EUROPEAN GMO REGULATIONS: A VICTIM OF BIOPOLITICS?
July, 2000
As overall public opinion in the European Union (EU) remains negative towards GM food1, there are indications that these negative opinions are leading to an effect on the regulatory formation process. This will have a direct effect on the US biotechnology companies operating in the European arena but also an indirect effect on many US producers attempting to sell their products into the European markets.
In April last, members of the European Parliament in Strasbourg voted on proposed amendments to the EU legislation (Directive 90/220/EEC) that governs the deliberate release of genetically modified organisms (GMOs) into the environment2. These amendments were designed to tighten regulations pertaining to GM products.
The Directive (implemented in all EU member states since 1995) is divided into three main sections: (i) definitions and provisions of the directive, (ii) experimental release, and (iii) products release, on a commercial basis, to the market3. It should be noted that there have been no new GMO approvals since April 1998. To date, there have been only 18 GMOs approved for commercial use and four are still awaiting approval.
The original aims of the Directive had been the harmonization of procedure and criteria for biosafety assessment under the concept of the EU single market. The regulation was `process based' in contrast to the `product based' regulation in the US.
The Directive failed its primary goal of harmonization, and its operation is currently effectively suspended. Over recent years, serious differences between the member states relating to GMOs (namely GM crops) have arisen because of differing concepts of risk, cultural and historical elements, and `biopolitics'.
`Biopolitics' is a catch phrase defined as the politicization of modern biotechnology issues within the political stream, which can influence public policy at local, national, and international levels4. The influence of biopolitics can be seen in the evolutionary pathway of Directive 90/220/EEC. The planned changes to this directive are driven mainly by public opinion rather that scientific fact. Distinct examples of this can be clearly seen.
In June 1999, the EU Council of Ministers met to discuss the GMO topic. At the time, European politics had become intensified due to EU parliamentary elections taking place throughout the member states. Candidates on election trials across Europe encountered the issue of GM food on a regular basis; added to this was intense media coverage of GM issues at the time. At the Council meeting, a French-sponsored declaration called for a moratorium on GMO approvals. A British Department of Environment spokeswoman accused the French of playing politics with the issue. She was cited as saying, "The French Minister made it clear there was no legal basis for a blanket moratorium. What they were putting forward was a political declaration." In essence, the French position was purely biopolitical posturing.
During the meeting, it emerged that there were actually two separate substantial declarations, both of which were negative in tone. The first statement asked the Commission to suspend new authorizations until new rules based on the precautionary principle had been developed and adopted. Signatories included France, Greece, Italy, Denmark, and Luxembourg.
The second declaration requested the EU not to allow new market releases until it was demonstrated that GM products had no adverse health or environmental effects. Austria, Belgium, Finland, Sweden, Germany, Spain, and the Netherlands signed this particular declaration. Interestingly Britain, Ireland, and Portugal didn't sign any of the above declarations. Eventually, the Environment Ministers agreed there was no legal basis for an official moratorium. They also agreed on proposals that included:
• Post-marketing monitoring of GM crops;
• New risk assessment rules;
• Phasing out of the use of antibiotic marker genes;
• Formal bioethics studies;
• Examination of the liability clause; and
• Increased public input and information.
The meeting proved to be an indicator of the political divisions within the EU, whose member states are supposed to emulate the concept of a single market.
It looks certain that similar biopolitical influences will again play an important role in discussions at the upcoming meeting of EU Environment Ministers on July 14th, 2000. Mrs. Dominique Voynet, the French Environment Minister, has already been quoted as saying that the new legislation due to be adopted would fail to meet public concerns about transgenic food.
Outlining her position, Voynet stated that she wanted the de facto moratorium to remain in place until the EU had clear rules on producer liability for environmental damage. Voynet told journalists that "the new directive . . . is not strong enough for us to lift the [de facto] moratorium. At this moment I don't see any reason to lift it." Voynet also added that five or six other EU countries supported her hard line, namely Austria, Denmark, Italy, Greece, Luxembourg, and possibly Belgium5.
The influence of biopolitics was again evident when the EU parliament considered the proposed amendments to Directive 90/220/EEC last April2. The EU Environment Commissioner, Margot Wallstrom, issued a statement further compounding the belief that the EU is attempting a biopolitical compromise by simultaneously operating a public attitude agenda and a scientific agenda. Commissioner Wallstrom acknowledged that there was no scientific evidence to support a ban on the use of antibiotic resistance marker (ARM) genes in certain GM products. However, she did say that the Commission supported a phase-out of the use of ARM genes for biopolitical reasons. She stated, "I am also fully aware of the political importance of certain other aspects raised by the proposed amendment . . . A phase-out [of ARM genes] is already foreseen in the common position. The Commission agrees to strengthen this political message. 6"
The emergence of biopolitics has shown its effects at all political levels in the EU, whether expressed through the local banning of GM food from school dinners by local councils in the UK, the failure of national governments such as Greece or Austria to pay due regard to European law, or even the international political effects on global trade. It seems that the public perceptions of modern biotechnology are having an effect on the public policy process, which in turn is causing changes in the regulatory guidelines. The vehicle for these changes has been, and will continue to be, biopolitics.
Sources
1. Eurobarometer 52.1 Report. 1999. The Europeans and Biotechnology. Directorate General for Education and Culture. Public Opinion Analysis Unit.
2. Session Document A5-0083/2000. Recommendation for Second Reading on the Council common position for adopting a European Parliament and Council directive on the deliberate release into the environment of genetically modified organisms and repealing Council directive 90/220/EEC.
3. Lunel J. 1995. Biotechnology regulations and guidelines in Europe. Current Opinion in Biotechnology 6:267-272.
4. Morris SH and Adley CC. 2000. Evolving European GM regulations: An example of biopolitics at work. Trends in Biotechnology 18:325-326.
5. Pomeroy R. 2000. France calls for tougher EU rules on GM crops. Reuters, 22 June.
6. EU Parliament. 2000. Verbatim report of proceedings. Sitting of Tuesday I, 11 April. Deliberate release into the environment of GMOs.
Shane Morris
Catherine Adley
Dept. of Chemical and Environmental Sciences
University of Limerick
Shane.Morris@ul.ie