The U.S. Food and Drug Administration (FDA) has published its final guidance document, titled, CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. The guidance is intended to help animal food manufacturers develop hazard analysis and risk-based preventive controls for animal food in compliance with the Food Safety Modernization Act (FSMA). 

The document specifically provides guidance on: 

  • 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 animal food production
  • 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, verification, and validation)
  • The recordkeeping requirements associated with a food safety plan and the implementation of a food safety plan.

The final guidance replaces the draft guidance of the same name that was issued on January 23, 2018.