1.  Genetic modification[1] (GM) is a branch of biotechnology. It involves the insertion of genes from one organism into another so as to produce a modified organism[2] (GMO) with different characteristics. Many different plants have been or could potentially be modified to change a wide range of characteristics, from herbicide tolerance and pest resistance to extended ripening or altered nutritional content. Present modifications are but the beginning of what is a technological development of great importance. There has been little progress in the genetic modification of animals[3], but experiments to modify fish for faster growth and tolerance to cold have been successful[4]. The private sector has invested heavily in the technology of genetic modification and five major agro-chemical/seed companies[5] control most of the agricultural applications world-wide.

2.  Genetic modification offers great potential benefits for agriculture, industry, the environment and consumers. As well as benefits, there are serious potential hazards and risks which must be addressed by proper regulation. Since 1990, the European Community (EC) has had in place a regulatory system for the control of GMOs. This consists principally of Directive 90/219/EEC on the contained use of genetically modified micro-organisms (the "contained use Directive") and Directive 90/220/EEC on the deliberate release[6] into the environment of genetically modified organisms (the "deliberate release Directive", hereafter referred to as "the Directive")[7]. The European Commission has now proposed amendments to both Directives[8]. This report is concerned with the proposed revision of the deliberate release Directive which will have to be agreed by the Council of Ministers and the European Parliament under the co-decision procedure[9]. The changes proposed by the Commission have provided us with the opportunity to assess the working of the Community's regulatory system. We have also considered the impact of the process of regulation on Europe's scientific and agricultural competitiveness. Finally, we have considered issues related to public confidence in the technology and its regulation.

Scope of this report

3.  This report examines the regulatory system for the agricultural and food use of genetically modified organisms. Its principal focus is plants and products derived from them because the overwhelming majority of organisms modified using genetic modification have been plants. The technology is not yet sufficiently developed for it to be of commercial use in relation to animals. Additionally, animals would normally be used in containment, not released into the environment, and it is release which is the subject of the Directive. We have concerns about fish, which, in relation to their release, are a special case, and are dealt with in paragraph 156. This report is concerned with issues which arise directly from the use of GMOs and does not attempt to deal with wider concerns raised by the industrialisation of agriculture, though experience of the latter gives useful insights.

4.  We are aware of the investigation into the ethical issues raised by genetically modified crops by a working party of the Nuffield Council on Bioethics. We had a valuable meeting with the members of the working party, but we have deliberately limited our inquiry to the efficiency and effectiveness of the EC regulatory structures.

5.  This report does not consider any of the issues relating to the patenting of living systems. Some of the pertinent issues have been addressed in our report on "Patent protection for biotechnological inventions"[10]. We have also not considered the issues surrounding liability either for GM crop failure or for any damage GM crops might cause to the environment or health.

Structure of this report

6.  Part 2 of this report gives a detailed background covering both the technology of genetic modification and the existing regulatory system. If further background is required, the May 1998 Parliamentary Office of Science and Technology (POST) report on "Genetically modified foods: benefits and risks, regulation and public acceptance" can be recommended. Part 3 contains the views of witnesses, together with the Committee's opinion on the potential benefits that the technology offers and also the potential risks. We consider how the risks can be assessed and managed as well as the questions of public acceptance of the technology and the effects of regulation. The committee's opinions are presented in bold print. A summary of the conclusions is presented in part 4. Appendix 1 contains the membership of Sub-Committee D which conducted this inquiry and Appendix 2 is a list of witnesses, to all of whom we express our gratitude. A glossary is to be found in Appendix 3.