May 27, 2020

May 27, 2020

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May 26, 2020

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FDA Releases Chapter 14: Recall Plans in the Latest Installment to the Agency’s Multi-Chapter Draft Guidance on the Human HARPC Rule

As discussed here, the Food and Drug Administration (FDA) has been rolling out chapters, as they are completed, to provide guidance on complying with FDA’s Final Rule for Preventive Controls for Human Food.  These rules, found in 21 Code of Federal Regulations (CFR) part 117, implement the hazard analysis and risk-based preventive control (HARPC) provisions for human food under the FDA Food Safety Modernization Act (FSMA).  Most human food facilities were required to comply with the human HARPC rules by September 2016.

FDA’s Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food will provide a comprehensive resource for understanding how to comply with all requirements of the human HARPC rule.  With the October 4, 2019 announcement of the most recent guidance document, Chapter 14: Recall Plan, the multi-chapter draft guidance is about half-completed.  Previously released documents are Chapters 1 (The Food Safety Plan), 2 (Conducting a Hazard Analysis), 3 ( Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food), 4 (Preventive Controls), 5 (Application of Preventive Controls and Preventive Controls Management Components), 6 (Use of Heat Treatments), and 15 (Supply-Chain Program for Human Food Products), as well an Introduction and Appendices 1 (Potential Hazards for Foods and Processes), 2 (Food Safety Plan Forms), and 3 (Bacterial Pathogen Growth and Inactivation).

Additional draft guidance yet to be completed for the human HARPC rule are Chapters 7 (Use of Time/Temperature Control as a Process Control), 8 (Use of Formulation as a Process Control), 9 (Use of Dehydration/Drying as a Process Control), 10 (Sanitation Controls), 11 (Food Allergen Controls), 12 (Preventive Controls for Chemical Hazards), 13 (Preventive Controls for Physical Hazards), and 16 (Validation of a Process Control), and Appendix 4 (Sanitation and Hygiene Zoning).  FDA indicates the remaining chapters and appendix are “coming soon.”

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...