Introduction
This blog entry describes the possible ways in which uses of algae or cyanobacteria for fuel or chemical production might be regulated in the European Union. 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. These include three general categories of regulation: biotechnology or biosafety regulations, aquaculture regulations, and renewable fuel standards or volume mandates. 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 (other than the section on aquaculture) would be applicable to the use of other genetically modified microorganisms for production of fuel or chemicals.
The discussion of the situation in the European Union is in two parts. This blog entry discusses biotechnology regulations, and the entry that follows will discuss aquaculture and renewable fuels regulations.
Biotechnology Regulation
Overview
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 covering commercial use of modified plants or microorganisms. 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 2009/41/EC, which amended Directive 90/219/EEC and Directive 98/81/EC, 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 90/220/EEC, on the deliberate release into the environment of GMOs, which applies to 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.
Contained Use
Under the “contained uses” directive, applicants are required to assign a risk level to its organisms, to adopt containment measures appropriate for that risk level, and to notify a designated national agency before beginning operations. However, specific requirements in any given EU nation would be governed by national legislation or regulation adopted in conformance with the EU directive, so that national requirements in any given country may differ from, and may even exceed, the requirements of the EU directive.
The definition of “contained use” in Article 2 of Directive 2009/41/EC reads as follows:
‘contained use’ means any activity in which micro-organisms are genetically modified or in which such GMMs [genetically modified microorganisms] are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment.
This definition appears to give an applicant proposing to use a GMM in Europe (called a “user” in the directive) a fair amount of leeway in determining that a system or process is “contained”, and what level of containment measures are called for.
Article 4 of the directive requires the user to carry out a risk assessment of the GMM, 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 the U.S. NIH Guidelines and other international biosafety guidelines, and most microorganisms used for fuel or chemical production would qualify to be included within the lowest level of containment, “Containment Level 1”.
Article 6 of the directive requires users to notify the “competent” national authority (i.e., 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 Class 1 organisms, the necessary information is fairly minimal.
The EU Contained Use Directive should be viewed as providing general guidance and baseline requirements for member state governments to adopt national regulations for oversight There is at least one recent (and very comprehensive) summary of national legislation under this directive available online – it is a report published in January 2011 by the Netherlands Commission on Genetic Modification – it can be downloaded from this site. One example of a national law adopted in conformance with the EU Contained Use Directive is the law adopted in the United Kingdom, described in the portal site accessible here. Briefly, the UK law requires advance notice to the relevant agency before any work with modified microorganisms is to begin, as well as the submission of a risk assessment for the agency’s review.
Environmental Use
In the years since the EU Directives were adopted, EU Environmental Release Directive has seen far greater activity than the Contained Use Directive, since the former applies to the testing and use of transgenic plants that are being developed worldwide for use in agriculture, food and feed. This directive also applies to the environmental uses of genetically modified microorganisms, and so in most EU member countries, national laws based on the Environmental Release Directive would apply to proposed uses of modified algae or cyanobacteria in open ponds, or in any proposed use of a GMM meeting the definition of “deliberate release” in the Directive:
‘deliberate release’. means any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment;
Article 4 of the Directive establishes that, for any proposed release, the applicant must prepare an environmental risk assessment, including the information specified in Directive, particularly including Annex III. This is a general requirement for any proposed open-environment use of a GMO. The Directive then goes on to specify procedures for review of proposed releases for research purposes (which it calls “deliberate release … for any other purpose than for placing on the market”) in Part B, and procedures for review of applications for commercial use (“placing on the market”) in Part C. In agricultural applications, Part B would apply to all field tests prior to commercialization of a plant or seed product, while Part C would apply to gaining approval for commercialization. For fuel or chemical production, presumably Part B would apply to pilot or even demonstration scale open-pond reactors where no commercial product is produced.
Briefly, under Part B, applicants proposing R&D use or other noncommercial use of a GMO must notify the appropriate national agency and provide a dossier including the environmental risk assessment and a plan to monitor the proposed use in order to identify any potential adverse effects occurring as a result of the use. The competent agency has a defined period of time, generally 90 days, to make its decision, and the agency may provide the public with notice of the proposal and the opportunity to comment. The proposed use can only go forward upon receipt of written consent from the agency having jurisdiction. National governments are required to report to the European Commission and to other member states the approvals it gives for applications under Part B. Although the public and all EU member states have the ability to comment on any such actions, all decision-making authority rests with the applicable agency in the country where the research activity is to take place.
Part C requires applicants to submit notifications to the competent authority in the EU member state where the GMO is to be placed on the market for the first time. In the context of the use of modified microorganisms or algae to produce fuel or chemicals, it may be worth noting that the definition of “placing on the market” is “making available to third parties, whether in return for payment or free of charge,” and that the notification requirement applies “before a GMO or a combination of GMOs as or in products is placed on the market.” One can argue that a GMO used to produce a product is not itself “placed on the market,” but it would be advisable to review the language of applicable national laws, and/or consult with legal counsel, to determine how a proposed use would be regulated in the applicable country. It is hard to imagine that most European countries would allow commercial use of a GMO algae or cyanobacteria, in open-environment production, without following the procedures of Part C of the Directive.
Under Part C, the agency receiving the applicant’s notification dossier has a specified period of time to prepare a formal “assessment report” which includes its decision on whether or not to allow the GMO to be placed on the market. The assessment report is to be provided to the applicant, and then to the European Commission, which will share it with the other EU member states. Decisions on approvals for commercial use, which would apply throughout the EU, are subject to comments and “reasoned objections” from other member states, and the Directive includes provisions for how to deal with any such objections that have been raised. The Directive also requires the national authority to notify the public of each notification it receives and to publish its assessment report. The proposed commercialization cannot take place until there has been written consent from the agency to which the application was made, which presumably will not take place unless any objections arised by other EU member states have been addressed, although all member states have the ability to restrict the sale of the product in its jurisdiction if it becomes aware of data or other information affecting the conclusions of the environmental risk assessment.
As is well known, the European Union has not granted any approvals under this Directive to use any genetically modified plant in commercial agriculture (i.e., for food use) and all such proposals have been controversial to some extent. I’m not aware of any proposed use of a GM microorganism that has progressed to an application for commercial use in Europe, so it is hard to know if any such proposal not involving food or feed use would engender the same level of controversy. As always, companies contemplating such activities should consult with the relevant government agency as far in advance of the proposed use as possible, to be sure all needed information is provided and the necessary procedures are followed.
D. Glass Associates, Inc. is a consulting company specializing in government and regulatory 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.
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