Determination of the safety of genetically engineered crops

The safety of FLAVR SAVR(TM) tomatoes was shown by a thorough evaluation and demonstration of substantial equivalence to nongenetically engineered tomato milt. The FLAVR SAVR tomato does not differ from other tomato varieties except for the specific, intended effects of the inserted genes. All data support this conclusion, including molecular analyses, biochemical analyses, nutritional levels, horticultural traits, genetic analyses, field trial results, and plant pest risk evaluation. No data indicate or suggest any safety risk. Calgene also conducted a thorough review and analysis of the use of the kan(r) gene and gene product, APH(3')II, for use as a selectable marker in tomatoes, cotton, and oilseed rape. The data generated concluded that APH(3')II is not a toxin or allergen, that the kan(r) gene is highly unlikely to move from the plant genome into microorganisms via horizontal gene transfer, that if such transfer could occur the impact would be minimal, and that APH(3')II in transgenic plants will not compromise antibiotic use in humans or animals. On May 17, 1994, the FDA completed its evaluation of the FLAVR SAVR tomato and the use of APII(3')II, concluding that the tomato ''is as safe as tomatoes bred by conventional means'' (1) and ''that the use of aminoglycoside 3'-phosphotransferase II is safe for use as a processing aid in the development of new varieties of tomato, oilseed rape, and cotton intended for food use'' (2).