Document Y7mmKBOZQ33ZDzMxO98j3OKO

ISpp 30 SpreoysaarMittel October 3, 2002 SMatPaaielrMoN 55144-1000 ARLa6_ 1134 DU.xS..OsEncvairrHoenmmeanntdaelzProtection Agency EPA East, Room 4410 W1a2s0h1inCogntsotni,tuDt.iCo.n A2v0e4n6u0e, NW. VIA FEDERAL EXPRESS Re: Draft Hazard Assessment ofPFOA and ts Salts Dear Dr. Hemendez: "Draft H3aMzahradsApsrseevsisoumselnytoprfoPveirdfelduocroomomcteanntosiconAcpiodrtainodnsIosfSEaPlAt's"s FIenbrthuiasrlyet2t0e,r,2w0e02 `stwuoduileds.likWeetoapprporevciidaetesothmeeeafdfodrittEiPonA choamsmpeunttisn,towithteh dpraarftticauslsaersesmmpenhta,siasndonhothpee hthuemsaen comments will facilitatetheagency's efforts. needs toOuberacdodmemdentotsthfeuldlraifnttoastshreesesmceantetg-oribeost.h Fnierswt,iwnfeorimdeanttiiofnyainmdpodrattaantthdatatwaetrheat adviasicluasbslieonboufttohmeitCteodt.tagSeecGornodv,ewmeordtiaslciutsyssstuodmye. sFuibnsatlalnyt,iwveeisnsoutcesarneguamrbdeirnogfEPspAe'cisfic: c phaso eoutomfocnem trhteaidenraffltn uaosrsoecthsesmmiessnttr,y,canod otvhherueimsasunrehse.ailthnissuges, GesatofuM'ss po Ss = L ADDITIONAL DATA FOR THE ASSESSMENT The Februaryreviewdraftnesds tobe supplemented,bothwithsubsequent E=X a 33g : ithnefodromcautmioenn,t.and also with information that was previously available but not referencedin= o3s75 A NewDa :a assessmFeinrtstw,awsepnroetpeartehda,t a3Mnd htahse dsoubcmuimtetnetd aneneudmsbteorboefuapdddaitteido.nalInsptaurdtiiecsulsairn:ce the draft 1. Human Health a IEnlddievrildyual Blood Samples for Children, Adults and Page2 Dr. Oscar Hemandez 3M's March 13, 2002 submission providedfina reports on the studies of pinrdeisveiadtueadlonblopoagdesa1m8p,lpeasrafgoreacphhil2d,reann,"d aidnutlhtes?taabnldeotnhe pealdgeerl1y9.," iPnrEePliAm'isndarrytdsathaould be replaced with these new data. b. HalifnHuLmainSfereum draft as`sTehsesmEexnctu,tdiivsecuSssuImnmtaerriymoRneppoargte#2,1aonndtshiex preatriargeerahpahlsfloinfepsatguedys.20I-n2t1eorifmthReeport #1 was entirely superseded by Interim Report #2," submitted on March 13, 2002. new infAocrcmaotridoinn.glyIn, tthheesseepcaornadgirnatpehrsiminretphoertd,ratfhteamsseeasnsmseentxushhoaullfdlibfeerfeoprlPacFeOdAwiwtahsthe 4a.n4oynegaorisn(gSsDtu=d3,.5t;heryansgheou1l.d5-r1e3p.5l)a.ceWthhieloebstohleestedeavtaalauersefarlosmo tsthielleianrltieerrimrevpoarltu.esTrheo.m fsiercstonidntienrtiemrriemporretp,oratnaddpdrreessesnetssmiandniyviodfutahledactoancfeorrntshenontiendeistutdhyeseuxbijsetcitnsgwtehxot ahbaodut the triplicate analyses ofPFOA measuredforeach collection fime period 2 Tosicolosy a Iwo Generation Reproductive Study AS EPA is aware, data from the two-generation study rat reproductive study of PFOA are now available. We assume the agency plans to add these data o the assessment. b. FinalMonkeyStudy cynomol3gMussmubomnikteeydstohneJfiannaulalrayb3o0r,at2o0r0y2.repTorhteoansstehses2m6e-nwtesehkoucladpsruelfleescttutdhyesiendata as well +MuOolrsoecnhGemWi,eaBlusrriiash7uMm,aLnunsdab.erIgIJ.KP.edHiaantrsiecnpaKrJt,icMiapnadntesliJnH2,GZroobuepl ALR.StrIedpetnotciofcicciatciloinniocfal ial investigation. St. Paul (MN): 3M Company, February 25, 2002. 2fuOolrsoecnheGrWni,caBlusrriinsmIMa,nLusnedab.er1g. JAKm,eHraincasnenRKeJd,CMraonsdsealduJlHt,bZlooboedldoLnRo.rs.IdeSntt.ifPiacualti(oMnNo)f: 3M Company, February 25,2002. >fOulosroecnhGemWi,caBlusrriinsJhuMm,aLn sueren. 1d1J. KbE,leHdearrnlsygepnartKiJc,ipMaanntsdeil JthHe,AZdoubletlCLhRa.ngIedsenitnifTihcoatuigohntoSftudy, Seattle, Washington. St. Paul (MN): 3M Company, February 25, 2002. "seBruurmrshaIlMf-,iLvuensodbfesregveJrKa,l OflusoernocGh,emSiicmaplss.onSCt.,PMaaunld(eVlINJ),:In3tMeriCmoRmeppaonryt,#J2a,nuDaertyer1m1i,n2a0t0i2on of Page3 Dr. Oscar Hemandez B. Musing Data I PublishedLiterature assessm`eTnhterdeoeissannotexrteefnesreinvceeb.oMdyuocfhpoufbtliisshelditelriatetruarteuhreasonbePenFOliAsttedhaitntbhiebldriaofgtraphies parpopvriodxeidmattoelEyP7A0wairtthic3leMs 3suMbmhiasssiloinsste.d nApipsebnidbilxioAgrtaophtiheiss tlehtatterdoprnoovtidaepspeaalirsitnotfhe aErPtiAcledsraafrtecoofveeqruianlgsbiogtnhiftiocxaincceo,loigtyisainmdpoerntvainrtontmoetnhteaclreedfifebcitlsi.tyoWfhitlhee naostseasllsmoefntthetsoe. indicate thet the published literature has been reviewed. 