Carcinogenic Potencies and Establishment of a Threshold of Regulation for Food Contact Substances

Abstract

This chapter presents a compilation of data on carcinogenic potencies in the form of a probability distribution and describes how, in this form, the data could be used as a scientific foundation for making regulatory judgments about the potential risk from substances that migrate to food from packaging and other materials that come into contact with food. The idea of establishing a threshold of regulation based on the concept of a de minimis level of migration of potentially carcinogenic substances into food is discussed as a possible regulatory approach that could use the type of data presented. The discussion does not represent Food and Drug Administration (FDA) policy, however, and it does not address the possible use by FDA of a de minimis risk approach to determining the status of certain color additives currently being evaluated by the agency.