The Delaney Paradox Resurfaces : Regulating Pesticides as Food Additives under Federal Law

Cancer has been the most longstanding public health concern of modem society,1its causes and cures remaining elusive for decades. During the early to mid-twentieth century, emerging scientific evidence showing that some forms of cancer were likely caused by dietary additives sent Congress scrambling to enact strict food safety laws. The culmination of this legislative activity was the 1958 enactment of a relatively low-profile provision of the Federal Food, Drug and Cosmetic Act (Food & Drug Act) called the Delaney clause. The Food & Drug Act prohibits the sale of any food containing an "unsafe" additive, and the Delaney clause declares that any additive which is a carcinogen shall automatically be deemed unsafe: “[N]o additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal....” The clause rests on the assumption that absolutely no risk of cancer is acceptable in the food supply as long as the scientific community cannot accurately determine a safe dose for carcinogens in humans. It is a clear and unambiguous congressional mandate that no cancer risk will be tolerated, no matter how negligible, and its ultimate goal is to provide a national food supply free from added carcinogens. The Delaney clause's farthest felt and most controversial impact has been in the area of pesticide regulation. The use of pesticides and other chemicals has increased dramatically in this country since the end of World War II. The EPA, the federal agency charged with regulation of the pesticide industry, is required to register every pesticide under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). In addition to FIFRA registration, pesticides used on food crops, whether for human or animal consumption, are treated as food additives and subject to the provisions of the Food & Drug Act. EPA regulators argue that conflicting standards and requirements contained in these two statutes create an unworkable regulatory scheme, which they fondly call the "Delaney paradox." This Note discusses the implications of the Delaney paradox and the legislative reform proposals under current debate in Congress. Part H addresses agency arguments that enforcement of the Delaney clause leads to absurd results in pesticide regulation. Part II reviews the de minimis doctrine used by agencies to interpret the Delaney clause and judicial rejection of this doctrine. Part IV examines the significance of Les v. Reilly for Congress and federal agencies, and Part V discusses aspects of legislative reform