Techniques of gene transfer are revolutionizing agricultural research and development. Within the past 15 years, a merging of science and technology and of the university research system with private industry has resulted in new products and applications. Problems have arisen such as patenting of living processes, maintaining academic freedom, determining strategies for risk assessment, furthering consolidation of agriculture, displacing efficient producers, and emerging monopolies. USDA has established review mechanisms to facilitate development of agricultural biotechnology, while protecting public safety and the environment. These include expanded research guidelines, a national infrastructure to identify outdoor test sites, expert reviewers for evaluating proposals, and post-release monitoring of test-site environments.