Summary
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™ tomato) have been conducted. A detailed safety analysis of thekan r selectable 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.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Anonymous. IMS-Imspact pharmaceutical database report. Plymouth Meeting, PA: IMS America; 1990a.
Anonymous. USP XXII, NF XVII, U.S. pharmacopeial convention. U.S. Pharmacopeia (USP), The National Formulary (NF). Easton, PA: Mack Printing Co.; 1990b.
Anonymous. Food intakes: Individuals in 48 states, year 1977–1978; Hyattsville, MD: U.S. Department of Agriculture Consumer Nutrition Division; 1983.
Anonymous. Toxicological principles for the safety assessments of direct food additives and color additives used in food. Washington, DC: U.S. Food and Drug Administration, Bureau of Foods; 1982.
Beck, E.; Ludwig, G.; Auerswald, E., et al. Nucleotide sequence and exact localization of the neomycin phosphotransferase gene from transposon Tn5. Gene 19:327–336; 1982.
Blaese, R.; Anderson, W. Unpublished submission of ADA human gene therapy clinical protocol: treatment of severe combined immunodeficiency disease (SCID) due to adenosine deaminase (ADA) deficiency with autologous lymphocytes transduced with a human ADA gene. Submitted for IRB/IBC/RAC/FDA approval. Memorandum from the Department of Health and Human Services, National Institutes of Health, and National Heart, Lung, and Blood Institute to the Office of Recombinant DNA Activities; 1990.
Davies, J. Aminoglycoside-aminocyclitol antibiotics and their modifying enzymes. In: Lorian, V., ed. Antibiotics in laboratory medicine. Baltimore, MD: William & Wilkins; 1986:790–809.
Davies, J.; Smith, D. Plasmid-determined resistance to antimicrobial agents. Ann. Rev. Microbiol. 32:469–518; 1978.
Ehrlich, S. Illegitimate recombination in bacteria. In: Berg, D.; Howe, M., ed. Mobile DNA. Washington, DC: American Society for Microbiology; 1989:799–832.
Garfinkel, D.; Simpson, R.; Ream, L., et al. Genetic analysis of crown gall: fine structure map of the T-DNA by site-directed mutagenesis. Cell 27:143–153; 1981.
Gould, W. Tomato production, processing and quality evaluation. Westport, CT: Avi Press; 1983:245–266.
Guyton, A. Textbook of medical physiology, 7th ed. Philadelphia, PA: W. B. Saunders Company; 1986.
Hiatt, W.; Kramer, M.; Sheehy, R. The application of antisense RNA technology to plants. In: Setlow, J., ed. Genetic engineering, principles and methods, vol. 11. New York: Plenum Press; 1989:49–63.
Hoskins, L. Host and microbial DNA in the gut lumen. J. Infect. Dis. 137:694–698; 1978.
Juskevich, J.; Guyer, C. Bovine growth hormone: human food safety evaluation. Science 249:875–884; 1990.
Kasid, A.; Morecki, S.; Aebersold, P., et al. Human gene transfer: characterization of human tumor-infiltrating lymphocytes as vehicles for retroviral-mediated gene transfer to man. Proc. Natl. Acad. Sci. USA 87:473–477; 1990.
Koncz, C.; Martini, N.; Mayerhofer, R., et al. High-frequency T-DNA-mediated gene tagging in plants. Proc. Natl. Acad. Sci. USA 86:8467–8471; 1989.
Kramer, M.; Sanders, R.; Bolkan, H., et al. Post-harvest evaluation of transgenic tomatoes with reduced levels of polygalacturonase: processing, firmness and disease resistance. Post Harvest Biol. Technol. 1:241–255; 1992.
Kramer, M.; Sanders, R.; Sheehy, R., et al. Field evaluation of tomatoes with reduced polygalacturonase by antisense RNA. In: Bennett, A.; O’Neill, S., ed. Horticultural biotechnology. New York: Wiley-Liss, Inc. 1990:347–355.
Kramer, M.; Sheehy, R.; Hiatt, W. Progress towards the genetic engineering of tomato fruit softening. Trends Biotechnol. 7:191–194; 1989.
Nevins, D. Why tomato biotechnology? A potential to accelerate the applications. In: Nevins, D.; Jones, R., ed. Tomato biotechnology, vol. 4. New York: Alan R. Liss; 1987:3–14.
Pao, E.; Fleming, K.; Guenther, P., et al. Foods commonly eaten by individuals: amounts per day and per eating occasion. Washington, DC: USDA Consumer Nutrition Center; Home Economics Research Rep. no. 44; 1982.
Radke, S.; Andrews, B.; Moloney, M., et al. Transformation ofBrassica napus L. usingAgrobacterium tumefaciens: developmentally regulated expression of a reintroduced napin gene. Theor. Appl. Genet. 75:685–694; 1988.
Sambrook, J.; Fritsch, E.; Maniatis, T. Molecular cloning a laboratory manual. Cold Spring Harbor, NY: Cold Spring Harbor Laboratory Press; 1989.
Sheehy, R.; Kramer, M.; Hiatt, W. Reduction of polygalacturonase activity in tomato fruit by antisense RNA. Proc. Natl. Acad. Sci. USA 85:8805–8809; 1988.
Sheehy, R.; Pearson, J.; Brady, C., et al. Molecular characterization of tomato fruit polygalacturonase. Mol. Gen. Genet. 208:30–36; 1987.
Stent, G.; Calender, R. Efficiency of transformation. In: Molecular genetics: an introductory narrative. San Francisco: W.H. Freeman and Company; 1978:191–193.
Tigchelaar, E.; McGlasson, W.; Buescher, R. Genetic regulation of tomato fruit ripening. HortScience 13:508–513; 1978.
Author information
Authors and Affiliations
Additional information
Presented in the Session-in-Depth “Field Test Requirements and Performance of Transgenic Plants” at the 1991 World Congress on Cell and Tissue Culture, Anaheim, California, June 16–20, 1991.
Rights and permissions
About this article
Cite this article
Redenbaugh, K., Berner, T., Emlay, D. et al. Regulatory issues for commercialization of tomatoes with an antisense polygalacturonase gene. In Vitro Cell Dev Biol - Plant 29, 17–26 (1993). https://doi.org/10.1007/BF02632234
Received:
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/BF02632234