Why FDA Has Adopted HACCP Regulations to Ensure the Safety of Food
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CitationWhy FDA Has Adopted HACCP Regulations to Ensure the Safety of Food (2006 Third Year Paper)
AbstractHACCP (Hazard Analysis and Critical Control Point) is a form of statistical quality control adopted by FDA as a regulatory tool to ensure the safety of seafood and juice products. HACCP evolved from the teachings of Walter A. Shewhart and W. Edwards Deming, pioneers in the field of statistical quality control. Their revolutionary conceptâ€”controlling the quality of the product by controlling critical steps in the productâ€™s manufacture rather than relying upon end-product inspectionâ€”provided manufacturers with a scientific means of identifying and preventing potential hazards from impairing product quality. FDA adopted HACCP-like regulations for low-acid canned foods and acidified foods in the 1970s, requiring food processors to control the heat sterilization portions of their manufacturing processes in order to prevent botulism toxin from forming in the final product. The regulations identified the hazards and manufacturing controls to be institutedâ€”tasks that HACCP leaves to the manufacturer. Indeed, FDA adopted seafood HACCP regulations in 1995 as a means of shifting the burden of identifying the myriad seafood hazards and appropriate manufacturing controls from the Agency to food processors. Although both FDA and industry have struggled in their transition to a HACCP system, federal regulators continue to view HACCP with favor. In 2001, FDA chose HACCP for its regulation of juice products, finding HACCP to be a flexible regulatory tool that both promotes industry self-education and allows manufacturers to engage in innovative methods of quality control. Although pure HACCP regulations continue to be unpopular with some members of the food industry, the concepts underlying HACCP are likely to inform FDAâ€™s promulgation of current good manufacturing practices for the food and dietary supplement industries.
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