Document z9dVeBVwB36v25MqOy7eeEEg

~rw _ loC~6 P. 16 f.s--o TAFT, STETTINIUS & HOLLISTER LL P NORTHERN KENTUCKY OFFICE CLEVELAND, OHIO OFFICE SUITE 171 7 COVINGTON, KIENTUCKYr 10114704 606-331 -2838 .381-2 3 FAX : 53 13-381-6613 340 3500 BP 425 WALNUT STREET, SUITE 1800 CINCINNATI, OHIO 45202-3957 TOWE R 200 PUBLIC SQUAR E CLEVELAND OHIO 114-2302 , 216-241-2838 FAX: 216-241-3707 COLUMBUS, OHIO OFFICE DAYTON, OHIO OFFICE 513-381-2838 21 EAST STATE STREET 11S 0 U NIO TR ET9 H0M 0 A FIA N X S:T 513R -381 -E 02E 05 T COLUMBUS, OHIO 43215-4221 614-221-2838 DAYTON, OHIO 454 02-1 937-228-2838 FAX : 937-228-2816 7 8 6 www .taftlaw .co m FAX :614-221-2007 -3 73 ROBERTA . (513) 357-9638 bilo tt@taftlaw.com BILOTT L /y October 2, 2006 C-) 4 FEDE L E RESS l ~~~~~~ Il I I ~ , II II ~ ~ I I ~ RA XP TSCA Document Processing Center (7407M) b E F A(,I -ll 1o11 111 b_1 , b[1 51 11ti,, =- EPA East - Room 6428 CD Attn : Section 8(e)/FYI -- U .S . Environmental Protection Agenc y 1201 Constitution Avenue, N .W. Washington, D .C. 20004-330 2 CONTAIN NO CB I Re : Perfluorocotanoic Acid (PFOA ) Preliminary Partial Non-Occupational Blood Data Dear 8(e) Coordinator : ..~ . . This letter serves as a supplement to the enclosed letter submitted by DuPont to USEPA on August 10, 2006, pursuant to Section 8(e) of TSCA. In that letter, DuPont provided USEPA with certain preliminary data collected from communities in West Virginia and Ohio pursuant to a settlement of a class action lawsuit that had been brought against DuPont involving residential exposure to PFOA in drinking water . As explained in the enclosed letter from DuPont, the Science Panel established under the settlement has asked that the parties to the settlement maintain the confidentiality of the community health study protocolsl~ developed by the Panel . DuPont, however, "informed the Science Panel that the Company would share the C-8 blood data with EPA because of the Agency's continued interest in perfluoronated substances and in particular, in nonoccupational blood data ." DuPont, therefore, submitted to USEPA in its August 10, 2006, letter certai n '-/ In its August 10, 2006, letter, DuPont referred to the protocols as "drafts ." The parties have since been advised by the Science Panel that the versions of the protocols distributed to the parties were, in fact, the final versions of all but one of the protocols . W0794491 .1 i~I ';~iN Il Il 1111111111 ~!'~1111 8 Si u n u (1 u 0 0 ~ 0q911?, p. 2 October 2, 200 6 Page 2 information contained within the Science Panel's community health study protocols, along with a statement from the Science Panel clarifying the preliminary nature of the data . (See enclosed August 10, 2006, letter and its Attachment 1) Because DuPont submitted some of the raw data, we are submitting in Attachment 2 to this letter the other raw data from the study protocols to ensure completeness of the submission . (We also have enclosed at Attachment 2 a corrected version of Figure 3 .1 from DuPont's letter ("distribution of log C-8 in blood") that was blank in the version set forth on Page 8 of DuPont's letter .) This data is submitted subject to the same disclaimer from the Science Panel as to the preliminary nature of the raw data from the community health study protocols, as set forth verbatim in Attachment 1 to DuPont's letter . Ve truly s, RAB/mdm Enclosures ` Robert A . Bilott W0794491 .1 ATTACHMENT 1 Andrea Y. Matisawski Corporate Counsel p. 3 ~4 r August 10, 2006 DuPont -,J Legal Wilmington Office Buildings 1007 Market Street Wilmington, OE 191396 302-774-6443 Tel 302-774-4812 Fax anrJrea .v .malinowski&3usa .dupont.com E-mail VIA FEDERAL EXPRES S TSCA Document Processing Center (7407M) EPA East - Room 642 8 Attn : Section 8(e)lFYf U .S . Environmental Protection Agenc y 1201 Constitution Avenue, NW Washington, D.C . 