Tuesday, 8 November 2005 - 8:35 AM
143-2

Managing Field Experiments with Transgenic Plants.

Kent J. Bradford, University of California, Seed Biotechnology Center, Extension Center Drive, Davis, CA 95616-8780

Field experiments with transgenic plants (i.e., those developed using recombinant DNA methods) may be conducted solely for basic research purposes or during the development and testing of varieties for commercialization. Transgenic plants are regulated in the United States by the US Department of Agriculture, and in some cases by the Environmental Protection Agency and the Food and Drug Administration, depending upon the nature of the introduced gene and the host plant. Prior to evaluation and deregulation by these agencies, procedures for growing transgenic plants in the field must be utilized to preclude contamination of food, feed, and the environment, or endangerment of humans and non-target organisms. The procedures required depend upon the risks of pollen or seed transfer and the consequences of such transfer. For example, the risk of pollen transfer to other plants is less for self-pollinated crops than it is for out-crossing crops. Low-risk plants, such as those in which the transgene(s) and products(s) are well known and have no toxic or allergenic effects, the recipient plant is not invasive, and the transgenic plants are similar in composition to the parent, may require only notification of the USDA about the planned experiments. Low containment (e.g., less well known genes) and high containment (e.g., plant-made pharmaceutical or industrial products) categories require permits from USDA and more stringent measures to prevent spread of transgenes. In addition to Federal or State regulations, local Institutional Biosafety Committees (IBCs) should be notified and involved in developing experimental protocols involving transgenic plants. Important considerations include training of personnel involved in the experiment, field-site selection, record-keeping and communications, biological and/or physical containment methods, storage and post-harvest disposal of plant materials, cleaning of equipment, monitoring during and after the growing season, and reporting guidelines.

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