I presented 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. I’ll also use this blog to provide some additional information on these various regulatory regimes, beyond what can be presented in the confines of the poster.
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.
I’ve discussed biotechnology regulatory issues in many countries around the world in previous blog entries, and in today’s entry and in ones that follow I’ll include links to those previous entries dealing with the countries covered in the 2014 poster. In some cases I’ll supplement those earlier posts with some additional information not previously covered. My earlier posts were made primarily during the following time periods.
- When I first originated the blog in 2010, I posted a series of entries discussing the regulations affecting the contained use of modified microorganisms and the outdoor use of transgenic plants in several of the more important countries and jurisdictions. These posts began with an entry on April 6, 2010.
- When I resumed the blog in 2013, I updated those entries and expanded the scope to several other countries – those entries, which were limited to discussion of the regulation of contained manufacturing with modified microorganisms, began with an entry of March 12, 2013.
- Last fall, to accompany a poster presentation at the 2013 Algae Biomass Summit, I posted a series of entries discussing how uses of microorganisms and algae would be regulated, both in contained manufacturing and in open ponds, in a number of countries. Those entries began with a blog on September 16, 2013.
Many national laws are based on the principles of the Cartagena Protocol on Biosafety, part of the Convention on Biological Diversity, which was adopted in January 2000. Under such laws, government approvals are generally needed for importation of Living Modified Organisms (LMOs) into countries, and for many industrial activities including “contained uses” or “environmental uses”. Such approvals may often require a risk assessment of the LMO and its proposed use. The principles of the Protocol are often a useful guide to the biosafety policies or regulations of many governments, particularly in the developing world. More information can be found at posts of March 12, 2013 and September 16, 2013.
In the next several days, I’ll post additional entries in the blog containing additional information on the specific countries covered in the 2014 BIO World Congress poster. I’ll add links to these blog pages below as they are posted.
- North America (Canada, US, Mexico)
- Brazil, Europe, South Africa
- Asia (China, Japan, Indonesia, Malaysia) and Australia.
By the way, there are other areas of regulation not discussed here, such as the requirements for certification of renewable fuels and the regulations governing the use of spent microbial biomass in animal feed (e.g., in dried distillers grains). I’ve discussed these other topics here in the blog from time to time, and I’d be happy to answer questions about these or any aspect of biofuels/bio-based chemical regulation.
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.