Document GKgQDNw34eK3d6rKRKkZn2OMn

PPiioonneeeerr RRiisskk AAsssseessssmmeenntt ooff AAddvveerrssee EEffffeeccttss iinn M Maarriinnee M Maammmmalalss ffrroommRPPicFFhOOPSSuriidnnytthhee FFoooodd CChhaaiinn 33 DDReecicceehmmPbbeuerrrd11y999988 IInnttrroodduuccttiioonn:: AnPPwFRiOOnSS(g(lpyerpfleuxoproeosoecdtarnePsFuOlfSfo.naTothe)ewwaarastssffohoauuotnnddhiadnswtPwoRooOcofSfdithhntrreheeeeppteoooppluatlasditoiwonensrsueoofffdnfavfiveoerdorsatt-hsa-t-tnthhcatotnbt,n,aretasdt)ssnxoct a. I knowingly exposed to PFOS. The rats that had PF.OS in their blood were fed food that contained reclomepihetesattpereddioctmiaskshPaFciOoSnlayniPfFbOcSailnt.iTshbiso.consistent withhestsrvaton oa Incomplete studies indicate that PFOS is in fishmeal. This is consistent with the observation that ding. fishmeal. fledgling eagles that eat predominately fish contain PFOS in their blood. `MMCooosnsttstsfiuseteuntnseaaBliyimsJamodandeeirfc~ooymmnmmdeecnPhhadldeenMneB(Brreer,voSoertiaevtryrrrpoaanmussc)5D(,D1r9r9raa).ftRiMRepeepoanorrttd: eSSoouucrrtccpeesasosofFfifioissnhhanFFoodoowdde CCcoooobmnnsssidthdietierurceeehdndtsaaesBsieeycncoJaaonhdrnslaiaGnkkieeinsnnytbbahynedUUtPSSeaurAAlftMldaane,ithimcrlecca,ooSamlsestpastleffmaooonobddedrccih6h,ia.ni1n.9.9TT8Th)h.heeyMyweasnerhesaofidnfettnuuerenaacbtepaaetldeannebkbtyyonto0htahenrerdrsaasrepeechciseesoeoffi fciasht,hwrheipcrheasreenin0 turonfea% ttheenUbSy octohmemrefrischi,aml afmamsahlsfalnderbierds. The mass of menhaden is so great that their catch represents 40% of the US commercial fmfish fisheries, SitroSrnicancnalcseeafntetthrhoreeeenssdseFuufipGpissohhthhaneaeopptpffpoceoeooaaddnrrc1atchoihcanacopinonnrnteaataancndiidncPcdPoRoFmaOmOpSap,Saa1,rreitshtshheeieisesemeavvaeidlldlueupepnrrtitouoooddnea8encncttooantn0opcccecepnanatlrrcratauotlaiaxoentne.tttthhesTaethamcamaopeuoususaennsptoaaodefdfvPvePesrOFrssOseSeSceffettfhhceaaectmtstmsmh.i. gEigTThehhthretebsbseeee ecadlciutlaetdionnsvdoinooat cmoentaniniparelcciseodractaesronetaheaiyeovwahnleusratieoanrisCaopnperaonxrimaiaoten.s haThe ae fect purpose is to see whether predicted environmental concentrations are anywhere near concenu'ations that cause effects. TfTrhhiisEasscesesosmsmelnenRtotswwkgaaAssoisorsrcgsgasananiczeladtoa(ndEdPepAeoGrfrSoOmrmRo.edd35iin00asc2ecFcoroAdpnarndicee1ww9i9ic8thh).tthhTeghgueuipiddraaonnccceeesgipivevesnncrbbiyyedEEPPinAAhiinseGGuuiiddeelliinneess iSfgodvurebidElleibclnoilneleoessgTiiicsoaaleRrepeipsewkeitiAintivsvoseerosonsmnmeeawewnnhhtece(EraeePnbaAeri/i6ss3ekk0ba/Rescsr-e9si5ssd/m0y0ten2tFissAheuuppprPdidlaart1teeo9dd9co8of)er. rsdTeodohonenespewraowhvcheeeisnsanpnerwcewaseninnbotfeeroddmrmaritnaeittiohnonensbeyiss he sk available. The new information can be generated by other processes or generation can be driven by the risk assessment. PPrroobblleemm FFoorrmmuulalattiioonn:: A stdofrs nxpurposely exposedto PEOS found a eyhod significant evesi n hei vers. A study of rats not purposely exposed to PFOS found that they had significant levels of it in their livers. Te kelsourcewas he bea er die. PFOS sobeh r sh,Fhcoinh mammals nd The likely source was the fishmeal in their diet. If PFOS b in fish then other fish, fish eating mammals and rds wecanniPnOSg.Thconcentrationsfound ee notEkely 1 cause oxic sponses, it what birds are consuming PFOS. The concentrations found are not likely to cause toxic