AMINOGLYCOSIDE 3'-PHOSPHOTOTRANSFERASE-II (APH(3')II) - REVIEW OF ITSSAFETY 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 (AP H(3')II), for use as a selectable marker in FLAVR SAVR(TM) tomatoes, i n 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 k a nr gene is highly unlikely to move from the plant genome into microo rganisms via horizontal gene transfer, that if such transfer could occ ur the impact would be minimal, and that APH(3')II in transgenic plant s will not compromise antibiotic use in humans or animals. At FDA's Fo od Advisory Committee meeting on April 6-8, 1994, the FDA Center for F ood 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 s ignificant impact on the environment and that an environmental impact statement is not required.'' On May 18, 1994, the FDA finished its saf ety review of the FLAVR SAVR tomato and APH(3')II. The FDA concluded t hat ''FLAVR SAVR(TM) tomatoes have not been significantly altered when compared to varieties of tomatoes with a history of safe use'' (Feder al Register 59:26646) and ''that the use of aminoglycoside 3'phosphotr ansferase II is safe for use as a processing aid in the development of new varieties of tomato, oilseed rape, and cotton intended for food u se'' (Federal Register 59:26700).