20004-3302 Phone: 202-564-894 0Dear8(E)Cordinator: Re : Perfluorooctanoic Acid (PFOA) Preliminary Partial Non-occuaational Blood Data Through it outside counsel, E . 1 . DuPont de Nemours and Company (DuPont or the Company) has received copies of draft protocols that contain information regarding initial, partial PFOA blood data collected from communities in West Virginia and Ohio by an entity known as ".13rookmar'- DuPont has no access to the entire Brookmar data set and Brookmar is not working at the direction of DuPont . Accordingly, the Company has incomplete information . Nonetheless, the Company is providing this partial information now to the Environmental Protection Agency (EPA or the Agency) in light of the Agency's continuing interest in perfluorinated substances . Background =-- _ In February 2005, a class action settlement consisting of several parts was approved in a lawsuit --' about releases of a chemical known as C-8, or PFOA, from the DuPont Washington Work . sfaciltyoednWCutysVirgna One major part of the settlement was the creation of a Science Panel, consisting of three epidemiologists, to conduct a community study to assist the Panel in evaluating whether there is a probable link between C-8 exposure and any human disease . Epidemiologists acceptable to both parties in the lawsuit were selected; none of the selected epidemiologists have ever worked for DuPont or with Plaintiffs' counsel . Similarly, any other experts selected by the Science Panel to help it must also be independent of DuPont and Plaintiffs and their counsel . To further ensure the independence and impartiality of the Science Panel, the settlement has specific rules about communications between the parties and the Science Panel . The question put to the Science Panel is whether there is a probable link between C'-8 and any human disease . A probable link in this setting means that given the scientific evidence available . it is more likely than not that a connection exists between C-8 exposure and a particular human disease among class members . The Science Panel is permitted to consider any evidence it believes is relevant to answer this question, but it must include an analysis of the following two E .1 au Pcnr,iz Nemo irs aey Ccn:;any ~ p. 4 TSCA Document Processing Center August 10, 2006 Attn : Section 8(e)/FYI Page 2 of 10 studies : (1) an ongoing study conducted by DuPont of its workers at Washington Works and (2) a community study which the Science Panel must lead . Another part of the settlement was a cash payment to Plaintiffs, some of which was to be used to fund community health and education projects . Plaintiffs elected, and the court approved, use of the entire cash payment to fund a Community Health Project administered by Elrookmar . Brookmar is collecting data from class members through questionnaires and blood testing . This data represents a portion of what the Science Panel will evaluate to answer the question of whether a probable link exists between C-8 and human disease . Preliminary C-8 Blood Data from Community Health Projec t Outside counsel for DuPont received copies of draft protocols for a series of studies the Science Panel intends to conduct to address its charge under the class action settlement . The Science Panel reported some preliminary summaries of the C-8 blood levels in these draft protocols .' The Science Panel asked that the parties to the settlement, including DuPont, maintain confidentiality of these protocols at this time . DuPont informed the Science Panel that the Company would share the