Caseflicks

Court of Appeals for the D.C. Circuit • 1987

Community Nutrition Institute, Laura A. Rogers v. Frank Young, Commissioner, Food and Drug Administration

818 F.2d 943 | 260 U.S. App. D.C. 294 | 1987 U.S. App. LEXIS 6385

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Takeaway

In short, FDA may use action levels, but when it treats them as binding enforcement norms, the APA requires notice-and-comment rulemaking; FDA’s choice not to enforce against blended corn remains unreviewable.

Background

The Food and Drug Administration regulates unavoidable poisonous or deleterious substances in food under the Federal Food, Drug, and Cosmetic Act. For aflatoxins—mold by-products that can contaminate corn—the FDA had set an “action level” of 20 parts per billion. The agency treated corn exceeding that level as subject to enforcement, while sometimes allowing producers to blend contaminated corn with uncontaminated corn so that the final product fell below 20 parts per billion.

Community Nutrition Institute and other plaintiffs challenged the action level on three grounds: the FDC Act required a formal regulation or tolerance; the action level was a legislative rule adopted without APA notice and comment; and FDA’s approval of blending violated the Act. The district court granted summary judgment to FDA on all claims.

On the first appeal, the D.C. Circuit held that the FDC Act required formal tolerances and invalidated the action level. The Supreme Court reversed, holding that the statute permitted FDA to use action levels. It remanded for resolution of the APA notice-and-comment claim and the blending claim, which the Supreme Court had not reached.

Issues

Issue #1

Whether FDA’s 20-parts-per-billion aflatoxin action level was a legislative rule that required notice-and-comment rulemaking under the Administrative Procedure Act.

Holding

Yes. FDA gave the action level present, binding effect, making it a legislative rule that could not validly be issued without notice and comment.

Reasoning

The APA exempts interpretive rules and general statements of policy from notice-and-comment procedures, but not legislative rules. Under D.C. Circuit precedent, the central inquiries are whether the agency pronouncement creates present rights or obligations and whether it genuinely leaves agency decisionmakers free to exercise discretion. FDA’s label for its own action levels as enforcement-policy statements received some deference, but the court gave greater weight to the language FDA used and the practical effect FDA assigned to the levels.

FDA’s regulations described an action level as defining the contamination level at which food “will be deemed” adulterated and as potentially prohibiting any detectable quantity of a substance. That mandatory language did not merely forecast future enforcement priorities. It indicated that, once set, an action level established a presently applicable and binding norm.

FDA’s exemption procedure reinforced that conclusion. The agency allowed it to exempt from regulatory action food that was otherwise unlawfully contaminated. Requiring a producer to obtain an exception implies that food over the action level is unlawful unless exempted; that consequence could arise only because FDA treated the action level itself as binding.

FDA’s own enforcement communications likewise treated 20 parts per billion as a fixed legal threshold. In a Federal Register notice, FDA stated that food containing more than 20 parts per billion of aflatoxin was adulterated and could not be shipped in interstate commerce. Such language conveyed more than an agency intention that might later be reconsidered case by case.

The court acknowledged that an action level did not bind producers in every respect: in an enforcement action, FDA would still have to prove that the food was adulterated under the statute rather than simply prove noncompliance with the level. But FDA had effectively bound itself, because it would be extraordinarily difficult for the agency to justify prosecuting a producer whose corn contained less than 20 parts per billion. That substantial restriction on enforcement discretion made the action level legislative in character.

The ruling was narrow. FDA remained free under the FDC Act to use genuinely nonbinding action levels as policy statements. But if FDA chose to accord an action level substantive and binding significance, it had to promulgate that level through APA notice-and-comment procedures.

Issue #2

Whether FDA’s decisions to allow blending of aflatoxin-contaminated corn with uncontaminated corn violated the FDC Act and were judicially reviewable.

Holding

No. Although blending adulterated corn into other corn produces an adulterated final product, FDA’s choice not to bring enforcement proceedings is committed to agency discretion and is not judicially reviewable.

Reasoning

The court agreed that deliberately blending contaminated corn with uncontaminated corn cannot reasonably be characterized as an unavoidable contamination. The resulting blended corn therefore falls within the Act’s definition of adulterated food, and FDA had itself conceded that using adulterated feed as an ingredient ordinarily makes the finished feed adulterated.

That statutory characterization did not compel FDA to prosecute every adulteration violation. The FDC Act authorizes FDA enforcement but does not require action against every product meeting the definition of adulterated food. Section 336 expressly recognizes FDA’s authority not to report or pursue minor violations.

Under Heckler v. Chaney, FDA’s decisions whether to use its enforcement powers under the FDC Act are presumptively committed to agency discretion and are not subject to judicial review. CNI’s blending claim ultimately challenged FDA’s decision not to initiate enforcement proceedings, so the claim could not succeed.

Concurrences

Judge Starr

Reasoning

Judge Starr agreed with the court’s resolution of the blending issue. In his view, even if the blended corn was adulterated under the FDC Act, FDA retained complete discretion over whether and when to institute enforcement proceedings. Heckler v. Chaney therefore foreclosed judicial review of FDA’s decision to permit the blending arrangement.

Dissents

Judge Starr

Reasoning

Judge Starr disagreed with the conclusion that the action levels were legislative rules. He would have treated the controlling question as whether an agency pronouncement has the force of law in a later enforcement proceeding, following Pacific Gas & Electric Co. v. FPC. A legislative rule, in his view, establishes a legal standard that the agency need only show was violated; a policy statement does not.

Under that test, the action levels had no force of law. In an action to sanction or enjoin shipment of corn, FDA could not prevail merely by showing that the corn exceeded 20 parts per billion. It would still have to establish, through scientific or other probative evidence, that the corn was adulterated under the FDC Act. Because the action level itself did not conclusively resolve that question, Judge Starr regarded it as a nonbinding policy statement exempt from notice and comment.

Judge Starr acknowledged that FDA’s use of mandatory language and formal exceptions made the action levels a close functional case. Nonetheless, he favored a clear, single-factor rule centered on legal force in subsequent proceedings. That approach, he argued, better distinguished law from policy and avoided the uncertainty of the majority’s multifactor analysis.