Document vVNXr44yORbjpaD7RrxwXmErm

M 2 S 6 _ 373C Andrea V. Malinowski Corporate Counsel pi ,,,rCONTAIN NO CBI /O \ 0 "''M1i .1:3 J August 10, 2006 VIA FEDERAL EXPRESS TSCA Document Processing Center (7407M) EPA East - Room 6428 Attn: Section 8(e)/FYI U.S. Environmental Protection Agency 1201 Constitution Avenue, NW Washington, D.C. 20004-3302 Phone: 202-564-8940 Dear 8(E) Coordinator: DuPont Legal Wilmington Office Buildings 1007 Market Street Wilmington, D E 19898 302-774-6443 Tel 302-774-4812 Fax andrea.v.malinowski@usa.dupont.com E-mail r-o J J o 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 of 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 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 88060000322 O O' E.t. du Pont de Nemours and Company P-2 TSCA Document Processing Center Attn: Section 8(e)/FYI August 10,2006 Page 2 o f 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 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 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 Panel 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 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 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' 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 1Brookmar has apparently provided a subset o f approximately 30,000 individuals to the Science Panel. P-3 TSCA Document Processing Center Attn: Section 8(e)/FYI August 10, 2006 Page 3 o f 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 1). 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 information 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. Andrea V. Malinowski Attachments (2) - 7 pages