Environmental Effects of Transgenic Plants The Scope and Adequacy of Regulation (2002) / Chapter Skim
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Executive Summary
Executive Summary
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. APHIS derives its authority for regulating transgenic plants from the Federal Plant Pest Act (FPPA)
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The committee used this framework to evaluate the scope and adequacy of the APHIS review process. COMPARISON OF ENVIRONMENTAL ASSESSMENT OF TRANSGENIC PLANTS WITH ASSESSMENT OF OTHER AGRICULTURAL TECHNOLOGIES Risk assessment literature and history demonstrate that environmental regulation of agricultural practices and technologies involves an inter
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Because decisions that are now being made with regard to transgenic plants could set a precedent for evaluating all agriculture, government agencies and the public must keep this in mind as regulations for transgenic plants evolve. it, ~ ~ ~ ~ ENVIRONMENTAL EFFECTS OF AGRICULTURAL PRACTICES, NOVEL GENETIC MATERIAL, AND THE PROCESSES USED IN PLANT IMPROVEMENT From a scientific perspective, the committee saw a need to place potential impacts of transgenic crops within the context of environmental effects caused by other agricultural practices and technologies.
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The two plant pest statutes (Federal Plant Pest Act and the Federal Plant Quarantine Act) , which are used by APHIS to regulate transgenic plants, were originally developed to regulate the introduction of nonindigenous plant species.
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The committee finds that the scientific justification for regulation of transgenic plants is not dependent on historically set precedents for not regulating conventionally modified plants. While there is a need to reevaluate the potential environmental effects of conventionally improved crops, for practical reasons, the committee does not recommend immediate regulation of conventional crops.
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The committee discussed a number of points of tension that arise between the use of risk analysis to create and maintain legitimacy and its use as a decision support tool. It is clear that democracy is best served when people affected by regulatory decision making can be significantly involved in the decision making, and that inclusion of diverse interests in the risk analysis process can be a powerful force to garner legitimacy of a decision.
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For purposes of decision support this committee agrees with previous NRC reports which conclude that risks must be assessed on a case-by-case basis with consideration for the organism, trait, and environment. Typically there are a number of comparisons that are appropriate for assessing the risks of transgenic crops.
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APHIS jurisdiction and the focus of its Environmental Assessments are confined to the United States, but some APHIS assessments discuss potential environmental effects of specific transgenic plants outside the United States. There is a need to clarify this discrepancy.
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The committee finds that the notification process is conceptually appropriate, but there is a need to reexamine which transgenic plants should be tested and commercialized through the notification process. In comparison with the notification process the permitting process requires more detail from the applicant, and if APHIS determines that there is a need for a formal Environmental Assessment of the plant, a description of the application is published in the Federal Register and is open to public comment.
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The committee recommends that before making specific, precedent-setting decisions, APHIS should solicit broad external scientific review well beyond the use of Federal Register notices. Specific attributes of APHIS's environmental assessments require comment.
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All of these changes would increase the utility of APHIS risk assessments in decision support. The increased rigor provided by these changes also could increase public confidence.
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As indicated above, there is a tension between use of the risk analysis process for decision support and maintenance of authority. APHIS could benefit from more attention to maintaining a balance between these two roles of its risk analyses.
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A good example of this is the use of toxicology-type testing of transgenic plants with pesticidal traits. These toxicology tests on a limited set of organisms are certainly helpful in preliminary assessment of hazards from effects on non-target organisms, but these acute toxicity tests might miss potential chronic effects that occur within field environments or effects that are not possible with the model organisms tested.
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One essential monitoring requirement will be the spatial distribution of transgenic crops. The committee recommends that a body independent of APHIS be charged with the development of an indicator-monitoring program.
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The types of new transgenic crops that are developed, as well as the rate at which they appear, will be affected by the interaction of complex factors including public funding and private financial support for research, the regulatory environment, public acceptance of the foods and other products produced from them, and the resolution of debates over need- versus profit-driven rationales for the development of transgenic crops. For future novel products of biotechnology, adequate risk analysis for decision support and maintenance of authority will depend on a regulatory culture that reinforces the seriousness with which environmental risks are addressed.
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borders. However, in an era of globalization, environmental effects of transgenic crops on the ecosystems of developing countries will be an important component of risk analysis.
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