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Ap226- [0SS THE OCCURENCE OF PERFLUOROOCTANOATE IN ENVIRONMENTAL, DIETARY AND HUMAN SAMPLES 1 on PREPARED BY: " THE ASSOCIATION OF PLASTIC MANUFACTURERS IN EUROPE (APME) AD HOC APFO TOXICOLOGY WORKING GROUP VERSION 1: JANUARY, 11 2002 a. CONTAIN NO CRI INTRODUCTION AND SUMMARY Several studies have been undertaken under the sponsorship of 3M to understand the distribution of perfluorooctanate (PFOA) in the environment. This document summarizes results from several of these studies that have been placed on EPA Docket Number AR-226. The general conclusion that can be drawn from this summary is that PFOA is not broadly dispersed in detectable, typically oceurs at low (< the environment, and, in those cases where 1 ng/g (ppb) or < | ug/L (ppb) concentrations. it It is is not possible from the results of these studies to draw conclusions as to the source of PFOA in those instances where PFOA has been detected in the environment. Summary oaf Survey of Perfluorooctanoic Acid (PFOA) in Wildlife Five studies conducted by JP. Giesy and K. Kannan of the Michigan State University determined the worldwide occurrence and accumulation of perfluorooctanoic acid (PFOA) and several other perfluoro compounds in aquatic wildlife and fish-cating water birds. PFOA did not seem to be widely distributed and was not present at concentrations above which the limit of quantitation (LOQ) levels in many of the PFOA was detected above the LOQ levels are listed in species studied. Table 1. Various Species species in in which PFOA was below the LOQ are listed species), 4 (marine and mammal species), 5 in Tables 2 (fish-cating (mink water and river otier), 3 (fish birds) and 6 (American oyster species). PfrFoOmA18w.a4stofo1u0n8d nign/g1,8/d3r1y mwitnwkitlhivearms efarnomfoMrastsheacphoussiettivtes s(a3m0)plaetscoofnc3e1n9t.r7atnigo/ngs,rdarnygiwni.g PFOA was below the LOQ in the mink liver samples from Louisiana (7), South Carolina (9) and Illinois (30). PFOA concentrations in $ river otter livers from Washington and Oregon were less than the LOQof 36 ng/g, wet wt. In fish, various PFOA species was found to be above LOQ levels only obtained from the Scheldiz River Estuary in in muscle tissue Belgium with obtained from a range of 7.5 46 lakes nglg, wet wt of Michigan (mean as well = as 17). Muscle tissuesof freshwater fish from several inland marine fish from the Baltic Sea, and the North Pacific and Antarctic oceans did not contain detectable concentrations of PFOA. aLinvderAlaansdk/anorcbolaosotadlsawmatpelress. otfhemanroirntehemranmmBaalltisc wSeerae, ctohlelecMteedditferrormanFclaornidSac,aC,alainfdorntihae Arctic. Ringed PFOA was found in seal samples (Baltic 1/6 California sea lions, Sea) and in 3/8 Caspian 1/26 seals grey seals (Baltic Sea), 6/109 (Russia). Examples of marine and polar mammals with tissues that do not contain PFOA (at levels above the LOQ) include polar bears, Baikal seal (Russia), and striped dolphins (Mediterrancan). MwaetaesrurbeirmdesntinsothfepUenriftleudorSotactoems pionuclnuddsinign allibvaert,roksisdenseyf,robmloSoadndorIselgagndy,oMlkidowfafyisAh-tcoaltlinign -2- the central North Pacific Ocean were performed. Similarly, issues of birds collected from the Baltic and the Mediterranean Seas and from the Japanese and Korean coasts were also analysed. PFOA was detected in all 12 cormorant (Mediterranean) livers and was also detected in the following birds: Stenella clymene (Gulf of Mexico). Layasan albatross (Sand Island, Midway Atoll), double crested cormorant (Lake Winnipeg and St. Martin Island, Great Lakes. black billed gull (Sulphur Island, Great Lakes) and sea cagles (Japan). With the exception of the Japanese sea gull (two out of six blood samples contained 4.5 and 6.2 ng/mL PFOA), PFOA was rarely found in Japanese and Korean birds. Oysters were collected from 77 locations in the Gulf of Mexico and Chesapeake Bay of the US coast. PFOA was not found in quantifiable concentrations. In conclusion, PFOA is not widely distributed in aquati (freshwater and marine) life and in mammals and birds that feed on fish. Summary of Survey of PFOA in Municipalities Samples were taken from six cities and included samples of publicly owned treatment works (POTW) effluent, POTW sludge, drinking water intake, treated drinking water, tap water, landfill leachate, surface water, sediment and quiet (standing) water. In all 101 sets of duplicate samples were analyzed. A summaryofthese findings occurs as Table 7. In 35 instances both duplicate samples had no detectable PFOA. In 14 instances, at least one replicate sample had detectable but non-quaniifiable (< LOQ of 0.025 pg/L (ppb) PFOA. Of those samples with quantifiable PFOA, eight had concentrations > 1 pg/L, 6 had concentrations < 1 ug/L and > 0.1 pg/L. and 18 had concentrations < 0.1 pg/L. All POTW effluent samples contained PFOA. All but one POTW sludge samples contained PFOA, and the highest PFOA concentrations in the study were found in sludge samples dfrrionmkiDnegc-awtautre,r-Arlelaabtaemdas(a2m4p4leusg/cLon(tpapibn)e.d nWoint-hdettheecetxacbelpetiPoFnOoAfC.oluTmhebudsr,inGkeionrgg-iwaa,taelrl related samples from Columbus, Georgia all contained non-quantifiable PFOA or PFOA concentrations just above the limit of quantitation. PFOA was detected at quanifiable levels in landfill leachate from Decatur, Alabama, Columbus, Georgia, and Port St. Lucie, Florida. Surface waters from Mobil, Alabama and Columbus, Georgia contained low, but quantifiable levels of PFOA. Only the 1999 sediment samples from Port St. Lucie, Florida contained quantifiable concentrations of PFOA. PFOA was not present in sediment from Port St. Lucie in 2000. PFOA was quantifiable in quiet water samples from Decatur, Alabama, Mobil, Alabama and Port St. Lucie, Florida. In summary, with the exception of POTW effluent and sludge from the six cities studied, and iandfill leachate from Decatur, Alabama, PFOA is either not detectable or occurs at concentrations generally Tess than | ug/L. (ppb) Market Basket Study Summary In over 230 samples of foodstuffs, PFOA was quantitated in only six samples above a `quantitation limit of 0.5 ng/g (ppb). PFOA was found in two samplesofground beef 3. (1.09 and 0.504 ng/g), one