Government and Regulatory Affairs
Use of Modified Microorganisms, Algae or Transgenic Plants for Biofuels

Commercial strategies using the advanced techniques of biotechnology for the production of biofuels may be affected by the framework of biotechnology regulation that exists in the United States and elsewhere in the world. Beginning in the mid 1980s, governments around the world began establishing regulatory programs for the oversight of commercial biotechnology, with many of the more controversial regulations directed at the products of genetic engineering intended for use in the open environment. Biofuels companies need to be prepared for the impact these regulations may have on the testing and commercial use of engineered microorganisms, algae, or transgenic plants being developed for biofuel applications.  

Genetic engineering of microorganisms to create improved catalysts (i.e. enzymes or the microorganisms themselves) for the conversion of biomass to ethanol or other fuels might be subject to regulation by the Environmental Protection Agency (EPA) under one of its lesser-known biotechnology programs. Using regulations promulgated in 1997 under the Toxic Substances Control Act, EPA has regulated certain industrial, environmental and agricultural uses of microorganisms that are not subject to oversight by any other federal agency. Depending on the makeup of the engineered microorganism, these regulations could cover microbes or microbially-produced novel enzymes intended for use in biofuel production, and would require notifications and certain data submission to EPA prior to commercial use. EPA has already reviewed at least one submission for biofuels production organisms under its TSCA biotechnology program.

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 (USDA), under rules that were first instituted in 1987. These regulations have been progressively relaxed over the years and today most research field tests of transgenic plants can take place upon a simple advance notification to the agency. However, in recent years, USDA has begun to use a more comprehensive permitting process for applications of transgenic plants outside of traditional agriculture (e.g. pharmaceutical production in plants) and it is likely that many biofuels applications would be treated in a similar manner. USDA is currently reviewing a petition that would allow commercial use of a transgenic corn variety engineered for enhanced ethanol production.

Recently, much attention has focused on the prospects for the use of algae to produce various types of hydrocarbon fuels. The status of genetically engineered algae under the biotechnology framework is unclear, and it is somewhat uncertain as to whether the programs of either the USDA or the EPA would cover use of genetically modified algae in biofuel production.

Dr. Glass has extensively published and presented on numerous topics in biotechnology regulatory affairs, including a poster presentation (June 2008 Cleantech Conference, Boston, Mass.) on the prospects for the use of modified microorgansims and transgenic plants for biofuel development (click to see the manuscript or the poster), a talk on February 2, 2010 at EUEC 2010 on prospects for the commercial use of genetic engineering in biofuel production, and a talk in September 2010 on "Impact of Government Biotechnology Regulations on Use of Genetically Modified or Synthetic Algae in Biofuel Production" at the 2010 Algae Biomass Summit (click to see the slides from either of these talks). Please contact David Glass for more information.

Dr. Glass is currently employed by Joule Unlimited, and he is no longer offering regulatory consulting services through D. Glass Associates, Inc. For more information, please contact Dr. Glass.