Delaney Amendment

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DELANEY AMENDMENT. In 1958, U.S. Representative James Delaney of New York added a proviso to the 1938 Federal Food, Drug, and Cosmetic Act declaring that the Food and Drug Administration cannot approve any food additive found to induce cancer in a person or animal. The clause inaugurated the federal government's role in protecting the public from cancer and eventually affected other areas of regulation, such as the Environ-mental Protection Agency's control of pesticides. As cancer risk became better understood and carcinogens more easily detectable, the "zero cancer risk" limit was increasingly seen by scientists and industry as an impractical standard. In 1996, Congress replaced the amendment to require a less-than one-in-a-million lifetime risk threshold.


Hollander, Earle. "The Delaney Era Ends." Frontiers: A Chronicle of Cancer Programs at The Ohio State University 5, no. 2 (Summer/Autumn 1997). Available from

National Research Council, Committee on Scientific Regulatory Issues Underlying Pesticide Use Patterns and Agricultural Innovation. Regulating Pesticides in Food: The Delaney Paradox. Washington, D.C.: National Academy Press, 1987.

Stever, Donald W. Law of Chemical Regulation and Hazardous Waste. New York: C. Boardman, 1986.

Eric S.Yellin

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Delaney Amendment A provision in the US Food, Drug, and Cosmetic Act (1958) which states that no food additive shall be deemed safe after it is found to induce cancer when ingested by human beings or animals, at any dose level. Such an additive therefore must not be used.