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.

Fishy manufacturer shut down until it literally cleans up shop

An Alabama district court has permanently enjoined a seafood manufacturer from distributing adulterated and misbranded seafood products. The Department of Justice (DOJ), at the FDA’s request, filed a complaint alleging that BEK Catering LLC d/b/a Floppers Foods LLC and its owners caused food to be held under insanitary conditions. The injunction prevents the company and its owners from processing, packing, and holding fish or fishery products.

Inspection and complaint

In 2015, the FDA found that the company failed to control the risk of the growth of three different types of bacteria, and did not have adequate control over hazards that could be created by allergens and additives. The bacteria found during the inspection can cause foodborne illness, botulism, and listeriosis. The complaint noted that five different inspections beginning in 2011 revealed insanitary conditions and repeated regulatory violations.

Consent decree

The consent decree requires the company and its owners to cease operations beyond those incidental to product transport and delivery. In order to resume operations, they must notify the FDA 90 days in advance, comply with a set of remedial measures, and undergo inspection. The remedial measures include hiring an expert to ensure that operations conform with seafood hazard analysis critical control point (HACCP) and current good manufacturing practice (cGMP) regulations, all deficiencies are addressed, an employee training program is developed, and the FDA approves all changes.