Document jBrE58136x7kxrD8jyEDnK26R

Memo SR To: Via: From: Subject: _ John Stine, Environment] Health Division Director lige PLaamreylaGuSsht,ibEan,viHreoanletmhenRtiaslk SAusrsveesislmlaenncteUannidt ASsuspeesrsmveinstoSre,cftio+n Managerfauf A.pl Helen Gooden, Health Risk Assssme Un sf1f Hou Health Based Values for Perfluorooctanoic acid (PFOA) ATian re "PFOA be lowered to 0.5 ug/L (ppb). Castaic PFOA 335-671 Fao i `hepatic (liver) system, `hemotopoietic (blood) KD) 0.00014 IVGE) 05 Smee `MDH 2007 gsbeefeS rom ois rgyee Teofpmiaoinn)fSpygnaujinei ! eT INDIthy probes ikns neGrdPrienAs ned med nhe rir el e, to situations where degradation has already occurred. Similarly, health-based values, whichare un- LLnyemon,n, J SJTpooemen sis 2134.0001 Exhibit 2134 Sp STATE_02430434 ATTACHMENT DATA FOR DERIVATION OF GROUND WATER HEALTH BASED VALUE (HBY) CChAeSm:ic3a3l5-N6a7-m1e(:acPledr)fluoronctanoic Acid (PFOA) 3825-26-1 (ammonium sal, APFO) 2333955-.90505-8(s(poodtiausmssiaulmt)salt) Non-Cancer Health Based Value (HBV) = 0.5 ug/L, = Loxicity value, mg/kg/d) x (relative source contibution) x (1000 um) (intake rate, L/kg ) =(000014me/(kg0d.)053 Lxi.k(g0l2d)ayx)(1000ug/mg) = 05ugl, Toxicity value 0.00014 me/kg-d (Cynomoigus monkeys) P`SooiunrtcoefoDfetpoaxritcuittye:value: MLDOH 2A030E7m(yLRkIgD,-dderived by MDH) Dose Metric Adjustment: 70 (1 adjust fo halflife duration of 3.8 years in humans versus 20 "Total uncertainty factor: 3da0y0s in male Cynomolgus monkeys) UE allocation: 3 interspecies toxicodynamic differences, 10 intraspecics variability; and 10 LOtAoNEOALEL (for lack of a no effect dose inth critical Critical effect(s)*: sItnucdrye)ased relative liver weight Co-citcal effect(s)*: wReeidguhctegdainn, dueveomlfoeprmbyetnhtreaolcyetrfefse,crtesd(udcecerdebaoseddywweeiigghhttgainnd,bdoeldayyed developmental progress, hypoactive response in nicotine-induced Additivity endpoint(s); bHeehpaavtiiocr(tievsetr),)ssuypspireems,sheedmIatgoMpotiiteetrisc (blood) system, developmental, Secondaryeffect(s)* immune system `Decreased postnatal survival, increase in the incidence of fuller rheosmoropntieosns(,Ta4lt&eTre3d)m,admimsraurptyiognloafndspdoervtealnocpmoeunstb,edhaevciroera,secdhatnhgyerosiidn foroption of terms seGlossatrhyeeasdteednaatl he coprtexes li ehroa otles ss id Auachment-Page 1 of 7 2134.0002 STATE_02430435 Cancer Health Risk Limit (RL) = N/A Volatile: No `ToSiucmimtayrVyoalfvceh(aRnIgDe)s: since 2002 HBV: Improved toxicokinetic (c.&., half-life) information allowed for the incorporation ofa 70-fold dosemetric sdjustment based on half-life differences between humans and monkeys anda 10-old decrease in th1e0taodtdarelsUsFu.ncIenrt2a0i0nt2ieas3a0r-ofulnddftaocxtiocrok(i3nienttiecr.species extrapolation + 10 subchronic-to-chronic) was used. Intake rate: PFOA, unlike most ground water contaminants, hasa long half-life and therefore will accumulate in the PboFdOyAifrweipllearteaecdheaxppolsatueraeuo(csctueardsy-osvteatrel).ongT-hpeerlieondgstohfotfitmie.meEvteonrteuaaclhlysttehaediynstteaetnealcocnodnicteinotnrsatiison of equivalent to approximately 5 half-lives. In the caseofPFOA the time to steady-state would