C-8 blood data with EPA because of the Agency's continuing interest in perfluorinated substances and in particular, in nonoccupational blood data . The Science Panel indicated that it did not realize that by sharing this preliminary data with DuPont, it would potentially become publicly available at this time . Upon learning that DuPont planned to submit the information to the Agency, the Science Panel requested that DuPont also communicate the following about the preliminary data : "We have prepared some outline protocols for several interlinked research components addressing the potential health effects of exposure to C8 around the Washington Works plant . `C8 Science Panel Community Health Study : Outline Protocols; June 30 2006 ' T7tese are not final but we shared them with the settling parties for the express purpose of allowing them to see the overall approach we are taking and the likely timescales for generating findings in the Community Study . Included in the protocols are some data that should under no circumstances be allowed to fall into the hands of the press, general public or general scientific community . We have received some preliminary data from Brookmar on the survey results of the C8 Health Project, understood by them and us to be confidential, and we have examined it for the purposes of helping us in developing study designs and calculated statistical power only, not to provide meaningful findings . We have included some tabulations of, for example, average blood C8 levels and some prevalences of self reported disease (though not any information on whether or not they correlate - we have not looked at that) . These data were arbitrary subsets of the data as they accumulate, and are not representative of the full database, any tabulations are crude rather than adjusted so are not comparable, the different protocols used the accumulating data at Brookmar has apparently provided a subset of approximately 30,000 individuals to the Science Panel . p. 5 TSCA Document Processing Center August 1 0, 2006 Attn : Section 8(e)/FY[ Page 3 of 10 different times, so the data used in different tables may be different . We judge these kinds of data su ffi cient for our purposes of study design, but not appropriate for any kind of inference about the health or exposure of this population . Further, complete results will be subject to release and dissemination after careful review and analysis by Brookmar (for a descriptive summary) and the Science Panel (analytical relationships) . We understand that Brookmar will make available a full copy of the anonymised data to any interested pa rties, as soon as they have completed the assembly and quality control of the data . We would therefore ask the settling pa rties' counsel not to distribute these draft protocols with the summary of some of the Brookmar data . We will issue a version of our protocols for dissemination without such results . " *sv Communication from Science Panel to Settling Parties, dated July 19, 2006. ( Full copy enclosed as Attachment 1 ) . To reiterate what is stated above, DuPont does not have access to th e Brookmar data. DuPont also has not verified with either the Science Panel or Brookmar that the numbers reported in the draft protocols are accurate and free of typographical errors . With all of these caveats, and although DuPont does not believe the information provided herein is indicative of substantial risk informati on under TSCA section 8(e), DuPont submits, in Attachment 2 , tables and excerpts fro m the draft protocols that contain information related to C-8 blood levels. ry truly yours, ~~ ~~~.