Caseflicks

Court of Appeals for the Ninth Circuit • 1992

Les v. Reilly

968 F.2d 985

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Takeaway

In short, this case holds that the Delaney clause is an absolute statutory ban: EPA cannot permit a food additive it has found carcinogenic merely because the estimated cancer risk is de minimis.

Background

EPA had previously issued regulations allowing benomyl, mancozeb, phosmet, and trifluralin to be used in ways that left residues in certain processed foods. In 1988, EPA found that each pesticide induced cancer in humans or animals. Some residues could become more concentrated during processing than the tolerance permitted on the corresponding raw commodity.

The Federal Food, Drug, and Cosmetic Act generally treats a food containing an unsafe food additive as adulterated. Its Delaney clause provides that an additive may not be deemed safe if appropriate testing shows that it induces cancer in humans or animals. Although EPA historically applied that language as an absolute prohibition, it announced in 1988 that it would allow carcinogenic pesticide residues in processed food when their cancer risk was de minimis.

Petitioners sought administrative revocation of the four food-additive regulations. EPA denied the petition in a final order, concluding that the pesticides posed only negligible cancer risks. Petitioners then sought direct judicial review of that final EPA order under 21 U.S.C. § 348(g)(1); there was no intervening lower-court decision.

Issues

Issue #1

Whether the Delaney clause permits EPA to retain food-additive regulations for pesticides found to induce cancer when EPA concludes that the resulting cancer risk is de minimis.

Holding

No. Once EPA has found, through appropriate tests, that a food additive induces cancer in humans or animals, the Delaney clause leaves EPA no authority to approve or retain its use on the ground that the actual risk is negligible.

Reasoning

The statutory text is mandatory: no additive may be deemed safe if it is found to induce cancer. EPA conceded both that the four pesticides had been found carcinogenic and that the clause facially calls for a zero-risk rule. The court held that, after the carcinogenicity finding, EPA retains no discretion to balance the degree of risk, benefits, or practical consequences of a ban.

The food-additive provision and the separate pesticide-residue provisions operate together rather than create an implied exception. A pesticide residue authorized on a raw commodity may flow through to processed food only when processing does not increase its concentration above the applicable raw-food tolerance. When the residue concentrates beyond that level, it is treated as a food additive subject to section 409 and the Delaney clause.

The legislative history confirmed the plain-language reading. Congress adopted the clause amid concern that science could not reliably identify a safe exposure level for carcinogens, and the approval of the carcinogenic pesticide Aramite was a principal impetus for the amendment. Congress therefore chose an absolute prohibition, including for pesticide residues that function as food additives in processed foods.

Longstanding administrative practice reinforced that conclusion. From enactment in 1958 until EPA's 1988 policy shift, the responsible agencies treated the Delaney clause as an absolute bar. Congress repeatedly amended related provisions without disturbing that settled interpretation, which the court treated as persuasive evidence that the strict construction matched congressional intent.

EPA argued that a de minimis approach would produce a more rational, risk-based system because the processing-concentration rule may not track comparative cancer risk. The court acknowledged that the statutory scheme had been criticized and that Congress was considering amendments, but held that neither EPA nor the judiciary may replace Congress's unambiguous policy choice with a preferred regulatory regime. EPA's refusal to revoke the regulations was therefore contrary to law and was set aside.