and that the proposed rule has too many exemptions. They are also concerned that the EPA rule does not adequately cover all of the risk issues. Several professional societies have argued that EPA is overstepping its boundaries by reviewing plant gene products as pesticides, stating that this could damage the progress of science by overburdening small biotechnology companies and public breeding programs with the cost of regulation, as well as undermining confidence in the food supply (Eleven Scientific Societies 1996; CAST 1998). Some congressional members are concerned about the lack of a formal cost-benefit analysis to accompany the rule and about whether the definition of a pesticide in FIFRA gives EPA the authority to regulate transgenic pest-protected plants (Hart 1999c).

Given the debate about its proposed rule, EPA held a workshop in 1997 to address some of the criticisms (EPA 1997c) and is incorporating changes into the rule on the basis of comments. One comment that is being considered suggests changing the terminology to avoid the use of “plant-pesticides” for gene products of transgenic pest-protected plants. EPA has sought input on a more appropriate name for these traits in a recent Federal Register notice (EPA 1999c). A change might address the public's concern about labeling plants as “pesticides”; however, it would not address other concerns, such as EPA's authority, its role in the coordinated framework, and whether the risks are being properly addressed by this framework.


In the past, the National Academy of Sciences (NAS) and National Research Council (NRC) have had the opportunity to provide guidance to scientists, regulatory agencies, and the public concerning rDNA issues. The 1974-1975 efforts helped to initiate the national debate over the safety of genetically engineered organisms (Berg et al. 1974). In 1987, given the proposed release of genetically engineered organisms into the environment, the NAS Council issued a white paper, Introduction of Recombinant DNA-Engineered Organisms into the Environment (NAS 1987), which proposed guiding principles that helped shape national policy for the review of genetically engineered organisms. In 1989, the NRC convened a committee to establish a framework for decisions regarding the field testing of genetically engineered organisms (NRC 1989); the criteria and methods for evaluation suggested by that committee have been guiding USDA oversight of field trials for transgenic crops in the last 10 years. Given the current political and social climate, the NRC believes that it has a role to play in addressing the scientific issues surrounding the regulation of transgenic pest-protected plants.

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