sampleofbread (0.524 ng/g), two samplesofapples (1.13 and 235 ng/g), and a sample of green beans (0.543 ng/g). An appropriate conclusion from this study is that PFOA is not distributed widely in foodstuffs. Human Populations `Table 8 summarizes results from studies of the presence of PFOA in the sera of human adult and pediatric populations. Among 652 adult Red Cross blood donors, PFOA serum concentration ranged from< the lower limit of quantitation to 57.3 ng/mL (ppb). The geometric mean PFOA concentration in adults was 4.6 ng/ml, and the cumulative 95th percentile concentration was 12.9 ng/mL. Among 599 children aged 2-12 years, serum PFOA concentration ranged from< the lower limit of quantitation to 56.1 ng/mL. The geometric mean PFOA concentration was 4.9 ng/mL and the cumulative 95th percentile concentration was 10.2 ng/mL. In both cases the standard mean concentration was 5.6 ng/mL. From this data, there do not appear to be significant differences between the adults and children with respect to PFOA serum concentration. oe TPaFbOlAe|Levels in Some of the Species Studied by Giesy and Kannan . " a | senP)ior TE Lmo oun | y5w% SpFeoc B wT TTR TE 1 VariouFsasnpecies SH TT wTerr) wor Various species | lakes 0 | 3 beeen | 280G1 | iin 38 Sa Speci quantified o1 |. iCl lima Sea I io MlI I oa | CTotE ten FlanConst Blood J Ey TnDgolepdhSinel | Bakes | Bieod 7 7 T= | SeLiuvemr 23 s"ahmiesn oisns | [CoSpneal ndSbemaelre|CapGruolfnorSeMa eRcoa||BUlonoed ||31|1 370m% [s7e5v]| | Toi rsha | oSel n WTvler Er EENiL dvayC Ati a T + or iid Tor | Smarin sand. | Blood | 2 | 1 ws 0s 1 a GGrreeatLLaakkeess Tr ET ware [[oSeeb [= ww T [Wee hre [ rTTr T3 Ra7 esieE ror aTi w aGuFnede T ancniicf.icndor Nersed Gy7 SE Sl Os 20 pS rE ot Eo (Ie oa aT ae Table 2 Species in Which PFOA Was not Detected Above the Limit ofQuantitation (LOQ) [oe i 1 ee Jl ero [oSoienugosn ate T|E7 T a5in te | 3 [TMEio 7] -e TFiasbhlS3peecies in Which PFOA Was not Detected Above the LimitofQuantitation LoQ) TChinaovSamoes t GreNsiWgas e Tae |-- ve e : m Ts EG CNEiTn s| aTchee | 6$ 3593 | Eras 2 [oTr ro Muscle | 5 S GTeTe AT T| NTher Ta eiw0 5u5o9 | Vig | sBinege || iao 35is Ser Sel Thor [To Wesemmet r |h Tha | <; 5 E3E FemaBtSloemirunfs Tpoewnn_--|| ro AainCeoass AAmaarrti | |7 WWMWoohhooekdee63 7 ] r35 7 --e----]--] VarTiosoSpecies od Wisc | 378 3 Fo wT SMavaiedre | \ ir T52s5o | VariousSpecies | oF SEAT Toew 5 | 3mn I a. Tabl4e Marine & Mammal Species in Which PFOA Was not Detected Above the Limit of Quantitation (LOQ) [[aE tosreSeal | Cao Cov[ erT [T 3s opini] ons | CallforaCoast Liver[3350 [|TorbeSnoFnoerSel_|| Cal"fCfromCioaCnotst| iBTvoaaer|1: ] 3E55H59------] NoamFor Se Polar Akar Coat pm I Kjirdney I 5 Ine TT T35y9 1 Tiis [ |GaSBnagleSaslDSoepTahlin| 1 | A TTavkeern BGaanagleCsRooisnsdiaa| |hLLioovneedrr 2 [|1220 35 59] i 71% ----] [SDI eoTdngfed Sger iiBna_nd|. C---- arsM-- |edThv-- oeiord e-- |r4 =n5 e7 ang 5SiTEe]a [r| "eTirstaops rrncatss || PalmCaaSSnodlionBrir:atFyleori| da BLliTvoievorrd | AnGnualPtVeoifsMreacwseeusn | LLiivvee lve TRopweb AVetnie nOes Liver Seno redanens w"nAnMoarsiaRSioveurnd TLiieerr 172 i [ao7s n]1 7s 35 