Impact of Government Biotechnology Regulations on Biofuel Development

Commercial strategies using the advanced techniques of biotechnology for the production of biofuels may be affected by the biotechnology regulatory framework that exists in the United States and other countries. Use of genetic engineering to create improved microorganisms or enzymes for production of ethanol or other fuels might be subject to regulation by the U.S. Environmental Protection Agency. Projects involving the genetic engineering of plants and trees to improve the feedstocks used in biomass conversion may be subject to regulation by the U.S. Department of Agriculture and equivalent rules in other countries. This paper explains the history and the basis for biotechnology regulation in the United States and elsewhere, and surveys the regulatory programs that might be applicable to biofuels projects, as well as the procedural and data requirements such projects might face. With advance planning it should be possible to gain timely regulatory approval for biofuels projects.