Автор |
Redenbaugh, K. |
Автор |
Hiatt, W. |
Автор |
Martineau, B. |
Автор |
Lindemann, J. |
Автор |
Emlay, D. |
Дата выпуска |
1994 |
dc.description |
AbstractCalgene conducted a thorough review and analysis of the use of the kan<sup>r</sup> gene and gene product, aminoglycoside 3'‐phosphotransferase II (APH(3')II), for use as a selectable marker in FLAVR SAVR™ tomatoes, in BXN™ cotton and oil‐modified rapeseed. The data generated support the conclusions that APH(3')II is not a toxin or allergen, that the kan <sup>r</sup> gene is highly unlikely to move from the plant genome into microorganisms via horizontal gene transfer, that if such transfer could occur the impact would be minimal, and that APH(3')II in transgenic plants will not compromise antibiotic use in humans or animals.At FDA's Food Advisory Committee meeting on April 6–8, 1994, the FDA Center for Food 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<sup>r</sup> gene and APH(3')II will not have a significant impact on the environment and that an environmental impact statement is not required.”; On May 18, 1994, the FDA finished its safety review of the FLAVR SAVR tomato and APH(3')II. The FDA concluded that “FLAVR SAVR™ tomatoes have not been significantly altered when compared to varieties of tomatoes with a history of safe use”; (Federal Register 59: 26646) and “that the use of aminoglycoside 3'‐phosphotransferase II is safe for use as a processing aid in the development of new varieties of tomato, oilseed rape, and cotton intended for food use”; (Federal Register 59: 26700). |
Формат |
application.pdf |
Издатель |
Taylor & Francis Group |
Копирайт |
Copyright Taylor and Francis Group, LLC |
Название |
Aminoglycoside 3'‐phosphotransferase II (APH(3')II): Review of its safety and use in the production of genetically engineered plants |
Тип |
review-article |
DOI |
10.1080/08905439409549873 |
Electronic ISSN |
1532-4249 |
Print ISSN |
0890-5436 |
Журнал |
Food Biotechnology |
Том |
8 |
Первая страница |
137 |
Последняя страница |
165 |
Аффилиация |
Redenbaugh, K.; Calgene, Inc. |
Аффилиация |
Hiatt, W.; Calgene Fresh, Inc. |
Аффилиация |
Martineau, B.; Calgene, Inc. |
Аффилиация |
Lindemann, J.; Calgene, Inc. |
Аффилиация |
Emlay, D.; Calgene, Inc. |
Выпуск |
2-3 |
Библиографическая ссылка |
Anderson, W.F., Blaese, R.M., Nienhuis, A.W. and O'Reilly, R.J. April 24 1987. Human gene therapy: Preclinical data document, April 24, Bethesda, Maryland: Submitted to the Human Gene Therapy Subcommittee. Recombinant DNA Advisory Committee. National Institutes of Health. |
Библиографическая ссылка |
Beck, E., Ludwig, G., Auerswald, E.A., Reiss, B. and Schaller, H. 1982. Nucleotide sequence and exact localization of the neomycin phosphotransferase gene from transposon Tn5. Gene, 19: 327–336. |
Библиографическая ссылка |
Blaese, R.M. and Anderson, W.F. 1990. 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, Memorandum from the Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute to the Office of Recombinant DNA Activities. Submitted for IRB/IBC/RAC/FDA approval |
Библиографическая ссылка |
Bryngelsson, T., Gustafsson, M., Green, B. and Lind, C. 1988. Uptake of host DNA by the parasitic fungus Plasmodiophora brassicae. Physiol. Molec. Plant Path., 33: 163–171. |
Библиографическая ссылка |
Carlson, T. and Chelm, B. (1986). Apparent eukaryotic origin of glutamine synthetase II from the bacterium Bradyrhizobium japonicum. Nature, 322: 568–570. |
Библиографическая ссылка |
Crawley, M.J. The comparative ecology of transgenic and conventional crops. Proceedings of 2nd International Symposium on the Biosafety Results of Field Tests of Genetically Modified Plants and Micro‐Organisms. 1992, Goslar. |
Библиографическая ссылка |
Ensminger, M. E., Oldfield, J. E. and Heinemann, W. W. 1990. “Excerpts with reference to cottonseed and cottonseed components”. In Feeds and Nutrition, Edited by: Ensminger, M. E. 252386–387. 404406–407. 440–441. 452474Clovis, California: Ensminger Publishing Company. |
Библиографическая ссылка |
1994. Federal Register, 59 May 23: 26646–26648. |
Библиографическая ссылка |
1994. Federal Register, 59 May 23: 26700–26711. |
Библиографическая ссылка |
1993. Federal Register, 58 July 16: 38429–38430. |
Библиографическая ссылка |
1991. Federal Register, 56 May 1: 20004–20005. |
Библиографическая ссылка |
1992. FDA Statement of Policy: Foods Derived from New Plant Varieties. Fed. Reg., 57 May 29: 22984 |
Библиографическая ссылка |
FDA. 1994. Background information: FDA's consultation with Calgene, Inc. concerning FLAVR SAVR™ tomatoes. Prepared for Food Advisory Committee meeting, April 6–8, 1994. Fed. Reg., 59(50): 11997–11998. |
Библиографическая ссылка |
