3HS00)
ATSDR
:
US. Environmental Protection Agency
Region lll
1630 Arch Street
Philadelphia. PA 19103-2029
Christopher Jones. Esq. Director Ohio Environmental Protection Agency
122 South Front Street ColumbuOsH, 43215
Greg Smith. Esq Officeof Legal Services Ohio Environmental Protection Agency 122 South Front Street PO. Box 1049 Columbus. OH 43216-1049
Lillian Pinzon, Esq. (C-141) U.S. Environmental Protection Agency Region V 77 West Jackson Blvd. Chicago. IL 60604-3590
Mary Dominiak FIORNCLUSIINARO-2N26 United States Environmental Protection Agency OfficeofPollution. Prevention and Toxics Chemical Control Division 1201 Constitution Avenue, N.W. Mail Code 7405M Washington. DC 20004-001
000124
une 10. age3
2002
Re: COr-d8erAsBseetswsemeenntDOuFPoTnotxicAintdy STteataemOWFoWrekstUnVdiergrinNioave(mObrdeerr N14o,_2G0R0W1-C3o0n0s1e.n0t15) adies and Gentlemen:
1idrgcioni-acAotsuonissneedrlivceiantaesCdhcaiornulnoessuetrlopnrf.iooWarrecscotlraVrsiesrsgopifonnaildal.epnhecarevsetoonbstehweehnSoctsearetteidfarinienddkiFbneydgaewrSaattlaetaregeiCsnocuirets,ionuWrelsasw fim
rPngeoiannmitia.ndaetANesedmcwloiaustrshscaoamunnmdsoeCnlo,imuwpmeanpsyeere'fkslcu(lo"arDroiufoPicocanantto'ioasnt"e)fr(Wo*aCs-h8i"n)gatnoinbuWtoarbklse itno WrealoeadosreCshoafusorbmye.oEy.W{es
{evaokbllcvilisanrhgiefdaicutanhtdrieeoarntot1fh0etthrheeemhaenalntehroifntwhheimcehmbtheerCs-of8tAhsesmecsltsahmseseanwgteenocrfiepTerosexswieicntit.htyrTeMseaparecemts(0p.ecC8ifASiTcpalTaleyar.rc.we
icnrkeiennginognlaevdeali"lyforbaCs-i8.feirAnesndcreeixdnpklCiaoningnsewedanttbeerOlroidnwe.WretshseetleiVcnitfreogdrimn1ai5at0.iopwnahtrihscahtpehmraesimlbbleeeornnsm(oapfpdtbhe)eaaevslaaiastsa are
ed1l0asgd"aeornrecy"ilngidufieictaditamenescdetrhfiaotnrktiihnnegtCewrAaprtTeetrTinehgaeamtth'hossaeadnvfaialscytossriisweisit"shf(ru"enDsdpWaeHmceAtnttoaltlhye cianlccounlsaitstieonntofwi"tshcrheeenfitanicgetsto
sdmpKbuiebnrldsitcaormeheeebiteriinnlggosnlges-dpto(e0nrsmboerhleeiadevbeythtahte dCrAinTkiTngeawmatreergwairtdhinugptSth"oe)11.5500BppappsbbedCn-uo8mnbpterhree.spetrnhetessscglrgaesleiesahses
dance 0 ppb.
do
not
support
eithealrth".scWreeendiongnoltevbeell"ioerveDtWhaHt Ais
caobrroevcet.evAevnaiIlapbplbe,
facts and let alone.
ksiit nongAtwlhtaehtCoeurAgTthhawTteeraermqeuqeufsoertstpweuadrspaonrseeofpusospeofdr.tduenWtieetrymditinodidnneogsti.agntnhaaetpreperfarooreperp.iraehtsaeevnsetcaarterieevnpeirneogfltehveelclfaosrsCm.eme:
i&olnsgdutcrhlieanrgCifAtyhiTantgTmeteheaetmi'dnesgt.amielAesotlitfnhtgohueognahnMwaaleyysuin6s-7u,se2d00b2y. tnhoerChAavTeTweearmecienisveeldecatnisynegnmtitanhteuitvCee.s8porsrecssreenretnesee.
muamtsisocrneetntinghalsevbeelcannamlaysdies amvoasiltabllikeeltyodedwraislttleanbnoydt ttbhheaetaCavAafiTloarbTmlaeelafrmoerptoahrnrtootsuhguehmrmisatservpieuzrbiallnigcmohmneetehCtsi.ntghe
`uVsedstayViarngdinFiraiadnaydoOfhtihoeoCnAMTayTea15m.'asnLdeaMdaeyr. ems with respect to the manner in which the
1D6r..20D0e2e.Aannnd dSutaraitnsg, CAT Team perfor
oius rsudfefpiocsieinttio0n
last raise
seri.
mpputblriecsholeuatlitohn.threat involved, we are compelled to aise these conmceedrnistswaintahlyysiosu, nBoewcafuosse
4g2rsstBsoaiodsmpetldhyauttpihotesntphturhreepsoihsnofelodwrmafoasrttitoornidgemgreairdvieengaaav"ascicllreaeabelnneuipntogordlaertveee.mle"wdeifaortuinCod-ne8rositnfaawnSaduttpeheraortfftuthheeConAaTturTeeoaime~ nd r other
5 i
Tee
000125
June 10, 2002
Paged
.