be. awpapsraoxtiimmaet-ewleyig1h9tyeedarasve(r5axgehiunmtaaknehoaflfa-nliufeppoefr3-.e8ndyecaorsn)s.uTmheer ionvtearketrhaftirsstel1e9ctyeedarfosrotfhelifreev(i0s.e0d53HLB/Vkg9). This take rate incorporates thehigher intake rates early in life Gi.c., infants and children) as well as the accumulation of the chemical over time. ConsiderationofSensitive Populations: Delayed development and growth deficits in the offspring of females mice exposed during pregnancy hsahvoewnbeteantrtehpeordteevdealtopdmoesnetlaelveelfsfescitmsilaarretmoatihnelyLdOuAeEtLo eoxfptohseucrrietdicuarlinsgtupdryeg(3namnec/ykrga-tdh)e.rtShtaundiaefstehrave: bsicretnh.aPrioosssiwbelreeHevBalVu,atebda:se1d)o.nlopnrogt-etcetrimonexopfo2suprreeg--naenxtpowsoumreantoetnhde mhoerthfeetrusf,rowemrbeiratlhsotocaalgceul1at9edy.earTsw, o and 2) a short-term exposure -- exposure to an infant. The long-term exposure scenario incorporated accumulation over ime and uiized a time-weighted intake rate 0.053 L/kg-d. Theshort.term exposure LsJckegn-adr.ioTdhiedrneostulitnicnogrppoorteantteiaalccHumBulVaftoirobnootvhersfceinmaerbiuots wiedreiihiigzheera tyhoaunntghienHfaBntYintbaakseeraotenothfe0s.e2l2e1cted critical study in monkeys Aachen Page 2 of7 2134.0003 STATE_02430436 Summary oftoxicity testing for health effects identified in the Health Standards Statute: Tested? Sec. Observations' Yes Yes Yes Yes TavoaeislbBlveernoFn sguesTocrondsupcteecdtfoTreoaelsTpeurtposweess.roMacstochnemiccalTsohrahviesbceehnersieecfotr0mmatiiolneSosueteUslincwHhichoy rveaslcurcbhaesresddonnthiffdcotosbswehrevreednao etfhfeecltoswweesrtedoobsacetrovseaadln,dahvaeilaobwleestsdoosie tihaclocnasuisdeedreodnepormoetreecteoifffvaelcet.obAertoexfifceicttys hat cocaatigh doses. Comments on extent of testing or effects: *obHsoerrmvoendailn plearbtourrabtaotriyoannsim(ca.lgs.,adtedcorseeasleedvetlhsyraopxpirnoexi(m1a4t)ealynd3-tfroiloddohtihgyhreorntihnaen (tTh3e)LlOevAelEs)Lhaanvde hbaeveen `bSeheonritd-etnetrimfiiedmmausnsoetcooxnidcairtyyesftfuedtise.s have shown that PFOA exposure suppresses humoral immunity and `hmaavyeabdeveenrsieldy aeffnectatcseilclof-mceirdiietaidtaeldefifmemcutsnity at doses similar {0 the critical study LOAEL. These effects d*oDseevelelvoeplmsesnitmailladre0laytsh,e lLoOwAeErLb.odyThweesieghetffweecitsghhtavgeaibneaenndidbeenhtaivfiieodrsisn ocof-fcsiptriicnaglheafvfeecbt.eenAotbdsoesrevsed3-at `fooplednihnigg,heirnctrheaansetdheiLncOiAdeEncLesodfdfiutlilo-nlatltedrreevseolropptmieonnt,alaletfefreacttison(sciencrmeaasmemdapruyp gvliaabnidlidtey,vedleloapymsenitn)eyaer.e oefbfsecetrsv.e. Effects occurring at doses approximately 3 old higher have been identified as secondary "reTshoerprteisounltwsaosfotbhse2egrevneedraattdioosneallesvetlusdy3-ifnodlicdahtiegthehratfheartniltihtey iLsOnAoEtLa,ffehcotweedvbeyr,trietaitsmeunntc.leaFrulwhleittheerr this dreesvuelltoepdmfernotmdmuartiencgnatlhetolxaicctiatytioornapdeirrieoctd ewfafsecobosnertvheeddeinvemliocpeinegxpoorgsaendistom.doAsletelreevdemlasmlimghairlyyhgilgahnedr talhtaenratthieoncrsiitnicmalasmtmuadyrLyOgAlaEnLd ddeuvreilnogppmreengatahnacyv.e bIencerneiadseendtiinfciiddaesncaesoefcofunldla-riyteerffreectsso.rption and *coH-ycproiatccatliveeffreecstpsonAsedtoosen-irceoltaitneedhianscrbeeaesne oinbsaetraxvieadiinntnheeonfaetmaallemircaesawnadshraespobreteend iinnctlhuedcehdrionnithce2liysteaorf stbuoddyyabtudorsdeoelrenviesnls9g0rdeaatyerstthuadnietshuetiLlizOinghAighhoewredvoesre,s.thDiisserfufpecttiownaosfsnpotonotbasneerovuesd ibnehmaavlieosrwfiotlhlohwiignhger oabcsuteervneedonaantdalaerexipdoenstuifrioeeddosseasseacpopnrdoaxriymaetfefelcyt,3-TfhoeldShAigBhehrasthraenctohmemcerintdiceadl satdudidtyiLonOalAnEeLurholaovgeicbaelen testing. Auschment. Page 3 of 7 2134.0004 STATE_02430437 `Thefollowingsources were reviewed in the preparationofthe HBV: Andersen, ME, et. al. 2006 Pharmacokinetic Modeling of Saturable, Renal Resorption of 2Pe2r7f:l1u5o6r-o1a6l4k.lecids in Monkeys ~ Probing the Determinants of Long Plasma Half-Lives. Toxicology `Abbot B.CJ Wolf, KPDas, CS Lau. 2007. Roleofperoxisome proliferator activated receptor-clpha T(oPxiPcAolRo)giisntm(esduibamtiitntgedthfeordetvheel2o0p0m7enatnanluatloxSicOitTyomfeetpienrgf)l.uorooctanoic acid (PFOA) i the mouse. The ACGIH DocumentationofTLV 2001. Ammonium Perfluorooctanoate. Buteahoff, e al, 2002. ToxicityofAmmonium Perfluorooctanoate in Male Cynomolgus Monkeys After Oral Dosing for 6 Months. Toxicological Sciences 69:244-257. ButenhoJfLf, et al. 2004a. Pharmacokinetics of peruorooctancate in Cynomolgus monkeys. Toxicological Sciences 82: 394-406 RBuattenThooxfifc,oeltoagl,y2109064:b9.5-T1h16e.Reproductive ToxicologyofAmmonium Perflucrooctanoate (AFO) in the Butenhofeft al, 2004s. Characterization of risk ofgeneral population expasure to perfluorooctanoate. Reg Tox and Pharm 39:363.380. Butenhoff etal. 2005. Response to lettetor the cditor. Reg Tox and Pham 42:146-147. CAmAmToTn2i0u0m2.PWeersfltucVriorogcitnaianoDaetpea(rCtSm)eAnstsoefsEsnmveinrtoonfmeTnotxailciPtryToteecmtion(C(ADETPT)). RAeupgourstt2002. Final Clewell HJ, Tan YM, Andersen ME. SocietyofRisk Analysis presentation Dec. 2006. Application of PCohnacremnatcroaktiinoentsicinMHoudemlainngPotpouElsattiiomnast.e PAbFsOtrAacEtxpMo2s-uCr.e1s.Associated with Measured Blood `DeWit IC, CB Copeland and RW Licbke. 2007. Dose-responseofperfluorooctanoic acid-induced miemtmiunngo)m.odulation in adult CSTBLI6 mice. The Toxicologist (submitted for the 2007 Annual SOT Emmet E, et al. 2006a. CommanityExposure to Perfluorootanoate: Relationships between serum levels and certs health parameters. JOEM 48(8)771-79. `EcxonnmceenlttrEa,tieotnsala.n2d00e6xbp.osCuormemsuonuricteys.ExJpOoEsuMre48t(o8P)e7r5f9l-u7o0r.ooctanoate: Relationships between scrum pFreenntaotnalSaEn,dClLaactua,tiEonPalHienxepso,suJrReTihnimbiocde.eaTuh,eaTnodxiScSclWohgiitset.suLbomnigt-tteedrmfohreatlhteh2e0f0fe7ctAsnonfuaPlFSOOATafter meeting). Atiachment. Page 4 of7 2134.0005 STATE_02430438 Food Standards Agency (a United Kingdom Government Agency), Committee on ToxicityofChemicals in Food, Consumer Products and the Environment. Second Draft Working Paper on the Tolerable Dily Intake for Perflourooctanoic Acid (May 2006). Food Standards Agency (a United Kingdom Goverment Agency), Committee on ToxicityofChemicals in Food, Consumer Products and the Environment. Mints ofthe July 11, 2006 