The US Food and Drug Administration's selection and validation of tests for foodborne microbes and microbial toxins

Abstract

To accomplish its mission in regulating the safety of the national food supply, the US Food and Drug Administration (FDA) must have testing methods that can be defended in a court of law. These methods must, at minimum, be reproducible. Whenever possible, the methods are validated according to procedures recommended by such international organizations as the AOAC INTERNATIONAL, the International Organization for Standardization (ISO) and the International Dairy Federation (IDF/FIL). Whenever it is not possible to validate a method fully prior to its use, FDA relies on the peer-reviewed scientific literature and the results of its own peer-reviewed research. FDA publishes its preferred methods to test foods for microbial pathogens and toxins in the FDA Bacteriological Analytical Manual (BAM), currently in its 8th edition (1995) and issued by AOAC INTERNATIONAL.