Previous entries in this blog have focused on U.S. government biotechnology regulations that might affect the use of genetically modified organisms in biofuel production, and the entry immediately preceding this one discussed the regulatory framework in Canada for such proposed industrial applications. Today’s entry will discuss applicable European Union regulations that might affect the use of modified microorganisms or plants for biofuel purposes.
The European Union (EU) has grappled with issues relating to genetically modified organisms (GMOs) since the 1908s, and to this day there remains a great deal of controversy over the growth of GMOs, principally plants) and their use in food. Today there are two primary pieces of EU legislation that might affect the use of modified plants or microorganisms in biofuel production. These are in the form of “Directives”, which are adopted by the European Commission and which are binding upon all EU member states, which must then adopt national laws that conform with the provisions of the directive. These two principal biotechnology directives have been adopted by the European Commission’s Environmental Directorate, DGXI, and they are as follows:
- Directive 98/81/EC, which amended Directive 90/219/EEC, on the contained use of genetically modified microorganisms (GMMs). This Directive regulates research and industrial activities involving GMMs under conditions of containment.
- Directive 2001/18/EC, which replaced Directive 90/220EEC, on the deliberate release into the environment of GMOs, which applies to two types of activities: the experimental release of GMOs into the environment, such as in connection with field tests; and the placing on the market of GMOs, for example the cultivation, importation or transformation of GMOs into industrial products, such as the sale of seed to grow GMO plants or the use of products of genetically modified plants in food.
European regulation of modified microorganisms for biofuel production
The Directive on the contained use of GMMs might be applicable to the use of modified microorganisms, yeast and algae for production of biofuel in Europe. However, the focus of this directive is to ensure that appropriate facilities, procedures and controls are used with GMMs in both the laboratory and in industrial practice to prevent or minimize the release of the organisms from the contained facility and to protect worker safety. The requirements of this Directive are similar to the U.S. NIH Guidelines and other international biosafety guidelines. For example, Annex IV, Table II of this Directive lists “minimum requirements for activities other than laboratory activities [i.e. industrial activities] using GMMs”, and lists procedures for handling, inactivating and disposing biomass from GMMs. Although the Directive would be implemented on the national level by the relevant government agency, its focus really is on the appropriate procedures or controls for use of the microorganisms, and the Directive does not speak at all to how the commercial product of, say, a microbial fermentation, would be regulated.
Therefore, unless covered by any specific national law, it would not appear that the EU has any specific regulations that might require product-specific approvals for microbial strains used to produce biofuels, or to produce the enzymes used in biofuel manufacture, unless regulated for another reason (e.g. the use of enzymes as feed additives would need to be approved by the European Food Safety Authority). The Directive also does not require that GMO-produced enzymes be labeled in any special manner. Industrial enzymes produced by modified microbes would be subject to the same registration or inventory procedures that might be required for all industrial enzyme products, such as the European Inventory of Chemical Substances or the European List of New Chemical Substances. According to one Internet source, there are quite a number of industrial enzymes on the market in Europe produced from modified microbes, including enzymes with biofuel uses such as cellulases, hemicellulases, and xylanases.
European regulation of genetically modified plants
The “Deliberate Release” Directive is applicable to the possible growth and use of transgenic plants as biofuel feedstocks. This Directive requires each EU member state to appoint a regulatory agency with the authority to review and approve environmental introductions within its jurisdiction. Proposals for R&D field tests must be made to the competent authority of the EU member within whose territory the experimental release is to take place, and the review of such proposals would address similar environmental issues as are considered in the United States (e.g. under the USDA regulations). Member states have sole authority to approve R&D uses within their jurisdiction, after European Commission notification and a 90 day review period. Although approvals are strictly up to each national government, other EU member states as well as the Commission itself may contribute observations and comments to the national authority considering any specific field test proposal. In spite of widespread public concern over GMO plants in Europe, there have been a large number of experimental field trials approved of transgenic plants over the past two decades.
