I’ll be presenting a poster on May 14-15 at the 2014 BIO World Congress on Industrial Biotechnology, summarizing the regulation of industrial biotechnology in several countries and regions around the world. You can find the poster here on my SlideShare site. The poster presents very brief summaries of relevant regulations in several important countries and global regions that might affect the use of genetically modified microorganisms, algae or plants for the production of biofuels or bio-based chemicals. Regulatory regimes are described for three industrial approaches: contained use of microorganisms in fuel or chemical manufacture; open-pond use of algae or photosynthetic bacteria to produce fuels or chemicals; and the field testing and commercial cultivation of transgenic plants as feedstocks.
This is the first of a series of blog posts providing further detail on some of the regulations discussed in the Poster. Today’s post covers North America: Canada, Mexico and the U.S.
Contained or Open Pond uses of modified microorganisms may require Environment Canada approval under the New Substances Notification regulations under the Canadian Environmental Protection Act. These regulations cover the use of any microorganism that is new to commercial use in Canada, and potentially cover many modified microbial strains as well as unmodified microorganisms that have not previously been used in Canada. The regulations potentially cover both contained and open-environment use of microorganisms, with a greater level of scrutiny dedicated for the latter, however, as of this writing the only microorganisms approved under the program have been for enzyme manufacture or other uses not related to biofuels. See the posts of March 18, 2013 and September 19, 2013.
Novel Plant Feedstocks: The Canadian Food Inspection Agency regulates “confined” and “unconfined” releases of plants with novel traits (“Confined” releases are field tests with controls to prevent potential spread of the modified plants or their pollen; “unconfined” releases are larger-scale or commercial releases of novel plant varieties). See the post of July 9, 2010 for a description of Canada’s regulatory regime for novel plants. As would be expected, most of the approved field releases and all of the commercial approvals have been for modified varieties of common agricultural crops, but the Canadian company Linnaeus Plant Sciences has received a number of approvals for confined field testing of Camelina lines with modified oil composition, which the company is developing for fuel or chemical use.
Contained manufacturing: Most contained uses of modified microorganisms would be regulated by EPA under TSCA (40 CFR Part 725) and would require filings of Microbial Commercial Activity Notices (MCANs). These regulations would cover proposed industrial uses of “intergeneric” microorganisms used for purposes such as biofuel or bio-based chemical manufacture. I have written about these regulations in quite a few posts going back to the inception of the blog in 2010. Detailed information on the EPA regulations can be found in a series of posts beginning on April 21, 2010, with a more recent summary on September 17, 2013. Other posts on the blog have described specific MCAN filings and other TSCA-related issues. Numerous MCANs have been reviewed by EPA in recent years for microorganisms modified for improved biofuel production, and overall the number of MCAN filings has risen in recent years (see Figure).
Under EPA’s TSCA regulations, open pond uses of genetically modified algae for research purposes would require EPA review and approval of TSCA Experimental Release Applications (TERAs) with ultimate commercial use requiring MCAN filings. I have discussed the TERA process and some recently filed TERAs, including the first approved TERAs for open-pond research using genetically modified algae strains, in posts of November 1, 2013, November 4, 2013 and December 19, 2013.
Feedstocks: Field testing and use of transgenic plants as biofuel feedstocks would be subject to the biotechnology regulations of the U.S. Department of Agriculture that have been used since 1987 to regulate the agricultural biotechnology industry (7 CFR Part 340). Although gaining approval under these regulations for commercial use and sale of transgenic food-crop plants has become a lengthy and sometimes controversial process, the regulatory regime as a whole has been quite successful in allowing transgenic plants to be field tested and moved towards commercialization, and should be straightforward for biofuel feedstock developers to comply with. See the series of posts beginning with May 18, 2010. Field tests have been conducted in the U.S. on plants and trees modified with traits that might make them more useful as biofuel feedstocks, including such species as switchgrass, Miscanthus, and Camelina.
CIBIOGEM, an Inter-Ministerial commission, coordinates oversight activities under Mexico’s Biosafety Law. Under the Law, uses of modified microorganisms in contained manufacturing would require review and approval, likely by the Environment Ministry SEMARNAT. The regulation of the use of modified microorganisms in contained manufacturing has been described in a post of March 18, 2013.
The possible outdoor use of modified algae in open ponds or the field testing or commercial use of transgenic plants as biofuel feedstocks must be approved Under the Biosafety Law by the Agriculture Ministry SEGARPA. With regard to transgenic plants, there has been considerable activity in Mexico in the field testing of transgenic varieties of agriculturally useful species. Hundreds of field tests and several commercial approvals for transgenic varieties have taken place in Mexico, although these have all been limited to five agriculturally-important species like corn, cotton and wheat. The regulatory apparatus for review of field uses of transgenic plants by SAGARPA seems to be well-established. A good recent description of the Mexican biotechnology regulatory regime and recent field testing activity can be found in the USDA GAIN Service’s 2013 annual report on Mexican biotechnology.
D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.