Pathways to Obtain Regulatory Approvals for the Use of Genetically Modified Algae in Biofuel or Biobased Chemical Production

摘要

Recent years have seen an increased interest in developing genetically modified microalgae and cya-nobacteria for use in biofuel and biobased chemical production, but 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 US and elsewhere in the world. However, a reasonable road map is emerging of a regulatory regime that can allow pilot, demonstration, and commercial stage uses of modified algae without jurisdictional conflicts. In the US, regulations of the US Environmental Protection Agency (EPA) would govern the industrial use of algae or cyanobacteria in contained photo-bioreactors and open ponds, but regulations of the US Department of Agriculture (USDA) could in rare cases also apply. Although these regulations require assessments of potential environmental risks, recent government approvals show that the process can be successfully managed with proper preparation, and that approvals can also be achieved both for contained manufacturing as well as for proposed outdoor, open-pond testing of modified algae.