Introduction to the Food Safety Modernization Act

The Food Safety Modernization Act (FSMA), signed into law in 2011, is transforming the U.S. food safety system by shifting the focus from responding to foodborne illness to preventing it. The U.S. Congress enacted FSMA in response to dramatic changes over the last 25 years in the global food system and in the U.S. Food and Drug Administration's (FDA) understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system. FSMA requires the FDA to establish prevention-oriented standards, from the farm through the distribution of food to retail outlets, that are based on sound science and risk analysis-standards that if adopted widely by the food industry should serve to reduce the risk of foodborne illness. Since September 2015, the FDA has published seven foundational final rules: Preventive Controls for Human Food, Preventive Controls for Animal Food, Produce Safety, Foreign Supplier Verification Programs, Accredited Third-Party Certification, Sanitary Transportation of Human and Animal Food, and Intentional Adulteration of Human Food. Understanding the regulation requirements, exemptions, and modified requirements can be challenging. This article focuses on the applicability and requirements of each regulation by identifying who is covered under each regulation, the key requirements, and compliance dates.