Advancing the FDA/Office of Regulatory Affairs Mycotoxin Program: New Analytical Method Approaches to Addressing Needs and Challenges.

The U.S. Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) oversees FDA field laboratories, monitoring the occurrence and levels of toxic mycotoxins in domestic and imported human and animal food products that have the potential to impact human and animal health when consumed. The mycotoxins being routinely monitored in human and animal foods and feeds by the Agency include aflatoxins (B1, B2, G1, G2, and M1), fumonisins (FB1, FB2, and FB3), deoxynivalenol, ochratoxin A, patulin, and zearalenone. There has been an ongoing expansion of the Sample Collection Operation Planning Effort (SCOPE) for the mycotoxin program to monitor more mycotoxins in a wider variety of food and feed matrices. To meet this pressing need, we are in the process of modernizing and harmonizing the FDA/ORA mycotoxin program in the field laboratories using approaches such as adopting new analytical technologies/methods to further advance the service. This short perspective gives an overview of the FDA mycotoxin program in the field laboratories and the current program status, discusses the need to advance the program, strategies for modernization and harmonization by implementing liquid chromatography-mass spectrometry technologies for multi-mycotoxin analysis, benefits of doing this, and challenges in taking this new approach. Perspectives on finding solutions to tackle challenges and addressing emerging issues are also discussed.