Les v. Reilly
ELR Citation: ELR 21303 No(s). 91-70234 (9th Cir. Jul 8, 1992)
The court rules that the U.S. Environmental Protection Agency's (EPA's) decision to allow the use of four cancer-inducing pesticides as food additives violates the Delaney Clause, §409, of the Federal Food, Drug, and Cosmetic Act (FFDCA) prohibiting food additives that induce cancer. When EPA originally promulgated regulations allowing the use of benomyl, mancozeb, phosmet, and trifluralin as food additives, no evidence of carcinogenicity existed. In 1988, EPA found these pesticides to be carcinogens, but refused to revoke the earlier regulations, reasoning that the chemicals posed only a de minimis or negligible risk of causing cancer. The court first holds that the language of the Delaney Clause, which provides that no food additive shall be deemed safe if it induces cancer, is clear and mandatory. The court finds that appropriate tests have established that the four pesticides at issue induce cancer in humans or animals, and the statute provides that EPA has no discretion once a finding of carcinogenicity is made. Although the FFDCA's scheme allows the use of carcinogenic pesticides on raw food without regard to the Delaney Clause, the court holds that FFDCA §402 harmonizes this scheme with the Delaney Clause prohibition by providing that residues on processed foods are to be treated as food additives. Further, the FFDCA's legislative history supports the conclusion that Congress intended to ban all carcinogenic food additives, and the court holds that this ban applies regardless of amount or significance of risk.
Counsel for Petitioners
Stephen P. Berzon, Indira Talwani
Altshuler, Berzon, Nussbaum, Berzon & Rubin
177 Post St., Ste. 300, San Francisco CA 94108
(415) 421-7151
Counsel for Respondents
Jonathan J. Fleuchaus
U.S. Environmental Protection Agency
401 M St. SW, Washington DC 20460
(202) 260-2090
Counsel for Respondent-Intervenor
Peter Barton Hugg, Bruce N. Kuhlik
Covington & Burling
1201 Pennsylvania Ave. NW, Washington DC 20044
(202) 662-6000
Schroeder, J. (before Chambers and Beezer, JJ.)