By the Select Committee appointed to consider Community
proposals, whether in draft or otherwise, to obtain all necessary
information about them, and to make reports on those which, in
the opinion of the Committee, raise important questions of policy
or principle, and on other questions to which the Committee considers
that the special attention of the House should be drawn.
EC REGULATION OF GENETIC MODIFICATION
6378/98/98 (COM(98) 85)||Proposal for a European
Parliament and Council Directive amending Directive 90/220/EEC
on the deliberate release into the environment of genetically
PART 1: INTRODUCTION
1. Genetic modification
(GM) is a branch of biotechnology. It involves the insertion of
genes from one organism into another so as to produce a modified
(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,
but experiments to modify fish for faster growth and tolerance
to cold have been successful.
The private sector has invested heavily in the technology of genetic
modification and five major agro-chemical/seed companies
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
into the environment of genetically modified organisms (the "deliberate
release Directive", hereafter referred to as "the Directive").
The European Commission has now proposed amendments to both Directives.
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. 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".
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.
1 Also known as "genetic engineering". Back
2 For the purposes of the EC Directive on the deliberate release
into the environment of genetically modified organisms (Directive
90/220/EEC (OJ L117 (8 May 1990) pp 15-27)), "organism"
is defined as any biological entity capable of replication or
of transferring genetic material; "genetically modified organism"
(GMO) as an organism in which the genetic material (DNA or RNA)
has been altered in a way that does not occur naturally by mating
and / or natural recombination (Article 2). Back
3 Cloning, as with Dolly the sheep, is not strictly genetic modification
as no gene has been inserted or altered. Back
4 European Parliament Committee on Agriculture and Rural Development,
report on the impact of biotechnology on agriculture, B1. See
also the Health and Safety Executive (HSE) on behalf of the Scottish
Office, pp 350-1. See also paragraph Fish are being modified for rapid growth and cold tolerance and further modifications are in development. Once released, it would be impossible to recapture a fish or to control its breeding (unless sterile). Fish do not respect national boundaries and we would be very concerned if sea or river releases were to take place here or abroad. We strongly recommend that there be an international agreement prohibiting such actions. Any trials or commercialisation must be in containment and not released into the sea or freshwater network. Back
5 AgrEvo, Dupont, Monsanto, Novartis and Zeneca (Q 627). Back
6 Article 2 of Directive 90/220/EEC defines "deliberate release"
as "any intentional introduction into the environment of
a GMO . . . without provisions for containment such as physical
[and/or] chemical . . . or biological barriers used to limit their
contact with the general population and the environment".
Crops are thus released when planted in the open. Back
7 Both Directives were set out in OJ L117, 8 May 1990. They were
due to be implemented in Member States by 23 October 1991. The
text of the revision of 90/220/EEC proposed by the Commission
was published on 26 February 1998. Any revision is not expected
to be adopted until late 2000. Back
8 A revised contained use Directive was adopted by the Council
of Ministers on 5 December 1998 (OJ L330, 5.12.98, p.1). Back
9 The Environment Committee of the European Parliament has yet to
report on the proposed revision of the Directive, but has received
a report from a consultant (Dr von Schomberg, "An appraisal
of the working in practice of Directive 90/220/EEC on the deliberate
release of genetically modified organisms" Final Study,
European Parliament Scientific and Technological Options Assessment,
(STOA), January 1998, PE 166.953/Final. (For Dr von Schomberg's
evidence, see pp 401-2.)) The committee had not reported when
this report was ordered to be printed. The Economic and Social
Committee of the European Community has volunteered an opinion
on the role of GM within agriculture ("Genetically modified
organisms in agriculture - impact on the Common Agricultural Policy",
July 1998) and has also produced a report on the revision of the
Directive (CES 1117/98, 9-10 September 1998). Back
10 European Communities Committee, 4th Report (1993-94), HL 28. Back