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   CRE Advisory Board Member Jim Tozzi and other plaintiffs filed suit against EPA October, 27, 2000, in a challenge to the agency’s use of “draft guidelines” for carcinogen risk assessments, including the forthcoming and controversial EPA Dioxin Reassessment. The new draft guidelines adopt a “weight of the evidence” approach to risk assessment which, for example, allows substances to be classified in the highest hazard category on the basis of animal and mechanistic data. Because the guidelines are used in a wide array of risk assessment settings, including pesticide registrations, soil and water standards, and other areas, the suit represents a major challenge to EPA regulatory practice.

   The suit is based on the agency’s alleged violation of two “good government” laws. First, according to plaintiffs, EPA’s use of the new guidelines violates the Administrative Procedure Act, 5 U.S.C. § 551 et seq., because the guidelines have not undergone formal notice and public comment and have never been promulgated as APA rules. According to the suit, the new guidelines nevertheless constitute “rules” under the APA, and the agency is using the new guidelines illegally to supplant guidelines which were formally adopted in 1986. 

   Second, the guidelines should not be used because they were never submitted to Congress pursuant to the Congressional Review Act, 5 U.S.C. § 801, et seq. That statute requires that, before a rule can take effect, it must be submitted to Congress (and to the Comptroller General), and Congress thereafter shall have 60 days to review the rule. In the case of the EPA cancer guidelines, the agency has taken the position that it need not submit the required report.

   The Tozzi plaintiffs are challenging EPA’s use of the draft guidelines in connection with two specific agency actions. The first action is the agency’s 1999 classification of pyrethrins, a botanical pesticide made from chrysanthemums, as a “likely” human carcinogen. The second action is EPA’s reliance on the newer guidelines to support the agency’s controversial dioxin reassessment. 

   In addition to Mr. Tozzi, the plaintiffs include a manufacturer of pyrethrin-based pesticide products and a company that manufactures medical devices that contain PVC. Another federal court recently held that the PVC maker had standing to challenge a government dioxin cancer classification in different context. See Tozzi v. DHHS, (Sept. 30, 2000).

   The suit is pending in the U.S. District Court for the District of Columbia and has been assigned to Judge Thomas Penfield Jackson. Copies of the key court filings will appear below.