Biosafety Review and Environmental Assessment for the Field Release of Genetically Engineered crop Plants and Microbes in the United States1

The United States Department of Agriculture (USDA), Food and Drug Administration (FDA), and Environmental Protection Agency (EPA) are the focal points biosafety regulations for field testing and release of genetically engineered plants in the United States. Public interest advocacy groups, environmental activist, and industry and consumer groups also play a role in the development of biosafety regulations. Before release of transgenic plants, applications are made to Animal and Plant Health Inspection Services (APHIS) for field testing or importation of genetically engineered organisms, after which an environmental assessment is prepared to evaluate the potential impact of the release of the transgenic organism (crop) into the environment. The first genetically engineered crop, the FLAVRSAVR variety of tomatoes, is now on market, and many more are in the pipeline to commercialization.