U.S. FDA Regulatory Monitoring of Ochratoxin A in Human Foods: 2008-2022

Ochratoxin A (OTA) is a naturally occurring mycotoxin produced by Aspergillus and Penicillium fungi that can contaminate a range of agricultural commodities and products, such as cereal grains, dried fruit, and coffee beans. While some OTA contamination in foods may be unavoidable, there are steps that can be taken to help prevent fungal growth and control the presence of OTA in foods. The U.S. Food and Drug Administration (FDA) has established a regulatory mycotoxin compliance program to sample and analyze human foods for mycotoxins. Each year, under this compliance program, samples of foods susceptible to mycotoxin contamination are collected and analyzed for various mycotoxins, including OTA. In this study, we present and discuss data on OTA levels for over 3,700 food samples collected between fiscal years (FY) 2008 and 2022. OTA levels ranged from non-detect to 116 µg/kg, with the highest findings seen in green coffee beans, dried fruits, grain products, and spices. The vast majority of samples (96.5%) had OTA levels below the levels of quantification (LOQs) of 0.21 to 24.9 µg/kg. The findings were similar to detection rates, levels, and affected foods seen in other surveys of OTA. Our findings support continued monitoring of OTA in susceptible foods and may be useful in future work to determine whether it is appropriate to establish regulatory levels for OTA in the United States.