Delaney Clause of Food, Drug, & Cosmetic Act (College Board AP® Environmental Science): Study Guide

Delaney Clause of Food, Drug, & Cosmetic Act

Background

• Introduced to address growing public concerns in the mid-20th century over cancer-causing chemicals in food

  • At the time, new food additives and preservatives were being developed without consistent safety testing

  • The Delaney Clause was one of the first laws to apply a “zero-tolerance” policy to carcinogens in the U.S. food supply

• Part of the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act

• Named after Congressman James Delaney, who was vocal about the need to prevent cancer risks from synthetic chemicals

Key Dates

• 1958: Delaney Clause enacted as part of the Food Additives Amendment

• 1996: The Food Quality Protection Act modified how the clause is applied

  • Introduced a more risk-based approach for pesticide residues in food

  • Shifted focus from zero-risk to reasonable certainty of no harm

How the Delaney Clause relates to the environment

• Originally prohibited the use of any food additive found to induce cancer in humans or animals

  • Applied to both direct additives (e.g. preservatives) and indirect additives (e.g. residues from packaging or processing)

• Although focused on human health, it highlights how environmental contaminants can enter the food chain

  • For example, pesticide residues or industrial chemicals in crops and processed foods

Evaluation

• Successes:

  • Raised public and scientific awareness of the potential cancer risks of food additives

  • Set a precedent for preventive regulation of chemicals in the food system

  • Helped pave the way for stricter testing and labeling requirements for food ingredients

• Challenges:

  • The zero-tolerance standard was often criticized as inflexible and overly simplistic

  • Difficult to enforce, especially when trace amounts of substances were detectable with modern technology

  • Created inconsistencies — a substance could be banned under the Delaney Clause but allowed in pesticides due to different laws

  • Eventually revised by the 1996 Food Quality Protection Act to include risk-based assessment