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Lp a SLaarrlyvRi. ZPorbeold,aMnD MPH Medical Director 3M Medical Department } 3StMPaCeun,tMe,NBu$i5d1i4n0g(1202000-06 WO 8811775333 35118512 Oafxfice AR 286 - 4722 am June 27,2005 CONTAIN NO CBI BEHR-0705- 1505) SDeuseiSghnaaltleald,FPeh.dDe.r Offer JEUHRE UV.iSa.eEmaPiAl:ScsiheanlclealAsduvhiasiorr@yeBpoaa.grodv ee eee a= Re: PFOA Review Panel S`ounbMmiasmsmiaonryofTPuamtohrolsoignyCWhorrokniincgSGturdoyuopfRPeFpoOrAt Noam 3 5 Dear Dr. Shallal: No | We are submitting for the PFOA Panel's consideration a copyof a recently-completed . } (PSaitbhionlsokigyetWoa.rk1i9n8g3)Grchoruopni(cPsWtGud)yroenpoPrtFOeAx.ami(nEixnpgertihmeemnattalnmPaartyhofliongdyinLgasbofrraotmortihees,3IMnc., "CPhartohnoilcoFgeyePdeienrgRSetvuidyewinanRdatPsawtihtohloPgFyOwAo,r"kiJnugneGr1o7,up20R0e5v.i)ewTohfeMpaatmhmoalorgyy Grleavnidesw wfarosmaa joint project of the 3M Medical Department and DuPont Haskell Laboratory: "The report concludes (p. 12): 2 TnehoeplPaWsmGscionntchleudsetuddtyhwatasthenoitncafifdeecntceedofbymcahmrmonaircydigeltaanryd ENTsOz administration of PFOA. The morphologic appearance, overall Ton ianncdidcoenntcreolanadnidmiastlrsibwuetrieonsoimfitlhaer.neoplasms observed in treated 2=on "The chronic study included a control group and two dose groups which received 30 or 305 ppm in the diet. The slides were retained, and were made available to the reviewing pathologist, Dr. Gabrielle Willson. Dr. Willson reexamined all sections of mammary gland from all female rats in all dose groups. Dr. Jerry Hardisty of Experiental Pathology Laboratories then convened a Pathology Working Group including Dr. Willson, Dr. Ray Brown and Dr. Emest McConnell to determine a consensus diagnosis for all neoplastic lesions diagnosed by cither the original study pathologist or the reviewing pathologist and to determine the toxicologic significance of the incidenceof mammary gland neoplasms present in the female rats in the PFOA study. The Pathology Working Group examined the slides without knowledgeofthe treatment group of the animals, and applied diagnostic criteria and nomenclatureofthe SocietyofToxicological Pathologists (Mann et al. 1996). IFEET EE : 227340 "Dr.JuneSu2b7a,i2r0S0h5allal * Page20f2 . "fTihnedipnrgismianriytiadlilfyferreepnocretebdetasweleonbutlhaer ohryipgeirnpallarseipaowrtheidchfitnhdeinPgsWaGndcltahsesiPfiWedGasrefsiulbtrsoaidnevnoolmvae.d p"Tehrefroerwmeerdestmaitnisotricdalifafnearleynsceess oinnctlhaessfiifnidciantgisonfoofr tohtehePrWfGin.dinTgsh.e PDrW.GDarveipdorGtasytlaoters: Thfeibrreoawdeenroemnao, astdaetnisotciacarlcliynsoimgani,fitoctaanltbdeinfifegrnennceeosplinastmhs ionrctiodteanlcmeaolfignant pnaeiorpwliassemcsobmeptarwieseonn.control and trated animals using Fisher's Exact Test for , + CCoommbbiinneidnginbtehniisgsntuadnyd,mtahleiregnwaanst nneoospilgansifmiscainstndoitfrfeerceonmcmeebnedtewde.enHcoownetrvoelra,nedven if weated groups. (p. 11) i . + SNiognniefoicfatnhtesutruvmiovralt-yapdejsuostrecdodmobsien-arteisopnosnosefttreunmdos.r t(py.pe2s0)exhibited statistically + aThnedrterawtaesdngoroiunpcsr.eas(ep.in11t)umor multiplicity or incidence with dose between control Tohbesermvoerdphionltohgeicconatprpoelargarnocuep,oifnndeicoaptliansgmtshaitnttrreeaattmeedngtrdoiudpsnowtaasffsecitlthae 1p0hetnhoosteype ofthe neoplasms in the study. (p. 11) + cTohnetrionlcdiadteancfeoorfunmtaremamtaedrCyrgll:aCnDdfneemoaplleasSmpsriaguteheDaswtuldeyyirsastismiinla1r0t4o-hwiesetokrisctauldies, as reported in the literature. (pp. 11-12) . Respectfully submijed, S7 taff Vice= PresidMenDt,anMd PMeHdical Director cEen:clEosPuAreAR-226 Docket DDrr.. JReonbneirfterRiScekeadrd