hhauzmaarndohuesalwtahstferosmitee.xap5osouprpeostoedC-t8o ainDdrWiHnkAingdewsaitgern.ed WspeeciffuirctahlelryuntodecrosntsaenrdvatthiavtelthyepCroAteTct
Team calculated five-step process:
its "screening (1) Selection
level for of "key"
C-8 in drinking toxicity studies
woantCe-r8t:hr(2o)ugIhdeuntsiefoicfatthieonfoofltlhoewin"gcrbiaessi!c
edfofseicntg" lfervoeml aCt-8wheixcphostuhere"cirnidtiiccaalteedffiencte"acochocfurtrheed "inkeeya"chsotfutdihese: "(k3)eyI"desnttuidfiiecsat(itohneo"fcrtihteicCal-3efizc:
level): "critical
(4) Calculation ofa effect level" by the
reference dose productof the
Ionrtr"aRsIpeDc/iReAsCE"xtfroarpeoalcahti"okneUyn"cesrttuadiynbtyy
dividing the Factor (LF
tEhxetrIanptoelrastpieocnieFsaEcxttorra(pUolFa)t,iotnheUnLcOerAtEaLint-ytoF-acNtOoArE(LUFE)x,tratpheolSautbicohnrUonnciecr-ttaoi-nCthyroFnaicctoErx(pUoFsu+re+:
RDaItDa/bRaIsCe dQeurailvietdy afonrdeCaocmhoplfettheene"skseyU"ncsteurduiienstbyyF"acUtSoErP(AUFR)e;giaonnd I(5X)SMcurleteinpilnicgatLieovnelosf"the
pasrsoupmopsteidodnrsinrkeignagrdwiantgeardsuclrtebeondinygwleeivgelh.t
aEnvdendraisnskuimnginwgatseorlecloynfsourmpputripoonselsevoeflatrogduemreinvet
the that
she
tChAe T"kTeey"amsudidieenst,ifainedd tthhee aapppprroopprriiaattee ""kcreiytisctauldeifefse.c"ttlheevealpsp"rofporrciaatceho"cfrittihceal"ekfefye"ctsst"udfioerse,ach ot
caovarirleasbploendiinfnogrRmaItDi/oRnIaCnsdogrutihdeanucletidmoatneostcsruepepnoirntg tlheeveCl AseTleTcteeadm'fosrcCa-l8cuilnathiuonmsaonfdrinking
water. let alone useofthe summarized below.
150
ppb
number
as
a
DHWA
for
C-8.
The
bases
for
our
concems
are
I TheCATTeamDidNotAssignAppropriate UncertaintyFactorValues,
CAT
TeIanmc.alCcuAlTatiTnegatmhereRpErDeSs/enRtIaCtsivfeosrheaavcehosftattehde
studies identified as the "key studies" by that each Uncertainty Factor is typically
`=.
aesvseingnleesdsaco"ndseefrauvlatt"ivvealvuaeluoefo1f0,1,wihfitchherceain osnulfyficbieenrtediuncfeodrmtaotiaolnesosrcdoantsaetrovactoinvfeirvamltuheatofth*e1
bbaysitshefoCrAtTheTsetaanmdairnddidceaftaeultthavtalthuee sotfan1d0arisd,noctonaspeprrvopartiiavtee.defAalultthovuaglhuetohefc1a0lcwualsatuiosnesd pbryosthdee.
CapApeTarTsetahmatftohretCheAUTFT,eaanmd gUeFn,erfaalcltyorsselienctceadlctuhleatlienagstRcIoDnsSeRrIvaCtsivfeorvaclaucehsoffortheeac"hkeoyf"tshteudies
jruesmtiafiynitnheg Uusnecoerfttahionstey Flaecsstocrosn.seArsvaetxipvleaUinnceedrbtealinotwy. Fitacitsonrost. cglievaernhaovwailtaheblCeAinTfoTremaatmiocnanon +
and agency guidance. (See, e.g., Exhibit C (USEPA's of Drinking Water Health Advisories").)
1/17/92
"Background Document 3:
Ottis
A. The CAT Team Did Not Apply The Correct "LOAEL-To-NOAEL
ExtrapolationUncertaintyFactor"(VF),
UnceraiAnvtayilFaabclteorda(tUaFa,n)dvgauluiedsanucseeddobeystnhoetCsAupTpoTrteathmeiLn OdeAvEeLloption-gNiOtsAsEcLreEexntirnagploelvaetliofnor + in drinking water. Available guidance confirms that the UF, factor, which addresses the
000128
June 10.2002 Pages
.
uncertainty inherent in ("LOAEL"). should be
extrapolating data kept at the default
from.z Lowest Observable Adverse Effect Level value of 10. unless a No Observable Adverse Exes:
pLoesvietlio(n"iNnOsAeEveLr"a)l owtahseraciwsukalalsysiedsesnmteinftised. fsourcthhaessUtuSdEyPiAn'qsueisstikoan.sseUssSmEenPtAfhoars1.ta3k-ebnuttahdeiere.
