At the 2013 Algae Biomass Summit, I’ll be presenting a poster summarizing some of the regulations around the world that might affect the use of algae or cyanobacteria, including genetically modified strains, in the production of fuels or bio-based chemicals. Because I’m only able to include a limited amount of information in the format of a single poster, I decided to use the Advanced Biotechnology for Biofuels blog to post more detailed information in support of the summary info included in the poster. This entry is an introduction to the topics covered in the poster and in the other blog entries in this series. Although this discussion centers on algae and cyanobacteria, much of the discussion (other than the section on aquaculture) would be applicable to the use of other genetically modified microorganisms for production of fuel or chemicals.
I’ve posted an advance copy of the poster on my SlideShare site.The poster summarizes regulations in various countries that may cover the use of naturally-occurring or genetically modified algae or cyanobacteria in fuel production. These include three general categories of regulation: biotechnology or biosafety regulations, aquaculture regulations, and renewable fuel standards or volume mandates.
Biotechnology Regulation: Many national biotechnology 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. As I’ve described in a blog post earlier this year, 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 will usually require a risk assessment of the LMO and its proposed use. The use of LMOs in contained manufacturing will likely face a fairly straightforward regulatory process in most countries, because such “contained” uses will generally pose far fewer hypothetical concerns about environmental or public health impacts. In contrast, the use of algae or cyanobacteria in an application such as open ponds will likely trigger a more rigorous review of potential environmental impacts.
Aquaculture Regulation: In many countries and jurisdictions, the industrial use of algae, particularly nonnative strains, may fall under laws governing safe practice of aquaculture, and permits may be required. Most aquaculture regulation has been enacted to cover activities such as commercial fisheries, particularly those in open waterways, but some national or provincial laws explicitly include algae within the definition of “aquatic organisms” (or the equivalent) that are subject to regulation. Other laws do not provide a precise definition of “aquaculture” or “aquatic organism”, leaving it potentially vague as to whether algae would be considered to be covered. I should add that the country-specific discussions on aquaculture regulations are largely based on my own interpretation of national laws I’ve been able to identify, and that I have not investigated possible precedents for the applicability of such laws to industrial uses of algae. Consultation with legal counsel in the applicable country is always advised.
Fuel Regulation: Algae-produced fuels may need to be registered or certified before sale in certain countries, and may also be subject to blending mandates or laws that may require documentation of sustainable production. I have discussed some of these programs in detail in earlier blog posts, for example, posts on this blog on the U.S. Renewable Fuel Standard and the EU Renewable Energy Directive, and posts on Biofuel Policy Watch regarding ethanol mandates and biodiesel mandates around the world. Laws requiring certification of fuels are usually fairly straightforward, and gaining certification should not be difficult for fuels that resemble or are identical to existing fuels. In countries where there are either mandates or targets for nationwide use of biofuels or other renewable fuels, it is often incumbent upon the fuel manufacturer to register with the government and/or to prove that the fuel meets the relevant definition so that its use can count against the mandated or targeted volumes.
The poster presentation includes very brief summaries of relevant laws in the following countries or regions. Follow these links for more detailed discussions.
- Overview: Cartagena Protocol on Biosafety
- United States (Part 1 — biotechnology regulations)
- United States (Part 2 — aquaculture and fuels regulations)
- European Union (Part 1 — biotechnology regulations)
- European Union (Part 2 — aquaculture and fuels regulations)
In addition, in two blog posts earlier this year, I’ve discussed biotechnology regulations in a number of countries, including ones not covered in the ABO poster. You can find these blog posts at the following links.
- International Biotechnology Regulation: the Americas and Africa.
- International Biotechnology Regulation: Europe, Asia, Australia.
I’d be happy to answer any questions you may have about applicable regulations in these countries, or in any country or region of the world not covered in these blog entries.
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. Dr. Glass also serves as director of regulatory affairs for Joule Unlimited Technologies, Inc. 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 Joule Unlimited Technologies, Inc. or any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.