FDA Issues Initial Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food

FDA issued today a new draft guidance to help industry comply with certain requirements in the final rule on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.  The new draft guidance was issued only in part because the agency is still working on additional chapters.  See generally Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability.

Available for review and comment now are the following highlighted chapters and appendices:

• Introduction and Purpose (PDF: 68KB)
• Chapter 1: The Food Safety Plan (PDF: 99KB)
• Chapter 2: Conducting a Hazard Analysis (PDF: 201KB)
• Chapter 3: Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food (PDF: 488KB)
• Chapter 4: Preventive Controls (PDF: 499KB)
• Chapter 5: Application of Preventive Controls and Preventive Control Management Components (PDF: 146KB)
• Chapter Six – Use of Heat Treatments as a Process Control (coming soon)
• Chapter Seven – Use of Time/Temperature Control as a Process Control (coming soon)
• Chapter Eight – Use of Formulation as a Process Control (coming soon)
• Chapter Nine – Use of Dehydration/Drying as a Process Control (coming soon)
• Chapter Ten – Sanitation Controls (coming soon)
• Chapter Eleven – Food Allergen Controls (coming soon)
• Chapter Twelve – Preventive Controls for Chemical Hazards (coming soon)
• Chapter Thirteen – Preventive Controls for Physical Hazards (coming soon)
• Chapter Fourteen – Recall Plans (coming soon)
• Appendix 1: Potential Hazards for Foods and Processes (PDF: 1,804 KB)
• Appendix 2: Food Safety Plan Forms (PDF: 261KB)
• Appendix 3: Bacterial Pathogen Growth and Inactivation (PDF: 165KB)
• Appendix 4 – Sanitation and Hygienic Zoning (coming soon)

See generally Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food.

The draft guidance essentially explains FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls, and includes a discussion about establishing a food safety plan.