NthOatAaEbLenocrhLmOarAkELdo.seshloeuvledl b(e"BvMieDwLe)d.asaltthheoeuqguhivnaoltednetfoinfeadLaOsAbEeiLn.g[tfhetheequBivMalDeLntiosfcleoitsheer10tn3e
LNOOAAEELL. iistinsotpairdteinctuilfaireldy fapoparrosptruidayt.estioncreenedfefrecittstmheayequtihveanloecnctuorftmhuechLObAeEloLw,tehsepeLcOiaAllEyLit13
BMDL. For the C-8 Team and the BMDL
2-generation reproductive rat (0.42 mg/kg/day) identified
study. by the
no NOAEL was identified by the CAT Team is close to the LOAEL
L
(1
\7
emfef/ekcgt/dleavye)l. fIonr tahdedi3tiMon,19t8h3e CtwAoT-yTeaerarmatisnctourdryecatslya NviOeAwEedL,theev1e.n6 tBhMouDgLh 1r.e6fewraesncieddenatsifaieidritc+..
ctahlecCulAaTtedTebyamthaesCaALTOTAeEaLmfwoarsthtehestsuadmyemaaskitnhegLitOiAmEpLo.ssibTlheetCo AdiTspTuteeamthaatlstoheerBreMdDiLn label:
the 0.47 critical NOAEL. given
effect level identified by the CAT that USEPA had just confirmed in
Tites adrmafftorhetahleth19a9s3sePsaslmaeznztolfoor9C0--d8atyhasttutdhse
2s
P0.e4r7fleufofreocotclteavneolawteasAcaiLd OaAndEtLs
- nota NOAEL. Salts (USEPA.
(See OPPT
Draft Hazard (2220/02) (as
Assessment of amended 4/15/02)
("USEP
\
Rveerpsourst)0..4a2tm4g7./)kg/Tdhaey)exiinsdtiecnacteesotfhaat9e0f-fdeactysLpOroAbEabLlyesoscecntuiralbleyloatwtthheecBhrMonDiLc BanMdDaLUF(0,.4o7f *
capopnrsoeprrviaattiev.e UNeFv,ervtahleuleessso,fi|t aapnpdea3rfsotrhsattutdhieesCiAnTwhTiechamLiOnAapEpLroSproiratBelMyDsLelsecwteerdefaurselde.ssinstc..
of NOAELS,
than
Evenifthere were NOAELS justify use
a dispute as to whether oaf default value lower
critical effect levels than 10 for the UF,
based on the CAT
anything othe: Team has no
explained why it human health as
did not choose possible, which
to err on the would have
sriedqeuiorfbedeisenlgecatsiocnoonfsterhveatdievfeaualntdvaalsuperootfec1t0i.v3e5
vt irc
aepxpirsotpenrcieaotefUaFn,NvOaAlEueL.for Iannyotohfetrhweorsdtsud,iiefs twhhereerewatsheacnryitircoalomefffeocrtalregvuemlewnatsansotto bwahsiecdhoLn Finc
vbaeliuneg ctahne mboesjtusptrioftieedctfiovreaonfyohfutmhaen "hekaelyt"hs-tudnioets.thwehlyeasdtidprtohteecCtAivTe?TeMoarmeonovtere,rritonsetehmessisdietar+...
tphraottetchteiCngAhTumTaenamhe(ailntchlaudnidngthmeeemnbveirrosnomefngto)voepmtmeednttoalselreecgtulfaatrolreyssagceonncsieersvacthiavreg(eadndwitthhere
laepspsropprroitaetcet.iveM)ovraelusepsecfiofrictahlelyU,Fi,n Jfaanctuoarrythoafn 2e0v0e2n.tthheemmaannuuffaaccttuurreerrooffCC-88,bethleie3veMd Cwoamspany
("3M"). submitted Report") in which
3toMUsStEatPedAathatLitfheetiUmFe,DfraicntkoirnfgorWtahteer26H-ewaelethk
AmdovnikseoyrysftourdyC-r8ev(itehweed"3bMy
it
CanAeTveTnealemssschoonusledrvbaetiavses,iglnesesdparvoatlecuteivoefU6.F,(Sveaelu3eMofRe3pfoorrt.thaet8e.)xactYesta,mtehemConAkTeyTestaumdy.selTeci:
simply does not make sense, particularly when 3M's lead toxicologist for C-8 was at the CAT
`Team meeting.
000127
June 10. 2002 Page 6 B. The CAT TfoneamFaDcitdoNrot A(UpE ply The Correct "Subclronic-To-Chronic Exposure
ExtrapolAavtaiiolnabUlnecedartaainatnyd Fgaucitdoarnc(eUFal)sovadloueessnsoetlescutpepdorbtytthheeSCuAbcThrToeniacm-tfoo-rCthhreovnaircioEuxspos"kuerye
astsusdiigense"draedveifeawueldt vbayltuheeoTfea10m,.unAlcescsortdhiensgtutdoyCaAt TissTueeaims are"pcrhersoennitca"t(ilviefse,titmhee)UsFt,udyf.actIornais
Jwahniucahrywa2s00s2u,bmrietpotretd pbryepDaurPeodnbty'sDaurPtoonmte'ysscotnostuhletaWntV,DEENPVILReaOdNero(tfheth"eECNAVTIRTOeNamR,epDro.rtD"e.c
A2-nyneaSrtaraattss,tEudNyVcIonRdOuNctsetdatoend btehahtaltfheorfe3hMadfbreoemn 1o9n8l3y (2thcehr"oSniibcin(lsikfyetsitmued)y"s)tuadinedsoaf2-Cv-e8ar--rai:ne
saltsuodystfarteodmt2h0at01threeoftehreerncsetdudaisesthteha"tBiheagdelbeSetnudcyo.nd"uc(tEeNdVwIitRhOCN-8Re(pionrctl,udatin6gatnhde 980)-dEayNVraItRsOtuNds
by Palazzolo "subchronic"
from 1993 and the 26-week studies, requiring useofthe
mdeofnakuletyvsatluudeyobfy10ThfoormfthoerdUfFrovmal2u0e01w)hewnercealacllulating
satnuRdyIDa/sRaI"Csufbrcohmrosnuicch fseteuddiiensg.st(uSdeye")ENanVdIaRtO7N. 2R6ep(orretf.eraetnci(nrgetfheere2n6c-inwgeetkhem1o9n9k3eyPalsatzudzyolcoo-
svaplounesoorfed10byis DthuePaopnptroapnrdia3teMUasFaf"ascutbocrhfroornuiscetionxiccailtcyulsattuidnyg")a.n R3IMD/aRlIsoCafgrroemedththea2t6t-hewedeefkault k
monkey Report,
study, based on recognition that the study was "significantly at 7.) USEPA also recognized that the 1993 90-day rat study
less than chronic." (3M by Palazzolo was a
.
