The Bush Administration Deals a Blow to Biotechnology—and to Itself

Tuesday, October 30, 2001

persistent complaint about the Bush administration, according to polls, is that its policies too often favor the interests of big business over those of consumers. These criticisms of "deregulatory" policies usually have been ill-founded, but on July 19 the EPA issued a regulation that is genuinely anticonsumer, antienvironment, and antifarmer. The only beneficiaries will be a handful of big agribusiness companies and the regulators themselves.

Ironically, but not surprisingly, the usual critics of the administration’s policies love it.

The subject of the regulation—the use of gene-splicing techniques to enhance the intrinsic pest resistance of crop and garden plants—offers a safe, viable alternative to chemical pesticides; but the testing and commercialization of these plants have been systematically obstructed since 1994, when the EPA first proposed to regulate them as though they were dangerous chemical pesticides. These innovative new varieties have already demonstrated their commercial, environmental, and public health benefits. An example is gene-spliced Bt-cotton, which differs from other varieties by the presence of a single protein from a bacterium called Bacillus thuringiensis (Bt). The protein, made by a gene transferred to the cotton plant by gene-splicing techniques, is toxic to certain insects but not to humans or other mammals. The approach is not new: for decades, preparations of live Bt bacteria have been sprayed onto plants by home gardeners and commercial farmers, with an admirable record of both safety and effectiveness.

The Bt-cotton is used to control several major pests, including the cotton and pink bollworm and the tobacco budworm, which account for a quarter of all losses due to pest infestations, costing farmers more than $150 million annually. In 1999, states that had a high rate of adoption of Bt-cotton showed a significant reduction in the need to treat fields with chemical pesticides; treatments were cut from an average of three treatments per acre to about one and a half. Bt-cotton has eliminated the need for more than two million pounds of chemical pesticides since it was introduced in 1996.

In purely economic terms, the aggregate advantage to cotton farmers nationally—the net value of crops not lost to pests, savings in pesticides, and so on—is in the range of $100–$150 million a year.

But the economic benefits pale beside the environmental advantages. Three of the chemicals that must be used in much greater amounts on conventional, non-Bt-cotton—endosulfan, methyl parathion, and profenos—are thought to have negative effects on birds, fish, and other aquatic organisms.

The adoption of Bt-cotton and the resulting lessened need for chemical pesticides also reduces occupational exposures to the toxic chemicals by workers who mix, load, and apply the pesticides and perform other activities that require their presence in the field. Moreover, the smaller amounts of pesticides that are applied, the less runoff into waterways, a major problem in many farming regions.

Since it was introduced in 1996, Bt-cotton—a new form of genetically spliced cotton—has eliminated the need for more than two million pounds of chemical pesticides.

Another agricultural threat amenable to these genetic approaches is the growing infestation of California’s grapevines by Pierce’s disease, a bacterial infection spread by a leaf-hopping insect, the glassy-winged sharpshooter. The introduction of new vines with enhanced genetic resistance to either the bacterium or the insect is a promising strategy. For example, one can transfer genes that confer resistance into California’s grapes from distantly related, noncommercial grapes that have natural immunity. But conventional grape breeding is a notoriously slow process, and attempts to use the more sophisticated and efficient gene-splicing techniques have run afoul of the just-finalized EPA regulatory policy; as does the approach of University of Florida researchers who have patented a group of resistant genes that are a synthetic version of those found in a variety of organisms; and as does another gene-splicing trick that could permit new vines to bear fruit years earlier than usual.

Federal regulation of gene-spliced plants is inconsistent and discriminatory and bears no proportionality to risk. In fact, there is arguably an inverse proportionality to risk, in that the more precisely crafted and more predictable gene-spliced organisms are subjected to far more stringent regulation than more crudely crafted organisms. This violates a cardinal principle of regulation: that the degree of regulatory scrutiny should be commensurate with the risk. The EPA holds the new technology to an inappropriate standard, requiring hugely expensive testing of gene-spliced crop and garden plants, such as cotton, grapes, and tomatoes, 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 crop 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.

Science versus Politics

By way of background, there is a broad and long-standing scientific consensus about the continuum between conventional and new biotechnology, which was capsulized in an authoritative 1989 analysis of the new biotechnology by the United States National Research Council: "With classical techniques of gene transfer, a variable number of genes can be transferred, the number depending on the mechanism of transfer; but predicting the precise number or the traits that have been transferred is difficult, and we cannot always predict the [behavior] that will result. With organisms modified by molecular methods, we are in a better, if not perfect, position to predict [their behavior]." A 1992 editorial in the distinguished scientific journal Nature made a similar point: "The same physical and biological laws govern the response of organisms modified by modern molecular and cellular methods and those produced by classical methods," and therefore, "no conceptual distinction exists between genetic modification of plants and microorganisms by classical methods or by molecular techniques that modify DNA and transfer genes."

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. For example, Triticum agropyrotriticum is a new man-made "species" of wheat that resulted from combining genes from bread wheat and a grass sometimes called quackgrass or couchgrass. Possessing all the chromosomes of wheat and one extra whole genome from the quackgrass (containing tens of thousands of genes), T. agropyrotriticum has been independently produced in the former Soviet Union, Canada, the United States, France, Germany, and China and is grown for both human food and animal feed. (If a single gene from quackgrass were introduced into wheat by gene-splicing techniques, however, the resulting plant would be subject to the EPA’s draconian review and licensing process for pesticides.)

