In the August 24, 2016, Federal Register, FDA announced the availability of a draft guidance for industry, "Hazard Analysis and Risk-Based Preventive Controls for Human Food." This draft guidance includes the first five chapters of a multi-chapter guidance intended to explain how to comply with the requirements for hazard analysis and risk-based preventive controls for human food. Specifically, the document provides guidance on understanding: (i) the biological, chemical, and physical hazards in manufacturing, processing, packing, and holding of FDA-regulated food products; (ii) the components of a food safety plan; (iii) how to conduct a hazard analysis and develop a food safety plan; (iv) how to identify control measures for common biological, chemical, and physical hazards associated with processed foods; (v) how to identify and apply the preventive control management components; and (vi) the recordkeeping requirements associated with the food safety plan. Comments are due February 21, 2017.
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