Second Joint Symposium on Food Safety and Nutrition:
Current Issues in Food Biotechnology

Stanley H. Abramson
Arent Fox Kintner Plotkin & Kahn, PLLC, Washington, DC 20036

Any meaningful discussion of biotechnology-derived crops must begin with the recognition of just how ill-prepared the general public is to grapple with issues related to food production and microbiology. Most people living in the developed world have little or no concept of how their food gets from the farm to the table and virtually no understanding of the science of genetics. The recent controversy over the StarLinkÔ variety of corn will ultimately serve as an important step in a learning process that is long overdue. Certainly there is enough blame to go around for government as well as industry when it comes to StarLink. But in contrast to the well documented risks associated with other food scares, including bacterial contamination and BSE, the economic losses resulting from the discovery that trace amounts of StarLink corn were present in the food supply are based on the perception rather than the reality of risk.

StarLink is one of several varieties of corn developed using techniques of modern biotechnology. In this case, corn has been engineered to produce a protein that protects the ear from the European corn borer. The protein is derived from a common soil microorganism, Bacillus thuringiensis or "B.t.," whose insecticidal properties have been known for over 100 years. Conventional and organic farmers alike value the use of conventional B.t. sprays because B.t. is a natural product and leaves no chemical residue. But the greatest value of the B.t. protein is that, in contrast to chemical insecticides, it targets only caterpillars - the protein is essentially harmless to other insects and completely nontoxic to birds, fish, humans and other mammals. Unfortunately, because the sprayed version breaks down rapidly in sunlight and washes off plants easily, its ability to stop the corn borer is limited.

Looking for a better way to protect valuable crops, researchers began to transfer B.t. genes into plant cells and grow B.t. plants in carefully controlled laboratory tests in the mid-1980's. Of course many plants produce their own protective proteins and the traits of insect and disease resistance have been bred into crops for years by conventional means without government oversight. But the U.S. had decided back in 1986 that biotechnology-derived crops that have pesticidal properties would be subject to review by three different regulatory agencies - USDA, EPA and FDA. The decision to regulate was not made because these crops are inherently riskier than conventional hybrids. Indeed the NAS has consistently found no evidence to suggest that unique hazards exist either in the use of genetic engineering or in the movement of genes between unrelated organisms. Rather regulation was provided largely in response to public perceptions concerning the novelty and potential power of genetic engineering. Beginning in 1988, hundreds of field tests were conducted under government supervision and volumes of health, safety and environmental data were submitted for review. Finally, between 1995 and 1998, about a dozen B.t. plant products were cleared for commercial introduction. Recognizing the value of lower crop losses and decreased pesticide usage, U.S. farmers were quick to adopt the new varieties, planting B.t. corn on over 25 million acres by 1999.

Much has been said about the potential adverse effects of B.t. corn. Allegations of environmental harm ranging from dwindling Monarch butterfly populations to B.t. resistant caterpillars have been carefully considered and ultimately rejected by the EPA based on sound science rather than political posturing or media hype. Public health concerns have been virtually nonexistent for B.t. crops and millions of people have eaten products made from B.t. corn without apparent difficulty. Indeed, after years of intensive governmental, commercial and academic oversight, not a single instance of actual harm to health, safety or the environment has ever been confirmed for any biotechnology crop on the market today.

So why is StarLink any different? While the protein in StarLink is nontoxic, it appears to break down somewhat slower than other B.t. proteins in simulations of the human digestive system leading some to speculate that it might cause allergic reactions in sensitive individuals. As a result, EPA approved StarLink for use in animal feed, but withheld approval for human consumption until these concerns could be addressed. Conditions were imposed on StarLink's producer, Aventis, and a stewardship program was put in place to segregate StarLink seeds, fields and harvests. Less than one-half of one percent of U.S. corn acreage was planted with StarLink in the 1999 and 2000 crop years. We now know that an even smaller percentage of StarLink was inadvertently commingled with other yellow corn.

Because of the manner in which commodities like yellow corn are handled after harvest and the relative ease of finding trace amounts of stray genetic material in the food supply, it was apparently not difficult for a miniscule amount of StarLink to contaminate relatively large quantities of grain, flour and finished goods, particularly dry-milled products. For that reason, and in light of the heavy publicity that ensued, it is particularly noteworthy that less than 50 reports of allergic reactions were received by the government nationwide. Nevertheless, without any confirmation that those reports were based on exposure to the StarLink protein or reflected a true allergenic response, Aventis withdrew the product from the market, voluntarily cancelled its EPA registration, retrieved over 90 percent of the 2000 crop and agreed to provide compensation for losses suffered by growers and elevators at a cost of hundreds of millions of dollars.

Benefits may yet emerge from the StarLink episode. Certainly it has lead to discussion of the future handling of biotechnology-derived commodities. In hindsight, industry and government agree that B.t. and other pesticidal proteins will be approved in commodity grains only after all requirements have been met for both human and animal consumption. For those products that are approved, the biotechnology, grain and food industries agree that validated test methods for detecting biotechnology-derived proteins in grain should be in place and accessible at the time the product goes on the market. In order to avoid the costs and adverse publicity of another StarLink, technology providers, seed companies and growers will all be compelled to institute significantly enhanced product stewardship programs. Finally, it is generally agreed that better techniques are needed for assessing the potential allergenicity of new foods and food ingredients, whether produced through genetic engineering or conventional means.

The introduction of any new product or technology is not risk free. Exercising a cautious approach to products of biotechnology, the United States established a regulatory framework to minimize the chance that biotechnology-derived crops would ever adversely affect health, safety or the environment. The StarLink episode has already served to strengthen that framework in spite of the fact that no adverse effects have been confirmed for StarLink corn or any other biotechnology-derived crop on the market today.

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