"subchronic" study in in Marchofthis year.
the draft Hazard Assessment (See USEPA Report, at4, 41.)
for
C-8 This
that the agency released to is not surprising, given that
the put USEPA
dDerfiinnkeisngchWroantiecraHselailftehtiAmdeviosronroitessuWbsetbantsiitael;lyUdSiEffPeArenRtisfkroAmssliefsestimmeen.t (GuUiSdEelPiAneOsf,fPiacretoAf
(1989)). USEPA
Its. therefore, not clear how the present, assigned values less than
CAT Team. with 10. including the
representatives of least conservative
DuPont. value of
3M. 1. 10
ans the.
exact same Palazzolo 90-day rat study and the Thomford 26-week monkey study that ENVIRON
3M. and USEPA all previously agreed were subchronic.
2002 asIata"lcshoroisninco"t sctluedayr,hwohwenttheheCApeTriToedafmrovmietwheedfitrshted2o-sgienngeroaftitohne praatresnttuadlygbeyneYroatrikonfrtoomthe
ssahcorritfeircetohfanth2eyesaersc.ondIngefnacetr,aetaiocnhogfenraetraptuiposn wofasthoenrlaytsawpparsodxiomsaetdelfoyr8onmloynathpser-i-ocdonosfiderably
approximately 4 months, which is only approximately 10% of the 2-3 year lifespanofa rat.
USEPA specifically defines such exposuresof lifespanas "subchronic." (See, e.g, Exh. C.)
approximately 10%ofthe experimental animal [tis nok clear, therefore, how the CAT Team
>
jwuhsteinfideadtsaelfercotmioanocfhrtohneicle(alsitfectoinmsee)rvsattuidvyeisvaulseude.of | for the UF, value, which is justified only
Itis not clear at this point whether the Cat Team even reviewed the Biegel Study.
000128
June 10.2002
Page 7
-
C. TCohmeplCeAtTenTesesamUnDciedrtNaoitntAypFpalcytoTrh"e C(oUrFr)ect "Database Quality And
selectioCnourfrtenhtelyl-eaavstaicloanbsleervdaattiavaenvdalaugeenocfy| gfuoirdtahneceDaatlasboadsoe nQoutalsiutpypoarntdtChoemCplAeTteTneeasms's
Unceruinty Factor members. the UF
(UF) factor
in calculating an is the value used
RID/RIC. to account
fAocrcpoortednitnigaltounscteartueamiennttysabryisiCnAg TfrTomeaamlss
EthNaVnIcRomOpNl.etsetadtaetdabinasietsfJoarntuhaeryp,ar2t0i0cu2l,arrecphoermtiscuablmiatttiesdsuet.o
DuPont's own consultant, the CAT Team's Leader. Dr.
Staats
vthaaltueadoafta1b0afsoer itshenoUtFcoo,nusnildeesrsedal"lcoofmtphleetfeo"llfoowripnugrdpaotsaesexoisftds:evi"a(t1i)ncghrfornoimctthoexisctiatnydsatrudddiees sinu
species studies
(1 in
2nosnp-ercoideesn.t"),((E2N) VaImRulOtNi-Rgeepnoerrta.tiaotn2r5e.)proAdcuccotridoinnsgtutdoyE, NaVndIR(3O)Nd,evtehleodpamteanbtaasle
toxiciny for C-
dcaenvneoltopbmeenvtiaelwetdoxaicsictyomsptluedtiee,sienve2nstpehcoiuegsh("rattheanavdairlaabbbilte)"daatnadba*s(eplfroerl[imCi8n]ariynrcelsuudletss ofa 2-
gtheinsertaitmieoan nroenp-rordoudcetnitocnhsrtoundiyc asrteudny.o"w(a/vda)ilaTbhleu.s".baecccaourdsientghteoaDvauiPloanbtl'esC-o8wndactoanbsausleta"nlta,cks at
ENVIRON, the C-8 database, even with viewed as "complete." Consequently, it
the existenceofthe 2-generation is, again. not clear how the CAT
rat study, Team can
cannot justify
be ~~ use ot
-
tahpeprloeparsitactoensUerFvavtailvuee,anwdhelenasetvpernotDeucPtoivnet'vsalcuoensouflt| afnotrbaellloifevtehsethaavtaitlhaebdleatCa-bassetufdoireCs-a8s itshenot
complete and could not justify a UF value of |
sponsor`eTdheby"cWomVpDleEtePneosns"Moafyth1e5,av2a0i0l2a.blien Cw-h8icdhattahbeaCseAwTasTedaismcursesperdesdeunrtaitnigveaspwubelriecnmoeteta:bi:c
tthoeid2e6n-twifeyekwhmaotnakcetuyalsltyudcya,uasneddtsheeedmeeadthtoosfuagngyeostftthhaet msoonmkeeoyfsthaet aenffyecotfstohbesdeorsveedleivneltshedurrating
sutnucdeireasimntayywnooutlcdoarprepleaatretwoitrhaiesfefescetrsiooubssecrovnecdeimnspwriitmhatreesspoercthutomatnhse."cSoumcphleatpepnaersesn"tof the
adaptpaebaarsteoosnupCp-ortwmiutlhtripelsicpaetctiootnopfrtimhaetesuanmdohfutmheanfihveealUtnhc.erStauicnhtyunFcaecrttoarisntbyywaonuladd,diitniofnaaclt.
