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The Academy is considered scientifically preeminent, and its studies are widely cited by the media and relied upon by the Congress and by executive branch agencies for the formulation of legislation and policy. Often considered to be the last word on the scientific basis for policy, they affect the allocation and expenditure of hundreds of billions of dollars in the public and private sectors. However, the published reports of two recent committees working under the auspices of the National Research Council (NRC), the research arm of the Academy, raise questions about both the competence and integrity of the Academy. The studies concern regulatory policy towards the testing and commercialization of gene-spliced plants, which are critical to American agriculture. It appears that in this critical area, the Academy has provided scientific advice to government agencies on the same terms that Burger King provides hamburgers — you pay your money, and "you get it your way." The reports are internally inconsistent, incompatible with a broad scientific consensus about gene-splicing technology, violative of basic principles of regulation, and profoundly damaging to U.S. research and development. USDA regulates plants, plant products, and other organisms that may introduce plant diseases or pests. The approach is risk-based: Each entity is either on a proscribed list of known plant pests — and therefore, requires a permit — or is exempt. For the past 15 years, USDA ALSO has maintained a parallel regime focused exclusively on gene-spliced plants. This approach to regulation, which ignores genuine considerations of risk, defines a new category, the "regulated article," as "any organism or any product altered or produced through [gene-splicing] which is a plant pest, or for which there is reason to believe is a plant pest." That last phrase has been broadly interpreted to include any organism that includes any amount of DNA from a plant pest — even a minuscule snippet of DNA that is incapable of conferring the ability to cause disease or other hazards. Regulated articles are disproportionately expensive to develop and test. A field trial with a gene-spliced plant may be 10 to 20 times more expensive than the same experiment performed with a plant that has identical properties, but that was modified with less precise genetic techniques. The EPA, which regulates pesticides, has its own version of regulated articles. In 1994, the EPA first began to regulate plants genetically improved to enhance pest- or disease-resistance — but only if gene-splicing techniques were used. Plants modified with less precise and predictable techniques were exempt from regulation. In this way, the EPA holds gene-splicing technology to an inappropriate standard, requiring hugely expensive testing of gene-spliced crop and garden plants, such as cotton, corn, tomatoes, grapes and marigolds, as though they were chemical pesticides — a policy that has been repeatedly condemned by the scientific community. The agency has imposed requirements that could not possibly be met for products of conventionally bred — and less precisely crafted — plants, and its policies fail to recognize that there are important differences between spraying synthetic, toxic chemicals, and genetic approaches to enhancing plants' natural pest resistance. Scientists worldwide agree that adding genes to plants does not make them less safe either to the environment or for humans to eat. Dozens of new plant varieties produced through hybridization and other traditional methods of genetic improvement enter the marketplace each year without scientific review or special labeling. Many such products are from "wide crosses," hybridizations in which "alien" genes are moved from one species or one genus to another to create a plant variety that does not and cannot exist in nature. During the past two decades, national and international scientific organizations — including the NAS and NRC — have repeatedly addressed the question of whether risks associated with gene-spliced organisms are unique, and whether they require special oversight. Their results have been remarkably consistent. A 1987 National Academy of Sciences white paper found no evidence of unique hazards, either in the use of gene-splicing techniques or in the movement of genes between unrelated organisms. A 1989 National Research Council report on the risks of recombinant plants and microorganisms went further, emphasizing that gene-splicing is more precise, circumscribed, and predictable than other methods. In other words, gene-splicing is an extension, or refinement — an improvement — over previous techniques, and its use generates less uncertainty, leading the committee to conclude, "the nature of the process of genetic modification is not a useful criterion for determining whether the product requires less or more oversight." The 2000 and 2002 reports on gene-splicing regulation cannot be reconciled with these earlier views, which reflect more than a decade-long consensus in the scientific community. On the basis of this consensus and the recognition in the 2002 National Research Council report itself that government agencies are in the "difficult position of enforcing a higher environmental standard for gene-spliced plants than the standards currently used to regulate the impacts of other agricultural technologies and practices," one might logically have expected an endorsement and extension of the 1987 Academy white paper and 1989 NRC report. Instead, the committee recommends maintaining or even increasing the stringency of the existing discriminatory regulatory system. It justifies this recommendation by invoking a variety of specious arguments. First, there is "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." There is no evidence to support this. If there were, it would raise strong concern about the widespread application of induced-mutation breeding. In common use since the 1950s, this involves exposing crop plants to ionizing radiation or toxic chemicals to induce random genetic mutations. (Even when one gets a mutant organism with new, desirable traits, there are inevitably large numbers of unknown, uncharacterized mutations in the organism that occur concomitantly.) The same applies to wide crosses, in which "alien genes" are introduced to create novel plants. For