~~_~~~ ~ ci- Andrea V- Malinowsk i Attachments (2) - 7 pages p. 6 TSCA Document Processing Center August 10, 200 6 Attn : Section 8(e)/FY1 Page 4 of 10 Attachment I July 19, 2006 "Note for settling parties" from the Science Panel (I page) Note for settling parties We have prepared some outline protocols for several interlinked research components addressing the potential health effects of exposure to C8 around the Washington Works plant . "C8 Science Panel Community Health Study: Outline Protocols ; June 30 2006" These are not final but we shared them with the settling parties for the express purpose of allowing them to see the overall approach we are taking and the likely timescales for generating findings in the Community Study . Included in the protocols are some data that should under no circumstances be allowed to fall into the hands of the press, general public or general scientific community. We have received some preliminary data from Brookmar on the survey results of the C8 Health Project, understood by them and us to be confidential, and we have examined it for the purposes of helping us in developing study designs and calculated statistical power only, not to provide meaningful findings . We have included some tabulations of. for example, average blood C8 levels and some prevalences of self reported disease (though not any information on whether or not they correlate - we have not looked at that) . These data were arbitrary subsets of the data as they accumulate, and are not representative of the full database, any tabulations are crude rather than adjusted so are not comparable, the different protocols used the accumulating data at different times, so the data used in different tables may be different . We judge these kinds of data sufficient for our purposes of study design, but not appropriate for any kind of inference about the health or exposure of this population . Further, complete results will be subject to release and dissemination after careful review and analysis by Brookmar (for a descriptive summary) and the Science Panel (analytical relationships) . We understand that Brookmar will make available a full copy of the anonymised data to any interested parties, as soon as they have completed the assembly and quality control of the data . We would therefore ask the settling parties' counsel not to distribute these draft protocols with the summary of some of the Brookmar data. We will issue a version of our protocols for dissemination without such results . If for reasons of complying with relevant laws the settling parties decide to share these tables with any regulators we would ask they attach this note of explanation . The Science Panel 19 July 2006 p. 7 TSCA Document Processing Center August 10, 2006 Attn : Section 8(e)/FYI Page 5 of 10 Attachment 2 Tables and excerpts from the draft protocols that contain information related to C-8 blood levels . Table 1 . Descriptive statistics for the communi ty cohort age>=20 a t baseline in 2005 (n=23,942 ) ;---- . .._ ........ . . _. __._.._ ..._ .__.._ - ...-- ._......_-~ . ...---- ---____--1 Mea n age in 2005 46 Age <2 0 20 -- -------- %Age20-3931% _ ...... - ..._ ., Age 40-4 9 -----___ ..... .----F1-8--%-_ __...----------; A. . g.._e...... .5. . 0._-.5.. .9.--- _. . ..____. _.....-- i 15 % _ ..--- .. .._ ._ _...: Age 60-69 1010 ge 7UT. .__ .. . ..-_.__ - --.. .... . . . ......~ 6 % ._.._............__ ... Median Body_ Mass In dex 2 7 . 9 ._ _ Mean ~-- C8 ---1..e.-.. . . _ .._. _._ 13 0 ppb n_M.._....edian_ C8 - le._._v ....--e - l 48 ppb P..e-r..c.. ..e.. .n.__ t >-=60 y rs age 20% ---_ .. . ..... Perce nt BMI>=30 36% =- - - Percent w... hite - 98 % - ~P.._e._.. ..r_._.c...e_n-t -m.ale- 46.% - ...__._.. ._ .__.. ..... ... . Percen t curre nt smokers 26% ----~- --.......