Thu, 12/13 2018: 12:00 PM
- 1:00 PM
Regularly Scheduled Series
WO 2: 2047
In the spring of 2007, FDA experienced one of the most extensive recalls in its history – the recall of melamine-contaminated pet foods. Quick and expert response by FDA and outside scientists enabled the discovery of a previously unknown link between melamine and melamine-related compounds (such as cyanuric acid) contamination of imported pet food ingredients and acute kidney injury in dogs and cats. Kidney injury occurred after crystal formation in the distal tubules. An unknown number of illnesses and deaths resulted but estimates are in the thousands based on the number of calls and reports to FDA during that time. Melamine contamination also extended into human food products, including livestock and fish feed after contaminated pet food scraps were fed to food animals. Additionally, contamination of infant formula in China in 2008 resulted in several infant deaths, followed soon after by the discovery of melamine-contaminated White Rabbit Creamy Candy in Connecticut.
The intensive and concerted efforts of many in and outside of the agency led to massive pet food recalls in record time. However, the outbreak revealed a gap in FDA's ability to detect pet food adverse event-related adverse events early, which came to the attention of Congress, among others. Why wasn't this outbreak of renal disease detected before deaths were reported to pet food companies and the FDA? Where was the surveillance system? There is no CDC for animals, and besides USDA's monitoring of foreign and food animal diseases, there is no national system for monitoring of disease in dogs and cats. The need for the FDA, which regulates pet food in the US, to have an early warning and surveillance system for pet food-related adverse events became apparent. As the FDA began developing a more robust surveillance system, it quickly became apparent that another pet food-related outbreak was underway. Reports of proximal renal tubulopathy (acquired Fanconi Syndrome or Fanconi-like Syndrome) in non-genetically pre-disposed breeds of dogs began to be received by the FDA District Offices in the second half of 2007 after the melamine issue resolved. Reports were also being noted by national veterinary organizations such as AVMA and ACVIM. This syndrome can be genetic in origin or acquired through exposure to various toxins. Initial tests conducted by FDA for melamine and other selected toxins were negative, however, reports of illness continued to be received. FDA's new Pet Food Early Warning and Surveillance system was developed and put to the test over the next several years with the Jerky Pet Treat outbreak. FDA developed centralized complaint review and analysis systems, and worked collaboratively with scientists and others from industry, academia and other government agencies, both national and international, to investigate this mysterious outbreak. A collaboration with the CDC to conduct a nationwide case control study enabled FDA to investigate other possible exposures in cases compared to controls and to better characterize the illnesses. The investigation has led to several important findings, including the presence of unapproved antivirals and antibiotics in the imported dried poultry meat in some treats leading to product recalls and an import alert. Additionally, unique analytical methods were developed and validated through FDA laboratories for the detection of antibiotic and antiviral residues, among other assays, in the tough, rubbery jerky matrix. Major shifts in the jerky pet treat market occurred because of this investigation, leading to more domestic sourcing and greater controls on the ingredient supply chain, after which complaint numbers fell sharply.
This presentation will describe the findings of the investigation, including the case-control study, as well as the collaborative approach developed that has helped FDA with new outbreaks of pet food-related illnesses. Due to an increasingly globalized food and ingredient supply chain and the typically limited diet pets eat, pet food can be an important early indicator of important food quality issues.
Explain why a Pet Food Early Warning and Surveillance system is important to both human and animal health|Describe how the approach to pet food adverse event surveillance differs between early 2007 and today|Describe some of the differences between surveillance of foodborne illness in dogs and cats and surveillance of foodborne illness in humans|List some of the organizations and government agencies that may collaborate in the investigation of a serious pet food related incident|Describe some of the challenges faced by FDA and CDC in carrying out a case control study in dogs|Explain ways in which some of the findings of the Jerky Pet Treat investigation are important to both human and animal health