Document 7ObVX5NRBL1Nv5p3eE8G2rXMa

M a t e - IIA7 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 .^OM ^r SEP 2 7 2002 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM SU BJECT: Revision of PFOA Hazard Assessment and Next Steps FROM: TO: Charles M. Auer, D ire c to f^ '^ r^ ^ Office of Pollution Prevention and Toxics Oscar Hernandez, Director Risk Assessment Division Mary Ellen Weber, Director Economics, Exposure, and Technology Division Ward Penberthy, Acting Director Chemical Control Division CD CD i GO --n_: y O Jm rsj GO As part of the effort by the Office of Pollution Prevention and Toxics (OPPT) to understand health and environmental issues presented by fluorochemicals in the wake of unexpected toxicological and bioaccumulation discoveries with respect to perfluorooctyl sulfonates (PFOS), OPPT has been investigating perfluorooctanoic acid and its salts (PFOA). OPPT released a preliminary Draft Hazard Assessment o fPerfluorooctanoic Acid and Its Salts, dated February 20, 2002, on March 28, 2002, and issued a minor correction to that document on April 15, 2002. That draft assessment indicated potential systemic toxicity and carcinogenicity, and observed that blood monitoring data suggested widespread exposure to the general population, albeit at low levels. It also noted, however, that additional toxicity studies were underway on other endpoints and that further data would be available within a matter of months. The Agency has since received considerable additional data. The additional toxicology data submitted to the Agency suggest a potential for reproductive/developmental toxicity, and additional blood sample analysis data indicate low level exposures to the general population that are unexplained at this time. Stephen Johnson, Assistant Administrator o f the Office o f Prevention, Pesticides, and Toxic Substances (OPPTS), met with representatives from the manufacturers and users of PFOA and related chemicals on August 13, 2002. He requested continued discussion with .gpNTAIN NO OP'Internet Address (URL) http://www.epa.! Recycled/Recyclable Printed with Vegetable Oil Based Inks on Recycled Paper (Minimum 50% Postconsumer content) 2 manufacturers and users o f PFOA and related chemicals to further investigate these issues, and raised the importance o f and need for communicating with the public. Following that meeting, OPPTS met with toxicologists from industry on August 30, 2002, to discuss the recent study submissions and any additional anticipated work. OPPT also met by conference call with manufacturer representatives on September 12, 2002 to explore existing exposure information and identify gaps in those data that may help to explain the presence o f PFOA in the blood o f the general population. Summaries o f these meetings are being placed in the public administrative record for this investigation, AR-226: PFOS, PFAS, PFOA, Telomers, and Related Chemicals. An interim revised hazard assessment updating the original Draft Hazard Assessment to incorporate OPPT's reviews o f these data has been prepared. As soon as this document completes internal review procedures, it should be placed in AR-226. Please proceed to finalize this interim revised hazard assessment within the next four to six weeks, at which time we will place the document in the public file. The reproductive/developmental toxicity data, the carcinogenicity data, and the blood monitoring data reviewed in the interim revised hazard assessment raise the possibility that PFOA might meet the criteria for action under section 4(f) o f the Toxic Substances Control Act. The Agency established a process in 1991 for determining whether the TSCA 4(f) criteria are met, and published that process in a Federal Register notice concerning refractory ceramic fibers (RCF) (56 FR 58693; November 21, 1991). With this memo, I am requesting that you now initiate a priority review, as described in that notice, to determine the significance o f the risks presented by PFOA and its salts. This priority review should begin while you proceed with the finalization o f the interim revised hazard assessment. It is my understanding that you have also initiated a request with the Science Advisory Board (SAB) for a peer review o f the preliminary risk assessment focused on developmental/reproductive toxicity that will be developed based on this priority review. It is my expectation that the hazard assessment priority review will be completed in the next four to six weeks. Please be prepared to discuss these issues when we meet with the Assistant Administrator on next steps cc: S. Johnson S. Hazen M. Schneider Administrative Record AR-226: PFOS, PFAS, PFOA, Telomers, and Related Chemicals