Response to Response

Response to Response The response by Fred Gould and Jennifer Kuzma1 to my description of the fundamental flaws in two reports from the National Academy of Science/National Research Council2 is reminiscent of the story about the drunk searching for his lost keys under the streetlight. A friend who happens upon the fellow asks if he's sure that he lost them there. The drunk answers, "No, I'm sure they're not here, but the light is better." Gould and Kuzma concede the consensus that the risk-related characteristics of a product, rather than the techniques used to make it, should determine the need for and extent of regulation. But they make an insupportable leap of logic by asserting that if "this principle is taken to its simplest logical conclusion, there are two options: regulate all plant varieties or regulate none," and that because both are unacceptable, a tiered approach applicable only to recombinant DNA-modified plants is the logical solution. Existing government regulation and models described in the scientific literature argue otherwise: As in the case of the drunk under the streetlight, the keys are elsewhere. To circumscribe in a scientifically defensible way what needs to be regulated, the long-standing US Department of Agriculture regulations (under the Plant Pest Act) that are applicable to conventionally modified plants incorporate an inclusive list of organisms that are or that harbor plant pests. This approach is essentially binary: A plant that an investigator might wish to introduce into the field is either on the proscribed, inclusive list of plant pests--and therefore, requires a permit--or it's exempt. This approach is focused on the likely risks of products, not on the process used to craft the organism; and it is risk-based, in that the organisms that are required to undergo case-by-case governmental review are an enhanced-risk group--organisms that can injure or damage plants--compared to plants not known to be plant pests. This two-tiered approach could easily have been expanded to encompass recombinant DNA-modified, as well as conventionally modified plants. Several years ago, the Stanford University Project on Regulation of Agricultural Introductions described a widely applicable regulatory model for the field-testing of any organism, whatever the method(s) employed in its construction.3 Its basis is the stratification by panels of experts of various organisms into risk categories, a multitiered variation on the USDA's binary approach. This model offers regulatory bodies a highly adaptable, scientific approach to the oversight of field-testing plants and other organisms. The approach is analogous to that used by the Centers for Disease Control and Prevention and the National Institutes of Health for categorizing microorganisms, in order to establish laboratory safety standards for the handling of pathogens4; and it is applicable whether the introduced organisms are "naturally occurring," nonindigenous "exotics," or have been genetically improved by either old or new techniques. Moreover, the model is sufficiently flexible that the stringency of regulation is variable, according to the preferences and needs of particular regulatory authorities, but always within a scientific framework. Under such a system, some currently unregulated introductions of traditionally bred cultivars and exotics considered to be of moderate or greater risk would likely become subject to review, whereas many currently reviewed recombinant DNA-modified organisms would likely become exempt. Finally, it is astonishing that Gould and Kuzma did not address the Academy's contriving to produce two biased and inaccurate reports by stacking the committees with antibiotechnology ideologues and others with clear conflicts of interest. Henry Miller, MD. The Hoover Institution Stanford, CA miller@hoover.stanford.edu References 1. F. Gould, J. Kuzma, "The Academy responds," The Scientist, 16[20]:12, Oct. 14, 2002. 2. H.I. Miller, "Nescience, not science, from the Academy," The Scientist, 16[19]:12, Sept. 30, 2002. 3. J. Barton et al., "A model protocol to assess the risks of agricultural introductions," Nature Biotechnology, 15:845, 1997. 4. Biosafety in Microbiological and Biomedical Laboratories, Centers for Disease Control/National Institutes of Health, US Department of Health & Human Services. Washington, DC: US Government Printing Office, 1988.

Response to Response

Response to Response

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