Young v. Community Nutrition Institute

Background

The dispute is between the Food and Drug Administration (an executive agency) and two public-interest groups plus a consumer who sued the FDA Commissioner. The contested substance is aflatoxin, a naturally occurring, unavoidable, and poisonous mold byproduct that can appear in some foods. The FDA had not issued a formal tolerance under the specific statute, but had used less formal “action levels” (20 ppb generally, and a temporary 100 ppb allowance for certain corn used as feed). The groups argued the law requires the FDA to set formal tolerance regulations before allowing such shipments.

Reasoning

The central question was whether the statute’s wording obliges the Secretary to issue formal tolerance regulations whenever an added contaminant cannot be avoided. The Court applied the two-step framework for reviewing agency interpretations and found the statutory language ambiguous. Because the FDA’s longstanding reading — that the agency may decide whether formal tolerance regulations are necessary — is a reasonable construction, the Court deferred to the agency. The Supreme Court therefore reversed the appeals court’s contrary reading and sent the case back for further proceedings consistent with this holding.

Real world impact

The ruling leaves the FDA with discretion to use formal tolerances or less formal action levels when dealing with unavoidable contaminants like aflatoxin. That discretion affects whether certain shipments may move in interstate commerce and how producers manage testing and compliance. The decision resolves only the statutory interpretation question; the case was remanded for further steps consistent with the Court’s view.

Dissents or concurrances

Justice Stevens dissented, arguing the statute’s plain language required mandatory rulemaking for unavoidable contaminants and criticizing the Court’s deference to the agency’s practice.