Background: Mycotoxins General
The levels at which the fungi produce mycotoxins are influenced by the fungus type and the environmental conditions under which the corn is produced and stored. Because of these differences, mycotoxin production varies across the U.S. corn-producing areas and across years. In some years, the growing conditions across the corn-producing regions might not produce elevated levels of any mycotoxins. In other years, the environmental conditions in a particular area might be conducive to production of a particular mycotoxin to levels that impact the corn’s use for human and livestock consumption. Humans and livestock are sensitive to mycotoxins at varying levels. As a result, the FDA has issued action levels for aflatoxins and advisory levels for DON by intended use.
Action levels specify precise limits of contamination above which the agency is prepared to take regulatory action. Action levels are a signal to the industry that the FDA believes it has scientific data to support regulatory and/or court action if a toxin or contaminant is present at levels exceeding the action level, if the agency chooses to do so. If imports or domestic feed supplements are analyzed in accordance with valid methods and found to exceed applicable action levels, they are considered adulterated and may be seized and removed from interstate commerce by the FDA.
Advisory levels provide guidance to the industry concerning levels of a substance present in food or feed that are believed by the agency to provide an adequate margin of safety to protect human and animal health. While the FDA reserves the right to take regulatory enforcement action, enforcement is not the fundamental purpose of an advisory level.
A source of additional information is the National Grain and Feed Association (NGFA) guidance document titled “FDA Mycotoxin Regulatory Guidance” found at http://www.ngfa.org/wp-content/uploads/NGFAComplianceGuide-FDARegulatoryGuidanceforMycotoxins8-2011.pdf.