77ss 1 2s T| i77ss | | 7s Oe Pspol Ewas Fr|eRAm | MLueswe 3 ns | ses] se Table Fish-Eating Water Birds in Which PFOA Was not Detected Above the Limit of QuanStpeictiaetsion (LOQ) (1) To oe Creses TE Chay hed Gr | Blood agi wHeotowsaisor mL. aii SivTaaLknaes. Gren | Blood 2 0s | LSaekreLCSreeorcr.ahnCriTsmhssikesr||| pBBloaonoodd | 43i 256955 | Com CGulil srBnaCdyoGenoty|| tTohaerd Nome a. Cn ti . | i 2719 | SopmerevnsC,lFfoimsa Lihnee :5 1w8o7 Unknown Lier , |TBRroFwonoPdelAicbanas |_SFanPdasHciangdowiiaRiyverMNasl|| LCiiverr17 17 11880 iy in Te Tern gol || ST TE Cry Taayr ToaT|[| RihSSaemms | 6 299 55 VCitSnoenr.rCuCromeu,nyLCaANksC Lriovedr :\ 1 77 Great BlHaeckr-obnacked Gall | CarteretJaCpoaunnty. NCI | LEivTer{7 1T8EE7 jf SCoamGmiut TT [a= aopnan oa: |wiTtvheBeres ri[1' TTiEs Cree lsHok(k3aBNideao.spJ)apaMn a| BLiovedr | a wr NuVoonn Lloions. | Liver 3 wr TWohWivocofridceSeiadoko.N s| | SSSoaD wcwhaClaireoyl.iCCmAAa tTLiihneeerr T|T T |ey 1&] 7]1 [Sow Egre [Franklinsgull 1" Fonda |Te |v7 |"RedRockLakesMonana| Liver | 4[187 | [WhkkePelican [BrownPelican | 3California. |Montana| |"MustangIsland.Texas| Liver Liver | 4| |1 | T&7 187 | | [Northern Gane 1CarteretCounty.NC_|__Tiver |11 TS -- T 7 = --r----7-- ~. Table 5 Fish-Eating Water Birds in Which PFOA Was not Detected Above Limit of Quantitation (LOQ) (2) [= Caper T Fo: rds T o o Theorr ToT t0m 0 57 e Red Throwed Toon | =CivrNCOcanCrioolol iung I LTLiiivvveeerrr A 118877 IL 1 ET Anarcic Heenr T1 aTE Sa Kidcnoegsy i| en Tver 4188 | TE SpBoolrdedFDauek |GratewsaNn gee|TwTaerTT_[_--ToBYs | SoAusCmaraina Oregon PPlaassmaa 25 Liver 2 p6e2 187 | { DSuaavann.ahC,allifnoomiisa | LLiivveerr 1| Michigan Liver . 115877 | 158 | MMiicchhiiggaann Michigan KiMdusncelye 6: Gallbladder| 1 53744 34 i MNiicchhigan TOevsatreys !1 144 GrAedraeeeTloPSmweeanldgluoOiwnn| | | MMAiicnchhaiigigmasnn |ComGpoestee |5 30|18 mises--%| I j--rie EMichS igan fee TS 3] [HeringGul| Wichgm Ean | 3 7 iss 115588 eonFege [eFe ord Tver TI% T a 507 | MBaetremscaa.nGe.rmaanlyy| Medicranean ily BLilvoetr | sai Serum i 31302 | 53 ++OnTewoasae mpwelorteosst dsureingextrsapilcl toutiofouben). 10- Oyster Species in Which PFOA Was not Detected Above Limit of Quantitation (LOQ) Pe Location ogg wet wi. i TMaUbeCrty Study Dat rom Table 4ofExceutiveSumanry A | ROR A" COR |eoT |RR | --samome | | Fpoirnsde e ro |i| FOroTneWtaSattde, or, 244 TI [TN wo Te: TESA TN ri es,ga|WWR NE--]oosomm |b or | ilwloagoSnartar| "| T | e|sr we ww Ei w om -- eur sa ara SENT | NDR SE |News oa|oosms fw] sma-- |s6------s--|-- Sb | {oars wx a Nw oes w fn inve NR we ~ sam a xo NL D =Noe tdeecef;mNQt=NotguwieNCs =NoecwolloesctemdNA=Not|a|nd --w-- {m Ree er i THaubmlaens Serum Concentrations of PFOA iR"aambenorfoeifSs~saompValles Gsri Nican i~h_ )|TAdG <uLlLiOr RQe$d C7ros5sBlood se Donors(ng/mL)|| LgChiyoldrgengAgeede 2r-12 (ne g/L) Si = 1 Median 47 _ _ Si _ CGeoometmricuM9eSann Peercen_t {1a6 ~ ~ ~ {4j9 g _ | aise 16 SOURCE Tsuhbemiitntfeodrmbayti3onMcCoontmapiannedyitnotthhise dUo.cSu.mEennvtirhoansmbeenetnalexPtrroatcetcetdiofnroAmgennucmyerionuJsunsteuodifes 2001, and available on the AR-226 public docket. re