Chapter 2 - The Era of the Food Safety Modernization Act and Hazard Analysis and Risk-Based Preventive Controls

Abstract

Continued occurrence of foodborne disease outbreaks; national recalls of human foods due to adulteration or contamination with undeclared allergens; intentional adulteration of food for economic gain with toxic substances, such as melamine; and the growing vulnerability of an increasingly global and complex food supply were factors contributing to the passage of the US Food Safety Modernization Act (FSMA) into law in 2011. Six years later, FSMA is still being implemented due to the enormous scope of the changes that are occurring. A tremendous amount of input from industry, consumers, foreign agencies, and others was carefully weighed in crafting the regulations. Industry training needs have been thoughtfully considered concurrently. By 2016 the seven foundational regulations of FSMA have been finalized. Of these seven regulations, the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods will likely have the largest impact on improving food safety of human foods. This rule, even with its purposeful flexibility, will likely also stimulate the most changes to the way food producers make food and how retail food businesses ensure the quality and safety of their supply chain. The key elements of this regulation, including the Food Safety Plan requirements, are introduced in this chapter. Risk-based, preventative (rather than reactive) approaches to food safety are not new, and this chapter includes a brief history of hazard analysis and critical control point (HACCP) as well as a comparison of HACCP with the preventive controls for human food requirements. Finally, it will be important for retail food businesses to understand and measure their suppliers' compliance with these rules to prepare for new enforcement requirements that will certainly impact their business.