Analysis of Flour and Food Samples for Genetically Modified Corn
Keith A. Lampel, Dan D. Levy, Samir K. Assar, Laurenda Carter, Paul K. South and Palmer A. Orlandi, CFSAN, FDA, Washington DC 20204
StarLinkTM is corn which has been genetically modified by insertion of the cry9C gene to allow expression of the insecticidal Cry9C protein. This product has been approved by US EPA for animal and non-food use, but not for use in human food. The presence of either the protein or the gene in the human food supply would render the commodity adulterated under FDA regulations. Independent laboratories initially reported the presence of cry9C in taco shells, leading to a voluntary recall of the product by the manufacturer. With assistance from Aventis Crop Sciences, the developer of StarLinkTM corn, CFSAN scientists developed a method for determination of the presence of StarLinkTM using PCR analysis for the cry9C DNA in corn flour, corn meal, and tacos shells. The method has been applied to a number of processed corn products including cereals, baby foods, and chips. Extraction methods were developed to increase detection of the target gene in food products and the method transferred to ORA field laboratories for use in assignments to analyze corn flour, corn meal, and finished food products for the presence of this adulteration.