ABSTRACT
This chapter addresses the concept of a "threshold of regulation" for food additives. To construct a threshold-of-regulation policy that anticipates all potential adverse responses that a compound may induce, including potential carcinogenesis is clearly impossible. It seems that knowledge ought to be applicable to the threshold-of-regulation question. The application of such an analysis to the problem of the threshold of regulation for food-contact materials was described. Once the principles of threshold-of-regulation policy have been established, it would remain to devise appropriate procedures for implementing the policy. It has been suggested that the agency could make such threshold-of-regulation judgments based on a sufficient summary of both chemical and toxicological information provided by an applicant. Once the agency is able to support a given migration level or range of levels as acceptable for a threshold of regulation, it will be in a better position than ever before to make threshold-of-regulation judgments on a consistent basis.
