Genetically Modified Pest-Protected Plants Science and Regulation (2000) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-18
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The NRC determined that there was a need for an overview of the current issues surrounding transgenic plants, in particular those engi
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Note: The study does not address philosophical and social issues surrounding the use of genetic engineering in agriculture, food labeling, or international trade in genetically modified plants. As instructed by the charge, the committee focused on transgenic pestprotected plants; however, many of its conclusions and recommendations are applicable to other categories of transgenic plants.
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Chapter 1 introduces the scientific and regulatory issues, chapter 2 focuses on the scientific impacts of conventional and transgenic pestprotected plants, chapter 3 addresses how the scientific information is reviewed in the regulatory framework and presents guiding principles for review, and chapter 4 discusses the positive and negative elements of the current regulatory framework and suggests improvements for the review and exchange of scientific information. The following pages highlight the committee's major findings, conclusions, and recommendations.
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Therefore, pesticidal substances, pest protestants, pest resistance genes, and other variations are used throughout this report. ES.3.2 Genetically Modified Plants Plant breeders use a variety of genetic techniques to enhance the ability of plants to protect themselves from plant pests.
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The 1987 paper focused on the safety of rDNA techniques and on ecological issues associated with the potential spread of transgenic organisms or genes associated with transgenic organisms, and it provided the following conclusions: · point 1 "There is no evidence that unique hazards exist either in the use of rDNA techniques or in the movement of genes between unrelated organisms." point 2 "The risks associated with the introduction of rDNA-engineered organisms are the same in kind as those associated with the introduction of unmodified organisms and organisms modified by other methods." point 3 "Assessment of the risks of introducing rDNA-engineered organisms into the environment should be based on the nature of the organism and the environment into which it is introduced, not on the method by which it was produced." The committee discussed the above principles in light of its knowledge of the underlying scientific processes involved in conventional and transgenic methods. It is important to point out that the committee is not aware of controlled field studies which directly compare the ecological effects of transgenic and conventional pest-protected plants bred for the same pesticidal traits.
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With transgenic methods, there is often more knowledge about the genes and gene products being transferred, but diverse traits and genes from unrelated organisms can be transferred so some specific products could have unique properties. Because both methods have the potential to produce organisms of high or low risk, the committee agrees that the properties of a genetically modified organism should be the focus of risk assessments, not the process by which it was produced (point 3~.
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The committee reviewed data concerning toxicity testing and potential pleiotropic or secondary effects of genetic modification. The committee concluded that monitoring for pleiotropic changes in plant physiology and biochemistry during the development of pest-protected plants should be an important element of health-safety reviews, in addition to testing the toxicity of the introduced gene products (see ES.6.4~.
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Therefore, the committee recommends research to Examine whether longterm feeding of transgenic pest-protected plants to animals whose natural diets consist of the quantities and type of plant material being tested (for example, grain or forage crops fed to livestock) could be a useful method for assessing potential human health impacts.
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The committee found that the transfer of either conventionally bred or transgenic resistance traits to weedy relatives potentially could exacerbate weeds problems, but such problems have not been observed or adequately studied. Therefore, the committee recommends further research to Assess gene flow and its potential consequences: develop a list of plants with wild or weedy relatives in the United States; identify key factors that regulate weed populations; assess rates at which pest resistance genes from the crop would be likely to spread among weed populations; and evaluate the impact of specific, novel resistance traits on the weed abundance.
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The committee concluded that pest resistance to pest-protected plants could have a number of potential environmental and health impacts such as a return to the use of more harmful chemicals or replacement of an existing pest-protected variety with novel varieties for which there is less information available about health and environmental impacts. The committee recommends that If a pest-protectant or its functional equivalent is providing effective pest control, and if growing a new transgenic pest-protected plant variety threatens the utility of existing uses of the pest-protectant or its functional equivalent, implementation of resistance management practices for all uses should be encouraged (for example, Bt proteins used both in microbial sprays and in transgenic pest-protected plants)
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In the last few years, there have been concerns expressed by several professional societies and other groups over the broad scope of the proposed EPA rule and opposite concerns expressed by consumer and environmental groups that the EPA rule does not adequately cover all of the risk issues. ES.6.2 Overall Approach The committee recognizes that There is an urgency to complete the regulatory framework for transgenic pest-protected plant products because of the potential diversity of novel traits that could be introduced by transgenic methods and because of the rapid rate of adoption of and public controversy regarding transgenic crops.
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EPA's current proposal for regulating pesticidal substances in pestprotected plants claims broad jurisdiction over such products in all seeds and plants sold with claims of pest-protection, but it grants a generic exemption from registration to those bred by conventional means. The committee agrees with EPA's proposed exemption of pesticidal substances in conventionally bred plants, because the committee recognizes that there are practical reasons for exempting those substances based in part on historical experience of safe use of, and the benefits provided by these crops.
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, and given the public controversy regarding transgenic products, EPA should reconsider its categorical exemption of transgenic pest-protectants derived from sexually compatible plants. The committee also examined EPA's proposed exemption for viral coat proteins expressed in transgenic pest-protected plants.
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Novel or less familiar plant-pesticides (that is, in comparison to viral coat proteins and Bt toxins) may require additional categories of toxicity testing.
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Only through effective coordination can the three lead agencies minimize duplication, avoid inconsistent regulatory decisions, address potential gaps in oversight, and ensure that regulations evolve with experience and scientific advancements. Ultimately, the credibility of the regulatory process and acceptance of products of biotechnology depend heavily on the public's ability to understand the process and the key scientific principles on which it is based.
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To improve coordination among the three regulatory agencies, EPA, FDA, and USDA should develop a memorandum of understanding (MOW) for transgenic pest-protected plants that provides guidance to identify the regulatory issues that are the purview of each agency (for example, ecological risk and pesticide tolerance assessment for EPA, plant pest risk for USDA, and dietary safety of whole foods for FDA)
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Taking into account the above suggestions, the committee hopes that the regulatory framework for transgenic pest-protected plants can be quickly completed by clarifying, revising, and finalizing the EPA 1994 proposed rule; publishing guidance on regulatory requirements; and developing additional interagency MOUs. However, once established, the committee recommends that Regulations should be considered flexible and open to revision, so that agencies can adapt readily to new information and improved understanding of the science that underlies regulatory decisions.
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ES.8 STRIVING FOR THE IDEAL REGULATORY FRAMEWORK In the time allotted for this report, the committee focused on providing meaningful input to improve the review of scientific data under the coordinated framework and the proposed EPA plant-pesticide rule. The committee's findings, conclusions, and recommendations will need to be tested before they are confirmed as useful methods to enhance scientific review during the regulation of transgenic pest-protected plants.
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