__ Percent finished college 13 % Table 2. Anticipated distribution of C8 in study participants . ---_ _......_ .__...-- _ _. ..--- C8 m edian 4 8 ppb ;,-C_8. ._m ..._. ean 13....__0___.Pp b -C ----- 8 ..._...__..__ _..__ 8% < 10 pb p o . . ........ . .. . ..----~ 10-49 _ 43% _. . . . . _._...-----; ~ 50-99 ,0 %. ... . .------__..-..---100- 14.._9.. 19 % - 1_ .2. .S,00-1099-2991~ 5-%-------, ._ . ., ~_..... ...__.._'-`..._..... ____ .-.._._.._ ....._. .. ...---.30-5 ----i5-%-- 505+ 4% - p. 8 TSCA Document Processing Center August 10, 200 6 Attn : Section 8(e)/FYI Page 6 of 10 Table t . Descriptive data on subjects>age 20 (n=23,942 ) --- _ ... .. .. . . .__.,-. Age ~ ....._ .-_ - --..._____...---- ~0-39 1 38 % 40-49 23% ~------- 50-59 19% _ .- .. ..... .... 60-69 12% ...__..... 70-79_ 6/o 80+ .... ... . .. .. . -- .. ._._ --- ....- ---- o 2 /o _ ._..._...._. _...._ _ -------- , ; ~h te 98% --- , ._....._..._ _ . . .._._ . .. _ .....__ _...... : ;... Female _- ---- __ . . .._._ .. _ ..._._. _..--- -- 54 % -----~---- Current smoker Schoo l ~ . .. .. . .. . .. .. .--- - - --- --?--- --- ---.. <12 ll% ._ ..... ... High School/GED ___ _- 43% Some College 34% College degree 12% C8 median 48ppb ; . .. .. ._. . ---- mea -C8 n 230pp b ~--C8 < 1 p 0 pb 8 o /o -..... .-- - .. .._ .. y -- 10-44 43% 5 0-99 20/ ; ... .. . ._. _. .. _.__. __ _ 100-149 ! .. ._ ... 9% 150-199 200-299 .....- .. 300-550 5% .{ - --- 5 50+ ~_ ._ . .. _ . . ... _~i4..%__ ;.._B . .-_-M _._..._ .. ._I. .... mean .....__ 28 . 9 , ...._ .__._~ BMl median ~ 27 .9 _ -BM ] 30+ ----- 30% ---- --- _ .. . -... ---- --- -% preva l--errt heart disease -- - - o 8 .5 /o - _ . . .. . _ ._ . _..__... ; % prevalent stroke 2% -1Cholesterol mean 200 mg/dl Cholesterol median 196 mg/dl p. 9 TSCA Document Processing Center August 10, 200 6 Attn : Section 8(e)/FYI Page 7 of 10 Table 3 .2 Blood C8 in participants by water district reported a s source of drinking water (last address, ignoring those not reporting one of the six water districts as source) . Mean, median and 10th and 90th percentiles. (Units ug/1) . . ..... . .. ~smct o last address(DW) r _ N P 1 : City of .Bel re,OH __...._ ... ._. __ ..... mean(c8) med~c8 10 c8 90( c8} _ ..---.._....... _. .......__. _ 2,8__3_;-1---_ 71 .6 45 .2, { 17 .6 134.9 2 . Tupper Plains 4,807 . ... . . 63 .0 48 .9t 18 .5 111 .7 3 : Little Hocking Water..t..._._ { ?-` ~ - -_.... -.~ _ ..A .... ...s. ..s......o.. ciat._:i....o.....n -4-,338 396 .9 290 .0 ...---- 4 : Lubeck Public Service Uistrict 5,494 131 83 .6 820 .5 ~_ .... .. . . ._..... --_ ------._......._ . _--------- --- -5 : Mason County 3,52 2 6 : Village of Pomeroy .7 90.4 30 .9 237 .0 _._. ...._.__ ..._.... .__.._ .._.... _ ._... ---...._..._ -.. _ .. .. 19 .1 15 .5 7 .4 34 .2 --- .. ~........_ .. ._ ..-_-_ L - . . . _ .-_ .. _ .... ........ __._...7.--3-. .4 ..... . 18 .6 15 .6 7.1 32 .6 Oth8e ,90r 3 82 .6 29 .1 91 1383 -_ ...----------------- ! ------ .- ....____-- ;---------...~ _ __......._ : _ _ Cotal 30,629 123 .0 47 .8 11 .7 284 .9 - 1. l ._ -..._ ...~__ . . . . .__ .. - Table 3 .3 Mean, median and range within some percentile fractions (Unit s ugll) . _........... ---- ----... _........_-- ...... _. N mean(c8 med (c8) min i max - _ _ __._._. ... ... ._. Lo~~est 3,1171 8 8 .5 --- .25 11 . 10% ; U ec 3,063 664 .4 47..__9 ..._..-- -285 :_ . _ _...1. .0. _%-_ : 113919 _.._ -- ._ ._ .. ..-- - -- ------;--_-----~- ; { r 15 .323 22 . 21 .21 .25-Lowe 47 .8~ 50%' _..-- - ._._ . . ...~ Up0~0pa 1er 15,306 f 1 2~ 23 .2; _11 3- 47 .9 11391 .91 p .10 TSCA Document Processing Center August 10, 2006 Attn : Section 8(e)IFl'I Page 8 of 10 Figure 3 .1 Distribution of log c8 in bloo d ~ _. ~ , ..