Safety Assessment of Genetically Engineered Fruits and Vegetables

Overview. Request for Advisory Opinion. FOOD SAFETY. IDENTITY OF FLAVR SAVRÔ TOMATO. Common or Usual Name. Formal Name. Synonyms and Tradenames. Chemical Formulae and Molecular Weights. Composition of Mixtures. Purity and Specifications. Methods of Analysis of FLAVR SAVR™ Tomatoes. Description of Manufacturing Process. Appendix A-1: Variation in the Physical, Nutritional, and Chemical Composition of Tomatoes. Appendix A-2: University of California, Davis, Report on Variation in Constituents of Tomato. Appendix A-3: Methods of Genetic Modification and Their Use. Appendix A-4: Molecular Characterization of Tomato Fruit Polygalacturonase. Appendix A-5: Reduction of Polygalacturonase Activity in Tomato Fruit by Antisense RNA. Appendix A-6: Agrobacterium as a Gene Transfer Agent for Plants. Appendix A-7: Improved Binary Vectors for Agrobacterium-Mediated Plant Transformation. Appendix A-8: Binary Vectors, pCGN1416 and pCGN1436, Containing the FLAVR SAVR™ Gene. Appendix A-9: Nucleotide Sequence of the T-DNA Region of pCGN1436. Appendix A-10: Efficient Transfer of a Glyphosate Tolerance Gene into Tomato Using a Binary Agrobacterium tumefaciens Vector. Appendix A-11: Tomato Transformation and Regeneration with pCGN1436. Appendix A-12: Comparison of Agrobacterium-Mediated Transformation to Classical Breeding. Appendix A-13: Control of Fruit Ripening. USES OF FLAVR SAVRÔ Tomato. Introduction to Tomato. Current Uses-Processing and Fresh Market Tomatoes. Proposed Use-FLAVR SAVR™ Tomatoes. Use Levels. Fate in Foods. Human Estimated Daily Intake (EDI) of FLAVR SAVR™ Tomato. Background Exposure to Components of the FLAVR SAVR™ Tomato. Labeling. Appendix B-1: Fresh Market Tomatoes. Agricultural Statistics 1990. Appendix B-2: Processing Tomatoes. Production Statistics. Appendix B-3: A Complete Course in Canning. Appendix B-4 Commercial Processing of Tomatoes. INTENDED TECHNICAL EFFECT OF FLAVR SAVRÔ TOMATOES. Intended Technical Effect. Demonstration of Intended Technical Effect. Min