2. Available 3M Data Not Cited `We also note specifically some omissionsof 3M data: MedicalSurveillanceData publicatAinonetnhtaitremepaasguer(epdp.to3t5a-l3o6r)giasndiecvfoltueordinteo cthoencGeinltlrialtaindonasnidnMCaonttdaegle(G1r9o9v3e) workers i(n1919939,0,19w9i5thaonudt 1a9n9y7m)ewnhtiicohn osfptehcirfeiecaslulybsaenqauleynztedmefdoircsaelrsuumrvPeFilOlAanceendextahmeisnaatmieons clinical chemistries. 23:603-620 (2000). These results were reported by Olsen, et al, in Drug Chem Toxicol Nor is there any mentionofthe 2000 medical surveillance -- either the cross. sectional analyses for POA among Antwerp and Decatur employees, nor the 1994-2000 `lTohnegsietu3dMinfailnaanlarleypsoirstosfwPerFeOsAubammiottnegdatsouEbPsAetoifnDAnetwecrpeam2n0db0D1ee,caarntudrcoermrpelcotyeedevse.rsions were provided with our March 13, 2002 submission. which p`rWoeviudregceotnhseisdeerpaabrlaygrmaoprhse dinactlautdheanthceusrerreenptolrytcsittehda.t are specific to PFOA and OpelrfiluncrGoWos,iaentoaalt.eA(PcFrOoAss)-siencrteiloantailoanntaolycsliisnoicfalsecrhuemmipsetrf,lutahryoroocitdahnoersumlofnoen,atheem(aPtFoOlSo)gaynadnd iSunoarloyssheimriecsaullmtefdriocmalmasulreveainldlafnceemparleogermapml,oy3eMe pCaortmipcainpayn,tsOocfttohbeer20101,02A00n1t.werp and Decatur pOelrsfleunooGctWa,noeattea,(PAFOlAon)giltevaedlisnalinanraellyatsiiosnoftsoelirpuidmapnedrfhleupaotriococctlianniecsaullcfhoeamties(tPryFtOeSs)t raensdults sfuorvmeimlallaneceempprloogyreamep,a3rtMicCipoamnptasnyof,tOecto1b99e4r/1915,,21090917, and 2000 fluorochemical medical Page 4 Dr. Oscar Hemandez b. MeasuofrPFeOAmineWornketrs Along the same lines, the last sentenceofthe fifth paragraph on page 3 states, "PFOA was not measured directly" in the medical surveillance exams. This is not correct. In fact, page 17 of the assessment,in paragraph 3, provides worker serum data from the medical surveillance. `Total organic fluorine in the serum was measured in Cottage Grove workers in 1990, but PFOA was measured in the serum for Cottage Grove employees in 1993, 1995 and 1997, (including and statistically analyzed in relation to their clinical chemistry values liver function tests) and various reproductive-related hormones (in 1993 and a1n9a9l5y)zaenddinCcCoKnjuinnc1t9i9o7n.wiItnhacdldiintiicoanl,csheermuimstPryFOdaAtacfoonrceAnnttrwateiropnsawnderDeecmaetausrureemdplaonydees in 2000. As noted above, all thesedata havebeen submittetdo EPA. CCKDataandConfounders id not Preapgoert34d,atpaaroangtrahphre2l,atniootnesshitphabtetthwee3enMCRCepKoratnodnPthFeOA19a9d7jumsetdeidcfaolr scuornvfeoiullnadnecres `These data can be found in Figure 1 and Table IT in Olsen, et al., Drug Chem Toxicol 23:603-620 (2000). In sum, there is a great dealofadditional information available. While we ccoommmmeenntds EwiPlAl afsosriiststehfefaorgtesnicnyrienvieneswuirnignag ltahartgetahemohauznatrodfadsasteassamlerenatdyi,s cwoemphleotpee.these. I. `COMMENTS ON MORTALITY STUDY Mortality experience at the Cottage Grove plant where 3M manufactured and processed PFOA was studied in'1992 by Gilliland as his Ph.D. dissertation. That study `was subsequently published as Gilliland and Mandel (1993). The study used duration of employment in the "Chemical Division," meaning the entire Cottage Grove facility and. not just the PFOA production buildings within that complex, as an (inexact) surrogate for exposure, and did not include any actual exposure data. The mortality study was recently usppedcaitfeicdalblyyDart.fBlurourcoecAhlemeixcaanldweororfkterhsewUintihvienrstihetyCohfeMmiincnaelsDoitvai;siAolne,xuasnidnegralnooikmepdroved `measure of exposure and with the benefitofpublished serum data for the workforce. draft assWesesmheanvte. several concerns about the presentationof the data on mortality nthe Page 5 Dr. Oscar Hemandez A. DifferenceinExposure Informationin OriginalandSubsequent Studies `employTmheentrdeturroastpieocntiivnetchoeh"oCrhtemmoirctaalliDtiyvsitsuidoyn,b"yreGfielrlriilnagndtoantdheMeanntdreelCoetxtaamgieneGrdove. fCahceilmiityc.alPDFiOviAsipornodoupcetraitoinonosc.cuTrrheediinnveosntliygacteorrtsaidnidarneoats