Safe Food_ Bacteria, Biotechnology, and Bioterrorism - Marion Nestle [118]
The Coordinated Framework applies to foods as well as drugs and assigns three agencies to their regulation, two at the cabinet level—the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA)—and a subagency of a third (the Department of Health and Human Services), the Food and Drug Administration (FDA). Genetically modified foods, however, do not easily fit into the existing regulatory categories of these agencies, leaving much room for interpretation. Moreover, the three agencies operate under different laws. The Plant Pest Act allows the USDA to regulate transgenic crops as plant pests when they contain genes or regulatory DNA segments from potentially harmful organisms: insects, nematodes, slugs, and snails, but also bacteria, fungi, and viruses. Because just about all gene donors are on this list, most transgenic plants require USDA permits to allow them to be field-tested, transported through interstate commerce, or imported. Over time, the USDA has modified its regulations to make it easier for companies to plant genetically engineered crops without having to obtain permits.2
In contrast, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires the EPA to “register” transgenic foods as plant-pesticides (or, as they are now called, plant-incorporated protectants). If a crop is bioengineered to contain the toxin from Bacillus thuringiensis (Bt), for example, the EPA considers it to contain a pesticide and regulates the plant as it would any pesticidal chemical. Ordinarily, makers of Bt crops must submit voluminous information about the toxin’s effects on health and the environment, but the EPA can and does grant exceptions.
To further complicate matters, the FDA regulates transgenic foods as food additives under the provisions of the Food, Drug, and Cosmetic Act. Unless food additives are generally recognized as safe (GRAS), meaning that they have a history of safe use, they require premarket approval; manufacturers must submit evidence demonstrating “reasonable certainty” that an additive will not be harmful if used appropriately. In practice, the FDA has jurisdiction over all genetically modified foods, although it shares regulatory authority over plants that have to be field-tested or transported across state lines with USDA, and those containing the Bt toxin with EPA. Dealing separately with two—let alone three—agencies is guaranteed to be a lengthy, complicated, and expensive process, and food biotechnology companies complain that the regulations are cumbersome and restrictive. They also complain that the regulations are contrary to the intention of the Coordinated Framework because they hold genetically modified foods to higher safety standards than conventional foods.3 To evaluate such contentions, let’s begin by examining the FDA’s role in regulating transgenic foods and the ways in which the biotechnology industry has influenced that role.
THE FDA’S “SCIENCE-BASED” APPROACH
The FDA’s main function is to regulate drugs, and its food activities are decidedly secondary. By the early 1990s, the FDA had approved at least 15 recombinant drugs for medical use, with recombinant insulin among the earliest in 1982. The benefits of many of these drugs seem evident. Recombinant insulin, unlike that obtained from pigs, has an amino acid structure identical to that of human insulin and can be produced in unlimited quantities. So can recombinant enzymes used in food manufacture such as chymosin, an enzyme used to coagulate milk in the early steps of cheese making. In the past, cheese makers obtained chymosin