This blog entry describes the possible ways in which uses of algae or cyanobacteria for fuel or chemical production might be regulated in countries having biotechnology laws or regulations that conform with the Cartagena Protocol on Biosafety, part of the Convention on Biological Diversity. This entry is one of several posts that provide additional information in support of a poster I’m presenting at the 2013 Algae Biomass Summit on the regulations in various countries around the world that may be applicable to the use of naturally-occurring or genetically modified algae or cyanobacteria in fuel production. You can access the poster on my SlideShare site, and please refer back to my September 16 introductory post for links to posts on the regulatory situation in other countries. Although this discussion centers on algae and cyanobacteria, much of the discussion is applicable to the use of other genetically modified microorganisms for production of fuel or chemicals.
The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement which was enacted to ensure the safe handling, transport and use of genetically modified organisms (which the Protocol calls “living modified organisms”, or LMOs) resulting from modern biotechnology that may have adverse effects on biological diversity, and possible risks to human health. The Protocol was adopted on January 29, 2000 as a supplementary agreement to the Convention on Biological Diversity and took effect on September 11, 2003. Considerable detail on the history of the Protocol and its development can be found on the Biosafety Clearing-House website, which is a site established under the Protocol to be a repository of information from various countries regarding compliance. I’ve described the Protocol and some of its implications for use of modified microorganisms in fuel production in a blog post earlier this year.
The Protocol is primarily intended to ensure that national authorities are notified of any proposal to introduce LMOs into their countries, particularly for the purpose of deliberate release into the environment or for use in food or feed, and further to ensure that information about uses of LMOs is provided to the public and to other countries and interested parties. A key provision of the Protocol is to require there to be “Advance Informed Agreements” (AIA) when LMOs are shipped across national boundaries, to ensure that the recipient nation is notified of the proposed shipment, and to allow the recipient nation to conduct needed risk assessments. The Protocol specifies that each party to the Convention designate one or more government agencies as the “competent national authority” having responsibility for oversight over activities that are subject to the Protocol. The Protocol specifies the basic information that an applicant is to provide to the applicable agency of the recipient nation, and provides general guidance for how risk assessments should be conducted, and requires the competent authority to make its decisions within defined time periods.
Signatories to the Convention need to adopt national laws, or amend existing laws, to establish procedures that conform to the provisions of the Protocol. Several of the countries featured in my ABO poster have created national biosafety laws in conformance with the Protocol. For any nation whose national laws are based on the Protocol, it is safe to assume that, at a minimum, government notification will be needed for any importation of an LMO into that country and for any proposed use of the LMO in the country, and that the government agency may need to conduct a risk assessment depending on the proposed use. However, it is important to remember that national laws and regulations may differ from the terms of the Protocol, particularly since parties to the Protocol are explicitly allowed to put in place requirements that are more stringent than those provided in the Protocol. So, although the Protocol does not itself call for “permits” of any kind, in many cases individual countries will require permits for certain activities with LMOs within their borders.
In most countries, uses of microorganisms within “contained” manufacturing will differ from applications such as open-pond cultivation of algae, and in general will be subject to far less stringent oversight. “Contained Use” is defined in Article 3 of the Protocol as follows:
(b) “Contained use” means any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment.
However, in the Protocol and often in national laws, regulatory procedures for contained uses are often not as well specified as are the procedures for outdoor uses. As I explained in more detail in my earlier post, although the Protocol contains detailed provisions governing the Advanced Informed Agreements required for transboundary shipments of LMOs, Article 6(2) of the Protocol provides an exemption from the AIA procedures for shipments of LMOs intended solely for contained use.
Furthermore, the definition of “contained use” in the Protocol does not distinguish between research uses and commercial uses. This ambiguity carries forward to a number of national laws, sometimes making it unclear whether any there might be any permit requirements for commercial “contained uses” over and above the notification and labeling requirements under the Protocol.
With regard to contained uses, the Protocol can be viewed as establishing minimum requirements for applicants proposing to use LMOs in contained commercial manufacturing, with the understanding that national laws may impose additional requirements in certain countries. Applicants should therefore consider taking steps such as documenting that the intended use in the country of importation is indeed “contained” in accordance with the definition in Article 3 of the Protocol; documenting in writing that the intended recipients understand that an LMO is to be shipped, and abiding by the labeling requirements for all shipments of the LMO into the country. It would also be advisable to identify the relevant agency(ies) that are the “competent national authority” for the activity to be undertaken, and to consult with that agency in advance. It is possible that national law or regulations or common practice in any given country might be to require a risk assessment even for proposed contained uses of LMOs, and if so, such a risk assessment might need to be carried out in conformance with the Protocol, e.g. as specified in its Annex III. Several of the national laws that I’ll describe in the forthcoming posts will indeed require a risk assessment and sometimes a permit application as part of the review of proposed uses of LMOs in contained manufacturing. Applicants considering contained uses of algae or cyanobacteria should also note that Article 23 of the Protocol obligates the competent authorities of signatory nations to “consult the public in the decision-making process regarding LMOs and [to] make the results of such decisions available to the public, while respecting confidential information…”.
In principle, under the Protocol, the required procedures to use an LMO in the open environment (e.g. in an open-pond algae reactor) would not be much different than for a proposed use in contained manufacturing, in that the recipient nation government would need to be notified and would need to conduct a risk assessment. However, in the case of an intended “release” to the environment, an Advance Informed Agreement would be absolutely be required (which is not the case for a proposed contained use) and the risk assessment would almost certainly be more rigorous. In many countries, a permit or some affirmative government permission would be needed before the LMO could be used in the open environment. Needless to say, certain such proposals may also engender public or community interest and perhaps opposition.
It is hard to generalize about what the likely requirements may be to obtain approval under the Protocol to use an LMO strain of algae or cyanobacteria in the open environment. Most international activity regarding open-environment use of LMOs has involved transgenic plants intended for food or feed use, and there are specific provisions of the Protocol that apply to such uses, which would not be applicable to the open-environment use of a modified microorganism or algae for an industrial purpose. However, the Protocol does provide specific guidance for the risk assessments are to be conducted, with the minimal information for the AIA found in Annex I and guidance for the risk assessment in Annex III. Applicants would be advised to study these requirements, as well as any requirements specified in applicable national law, and to consult with the applicable government agency, in order to prepare a dossier containing the necessary information to support a positive finding of a risk assessment. Finally, applicants should also be prepared for whatever provisions the competent authority has made for public consultation and comment in accordance with Article 23 of the Protocol.
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.