~..,-_-_-.,. . ~ ....._.. . . ,- . .~ 3 .3 Power Power is presented in Table 3 .4 as the chance of being able to detect a significant result for a modest increase in RR (1 .25) and a substantial increase in RR 2 .0 for the simplest comparison between the upper and lower half of the population (with C8 in blood, mean 223 ugJl and 23 ugfl respectively) . [With alpha 0 .05, two sided. Calculated with 'sampsize' in ST=ATA .] Note that this may underestimate power relative to analyses that consider the full range of exposure or ordered categories, but ignores more complex models with multiple covariates which can reduce power somewhat. Nonetheless, these estimates convey a good sense of the magnitudes of association we will be capable of detecting . Table 3 .4 summary of power calculation s .___- ..._. ._ ...-------__.._ -- .._ ._....... ..___._------.._----------% Power to detect RR Uf : ------ Expe_cted n 1 .25 ._..........._ ... 2.0 ~. - _ --- _ .....__ ... -- .._ ........_.._ .. .. Bl_a_- _d__ .d.. ._re...._r_ _i... .1----0---6---...._ ..... ._ _--18--- _....._ .. ..._9. _2_ ..._ .._..._.. ..----~ Breast (femy 559 75~ 100 _ . .._Kidney 113 -._....._ ._ ...-_...1 93 Testes 59 ~ 11 68 p .11 TSCA Document Processing Center August .10, 2006 Attn : Section 8(e)/FYI Page 9 of 1 0 The Science Panel also reports the following with respect to a trend observed in the C-8 blood levels: 3 The C'8 health proiect data and trends in PFOA levels in the studv area [The Science Panel has] a very detailed source of good quality data on C8 levels at an individual level by virtue of the large amount of data collected by the Brookmar team . This will be supplemented by a detailed assessment of the patterns of metabolism and clearance of C8 in the half life study component. This data have been assembled over nearly a year and an initial examination of it reveals a significant trend in C8 by community, which has implications for the design of our study. He following figure shows the pattern of C8 levels for people classified by the current water district in which they live (after excluding those who live outside the catchment area of the 6 water districts) . Each. point is the average of a weeks' collection of blood samples over 47 weeks of data collection . In each water district they appear to have a downward slope . Y ~ _ ,} ~ -. _ ';'"'..~n^,.' .''w ~'~^""~... .:.^- .-r .. . -.: " t:* ;:" ,a, ; ; ~, : . . , .~ ' ~ imr,an , :,g :~ ; , . . . . . . . . .. . . wasaw .,.. . . . . ... .. . .. ..~,. . . _-- .__.._ fk1oG va N ws . ea t The trends are more readily seen in the log-transformed C8 data : the following graphs illustrate the similar proportional trend in average weekly mean log c8 within each of the six water districts : TSCA Document Processing Center Attn : Section S(e)/FYI p . 12 August 10, 2006 Page 10 of 10 .f y ~ a ; ~ *. ..+..*.~!~ ~t~g~'si ~~ . 's-f_ . .. ~ ~~ ~~= . ` ` ~~~i~~ a irfi~~' ;~~Z~~-t-~si -q^Y+~-. ..._.Y .. ' ~ g- -aL i ~`2.~~.. ... _ ..~. ... . .. .... .. t ~ ;: "# ~ ,, a - 6 ~ T .`-* _a^i` .- .1il lt. .~ ~_.~~.?,-- !J { y~ '/ai', 0 17 20 Idait:.; SQ 40 39 . ' ~iT<_ . .i .~t ~k ~ hs ... The magnitude of the slope is about a 7% drop per month : If the within-individual trend is comparable to the observed slope for the community (i .e . the observed slope is not due to a downward trend in the proportion of individuals who happen to have relatively high C8 in blood unlikely to have been repeated in each water district) then this would indicate a rather steep decline : the combination of reducing intake and clearance would then appear to be associated with a half life of less than a year. At this rate the c8 level in the blood has fallen by nearly 60% in a year .