biofuels, biotechnology, regulation, engineered organisms
Biofuels projects involving the use of advanced biotechnology strategies may be affected by government biotechnology regulation. Transgenic plants engineered to improve biofuels feedstocks may be regulated under the U.S. Department of Agriculture’s biotechnology regulations. Genetically engineered microorganisms used as catalysts or to produce enzyme catalysts for biofuel production may be regulated by the U.S. Environmental Protection Agency under its biotechnology rules. This presentation will explain the history and the basis for biotechnology regulation in the United States and elsewhere in the world, and will survey the regulatory programs that might be applicable to biofuels projects. We will discuss likely procedural and data requirements for projects that might be subject to such regulations, and strategies to successfully manage the regulatory process. Biofuels companies pursuing biotechnology strategies should take these regulations into account, and with advance planning it should be possible to gain timely regulatory approval for biofuels projects. The author has over 20 years experience dealing with regulation of agricultural, environmental and industrial biotechnology projects under both USDA and EPA regulations.