Government Regulation of the Uses of Genetically Modified Algae and Other Microorganisms in Biofuel and Bio-based Chemical Production

Abstract

Recent years have seen an increased interest in developing genetically modified algae and other microorganisms for use in biofuel and bio-based chemical production. However, this comes at a time when there is uncertainty within the industry and the academic community about how such uses will be regulated by governments in the U.S. and elsewhere in the world, as well as concerns by some observers over the adequacy of existing regulations to cover organisms created using techniques known as synthetic biology. However, a reasonable road map is emerging of a regulatory regime that can allow pilot, demonstration and commercial stage uses of modified microorganisms. In the U.S., regulations of the U.S. Environmental Protection Agency and possibly of the U.S. Department of Agriculture might govern the industrial use of microorganisms in contained photobioreactors or algae in open ponds, and these regulations generally require conducting assessments of the potential environmental risks of such large-scale uses. The EPA regulations include a mechanism by which outdoor experimentation of modified microorganisms can take place in a stepwise approach, with risks assessed as the scale of experimentation increases, which provides an accessible path to exploration of the use of modified algae in open ponds. Such risk assessments will address legitimate questions of potential ecological impact, such as the potential survival and dissemination of the production organism, the potential for heterologous genes to horizontally transfer to indigenous microorganisms, and the chance for other unintended effects on nontarget species. Numerous companies have successfully navigated these regulations, including some recent project approvals in the U.S. and elsewhere in the world.

Keywords

Genetic modification Genetically modified organism Government regulation Environmental impact Risk assessment Biofuel Bio-based chemical 

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Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  1. 1.D. Glass Associates, Inc.NeedhamUSA

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