Regulatory Aspects of Fumonisins with Respect to Animal Feed

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The fumonisins are a recently discovered class of mycotoxins produced primarily by Fusarium (F.) moniliforme and F. proliferatum. Fumonisins present in mycotoxin-contaminated feed have been identified as the causative agent of equine leukoencephalomalacia and porcine pulmonary edema. To prevent these diseases, FDA has utilized informal guidance levels for fumonisins in feed and initiated a surveillance program for fumonisins in feed corn and corn by-products during FY 93 and 94. Natural contaminants present in animal feed can enter the human food supply as residues present in animal tissues and other animal derived products. Although fumonisin guidance levels were originally set based on animal safety, FDA also ensures the human food safety of animal products from animals fed mycotoxin-contaminated feed. Recent pharmacokinetic studies in food-producing animals as well as statutory requirements for regulating natural toxins will be discussed in light of FDA’s human food safety mandate.