• On July 6, 2022, FDA announced it had finalized its Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. The guidance aims to help food facilities develop a food safety plan to prevent or significantly minimize hazards in food for animals that could cause illness or injury to people or animals. Additionally, it provides detailed information to help animal food facilities anticipate possible food safety hazards, identify risk-based preventive controls to prevent or minimize those hazards, and create and implement a plan to keep unsafe animal food from entering the marketplace.

• The document details:

  • How to recognize biological, chemical (including radiological), and physical agents that are known or reasonably foreseeable hazards in manufacturing, processing, packing, and holding of animal food;

  • Ways to identify and implement preventive controls for hazards that require preventive controls in animal food;

  • Components of preventive control management (e.g., monitoring, corrective actions, and verification (including validation); and

  • Recordkeeping requirements associated with the food safety plan and the implementation of the food safety plan.

• By way of background, FDA released draft GFI #245, a draft of this guidance in January of 2018. One of the most notable changes in response to stakeholder feedback is the clarification that not all the hazard examples in the guidance are applicable to all animal food or all facilities.

• Animal food facilities with questions about how this guidance applies to them can contact AskCVM@fda.hhs.gov for further assistance. Comments can be submitted here.

Nicholas Prust, Natalie Rainer, and Frederick Stearns also contributed to this article.