Preventive Controls for Human Food Regulation Overview

The Preventive Controls for Human Food rule promulgated in accordance with the FDA Food Safety Modernization Act (FSMA) requires that domestic and foreign facilities that must register with FDA because they manufacture, process, pack or hold food for consumption in the U.S. develop a food safety plan.  The food safety plan contains a hazard analysis, preventive controls for identified hazards, and procedures for monitoring, verification, and corrective actions.  When a hazard in a raw material or other ingredient has been controlled by a supplier, a supply-chain program must be implemented and control of the hazard verified.  Certain activities related to the food safety plan must be conducted by a “preventive controls qualified individual,” who is qualified by training or job experience to conduct those activities. In addition, U.S. importers must verify that food imported into the United States has been produced in a manner that meets the same level of public health protection as U.S. safety standards.  Thus, it is important for companies exporting to the U.S. to understand how to comply with the new FSMA regulations.