""eMxopdriefsysiinngg rFeascitdoural(MuFnc)e"rttahiatn,tyacacsosrodciinatgetdowDiutPhotnhte'sstcuodnysualntdandta,taEbNaVseIRnoOtNe,xplisicjiutsltyiftireedatfeodr by
the standard examined).
UF (e.g., completeness (ENVIRON Report, at
of the overall database 21) "As with the UF,
or the numberof species the value ofthe MF may
be
up
to
10." (4d) It would appear that use ofa Modifying Factor would be particularly appropriate in
evaluating C-8 studies, given indications from the recent 2-generation rat study that C-8 causes
developmental effects. Yet, despite comments made by the CAT Team representatives
themselves during the public meeting expressing uncenainty with extrapolationofthe existing
database to human health and again during the depositionof the CAT Team's leader, Dr. Staats
it does not appear that the CAT Team considered use of any Modifying Factor ofany value in
calculating its RIDYRECs.
000123
June 10. 2002
Pages
.
IL.
The CAT Sources.
Team
Ignored
Potential
C-8
Exposures
From
Noa-Drinking
Water
CAT TeItaims cnoontvcelretaerdfirtosmRtIhDeSiRnIfCorSmaitnitoonitms a1d5e0 apvpabilnaublmebetordfaotreCb-y8tihnedCriAnTkiTngeawamtehr.oworthe
exactly what the purpose Dr. Staats. has explained
of such that the
aRI"DsScr/eReInCisngwelerveelc"onivs eirnttehdisicnatsoe.a
The CAT Team's 150 ppb screening
Leader. levei
cuaslicnugla"tUioSnEsPwAerReeghaisonnoItXySetcrbeeeenninegxpLleavienle"d.caitlcauplpaetairosnst.haAtltthheocuaglhcuelxaatcitolnys wihncaotrtphoorasteed the
sfoarmuesestianndcaalrcduUlaStiEnPgAa dDeWfaHuAlt,vawlhuiecshfoarsscaulmceulaatsitnagndaadrrdinhkuimnagnwabtoedryewxepiogshutreofli7m0itk(g"aDnWd 1
sintcaonrdpaorrdahtiuomnaonfdtrhienCkiAnTg wTaetaemr'rsat0e.o00f242liRteDr/s RpeIrCdaiyn:to DthWisEsLam=e(sRtAaDnd/aRrEdCDxW7E0)L/ f2.ormAuftlear+11.
=14174p7ppbp.b)w.hiTchhewCeAuTndeTresatmanadppwaarsentthleyn
rounded used this
up by the CAT Team to DWEL as its "screening
150 ppb (0.0042 level under the
5
"1
*
s1e5f0erpepnbceDdWCoEnLseinnttoOradDerW,HiAns.teaIdnofffacotl, lwoewiunngdetrhsetasntdantdhaartdtahgeeCnAcyTgTueiadamn'cselfeoardecro,nDvre.rtSitnagattshe
odfitdhneottyvpieeowft"hesctraeseknionfgthleevCelA"TtyTpiecaalmlyasudseerditvointgriaggleirfectliemaenDupWoHblAiga(taisonosp)p,oasnedd tthoedreerfiorveatdiiocn. -
not consider the available agency guidance "screening level" approach actually used by
for deriving lifetime the CAT Team. the
DHWAS,Ifthis is CAT Team ignored
the the
relat::
:
saloiufrecteicmoentDrWibHuAti,onwfhaicctohrb(o"tRhS3C"M)arnedquDiurePdonutn'dsercoangseunltcayntg,uiEdNaVncIeRfOoNr,cosntvaetretdisnhgoaulDdWbEe Luse.:
calculating any C-8 could be exposed to
drinking water standard C-8 from sources other
tthoaanctchoeuinrtdrfiornktihnegpwoatteenrt.ial
that
community
mem
=
ENVIRAOsNrheqauvierestdautenddetrhaagatenDcWyEguLidsahnocueldfobrecmaullctuliaptliinegd lbiyfetthiemesuDaWndHaArdS,RSBoCthde3faMultanvdalue
0.2 (20%) exposure"
to account for such as "food
the and
"relative contributionof air." (3M Report. at 4.
various See also
potential pathways ENVIRON Report,
to at
total 26.)
