The Delaney Clause, incorporated into the Federal Food, Drug and Cosmetic Act by the Food Additives Amendment of 1958, requires the Food and Drug Administration (FDA) to ban food additives which are found to cause or induce cancer in humans or animals as indicated by testing. GAO made a review to: (1) determine if modifications were needed to the Delaney Clause, and (2) present an overview of the social, scientific, and regulatory issues involving food additives that might cause cancer.

The center of the controversy surrounding the Delaney Clause is the concept that no substance, in any amount, may be intentionally added to food if it has been shown to cause cancer. Tests to determine whether food additives cause cancer and statistical models to assess their risk to humans are available, but they have not yet been developed to the point where many experts totally accept their reliability. Most experts believe that the Clause should be changed but differ significantly on how to change it. Opponents of change argue that the Clause is the most effective way to deal with food additives that may cause cancer since not enough is known about cancer to allow their use. Twelve public opinion polls conducted over the past 10 years have shown that the public approves of the general policy of banning cancer-causing food additives. However, the public is opposed to a ban for specific substances like saccharin which have perceived benefits. Cancer-causing substances are regulated differently within FDA and among FDA and other federal agencies. GAO believes that Congress should reexamine whether the Clause is still appropriate because of advances in the ability of analytical detection methods to identify substances at very low levels, uncertainties about the human risk from low levels of carcinogens, and the inflexibility of the current law. If the Clause were deleted, under the remaining legislation, a cancer-causing additive could be used if there was a reasonable certainty that no harm would come from its proposed use.

• View Report (PDF)