Document dDYqYjwENjveK2XdEpYyYgdB5

AL2261770 arme DuPont Legal |3 hamAConrdporreaateVC.ouMnasellinowski DW1u0i0Pi7onngMtairoLkeneg,talDSteDrl-ea7ewt0a7r8e 19898 Foc" Smet E-mail: AMnadrleia.nVo.wski@usa.dupont.com FYI- 0S04. 0157 mn | or275_ 07 3 | T HARE ERRIT AERTII ET April 29, 2004 VIA OVERNIGHTMAIL CONTAINS NO CBI Mr. Richard H. Hefter Chief High Production Volume Chemicals Branch (7403M)) Office of Pollution Prevention and Toxics U.S. Environmental Protection Agency 1201 Constitution Avenue, NW `Washington, DC 20004-3302 Ret FYIScbmission [RSA DEA Dear Mr. Hefter: During discovery ina class action lawsuit against DuPont, plaintiffs' counsel recently provided DuPont with what appear to be three versionsofan abstract for a paper authored by James Dahlgren, etal. These three abstracts are enclosed. We understand that Dr. Dahlgren undertook this work onbehalfof plaintiffs in the lawsuit. DuPont does not know whether plaintiffs' counsel has already submitted these abstracts to EPA. DuPont is submitting these abstracts for informational purposes only, and because DuPont recognizes EPA's interest in and desire to obtain as much information as possible on perfluorinated compounds. DuPont's submissionofthe attached abstracts is not intended to imply that, nor should it be construed that, DuPont believes the information contained in them is in any way indicative of any actual risk, or that the information meets EPA's criteria for reporting under TSCA Section 8(). `The limited information reported in the abstracts cannot reasonably support any conclusionofrisk, for many reasons. For example, the abstracts' authors conclude only =z E == e23: Sz = Cerny ; MOfrf.icReiocfhPaorldluHt.ioRnefPreervention and Toes Page2 April 29,2004 that the information that they collected via questionnaire "suggests" that exposure "may" cause an effect. EPA guidance on Section 8(e) states that information that only "may suggest" a concern does not require reporting. In EPA's 1978 TSCA Section 8() Statement ofInterpretation and Enforcement Policy, EPA noted that the Agency was deleting proposed language that would have required reporting when a person obtains information that "may suggest" a substantial risk. EPA deleted this language in response 10 numerous comments pointing ou that the Administrator lacked authority to compel rTeSpoCrAtinSgeocftiionnfo8r(em)atNiotoinfitchaattioonnloyf"SmuabsytasnutgigaelstR"isak;suPbosltiacnytiCallarriisfki.c!atEioPnAa'nsdJRuenpeo3r,ti2n0g03 Guidance (68 FR 33129) does not question or ater this longstanding Agency position. DuPont also notes that the abstracts do not provide sufficient information to meaningfully evaluateorto reach any objective conclusion regarding the authors' statement that the results "suggest" an effect. For example, the results appeatro be made from inappropriate rate comparisons and consequently reach erroneous conclusions. Plaintiffs' counsel has provided DuPont with what appears to be raw data from the questionnaires referenced in the abstracts. DuPont has asked plaintiffs' counsel to provide additional information and data necessary to interpret and analyze such raw data. Plaintiffs' counsel has not, as ofthis date, provided the requested information. DuPont suggests that EPA contact Dr. Dahlgren for more information,ifthe Agency believes that this survey is worth investigating further. DuPont also understands that oneofthe abstracts was made public as a poster presentation at a conferenceof the SocietyofEnvironmental Toxicology and Chemistry (SETAC) conference in Prague, Czechoslovakia on April 19, 2004,andtherefore EPA may already have received this abstract. It is our understanding thaat hard copyofthe abstracts was made available to all conference attendees and that the full manuscript would be made available upon request. The abstract (without the results Table) may be obtained through the SETAC website at www.setac.org. (specifically, at hutp://www.zuova.cz/ve/index. php?a=topic&x=13298). Other abstracts presented at the conference and pertaining to perfluorinated chemicals are accessible through the SETAC website at http://www.zuova.czivel. If you need any additional information, please contact me directly. Very uly yours, S2ie,te Velo / de AY Andrea V. Malinowski Counsel for E. I. DuPont de Nemours and Company P"oSleiecyS;uNpoptliefmiecanttiaornyofISnufbosrtmaanttioina,l PRaisrka,gr4a3phFe(d3.) Rfergo.m 1E1P1A1'0s(SMaatrecmhen16t,o1fI9n7t6e)r.pretation and Enforcement  OMfrf.icReiocfhaProdllHut.iHonefPtreerveation and Toxics Attachments (3 abstracts) cc: ADtotcnu:meFnYtI SPruobcmeissssiinognCenter (7407M) Office of Pollution Prevention and Toxics US. Environmental Protection Agency 1200 Pennsylvania Avenue, NW `Washington, D.C. 20460-0011 April 29P,a2g0e034 . OMfef.icReiocfPhoalrlduHt.ioenftPreervention and Toxics ATTACHMENTS April 29P,a2g0e04s 1. Abstract: Cancer Prevalence in Subjects Exposed to Perfluorooctanoic Acid (PFOA) - 3 pages [LE 180--6 LE 1808] 2. Abstract: Cancer Prevalence in Subjects Exposed to Alkylated Substances (PFAS) - 3 pages [LE 182-4 LE 1826] 3. Abstract: Cancer Prevalence in Subjects Exposed to Alkylated Substances (PFAS)- 3 pages [LE1828 -- LE1830]