[C-! [n otc
dwroirndksi.ngthweatmeorr,erceoqunisreersvautsieveofDthWeHRASCprtoocetsaskefoirntiodeanctciofuynitngthae "fsaacfte"thlaetvcelomomfauncihteymimceamlbienrs
ctoypnitcaailnliyngmathyebceheemxipcoasle,dsotiolsa ccohnetmaimcianlaftreodmwintohn-tdhreinckhienmgicwaalt.efrosoodurccoenst,asmuicnhataesdawiitpholtlhuetion
chemical, erc., which,ifignored result in 100 high ofa total daily
when determining an dose of the chemical
exposure level for drinking from all sources. combined.
water. could Conversion
tfahcetCorAaTdvToecaamte'dsb1y50boptphb3nMumabnedrDiunPtoonatm'sorceonpsruoltteacntti.veENDVWIHROAN,bywuosuilndg trheequsitraentdhaerdCRASTCTea:
taoccmouulnttiptlhye iptoste1n5t0iaplptbhantummebmebrebryso0.f2t(haerceodumcmtuinonitoyf tmhaey15b0e pexppbonseudmbteorC-b8y 8fr0o%m)sotourtcaekseontth.e
tnhuamnbderrinfkrionmg 1wa5t0erp,pbsutcoh3a0spapibr.polUlsuetioofn.theThDatWsHteAp aRlSonCe wwoouullddarpepdeuacre ttohebeCpAaTrtiTceulaamr'lsy
000139
June 10, 2002
Page9
:
iatpsprWoapsrhiiantegtionnthWiosrskitsuaptliaontn.when DuPont is discharging C-8 directly into the air from stacks st
factor.
In the
addition. when asked CAT Team members
specifically why stated during the
the CAT Team did not recent public meetings
use the 0.2 (20%) RSC that the 0.2 (20) RSC
was C-8
"not applicable." is nota "olatile"
because the CAT Team members allegedly chemical and, therefore. could not possibly
had "unanimously" agreed escape from the drinking
that 1:
stotactreemaetnetasniyn iintsharleacteinotndrriasfkt fHraozmartdheAdsrsiensksimnegnwtatfoerrCit-selft.haTth"iqsuasneteitmastisvteracnognec.lguisvieonnsUrSeEgaPrAin+s
aPtFeOsSofarveolcaatpialbilzaetoifotnrfarnosmpowratteorutorofHweantreyr'.s" L(aUwScEoPnAstaRnetpoarretnaott1p1o-s1s2i.b)le.MorHeoowveveerr,,evAePnFifOnsert
eixnihsatliantgiodnatriaskp,rtohveedCtAhTatTiteaismn'ostrpeojsescitbiloenofforthaenyRCS-C8 btaoseesdcoapnetfhreoimnhdarliantkiionngrwisaktefrrotmo ptohese ane
d0ritnakkienignwtoataecrcoiutsnetlfpcootemnptlieatleelyxpiogsnuorreestothCe-8pufrrpoomsesofourrcwehsiocthhetrhtehRanSCdrfiancktionrgiswautseerd,
~ namely such as C
-
T8eian maicraenmijsusstiiofnysnfotroumsitnhge tDhuePoRnStC'sfaWcatsohrifnogrtpounrpWoosreksso.f c[atliscunloatt,intghearedfroirnek,icnlgeawratheorwstthaendCarAdT
fRoSrCC-s8h.opualrdtibceuluasreldy,wahnednitboistnho3t McleaanrdtDhautPoCn-t8'wsilolwnnotcoensscualpteanft,roEmNdVrIinRkOinNg,waagtrere.e that the -
MI TheCAT TeamDidNotIncludeCancerData[nIts ScreeningLevelCaleulations.
:
cancer
[tis not clear why the CAT Team did not perform a endpoints. Recognizing that C- exposure has been
dose-response analysisfor confirmed to cause Leydig
C-8 cell
user
:
atunmiomrasl,mhoedpeatlocuesleldultaoritduenmtoirfsy,parnodbapbalnecrheuatmiacnaccairnacrincoeglelntsu,mDourPsoinnt'rosdeonwtsn, ctohnesumlotsatntc, ommon
EreNpoVrItRitOsNu,bmiintctleuddetod tahdeoCseA-TresTpeoanms'esaLnealaydseirs, fDorr. cSatnacaetrs.einndpJoainnutasryinotfh2e0o0r2i.gitnhaalt vaedrvsoicoanteofd t3h
10 ppb level for C-8 in drinking water. (See ENVIRON Report. at 26-30.) In addition, the
Cpeornfsoernmt aOr"ddeertebremtiwnaeteinoDnoufPtohnet paontdentthiealStcaatrecionfoWgeensitciVtiyrogfiCn-i8a.r"equ(iCroensstehnetCOArdTerT,eaatmC4to.) }
`scwrheeennaisnkgeldevheolfwotrhderiCnAkiTngTewaatmeri,ncCoArpTorTaeteadmtrheepCr-es8enctaantcievresdahtaaventsotaittesdctahlactultahteiotrnisadfoorfa C-
ctoatnaclelrys"airurreilbeuvtaanbtl"ettoohCum-anesx.poAsunrye shuacdhscoomncelhuosiwobneweonudledt.ehromwienveedrb,ybtehecoCmpAlTetTeelyaminctoonbseister:
jwuistth2tmheonctonhcslaugsoi,oinnrwecheinctlhyUrSeaEcPheAdsbtyatUedStEhPatA"aisn tithsedmraefcthHaanziasrmdsoAfscsaerscsimneongtenfoircCa-c8tiroenloefased
h(uC-m8a]nsh.a"ve(nUotSEbePeAn Rfeuplolryte,luactida(teedm,pihiassiassasdudmeedd)t(hRaetptohrettaulmsoorresfienrdsutcoe1d9i9n7rCaltseagrgerpaenleelvant
findings that Leydeg cell tumors in rodents are a legitimate end point for cancer risk assessment
when the mechanismsofaction are not completely understood.) It i, therefore. not clear how
the CAT Team, with USEPA participants, could support a totally contradictory conclusion.
