Use of genetically engineered plants for food production has raised many questions about food safety. Scientists, environmentalists, and government regulators have debated safety issues since the advent of genetic engineering. Recently, Calgene, Inc. became the first company to go to the FDA to request its evaluation of what will likely be the first whole food produced using genetic engineering technology: the FLAVR SAVR™ tomato.
This book outlines Calgene's strategy and approach for obtaining FDA approval, providing a detailed description of information and data necessary to demonstrate the safety of a genetically engineered whole food. The book serves as a model for other organizations attempting to demonstrate safety of their genetically engineered food products. For researchers and faculty, it provides the most extensive data and discussions on engineered foods. The book will provide a valuable resource for students, environmentalists, and others concerned about the use of genetic engineering, demonstrating the exact precision of the technology and its value as a breeding tool for crop development.
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. Minimum Amount to Accomplish Intended Technical Effect. Appendix C-1: The Application of Antisense RNA Technology to Plants. Appendix C-2: Product Selection. Appendix C-3: Field Evaluation of Tomatoes with Reduced Polygalacturonase by Antisense RNA. Appendix C-4: Effects of Reduced PG on Tomato Fruit. Appendix C-5: Processing Data. Appendix C-6: Biochemical Analysis of Processed Samples. Appendix C-7: Sensory Evaluation of Transformed Tomatoes Containing the FLAVR SAVR™ Gene. ANALYTICAL METHODOLOGY AND RESULTS. Relevant Analyses. Methods Needed to Detect and Determine Concentrations. Sample Preparation and Analysis. Analytical Results. Discussion of Methods and Analytical Results. Appendix D-1: Selection of Eight Lines of FLAVR SAVR™ Tomatoes for Analysis. Appendix D-2: Characterization of the Inserted FLAVR SAVR™ and kanr Genes by Southern Blot Analyses. Appendix D-3: Kanamycin Germination Assay. Appendix D-4: PG Extraction and Assay of Tomato Fruit. Appendix D-5: Tomato Processing Analysis. Materials and Methods. Appendix D-6: National Food Laboratory Methods for Compositional Analysis. Appendix D-7: Results of Compositional Analysis. Appendix D-8: Tomatine Data. Appendix D-9: DNA Isolation Procedure. SAFETY INVESTIGATIONS ON FLAVR SAVRÔ TOMATOES. Introduction. Identifying the Concerns. Analytical Results. Discussion of Methods and Analytical Results. Safety Evaluation. Appendix E-1: Naturally Occurring Toxins. Appendix E-2: Material Safety Data Sheets for Tomatine and Tomatidine. Appendix E-3: Genetics of Lycopersicon. Appendix E-4: Acute Oral Toxicity Test (Limit Test) of Tomatoes in Rats. LIST OF PREPARERS. LIST OF REFERENCES. INDEX.