CHILDREN OF THE CORN: TOO MUCH STARCH IN THE REGULATION OF GENE-SPLICED FOODS

By HENRY I. MILLER, M.D.

On September 18, a coalition of environmental groups reported that tests of Kraft Foods' Taco Bell Originals taco shells had detected genetically engineered corn containing a protein called Cry9C. This bacterial protein, introduced into corn with gene-splicing techniques, has not been approved for human consumption ONLY because of a theoretical possibility that it could cause an allergic reaction in humans. Accordingly, after the report was issued, Kraft Foods recalled the taco shells from markets.

Kraft's voluntary recall was appropriate damage control by a company that may be in violation of approval granted by a regulatory agency, in this case the Environmental Protection Agency. But there's more to the story. The taco shells are actually far less likely than thousands of other products on the market to cause allergy or any other health problem. For example, occasionally peanuts -- a known, potent allergen for some people -- contaminate a product that is supposed to be "peanut-free." In contrast, no allergenicity, toxicity, or any other problem has been demonstrated with Cry9c or any similar substance. Nevertheless, the EPA's policy is to consider such molecules guilty until proven innocent. As I will argue, that policy makes little sense.

The EPA's Illogical Policy on Gene-Spliced Foods, and the Scientific Backlash

The underlying problem is that the EPA and other government agencies hold gene-spliced foods to a much higher standard than other, similar foods, making it more likely that companies producing these foods will occasionally trip up. But the imposition of this higher standard on a superior, highly priced technology makes little sense, because it does not improve consumer safety at all.

The EPA policy in question requires the testing and review, as if they were pesticides, of gene-spliced crop and garden plants such as corn, cotton, wheat, and marigolds, that have been modified for enhanced pest or disease resistance. The policy fails to recognize that there is a difference between spraying synthetic, toxic chemicals and applying genetic approaches to enhancing plants' natural pest and disease resistance.

EPA's policy is so potentially damaging and outside scientific norms that it has galvanized the scientific community. Eleven major scientific societies, representing more than 80,000 biologists and food professionals, published a report warning that the EPA 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 the United States in competition for international markets.

The Consensus about the Safety of Gene-Splicing

Scientists worldwide agree that adding genes to plants does not make them less safe, either to the environment or to humans. Dozens of new plant varieties produced through hybridization and other traditional methods of genetic modification enter the marketplace each year, without scientific review or special labeling. Many such products are from "wide crosses'' - that is, hybridizations in which genes are moved from one species or one genus to another to create a variety of plant that does not and cannot exist in nature. While the changes may sound dramatic, the results are as mundane as a tomato that is more resistant to disease or has a thicker skin that won't be damaged during mechanical picking.

Gene-splicing is actually safer than hybridization, because its results are more precise, circumscribed, and predictable, and because it takes advantage of the subtleties of plant pathology. The so-called ``Bt corn'' in the recalled taco shells is a good example. It was made by splicing in a bacterial gene that produces a protein that is toxic to corn borer pests, but not to people or other mammals. The gene-spliced corn not only repels pests, but it also is less likely to contain Fusarium, a toxic fungus often carried into the plants by the insects. This in turn reduces the levels of the fungal toxin fumonisin, which is known to cause fatal diseases such as esophageal cancer in humans. Thus, gene-spliced corn is not only cheaper to produce but is a potential boon to public health.

Excessive, Discriminatory Regulation Of Gene-Spliced Foods

These agencies have imposed upon gene-spliced foods requirements that could not possibly be met by conventionally bred crop plants. For example, commercial varieties of wheat used for bread are bred to contain genes from several hardy wild grasses, in order to make them resistant to certain fungi and also to increase the amount of protein in the kernel. Hundreds or thousands of genes have been transferred during these crosses, with little characterization of their identity or function possible, and with little probability of predicting obscure problems. There is no way these conventionally produced foods could meet the strictures imposed on gene-spliced plants. Nevertheless, these conventional varieties of wheat routinely go into field trials and onto our bread plates without any government scrutiny, screening, testing, or labeling.

However, for the more precisely crafted - and safer - gene-spliced crops, new varieties must be exhaustively, repeatedly, and expensively reviewed before they go into the field or enter the food supply. Meanwhile, the potentially more dangerous, "natural" products undergo no review at all.

In other words, from a scientific vantage point, federal regulators have the paradigm exactly backwards, ignoring a fundamental rule of regulation: that the degree of scrutiny of a product or activity should be commensurate with the risk.

Rather than punish Kraft for marketing taco shells that contain an improved, insect resistant, low- fungal-toxin, potentially more healthful corn, we should "craft" federal regulation so that biotech's shackles are removed. Its regulation would then make more sense, cost less, and maximize benefits to the consumer.


Henry Miller is a fellow at the Hoover Institution and an adjunct scholar at the Competitive Enterprise Institute. He was an FDA official from 1979 to 1994 and is the author of "To America's Health: A Proposal to Reform the Food and Drug Administration."

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