example, Triticum agropyrotriticum possesses all the chromosomes of wheat and one extra whole genome from quack grass — thereby adding tens of thousands of genes. Such genetic constructions are exempt from regulation in spite of the (theoretical) possibility that they could be more weedy, toxic, or allergenic than parental wheat varieties. Yet the use of gene-splicing techniques to add a single quack grass gene to wheat would precipitate an extensive and expensive premarket review. This is the kind of anomaly that is insupportable. Second, the committee claims there is greater risk from gene-splicing than other techniques because "a much broader array of [observable] traits can potentially be incorporated into plants than was possible two decades ago." But this is a second-order kind of concern: Greater versatility is not the same as enhanced risk and should not determine how much oversight is appropriate. The panel concludes, "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." Practical reasons, indeed! In fact, not a single conventional crop could (or should) meet the requirements being imposed on gene-spliced plants. Conventional plant breeding, in which the mechanisms for enhancing the host's resistance to pests and diseases are largely unknown, would grind to a halt if USDA's regulatory approach were applied to it. (Fred Gould, the chairman of the NAS committee, conceded that such requirements would "bankrupt" conventional plant breeders-but it seems to have escaped his notice that it will do the same to those who use gene-splicing techniques.) On the basis of such reasoning, the NAS panel recommends continued compulsory case-by-case oversight by USDA of the field trials of all gene-spliced plants. Perhaps one such scientifically flawed, internally inconsistent report could be dismissed as an anomaly, but the NRC's previous report on a parallel subject — the EPA's oversight of gene-spliced plants with enhanced pest or disease resistance — was similarly defective. The committee failed to address crucial aspects of its charge — namely, "to examine the existing and proposed regulations to qualitatively assess their consequences for research, development, and commercialization of" gene-spliced plants modified to enhance pest resistance. This point is crucial because previous analyses had found the EPA's existing and proposed regulation to be unscientific, illogical, and potentially damaging to agricultural research. For example, a 1996 analysis by eleven scientific societies excoriated the EPA's approach and warned of a number of negative consequences for agriculture and consumers. In 1998 the Council on Agricultural Science and Technology, which represents dozens of scientific societies, reiterated the criticisms, characterized the EPA's approach as "scientifically indefensible," and warned that treating gene-spliced plants as pesticides would "undermine public confidence in the food supply." It was extraordinary, therefore, to find in the 2000 report from the Academy that "the committee has chosen to take EPA's proposed rule and the overarching federal governmental coordinated framework as given," especially inasmuch as "the committee agrees that the properties of a genetically modified organism should be the focus of risk assessments, not the process by which it was produced." There is a logical inconsistency here. How could the National Academy of Sciences twice have gone so far wrong in its assessment of the scientific basis for federal regulatory policy? How could it have ignored a fundamental principle of regulation — that the degree of oversight should be commensurate with the perceived risk? Easy. Like baseball's Black Sox scandal of 1919, when the Chicago White Sox took bribes to throw the World Series, the game was fixed. The Academy took a dive. The USDA committee was stacked with members known to harbor antagonism or skepticism toward biotechnology. Moreover, unlike the 1987 and 1989 NRC committees, it contained few fellows of the Academy (two of 12 members). The EPA committee contained none, save the elderly, retired chairman. The members of the EPA committee and the invited reviewers of the EPA report were selected with disregard (or even a preference) for apparent conflicts of interest and known bias. The report on EPA oversight had a major impact: After seven years of opposition from the scientific community to the proposed rule, the Academy report offered sufficient cover for EPA to issue a final rule in 2001. A rule hugely debilitating to research and development, and one that regulators will never, ever relinquish. In a similar vein, the prestige of the Academy report on USDA's regulation virtually assures the permanence of stultifying, unscientific regulation at USDA that will unnecessarily inflate the costs of research and of commercialization of new plant varieties. Finally, the imprimatur of the Academy on such views will hamper possible U.S. challenges at the World Trade Organization of unscientific regulation (which is, by definition, a non-tariff trade barrier) by our trading partners. How can the United States challenge policies endorsed by the National Academy of Sciences and adopted by our own regulatory agencies? The federal government — as well as American society at large — now finds itself without an estimable, incorruptible, reliable source of advice on scientific, technological, and medical issues. How can Americans and American political institutions trust the veracity and integrity of future NAS assessments, on critical subjects ranging from air pollution to bioterrorism and national vaccine policy? Where can we turn now? — Henry I. Miller, a physician and molecular biologist, is a fellow at the Hoover Institution. He was an FDA official from 1979 to 1994. |
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National Academy of Sciences is a private, nonprofit, self-perpetuating
society of distinguished scientists and engineers "dedicated to the
furtherance of science and technology and to their use for the general
welfare." It regularly conducts studies for a variety of sponsors,
most often the federal government. Recent topics include: "Students
Are Safer in Buses Than Cars," "No Link Found Between Hepatitis
B Vaccine and Multiple Sclerosis," "Heavier Trucks Should Be
Permitted on Interstate Highways," and "Most Ocean Pollution
Not From Tanker or Pipeline Spills."