cwointshtirnuctthea mPuFcOhAlaerxgpeorsure pmaatgreix3. shAocuclodrdrienagdl,y",Awreetsruogsgpeescttitvheacothhoerotpmeonritnaglisttyatsetmuednytdienmothnestfroautrethdpaawreagarkaph of SaasscolcaiyatwihonerbeetPwFeOenApwroasstamtaencuafnaccetrurmoerdtoanliltyyianncderetmaipnloayrmeeasnotfdtuhreatfaicoinliintya" chemical particul`aTrhley dgaitvaenfrtohamttthheeuepxdpaotseudrestculdasyssifhiocualtdioanlssobebceacmietesdpiencitfhiecEfxorecPuFtOiAv.e Sinumthmeary, uthpedautpeddatsetdudsyt.udWyebyreAcleoxmamnedenrd,tahne efxoploloswuirnegmsaetnrtiexncweassbdeeavdeldoepdetdottohiisdepnatriafgyrcaaplhe:n"dTanrymoeratraslpietcyifwiacsdneoptarstimgeninftiscaanntdlyjoabsssowcihaetreed PwiFtOhAdeefixnpiotseuorreprooccbuarbrelde. PPFrOosAtaetxepcoasnucreer categories." did not pOrnovpiadgeesan3aannadly3s2i,s tbhyeedxrpaofsuarsseedsusrmaetniotnn.otSeuscthhaatnaAllyesxiasnwdielrbinehpirsorveipdoerdtitnoD3r.M Ablyedxuarnadteiro'nos ffoerxtphocsoumrienginpuPbFliOcAatdieofnoinfitteheorspturdoyb.ablTehjeombas,nuosbcsreirpvtesdttaoese,xp"eCcatteedgoprriozsetadte c1a0nyceearrmso(r0t1a0l.i8t2y)raatnidos2w1e0reye(airnsp(ar4e2n9t5h)e.sesT)h0e-S<1MyReawra(s101..0316)(,915-%<5C1ye0a.r3s7-(32./14.84)2)f,or5 - < ppraotstteamtewictanhcdeurrmaotritoanloifteyxipnotshuere>,1a0ndyetahred9ur5a%ticoonncfaitdeegnocrey.i"nteIrnvaslhoarrt,outnhedrtehweaSsMnRo cfloerar prostate cancer mortality workers exposed longer than ten years included the null value. the studGy,ivweendtohenmoutcuhndmeorrsteanddetwahilyedtheexpdorsafutreasisnefsosrmmeanttioonniyn dthiescAulsesxeasn(daetrpaugpeda3t1e,of pbeyrAalgerxaapnh5der,thwehpiolteennteivaelrfdoirsecxupssoisnugreexmpiossculrasesmiifsicclaaisosnifiinctahteiounpcdoatnecdemmosrrteagliatrydisntgudthye cGaillleinldaanrd-yaenadrMdaenpdaerltm(e1n9t93a)ndstjuodby-.spAelciefxiacncdlearssdiefviecaltoipoensdtaonPeFxpOoAsuirneomraderritxofaorrrive at hMiasnsdteuldydiddefniontitdieovnesolfopdeafniyniPtFeOaAn-dsppercoibfaibcleexPpFoOsuAreexmpaotsruixr.e, GwihlillielaGnidlalinldanMdaannddel butaisleidzeodntlhyeenmopnl-sopyeeceisf'icsteaxrpoasnudrequdietfdiantietsi.onoAfleyxeaanrdsewrowrokrekdedinfarochmewmoircaklhpilsatnotrythraetcowradss {thtahtrowuegrhoeutcotmhpeustteurdiyzepderfioordtohebsetuedvyalaunadtetdhefroerftorhee paoltleonwteidalalflorjoPbFsOanAdedxeppoesrutrem.ents Iinntdoustthreiaelxhpyogsiuerneisctlsa,sspilfainctatmiaonnasguesmeednbty,Aplreoxdauncdteiro.n wTohriksewrassannodtrdeiorneeesbyprGoivlildieladndinapnudt Mandel. Page 6 Dr. Oscar Hemandez AlexandMeorruesaevdesi,n atlhethuopudgahtneodtmsopretcailfiitcyalsltyusdyatweadsincotnhsetrruecptoerdt wtihtehetxhpeosbeunreefimtaotrfitxheDr. rseeprourmtePdFbOyAOlcsoennceenttarl.atiinonDsrmuegasCuhreemd Tionxeimcpollo2y3e:e6s03a-t6C2o0tt(a20g0e0G).rovTehesriencfeor1e9,93i,tisas (isnaeprpurmopPrFiaOteAtloevceolsm)m,eint tisodinffpiacgulet3t2o,jtuhdigred ptahreargerlaipabhi,litthyatof"ewxiptohosuutremecaasteugroerdieesxtphoastures wnoetreusdeedfidnierde.ct"lySienruthmePupFdOaAteddasttauadrye, atvhaeiylawbeler.e tWahkielneintthoecsoenrsuidmermaetaiosnu.rements were wes far For allofthese reasons, greater in the Gilliland we believe the potential for study than in the Alexander exposure study. misclassification B. Prostate Cancer carlir vAesrsiinodniocfattehdebsyttuhdeyplreeacdesdtionagnduisncfuosusniodne,dweempbhealsiiesveoEnPpAr'osstaetmepchaansciesr.onPtrhoestate c`eaxnpcoesrurmeorctaatleigtoyriweassinnotthesiugpndiafitceadntsltyudays,sowchiiatcehduwsietdhadeffairnmitoeroerapcrcoubraabtleeePxpFosOuAre: classification scheme. ChemicaIlndDeievdi,siinonthweorGkiellrisl,anads stthueddy,ratfhearsesweesrsmeefnoturnoptreosstoantepacagnec3e0r.deHaotwhesvoebrs,erved in psruobdsuecqtuieonntbrueisledairncgh.haSsees..h.owOncctuhpa.t o&nlEynvoinre.oMfetdhiecsieneem4p0l:o6y1e4e-s62w1or(k19e9d9)i,n tathepaPgFeO6A15, column 2. employm`Tehnuts,itnhethaesCsohceimatiiconabDeitvwiseieonneamnpdlporyomsetantteicnanthceerCmhoermtiacliatly,Diivsinsoitonmeoarnliennggftuhloifn atributing the results to