meeting. Food Standards Agency, Commitee on Toxicity (COT)ofChemicals in Food, Consumer Products and 2th0e06E)n,vironment. COT Statement on the Tolerable Daily IntakeforPerfluorooctanoic Acid (November ``wGaetnemrawnitMhintihsetgruyiodfeHseuablstthanDcreisnkpeisnfglWuoartoeorctCaonmomicisasciidon(.PPFrOoAv)isaionndapleervfalluuoartoioocntaonfeFsFuTlfoinnadtrein(kPiFnOgS) as ewaxtaemrplpesd.f July 13,2006. hitp//snsnv.umweltbundesamt.defuba-info-presse-e/hintergrund/pf.in-crinking.TGourxuSgceie8t9a(l1,)29030-61.07.Gene Expression Profiles in Rat Liver Treated With Perfluorooctanoic Acid (PFOA). HinenFdeetralsoannWd MNaeonndatMaAl MSimciethF2o0l0l7.owPienrgflIunorUotoectraonoEixcpaocsiudr(ePFtoOA8)-a2ndFlPueorrfoltueolroomneornaAlnciochaoclid((FPTFONHA).) Toxicological Sciences 952)M52-61. Hinderliter, PM, E Mylchreest, SA Gannon,JL Butcahoff, GL Kennedy Jr. 2005. Perfluorooctanote: Placental and lactational transport pharmacokinetics in rats. Toxicology 211: 139-145, Hinderlicttearl,2006. Ago effect on perfluorooctanoatc (PFOA) plasma concentration in post-veaning sats following oral gavage with ammonium perfluorooctanoate (APFO) Toxicology 225:195-203 Johansson, N, et al, 2006. Neonatal exposure 0 perfluorooctane sulfonate (PFOS) and pseyrsftleumcrionoacdtualntoimcicaec.idTh(ePFTOoxAi)coclaougsiesstdAebrsatnrgeecdbte#h1a4v5i8ourand increased susceptibilityof the cholinergic: Karman A, | Ericson,B van Bavel, PO Damerud, MAune, A Glynn, S Lignell inGd Lindstrom. 2006. Exposure of Perfluoroinated Chemicals through Lactation -- LevelsofMatched Human Milk and Serum and aTemporal Trend, 1996 ~ 2004, in Sweden. EHP Online November 2006. Kennedy ct al., 2004. The Toxicology of Perfluorooctanoate. Critcal Reviews in Toxicology 34(4)351383. Kudo N and Y Kawashima 2003. Toxicity and tosicokinelics of perfluoroocianoic acid in humans end animals. The Joumalof Toxicological Sciences 28(2)49-57. Lau, C, JL Butenhoff,andJM Rogers. 2004. The developmental toxicity of perfluroalkyl ids and their derivatives. Tox Appl Pharm 198:231241 Atachment. Page 5 of7 2134.0008 STATE_02430439 PUeSr.flEunorvciorcotnamnecnitcaAlcPirdotaencdtiiosn SAagletsn.cy. November 4, 2002. Revised Draft Hazard Assessment of USS. Environmental Protection Agency. October 2004. Etimied Per Capita Water Ingestion and Body `Weight in the United Sates - An Update. hup/ww.epa.gov/vterscience/drinking/percaita) UHSeSa.ltEhnvEfifreocntmseAnstsaolciParotteedcwtiiotnh AEgxepnocsyu.reJatnouPaerryfl4,uo2r0o0o5c.tanDoriacftARciisdkaAnsdsIosssSmaletnst of the Potential Human hpi pagovioppUploalpfoarisk him UPSoSt.entEinavliHrounmmaenntaHleaPlrtohteEcftfieocntsAAgsesnoccyi.atMeadywi2t0h06E.xpSoAsBurReetvoiePwe:rfolfuoErPoAo'ctsaDnroaifetARciisdkaAnsdseIsssSmaelnt,t of the hp: epagovisab/pdisab 06006pdf US. Environmental Protection Agency. Nov. 17, 2006. Memorendu to Walker Stith rom C(hPrFisOtAooprhCer8W;eiCsA:SHa#z3a3r5.d6E7v-a1l)uaintidornisnkainndg RweavtiesrendeSairtteh-eSpDeuciPfoinctThWraesshhionlgdtfoonrWPoerrfklsufoarcoiolcittya,noWaetset Virginia. UWSaSs.hiEnngvliornonWmoerntkaslFParcoitleictytiownwwAg.enecpya.goNvoivr.eg20i,on20030e6.nfSorDcWemAen1t4d3u1poCnotnseorndteOrr.dpdefr~ DuPont IWRhiTtheibSoSd,eAauMx,CaClaWfoaot,dZ, KaunkdlSeEnyFiekn,toLnT. W2i0l0l7a.nuGeevsat,atRioDnaZlePhrF,OLAHEelxfpaonstu,rMeJofStMriycnaer,isAABssLoicnidastterdowmi,th Altered Mammary Gland Development in Dams and Female Offspring. Toxicological Science 96(1), 133-144. Wolf, CJ, SE Fenton, JE Schmid, AM `White, CS Lau, and BD Abbott. 