The Academy Takes a Dive

Thursday, January 30, 2003

The National Academy of Sciences (NAS), a private, nonprofit, self-perpetuating society of distinguished scientists and engineers, is often in the news. Its 1863 charter commits it “to the furtherance of science and technology and to their use for the general welfare” and to “advise the federal government on scientific and technical matters”; thus the NAS conducts studies on a broad range of subjects related to science and technology. Most of these are sponsored (that is to say, paid for) by the federal government.

Recent studies include topics as diverse and weighty as “More Study Is Needed Before Utah Uranium Is Sealed or Moved,” “No Link Found between Hepatitis B Vaccine and Multiple Sclerosis,” “U.S. Should Restore Lands Near Lakes, Rivers, and Oceans,” “Heavier Trucks Should Be Permitted on Interstate Highways,” and “Most Ocean Pollution Not from Tanker or Pipeline Spills.” It is generally assumed that these analyses are unbiased and performed by disinterested experts and that they are, therefore, a benchmark for accuracy and objectivity. Consequently, NAS studies are widely cited by the media and relied on by Congress and by executive branch agencies for the formulation of legislation and policy. These reports thus affect the allocation and expenditure of hundreds of billions of dollars in both the public and the private sectors.

Although much of the NAS’s work is highly regarded, two recent “expert” committees that were to assess the scientific integrity of governmental regulation of biotechnology have been plagued by apparent bias, with the result that their analyses are problematic. It appears that, in this critical area, the NAS offers scientific advice to government agencies on the same terms that Burger King offers hamburgers—you pay your money and you “get it your way.”

These two NAS committees—working under the auspices of the National Research Council (NRC), the research arm of the NAS—conferred the NAS’s imprimatur on two questionable analyses of federal biotechnology regulatory policy toward field trials and the commercialization of recombinant DNA–modified plants. First came a report in 2000 concerning oversight by the Environmental Protection Agency (EPA), followed in 2002 by another on regulation by the U.S. Department of Agriculture (paid for by the USDA). These reports have already caused mischief by serving as the basis for unscientific, inconsistent, and excessively burdensome new regulatory proposals from the Bush administration.

The Academy Endorses Unscientific Policies

The USDA regulates plants, plant products, and other organisms that may introduce plant diseases or pests. The approach is risk-based: Each entity either is on a proscribed list of known plant pests—and therefore requires a permit—or is exempt. For the past 15 years, the 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 contains any amount of DNA from a plant pest—even a minuscule snippet that is incapable of causing disease or other hazards. Regulated articles are disproportionately expensive to develop and test, meaning that 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 proposed to regulate plants that had been genetically improved to enhance resistance to pests or disease—but only if gene-splicing techniques were used. Plants modified with less-precise techniques were exempt from regulation.

In this way, the EPA is holding gene-splicing technology to an inappropriate standard, requiring hugely expensive testing of gene-spliced crop and garden plants, such as cotton, corn, tomatoes, and grapes, 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 by products of conventionally bred—and less-precisely crafted—crop plants. Its policies fail to recognize the 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 human consumption. 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 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 themselves—have repeatedly addressed the questions of whether risks associated with gene-spliced organisms are unique and whether they require special oversight. Their results have been remarkably consistent. A 1987 NAS 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 NRC 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—of previous techniques, and its use generates less uncertainty, leading the committee to conclude that “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 NRC 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 NRC 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 NAS 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.

The committee claims, for example, that there is greater risk from gene splicing than from 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 committee 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 both the nature of the DNA that is transferred and the mechanisms for enhancing the host’s resistance to pests and diseases are largely unknown, would grind to a halt if the USDA’s regulatory approach were applied to it. (The chairman of the NAS committee conceded that such requirements would “bankrupt” conventional plant breeders—just as it will many of those who use gene-splicing techniques.) On the basis of such reasoning, the NAS committee recommends continued compulsory case-by-case oversight by the 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 resistance to pests or disease—was similarly defective. This 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 11 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 NRC report 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 [italics added].” There is a logical inconsistency here.

How could the NAS 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 scandalous Black Sox World Series of 1919, the game was fixed. The USDA committee was stacked with members known to harbor antagonism or skepticism toward biotechnology. Moreover, unlike other NRC committees (including those that had studied biotech previously), it contained few NAS fellows (2 of 12 members). The EPA committee contained just one NAS fellow: its elderly, retired chairman. The members of the EPA committee and the invited reviewers of the EPA report were selected with a disregard (or even a preference) for apparent conflicts of interest and known bias.

The response of the NAS to these criticisms is both noteworthy and risible. The NAS concedes 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; and the NRC itself has concluded that, because gene-splicing is so precise and well-characterized, with “organisms modified by molecular methods, we are in a better, if not perfect, position to predict their characteristics.” But the authors of the NAS’s response incorrectly conclude that there are “two options: regulate all plant varieties or regulate none” and that, because both options are unacceptable, a tiered approach applicable only to gene-spliced plants is the logical solution. However, long-standing, risk-based federal regulations and models described in the scientific literature illustrate that this is a false dichotomy.

To circumscribe what needs to be regulated, the long-standing USDA regulations for experiments with plants (whether genetically modified or not) incorporate an inclusive list of organisms that are plant pests or that harbor them. This approach is essentially binary: Either a plant or micro-organism that an investigator might wish to introduce into the field is on the proscribed, inclusive list of plants pests—and therefore requires a permit—or it’s exempt. This approach focuses on products, not processes, and 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 considered to be plant pests. This two-tiered approach could easily have been expanded to encompass gene-spliced plants.

Several years ago, the Stanford University Project on Regulation of Agricultural Introductions (on which I was a principal investigator) described a widely applicable regulatory model for field-testing any organism, whatever the methods employed in its construction. It is based on the stratification (by panels of experts) of various organisms into risk categories—a multitiered variation of the USDA’s binary approach. This model offers regulatory bodies a highly adaptable, scientific method for field-testing potential agricultural crops or other organisms. The approach is applicable to any organism, whether unmodified, an “exotic,” or genetically improved by either old or new techniques. Moreover, the model is sufficiently flexible that the stringency of regulation may be varied, 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 most currently reviewed gene-spliced organisms would likely become exempt.

Finally, it is astonishing that the NAS neglected to address having stacked the committees that produced the flawed reports with anti-biotechnology ideologues and others with clear conflicts of interest.

Where Can We Turn?

The report on EPA oversight had a major impact. After seven years of opposition from the scientific community to the proposed rule, the NRC report offered sufficient cover for the EPA to issue a final rule in 2001 that is hugely debilitating to research and development and that regulators will never relinquish.

In a similar vein, the prestige of the NRC report on USDA regulation virtually ensures the permanence of stultifying, unscientific regulation at the USDA that will unnecessarily inflate the costs of research and the commercialization of new plant varieties.

Finally, the imprimatur of the NAS on such views will hamper possible U.S. challenges at the World Trade Organization to unscientific regulation (which is, by definition, a nontariff trade barrier) by our trading partners. How can the United States challenge policies endorsed by the NAS and adopted by our own regulatory agencies?

The federal government—as well as American society at large—now finds itself without a reliable and incorruptible 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 to national vaccine policy?

Where can we turn now?