BRUSSELS, Belgium - In addition to internal European Union disputes over genetically modified organisms released into the environment - most notably are GMO crops - there are plenty of criticisms brewing over the EU rules on the confined use of GMOs.
The UK said the rules, which require official approval for research installations and for projects undertaken there, are "unduly complex." Italy said they are poorly adapted to practical realities, because the system of classification is not consistent with international practice. Germany is insisting the rules need to be adapted to keep up with technical progress.
The UK also complained of long notification periods and a lack of appropriate detail of control measures and risk assessment. It said it favors simplification "based on the increased knowledge of the risks associated with genetic modification and control techniques enabling the earlier, very broad precautionary approach to be refined." Italy said the administrative procedures are not linked to the risk of the activities and in some cases are unnecessarily restrictive, and there is insufficient guidance on containment and control measures.
The criticisms were made in an unpublished report that the European Commission, the EU's executive body, recently completed. The report covers some of the newer operations of the 1990 rules on the confined use of genetically modified micro-organisms (Directive 90/219/EEC). It shows some of the EU's 15 member countries still have not fully transposed the rules into national law or designated national authorities responsible for enforcement, despite an October 1991 deadline. Luxembourg and France failed even to deliver their inputs for this report on time.
The EU rules have been in operation in the UK, the Netherlands, Italy and Portugal since 1993; in Ireland, Sweden and Spain since 1994; and in Austria, Greece and Finland since 1995. Denmark did not come fully into line until 1995 (until then Danish law was even stricter, and it was only in 1995 that it conformed to EU rules by introducing a simplified notification system for the use of low-risk GMOs).
Germany's 1990 law and France's 1992 law still need updating. Belgium's 1995 legislation still has to be finalized in the country's Wallonia region. And, the report said, in Luxembourg a draft legislative text has been presented to parliament and is under discussion.
Member States Differ In Approaches
The report also demonstrated some of the profound differences in the national systems for controlling biotechnology research across the member countries of the EU. For instance, in the UK the authority for implementing the rules is shared between the Health and Safety Executive - which has a full-time specialist inspectorate - and the Department of Environment, advised by the Advisory Committee on Genetic Modification, with an independent chairman, and members representing employer groups, industry, universities research councils and employee organizations, as well as scientific and medical specialists.
Under the German system, the Londer regional authorities are responsible, but they coordinate their approach via a Central Commission for Biological Safety. In France, the Ministries of the Environment and of Research are responsible, advised by a consultative committee of scientific experts. In Spain, the national government environmental protection secretariat is to hand over its powers to Spain's autonomous regional authorities. In Italy, the competent authority is the Ministry of Health, supported by an inter-ministerial coordinating committee. The Netherlands has put the Environment Ministry in charge, assisted by an Advisory Committee on Genetic Modification, which consists of scientists. In Denmark, the Ministry of the Environment and Ministry of Labour receive expert assistance from the Food Agency attached to the Department of Health, and from universities.
This directive was drafted on the basis of scientific information available at the beginning of the 1980s, and the evolution of research and the increasing use of genetic modification techniques since then has revealed weaknesses in the system of classification of genetically modified micro-organisms, which is no longer compatible with international practice.
The commission said some of the problems identified in this report already have been dealt with by slight modifications at the end of last year, and some administrative procedures and requirements are now more closely related to the real risks presented by activities. Confinement and protection measures to preserve human health and the environment, it said, have been stepped up and some flexibility has been introduced to ease adaptation of the rules.
But member states have not been cooperative in providing input for the report. European environment commissioner Ritt Bjerregaard told fellow commissioners when she presented the draft report to them that finalization "has been delayed primarily due to delayed and incomplete replies from member states."
An update to this report already is pending. Further national reports covering 1999 are due to be submitted to the commission in September. These will take account of the 1998 modifications to the directive. "It is imperative that future changes in the technology and further advances in scientific knowledge are accounted for in the regulatory process and this requires continued interaction and consultation with member states and other interested parties," the commission said.
The report also provides some provisional figures on biotechnology research capacity and activity across the member states. The UK has 560 facilities for contained use of genetically modified micro-organisms, and in the most recent reporting period about 170 notifications had been received, with fewer than 10 in the "high risk" categories of research. In Germany, 2,181 installations have been notified as well as 3,376 research operations, involving mainly research or academic work.
Denmark lists a total of 387 low-risk research projects and 39 of higher risk, and said that in no case has consent been refused or withdrawn. In Austria, 96 installations have been notified. The Netherlands has 220 laboratories and installations using genetically modified organisms, and just six requests for clearance were refused (due to lack of information) out of 635 notifications in the most recent reporting period. Out of 315 installations notified in Italy, 295 were approved, as were 80 out of 89 operations notified.