The Academy Responds

Image: Anthony Canamucio Although Henry I. Miller is certainly welcome to express his opinions about the risks of biotechnology,1 he should not criticize a detailed report without reading it carefully. Miller indicates that the 2002 National Research Council report2 "invokes a variety of specious arguments." His main example is that the report puts forth "a general assumption that the risks associated with the introduction of genetic novelty are related to the number of genetic changes and the origin of the novel genes." In fact, the report addresses this assumption in detail and concludes that there is no support for it. The executive summary states, "The committee compared empirical evidence of environmental impacts involving small to large amounts of genetic novelty from taxonomically related and unrelated sources and found no support for this assumption." Concerning Miller's main point about regulation and logical inconsistencies, we would like to clarify the National Research Council's (NRC) positions. In both the 20003 and 2002 report, the NRC committees agreed with the general principle that certain conventionally bred plants could pose risks equal to or greater than certain transgenic plants--in the words of the 1987 NAS white paper,4 the "product, not process" is the major concern. If this principle is taken to its simplest logical conclusion, there are two options: regulate all plant varieties or regulate none. Neither option was acceptable to the NRC committees on the grounds of practicality and safety. Regulate all varieties? Think of the economic cost of regulating every conventionally bred plant variety. Regulate none--even plants engineered with bioindustrial products or pharmaceuticals? The real question is, which option would a prudent person choose? And how would he or she make a decision to choose between the two? In fact, it is impossible to choose an option without bringing into consideration factors that go into decision-making that are not strictly based on science or quantitative scientific risk. That is where regulators need to make tough decisions about where to draw boundaries around plant products that need regulatory scrutiny. Both NRC committees recognized this dilemma in the reports and concluded that it was impossible to develop a realistic decision-making approach without bringing into consideration factors that go beyond quantitative scientific estimation of risk. Both committees called for a tiered approach to regulation of transgenic plants in which most of these plants could be examined without long-term, intensive testing. Such an approach would assure public and environmental safety while decreasing theburden on the regulated community. With regard to conventionally bred plants, both committees concluded that it was premature and impractical to regulate conventionally bred plants, but that it was important to reevaluate the potential risks of such plants with the best tools of modern science. Finally, both committees called for more effort on the part of regulators to communicate openly with the public in developing their decision-making framework and in making specific decisions--recognizing that this effort is necessary for increasing and maintaining public confidence in the system and the products themselves. In summary, the committees chose to move beyond the stalemate in the "process vs. product" debate and to focus their efforts on making the current regulatory system, which does focus on transgenic plants, the best that it can be. Regulators, the regulated community, and the public all need to move forward in strengthening the current regulatory system, which will ultimately permit the potential of biotechnology applications to be realized. Fred Gould, PhD, is W.N. Reynolds Distinguished Professor of Entomology and Genetics; chair, National Research Council Committee on Environmental Effects of Transgenic Plants; and member, NRC Committee on Genetically Modified Pest-Protected Plants. Jennifer Kuzma, PhD, of the NRC staff, is program director of the Committee on Agricultural Biotechnology, Health and the Environment, and study director of the Committee on Genetically Modified Pest-Protected Plants. References 1. H.I. Miller, "Nescience, not science, from the Academy," The Scientist, 16[19]:12-4, Sept. 30, 2002. 2. "Environmental effects of transgenic plants: the scope and adequacy of regulation," available online at www.nap.edu/catalog/10258.html. 3. "Genetically modified pest-protected plants: science and regulation," available online at www.nap.edu/catalog/9795.html. 4. "Introduction of recombinant DNA-engineered organisms into the environment: key issues," Washington, DC: National Academy Press, 1987.

The Academy Responds

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