PFOA. . UseofConfidenceIntervals update,ItnhethderasfctcsoantdespahraatgarapfhewonSMpaRgse 3w1e,redicslceuvsastiendgtfhoerreemspulltosyeoeftshien tAhleexdeafnidneitre pPoFiaOtAesetxipmoasteusr.e gTrhoeupc,obnuftiddeonecseniontteprrvoalvsidaere9c5ri%tiCcaolnffoirdeenvacleuIanttienrgvatlhse(eCxItse)ntotro wthheisceh 9th5e%SMClRs'sshaorueldmebaenipnrgofvuild,edasfotrhcainncteerrovafltshaell lianrcgleudienttehsetinnuel(l SbyMpoRth=es1i.s6.7,T9he5r%efCoLr0e,.026.02), pancreatic cancer (SMR = 1.34, 95% CI 0.03-7.42) and prostate cancer (SMR = r1e.s3ul0t,s9i5n%thCe10p.r0o3b-a7b.l2e0)e.xpoSismuirlearglryo,upi,n 9th5e%neCxltspaarreagprraopvhidoerdpfaorgese3v1eraadldernedspsoiinngtst,hebut notforthedeficitofprostate cancer (CT 0.28-2.02). D. BladderCancer Grove mtoirtsaulintfyosutnuddeydbtloadsdugegrecsatn(cietmhoersaelciotnydrpesaurlatgsraarpehcoonnspiastgeent32w)itthhtthtohseeCroetptoargteed for the Decatur mortality study, or that they ae ofparticular significance becauseof the Page? Dr. Oscar Hemandez rpeasrualgtrsaapthDedciasctuusrs,iwnghetrhee belxapdodseurrceainscperrirmesaurltistlbyoePdFeOleSt.ed.We recommendtha this + aFisrssotc,itahteerdewwietrhetzheerdoebflianidtdeePrcFaOnAceerxdpeoastuhrseignrtohuepsCo(totnalgye0G.2r3oveexpmeocrtteadl,it9y5s%tuCdIy (01..0608-1e5x.p7e2c)teadn,dSjuMstRo-ne0.b5l9a,d9de5r%cCaInc0e.r02d-e3a.t3h0)i.n the probable PFOA exposure group + eCxopmobsiunreedj,obthgerwoourpkserressuwlittehdainmi1 noibsmeurmvoefdoannde1y.e4a7reixnpdeecftienidtdeeaantdhsprfoorbabbllaeddPeFrOA cancer (SMR =0.68, 95% C1 0.02-3.79). + T5.h4e0)reomcaciunrirendg 4ambolandgdeirndciavnicdeuraldsewathhos n(eevxeprecwtoedrk1e.d89i,nStMheRch=em2.i1c1a,l9di5v%isCiIon0a.t5- Cottage Grove. `mort"aTlhiutsy, aunndlikfeluDoercoacthuerm,ictahlereexwpeorseurneospaotstihteivCeotatssaogceiaGtrioovnes bcehtewmeiceanlbdliavdidsieorn.canIcteirs iwniatphpr$ocparsieasteotbosesruvgegdeswthtehreeov3e.r8a3llweCroetteaxgpeecGtreodve(SreMsRult1s.3f1o,r9bl5a%ddCe1r 0c.a4n2c-e3r.0m5o)r,alairtey, indicative oafn association between PFOA and bladder cancer. ofparticMuolracrosviegsn,ifiitciasncilelobgeiccaalusteobsluagdgdeesrt ctahntcetrhewCaostetlaegveaGterdovine tfhiendmionrgtsalaizteyssotumdeyhaotw twheereDerceastpuornspilbalnet,fowrheblraededxeprocsaunrceerw,aosneprwiomaurlidlyextpoePcFtOtSo-rsecleatthead actoCmoptotuangdesG.r1ofveP,FOA `thwahterseheoxwpsosbulradedsetrocPaFncOeAr (wSerMeRh8i.g6h8e,r9t5ha%nCatID1e.c7a9t-u2r5..3I9nsatmeaodn,gitwiortkheersDewciatthuar study minimumofone year exposure). The results in the two studies are not comparable. suggestsFitnhaaltlyP,FiOnAt.heexdpiosscuursessiaotnoDfebclaatdudrewrilclanlciekerlaytiDneccraeatsuer.,Tthhiesdriasftinacsosrreescstm.enPtFOA `epxrpoodsuucrteisonwaitllthneosteipnlcarnetasseasat ceeiathseerd,thpeerCotthtea3geMGCroomvpeoanryD'escMatauyr p1l6a,nt2s0.00PpFhOasAe-out announcement. Thus, we urge EPA 10 delete the bladder cancer paragraph on page 32. ee Page Dr. Oscar Hemandez E. Effectof Missing Death Certificates there weArleth1o7udgehaats cneortteidfiocantepsag(e3%3)2tihnatthceoullasdtnpoatrabgerlaopchatdeids,cuosnsliyng6otfhtehmoosrteamliitsysisntugdy, c(enrt=if6)i.catCeosnbseelqounegnetdlyt,o tshuebj1e7ctdsewathhocehratdifdiecfaitnesitweoeuxlpdosnuorte"(g1re=at0l)yocrhapnrgoebabtlheeePxFpoOsAure canaatleygsoersi.es,OnWlhyi6ledewaethcecretrtaiifnilcyataegsreceouiltdisaiffmepcotrtthaentantaolcyosnetsifnouretahnealPyFsiOsAofexthpeoscuorhoert, athnedltihmaittamtiisosnitnogsdteaattehthceesrteidfiecaatthescearrteifaiclaitmeistactoiuolnodfgtrehaetlsytucdhya,nwgeetbheelireesvueltitsoovfetrhsetatsetusdy. II. SPECIFIC COMMENTS A. DisocfHuumsanHsealithSotudnies human hWeealtohffdeartet:he following editorial suggestions with regard to the presentation of + 4S,maplalraNgurampbher1ofpaSgteu2d2y,SpuabrjaegcrtaspHhi2ghalnydEpxapgosee3d3., pIanrsaegvrearpahlspl2acaensd,5i,ntchleuddirnagftpage tahsasnes1s0mepnptmnowtaess athlaitmtihteatsimoanollfnausmtbuedyro. fWweorskuegrgseswtitthhisPsFeOntAensceerubme rleewvrelisttgerneattoer sitnattheemsoerreupmrwecoiusledlybtehadtififnifceulrtentcoedserreigvaerdduiengoretshueltfsoiwn