FDA Posts Draft Guidance on Compliance With New Human Food Preventive Controls Regulations
The Food and Drug Administration released a draft guidance document (here) on the agency’s recently issued regulations on hazard analysis and risk-based preventive controls for human food. Under the regulations, issued in September 2015, any U.S. or foreign establishment that is required to register with FDA as a “food facility” must compile a written food safety plan, conduct a hazard analysis and implement preventive controls for mitigation of those hazards, among other requirements, with the first compliance dates coming in September (see 1509100021). Once finalized, FDA’s guidance will help facilities covered by the regulations comply with specific preventive controls requirements, FDA said. Comments must be submitted by Feb. 21 to receive consideration before FDA finalizes the guidance, the agency said (here).
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The draft guidance is divided into 14 chapters, of which only five are currently posted. Existing draft chapters explain what a food safety plan is and how it differs from a Hazard Analysis and Critical Control Points (HACCP) plan; how to conduct a hazard analysis; common biological, chemical and physical hazards associated with food; and an overview of common preventive controls, and how to identify, implement and monitor them. Also included are appendices listing potential hazards for specific foods and conditions for limiting growth of specific bacterial pathogens, as well an appendix with forms for compiling a food safety plan. Not yet posted are chapters on how to apply specific preventive controls, including how to use heat treatments, time and temperature controls, formulation controls, dehydration and drying controls, sanitation controls, food allergen controls, and preventive controls for chemical and physical hazards. Also “coming soon" are a chapter on recall plans and an appendix on “sanitation and hygienic zoning.”