Document k6mZ8Rz8noLRGBmybJ6qxrKGJ

NORTHERN KENTUCKY OFFICE SUITE 340 1717 DIXIE HIGHWAY COVINGTON, KENTUCKY 41011-4704 606-331-2838 513-381-2838 FAX: 513-381-6613 DAYTON, OHIO OFFICE SUITE 900 110 NORTH MAIN STREET DAYTON, OHIO 45402-1786 937-228-2838 FAX: 937-228-2816 R o b e r t a . B ilo tt (513) 357-9638 bilott@taftlaw.com gHQ_ 1 0 0 6 1 ^ ^ 0 TAFT, STETTINIUS & HOLLISTER LLP 425 WALNUT STREET, SUITE 1800 CINCINNATI, OHIO 45202-3957 513-381-2838 FAX: 513-381-0205 . www.taftlaw.com M CLEVELAND, OHIO OFFICE 3500 BP TOWER 200 PUBLIC SQUARE CLEVELAND, OHIO 44114-2302 216-241-2838 FAX: 216-241-3707 COLUMBUS, OHIO OFFICE 21 EAST STATE STREET COLUMBUS, OHIO 43215-4221 614-221-2838 FAX:614-221 -2007 zt-G _ 3 7 3 Y October 2, 2006 FEDERAL EXPRESS TSCA Document Processing Center (7407M) EPA East - Room 6428 Attn: Section 8(e)/FYI U.S. Environmental Protection Agency 1201 Constitution Avenue, N.W. Washington, D.C. 20004-3302 I III ! I III II III 8 EHU o CONTAIN NO CBI Re: Perfluorocotanoic Acid (PFOA) Preliminary Partial Non-Occupational Blood Data r>j -f-~ 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) o f TSCA. In that letter, DuPont provided USEPA with certain preliminary data collected from communities in West Virginia and Ohio pursuant to a settlement o f 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 o f the community health study protocols17developed by the Panel. DuPont, however, "informed the Science Panel that the Company would share the C-8 blood data with EPA because o f 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 certain - 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 o f the protocols distributed to the parties were, in fact, the final versions o f all but one o f the protocols. W0794491.1 89070000003 U0 P-2 October 2,2006 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 o f the data. (See enclosed August 10,2006, letter and its Attachment 1) Because DuPont submitted some o f the raw data, we are submitting in Attachment 2 to this letter the other raw data from the study protocols to ensure completeness o f the submission. (We also have enclosed at Attachment 2 a corrected version o f Figure 3.1 from DuPont's letter ("distribution o f log C-8 in blood") that was blank in the version set forth on Page 8 o f DuPont's letter.) This data is submitted subject to the same disclaimer from the Science Panel as to the preliminary nature o f the raw data from the community health study protocols, as set forth verbatim in Attachment 1 to DuPont's letter. RAB/mdm Enclosures W0794491.1 ATTACHMENT 1 P-3 Andrea V. Malinowski Corporate Counsai .'.S i , f, -V '4( ... iy h l August 10, 2006 VIA FEDERAL EXPRESS TSCA Document Processing Center (7407M) EPA East - Room 6428 Attn: Section 8(e)/FYf U.S. Environmental Protection Agency 1201 Constitution Avenue, NW Washington, D.C. 20004-3302 Phone: 202-564-8940 Dear 8(E) Coordinator: r *-i DuPont i.ogal Wilmington Office Buildings 1007 Market Street Wilmington. 0E 1989B 302-774-6443 Tel 302-774-4812 Fax andrea.v.irialinovvski@usa.dupont.con] E-mail Re: Perfluorooctanoic Acid (PFOA) ______ Preliminary Partial Non-occupational Blood Data Through it outside counsel, E. I. 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 "Brookmar". 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 o f several parts was approved in a lawsuit about releases of a chemical known as C-8, or PFOA, from the DuPont Washington Works facility located in Wood County' West Virginia. One major part o f the settlement was the creation of a Science Panel, consisting o f 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. rhe question put to the Science Pane! 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 llie following two f.l du Pcrtttia Nemours and Comoanv P-4 TSCA Document Processing Center Attn: Section 8(e)/FYI August 10,2006 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 Brookmar. Brookmar is collecting data from class members through questionnaires and blood testing. This data represents a portion o f 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 Project 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 1anel reported some preliminary summaries of the C-8 blood levels in these draft protocols 1 The Science Panel asked that the parties to the settlement including DuPont, maintain confidentiality ot these protocols at this time. ' DuPont informed the Science Pane! that the Company would share the C-8 blood data with EPA because o f the Agency's continuing interest in perfluorinated substances and in particular in non occupational 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' 'i fhese are not final but we shared them with the settling parties for the express purpose ot allowing them to see the overall approach we are taking and the likelv timescales for generating findings in the Community Study. * Included m the protocols are some data that should under no circumstances be allowed to fall into die 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 Attn: Section 8(e)/FYI August 10, 2006 Page 3 of 10 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." *** Communication from Science Panel to Settling Parties, dated July 19, 2006. (Full copy enclosed as Attachment IV ' To reiterate what is stated above, DuPont does not have access to the 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 Under TSCA section 8(e)' DuPont submits, in Attachment 2. tables and excerpts from the draft protocols that contain information related to C-8 blood levels. truly yours, ( / J fM/d iiM- L- 1 Andrea V. Malinowski Attachments (2) - 7 pages P-6 TSCA Document Processing Center Attn: Section 8(e)/FYI August 10,2006 Page 4 of 10 Attachment 1 July 19, 2006 "Note for settling parties" from the Science Panel (1 page) Note for