The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, 2011, enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur.<br/><br/>Currently, FDA has issued seven foundational rules directed by FSMA. This presentation will focus on one of these foundational rules, the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food final rule (found in 21 CFR Part 117). This final rule is the product of a tremendous level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local and tribal regulatory counterparts, academia and other stakeholders. In general, Part 117 establishes new requirements for covered domestic and foreign facilities producing human food to develop and implement a food safety plan based on hazard analysis and risk-based preventive controls. This involves: (1) evaluating the hazards that could affect food safety, (2) specifying what preventive measures, or controls, will be put in place to significantly minimize or prevent the hazards, (3) specifying how the controls will be monitored to ensure they are working, (4) maintaining records of the monitoring, and (5) specifying what actions the facility will take to correct problems that arise.

FSMA and the current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food rule

254th National Meeting (2017)

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