. "1 Ecological, Genetic, and Social Factors Affecting Environmental Assessment of Transgenic Plants." Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press, 2002.
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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation
The 1986 coordinated framework was constructed to be a flexible policy that would evolve as needed. In 1992 the policy’s scope was clarified. While each agency’s statute clearly specifies the scope of oversight that each agency can exercise, the diversity of statutes meant that regulatory oversight could vary in degree from agency to agency and statute to statute. This could create a situation where under one statute a transgenic organism is inadequately regulated while under another it is overregulated. To address this possibility, the Office of Science and Technology Policy (1992) issued two principles to restrict the scope of oversight. First, federal agencies were mandated to exercise oversight of transgenic organisms only when there is evidence of “unreasonable” risk. An unreasonable risk is one in which the value of the reduction in risk obtained by oversight is greater than the cost of oversight. The evidence of risk must include information about the transgenic organism, the target environment, and the type of application. The scope policy is vague as to the appropriate valuation system that should be used in making regulatory judgments. Second, federal agencies were required to focus on the characteristics and risks of the biotechnology product, not the process by which it is created.
Since 1992 there have been a few more changes in the policy, including shifts in the responsibilities assumed by each agency. For the purpose of this discussion, one significant shift has been the assumption of responsibility by EPA for a subgroup of transgenic plants that were designated as pesticidal transgenic plants, including insect-resistant crops, such as Bt corn, and virus-resistant plants.
In response to the coordinated framework, the Biotechnology, Biologics, and Environmental Protection unit (BBEP) of the USDA-APHIS published regulations for the release of transgenic organisms in 1987 (APHIS 1987), under the statutory authority of the FPPA and the FPQA. While the coordinated framework explicitly provided that federal agencies should focus on the characteristics and risks of the biotechnology product, not the process by which it is created, APHIS explicitly used the process of genetic engineering to trigger its oversight. However, in the 1987 Final Rule (APHIS 1987), APHIS argues that it is not treating transgenic organisms differently than so-called established plant pests or naturally occurring organisms, which may be plant pests. For example, APHIS regulates the movement and release of geographically separated populations of known plant pests because a new geographic population may have genetic characteristics absent in the recipient geographic population, which could increase the plant pest risk in the recipient population. In all cases a permit must be obtained from APHIS prior to importation and interstate movement of potential plant pests. For certain transgenic organisms, APHIS has determined that the release of these organisms