Document w5J57G43ogq0DO8QrzdwYakB
TTSSCCAA SSeeccttiioonn 88((ee)) CCoommmmitittteeee MMeeeteitinngg.
RReeccoorrdd ooff PPrroocceeeeddiinnggss
DDRRAAFFTT 66//11//0011
DaofMteetieng: 5/15/01
Date of Meeting: 5/15/01
PPrroodduucct/t/MMataetreiraila:l: PPFFOOSS aanndd NN EEItFFOOSSEE Description ofinformation whichispotentially reporable per TSCA Section 8(e) DSsStuteaamtstimcissarttiriipccitaaiellosnaanfnoaarlflyyoisnJsmeef.sosorBomfufttatethhineeohn22ofwyyTeehaaicrrhccaaisnnccpeeorrtebbniiotoiaaasslslsyaayyrssepooonnrtbbaoobttlhhe ccpooemrmpTpooSuuCnnAddssSiienncddtiiioccaanttee8(ssett)aattiissttiiccaall
summaries from J. Butenhoff.
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Butenhoff, Geary Olsen
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Subject to Protective Order In Palmer v. 3M, No. C2-04-6309
11778833..00000011
Exhibit 1783 I3MMAA0022660068778888
Initial notification to Committee :
PP FOE S FO romS JJoohh_ nnBBuF utetennr hhooffo Yf55//88m //0011
Kathy, I reviewed the "Statistical Report of Survival, Nonneoplastic, and Neoplastic Lesions" from the two-year
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tumors. Marv has had a chance to review the report, and I have discussed aspects of it with Jeff, Larry and Geary. Today, I forwarded the report to Dr. Jack Moore for his review and comment relative to TSCA 8(e). Hepatocellular combined adenoma and carcinoma is clearly significant in the females at the high dose, a result
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in the N-EtFOSE two-year study. I have prepared the following DRAFT notification letter for committee consideration. Please let me know if any clarification is necessary.
TABLE: RESULTS OF STATISTICAL ANALYSIS OF SELECTED NEOPLASTIC LESIONS FROM TWO-YEAR DIETARY STUDY OF PFOS IN tL~_TS.
FEMALES
TumoTur mor
|CoCnonwtrooll | 00S.5ppppmm
Hepatoccllular Adenoma
p=0/60
p =
00..0015135*3(a*)
NAD 1/50
NA(b)
Hepatocellular Carcinoma
0/60
0/50
Hepatocellular Adenoma &
0/60
1/50
Carcinoma
p - 0.0057**
NA
[| 2p2 pppmm
NA1/49
NA
0/49 1/49 NA
| Sp5 pppmm
NA1/50
NA
0/50 1/50 NA
| 2200ppppmm |2200 ppppmmRReecc|
|
p=050/63086*
p = 0.0386*
|
pp==0022./240004400(%)
pp = 00..33005500(4a")
1/60
0/40
6/60
2/40
p - 0.0204* p - 0.2040
p = 0.2114
Ee EEE EE MALES
TumoTur mor
| CCoomnwtrooll | 00S.5ppppmm| 2p2 pppmm | Sp5 pppmm | 2200ppppmm |2200ppppmmRReecc|
Hepatocellular Adenoma
0/60
3/50
3/50
1/50
7/60
0/40
p - 0.0276* p - 0.1345 p - 0.0689
NA
p - 0.0456*
NA
p = 0.0240*
Pancreatic Islet Cell
0/60
2/49
1/50
4/50
5/50
3/40
Carcinoma
p - 0.0237* p - 0.1793
NA
p - 0.2148 p - 0.0463" p - 0.1102
p = 0.4972
: Thyroid Follicular-Cell
3/60
5/49
4/50
4/49
4/59
9/39
Adenoma
p = 0.4998 p = 0.3967
NA
NA
NA
p = 0.0280*
p = 0.0121"
Thyroid Follicular-Cell
3/60
1/49
1/50
2/49
1/59
1/39
CaCracrciinnoommaa
pPp-=00.22221100 | pp =-003.3885555 | pp=-002.2444488
NNAA
pPp-=00.11773344 | pp=-004.4228800
NA
TThhyyrrooiidd FFoolllliiccuullaarr--CCeellll
6/6/6600
66//4499
55//5500
55//4499
55//5599
1100/3399
Adenoma & Carcinoma
p = 0.2520
NA
NA
NA
NA
p = 0.0970
Made Available by 3M for Inspection and Copying as Confidential Information: Subject to Protective Order In Palmer v. 3M, No. C2-04-6309
11778833..00000022
3MA02608789
--
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d) For high-dose recovery values, the second p value is for one-tailed, pair-wise comparison to the high-dose group.
