## Facts

- The EPA had issued food-additive regulations permitting pesticide residue tolerances for benomyl, mancozeb, phosmet, and trifluralin when there was no evidence they caused cancer.
- In 1988, the EPA determined each of the four pesticides induces cancer.
- Despite those findings, the EPA refused to revoke the existing food-additive regulations, concluding the cancer risks were “de minimis.”
- Individual consumers and public-interest intervenors petitioned the EPA to revoke the regulations and, after denial, sought judicial review of the EPA’s final order under the Federal Food, Drug, and Cosmetic Act (FFDCA).
- Petitioners argued the Delaney Clause categorically prohibits approval of any food additive found to induce cancer, without regard to risk level.

## Issues

1. Whether the Delaney Clause, 21 U.S.C. § 348(c)(3), permits the EPA to allow a carcinogenic pesticide residue as a food additive based on a “de minimis” cancer-risk determination.
2. Whether the EPA may retain food-additive regulations for substances it has found to induce cancer.

## Decision

- The court granted the petitions for review and set aside the EPA’s final order.
- The court held the Delaney Clause does not allow a de minimis exception for carcinogenic food additives.
- Because the EPA found the four pesticides induce cancer, their use as food additives could not lawfully be permitted under the Delaney Clause, regardless of the EPA’s assessment that the risk was extremely small.

## Legal Principles

- Under the Delaney Clause, a food additive “found to induce cancer” cannot be deemed safe, and the prohibition applies without a quantitative risk threshold.
- When statutory text is categorical and unambiguous, an agency lacks authority to create exceptions based on policy or risk assessment.
- Legislative history and statutory purpose may confirm that Congress adopted a strict prohibition rather than a risk-balancing standard for carcinogenic additives.
- Agency discretion in administering a statute must remain within the limits set by Congress; an agency may not effectively amend a clear statutory command through regulatory policy.

## Conclusion

The Ninth Circuit invalidated the EPA’s attempt to preserve food-additive tolerances for four pesticides after finding they induce cancer, holding that the Delaney Clause imposes a categorical ban that leaves no room for a de minimis cancer-risk exception.


Les v. Reilly, 968 F.2d 985 (9th Cir. 1992)