July 27, 2022

FDA finalizes FSMA animal feed guidance

FDA finalizes FSMA animal feed guidance

By: Sydney Sheffield

The United States Food and Drug Administration (FDA) has finalized the Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals  (FSMA) to help animal food facilities develop a food safety plan that complies with FDA’s Hazard Analysis and Risk-Based Preventive Controls requirements. The FDA released draft GFI #245 in January 2018 and the agency received numerous comments from stakeholders, which were considered when finalizing the guidance.

The FSMA guidance 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 FDA added additional information, resources, and examples of certain hazards in animal food, including information on animal food recalls that occurred since the draft guidance was published.

The FSMA document specifically guides:

  • The biological, chemical (including radiological), and physical agents that are known or reasonably foreseeable hazards in manufacturing, processing, packing, and holding of animal food
  • The components of a food safety plan and the importance of each component
  • How to conduct a hazard analysis and develop a food safety plan for the animal food that you produce
  • Identifying preventive controls for biological, chemical, and physical hazards associated with animal food and how to apply those preventive controls
  • Preventive control management components (i.e., monitoring, corrective actions and corrections, and verification (including validation))
  • The recordkeeping requirements associated with the food safety plan and implementation of the food safety plan

One of the most significant changes is, in response to stakeholder feedback, the FDA removed Appendix E: “Aid to Identifying Animal Food Hazards” and clarified that not all the hazard examples in the guidance apply to all animal food or all facilities. Facilities should use the hazard information in Chapter 3 of the guidance as they consider whether hazards are known or reasonably foreseeable for their animal food, the agency noted.

Read the guidance here.