Usda Regulations For Transgenic Organisms

The USDA regulation of organisms and products developed through biotechnology is, in general, related to the Department's mandate from the U.S. Congress to protect the nation's plant and animal health. Under the authority granted by the Federal Plant Pest Act and the Plant Quarantine Act, the USDA regulates the movement into and through the United States of plants, plant products, plant pests and any product or article which may contain a plant pest at the time of movement. Under this broad authority, the USDA regulates a number of potential food products of biotechnology and products used in food animals, inclu'ding: 1) transgenic plants and microorganisms; 2) veterinary biological products developed through biotechnology. 3) animals used in biotechnology research. The Federal policy statement on biotechnology regulation that was published in final form in June 1986 contains several main elements: 1) the products of recombinant DNA technology will not differ fundamentally from unmodified organisms or from conventional products; 2) the existing laws are adequate for regulating organisms and products developed by the new processes; 3) the product and the risk should be regulated, not the process and 4) regulation should be based on the end use of the product and conducted on a case-by-case baseis. The USDA policy has been consistent with the overall Federal policy and National Academy of Sciences recommendations. The USDA Agency directly concerned is the Animal and Plant Health Inspection Service (APHIS) which has combined a number of existing staffs to create the Biotechnology, Biologies, and Environmental Protection Division.