Regulatory issues for commercialization of tomatoes with an antisense polygalacturonase gene

Summary Significant progress has been made in development of transgenic plants containing agriculturally useful genes. Concurrent with scientific advances has been development of a regulatory infrastructure within the U.S. Department of Agriculture (USDA) for assessing safety of controlled release of genetically engineered plants into the environment, as well as creation of a food policy by the Food and Drug Administration (FDA). Field trials and safety assessments of tomato containing an antisense polygalacturonase gene (FLAVR SAVR™ tomato) have been conducted. A detailed safety analysis of thekan ^r selectable marker was also done. Based on these data plus nutritional measurements, lack of changes in levels of natural toxins, and lack of any unintended changes, we have requested that the USDA and FDA determine that this genetically engineered tomato is safe for release into the environment and human consumption. Presented in the Session-in-Depth “Field Test Requirements and Performance of Transgenic Plants” at the 1991 World Congress on Cell and Tissue Culture, Anaheim, California, June 16–20, 1991.