The responsibility for regulating biotechnology was delegated by the Secretary of Agriculture to the Assistant Secretary for Marketing and Inspection Services, who in turn delegated this responsibility to the Administrator of the Animal and Plant Health Inspection Service (APHIS). The delegation was based on three existing statues which provided for the protection of American agriculture, but now definitions and regulations specific for genetically engineered organisms were required and are not in place. An interpretation of the new regulations in the context of the statutes is presented.