6.1. Genetically modified organisms (GMOs)
The advent of gene technology in the 1980s caused some anxiety in Denmark, which was consequently among the first countries to regulate the area (1986).
The EC now regulates the area by means of two Directives. The first, Directive 90/219, regulates industrial production involving the contained use of GMOs and requires detailed control of such activities by the authorities on the basis of information from the manufacturer. The Directive requires an authorization system for large-scale work with high-risk organisms (i.e. over 10 litres); otherwise, however, Member States can suffice by establishing a reporting system.
Directive 90/220 regulates the environmental release of GMOs. The central set of rules concerns EC authorization of GMOs intended to be placed on the market in the Union. Authorization is issued by the individual Member States, but using a procedure that ensures the Commission and the other Member States the chance to react. The authorization is valid in the entire EC.
The Danish rules on the area are stipulated in the 1991 Environment and Genetic Engineering Act. This is the second law concerning the area and it has been adapted to the EC Directives. It is Danish administrative practice to distinguish between experiments, industrial production and release.
Experimentation with GMOs is regulated by means of special rules. These are administered by the Danish Working Environment Service, which already has responsibility for supervising the laboratories in question. Containment or the implementation of emission-limiting measures is required.
Industrial production employing GMOs is mainly undertaken at a major bioindustrial company with several production plants (85% of all authorization permits). Approximately 40 different bioproduction processes have been authorized so far (the Danish rules are thus more stringent than the EC Directive in that authorization is a requirement). A certain degree of emission to the external environment can be accepted in the case of industrial production. The authorization procedure has to ensure that the organisms in question are not an environmental hazard, and that they are only released in very limited amounts that do not have an untoward environmental impact. Denmark also regulates the transport of GMOs, even though it is not regulated by the EC.
Permits for the experimental release of genetically modified plants have been granted on 15 occasions in Denmark, but no EC permits for the marketing of such plants have yet been issued on the initiative of Denmark. Authorizations for marketing in the EC have been issued on the initiative of other Member States on four occasions. The Danish rules on release are influenced by the anxiety that the other Member States are not sufficiently cautious. The EC system provides that possible disagreements as to the line that should be followed with respect to authorizations are to be settled by the Management Committee established in accordance with the Directive.
Decisions in cases concerning the release of GMOs are taken by the Minister for Environment and Energy. Cases concerning industrial production are decided by the Danish Environmental Protection Agency until October 1995, whereafter the authority to issue authorizations will pass to the Counties, who currently supervise such production.
Progress in the regulation of this area is reflected by the fact that
there have not been any serious leaks. Whether such problems would have arisen if
regulation had not been imposed is hard to say. However, at least regulation has calmed
the population.