BioWorld International Correspondent
BRUSSELS, Belgium - The European Union member states are behind schedule on implementing the EU rules on biotechnology research, according to a new report from the European Commission. Only three of them have so far transposed the latest modification of the rules into national law. And although they are obliged to report every three years on experience in operating the rules, they were up to a year late in delivering their input for this latest update.
The 1990 directive on contained use of genetically modified microorganisms - largely focused on ensuring safety in research procedures - was significantly modernized in 1998, to take account of the increased knowledge base and understanding of biotechnology. Member states were required to bring in the amendments by June 5, 2000, but so far only Finland, Denmark and Sweden have done so, the Commission said.
Similarly, there is little evidence that member states have made much use of guidance notes the Commission produced to create a harmonized approach to the risk assessment that is at the heart of the new rules, and so far member states have not approved a Commission proposal on criteria for assessing the safety of types of genetically modified microorganisms.
"It is imperative that future changes in the technology and future advances in scientific knowledge are accounted for in the regulatory process, and this requires continued interaction and consultation with member states and interested parties," the Commission said in its report. It has told member states to submit further reports by September 2002, which "should encompass experiences with the above amendments."
However, the Commission said the member states' reports this time are "vastly improved in comparison to previous submissions," and do at last contain some detailed information. The Commission compilation of the data provided lists the activities reported by the member states - ranging from no new notified projects in Greece between 1996 and 1999 and only one in Portugal since 1991, to 5,235 in Germany between 1990 and 1999 - mainly in cell biology, virology and bacteriology. In Denmark, Finland, the UK and Italy, around 200 projects were notified in 1995-1999, while there were about 600 in France and 800 in the Netherlands. Sweden, Ireland and Spain notified around 50 each in 1996-1999.
The Commission records a low incidence of accidents: in the Netherlands, four accidents were reported, three of them involving damage to greenhouses, necessitating transfer of genetically modified plants under study to another greenhouse. In Spain, one installation identified a pathogenic fungus invading its microbiology laboratory, and dealt with it by sterilization and fumigation.
Inspection systems are in place in all member states, but only in the UK was there any action taken following inspections. Four improvement notices were issued by the authorities, one prosecution was initiated for failure to conduct adequate risk assessment, and permission for one project was withdrawn.