Institute for Food Laws and Regulations

Fortin, Neal D., HACCP and Other Regulatory Approaches to Prevention of Foodborne Diseases (2013). Foodborne Infections and Intoxications, Chapter 38, 4 Ed. (Elsevier 2013). Available at SSRN: https://ssrn.com/abstract=2264865.

Science-based, preventative regulation was slow in coming to food law. It took more than half a century from the development of HACCP — Hazard Analysis and Critical Control Point — in the 1950s, for Congress to direct the Food and Drug Administration (FDA) to apply comprehensive, science-based, preventive controls across the food supply. Full implementation will likely take several years, but the FDA Food Safety Modernization Act (FSMA) signed into law on January 4, 2011, provides FDA with a mandate to shift the focus of the FDA from primarily reacting to food safety problems to prevention.

FSMA requires that all FDA regulated food companies implement a written hazard analysis and risk-based preventive control plan unless specifically exempt. In addition, FSMA directs FDA to work with the U.S. Department of Agriculture (USDA) to propose “science-based minimum standards for the safe production and harvesting” of fruits and vegetables that are raw agricultural commodities for which FDA has determined such standards will minimize the risk of “serious adverse health consequences". The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention and risk-based food safety standards.

This chapter summarizes the evolution of science-based risk control systems into food regulation in the United States beginning with the development of HACCP and finishing with enactment the Food Safety Modernization Act in 2011. Key points of the HACCP regulation for seafood, meats and poultry, juices, and FSMA risk-control plans are covered. Finally, the chapter provides advice on compliance with these control systems.