Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products

Three federal agencies--the Food and Drug Administration, the Department of Agriculture and the Environmental Protection Agency--have primary responsibility for the regulation of biotechnology products. At least ten different laws and numerous agency regulations and guidelines cover such products as food, animal feed, human and animal drugs and biologics, pesticides, plant pests and toxic substances. Each of these laws was developed before the advent of biotechnology products and reflects widely different regulatory approaches and procedures.

This report is intended to provide a general descriptive guide to the current set of U.S. laws and regulations under which products of biotechnology are reviewed for health, safety, efficacy, or environmental impacts. It focuses primarily on agricultural biotechnology, defined for the purpose of the report to mean the use of rDNA techniques to modify plants and animals traditionally used as food or fiber sources.