FDA delays routine regulatory inspections for large animal food facilities

The FDA has announced that routine regulatory inspections for large animal food facilities to ensure compliance with regulations under the FDA’s Preventive Controls for Animal Food rule (80 FR 56170) will not begin until the fall of 2018. Effective September 18, 2017, large animal food facilities must comply with preventive controls requirements mandated by the Food Safety Modernization Act (FSMA) (P.L. 111-353).

Education and flexibility

Large animal food facilities, those with 500 or more full-time equivalent employees, also had to comply with the current Good Manufacturing Practice (cGMP) requirements by September 2016. Based on feedback from animal food producers, the FDA has decided that although the new preventive control regulations will take effect as announced in the final rule as of September 18, 2017, the FDA will first focus on education before regulation. The agency noted that the industry needs additional time and technical assistance to fully understand the requirements of the new regulations for preventive controls. Jenny Murphy, a consumer safety officer with the FDA’s Center for Veterinary Medicine, said in a recent interview that the FDA will allow larger facilities some flexibility to further develop their plans and ensure that their system is operating correctly as guidance from FDA and other resources are put in place.

Increased inspections

While the FDA announced a delay in the routine regulatory inspections for the prevent controls requirements, the FDA will increase oversight of cGMPs with more routine inspections. Effective September 18, 2017, both large and small animal food facilities must meet the cGMP requirements. The cGMPs establish a foundation before establishing preventive controls. “CGMPs establish a base to make sure you don’t contaminate the animal food and the preventive controls take it a step further by making you really concentrate on things that, if they’re found in animal food, could be a public health concern,” said Murphy. “Once you have CGMPs in place, you can see where you need extra layers of protection.”

The FDA adopted the Final rule in an effort to improve public health, and established for the first time cGMPs for food for animals, which are akin to the cGMPs that have long applied to human food. Along with the cGMPs, facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The rule also mandates that animal food facilities establish a supply chain program.