Document M4G8B2YvrdKr7K23KVdkwpXM

o^OSr% rr w 'V PRO^t0 A t f 2. G _ / 3 I $ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 IE - 3 7t H p ~ < g o - O 0 3 - OO7 May 22, 2003 y E P A - O T S 000811854R DuPont Haskell Laboratory G0D f l l i a S 9R Attn: A. Michael Kaplan, Ph.D. Director - Regulatory Affairs and Occupational Health Elkton Road, P.O. Box 50 Newark, DE 19714-0050 SUBJECT: TSCA 8(e) Reporting Requirements for PFOA Information Dear Dr. Kaplan: OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES O CO X--A, - TO P-O r\j :l /roVnl 3 pi cn o CO In a recent report by the Environmental Working Group (EWG) on risks associated with perfluorooctanoic acid (PFOA), posted on the internet (http://www.ewg.org/reports/pfcworldy'). and in a letter to Administrator Whitman alleging reporting violations of TSCA Section 8(e) (enclosed), there is a reference to a "Personal and Confidential" DuPont document containing information on PFOA blood levels in female workers at a DuPont plant in West Virginia in 1981 (enclosed). This one-page DuPont document also notes that PFOA was found in the umbilical cord blood from one baby and in the blood of another baby, both of whom were bom to women working in the West Virginia plant. According to this same DuPont document, among the seven individuals listed in the table one gave birth to a child with an unconfirmed eye and tear duct defect and a second individual gave birth to a child with a nostril and eye defect. The EWG report further states that in 1981 DuPont reassigned 50 female workers at the plant to reduce PFOA exposure. In addition, the EWG report also describes DuPont studies of PFOA contamination of drinking water supplies in areas surrounding the Parkersburg, West Virginia plant. N) Cc=o> cz 4T1- --i n r r r'S "S f\5 o o xx-- As you know, TSCA section 8(e) states, "Any person who manufactures, processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the [EPA] Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information." Assuming that the information described above is accurate and was in DuPont's possession since 1981, please provide the contemporaneous logic for DuPont's decisions not to submit to EPA under TSCA section 8(e) the reports of (1) PFOA blood monitoring data on female workers and Internet Address (URL) http://www.epa.gov Recycled/Recyclable Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper / their offspring and (2) human developmental effects (a) in 1981 and (b) subsequently as additional data on PFOA's hazards and exposures (including the drinking water data related to its West Virginia plant, the 3M blood monitoring.data, the 2-generation reproductive toxicity study, etc.) were accumulated. We are concerned that the blood and umbilical cord monitoring data, together with the known or suspected toxicity of PFOA and other exposure data on PFOA, may present a TSCA 8(e) reporting obligation. In addition, please provide the drinking water data to the Agency and provide an explanation as to why it was not submitted when Dupont obtained the data. We request a response to this letter within 30 days. Please address your response to: Document Processing Center (7407M) EPA East - Room 6428 Attn: Section 8(e) U.S. Environmental Protection Agency Office of Pollution Prevention and Toxics 1200 Pennsylvania Avenue, NW Washington, D.C. 20460-0001 Deliveries: 1201 Constitution Avenue, NW Washington, DC 20004-3302 Questions regarding this request should be directed to Mr. Terry O'Bryan of my staff at (202) 564-7656 or email OBRYAN.TERRY@EPA.GOV High Production Volume Chemicals Branch Enclosures cc: Charles Auer Oscar Hernandez Terry O'Bryan ENVIRONMENTAL. W ORKING G RO U P April 11, 2003 The Honorable Christine Todd Whitman Administrator ' U.S. Environmental Protection Agency Washington,'D.'C. 1436 U Street NW, Suite 100 Washington, DC 20009 USA i: 202.667.6982 f: 202.232,2592 wrwww.ewg.org : T-<?dc Re: DuPont's failure to submit key health studies under the requirements of TSCA 8(e), 15 U.S.C. 2607(e). ; .'>o\. T ' C. Dear Administrator Whitman: /)) 9As your Agency moves forward with its assessment of public health risks posed by - the Teflon-associated.chemical.known as PFOA (perfluoroocta.noie acid, also called C8), we write to notify you of apparent violations of reporting requirements under 3 . 0 1w Section 8(e) of the Toxic Substances Control Act ("TSCA"), 15 U.S.C. 2607(e), by a T) . leading manufacturer and user of PFOA, DuPont, that may be hindering your ` assessment. We request that you'investigate these potential.violations of law by C ;' DuPont, and require full submission of the relevant, studies to the public record to allow for an accurate assessment of the health risks posed by this persistent global :- A , ' w pollutant that widely contaminates human blood...Given the nature and seriousness of the omissions, we recommend that the Agency levy the maximum allowable penalty under the law, a $25,000-fine per day to account for civil violations pursuant to 15 .S.C 2615 (a). We also ask that you investigate potential criminal violations for DuPont's knowing and willing failure to produce these studies, which would also subject the company to a maximum daily fine of $25,000. Id . a t 2615 (b ). ; t In a 1981 internal company study (attached as Exhibit A) DuPont found