The EPA’s policy is so potentially damaging and outside scientific norms that it has galvanized the scientific community, which has repeatedly and unequivocally condemned the agency’s approach. Dozens of major scientific societies representing more than 100,000 biologists and food professionals have warned that the EPA policy discourages the development of new pest-resistant crops, prolongs and increases the use of synthetic chemical pesticides, increases the regulatory burden for developers of pest-resistant crops, expands federal and state bureaucracy, limits the use of biotechnology to larger developers who can pay the inflated regulatory costs, and handicaps the United States in competition for international markets.

The EPA’s draconian overregulation of genetically spliced plants violates a cardinal principle of regulation: that the degree of regulatory scrutiny should be commensurate with the risk.

As predicted, the EPA’s policy has already caused extraordinary mischief: a prime example is the recall of corn products found to contain minuscule amounts of a gene-spliced corn variety called StarLink, which differs from other commercial varieties by containing a protein called Cry9C. This bacterial protein, introduced into corn with gene-splicing techniques, was approved by the EPA for animal feed but not for human consumption because, although it does not resemble known allergens, it was not immediately degraded in digestion tests. (Most food allergens are not readily digested, so the EPA wanted more data before concluding that consumers could not be allergic to the protein.)

However, the food products in question are actually far less likely than thousands of other products available on the market to cause allergic or other health problems. Tens of millions of Americans report that they are allergic to peanuts, for example, and hundreds die annually from anaphylaxis; and fava beans, a fixture of upscale restaurant cuisine in North America and Europe, can be life-threatening to persons with a relatively common hereditary enzyme deficiency. Unlike those situations, however, even after exhaustive testing, no allergic reactions, toxicity, or any other problem has been demonstrated with Cry9C or any substance similar to it.

The EPA’s policy on gene-splicing lies so far outside scientific norms that it has galvanized the scientific community, which has repeatedly and unequivocally condemned the agency’s approach.

The ripple effect of this StarLink nonproblem is monumental and growing. Because the EPA classified Cry9C as a pesticide, FDA was forced to recall the hundreds of products found to contain minute traces of it. (EPA sets acceptable pesticide residue levels and FDA enforces them.) "Contamination" with StarLink’s Cry9C has been found in corn exported to Japan, which annually imports about 16 million tons of U.S. feed corn (worth around $2 billion) and has a policy of "zero tolerance" for the banned variety (and considers violations to be criminal). The Japanese Ministry of Agriculture, Forestry and Fisheries finally accepted a baroque U.S. plan for testing corn exports to ensure that they are free from StarLink.

The EPA’s Tortured Logic

The just-finalized regulation concerned with gene-spliced plants is not the first time that biotechnology (and society) has been a victim of EPA’s wrong-headed policymaking. In 1997, the agency issued a regulation under the Toxic Substances Control Act, the effect of which has been to halt most research into any "new’’ microorganism—defined inexplicably as one containing combinations of DNA from unrelated sources—that might be used, for example, to degrade oil spills or clean up toxic wastes. For EPA, "newness" is synonymous with risk, and because gene-splicing techniques can easily be used to create new gene combinations with DNA from disparate sources, these techniques "have the greatest potential to pose risks to people or the environment," according to the agency’s tortured logic. As described above, however, a broad scientific consensus disagrees, holding that the genetic technique employed is irrelevant to risk, as is the origin of a snippet of DNA that may be moved from one organism to another; what matters is its function.

The EPA is promoting the interests of big agribusiness companies at the expense of the public interest.

The final regulation on gene-spliced plants emerges at a time when the Bush administration is still operating with a skeleton crew, one that includes a scientifically challenged EPA chief, Christine Todd Whitman, and her deputy, Linda Fisher, a former Monsanto senior executive who continues to promote industry’s interests at the expense of the public interest. The vast expense of the EPA’s policy—actually a kind of punitive tax—acts as a market-entry barrier to seed and biotech companies undertaking gene-splicing research, so big agribusiness companies and the monolithic Biotechnology Industry Organization have lobbied hard for it.

Little can be done in the short run to remedy this public policy debacle. Even a direct order from the president to revise the policy and undertake remedial rule making would likely be ignored by tenured bureaucrats—and would take years, in any case. Getting the current regulation written and published took more than seven years—with the EPA and the Clinton White House strongly behind it.

EPA’s inept approach to biotechnology is not an anomaly. The agency has been widely criticized for being inefficient and unscientific. When the Office of Management and Budget analyzed the cost-effectiveness of a panoply of regulations throughout the federal government, of the 30 least cost-effective regulations on the list, no fewer than 17 had been imposed by the EPA. This impression of inefficiency is reinforced in an analysis by Washington, D.C.–based Resources for the Future (RFF) of eight major EPA regulatory programs of the past two decades. RFF concluded that the science behind the policy often gets distorted or ignored: "EPA for a variety of reasons is unwilling, unable, and unequipped to address and acknowledge the uncertainties in the underlying science."

EPA administrator Whitman should be put on notice that she is on probation, that another major blunder will result in President Bush "accepting her resignation," as the euphemism goes. And Ms. Fisher should depart now, before she does further damage.

The new EPA regulation is only one symptom of the rot within, but it is a serious one. It ensures that the potential of biotechnology applied to agriculture and food production is tarnished. So is the health of the environment. And so is the reputation of the Bush White House.