Animal Food and Pet Food: CGMP and Preventive Controls

Animal food includes ingredients as well as finished feed and pet food. Manufacturing, processing, packing and holding activities can have different regulatory consequences. Farm-related exemptions and other provisions must be applied to the actual organization and activity. A product intended for animals is not automatically outside food-safety controls because people do not consume it directly. FDA animal-food framework.

Part 507 CGMP addresses personnel, facilities, sanitation, equipment and production practices adapted to animal-food operations. Controls protect the food from contamination during manufacture, packing and storage. The relevant condition is what happens in the operating environment; a human-food procedure copied without considering bulk ingredients, animal species or the actual process may overlook important hazards. CGMP requirements.

The hazard analysis considers known or reasonably foreseeable biological, chemical and physical hazards. Nutrient imbalances and species-specific sensitivities can matter in animal food. FDA’s finalized guidance cautions that its hazard examples do not all apply to every facility or food. Select hazards using the ingredients, process, intended animals and exposure rather than treating examples as universal findings. FDA guidance explanation.

When a hazard requires a preventive control, written controls and applicable management components address it. Monitoring, corrective actions, verification and validation have distinct purposes. Records should link the control to the actual material and production conditions. Supplier controls and a recall plan are evaluated under the applicable provisions rather than added as disconnected policy documents. Preventive-control regulation.

Qualified facilities and certain holding operations may receive modified requirements or exemptions from specified subparts. Human-food by-products used for animals raise separate applicability questions depending on handling and further processing. An exemption from the preventive-controls subpart is not necessarily an exemption from CGMP, adulteration provisions or applicable state requirements. FDA animal-food resources.

Describe each food and intended animal, map the process and assess the applicable subparts. Connect each identified hazard to the control, monitoring and supporting evidence. FDA finalized GFI 245 in July 2022; its recommendations assist plan development but do not approve an individual food safety plan or replace the regulatory text. FDA finalization and scope.