wsuobrjkeecrtss.aHboowveeve1r0,piptmshPouFlOdA nboetclliemairttthhaet atbhieliltaycktoofmsatkateisitnifcealrpeoncweesrfrionmhilgohwePrFsOeArucmonPcFenOtAractoinocnecnattreagtoiroinesswdhoeerse data are more numerous. + gNivuingmWoorbfkCeoerttsaergreumGrdoatvaenEomtpelsotyheatest.heTohteadlrnaufmbaesrseosfesmmpenltoaytepeasgewo1r7k,ipnagraagtrtahep.h 3, tChoettpaugbleiGcratoivoenprleapnotrtwiansg nthootsreepdoarttse,d.OlseHno,weetveal.r,DrthuatgnCuhmebemrTcoxaincoble.d2i3s:c6e0m3e-d62f0rom (th2e0s0e0)t,hareepcargoess6-0s5e:cti"oTnhael itontvaelstniugmatbieornosfwemrael:e1s9u9b3je(ctn=s, b1y11y)e;ar1,99w5ho(ap=art8i0c);ipaantedd in a1n9a9ly7s(ias..)=74E)l.igi(blTehevroeluwnetraerytopoarftiecwipfaetmiaolneraetmepslaomyoenesg ttoheisneclpurdoeduicnttihoendwaotrakers proapnugleadtfiornomraanpgperdoxfirmoamte8l0yi5n01(9199797to) 1to5780in(11999933). percent." Thus, the eligible + Table ofSerum Levels. Table 1 on page 19 mightbeclearerifboth occupations and gadednietriaoln,potphuelraetfieornenlcevee{l0s owcecrueparteipoonratledacnodngseisnteernatllpyoipnuplaarttisonpeerxpmoilsluiroens,(prepfme)r.rinIgn to ttaybpleesoprfeesxepnotssuerxepso,sucrouelldevbeelscornafthuesrintghiafntsheerruemaldeevrelwse.re to infer erroneously that the + PmaenntcieosnsedFiantdpiangges i3n7,Eppiasroadgersaophf5C,airtewoStuulddy.beIafpdpirsooprrdieartseooftmheenptainocnrtehaesfaarcet ftohabtein PDra.gOesscar Homandez ihe igh exposure, long-term employment group (Table 10 in the EpisodesofCare Creppiosrotd),esthoifscaasrsocfioaratciuotnewapasncbraesaetditoins.one individual in the chemical plant who had 6 B. Discussion of PFOA Production 3M: phWasee-aoruetcoofncPeFrOnAe.d thEaPtAthoendopcaugmeentsayds:oc"oInftaecmcusraotfoenly-gcaopitnugreprsoeduscttaitouns,o3fM has not committed publicly to a complete phase-out ofPFOA and PFOA-related chemicals as it has for PFOS and PFOS-related chemicals. However, 3Mhas indicated tithsatsailttissspuhcahsiansgFoCu-t26c,erFtaCi-n1F18L,UaOndRAFCD-1B4r3a,ndFXs-p1ec0i0a1ltaynmdatoetrhiearlss(t3haMt cCoonmtpaiannyP,FOA and 2000). To the contrary,on May 16, 2000, 3M announced the phase-outofthe. productionof "perfluorooctanyl chemistry" and related products. This announcement incl end udes PFOA 2nd its salts, of 2002. 3M will contin uaendtoitmiasn3ufMa'cstiunrteenotniloyn atoscmeaalsleapmrooudnutctoifotnhfeorsusbasletabnycethien FGeLrUmOaRnyAfDorbrinatnedrnnalamuesensowtibtehimnenthteiocnoemdp,atnoyavafotiedr that time. confusion 3M requests tha generated when t the relating chemisttroy brand names. However, EPA can note 3M's phase-outofU.S. production and sales of PFOA-related products. Further, based on our knowledge and experience, we disagree withthe speculation on page 10ofthe draft assessment, which `physicochemical propertiesofthe saltsof PFOA, they says: may "Based on the also haveother related Surfactant or cmlsifer uses 3 photographic chemical of in he manufac of etoleecxtprlonoirce cPoFmOpoAnaesntasrseuplcahcaesmesnetmicchoenmdiuccatlorfso.r PTFhOeSseisnaomteheprroappeprltiiceastimoansyilnewadhiicnhdustry PFOA is not currently used." While some physicochemical propertiesofPFOA and PFOS may be similar, these substances exhibitdistinctproduct performance characteristics that would make direct replacement either unfeasible or very difficult. aueston`sW.e WhoepesptphriosciinaptuettwhielalpapsosirsttutihteyAgepnrcoyv,idaendcowmemewnotusl,d be pleased to answer any Respectfully sub ec: Br. Charles Auer- EPA Room 4146 Dr. Jennifer Seed DViirceictaocrAo.fESaZvairrosnmentl, Health S3aMfeStpyeasinadlRteygMualtaetroirayl AMfafrikrests 3M Center, Building 236+1B-10 St. Paul, MN 55144-1000 -- Page 10 Dr. Oscar Hemandez APPENDIX A PFOA-related Publications Not Cited in Draft Assessment 1. pArbodleilfleartaitfi,oAn aGn.d mVo.dPurlaatt,ioJ.n oVfarmaetciqv,eRr.cNairlcsisnoong,enaensdisMb.yR2o,b3e-rdfircoihdl,oroPpehreonxoixsyaocmeetic aCcairdc,i2n,o4g,e5n-etsriisch1l1or(o1p9h9e0n)ox1y8a9c9e-t1i9c0a2c.id, perfluorooctanoic acid and nafenopin. 