SPSG #1: Food Law and Chemical Safety

This is an historical review of food law concerned with chemical safety. It commences with a discussion of the 1906 Pure Food and Drug Act and ends with the Dietary Supplement amendments of 1994.  All told, there are about a half dozen statues that pertain to the regulation of chemicals in food by the U.S. Food and Drug Administration (FDA) that differ in many ways.  While virtually all of the laws governing the safety of chemicals in food require scientific interpretation, the way in which scientific expertise is to utilized to create a legal definition of what is considered safe or not by the agency necessarily differs among different statutes.  The statutes differ in the definition of harm, the burden of proof, and in their evidentiary standards. For the purposes of the rest of the book, the most important distinction is between additives and contaminants. Food additives are deliberately added to food, have an intended use, must be approved by the FDA before they can be used, and the burden of proof lies on the manufacturer. Because the approval process is structured and planned, the way in which scientific expertise is utilized also occurs in a somewhat predetermined manner. The evidentiary standard for arguing that an additive has not been shown to be safe is also very low; it must only be argued that there is substantial evidence that harm is possible. Contaminants are, by definition, present in food unintentionally and many occur naturally. Therefore, they don't have an intended use, they don't need to be approved, and the burden of proof is on the government to show that the contaminants is harmful enough to be worthy of regulation, and the judicial branch often makes the final determination of what will be considered "safe".  Other classes of chemicals fall soemwhere between those two extremes.  In particular, food additives in use prior to the Federal Food Drug and Cosmetic Act amendments of 1958 were exempted from the approval process.  This created a class of chemicals that are “Generally Recognized as Safe” where FDA approval is obtained by demonstrating history of use rather than going through a rigorous testing regimen.  As the end result, there is no consistent definition in either law or science about what the word "safe" really means.