responses, but what Sho shee bomagiicaion rough ood ui about afier biomagnification through a food chain? "Tobypothesstoes:The cocenraotf iPOoSn in oodof rine aimscausesadverse fects. The hypothesis to test: The concentration of PFOS in food of marine animals causes adverse effects. was decided keep he problem narow in issessmenitn order simpytealysis. This is ot It was decided to keep the problem narrow in this assessment in order to simplify the analysis. This is not 10 imply ht is he met imranor ly preen. T adion is ioe wd possibly isk to imply that this is the most important or only problem. In addition this is a pioneer and possibly first eratoifobins sesmen. Reaemens no ays andmoredoe wil low ie cations {i iteration of this assessment. P,ef'mements in the analysis and more data will allow other iterations if this lonerssn cae et maybe icanttk.The puposeof his oneswesc10 pioneer assessment indicates there may be a significant risk. The propose of this pioneer assessment is to Ecmin te magicof he rk and ehre erions wate. determine the magnitude of the risk and whether other iterations are warranted. 11553344..00000011 Exhibit 1534 M3MAIA010003311558811 AAnnaallyyssiiss CChhaarraactceterriizzaattiioonn ooff EExxppoossuurree:: The task oftis characterizationis 0 simat th concentain of PFOS the od chin orgstht The task of this characterization is to estimate the concentration of PFOS in the food chain organisms that est menhadenand he conenraion i th nial ccmprsiag henext steps sh aodasin To eat menhaden and the concentration in the animals comprising the next tw~ steps in the food chain. Two Cxamples of hemany food chains possibleae examples ofthe many food chains possible are: "Menha>dceond ea > lrwhile Menhaden -> cod -> seal -> killer whale Meshaden camvorsfn1 >camivsoh 2r>eessl Menhaden ->carnivores fish l -> carnivores fish 2 -> seal Forthepurposes ofi analysis hebamagaifcaton by[sh odmammals shoteusamte, This For the purposes of this analysis the biomagnification by fish and mammals is about the same. This is suppbyotremieabeoldic is aly consumpionandgrowth tes publised(Fugacity Based Modeolf supported by the metabolic rates, daily consumption and growth rates published (Fugacity-Based Model of PCBBlosccumulaion inComplexAqua FoodWebs, JanCampinsndDonaldMackey i Envi. Sel. PCB Bioaccumulation in Complex Aquatic Food Webs, Jan Campfens and Donald Mackay in Environ. Sci. Technol. 31,77-SEX(1997) ed Wile ExposeFactorsHanehook, EPA/GOOR 53187 December Technol. 31,577-583(1997) and'Wildlife Exposure Faztors Handbook, EPA/600/R-93/187 December 1993)Based ontheda i hese erencessn eclosion omoereadings,ua averse 1993). Based on the d~_t=_ in these references and recollect'ion from other readings, an average biowagaiicvatio3n. biomagnification value is 9. 103n evaluation of PROSinthe vrsofaverts an average vel oundin le3d female 10-14 week In an evaluation of PFOS in the livers ofnaive rats an average level found in male and female 10-14 week aw0a09msga. The foo abel ied sme th (1hingrdieo. AccotsDrordncie nougght rats was 0.09 mg/kg. The food label listed fishmeal as the fifth ingredient. According to Dorenee Hought 2 urncenifed rodeochow bas es han 4 shim and hemea select menhade fms. For at Purina certified rodent chow has less than 8% fishmeal and the meal is select menhaden fishmeal. For {hi nahi was assumed ht hedieconnedT% shines and hat he fnewthanySore this analysis it was assumed that the diet contained 7% fishmeal and that the fishmeal was the only source OTPiFn hOedSie. 