NKNa--tEEhtyL.FFOtOhSSisEEmoFFrrnroiomnmgJJ|oowhhannsBBuruteteveninhehowofiftnfg5//c99o//n00t11rol incidence in a report recently received from Covance on the NEhKEatatFdtFhOOaySS,sEEtihgissnsittufumiddcoyyarnttntuuinm(mgpoor<rI wii0nn.acc0sii5dd)reeeninvncciceeeiwssditetnaangttciisescottoiicfncssttrhttooyolrccionooicdmmidpfpeaoanlrrcceeuelwwaiinirtthhacettlrhheleepaodddaraetttanareorrcmeeeccaneetninltyntlltyyrhererceeemcciaveeielivvdeeesddfrfooormnnomPPCtFFohOOveSaS.Nn.-cEe|I InnoFoontOtiictScheEeeddsNttthhu-aadtyt.wwee 323hMa0Md0p0parrfeesevvtiigieoorn.uuisfsilclyIyamnrreteopp(noporrmt<teyed0d.w0ooa5nny) hhioeneupcptaiaodtfoteocncteceloellwluunollfaafrtrohraayaddroeedinnadyoo;fmmoalhallioc/ccwuaaelravrcceriirncn,oeo|lmlmiaaaddiiennpntutohhtmeetaffoeegimenmtaathlhleeeerssmaffooadrrrleatthfshtiissffroossrmttuucddotyhymemiininNtaa-tEeDDteeFeccOceeoSnmmsEbbiedesretrur44ad,,tyi.on 2T"T0hh0iiss0adlrreaatftftet rww.ililllI'mpprrooobbnaabmbllyyy wnneeaeeyddouaatssottrfrootonnwggeenrrfftoiiere oatodttahhyee; pphrroiioowrressvuuebbrm,miIsisdssiidioonnpssu..t together a draft for committee consideration.
TFTAARBBOLLMEE:T: WRROEES-SUYULETLSATRSOODFFIESSTTTAAARTTYIISSSTTTIICUCAADLLY AAWNNIATAHLLYNYS-SIESIOFOOSFFSSSEEELLEECCTTEEDD TTHHYYRROOIIDD NNEEOOPPLLAASSTTIICC LLEESSIIOONNSS IINN MMAALLEESS
FROM TWO-YEAR DIETARY STUDY WITH N-EtFO SE
Tumor ThTyurmoiodr
| CCoonnt0trr5ool5l 1
|
CCoonntrtolr22o(la) | 0/60
FFAooldlilTiecchunuylloaraorrmi--dCCaeellll | pp==0000/.501517711%"|
NA 0/60
NA (d)
ATTdhhyeyrnroooimidda
[4(~)
0/55
T0/e6o0
FoFCloalilrlciccuiulalnaror--mCCeaellll
NNAA
NNAa
FoTCllhTacyrhucrylionarorioi-mddCeall | p=0000/5515555* | 0Ne/6Ao0
FAAoClddaleirecnncuooilamnmroa-amCa&&ell p = 0.0155"
NA
Carcinoma
01p6ppp0mm| 333pp/pp5r0m
NA0/60
NA
pp ==0031./15660622|
0N0/6a0
05N/5A00
NA
NA
00N/66A00 | po337l5/50es
NA
p = 0.1662
3300Upsppopmm||| 110060i0cp0pmppm |
NA1/50
NA
|
oowon 6/60
0.0107"
1TN/s5Ao0
00N/66a00
NA
NA
|p=720/3506067| | e6p/6e=0 p = 0.3667 00.00p11=0077' |
110000pp1pp4mm0RReeec
p-0NN1.AA/14(D20f)04
p
=
0.1204(g)
1N4A01/40
NNNAAA
ppp===0020./24.113077011333
p = 0.2303
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Subject to Protective Order In Palmer v. 3M, No. C2-04-6309
11778833..00000033
33MMAA0022660088775900