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 second of a series of blog posts providing further detail on some of the regulations discussed in the Poster. The first post covered North America. Today’s post covers Brazil, the European Union and South Africa.
Under the National Biosafety Law, all proposed uses of living modified organisms would require approval from the Biosafety National Technical Committee (CTNBio), followed by authorization from the applicable Ministry. CTNBio is part of the Ministry of Science and Technology, and it is a multidisciplinary committee composed of representatives from many different ministries and branches of the government, which is responsible for the technical reviews of biotechnology applications. Responsibility for formulation and implementation of the National Biosecurity Policy falls to the National Biosecurity Council (CNBS), which reports to the Presidency of the Republic. Once CTNBio grants an approval for a project, the formal authorization is granted by a government ministry: either the Ministry of Agriculture for most agricultural activities; the Ministry of the Environment for nonagricultural activities taking place in the environment, or the Ministry of Health for “human and pharmaceutical uses”. Note however, that the approvals for contained uses of LMOs for biofuel production have been issued by the Ministry of Health (see my previous post of February 20, 2014).
There have been previous approvals for contained industrial uses of LMOs and transgenic plant field testing. Brazil has seen a significant amount of activity in the field testing and commercialization of transgenic varieties of several agriculturally-important species. Approvals for field tests must be obtained from CTNBio, and then receive the authorization of the Ministry of Agriculture. More information on the status of transgenic plant regulation and field testing in Brazil can be found in USDA GAIN’s 2013 Annual Report on Brazilian biotechnology.
Regulations affecting the use of modified microorganisms in contained manufacturing have been described in a post of March 18, 2013, with additional information on open-pond uses in a post of September 26, 2013. I also recently commented on recent approvals for contained manufacturing with modified microorganisms on February 20, 2014.
Under the Genetically Modified Organisms Act of 1997, as amended in 2006, permits are needed from the Agriculture Ministry for the importation, contained use, and environmental use of LMOs, including the field testing and commercial use of transgenic plants. Applications must be made to the Registrar of GMOs within the Agriculture Ministry, and there is a website that is the gateway to downloading all the different permit applications that may be required. An Advisory Committee conducts risk assessments, and an Executive Council makes the final decisions.
It appears likely that applicants wishing to use an LMO for contained manufacturing in South Africa would need to file applications to allow the importation of the organism, the registration of the facility, and to approve the proposed commercial use. Companies planning field tests of transgenic plants in the country would need to file similar applications as well as obtaining approval for the field tests themselves.
You can find a little more detail about the regulations affecting the use of modified microorganisms in contained manufacturing in a post of March 18, 2013.
The EU has adopted two directives to cover biotechnology – one covering contained uses of modified organisms, and the other covering uses of modified plants and other organisms in the open environment. Each EU member state is obligated to adopt national laws corresponding to EU directives, and so all 28 EU members should have their own biotechnology laws or regulations that mirror the provisions of the two EU directives. Therefore, for activities in any EU member state, relevant approvals would be needed under national laws corresponding to the EU Directives.
Contained manufacturing: Contained uses of modified microorganisms would require national government notification, and in some cases possibly also approval, in accordance with the EU “Contained Use” Directive 2009/41/EC. Article 2 of the directive defines “contained use” in a way that gives an applicant proposing to use a GM microorganism in Europe a fair amount of leeway in determining that a system or process is “contained”. Article 4 of the directive requires the user to carry out a risk assessment of the microorganism, using considerations set forth in Annex III of the directive. As a result of this assessment, the user would determine which of four containment levels is appropriate for the organism, after which the user would have the requirement to adopt appropriate containment measures in accordance with Annex IV of the directive. These requirements are similar to most other international biosafety guidelines, and most microorganisms used for fuel or chemical production would qualify to be included within the lowest level of containment. Article 6 of the directive requires users to notify the government agency designated in national legislation as having jurisdiction to enforce the contained use directive before a facility is to be used with GMMs for the first time. Annex V specifies the information required to be submitted with such notifications, and for organisms in the lowest class of risk, the necessary information is fairly minimal. The laws of individual EU nations should conform to these provisions, and in most cases there would not be any need to seek government approval for contained uses, beyond the notifications described here.
Uses of modified microorganisms in open ponds and the field testing and commercialization of transgenic plants would be covered by national laws corresponding to EU Directive 2001/18/ECon “Environmental Release”. Generally speaking, any outdoor activities with LMOs in Europe, including small scale field testing, would require approval from the country in which the activity is to take place. Applications for commercial use are more complicated, in that all EU member states have some say in commercial approvals granted by individual countries. Although most if not all EU members have approved numerous field tests of transgenic plants over the past two decades (most of which have been for food-producing crops), commercial approvals for food crops have proven extremely problematic, and at times have effectively been barred in Europe. It remains to be seen if the use of a modified non-food-crop plant species as a biofuel feedstock would generate the same level of controversy in Europe as has some transgenic food species.
The EU Biotechnology Directives have been described in a post of July 12, 2010 (which includes information on transgenic plant regulation),with additional information in a post of March 26, 2013. A further update, which includes a discussion of the applicability of the directives to open-pond uses of modified algae, can be found in a post of September 23, 2013.
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.