Case Citation
Legal Case Name

Les v. Reilly Case Brief

Court of Appeals for the Ninth Circuit1992Docket #66275156
968 F.2d 985 1992 WL 153883

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Case Brief Summary & Legal Analysis

General Brief
3 min read

tl;dr: The EPA’s attempt to create a “de minimis” risk exception to the Delaney Clause for carcinogenic pesticides in food was rejected. The court held the statute mandates a zero-risk standard.

Legal Significance: This case affirms the strict, literal interpretation of the Delaney Clause, limiting agency discretion to permit carcinogenic food additives based on perceived minimal risk, reinforcing congressional primacy in setting safety standards.

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Case Facts & Court Holding

Key Facts & Case Background

The Environmental Protection Agency (EPA) identified four pesticides (benomyl, mancozeb, phosmet, and trifluralin) as carcinogens. These pesticides were previously permitted as food additives. Despite the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 348(c)(3), which prohibits any food additive found to induce cancer, the EPA declined to revoke regulations allowing their use. The EPA reasoned that the cancer risk posed by these pesticides was “de minimis.” This interpretation marked a change from the EPA’s prior strict enforcement of the Delaney Clause. The FFDCA allows pesticide residues on raw agricultural commodities under section 408, and these can “flow-through” to processed foods if concentrations do not exceed raw food tolerance levels (section 402). However, the EPA regulations at issue permitted concentrations of these carcinogenic pesticides in processed foods exceeding those allowed in raw foods, thus treating them as food additives subject to section 409 (the Delaney Clause). Petitioners challenged the EPA’s final order refusing to revoke the regulations.

Court Holding & Legal Precedent

Issue: Did the Environmental Protection Agency violate the Delaney Clause of the Federal Food, Drug, and Cosmetic Act by permitting the use of carcinogenic food additives based on a determination that they posed only a “de minimis” risk of cancer?

Yes, the EPA violated the Delaney Clause. The court set aside the Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis au

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Legal Issue

Did the Environmental Protection Agency violate the Delaney Clause of the Federal Food, Drug, and Cosmetic Act by permitting the use of carcinogenic food additives based on a determination that they posed only a “de minimis” risk of cancer?

Conclusion

This case underscores the principle of statutory fidelity in administrative law, holding Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderi

Legal Rule

The Delaney Clause, 21 U.S.C. § 348(c)(3)(A), mandates that no food additive Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim a

Legal Analysis

The court found the language of the Delaney Clause, 21 U.S.C. § Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit a

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