Proposals for marketing or commercial use of a GMO must first be made to a single member state, although the decision to authorize the commercial use will involve all member states, and any approvals granted would (in theory) allow commercial use throughout the EU. The application (called a “notification”) must include a full evaluation of the environmental risks of the GMO, based on data from prior experimental use. After its review, the national authority must issue an opinion which will take the form of an “assessment report”, which may be favorable or unfavorable. If the national authority issues a favorable report, it will notify the other member states via the European Commission. The other member states and the Commission are entitled to provide their observations and objections to the report. If there are no objections, the original national authority can authorize the commercial use of the product, although the agency can place restrictions on the approval, and all product approvals are limited to a ten year duration. The Directive includes procedures for resolving disputes, e.g. if one member state lodges an objection to a proposed commercial use.
In practice, the European Commission’s decisions regarding commercial approval for GMOs (all for modified crops that would be destined for food use) have been controversial. There have been frequent deadlocks between different member states regarding approvals for specific products, and even for those products that have been approved by the Commission, there are a number of individual nations, including Ireland, France, Austria and others, that have imposed either a product-specific ban or an overall ban on the growth of GMOs. However, it has been reported that the European Commission is planning to formally propose modifying the approval procedures for GMO crops, so that decisions can be made on a nation-by-nation basis rather than requiring one decision that would cover the whole European Union. Although most of the controversy has arisen over concerns about the food use of the products of these modified plant varieties, there is no doubt that the political and public relations situation in Europe may make it quite difficult to commercialize transgenic energy crops, even non-food crops, in the near future.
A database of notifications of proposed field uses of GMO plants can be found here. This database is hard to search, but I found the following proposed field tests which seemed to involve plants engineered for improved biofuel production. There may well be others, where the plant phenotype was identified in a way that was not picked up by the keywords I searched.
Notification B/FR/03/02/07, France, published 03 March 2003, Biogemma
Field experiment of genetically modified hypolignified tall fescue
Notification B/FR/03/03/05, France, published 31March 2003, Biogemma
Field experiment of corn genetically modified for the lignin biosynthesis pathway
Notification B/FR/07/06/01, France, published 02 July 2007, INRA
Field trial of genetically modified poplars for wood properties and bio energy production. Agronomical and environmental assessment
Notification B/ES/10/40, Spain, published 23 March 2010, Idén Biotechnology S.L.
Study of maize lignification for the improvement of digestibility and bioethanol production.
Notification B/ES/10/50, Spain, published 24 June 2010, ABBA Gaia, S.L.
Field test of Nicotiana glauca genetically modified as an energy crop
Finally, I would note that the European Union also maintains regulations affecting the importation and international movement of GMOs. These rules are largely in conformance with the requirements of the Cartagena Protocol on Biosafety. The Cartagena Protocol was annexed to UNEP’s Convention on Biological Diversity, which took effect on September 11, 2003, and the purpose of this agreement was to set common rules for all nations to follow regarding the transboundary movements of GMOs. Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms was explicitly adopted (as a modification to the EU’s previously-adopted Directive on “deliberate releases”) to conform with the provisions of the Cartagena Protocol. The Protocol and its implementing regulations are intended to ensure that national authorities are notified of proposed deliberate releases or transboundary movement of GMOs in their countries, that information is provided to the public and to other countries regarding on EU practices, legislation and decisions on GMOs, as well as on accidental releases of GMOs, and that rules are in place for the export of GMOs, particularly those to be used for food or feed.
There appears to be a great deal of interest in Europe in developing novel technologies for biofuel production, and many of the companies I profiled in earlier entries in the blog are located in the European Union. EU regulations don’t appear to pose too significant a barrier for possible use of genetically modified microorganisms for biofuel manufacture, but the outlook is far more unclear for the possible use of transgenic plants. Presumably, however, a well-prepared, well-thought-out proposal to use an engineered non-food species as a biofuel feedstock could win governmental and public acceptance at some point in the near future.
D. Glass Associates, Inc. is a consulting company specializing in several fields of biotechnology. David Glass, Ph.D. is a veteran of nearly thirty years in the biotech industry, with expertise in industrial biotechnology regulatory affairs, patents, technology licensing, and market and technology assessments. This blog provides back-up and expanded content to complement a presentation Dr. Glass made at the EUEC 2010 conference on February 2, 2010 entitled “Prospects for the Use of Genetic Engineering in Biofuel Production.” The slides from that presentation, along with more information on D. Glass Associates’ regulatory affairs consulting capabilities, are available at www.slideshare.net/djglass99.