2. An YJ, Caraway ER surfactant solutions. W(a20t0e2r)R.esP.A3H6:d3e0g9-r3a1d4a,tion by UV/H;0; in perfluorinated 3. AhyndrYoIc,aCrbaomnaswbayypEeRrl,uSorcihnaltaedustumrMfaaAcnta(n2t0m02i)c.ellSeosl.uWbialtiezartiRoenso.f3p6o:l3y0c0y-c3l0i8c.aromatic 4. bBelloiosdlea,nId,oatnhderD.bioHlaoggeinc.alAsammpeltesh.odfAonrabdteitcearlmiBniaotcihoenomifspterryfl1u01or(o1o9c8t0a)no3i6o9-a3c7i6d.in 5. B(iCe8g)elo,nLL.eBy.,diMg.Ece.llHufurntc,tiaonnd: JI.nC.viCvooo,ke.x vEifvfoe,ctasnodfianmvmitornoistuudmiepse.rfTluhoeroToacxtizcnolooagtiest 13(1] (1993) 399. 6. Bpieergfellu,orLoBo.c,tRan.oCatMe.onLiLue,ydMiEg.ceHllurftun,catinodn:.CI.n vCiovook,.exEfvfievcot,saonfdaimnmvoitnrio ustmudies. Toxicology & Applied Pharmacology 134 (1995) 18-25. 7. `Bsoyrnjtehse,siHsKa.ndasntdimRu.lGa.teTphruortmeiann.kinPaesreoxCisinomvailvop.roTliofxeicceotlorosgyin&hibAiptpAlciyeld CoA Pharmacology 126 (1994) 233-239. 8. Calnadppneeruttorno,n RscMat,terBi.nTg.stIundgireasmo,nRaHm.mOotntiewuimlld,eacnadnAoRst.e-Reanmnmioen,iNumMR spectroscopic `5p0e1r,flBudso.r:ooPct-aMn.oaHtoelmliaxntduraensd.DI.n:N.MiRxuebdinSgihu,faAcmteanrticSyasntCemhse.miAcCaSlSSyocmipeotsy:ium Series `Washington, DC, 1992, 268-277. 9. `Caodoekn,omJ.aCs.,byS.aMm.mMounrriauym,pSe.rRf-luForraomoec,taannoadtMe.:EA. pHourststi.blIenednudcoticornionfe rLeelyatdeidg cell mechanism. Toxicology dApplied Pharmacology 113 (1991) 209-217. 10. C`oaomkm,onJ.iC.u,mMp.eEr.fluHourrtoto,ctSa.nRo.atFera(mCeE,) LinBC,rBli:eCgDelB.REf(fCeDc)tsorafts.WyeTthhe-T1a4x,i6co4l3og(iWstY)13a(n1]d (1993) 399. 11. Fpeelrlfelru,orDiRna.teadndfaUtt.yIanctirdassuiknsrpir.imMaercyhcaunltiusrmeosoffprearohxeipsaotmoecyptreosli(faebrstartaicotn).by Toxicologist 13 (1993) 395. ee Page 11 Dr. Oscar Hemandez 12. Hpaenrdolxeirs,o1m.eAs.,byC.tBr.eaStemeedn,tBw.iUt.hBpreardfflourodr,ooacntdaRn.oaGt.e dToheusrmnoontdi.ncIrnedauscetriaotnsooff Hy0; production in intact liver.Toxicology Letters 60 (1990) 61-68. 13. oHfaPuegrhfloumo,roBo.c,taanndoiOc.AScpiydde(vPoFlOdA.)T,hPeerMfelcuhoraonoicstmanUenSduelrplhyoinnigctAhceiHdy(poPlFiOpSeAm)icaEnfdfect Clofibric Acid. Biochim. Biophys. Acta. 1128[1] (1992) 65-72. 14. Hosokawa, M., isozymes in rat lainvderTm.icSraotsoo.mDeisffbeyrepnecrefsluionrtihneatienddfuactttiyoanocifdsc.arXbeonxoyblieosttiecraas2e3 (1993) 125-1133. 15. Huang Q and `water systems Hong CS (2000). containing fluoro sTuirfOa;ctpahnot.tocCahtaelmyotsicphdeegrread4a1t:i8o7n1o-8f79P.CBs in soil- 16. H`umretdti,atMe.dE.m,ecSh.aMn.iMsumrrfoery,amS.mRo.nFiruammep,erafnlduJo.rCo.oeCtoaonko.atIen(veCs8t)i-giantdiuocneodfaLehyodrimgocneallllyadenomas. Toxicologist 10 (1990) 192. 17. oTncotuaen,oaTt.e, aT.ndIwsaondaiguam,pKe.rfFluukoursohoictmaan,oaatenoRdn. tShheigmeolz-atow-al.iqEufifde-cctrsyosftsaloldneipuhmase. transitionofdipalmitoylphosphatidylcholine 46.(1988) 25-30, vesile membrane. Chen. Physics Lipids 18. JBuisotc,hWe.mWi.ca,lKe.ffGeocrtgsaasn,dF.zoHnaarlth,ePt.erHoegienneeimtaynonf,pMe.roSxailszoerm,eapnrdolHi.feSracthiiomnasisnedku.ced by perfluorocarboxylic acids in at liver. Hepatology 9 (1989) 570-581. 19. K`paewraflsuhoirmooac,taYn.c,icT.acMiadtosfumnaigcar,osNo.mUayl-IY-ua,cyalngdlyHc.erKoopzhuoksap.hoIcnhdoulcitnieonacbyyltransferase in at kidney. Sex related difference.BiochemicalPharmacology 42 (1991) 1921-1926, 20. Kawashima, Y., S. Suzuki, H. Kozuka, J. Sato, and administrationofperluorooctanoic acid on hepatic aYc.tiSvuiztuikesio.feEfnfzeyctmseofspwrhoilcohnged detoxify peroxide and xenobiotic in the rat. Toxicology 93 (1994) 85-87. 21. Kcealrlceirn,oBg.e1n,s uDn.cS.ouMpalresmmiatno,chJo.nAd.riPaolppo,xiadnadtiRv.eGp.hoTshpuhromraynla.tiSoenv.erBailoncohnigmeincoatoextic: Biophysica Acta. 1102 (1992) 237-244. 22. Kpeirnfnleuyr,ooLc.tAan,oaNt.eC.(aCbshtrraoctm).e,FGo.oL.d KCehnenme.dTyo.xiAcoclu.te21in(ha1l9a8t9i)on46t5ox-i4c6i8t.yofammonium 23. Kpeorjfol,iAo.r,o-Ho.ctHaannobiicjiarcviid,iMn.thYeliWniesnt,ararnadt.VA.r-cMh.ivKeososfmTao.xTiocxoilcoitgyy and kinetics of (Toxic Interfaces of Neurones) Supplement9 (1986) 465-468 . ---------------------------- PDra.gOes1c2ar Hemandez 24. pKeurdflouoNr,inBaatneddafiatNt,y aScuizduskiwiEt,hKdaitffaekruerntacMa,rbKoanwcahasihnilmeYnagt(h2o0f00p)e.roIxnidsuocmtailonbebtya `oxidation in the liverofats. Chem. Biol Interact, 124:119-132. 