Mycotoxin Contamination: Anatomy of a Chemical Hazard While the FSMA leaves it up to each facility to determine whether a particular contaminant warrants preventive controls, experts in some segments of the food industry see the inclusion of mycotoxin controls in their members’ food safety plans as all but inevitable. According to a FSMA training module from the Iowa Grain Quality Initiative at Iowa State University, “at least one type of mycotoxin at every FSMA-regulated [grain] facility is likely to be deemed a significant hazard and need preventive controls.”4 Perhaps best known as a safety concern of corn and peanut dealers and buyers, the specter of mycotoxin contamination looms over upstream and downstream businesses in as variety of other markets as well. These potent naturally occurring toxins span commodities across the food chain from plant-based foods vulnerable to infection by mycotoxin-producing molds to products from animals that consume contaminated forages and processed feed (see Table 1). FSMA guidance documents identify the first five mycotoxins listed in Table 1 as potential chemical hazards5; the two other mycotoxins listed are also considered a safety risk by many foreign and domestic buyers.
The FDA has set recommended maximum limits for four mycotoxins (see Tables 3, 4, and 5). Companies that violate these recommendations can face serious repercussions. The action levels for aflatoxins, the strongest known human carcinogen, represent the point at which the FDA will pursue court action. Mycotoxin levels that exceed these or any of other of the FDA’s recommended limits can also serve as evidence that a product is unfit for sale. The FDA plans to develop legally binding aflatoxin regulations,6 which would relieve the FDA of its obligation to prove to the court that aflaxoxin contamination represents a significant health risk. In response to concerns about the carcinogenic potential of ochratoxin A, the agency is also currently collecting data on the occurrence of this mycotoxin to assess the need for maximum limits.7