AMINOGLYCOSIDE 3'-PHOSPHOTOTRANSFERASE-II (APH(3')II) - REVIEW OF ITS SAFETY AND USE IN THE PRODUCTION OF GENETICALLY-ENGINEERED PLANTS

Calgene conducted a thorough review and analysis of the use of the kan(r) gene and gene product, aminoglycoside 3'-phosphotransferase II (APH(3')II), for use as a selectable marker in FLAVR SAVR(TM) tomatoes, in BXN(TM) cotton and oil-modified rapeseed. The data generated support the conclusions that APH(3')II is not a toxin or allergen, that the ka nr 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. At FDA's Food Advisory Committee meeting on April 6-8, 1994, the FDA Center for Food Safety and Applied Nutrition (CFSAN) concluded that the FLAVR SAVR tomato was as safe and nutritious as other commonly consumed tomatoes and ''that the use of the kan(r) gene and APH(3')IT will not have a significant impact on the environment and that an environmental impact statement is not required.'' On May 18, 1994, the FDA finished its safety review of the FLAVR SAVR tomato and APH(3')II. The FDA concluded that ''FLAVR SAVR(TM) tomatoes have not been significantly altered when compared to varieties of tomatoes with a history of safe use'' (Federal Register 59:26646) 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'' (Federal Register 59:26700).