25. `KCuodmopaNr,isSounzuofktihEe, eKlaitmaiknuatriaoMn ,beOthwmeoernipKe,rflNuoosrhiinraoteRd,fKataywaacisdhsiwmiYtah (2001). different carbon chain in rats. Chem. Biol. Interact, 134:203-216. 26. IKnuvno,lvBi.ngFlCuaorrboocnar-bFolxuyolriicneacBiodnsdass.enEzd:ymRa.tiFiclalne.dAmCetSabSoylmicpoprsoibuesm. In: Biochemistry Series Number 28, `American Chemical Society, Washington 1976, 1-22. (QDI Am3s #25) 27. Kpuesrlfilkuiosr,odBeLc,anoyJ.lP.-VoranpderefnlHueourvoeolc,taannodylR-.cEo.ePneztyemresoAn.fLoramcaktoifoenviindmeanlceeafnord female rats. J. Biochem. Toxicology 7 (1992) 25-36. 28. 0Levpiltta,smD.a,maenmdbrA.anLeisss..JPoeurrfnlauloorifnTaotxedicfoaltoygaycdidsEnavltierromnemreonctyaalnHienael5th402d0y(e19b8i7n)di3n0g3316. 29. Levitt, cell lines. D.,TaonxdicAo.loLigsys.&TAopxpilciietdyoPfhpaerrmfalcuoorliongayte8d6fa(t1t9y8a6c)id1s-1f1o.r human and murine B 30. Liu, M.S. and administration DinMa.lveLoolnogg.raBipohlyoagnicdablrdoinscphoosigtriaopnhoyf.peIrnfvlesutcirgoacttiyvlebRraodmiiodleo:gTyr1a1cheal (1976) 479-485. 31. Lpieur,flRu.oCr;ooMcaEn.oaHtuert(tC,BL)Co.nCaorookm,atLaBs.e aBciteigveilt.y iEnftfiescstuoesfoafmmmaolneiCurml:CD BR (CD) rats. Toricologist 14{1](1994) 300. 32. Liu, RCM, C. proliferators on rHaathenL,eyadnidgMcEel.l fHuunrcttti.onThinevdiitrreoct(aebfsfteeacctot)f.heFpuantdiacmpeenrtoaxlis&omAep.plied. Toxicology 30 (1996) 102-108. 33. L`Goenngosttoaxfifc,itEy,aMn.d cRaorbciinnsoogne,niCc.itByroafdbfrlouookr,ocJa.rA.b,ona:ndASstsyleesss,mFe.nHt. bPyurschhoarste-.term in (Vi1t9r8o4t)es1t5s-a31n.d chronic exposure in rats (abstract). Toxicol. Appl. Pharmacol. 72 34. MpeoroilduyorCinAa,teKdwsaurnfaWcCt,antMairntsiunrJfaWc,ewMautierrDsaCm,pMleasbubryytwSoAi(n2d0e0p1)e.ndDeenttearnmailnyatticiaoln of techniques: liquid chromatography/tandem Chem. 73:2200-2206. mass spectrometry.and 19F NMR. Anal. 35. cMoonrsotianYt,soYfapneorfHl,uoSrhoiablaktaanoOi,cYaocniedsm.itBsulul.T(C2h0e0m1.).SoDc.etJeprnm.inT4a:t6i6o7n-o6f7a2c.idity ee Page 13 Dr. Oscar Hemandez 36. NAacbibde-fBeilndd,inDgJ.PrAotneiInn.veAsttihgeastiisonsoufbtmhieteEdffteocttshoefGFrlaudouraotcehSecmhiocoallosfotnheLiUvneirveFrastittyy of Minnesote, April 1998 . 37. NFaabttbyefAeclidd,Ceatnaile,rDiPrsoptleaicnesmbeyntWoyfetaFhl~uo1r4e,s6c4e3n,tlAymLmaobnelieudmFaPtetryflAucoirdooAcntaanlooagtue,e from P`Aobtsatrsascitu,mSoPceireftluyoorfoTooctxainceolSouglyf,on1a9t9e8anAdnnOutahlerMeKentoiwnng .Peroxisome Proliferators, 38. Nordby, albumin. GJ.oLu.r,naalnodf BJiM.olLougcikc.alPCehrefmliusortoroyc2t1an9oi(c19ac5i6d) interactions 399-404. with human serum 39. Osedxeulall, Wm.atDu.r,atRiSo.n Sownetredsltoifcutl,a.r rBeasipno,nFs.e WtoolLlHenssteinm,ulaantdioPnoXf.teGsrtovoesrt.erTohneeseefcfreecttioofn in theintactrat.Endocrinology 95 (1974) 1380-1384. 40. O`ohyyHai,geht-Pale.rfDoertmearnmcineaLtiiqouniodfCPherfolmuaotroignraatpehdyC.ar.Jb.oCxhyrloimcaAtcoigdrsaipnhyBi,o7lo2g0ic(a1l99S8a)mp1.l7e.s 41. OHlespeant,icGEWn,zyBmuersi,s,ChIoMl,esBtuerrloelwa,nMdMLi,poapnrdotMeainndseiln,AJmE,moPnlaisumma CPheorlfelcuyosrtoookcitaaionataend `ProductionWorkers,Drug and Chemical Toxicology 23(4): 603-620 (2000). 42. Opelrsfolnu,oCr.oTd.e,caainodicM.aEci.dsAnidnemrasotne.raTthseanadcuetfefetcotxsicointyiosfspueerafcliudos.roTocotxaincooilcogaynd& Applied Pharmacology 70 (1983) 362-372. 43. iOlnsvsoolnv,emUe.,ntCo.fSsuelnednbieurmgKi,n.pAenrdoexrisssoomne,parnodliJf.erWa.tDioenPiienrrraet.lFivuerrt:hCeormsptaudriiessoonntohfe e{f1f4ecCt}s wcliotfhibcrlatoef,ibBriicocachiedmiacnadlpPehraflrumoarcooocltoagnyoi4c6a(c1i9d9a3n)d1t8h0e5-p1h8a1r0m.acokinetics of 44. Pwailtehpsuo,dR.i,umanpderVf.lCu.oroRoecitnasnbooartoeu.gCha.nSaodliuatnioJnoiunrcnlaulsioofnCchoemmpilsetxreys6o7fc(y1c9l8o9d)e1x5t5r0i-ns 1553. 45. oPaxnyagreentsapkescTie,sSahnabdamliitnoacIhGo,ndGrriaanmdeedriDa,teShthoeshiandnuMctCi,onoDefPiseprorpteoJsiWs (i2n0h0u1)m.anReactive pheerpfaltuoormoaoHcteapnoGi2c caceildl. bTyoxtihceorl.odAepnptl.pePrhoaxrimsaocmoel.pro1i7f3e:r5a6t-o6r4.and hepatocarcinoges, 46. Paenrdkipnesr,oRx.ysIonvmeestpirgoaltiifeornoatfiaonmimnotnheiruatm. perflucrooctanoate effect on oxicologist 12 (1992) 38. hormone levels 47. Pfearymaadcii,dsH.o,nBx.enLoubniodtgircmeenKt,a.bAonldiezrisnsgone,nazynmdes1,.We.nDzeyPmieesrrweh.iEcfhfedcettsooxfipfyerrfelacutoirvoe. 