CONTAINED USE OF GENETICALLY MODIFIED
Draft Council Decision amending Directive 90/219/EEC as regards the criteria for establishing the safety to human health and the environment of types of genetically modified micro-organisms.
||Article 175 EC; qualified majority voting
||Environment, Transport and the Regions
|Basis of consideration:
||Minister's letter of 7 February 2001
|Previous Committee Report:
||HC 28-iii (2000-01), paragraph 6 (17 January 2001)
|To be discussed in Council:
||Legally and politically important
9.1 Since 1990, the Community has had a
legislative framework governing genetically modified organisms
(GMOs), in order to protect human health and the environment.
This comprises a number of specific sectoral measures and a series
of horizontal Directives, including Directive 90/219/EEC on the
contained use of genetically modified micro-organisms (GMM) in
research and industrial facilities.
9.2 In a 1994 Communication and White Paper,
the Commission recognised the importance of biotechnology and
the need for regulations to ensure oversight appropriate to the
risks and to the competitive development of the industries involved.
This led it to propose
in December 1995 an amendment to Directive 90/219/EEC, which sought
to link the administrative procedures and notification requirements
for GMMs to the likely risk, rather than (as previously) to the
scale of the operation involved. The proposal was eventually adopted
in Council Directive 98/81/EC,
which also provided for the Council to decide subsequently on
the exemption of certain types of contained GMMs (to be listed
in Annex II, Part C) which meet criteria (to be listed in Annex
II, Part B) establishing their safety.
9.3 In October 2000, the Commission put
forward the present proposal to secure the Council's agreement
to the relevant criteria in Annex II, Part B for determining whether
a GMM is suitable for inclusion in Part C. This envisages exemptions
on a case-by-case basis for clearly identified GMMs used in the
contained conditions set out in the main Directive, with documented
evidence of their safety being provided, together with evidence
of stability where this could affect safety. The proposal also
contains a number of more specific criteria of the kind set out
in paragraph 6.3 of our Report of 17 January 2001, together with
a set of detailed guidance notes.
9.4 In an Explanatory Memorandum of 21 December
2000, the Minister for the Environment (the Rt. Hon. Michael Meacher)
told us that the UK fully supports the principle of allowing the
exemption of GMM which meet strict safety criteria, and that it
is satisfied that those proposed are rigorous and comprehensive
(though it will be clarifying with the Commission such aspects
as the application of the precautionary approach and gene transfer).
It will also want to underline that all arguments will have to
be very thoroughly justified, and worst-case scenarios considered.
9.5 A Regulatory Impact Assessment provided
with the Explanatory Memorandum pointed out that there are approximately
500 centres in the UK undertaking genetic modification activities
under contained use, which have played an important part in medical,
biological and chemical research and in a wide variety of industrial
applications. It is estimated that one GMM each year will meet
the criteria proposed, and be used in 50 projects, leading over
a ten-year period to total savings of just under £70,000.
Costs over the same period would amount to about £45,000.
9.6 The Minister was concerned at the Commission's
proposal that the detailed guidance should be adopted through
a regulatory committee procedure, which he regarded as inappropriate,
since such a procedure was not envisaged in the parent Directive.
9.7 In view of the technical content of
this proposal, we sought views from the Parliamentary Office of
Science and Technology (POST), which commented that the general
approach of exempting specific GMMs from regulations appears to
be more in tune with US regulatory philosophy than the more precautionary
approach traditionally adopted within the Community, but that
the criteria and accompanying guidance seemed to be comprehensive,
with nothing obvious having been overlooked. However, POST also
pointed out that there is still considerable uncertainty associated
with assessing GMMs against the various criteria identified, and
that the science will not give clear unambiguous answers. It therefore
concluded that decisions on exemptions will also reflect the attitude
of the regulators as to how much scientific uncertainty can be
9.8 In the conclusion to our Report of 17
January 2001, we noted that, whilst the Government supported the
proposal, POST felt that the guidance proposed cannot be clear-cut:
also, the net benefits expected to arise from the exemption in
the UK were minimal, even over a ten-year period. In view of this,
the doubts over the legality of the procedure proposed by the
Commission for adopting the detailed guidelines, and the points
which the Government itself intended to pursue with the Commission,
we expressed doubts as to whether the gains from the proposal
would outweigh its uncertainties. We therefore decided not to
clear the document, and to ask the Minister to comment.
Minister's letter of 7 February 2001
9.9 We have now received a letter of 7 February
2001 from the Minister in response to our request. As regards
the major point about the uncertainty involved, he says
that absolute certainty is never possible, and that it is therefore
important to recognise this, to test the implications, and to
take a precautionary approach. He adds that, in applying such
an approach to the exemption of a GMM from the contained use Directive,
an exemption will not be allowed if "the margin of uncertainty
is such that it cannot with reasonable certainty be said to be
of acceptable risk". He also points out that GMMs encompass
an enormous range of organisms, some of which are clearly hazardous
and will never be considered for exemption, whilst others for
which there is significant uncertainty would also not be exempted.
However, he suggests that there are some GMMs where there is a
great deal of data available, which could be considered for exemption
(where he says they would have to be equivalent to yoghurt or
bakers yeast in terms of harmfulness and degree of uncertainty).
9.10 On the net benefits of the proposal,
the Minister accepts that the assessed benefits are low, but he
says they are based on "very conservative" projections,
and that, once the possibility for exemptions exists, it might
provide the impetus for development of useful products. He also
says that the Government's earlier concerns about the legal
basis have been met as a result of changes which the Commission
has since made, and that it is continuing to press the various
points referred to in paragraph 9.4 above.
9.11 The Minister concludes by saying that
he completely accepts the need to be cautious about exempting
GMMs, and that any decisions taken must fully acknowledge uncertainty
by explicitly incorporating a precautionary approach. He also
points out that, even if a GMM has been accepted in Europe as
exempt, it will still be possible for the UK to take a different
view. In short, he considers that the safeguards are "robust",
and that the UK should support the criteria proposed for the Annex
to the contained use Directive.
9.12 We are grateful to the Minister
for this further information, and, in the light of the assurances
he has given, we are now clearing this proposal.
22 (17128) 5791/96; HC 51-xix (1995-96), paragraph
13 (15 May 1996). Back
OJ No. L 330, 5.12.98, p.13. Back