Flavell, R., Dart, E., Fuchs, R. and Fraley, R. 1992. Selectable marker genes: Safe for plants?. Bio/Technology, 10: 141–142. 144 |
Библиографическая ссылка |
Henschke, R.B. and Schmidt, F.R.J. 1989. Survival, distribution and gene transfer of bacteria in a compact soil microcosm system. Biol. Fertil. Soils, 8: 19–24. |
Библиографическая ссылка |
IFBC (International Food Biotechnology Council). 1990. Biotechnologies and food: Assuring the safety of foods produced by genetic modification. Regul. Toxicol. Pharmacol., 12: S1–S196. |
Библиографическая ссылка |
Joint FAO/WHO Consultation. 1991. Strategies for assessing the safety of foods produced by biotechnology, 59Geneva: World Health Organization. |
Библиографическая ссылка |
Kantoff, P.W., Freeman, S.W. and Anderson, W.F. 1988. Prospects for gene therapy for immunodeficiency diseases. Ann. Rev. Immunol., 6: 581–594. |
Библиографическая ссылка |
Kasid, A., Morecki, S., Aebersold, P., Cornetta, K., Culver, K., Freeman, S., Director, E., Lotze, M.T., Blaese, R.M., Anderson, W.F. and Rosenberg, S.A. 1990. Human gene transfer: Characterization of human tumor‐infiltrating lymphocytes as vehicles for retroviral‐mediated gene transfer in man. Proc. Natl. Acad. Sci., 87: 473–477. |
Библиографическая ссылка |
Nap, J.‐P., Bijvoet, J. and Stiekema, W. 1992. Biosafety of kanamycin‐resistant transgenic plants. Transgenic Res., 1: 239–249. |
Библиографическая ссылка |
Pao, E.M., Fleming, K.H., Guenther, P.M. and Mickle, S.J. 1982. Foods commonly eaten by individuals: Amount per day and per eating occasion, U.S. Department of Agriculture. Home Economics Research Report Number 44 Washington, D.C.: Consumer Nutrition Center. Human Nutrition Information Service. |
Библиографическая ссылка |
Pariza, M. and Foster, E. 1983. Determining the safety of enzymes used in food processing. J. Food Protection, 46: 453–468. |
Библиографическая ссылка |
Piercey, L. 1994. FDA paper calls Flavr Savr safe. BioWorld Today, 5(65): 14 |
Библиографическая ссылка |
Potera, C. 1989. W. French Anderson: Bridging the gap between gene transfer and therapy. Genetic Engineering News, May: 31 |
Библиографическая ссылка |
Redenbaugh, K., Berner, T., Emlay, D., Frankos, B., Hiatt, W., Houck, C., Kramer, M., Malyj, L., Martineau, B., Rachman, N., Rudenko, L., Sanders, R., Sheehy, R. and Wixtrom, R. 1993. Regulatory issues for commercialization of tomatoes with an antisense polygalacturonase gene. In Vitro Cell. Dev. Biol., 29P: 17–26. |
Библиографическая ссылка |
Redenbaugh, K., Hiatt, W., Martineau, B., Kramer, M., Sheehy, R., Sanders, R., Houck, C. and Emlay, D. 1992. Safety Assessment of Genetically‐Engineered Fruits and Vegetables: A Case Study the FLAVR SAVR™ Tomatoes, 267Boca Raton, FL: CRC Press. |
Библиографическая ссылка |
Rochon, D. and Siegel, A. 1984. Chloroplast DNA transcripts are encapsidated by tobacco mosaic virus coat protein. Proc. Natl. Acad. Sci. USA., 81: 1719–1723. |
Библиографическая ссылка |
Rosenberg, S. 1992. The immunotherapy and gene therapy of cancer. J. Clinical Oncol., 10: 180–199. |
Библиографическая ссылка |
Rosenberg, S. 1991. Immunotherapy and gene therapy of cancer. Cancer Res. (Suppl.), 51: 5074s–5079s. |
Библиографическая ссылка |
Rosenberg, S., Aebersold, P., Cornetta, K., Kasid, A., Morgan, R., Moen, R., Karson, E., Lotze, M., Yang, J., Topalian, S., Merino, M., Culver, K., Miller, A., Blaese, R. and Anderson, W. (1990). Gene transfer into humans ‐immunotherapy, of patients with advanced melanoma, using tumor‐infiltrating lymphocytes modified by retroviral gene transduction. New England J. Med., 323: 570–578. |
Библиографическая ссылка |
Shatters, R. and Kahn, M. (1989). Glutamine synthetase II in Rhizobium: Reexamination of the proposed horizontal transfer of DNA from eukaryotes to prokaryotes. J. Mol. Evol., 29: 422–428. |
Библиографическая ссылка |
Smith, M., Feng, D.‐F. and Doolittle, R. 1992. Evolution by acquisition: The case for horizontal gene transfers. Trends in Biochem. Sci., 17: 489–493. |
Библиографическая ссылка |
Stotzky, G. 1989. “Gene transfer among bacteria in soil”. In Gene Transfer in the Environment, Edited by: Levy, S.B. and Miller, R.V. New York: McGraw‐Hill, Inc.. |
Библиографическая ссылка |
Tisdale, S. and Nelson, W. 1975. Soil Fertility and Fertilizers , 3rd edition, 152–154. New York: Macmillan Publishing Co.. |
Библиографическая ссылка |
Van Elsas, J.D. and Pereira, M.T.P.R.R. 1986. Occurrence of antibiotic resistance among bacilli in Brazillian soils and the possible involvement of resistance plasmids. Plant and Soil, 94: 213–226. |
Библиографическая ссылка |
Zambryski, P., Depicker, A., Kruger, K. and Goodman, H. 1982. Tumor induction by Agrobacterium tumefaciens: analysis of the boundaries of T‐DNA. J. Molec. Appl. Genet., 1: 361–370. |