SPSG #3: The Safety Assessment Paradigm

This chapter is about the procedure originally developed for the premarket approval of pesticides and food additives, which is referred to throughout the book as the Safety Assessment Paradigm.  The SAP gave birth to the Acceptable Daily Intake (ADI), which was the daily exposure to a chemical that would be considered acceptable by the FDA. The ADI was originally calculated by dividing the highest dose found to not have an observable (statistically significant) effect in a laboratory study by a safety factor of 100. There are three key features of Safety Assessment that are especially worth noting. First, since the SAP delegates the regulatory decision to experts, it is thoroughly technocratic.  Second, premarket approval and the SAP were designed to be precautionary; a chemical couldn't be used until it was shown to be safe. Third, it is presumed that the way to limit exposure to a chemical is the set a level that the government will consider to be acceptable. Although the SAP has evolved from its 1954 introduction, it still retains its unmistakable premarket approval origins.