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FDA Issues Draft Guidance on HARPC for Animal Food

  • As previously reported on this blog, FDA published final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions for human and animal food under the FDA Food Safety Modernization Act (FSMA) on September 17, 2015. The Federal Register publication of the final animal HARPC rule (80 Fed. Reg. 56170) can be found here. Businesses that are not small or very small businesses under the rule were required to comply with the animal food preventive control provisions as of September 18, 2017. Small businesses need to comply by no later than September 17, 2018, and very small businesses need to comply with limited provisions by September 17, 2019. In August 2017, FDA announced that it intends to delay routine preventive controls inspections for large businesses until fall 2018 to allow the animal food industry more time to focus on development of their food safety plans and to consider information in the draft guidance.

  • To assist industry with complying with the Final Animal HARPC rule, this week, FDA published Draft Guidance for Industry #245 titled, “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.” The draft guidance currently contains the following chapters:

    • Introduction

    • Chapter One—The Food Safety Plan

    • Chapter Two—Conducting a Hazard Analysis

    • Chapter Three—Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Animal Food

    • Chapter Four—Preventive Controls

    • Chapter Five—Overview of Preventive Control Management Components

  • Based on comments made by the American Feed Industry Association (AFIA) at yesterday’s AAFCO Feed and Feed Ingredient Manufacturing Committee meeting industry was surprised to see that the guidance documents contained a list of hazards and 145 references some of which date back to 1989.

  • FDA is developing additional guidance on the animal food preventive controls provisions and will continue to announce additional guidance as it becomes available. Comments on Draft Guidance for Industry #245 are due by July 23, 2018. 

© 2020 Keller and Heckman LLPNational Law Review, Volume VIII, Number 24



About this Author

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...