Czech scientists and EU regulation

The regulation of transgenesis - genetic modification - in Europe is twenty years old. Any rules concerning fast developing field are more or less fossil after such period. More that that: the foundation stone - Directives 90/219/EEC and 90/220/EEC were designed and enforced by the policy pressure by Greens and Communists rather by science experts.

Early suggestion of a Directive regulating techniques based on recombinant DNA was formulated in 1978. The term "genetic manipulation" was used for "recombinant DNA work". The proposal was very rational stating:"Because of the unceasing progress of knowledge and techniques in the field of basic and applied biology, this Directive and its continued applicability to production activities of industries shall be thoroughly reviewed, and revised if necessary, at regular intervals not exceeding two years." Such open-minded approach is only dream in 2009.

Nevertheless, that time the Economic and Social Committee (ESC) emphasized in the report in 1979 the declining assessment of risk, the absence of specific problems and stressed that the provision of costly safety measures are not necessary. Thus, the Commission on the advice of DG XII (Science and Technology) Director-General Gunther Schuster replaced the Directive by non-bonding Recommendation on 1980.
In the eighties the situation started to change. The European Parliament was deeply divided in this issue. In May 1981 the reporter for the ESC was an Italian Communist Domenico Ceravolo and advocated the Directive. But liberals were still strong and the Recommendation was approved and adopted by Council in June 1982. However, on American continent the application of transgenesis slowly approached agriculture. This in combination with the traditional conservatism of Europeans offered a strategy how to protect the European farmer from cheap imported products forced by subsidies. This in addition to ideology was another factor paving the way for next political development.

The main structure of future Directives was predetermined by German Green reporter Friedrich Wilhelm Graf zu Baringdorf in his report presented at Plenary session of the European Parliament in February 1987. It was pointed against "industrialisation" of agriculture and biotechnology in particular. The Parliament resolution was then very conservative seeing "special risk associated with genetic engineering", demanding complete ban on field releases "until binding Community safety directives have been drawn up".

This task has to be performed by a new structure - BRIC - Biotechnology Regulation Inter-service Committee. The Chair of it was divided between DG III (Internal Market and Industrial Affairs) and DG XI (Environment). BRIC took over the agenda from BSC (Biotechnology Steering Committee) headed by DG XII. At the end of eighties DG V (Employment and Social Affairs) was preparing a Directive for the protection of workers against the risk of exposure to biological agents amending the Council Directive 80/1107/EEC. The proposal addressed all biological agents calling them "microorganisms" including cell cultures, endoparasites, and genetically modified microorganisms as well. The resulting Directive 90/679/EEC was adopted in November 1990.

BRIC issued in May 1988 the Communication COM (88)160 presenting proposal for two directives - contained use of genetically modified microorganisms (GMM) and release of genetically modified organisms (GMO). The Annex I of both Directives defining techniques that are included or excluded from regulation was removed from amendment being in this way "frozen" for ever with no regard to science progress and experience.
On October 1st 1988 the Council of EMBO (European Molecular Biology Organisation) discussed the Directives proposal and issued a statement saying mainly: "Over the last 15 years, experience has shown that recombinant DNA methods are far from being dangerous and are important tool valuable to humankind and environment." "Any rules or legislation should only apply to the safety of products according to their properties rather than according to the methods used to generate them." The statement with covering letter was transmitted to members of European Parliament on 16 May 1989 by the Chairman of EMBO prof. Max Birnstiel.

On 18 May 1989 an open letter by 16 European Nobel Laureates in Medicine and Chemistry was delivered to the Presidents of the European Parliament, the EC Council and the Commission. Recalling the proposed Council Directives the letter states: "....there is no justification to single out a technique for regulation instead of basing it on the properties of the generated organisms." "Amendments have been proposed which are based on unfounded fears rather than on scientific risk assessment. They are both impractical and widely inhibitory to the progress of knowledge and its responsible beneficial application."

After adoption by Council the Directives came back to the Parliament for the second reading. On 8 February 1990 the Nobel Laureates sent another letter to the Presidents. All this came to vain. Politics overruled the science and Directives 90/219/EEC and 90/220/EEC were adopted on 23 April 1990. Directives created the basement for the legislative for next twenty years. Neither millions of hectares of planted GM crops, nor billion of tunes of consumed GM products have moved EU politicians to adjust the legislation to the progress.

This is why 64 Czech specialists comprising 36 university professors issued a White Book analyzing the inadequacy of the recent EU legislation in the field of transgenesis application in the agriculture. The WB also demonstrates the contribution of Czech science in this field supporting the legitimacy of Czech scientists to present their critical view. The WB was presented at two press conferences on 9 and 10 June and will be distributed to European scientific organisations. It is available on http://www.bc.cas.cz/en/MOBITAG.html. The press release can be found on www.biotrin.cz.

Author: Prof. Jaroslav Drobník