Regulatory issues for commercialization of tomatoes with an antisense polygalacturonase gene

• Published in: In vitro cellular & developmental biology. Plant 1993-01, Vol.29P (1), p.17-26
• Main Authors: Redenbaugh, K, Berner, T, Emlay, D, Frankos, B, Hiatt, W, Houck, C, Kramer, M, Malyj, L, Martineau, B, Rachman, N
• Format: Article
• Language: English
• Subjects: ADMINISTRACION; ADMINISTRATION; ADN; Agronomy. Soil science and plant productions; Antibiotics; ANTISENSE DNA; antisense genes; BIODETERIORATION; BIODETERIORO; Biological and medical sciences; Biotechnology; DNA; Drug regulation; Environment and pollution; Enzymes; ESTADOS UNIDOS DE AMERICA; ETATS UNIS; FIELD EXPERIMENTATION; flavr savr tomatoes; Food consumption; FOOD HYGIENE; Food law; FOOD SAFETY; FRUITS; FRUTAS; Fundamental and applied biological sciences. Psychology; Genes; Genetic engineering applications; GENETIC TRANSFORMATION; Genetically engineered organisms behavior (microorganisms, plants, animals); Genetics and breeding of economic plants; HIGIENE DE LOS ALIMENTOS; HYGIENE DES ALIMENTS; Industrial applications and implications. Economical aspects; LYCOPERSICON ESCULENTUM; METHODE D'ESSAI; METODOS DE ENSAYO; PERDIDAS POSTCOSECHA; PERTE APRES RECOLTE; Plant breeding: fundamental aspects and methodology; POLIGALACTURONASA; POLYGALACTURONASE; POSTHARVEST DECAY; POSTHARVEST LOSSES; REGLAMENTACIONES; REGLEMENTATION; REGULATIONS; SAFETY; SECURITE; SEGURIDAD; TOMATE; TOMATOES; TRANSFORMACION GENETICA; TRANSFORMATION GENETIQUE; TRANSGENIC PLANTS; TRIAL METHODS; USA; USDA
• ISSN: 1054-5476; 1475-2689
• DOI: 10.1007/BF02632234

Significant progress has been made in development of transgenic plants containing agriculturally useful genes. Concurrent with scientific advances has been development of a regulatory infrastructure within the U.S. Department of Agriculture (USDA) for assessing safety of controlled release of genetically engineered plants into the environment, as well as creation of a food policy by the Food and Drug Administration (FDA). Field trials and safety assessments of tomato containing an antisense polygalacturonase gene (FLAVR SAVR)[TRADE MARK] tomato) have been conducted. A detailed safety analysis of the kanrselectable marker was also done. Based on these data plus nutritional measurements, lack of changes in levels of natural toxins, and lack of any unintended changes, we have requested that the USDA and FDA determine that this genetically engineered tomato is safe for release into the environment and human consumption.