Today, the Food and Drug Administration (FDA) announced the installment of Chapter Six to its “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food” (Draft Guidance). The Draft Guidance explains FDA’s current thinking on how food facilities may comply with the FDA’s final rule on Hazard Analysis and Risk Based Preventive Controls (Preventive Controls Rule), mandated by the FDA Food Safety Modernization Act (FSMA).
Chapter six, specifically, explains how to establish and implement a heat treatment as a process control. Essentially, heat treatment includes baking or cooking and is a control for bacterial pathogens. The selection of process controls based on a hazard analysis; therefore, heat treatment is only one of many process controls that may be used (or in combination with other controls) to produce a safe product.
FDA is requesting comments on Chapter Six on or before February 27, 2018. Notwithstanding comments may be made on Draft Guidance at any time. Prior chapters and certain appendices in the Draft Guidance were issued in August 2016 (see our blog on those here), including:
- 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)
- 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)
A number of remaining chapters of the Draft Guidance are not yet available, although FDA indicates that the following are “coming soon”:
- Chapter Seven – Use of Time/Temperature Control as a Process Control
- Chapter Eight – Use of Formulation as a Process Control
- Chapter Nine – Use of Dehydration/Drying as a Process Control
- Chapter Ten – Sanitation Controls
- Chapter Eleven – Food Allergen Controls
- Chapter Twelve – Preventive Controls for Chemical Hazards
- Chapter Thirteen – Preventive Controls for Physical Hazards Chapter Fourteen – Recall Plans
- Appendix 4 – Sanitation and Hygienic Zoning
As a reminder for our “food facility” friends, September 18, 2017, is the compliance date for small businesses (those with fewer than 500 full-time employees) to comply with the preventive controls for human food rule.