U.S. Regulation of Genetically Modified Crops
Regulation of GM crops in the United States is divided among three regulatory agencies: the Environmental Projection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA). Each of these agencies regulates transgenic crops from a different perspective.
EPA regulates biopesticides, including Bt toxins, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). If a crop is genetically engineered to carry a gene for a Bt toxin, EPA requires the developer to verify that the toxin is safe for the environment and conduct a food-safety analysis to ensure that the foreign protein is not allergenic.1
FDA is responsible for regulating the safety of GM crops that are eaten by humans or animals. According to a policy established in 1992, FDA considers most GM crops as “substantially equivalent” to non-GM crops. In such cases, GM crops are designated as “Generally Recognized as Safe” under the Federal Food, Drug, and Cosmetic Act (FFDCA) and do not require pre-market approval. If, however, the insertion of a transgene into a food crop results in the expression of foreign proteins that differ significantly in structure, function, or quality from natural plant proteins and are potentially harmful to human health, FDA reserves the authority to apply more stringent provisions of FFDCA requiring the mandatory pre-market approval of food additives, whether or not they are the products of biotechnology.9
The FDA Consultative Process
In 1997, FDA established a voluntary consultation process with GM crop developers to review the determination of “substantial equivalence” before the crop is marketed, such as assessing the toxicity and allergenicity of the gene product and the plant itself. If the data in the food-safety assessment are satisfactory, FDA notifies the developer that marketing of the crop may proceed.
Critics have raised questions about whether this voluntary consultation process provides adequate assurance that GM crops are safe. In particular, the use of food crops like corn for the production of non-food products, such as pharmaceuticals, does not fall under FDA’s authority unless the gene product ends up contaminating a food crop, at which time the crop is considered adulterated and must be recalled. Because of this gap in regulatory authority, FDA may not perform appropriate oversight until it is too late.6
In 2004, Senator Dick Durbin (D-IL) introduced legislation that would have required any product grown in a food crop to receive pre-market approval, whether or not it was intended to be eaten. Thus, before any pharmaceutical was produced in a food crop, FDA’s Center for Food Safety and Applied Nutrition would conduct a food-safety analysis to ensure that accidental human exposure to the drug through the food supply will not cause health risks.9