quantifiable, levels of PFOA in .umbilical cord blood from one baby, and the blood of another baby, both of whom were born to women working in the company's Teflon plant in Parkersburg, West Virginia. This study provided evidence that PFOA crosses the placenta and exposes a fetus in utero, at a time when DuPont had accumulated a significant body of knowledge on the toxicity o f PFOA. The study documentation, made public through litigation, shows that DuPont measured PFOA in the blood of eight pregnant women employed at the plant, and for seven of these women recorded information on the baby's.health after birth. DuPont found quantifiable- levels of PFOA in the blood of seven of eight, women tested, at concentrations ranging.up to 2.5 parts per million (ppm)..DuPont found PFOA in umbilical cord, blood from one-baby at a concentration of 0.055 ppm, and in the blood of another baby at a concentration of 0.012 ppm: The study documentation . shows that two of seven women gave birth to babies with birth defects, one an ... "unconfirmed" eye and tear duct defect, and one-a nostril and eye defect. That same year, DuPont reassigned 50 women at the plant to reduce PFOA exposure. We have 3 m a* u*s a o ri w ? a a k a t x ftN The Honorable Christine Todd-Whitman DuPont Reporting Violations 4/11/03, page 2 of 3 thoroughly reviewed 8(e) submissions from DuPont regarding PFOA, and find no '. record.of this study in. the Agency's.files. ISCA requires that a company inform the Administrator.when it finds information "that reasonably supports the conclusion that such substance...presents a substantial risk of injury to health." 15 U.S.C 2607(e). Given the unique susceptibility of a fetus to permanent health harms, from exposures to .industrial chemicals, the finding of an industrial chemical in umbilical cord blood inherently qualifies as "information that reasonably supports the conclusion that such ' . substance...presents.a substantial risk of injury to health..." and therefore should trigger a submission of the study to EPA under the provisions of TSC 8(e). In the case of DuPont's 1981.blood study, however, the company, also possessed at the time a significant body of knowledge on PFOA's to xicity that further supported what should have been a reasonable- conclusion th at the blood tests indicated a . substantial risk to health. According to a 1961.internal company memorandum on the toxicity pf C8 and related ' chemicals, another document made public through litigation, a DuPont toxicologist found that "C8 and C9 acids... have the ability to increase the size of.the liver of rats' at low doses," and further recommends th a t "all of these materials...be handled with extreme care. Contact with the skin-should be strictly avoided" (DuPont 1961). Between 1961 and 1981 DuPont.and its PFOA supplier (3M) conducted or summarized. 32 additional PFOA toxicity studies in dogs, rats, monkeys, guinea pigs, rabbits,'and mice (B ilo tt 2002). . , Among other.studies that DuPont failed to submit to EPA Under requirement of law are the company's studies of PF0 'contamination in drinking water supplies in areas surrounding its Parkersburg, West Virginia plant (see DuPont documents at .EWG ' . 2002). Upon information and belief, DuPont's 1981 study of PFOA in babies' blood, and their finding of PFOA contamination in tap water, are ju st two of the health and safety studies conducted by DuPont beginning at least 22 years ago that the company failed to submit to EPA under.the requirements of TSCA Section 8(e). 15 U.S.C . 2607(e). . We appreciate your prompt attention to the concerns we.raise in this letter, and hope that the full record of PFOA's- toxicity to humans will soon be available to the..', public and Agency as you proceed .with your assessment .of human helth .risks po.sed by the chemical. President, Environmental Working Group '..EWG: THE POWER.'OF .INFORMATION The Honorable Christine Todd Whitman ' DuPont Reporting Violations 4/11/03, page 3 of 3 cc; Charles 0. Holliday, J r ., Chairman & CEO, DuPont Steve Johnson, EPA's Assistant Administrator for.Prevention, Pesticides, and Toxic Substances . References Bilo tt,. R. 2002. Letter from Robert A. Bilott of Taft, Stettin.ium, & Hollister LLP to IRIS Submission Desk. IR IS Submission Inventory.for Perfluorooctanoic.Acid - Ammonium Salt. April 12 2002. DuPont. 1961. Internal memo Re Toxicity of teflon Dispersing Agentsl Environmental Working Group (EWG). 2002. DuPont Hid'Teflon Pollution for Decades. Available online at ' http://w ww .ew a.ord/policvm em o/2002lil3/2002i213.php. December 12 2002. Attachment ' Exhibit A. DuPont. 1981. Births and Pregnancies. (Documentation of DuPont study of PFOA in the blood of female employees and their babies;) : :' . E W G : THE; P O W E R O F I N F O R M A T I O N S  Births and Pregnancies .PPM C-8 ' in Bloody ' tz/zrm r/ 0.45- .. . Status . . .. Normal child - born June 1980; Transferred out of Fluorocarbons 4/79. 0. 28 Normal c h ild - b o m A p r il 1981.. 0.078 1.5 Normal child - b o m April 1981. Umbilical cord blood 0.055 ppm. Five months pr egnant. O / ^ 2 ^ . 0.0i; ~CUx^M#' / 2.5* Child - 2 plus years. : Unconfirmed eye and tear duct: defect. 0..048 Child - 4 months. ,0O1 -r:J f & V y j f *Current blood level - in fluorocarbons area only one month before.pregnancy. j r ~T ' 00 i 'T g 'E!D0