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Lp a SLaarrlyvRi. ZPorbeold,aMnD MPH Medical Director
3M Medical Department
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am June 27,2005
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Re: PFOA Review Panel
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Noam
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Dear Dr. Shallal:
No
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We are submitting for the PFOA Panel's consideration a copyof a recently-completed
.
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"CPhartohnoilcoFgeyePdeienrgRSetvuidyewinanRdatPsawtihtohloPgFyOwAo,r"kiJnugneGr1o7,up20R0e5v.i)ewTohfeMpaatmhmoalorgyy Grleavnidesw wfarosmaa
joint project of the 3M Medical Department and DuPont Haskell Laboratory:
"The report concludes (p. 12):
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administration of PFOA. The morphologic appearance, overall
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ianncdidcoenntcreolanadnidmiastlrsibwuetrieonsoimfitlhaer.neoplasms observed in treated
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"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
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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)
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+ 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
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