Establishing a Threshold of Regulation

Abstract

The 1958 Food Additives Amendment to the Federal Food, Drug and Cosmetic Act defines a food additive as “...any substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component ... of ... food....” Thus, even materials which may migrate to food in very small quantities from packaging materials have been subjected to regulation. With advances in analytical methods of detection over the years, ever lower levels of migrating substances are technically subject to food additive regulation. Is there some level below which a substance need not be considered a food additive? The agency has grappled with this “Threshold-ofRegulation” (T/R) question ever since 1958 and generally has handled such situations on a case-by-case basis. Increasingly, however, there have been calls for the agency to develop a T/R policy. To develop such a policy, the agency must consider a number of important issues such as the reliable measurement of low levels of migration; low dose risk assessment; the likely potencies of possible carcinogens; and an array of legal and regulatory constraints. The presentation will center on possible ways the agency might weave together this array of considerations to arrive at a viable policy for the Threshold of Regulation.