FSMA Guidance Published: Hazard Analysis and Preventive Controls for Animal Food

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banner image. finalized guidance document from FDA

The U.S. Food and Drug Administration (FDA) has finalized Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. This guidance has been available as a draft since 2018, but was finalized in July 2022.

Guidance for Industry #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

The finalized guidance provides information about:

  • Recognizing and evaluating hazards that may occur in the manufacturing, processing, packing or holding of animal food;
  • How to identify and implement preventive controls;
  • Preventive control management; and
  • Recordkeeping requirements for food safety plans.

Changes to the guidance document

A number of notable changes have been made in the finalized document compared to the draft guidance, based on stakeholder feedback:

  • Appendix E: Aid to Identifying Animal Food Hazards has been removed from the document. The FDA stated that not all hazard examples within the guidance are applicable to all facilities or types of animal food. Chapter 3 of the guidance can be used for consideration of whether hazards are known or reasonably foreseeable in their facility and for the types of animal food being produced.
  • More information, resources and examples of hazards in animal food, including information about animal food recalls have been added to the final guidance document.
  • Editorial changes were made to enhance clarity and consistency throughout the document.

The finalized guidance document can be found on the FDA website.

Learn more about creating a food safety plan in our Example Food Safety Plan Extension Factsheet

If you have questions or comments regarding the finalized guidance document, contact AskCVM@fda.hhs.gov or submit comments online.

If you have questions about animal food safety, contact Marissa Cohen.