000131
JPuangee 1100. 2002
gusuiindgantchTeehgCeeAnieTnrhaeTtreeeanstmtuiannncnaoilnnysgsiisdstiefanfncedireetsnhcebeseltebvweeetleswnetehtanhtetwChoeAuTl"sdcTrbeeeaemngi'ensngearlnaeatvleeydsliucssliaennagdnauapvaaninulmaablbeverssfahcgatestnea1rnadted
dmmraoinrnnekeicrnognrsewiqastuteierrn.etdwTtihotehennasavuuarireleaabdolefeqsduoaamttaee aponrftdohtaeocgsteeinocdnyoiffgfeuhrieudnamcnaecsneihisenhatilegtrhhplrfiergtihontmgedetxhipantotsdhuaeraetantochcthheeedcmcoihncatarelsr1s.att
(pwuoEruxploidsteassppoAefaaarrntgdouBbm)eensmthooorweliysnugtphptahoteratnneuedmdbboyeerassvanaiolltlaebdglieesdpdluyatteuastaehnedd"bkayegtyeh"necsyCtuAgduiTeisdT,aen"cacemt,iacanasdlsuftmheienengusmfobrearnsd ssc
ui"sneedoricifacataendeefifxnepctothsolusereveaerll"aecvseheleldoecrctheCda-rb8sy,intuhsdeeroCifnAkaiTvnagiTlewaaabtmleeradnaadbtoatvhaeantednvoaegnMeon1dcpiypfbgy,uiinwdghaiFncachcetawosroouilhdwaapnnpoertnausnpe1pdeorc \
ltTehvheesl"sfagofirev"Cenl8etvheiln fdforaricnCkti3hnatginawvadartiielnarkbilwneedgarwteaaqtaueensdtthtaghtuaitDdutahPneocneSttdatoheeassannudosteFdseudipenrptaeorlrntaalgtlheyencsCiieAnscTetaaTtkeelaamism'sism1e19d39i01anpep
tcsoitnemspeussl0thaingcthl,earraintydhahmnootwrheeantndhuamwnbhe1yr50sthtceiamlCecAuslTahtiTegdheejarumstthcasanemvaeernayulpnmwuoimtnbhterhntauhgamotbwbeoyrubtlohdtahbie3s pMmoosarsneidblhDeaunwPho1en0tn-'1s3
haveliaselowthbi.enegpnatrhrteiecvauivleaawirlelydabwbehyefDancutPtshoeanntCdAaanTvdaiT3leMaba.lmeWdaigedenanlcisytogrrueeivqdiuaeenwstctehperinortemhsputltlcsilgaohrftiafmniocyasttsitopunrdotitoeescthtteihavpteouhbfaidhcuntomhteatn
ntDehWecHe"sAsscsarr.eyentWioneagbaalltesevoealrn"edqnuureemsmbteedtrhisaattbetehitenhigSstdaotenev-eaglnooidpneFgdedtbehyrraetlaheatgoCepnAucTbileiTsceiahmemmaletadhri.atnToethlaytnhtkeaksyeaomhueostehisntgep3s5
:
Very rly yours,
Bob ut L. Bile#F fhikor
Robert A. Bilort
ARrAaBc/hmmednmts
.
cei RL.arErdyiAs.onWaHitlel,r,EsEqs.q(.w(owoanaancshcmhemnetnst)s)
Gerald J. Rapien, Esq. (wlo anachments)
000152
mem Jom] etme[re[onTe To |
i mrE=E=LE TTT Yorketal 00001 Iocrveeewesighmtiemmlde
Si
ed A ETE,
emrecommm----
| vm |
fmm Pe[Ee
crmpt---- [no --
erie------------------
CE CI = lM
rr [eT
--
teeter So- m E - ELLIE
| "
-
RR
c [rhr ioy ie
a er
-
Tooyewinnty |mmr
femmes Pony[oo[oo[oe[om[om
[Toimme
SEET,|S| [emri
Tw
|
ae oy
:
-
000134
.
9As IRIS Sie Dring Water Heath Adwsones
pase 100
SEPA
nornaynsent protacsan
i Ry ~ BaNalEJ o~l
ovis OFOFFFIICCEE OOFFDBRDRIAINCNKKKIGINRNGGOWUWANATDTEEDRROHCHEUEAMALELTTNHHTAAD3DVVIISSOORRIIEESS __
afToyhre.mULdSioE]PnAcgOo(fsfnneceaeoxsfnpDotrEsienkpionfgesWuasetetrem(soOrtWh)edeve10e3leopessxHpreoasteahsdAodofvirsoeri2e0s1 R{exoepmfoisrcutnryceseF.ADTsohsdeeeFv(LeRAlISoDp)ed(GfeoerkvLieoipdeednmBoaemcxkdtpaoosusnGdessDeeopacsiumsgetonotn m1s1),ceinonsresesn tpinifolermoarlCeohcmahtnmagamsnla3snioednawSnchoeirIovanesto0ec2rs3o9T5mheeprsuabsrahoetnutephuaFliecs nhesesmeens eOTnhxee-dpHayos, ruTeecpnhr-ed1saeyonnodddaLonocane.erlFeeovrerls3hoer.pdhokesietngpnuwgaetesrvideoxnpoo5noePsmEnLTihseSovalomuesusfrrhse! XoonfpayonufirorenabndysupdsinfEogxm3paNoCrcEoommessSoyTco,mdcdrooeesnsscke nwaRrScCTo)htriMn m08sspoHennmsoatnesnemrs Speacifric adrer. ean RcSoComf1m01ss u(ivda.or1o9r7g3anic comamnats and on ROCa 5 1 f2TohrCeOhHeKuEbaLadlr(yeofwdeeLirOgihNvteEodLfe)mhpseliorydeinecgtidenbdyaanpnroiuunccnhesanmitdlyasctntotmohetd(-uFstyeudyTtmoaodcesseceoDbrsconss