2001 AACC Annual Meeting Charlotte, North Carolina October 14-18, 2001 Charlotte Convention Center

Agricultural biotechnology companies have developed crops exhibiting novel characteristics by inserting new DNA into the host genome that causes the production of new effecter proteins. The novel protein and DNA can be found in many tissues of these crops including seed and grain and the processed fractions prepared from them. Large percentages of commercial acreage have been planted in these biotech crops and the harvested grains are used to prepare finished foods. Food labeling laws have been enacted, notably in Europe and Japan that require foodstuffs containing biotech ingredients above specified threshold concentrations to be labeled as such. The approach to determining the concentration of biotech ingredient in a sample is to measure the amount of novel protein or DNA in a sample and use this to estimate the concentration of biotech ingredient. Protein tests have been developed that can detect the majority of biotech crops. The utility of any given test is determined by the particular application and the biology of the biotech crop. In order for a protein test to be useful the protein must be present in the sample at sufficiently high concentrations to be detected and in a form recognizable by the test. Testing of finished foods requires that the performance of the test be validated for use with the particular food substance to be tested. Bulk grain testing has been implemented on a large scale in the United States using rapid lateral flow strip tests that detect novel biotech proteins in samples of ground grain. Based on existing USDA sampling protocols and statistical methods for estimating the probability of a biotech kernel or bean occurring in a fixed number of negatives, these tests provide statistical confidence that a consignment of grain is above or below specified threshold concentrations. Given the large number of different finished food products that need to be tested and the effort required to validate test methods with each finished food, the bulk of routine testing is currently focused on control of the inputs to the food production system using rapid threshold screening protein methods. Once the inputs have been characterized the concentration of biotech ingredient in finished foods can be controlled through the use of documentation and testing at critical control points and final quality control.