June 20, 1986
President Reagan has approved for publication in the Federal Register, the Coordinated Framework for the Regulation of Biotechnology, a comprehensive regulatory policy for ensuring the safety of biotechnology research and products. Biotechnology is expected to become a major industrial force in the Nation's economy. Applications of biotechnological products for use in health care, agriculture, and the environment are developed through genetic engineering techniques. Current projects include vaccines and diagnostic tests for a host of animal and human diseases, creating crops that are insect or frost resistant or make their own fertilizer, and many others.
The United States is the world leader in biotechnology, owing to government-sponsored research, innovative private enterprise, and an appropriate regulatory climate. As the new biotechnology moves from research to commercial manufacture, this advantage is believed to provide a solid base for the U.S. industry and strengthened U.S. competitiveness. To ensure a consistent Federal Government approach, the framework sets forth the basic policies and procedures of the several agencies that have jurisdiction over the different types of products that biotechnology may produce. The framework balances concerns for health and the environment. It designates categories of engineered organisms that are believed to pose risks of sufficient concern to merit Federal regulation, and it expedites review for others of less concern. The framework requires Federal agencies to review the application in the environment of living microorganisms, such as microbial pesticides.
Implementation of the policy is expected to reduce concerns about overlapping reviews by several agencies. The framework identifies lead agencies responsible for particular classes of products or research categories. Included are: the regulatory and/or research policies of the Food and Drug Administration, the Environmental Protection Agency, the Department of Agriculture, the Occupational Safety and Health Administration, the National Institutes of Health, and the National Science Foundation.
The framework is a refinement of a proposal published in December 1984. Upon analysis of public comments, the framework was reformulated with special attention to fostering a rational, integrated regulatory structure that is neither unduly burdensome nor carelessly incomplete. The framework emphasizes that this structure must evolve along with technological developments. Controls are adequate for the present, but they will be frequently monitored and improved. The framework is intended to ensure timely focus on emerging issues that need to be addressed. The framework provides a measure of regulatory certainty for industry. Implementation of the policies in the framework will allow U.S. industry to efficiently deal with commercialization and promote increased competitiveness internationally.