Delaney Amendment Essay

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The Delaney amendment that was introduced in 1958 to the Federal Food, Drugs, and Cosmetics Act outlawed the use of any food additives that might lead to the causing of cancer, specifically: “the Secretary [of the Food and Drug Administration] shall not approve for use in food any chemical additive found to induce cancer in man, or, after tests, found to induce cancer in animals.” This amendment was clearly aimed at protecting consumers from the negligent or malevolent actions of food producers who may include such dangerous elements in their products and make them liable to prosecution if they should do so.

Delaney’s argument was that no level of safety in terms of carcinogenic substances could be tolerated. The only safe level, therefore, was zero. Consequently, if in laboratory experimentation conditions test animals could have cancers induced through often large-scale introduction of a particular substance, then that substance was forbidden for use in food of any sort. Rep. James Delaney, D-N.Y., had served on a committee investigating food safety and additives issues that held two years of hearings around 1950. The Delaney Amendment was supplemented by others, notably the 1960 amendment concerning coloring additives, aimed at increasing consumer protection through the same policy of zero inclusion, as was a provision for animal feed.

Clearly, this amendment was considered to be antithetical to the interests of business and to some extent contradictory to existing legislation, which stipulated a legal dose for the inclusion of pesticide residuals, for example. Industry lobbyists spent a great deal of time and effort trying to have the Amendment repealed, and attempted to publish research intended to show that the zero-tolerance policy was inappropriate.

The amendment was repealed in 1997 after years of investigation, led by Monsanto and other corporations and beginning during the Clinton administration, and replaced by a package of legislation aimed at addressing issues that had arisen through scientific research in the intervening years. The concept of tolerable risk replaced the Delaney principle. Clearly, it is impossible to eliminate risk altogether, and technology does provide solutions to problems previously observed. This principle operates with respect to other consumer goods and services, and it would be inconsistent to maintain dual standards.

Further, recent research suggests that changing environmental conditions is leading to changes in allergic response to certain kinds of food, and it would be unfair to hold manufacturers to an unsustainable principle. Even so, it is true that the amendment was ended during a period of politics in which business interests were favored. Continued application and policing of strong regulations remain necessary to protect consumer interests.


  1. Harvey Levenstein, Paradox of Plenty: A Social History of Eating in Modern America, Revised Edition (University of California Press, 2003);
  2. Richard A. Merrill, “Food Safety Regulation: Reforming the Delaney Clause,” Annual Review of Public Health, (V18 May, 1997);
  3. Kristin Shrader-Frechette, “Technological Risk and Small Probabilities,” Journal of Business Ethics, (V4, No.6, December 1985).

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