The enactment of the Preventive Controls for Human Food regulation (21 CFT Part 117) has profoundly affected the food processing industry in the United States and throughout the world.
The regulation is one of many enacted to allow enforcement of the Food Safety Modernization Act of 2010. It basically mandates that all food processors regulated by the United States Food and Drug Administration develop, document, implement and maintain a HACCP-based food safety management system that incorporates risk assessment into the decision-making process for determining potential hazards.