The FDA’s Food Safety Modernization Act (FSMA) is the most modern body of legislation governing the U.S. food industry. FSMA is the agency’s first major regulatory overhaul in 70 years and was signed into law by President Obama on Jan. 4, 2011. Much like HACCP, these regulations completely revamp the FDA’s approach to food safety by changing the focus from reaction to prevention. The law requires facilities to 1) develop documented food safety plans, called Hazard Analysis and Risk-Based Preventive Controls, which identify all potential hazards associated with the process or product, 2) implement risk-based preventive control measures that minimize or prevent the identified hazards, and 3) describe the methods of prevention. The law also updates the cGMPs, clarifies the definition of “farm,” and mandates specific preventive control programs for production processes, food allergens, sanitation controls, supply chain controls, and recall plans.
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Additional information on the specific requirements for preventive controls and the modernization of the cGMPs will be discussed in the second and third articles in this series.
Thoma, a food safety and quality professional with nearly 20 years of experience in food manufacturing and food safety auditing, has worked for NSF International for four years as both a GFSI certified auditor and as a technical specialist in the Supply Chain Food Safety group. Reach her at firstname.lastname@example.org.