1amanwere at 100% fish, 8rayfh4dsn smaldo. shoud ave of PFOS in the diet. If an animal were to eat 100% fish, as many fish and sea mannnals do, it should have Shout 12 me 8machin vers cs ts do.That evelwuldbe1 mgs 0OmEGOT. about 12 times as much in its livers as these rats do. That level would be 1.3mg/kg (0.09mg/kg/0.07). "This sthe estimatedlve i the ivr, whichi erga thtconsismost fhe FOS, Theblood This is the estimated level in the liver, which is the organ that contains most of the PFOS. The blood conhe ntet haigheist envel. Work wihrts ba show ht oodcoin abot13te mountof contains the next highest level. Work with rats has shown that blood contains about 1/3 the amount of PROStobe found nthelvrpersona commision withMary Case). Assthuat hme iive nssg5. PFOS to be found in the liver(personal communication with Mary Case). Assuming that the liver mass is 394and load 85 th sof nsnc] ed hthconcern in er orgs sigaificn i 3% and blood is 8% the mass of an animal and that the concentration in other organs is insignificant in Comparison 1th eels nnerandblood, then he ial bodyburden f PFOS tn the st epof he fod comparison to the levels in liver and blood, then the total body burden of PFOS in the first step of the food Chainabove menhadeins 0.073my (13mg X 0.03 + ( mgs 3) X 008) chain above menhaden is 0.073 mg/kg (1.3mg/kg X 0.03 + (I.3mg/kg/3) X 0.08) "The eve inthe secondfoodchinkthe would be nie timesti velo 0.6 pike The level in the second food chain link then would be nine times this level or 0.66 mg/kg. Usingdat sels, he accumulated doeattim ofwhepin sclulate. tisumhat1e00%dof Using data on seals, the accumulated dose at time of whelping is calculated. It is assumed that 100% of PFOS consiusramineedd. DutfoKiller whale food consumptionsexualmatron wishot PFOS consumed is retained. Data for killer whale food consumption sexual maturation was not immediately vali,bt heyaeasumediobe sire in~nediately available, but they are assumed to be similar. "TEEsTxhhxpeephomomseswuueararaneenFFtaimuamccettenoforrfossodrHHssaeae0nxnxbdudubaebaoleolmoonmkkia,a,nEtnEugPrPiyAstAy/h/f6Sfwoo0Orir0Oft/fRReehmm-9ta9h3ale3/le/e1ha1hb88hao77rDvbDoeeoecrsaceselememolabllsbesteriresd15159.9.9c5593o3)yyn).ce.eeaSanSrsotsoarafanfontoddiropegunpesotsft6ttooaat7i6on7mnmoimiosn1np1t1t1hmsmobbPeooefFcnfoohtOhrrsSees(,(wWhShWeeeillaldppleliiinnfegg. c5aeaass-tee68ao-l58fw%caoslofafesthshaueemeinrwewdeieitgiogwhhbtstepspeeeruartdmidnoageyyfidiinnshhfaiwtsh.it.ahTnThthShe0eeykyagbeesoeatvtle13e3c9x%atlcsthuh3le5eaitroedfr'~scs5totynhyece/aeardnraataryannt.diToh11n0i0o%s%fww0woh.6hre6eknnsmogcgea/stkttgaitnPin1gFg,5O. XSFF.1oo0rSrtethakhelgsof tFefhiasheshne((o77sf77ecmmasolocwnnutohltasuhtXiXsonc33 oi0tndwsauaymss/0 eamsbosuonmtuhtea XXd96.t96h.a4hXtkgm agl1n!dd0y8a)m0y.k)g.gAPAssFesuaOslumSmei(aint0nsgg88tt6%hhemeogFfrish6h.4Xasksgee1/da5lacXyco1.onnT0sshuukimsmgew)ed.doTrcckhoosnsiotawunitneteoodd 100r5.66xX6kt6m01gsm03!8k3gkgg., of Cumuldaostbiefvoreewhelping of hou 123mg (99 X10mpS0KE) then a seal would consume about 9.9 X 103 mg PFOS {0.66mg/kg X 15 X cumulative dose before whelping of about 123mgikg (9.9 X 103 mg/S0kg) 10J kg). This works out to a "pTCTprhorohiolbisbsuaabaccbulculymeymduuonlaoctatuithmitvvhueeelednadnotoooisrsrveemmecc..adaTnenThsbhe.beeeuvpaurverseeaodrdgabFgfeooaesrsrsaseeeaaplalrlleiisssptepthnrratotoscbabahrlebaltywtywosooenonfefeoobffoodoydoopcddchhocacahhipianaiiunleenlnllgeganatgghottssshfaiahKabbioboloovolvvneevereemmmwemeescenhnhbhahaaadddatdeeeehnnnn.t.l.cTBTBhtuheiuitssst stishishsisiss pcBBraeeelccccaauiuuslsaeseteeekdksiiilclllmueearmrtwwuihlhoaaatlsilevehsseotutdalaokdkeseesaahkpboorouiubtwsatbwilniytccoers4eap5esrlelcooseunnnggrtstobthbeaectcosoemmeenesbseeyxcpuaoaplluylmamatiatotunursreeoaafssksislelaearlssw(8h-1a16l6eysyeeathararsts)),e,asatmmsoeorarelse. precise estimation should take this into account. 11553344..00000022 M3MA1A010003311558822 Characterizationof Ecological Effects: Characterization of Ecological Effects: SpeIp1ener8rasdtdtauwawyymoogegPPeeFnRdneOOterSSroaawtbtiwieeooennr1rrerabaabttdsoosetrtmqnuuuddddayyeteieaaittddwsooratarssuddoimfieeouoddunwgnwiaddtitththhehiisasnntpfef43ooc4uiu%rerrdsodafradoyythssmeoaopfprfuuipbipnsitrsesth.b.oFmroFnmo1tr0otlthhaeenepmipmuaTurlahrpslpesoodrsdsoeeossssieoeofddnfhbbtyhcysgisgaeaaavrsrsaasgesgaseeebs1imos1t6.e6mthnmemftyoarngah/sttksg aWre ahssumeedrittoembeahamnmaeadlequriatcehte1s3tesusr,rosgaate sopnesc,iaesdfoKrimlaerwinhealmesamamealess. Thseirevies uonceorrtaientyerbaottihvteohan whether marine mammals such as seals, sea lions, and killer whales are less sensitive or more sensitive than "oTTfohmeeatlloiownwegesssttndddoostseeheoo2ff 11d.m6ymspgo/kfgtgthehsatttcicoaanusseefoddra08naoaddtvvseerorssfee71effdefaeccyttsww.aTasshggeiivvceennfufoorr m6wweedueeokLssslebbueepffso1orreeimmaattviinnnge,e,otthhfeewweeeekk helsp1i13mnphge of" mating and the 22 days whelping is 113mg/~g. of gestation for a total of 71 days. The cumulative dose up to the time of dIyttshhfaaussnbbceeieoannrr(eepPpoeortrttreedRdotthshasat,tsEnaavtiunrcaaalppmooeppuaultalatltiiCooonnsnsoaofmfisseaiaaolninosnsasanardreteheeexxppieerkrieioncfciiAnggsvsieiggrinefifiicaTanntctrreepiprnorMdouadertuivicee dMMreypasramfoudmnumcactilisnom:gnA.An(anTPOehOvtlieevrresRrvvioNiesei:swwg,,,eE1r1n99vt99hi88raonSSntmEEhTTeeAAnotCCarlAmAnC.nnounnAuatpaalpmlaMrMineenaeetnetlttiiysnaSaggn)o).d.mAtAehllefssioRel77ids00bk%%iolofofAafagadrvsrieisnnrgsgbeeeelddEsisfefevaeaeclKptpsloopeinpueulMawlachatiairooilnnnewewasasancott repprorodducutciinogn.s bTahsisdeisclhiingehde,rbtohtanhethreehnaosrmb.eAepmpoarsenitleytsoemedyfield ver his. biologists believe killer whale reproductions has declined, but there has been no scientific study to verify this. RRiisskk CChhaararcatceterriizzaattiioonn:: "TiThohenesp,prrkeeiddliiclctsteweddhacculummesuinlaadtiipvveerddioossseeeoosffwPPaFOsOScStaltchhurloarutgehod tttwwouboegffooohoodduccthha1ai2in3lmliinnpkkgss ,t0osTsaehairsmaavmmamlmualailsss ssaubucochthaatshsseeesallas,,nssc3e.a3 hhtlhieoeencrcsa,aelklcsiullslleaeirtgdenwdihfcciauuclmemasnlutaulraniitdsivvkpee.odTdrophososeeeirsoeofisfsw111n1a3o3stmcmcgaoglcu/kugglaPhPtFeiFdnOOpStuoSttdbthhaeattatabccaoauuusctseaes1ls2c3rueelpmpartrgoeo/dukcungtcc.tieiTvrvehaiioismtmvypapaluniaremrsiestnartbttkoooum.mtatahSmmeumcmsahaadlmls.e.aTTasshhuss ctheedreedis oa srignehSecanvt rhiasekd.legTurheeesroeftis noeokt.enough input data to calculate uncertainty in this risk. Such data is needed to reevaluate the degree of risk. 11553344..00000033 M3MA1A010003311558833