REGULATORY ISSUES FOR COMMERCIALIZATION OF TOMATOES WITH AN ANTISENSEPOLYGALACTURONASE GENE

Significant progress has been made in development of transgenic plants containing agriculturally useful genes. Concurrent with scientific ad vances has been development of a regulatory infrastructure within the U.S. Department of Agriculture (USDA) for assessing safety of controll ed release of genetically engineered plants into the environment, as w ell as creation of a food policy by the Food and Drug Administration ( FDA). Field trials and safety assessments of tomato containing an anti sense polygalacturonase gene (FLAVR SAVR(TM) tomato) have been conduce d. A detailed safety analysis of the kan(r) selectable marker was also done. Based on these data plus nutritional measurements, lack of chan ges in levels of natural toxins, and lack of any unintended changes, w e have requested that the USDA and FDA determine that this genetically engineered tomato is safe for release into the environment and human consumption.