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U.S. Department of Health and Human Services

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Volume IV - 7.1 Introduction

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Orientation and Training

Food and Drug Administration



Section 7 - Mycotoxin Analysis

EFFECTIVE DATE: 04-27-04REVISED: 02-14-13

Mycotoxins are natural poisons produced by fungi as secondary metabolites. Foods may become contaminated with mycotoxins as a result of mold growth during harvest, or storage. Three genera are responsible for the majority of the mycotoxins with which FDA is concerned: the Aspergillus sp., Penicillium sp., and Fusarium sp. Of the numerous mycotoxins elaborated by these fungi, FDA is actively concerned with the aflatoxins, fumonisins, trichothecenes, ochratoxins, patulin, and zearalenone. The potential for a product to contain a naturally incurred mycotoxin depends on whether the product contains and supports the growth of a mycotoxin-producing mold species, and whether the optimum temperature and humidity are present.

In addition to giving instructions to the FDA field (the laboratory, inspection, and compliance branches) on how to accomplish their mycotoxin assignments, the FDA mycotoxin compliance programs give introductory information about these mycotoxins and the products which are susceptible to contamination by them (see Section 7.5 References 1-3). The compliance programs also list the analytical methods for each mycotoxin. For more information on mycotoxins, see Section 7.5 References 4-6. Chemical data (UV, IR, NMR, and mass spectra), general characteristics, and toxicity data may be found in Section 7.5 References 7. 

A large amount of information about mycotoxins is found on the web. An example is found in Section 7.5 References 8, which covers the considerations for establishing an action level for patulin in apple juice, apple juice concentrate, and apple juice products. Other examples are found in Section 7.5 References 9, which is a background paper for fumonisin levels for corn and corn products intended for human foods, and Section 7.5 References 10, which is industry guidance for fumonisin levels in human foods and animal feeds. Information on fusarium toxins such as T-2 toxin, diacetoxyscirpenol (DAS), deoxynivalenol (DON), fumonisins, and others is found in Section 7.5 References 11. For physicochemical data for selected fusarium, toxins, see Section 7.5 References 12. (For each mycotoxin that has an actionable level, there is a Compliance Policy Guide (CPG). CPGs give guidance for recommending legal action such as detention of imports. They specify criteria for recommending action , the wording of the legal charge, and which analyses are needed (e.g. CPG for paulin, Section 7.5 References 13). More information on these and other mycotoxins may be found in Section 7.5 References 14 -17.