settling parties We have prepared some outline protocols for several interlinked research components addressing the potential health effects o f 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 o f allowing them to see the overall approach we are taking and the likely timescales for generating findings in the Community 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 rookmar on die survey results o f the C8 Health Project, understood by them and us to be confidential and we have examined it for the purposes o f 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). Ihese data were:arbitrary subsets o f the data as they accumulate, and are not representative o f the full tabulatlns are crude rather than adjusted so are not comparable, the different protocols used he accumulating data at different ttmes, so the data used in different tables may be different We judge about SuffiCient f r ur of study design, but not appropriate for any kind of inference about the health or exposure of this population. C ^ P lete/ eSUltS Wil1 be subject t0 release " d dissemination after careful review and analysis bv Brookmar (for a descriptive summary) and the Science Panel (analytical relationships). We understand 'that Brookmar vvill make available a full copy of the anonymised data to any interested parties, as soon as thev 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 " rcTults f ^ Br kmar ^ Wi" iSSUe 3 VCrsi0n f - P r o o f s f - dissemination without r e i ? 35005 f c TMlpl>'inig with relevant laws settling parties decide to share these tables with any regulators we would ask they attach this note of explanation. y The Science Panel 19 July 2006 p .7 TSCA Document Processing Center Attn: Section 8(e)/FYl August 10, 2006 Page 5 of 10 Attachment 2 tables and excerpts from the draft protocols that contain information related to C-8 blood levels. Tabic 1. Descriptive statistics for the community cohort age>=20 at baseline in 2005 (n=23,942) Mean age in 2005 Age <20 '46 20% Age 20-39 31% Age 40-49 Age 50-59 18% 15% Age 60-69 10% Age 70+ ^6% Median Body Mass Index 27.9 Mean C8 level 130 ppb Median C8 level 48 ppb Percent >=60 yrs age 20% Percent BMI>=30 36% Percent white 98% Percent male 46% Percent current smokers 26% Percent finished college 13% Table 2. Anticipated distribution of C8 in study participants. C8 median C8 mean C8 <10 ppb 10-49 50-99 100-149 150-199 200-299 300-550 505+ 48 ppb 130 ppb 8% 43% 20% 9% 5% 5% 5% 4% : TSCA Document Processing Center Attn: Section 8(e)/FYI Table l. Descriptive data on subjects>agc 20 (n=23,942) Age 20-39 40-49 50-59 60-69 70-79 80+ White Fem ale Current smoker School <12 High School/G ED Some College College degree C8 median j C8 mean : cs < I0 ppb 10-49 50-99 100-149 50-199 200-299 300-550 550+ BMI mean BMI median BMI 30+ % prevalent heart disease % prevalent stroke Cholesterol mean Cholesterol median 38% 23% 19% 12% 6% 2% 98% 54% 26% 11% 43% 34% 12% 48ppb 130ppb 8% 43% 20% 9% 5% 5% 5% 4% 28.9 ; 27.9 30% 8.5% 2% | 200 mg/dl ; 196 mg/dl | p .8 August 16, 2006 Page 6 of 10 TSCA Document Processing Center Attn: Section 8(e)/FYI P-9 August 10,2006 Page 7 of 10 Table 3.2 Blood C8 in participants by water district reported as 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). 0so0_ Q District o f last address (DW) N mean(c8) med(c8) 1: City o f Beipre.O H 2: Tupper Plains 3: Little Hocking Water Association 4: Lubeck Public Service District 2,831 4,807 4,338 5,494 5: Mason County 6: V illage of Pomeroy Other 3,522 734 8,903 ..... ...... . ... Total 30,629 71.6 63.0 396.9 45.2 48.9 290.0 131.7 19.1 18.6 82.6 I 123.0 ! i...... ..... 90.4 15.5 15.6 29.1 47.8 17.6 18.5 83.6 30.9 7.4 7.1 91 11.7 p90(c8) 134.9 111.7 820.5 237.0 34.2 .32.6 138.3 284.9 Table 3.3 Mean, median and range within some percentile fractions (Units ug/1). v1 N mean(c8^ med (c8) min max Lowest 10% Upper 10%' Lower 50% Upper 50% 3,117 3,063 15,323 15,306 8.0 664.4 22.9 223.2 8.5 .25 479 285 21.2 .25 113 47.9 11.7 11391.9 47.8 11391.9 TSCA Document Processing Center Attn: Section 8(e)/FYI August 10, 2006 Page 8 of 10 Figure 3.1 Distribution of log c8 in blood r 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 ug/1 and 23 ug/1 respectively). [With alpha 0.05, two sided. Calculated with 'sampsize' in STATA.] Note that this may underestimate power relative to analyses that consider the full range o f 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. 'fable 3.4 summary' of power calculations Expected n Bladder Breast (fem) Kidney Testes 106 559 113 59 % Power to detect RR of: 1.25 18 75 19 11 1 2.0 .. - 92 100 93 68 TSCA Document Processing Center Attn: Section 8(c)/FYI August 10,2006 Page 9 of 10 The Science Panel also reports the following with respect to a trend observed in the C-8 blood levels: 3 The C8 health project data and trends in PFOA levels in the study area [The Science Panel has] a very detailed source of good quality data on C'8 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 o f it reveals a significant trend in C8 by community, which has implications for the design o f our study. He following figure shows the pattern o f C8 levels for people classified by the current water district in which they live (after excluding those who live outside the catchment area o f the 6 water districts). Each point is the average o f a weeks' collection o f blood samples over 47 weeks o f data collection. In each water district they appear to have a downward slope. 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 8(e)/FYI ** ****** * ~* * ** ................ . * * . ** ;** ` '' J P August 10, 2006 Page 10 of 10 :o so id'.v 40 50 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 o f less than a year. At this rate the c8 level in the blood has fallen by nearly 60% in a year.