2007. Calafat, Z Kuklenyik, XA Bryant, Developmental Toxicity of perflu J Thibodeaux, KP Das, S$ orooctanoic acid (PFOA) in the 4C6D2--147M3o.useafter Cross Foster and Restricted Gestational Exposures. Toxicological Science 95(2), Atschment Page 7 of 7 2134.0007 STATE 02430440 La#1u2,3e2t)al. 2005. Pharmacokinetic evaluationofperfluorooctanoicacid nthemouse.Toxicologist (Abstract Lau et al, 2006.Effectsof perfluorooctanoic acid exposureduringpregnancy in the mouse. Tosicological Sciences 90(2)S10-518. LauC,B Abbott, and DC Wolf. 2007. Perfluorooctanoic aidand WY 14,643 treatment induced peroxisome: aprnonluiaflerSatOiTonmienetliinvge)r.s of wild-type but not PPARa-null mice. The Toxicologist (submitted for the 2007 Loveless et al., 2006. Comparative responses of rats and mice exposed to lincarbranched, linear, or branched ammonium perfluorooctanoate (APFO). Toxicology 220: 203-217. Luebke et al, 2006. Evaluation ofperfluorooctanoic acid immunotoxicity in adult mice. Tosicologist (Abstract #255). New JerseyDepartment of Environmental Protection. 2006 Draft preliminary Health-besed Guidance for PFOA in Drinking Water at Pennsgrove Water Supply Company. Ohmori K, N Kudo, K Katayama, Kawashima. 2003. Comparison of the toxicokinetics between perfluorocarboxylic acids with different carbon chain length, Toxicology 184:135-140. Olsen et al., 2003. Perfluorooctancsulfonate and Other Fluorocheanicals in the Serum of American Red Cross Adult Blood Donors. Environ Health Perspec 111:1892-1901. Olsen etal. 2004. Quantitative EvaluationofPerfluorooctanesulfonate (PROS) andOther Fluorochemicals in the SerumofChildren. Journal of Children's Health 2:53.76. Olsen et al, 2005. Evalustionofthe half-life (112)ofeliminationof perflucrooctanesulfonte (PFOS). pIenrtfelmuaotrioohneaxlanSeysmulpfoosniatuem.o(nPFFlHuSor)inaantdedpAelrkfyluOorrgoaoncitcansoiantethe(PEaFvOiAr)onmfernotm,ThOuXmOa1n7.serum. FLUOROS: RtyopseenanMdBP,PBADRAnbublolttm,icJeReSxcphomsiedd,RtoDPFZOAe. hTKhPerDTao,sx,icCoJloWgoisltf(asnudbmCitLtaeud. f2o0r0t7h.eG2e0n0e7 ApnrnoufailliSinOgnTwild. meeting). Sak, C,R Leonard, M Cullen. 2006. Twenty-five year longitudinal studyofserum total cholesterol elated 10 a serum biomarker of exposure (serum perfluorooctanoste or PFOA) in apolymer production plant. Presentation at the American Occupational Health Conference, May 2006. "Takacs ML and BD Abbot. 2007. Activation of Mouse and Human Peroxisome Proliferator-Activated R10e8c-e1p1t7o.rs (a, 5,7)byPerfluorooctanoicAcidandPerfluorooctane SulfonateToxicological Sciences95(1). `ThayerK,. 2002. Environmental WorkingGroup: Prfluorinaiedchemicals: Justificationfor inclusionofthis hchtetmpi/csawlnw.cwlagss orignlreptohrets/npafteiwoonralldlprdepEoWrtG.onCDCh.upmdafn exposure to environmental chemicals Atachment- Page 6 0f 7 2134.0008 STATE_02430441