Biotechnology; Managing the Risks of Field Testing Genetically Engineered Organisms

摘要

The Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce, requested that GAO review the federal risk management of genetically engineered organisms intended for agricultural and health uses in the environment. This report (1) evaluates the scope of regulatory policies applicable to deliberate, small-scale releases, (2) reviews the administrative procedures for implementing these policies, and (3) identifies technical methods available to control and monitor risks posed by field testing. It focuses on agencies directly responsible for regulating environmental introductions: the Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). USDA, EPA, and FDA have limited experience with genetically engineered organisms used in the environment and are uncertain about their effects. Each agency generally uses a detailed prerelease evaluation process that draws upon a broad range of scientific expertise to review proposals for field tests on a case-by-case basis. The agencies have made efforts to coordinate their policies and review procedures. USDA has issued a new rule and EPA is considering amending regulations to cover the range of products under their jurisdictions more completely. Even so, some organisms are not subject to regulation due to differences in legislative mandates and risk management policies. Although genetically engineered microorganisms cannot be completely contained at the field-test site, a variety of control methods are available to limit their dispersal and impact. These include setting physical barriers at the test site and selecting organisms with vulnerable biological features.