In June of 2008, following an inspection, FDA initiated a mass seizure of animal food at a pet food distribution center after finding the animal food products were vulnerable to contamination, such as microbial contamination, as a result of infestation of the facility by rodents, birds and other pests. Rodent pellets, rodent urine stains, and bird droppings were found throughout the facility, including on bags and pouches of pet food. Rodents had chewed holes in some of the bags of dry dog and cat food and bird seed. The facility was not taking measures to control pest infestation.
Another mass seizure of animal food was executed in August of 2009 at a feed mill because of similar violations. In both cases, the seized products violated section 402(a)(4) of the FD&C Act because the animal food was being held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.
In April 2012, epidemiologic and laboratory investigations conducted by officials in local, state, and federal public health, agriculture, and regulatory agencies linked a Salmonella Infantis outbreak to contaminated dry dog food produced by a single production facility located in South Carolina. A total of 49 people (47 individuals in 20 states and 2 individuals in Canada) were reported infected with Salmonella Infantis. Among the 24 human patients with available information, 10 were hospitalized. The results from product testing by multiple agencies along with production codes provided by ill persons, led to multiple recalls by several companies with animal food products manufactured at the implicated production facility. The recalls included 17 brands representing over 30,000 tons of dry dog and cat food produced at the facility. This was the second documented outbreak of human salmonellosis linked to dry pet food in the United States (Ref. 27) (Ref. 28).
These examples demonstrate that the safe production and distribution of animal food and ingredients, along with safe meat, milk, and eggs derived from animals that consume this food is an important public health concern, both domestically and globally. The Agency needs to assure the consumer, both here and abroad, that it has a regulatory system designed to ensure production of safe animal food in the United States. Requiring facilities to manufacture, process, pack, or hold animal food under these proposed CGMPs and proposed preventive controls program would help provide that assurance. In addition, the U.S. Government, the animal food industry, animal producers, pet owners and consumers need to have assurance that animal food imported into the United States is safe.
2. Monitoring and Recalls
FDA monitors adverse food events through various means, such as FDA's Reportable Food Registry, FDA's Pet Food Early Warning Surveillance System, consumer complaints, tracking industry recalls and FDA and State inspection findings. From fiscal year (October through September) 2006 through 2012, there were 2,277 animal food product recalls. In 2007 alone, 1,054 animal food products were recalled due to contamination with melamine. Reasons for other animal food recalls include contamination with aflatoxins, dioxins, Salmonella, or metal fragments; improper labeling, such as no BSE warning; and subpotent or superpotent nutrient levels, such as elevated levels of vitamin D, copper, zinc, or urea and low levels of potassium, vitamin D, or thiamine. In fiscal year 2012, there were 191 consumer complaints of ill pets reported to FDA related to the dog food contaminated with Salmonella Infantis, discussed previously in this section.