TCS Daily

Kernels of Truth

By Henry I. Miller - June 29, 2005 12:00 AM

The world is going corn-crazy and maize-mad . . . again. Five years ago, there was near-hysteria over "contamination" of yellow corn and products made from it -- chips, tortillas, taco shells and the like -- with tiny amounts of a gene-spliced variety called StarLink. Federal regulators, who had approved the variety for livestock, but not human consumption, initiated a massive recall of more than 300 perfectly safe corn products, costing StarLink's producer more than $100 million and disrupting U.S. corn exports.

History is repeating itself. In March, it was reported that between 2001 and 2004 the Swiss agribusiness company Syngenta had inadvertently mislabeled and sold to American farmers small amounts of an unapproved corn variety called Bt10, as Bt11, an approved variety. The European Union and Japan are demanding that corn imported from the United States be tested and found to be free of Bt10.

However, except when sophisticated genetic tests are employed, Bt10 is indistinguishable from another government-approved and widely planted, insect-resistant variety, Bt11; the two differ only by the presence of an antibiotic-resistance gene and by a handful of nucleotides (the building blocks of DNA) in an inert region of the newly introduced gene that confers resistance to an insect called the corn borer - far less than the differences between various commercial varieties of corn. Moreover, both StarLink and Bt10 are actually far less likely than thousands of other products on the market to cause allergic or other health problems.

Predictably, anti-biotech groups have made a meal of this mishap, blaming both Syngenta and inadequate government regulation. As usual, they've missed the point. Syngenta is certainly culpable for having sold a variety that had not yet been approved - and the company deserves to be sanctioned - but the fundamental problem with both StarLink and Bt10 lies not with the industry or its products but with the Enivronmental Protection Agency's wrong-headed regulatory policies toward gene-spliced plants. The furor over such inconsequential incidents amounts to a monumental - and terribly costly - hoax.

Why costly? Even after it was obvious that StarLink posed no harm to consumers, EPA failed to establish tolerance levels for its presence in food - which, in turn, required FDA to recall harmless but technically "adulterated" foods that contained minuscule amounts of StarLink, subjecting the producer to legal liability. Although this situation was of no more concern than the presence of tiny amounts of non-iodized salt in boxes of the iodized variety, a class-action lawsuit alleging that consumers ate food unfit for human consumption resulted in a settlement against Aventis, StarLink's producer. In other words, the distribution of crops not approved for human consumption presents the risk of legal liability even if no consumer has suffered any toxic, allergic, or other health-related harm. What ever happened to the concept of "no harm, no foul?"

These kinds of kerfuffles are the inevitable result of regulations that treat gene-spliced products as though they pose some inherent, systematic, unique risks, when it is clear that they do not. Gene-splicing is an extension, or refinement, of less precise and predictable techniques for genetically improved products with which consumers and government regulators have long familiarity and comfort.

Gene-spliced food and other products are actually safer than those made with less precise techniques, but EPA holds gene-spliced foods to a higher standard than other similar foods. For gene-spliced crop and garden plants such as corn, wheat and tomatoes that have been genetically improved for enhanced pest- or disease-resistance, regulators require hugely expensive testing that actually exceeds what is required for toxic chemical pesticides. This policy fails to recognize that there are important differences between spraying synthetic, toxic chemicals, and genetic approaches to enhancing plants' natural pest and disease resistance.

EPA's policy is so damaging and outside scientific norms that it galvanized the scientific community. A consortium of dozens of scientific societies representing more than 180,000 biologists and food professionals published a report almost a decade ago warning that unscientific regulatory policy would discourage the development of new pest-resistant crops and prolong and increase the use of synthetic chemical pesticides, increase the regulatory burden for developers of pest-resistant crops, limit the use of biotechnology to larger developers who can pay the inflated regulatory costs, and handicap American companies competing in international markets. All of these misfortunes have come to pass.

Scientists worldwide agree that adding genes to plants does not make them less safe either to the environment or for humans to eat. Even so, activists and regulators have leveled their sights on gene-splicing, which is more precise, circumscribed and predictable than other techniques and can better exploit the subtleties of plant pathology. For example, both StarLink and Syngenta's Bt10 varieties were made by splicing into corn a bacterial gene that produces a protein toxic to corn borer insects, but not to people or other mammals. The gene-spliced corn not only repels pests, but when harvested is less likely to contain Fusarium, a toxic fungus often carried into plants by insects. That, in turn, significantly reduces the levels of the fungal toxin fumonisin, which is known to cause fatal diseases in horses and swine that eat infected corn, and esophageal cancer in humans. Thus, gene-spliced, insect-resistant corn is not only cheaper to produce but is a potential boon to public health; and, by reducing the need for spraying chemical pesticides on crops, it is environmentally friendly.

Policy makers have ignored a fundamental rule of regulation: that the degree of scrutiny of a product or activity should be commensurate with the risk. Instead, for agricultural research and development the degree of oversight of gene-splicing is inversely proportional to risk, but there is virtually no impetus from any quarter for rationalizing this deplorable status quo.

Flawed regulatory policy ensures that StarLink- and Bt10-like debacles will continue to occur. American farmers, companies and consumers will all reap what government regulators have sown.

Henry I. Miller, a fellow at the Hoover Institution and the Competitive Enterprise Institute, headed the FDA's Office of Biotechnology from 1989-1993. His latest book, The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution, was picked by Barron's as one of the Best 25 Books of 2004.

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