Risk assessment and the credibility of federal regulatory policy: an FDA perspective

FDA's fundamental goals are to protect and promote the public health, using the best possible science and the law. The evolution of food safety policy toward potential carcinogens reflects a conscious decision by the agency and Administration to use risk assessment in carrying out these goals. Examples include FDA policies toward assessing the safety of animal drug residues, setting specifications for constituents of food and color additives, and most recently, a common sense de minimis interpretation of the "Delaney clause." While committed to risk assessment as a useful tool, FDA acknowledges that judgments must be made on less than perfect data. In addition, recent history shows that there may be a serious "credibility gap" in public acceptance of regulatory toxicology. To ensure that there is an adequate science base for regulatory decisions, the challenge is twofold: First, the data necessary for sound safety evaluations in individual cases must be developed, based on current knowledge; and, second, the validity of assumptions underlying risk assessment should be tested and refined and scientific consensus achieved. Otherwise, risk management policy will rely on assessments based on extremely conservative assumptions, tending to overestimate risk. Risk assessment assumptions must also be better communicated to policymakers and the public. If these challenges are successfully addressed, public confidence in marketed products, and in science-based regulatory policy, will be enhanced.