Genetically Modified Foods: Recent Developments: Regulation

The U.S. government agencies treat GM foods as substantially equivalent to those produced through traditional means if the GM variety does not introduce allergens or substantially alter the nutritional value of the food. The objective of such an approach is not to establish absolute safety but to consider whether a GM food is as safe as its conventional, generally recognized as safe, counterpart. The 1986 “Coordinated Framework for Regulation of Biotechnology” reflected a position that GM foods could be adequately regulated through the existing federal infrastructure by adapting existing laws to these new technologies. Under the Coordinated Framework, the responsibilities for evaluating and regulating GM organisms is divided among the FDA, the USDA, mainly through the Animal and Plant Health Inspection Service (APHIS), and the U.S. Environmental Protection Agency (EPA). Depending on its characteristics, a product may be subject to review by one or more of these agencies; their responsibilities are usually complementary, but in some cases, their responsibilities overlap. Before humans or animals can consume a new GM crop variety, the FDA must evaluate its safety. The USDA monitors field trials and evaluates the potential impact of widespread environmental release of the plant. The EPA investigates the pesticide levels in GM crops; this jurisdiction extends to both human health and environmental impacts of the pesticide. While the United States has adopted a policy of substantial equivalence, other countries adhere to a precautionary principle in their regulations. As such, there are remarkable differences in regulations for GM foods around the world, often leading to international political and legal disputes surrounding international trade and environmental law.