sTThhieegrsedufdoercs.eroleyScvhfoesrrdeeedrxhecipnhogaeHaArm5dc3esuelpeepsmap5bleonrasamarraoncnuwtdaeoeosfe5rxeepoaouseSm1ssts+ Inranceotsowfhwoewreoeraladpatas serennx Be ano Ins Spee som ihTdheeealHldyAabteismreeodpmfeoroadngeiirenigxvpactoisuoancesuHaorwFeyonvreer3raOlllnoyndrgeoormSHeAy.sttddhryeoasftoacnoysmpmmaareaybpoleeerisdoud srhinpe oIfrhieeeSqudealaoa10nb3]0adparysiotdDeehdavveeTlhioespoTmbeeeenhd1osHe5A Lmmooengleoorenoscilmiantkiesmdleoxepmdoenresedsmapnofntsssis Subihronc Suds where sal re 5osEs or sopra 0% of the me
po pa oviriwepirwaes bd
ost:
000155
EPA [RIS Site - Dining water rieaitn Advisories
--_--
(fo ample, 0 dys for rodencs) aThretNOoArEgLSAcortLeOdAEALssuace rdetndieemdonrsormaesseddiossheatesrpoorvseeentoornmsapn+nrc oprtefceraendaovdear fsotruidyrwdheerrveatoorny singe doe as see ened Lehalay is ce <TH0eawnsedaiargyehdH1es0r.kegdtuheolperpsorrotevchetseedsriaenvdneoiteamde5mIbtaesrs5s 0oafah1essp2oepdu3lhahtitidontTeFhocrhnthiedcOosnnesusmsa1| 8 SLaiaFflwettaitmTresdeaxsypioFsnorre,ahLheaoHtnAagnrscromtlywexcopoushuere7,d0 Hkgfoaaradasrncscoen,lsestsendc2fhoorefscowhatiidhodiady2aFeodr75 us expose category fora feime Fsre caeuaed sccording 0 the xan A= (NOAEL or LOAEL) (BW)/ (LP) __ Lida) = _ mg. ihneereexNpOoAnEeLn =meo-gObDswesie)dAdverseEct Level
(LiOheAeExLpo=sLroewedsotsObnsemrgvesd:wAdivedr)se Eft Level (5100 k=gscuimdeodr 7b0od3y wdeiug)htofprveted nda UF = cern factors, based on ual and re of dea _7 UUdtaayyf=oracsiumdeodr w2aLtearycoonrmuampli)on
SPTohoeodnscpetruea1ia1lmdycibhferoooeirecnnhauchmoeaunnaentsaaflortsipaheecdiheeesrneAynntcveNrOtaAaEiinLsawcrieoktrie tbohafes0ihssuomrasnetde 4h3e1 NxheOuAhnEucmLeannsfiodnmayasfswirlceiolofc1goon0od0udcstqeuudasdsy.,maAbluntucdeesrn.stearvnesLyaOsfAacEtthLoerbrOaast0ihse0rofhaine aHNAuOseA(dFEawLnher've3ofSafmcttahoerliFcir.yltyhtehnajtaunddgenmnecinteaasl aaLndOtAmoaEryLaooke(n0010n1 icpmoosusetnuddh.yeofUquIalotifsteythoqef ucheaayosrvehaocg5i0a5 aa bai, the siganofthe srie ceo the counerbahncing of pose
beneficial effects.
LifeimeHAs (ronsaeinogens ony) re clued from the Dring Water
hp sepa soviriowehplrigater hunt
os:
006133
.
EPAS IRIS dite - Urining waiek Reds awriveccs
ago
EcaqluciuvlaalteendtfLreovmelth(eDeWqEuaLt)iownhich, in urn, is based on the untounded RID DWELS are
DWEL = (RID) (BW) / (_ Liday)
. +. wBhWeraendRI_D Li/sdthaey aurnerotuhnedaeddultorarlefReIreDncdeerviavleudesinfSoecbtoidoynw|eiofghtheancdhewmautcearl fle. 2nd. cootnasucmoptmipoonu.ndresipnetcatkieveislybyLdirfientkiimengLwAaStearassnudmeartehadteonvneldy3bgyitvheen epqeuracteinotnage of ze Lifetime HA = DWEL x RSC where RSC = relative source contribution. the assumed exposure from drinking.
bLiefceatuismeeoHftAhseadeiffneortednceeriivneadsfsourmcptoimopnosucnodnsceprontienntgia(lolxyicatrhcriensohgoelndiscffoorrcahrucmiannogsenic and noncarcinogenic efects
mInaysitbueatrieoncsomwmheernededdatfaorartehenoLtonagvearl-atleermtoHcAa.lcuFloartethLeonchgielrd-LtoenrgmeHrA-St,ermtheHAD.WtEheL 'DWEL may be recalculated using the culd's weight and water consumption. (Fo2r02m)o3r8e2-i7n5f7o1rmoartiFoTnSab3o8u2t.7H5e7al1th Advisories, cal the OfficeofDrinking Water at RVeoflere|ncWea:shNiAngSto(nN.atDioCnal AcaodfSeciemnciyes) 1977 Drinking Water and Hearts
Sena
Scia omo en
RL Liaspt pwasted9a20goFvebruary 1998 hum
hutp sow epa goviiriswebplniydwater hum
cen: 000137