Who must comply with food safety regulations and how do major programs work together?

Food safety regulations apply to a wide range of businesses involved in the production, processing, distribution, and sale of food. These requirements are designed to ensure that food is safe, properly handled, and free from hazards at every stage of the supply chain.

The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) oversee food safety in the United States, with each agency having jurisdiction over different types of food products. The FDA covers most foods (including shell eggs), while USDA covers meat, poultry, and certain egg products (liquid, dried, frozen).

These agencies establish and enforce regulations that work together to address food safety from a comprehensive, preventive approach. Food safety programs work together in practice and are built around a risk-based framework. For example:

• Current Good Manufacturing Practices (CGMPs) establish baseline requirements for sanitary facility design, operations, and employee practices. Any FDA-regulated food facility that manufactures, processes, packs, or stores food must follow CGMPs.

• Hazard Analysis and Critical Control Point (HACCP) systems identify and control specific biological, chemical, and physical hazards. FDA mandates HACCP for seafood and juice processors, while USDA/FSIS mandates HACCP for establishments producing meat, poultry, catfish, and egg products (liquid, frozen, dried).

• Food Safety Modernization Act (FSMA) builds on similar risk-based concepts. FSMA applies to most FDA-regulated businesses involved in growing, harvesting, manufacturing, processing, packing, holding, transporting, or importing food. The law requires covered organizations to identify food safety hazards, implement preventive controls, maintain records, and take a proactive approach to preventing contamination before it occurs.

During inspections and audits, regulators evaluate based on the specific applicable requirements rather than as one combined system.