The U.S. Food and Drug Administration issued an order requiring that Evanger's Dog & Cat Food Co., Inc., in Wheeling, Ill., obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce.
A recent inspection revealed significant deviations from prescribed documentation of processes, equipment, and recordkeeping in the production of the company's thermally processed low acid canned food (LACF) products. These problems could result in under-processed pet foods, which can allow the survival and growth of Clostridium botulinum (C. botulinum), a bacterium that causes botulism in some animals as well as in humans.
"As outlined in the Food Protection Plan, the FDA uses a risk-based approach to locate the areas of greatest risk for foods, and targets preventive controls and inspections to those areas, " said Dr. Stephen Sundlof, director, Center for Food Safety and Applied Nutrition. "The FDA's authority to issue an order requiring an emergency permit is an enforcement tool designed to prevent unsafe foods from reaching consumers.”
The FDA issues an "Order of Need for Emergency Permit” if the agency determines that a company fails to meet the regulatory requirements to process a product that does not present a health risk. For Evanger's to resume business, the company must document that corrective actions and processing procedures have been implemented to ensure that the finished product will not present a health hazard.
Botulism is a powerful toxin that affects the nervous system and can be fatal. The disease has been documented in dogs and cats. Signs of botulism in animals are progressive muscle paralysis, disturbed vision, difficulty in chewing and swallowing, and progressive weakness to the body. Death is usually due to paralysis of the heart or the muscles used in breathing.
In light of human botulism illnesses and recalls that occurred due to under-processed hot dog chili sauce, and potentially under-processed canned green beans, FDA has urged all LACF processors to review their operations and the apply scientific principals and regulations that have been established to provide a safe product.
While FDA's Center for Veterinary Medicine has authority over animal feed and foods, CFSAN is responsible for regulating all human and animal LACF processing. The two centers are collaborating on this enforcement action.