The FDA has finalized its Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. The purpose of this guidance, per the FDA, is to help animal food facilities develop a food safety plan that complies with FDA’s Hazard Analysis and Risk-Based Preventive Controls requirements.

The guidance document covers facilities that manufacture, process, pack or hold food intended for all animal species including food-producing animals (e.g., cattle, swine, poultry and aquaculture species), companion animals (e.g., dogs, cats, horses and guinea pigs), laboratory animals and animals maintained in zoological parks.

Specifically, the document provides guidance on:

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