4fo4r(m1s9o9f2o)x1y1g83e-n11a9n1d.lipid peroxidation in mouse liver. Biochemical Pharmacology FE Page 14 Dr. Oscar Hemandez 48. Ppeerrfmlaudoir,ofHa.t,tyB.acLidusnodngpreernKo,x.iAsnodmeerpsrsoolni,feCr.atSiounndabnedrgm,itaoncdhoJnWdr.iaDlepsiiezrerien.Emfofuescets of liver - dose and time factors and effect ofchain length. Xenobiotica 23 (1993) 761. 49. Ppeetreorxsiosno,mRe.E.p,rolBi.fLeaKtuosrlsikpiesr,flaunodroJ.dPe.caVnaonidceanciHdeu(vPeFlD.AP)roatnedinpaecryfllautoiroonocbtyantohiec acid (PFOA) inats.Zoicologist 11 (1991) 185. 50. Rpeerifclhu,orLLo.o,ctHa.nJc.icReaincdh,peLrAf.luoMreondaehcaanno,iacnadciRd-s:E.puPreitfeircsaotni.onSoyfntpheersfilsuoorfod"eCc-alnaobiecl.ed acid. JournalofLabeled Compounds & Radiopharmaceuticals 24 (1987) 1235-1244 51. Raenod,PNhoVs,phAadtiindeyhlzeatdheahm,inNeMBiRosSypnetchtersoisscionpiRcatAsnaElxypsoesseodfLtoivPeerroPxhiossopmheatPirdoyllicfheroaltionres P- hAarCmlaascsoolfogNyon2g0e0n0o;t1o6x4i:c1H1e3p-a1t26o.carcinogens, Toxicologyand Applied 52. Rozner, M.A. `peroxidation. PThhaeremffaecctoolfopeg4ry1fl(u1o9r8o1o)ct2a9n9o7i-c3a0c1i3d.upon microsomal membrane 53. Sandford G (2000). 3581455471. Organofiuorine chemistry. Phil. Trans. Royal Soc. London A 54. SPoebrlfelnuiourso,ocAt.aKn.e,sAulMfo.niEcraickidssiosnC,.poHteongtstirnodmuc,eMro.fKpiemrloaxnids,omJa.lW.faDtetpyiearcride.B- omxoiudsaetiloinvear.ndPhotahremraaccotlivoigtiyes&kTnaoxwincotloogbye affected by peroxisome 72 (1993) 90. prolferators in 55. rSetpaoprlte.s,PRrEev.enItmiponroofpePrhyinstiecraplreatnadtiMoenonftadlatCaoncgoenncietranlinDegfteecrtast,ogPeanritciCt:y:BaAsiccaasned Medical Science, Education and Future Strategies (1985) 161-163. $6. Thottassery, ., L. perfluorooctanoic aWciindg-eirngd,ucJ.edYopuesrsoexfi,soMm.alCeunnnziynmgehaacmt,ivaitnidesMa.ndBahderp.atRoecgeulllautliaorn of `growth by adrenal hormones. Hepatology 15 (1992) 316-322. $7. bTreetiwneeer,nCwa,taenrdanAdKa.lkCahlaitpteorpfaludohryoaoyc.iaTnohaetepamritcietliloens.coeJfofuircnieanltofoCfovalrlioouis&dalIcnotheorlfsace Science 92 (1984) 447-455. 58. Trosko, James E. Oxidative Stress, Signal Transduction,Cell. Cell Communication, US. Dept. of Commerce, NTIS # F42960-97-0022 (February 28, 1999). 59. Pbreell,imFi.nAa.r,yeRtaelp.orHte,aAlmth. SItnadt.uHsoygf.PAlsasnotcW.oJr.k4e1rs(AEuxgpusots1et9do80F)l5u8o4r-o5c8h9e.micals- A 60. UAdym-iynui,sNt.r,atYi.onKoafwPaesrfhliumo,roSo.ctHaonroii,caAncdidH.onKFoamttay.AcEifdfeMcettsaofbCohlriosnmiicn.Rat Liver: Relationship among Stearoyl-Coenzyme A Desaturase, 1-Acylglycerophosphocholine ee Page 15 Dr. Oscar Hemandez APchyalrimcaacnasfbeiroa-sDey,na.nd13Ac(y1l99C0o)m5p8o1s-i5tionofMicrosomal Phosphatidylcholine. .. 61. IVsaonladteinonHaenudveplu,riIfPic,atMi.oJno.fVpaenrfRlaufoerlogdheecma,ncLi.cA.anMdopnearhfalnu,oaronodctRaEno,icPeatceirdssonf.rom rat issues. Lipids 23 (1989) 526-531. 62. Wdiintenzsmiaonnanl,ElFe.Ac.,trC.opFhuolrtezt,icaPnatdJterLnisposfcoHmebp.atTiocxaincdanRte-nianlduScterdesAskPerroatteiinosn.s in TwoElectrophoresis 17 (199) 198-202. 63. IWiimtuznmoagnlno,bFu.lAi.n, BH.eMa.vyJaCmhoati,nDBNin.diPnargkPerro,tJeiWn.(BCIlaPc/kG.rpMo75d)ifFioclaltoiwoinongfEHxeppoastuirce to Structurally Diverse 23.1994) 18 Peroxisome Proliferators. Fundamental & Applied Toxicology 64. LWiDtSz0maEnxnp,osFu.rA.e,Dto,PePrafrlkueorr,oacnadrbBo.xyJlaircnoAtc.idIsndDuectteicotneodfbEynoTywol--dCiomAenHsyidornaatlase by Electrophoresis. Toxicology Letters 71 (1994) 271-277. 65. tYhaynmguQs,aZnidesYp,leDeenPoifemrirceeJ.WC(li2n0.00E)x.p.EfIfmemcutnsoolf.pe1r2o2:x2i1s9o-m2e26pr.oliferators on the 6. YthaenignvQo,lXvieemeYn,toEfriinkhsisbointiAoMno,fNceellslopnroBlDi,ferDaetPiioenrarnedJdWev(e2l0o01p)m.enFturinthtehryemviicdaenncde for msipcleen.icBiatorcohpehmy.iPnhdaurcmeadcobly,th6e2:p1e1r3o3x-i1s1o4m0e.proliferator perfluorooctaroic acid in 67. 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