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them. As discussed in chapter 8, allergenicity and other safety concerns about transgenic foods raise complex regulatory issues. Under a policy developed by the FDA in 1992, the company was encouraged—but not required—to consult FDA staff about the need to test products before marketing them.18 Pioneer Hi-Bred, a company with a long tradition of ethical practice dating back to the days of its founder, Henry Wallace, did so voluntarily. Once testing revealed the allergenicity of the transgenic protein, FDA policy required the company to label its soybeans as genetically modified. Although the soybeans were intended for chicken feed, the company could not imagine how the beans could be kept separate from the human food supply, and it withdrew them.

In this unique instance, the company recognized that the gene donor came from a food known to be allergenic, was able to obtain blood samples from people allergic to Brazil nuts, and ended the project. Supporters of the FDA policy interpreted these events as a demonstration of its effectiveness; the soybeans never entered the food supply. Others, however, thought that this case proved that the FDA policy favored industry and could not protect consumers against less well studied transgenic proteins. The next case might not be so ideal, and the public less fortunate. Transgenic foods do not have to be labeled (see chapter 7), and avoidance is often the only effective way to prevent food allergies. Without labels, people with food allergies have no choice.

In 1993, the FDA asked for public comment on whether and how to label food allergens in transgenic foods and held a conference the next year to consider developing rules on this issue. The agency never released such rules, however, almost certainly because of industry pressure. The initial FDA proposals required “premarket notification”—informing the agency in advance about development of transgenic foods—but the biotechnology industry objected. Industry leaders wanted limits on any rules governing the safety of transgenic allergens and demanded that they “sunset” (be withdrawn and disappear) after three years.19 Since then, international groups have had problems reaching consensus on the level of risk posed by transgenic allergens but do agree about how to minimize risk: developers should gradually introduce products into test markets and then monitor their effects.13 This approach, no matter how sensible, will not be easy to implement. The unresolved status of FDA policy on transgenic allergenicity means that the industry retains voluntary responsibility for protecting the public against uncommon or unidentified allergens in genetically modified foods.

One especially ironic aspect of this situation is that the food biotechnology industry, in achieving an unregulated marketplace, made itself vulnerable to charges of producing allergens (through lack of testing) and covering up the hazards of transgenic foods (through lack of labeling). The StarLink corn episode illustrates this irony. Pioneer Hi-Bred knew in 1996 that soybeans intended for chicken feed could not possibly be kept separate from those intended for human consumption. As described in the introductory chapter, both Aventis and the Environmental Protection Agency (EPA) ignored this lesson at great cost. With their success in finding evidence of StarLink corn in common food products and revealing gaps in the regulatory system for genetically modified foods, advocates could use allergenicity—a safety issue—as a means to oppose the industry’s economic and political goals. StarLink’s owner could not demonstrate the safety of the corn to the satisfaction of EPA advisory committees and was forced to withdraw it from the market, albeit too late.20 Supposedly scientific arguments about the degree to which transgenic foods might be allergenic reflect underlying concerns—less easily debated—about who is entitled to decide what people eat.

Antibiotic Resistance

A second legitimate safety issue is antibiotic resistance. In chapter 1, we saw how the routine use of antibiotics