COMMENTS ON THE PROPOSAL FOR A DIRECTIVE AMENDING
THE COUNCIL DIRECTIVE
ON THE DELIBERATE RELEASE INTO THE ENVIRONMENT OF
1. THE CONCEPT
22. Member States have experienced considerable
difficulties in reaching agreement on decisions whether to allow
the marketing of genetically modified organisms (GMOs) under Part
C of 90/220. Every application has been disputed and the French
Government has now introduced a moratorium on the commercial use
of GMOs while a public consultation takes place. This has further
highlighted the problems and confusion.
23. Disagreements about the scope of the Directive
are partly the cause of the problem. Some Member States (such
as Denmark and Austria) consider that an evaluation of the environmental
impacts of GMOs should include all possible effects, direct and
indirect, as is the case with agricultural practice. Others (such
as the UK) have restricted the definition of environmental harm
to the immediate impacts of the GMO. For example, under the wider
definition, an assessment of GM herbicide resistant crops would
also include the impacts on herbicide use, ground water pollution
and weed evolution. Under the narrow definition, the possibility
of gene transfer and establishment of the GMO outside the agricultural
environment are the main focus of the assessment.
24. However, the Commission's proposals for
the principles of the environmental risk assessment (Annex II)
and the information requirements (Annex IIIA/B) take a narrow
view of the risks limited to the genetic modification and the
release of the GMO itself.
25. For full environmental protection, the
Commission's proposal for the principles of the risk assessment
(Annex II) should be amended to include all effects from the use
of the GMO, including long-term effects from the use of chemicals,
and take into account the availability and suitability of alternative
production systems. The information requirements (Annex IIIA/B
and Annex IV) should be amended accordingly.
2. RELEASES MUST
26. As well as the narrow scope causing problems,
there are also disagreements over whether identified risks are
significant or not. For example, some countries feel that the
emergence of herbicide tolerance weeds should be avoided and so
opposed commercial scale releases of herbicide resistant oilseed
rape. Other felt the risks are tolerable and manageable with the
use of different herbicides. This lack of agreement on the "so
what?" question reflects the considerable scientific uncertainty
about scale, extent and degree to which any risk will be experienced.
Therefore the disagreements are over what is considered justifiable
harm. However, neither the Deliberate Release Directive nor the
Commission's proposed revision allow the debate to be articulated
in honest terms like these. Rather the emphasis is on conducting
the debate in technical terminology even though this does not
form the real basis of the conflict over the risks and no scientific
certainty exists with which to resolve the issue.
27. The narrow, technical nature of the regulations
conceals a "taken-for-granted" assumption inside the
system that genetically engineered organisms represent positive
progress, yet this is a view which research shows is far from
widely held. Therefore, its assumption in policy is profoundly
anti-democratic. Considering the physical dimensions of risk alone
excludes articulation of value judgments about effects on future
generations, or the morality and justification for taking any
particular risk and these are of fundamental importance to evaluating
risk for most people. Therefore if the Directive does not tackle
this issue it will never command public confidence.
28. GeneWatch believes the revised Directive
must allow for an explicit evaluation of whether the risks of
a GMO release are in the public interest.
29. Such a public interest provision in the
risk assessment would be analogous to the requirement to justify
nuclear discharges and demonstrate a social benefit in the regulation
of the nuclear industry, the Fourth Hurdle used to assess BST
and the provisions in Norwegian Gene Technology Act. There are
practical tools which could be used to help decision makers in
evaluations of public interest. These include techniques such
as multi-criteria evaluation, citizens' juries and consensus conferences.
An explicit public interest clause could result in decisions being
more robust as they should more accurately represent public opinion.
3. MANDATORY SEGREGATION
30. The Commission's proposed revisions include
a requirement for post-marketing monitoring (Articles 15(2) and
22(2)) and a re-evaluation of the licence after a seven year period
(Article 22 (3)). However, monitoring and re-evaluation cannot
be considered to provide reliable safety mechanisms because they
have serious limitations in practice. Firstly, deciding what to
monitor, how often and where, presumes the risks are known and
this is a dangerous assumption. The emerging evidence that certain
chemicals cause sex changes in fish was not predicted and was
discovered by chance. Unexpected impacts of GMOs may cause similar
surprises. Secondly, the irreversible nature of the risks of releases
of GMOs means that when harm is discovered through monitoring
or by chance, it is unlikely that anything will be able to be
done to rectify matters. Thirdly, the time-scale over which harm
may arise may not be detected inside seven years. Damage from
the introduction of exotic species to new environments can take
decades to emerge. A false sense of security may be engendered
if a positive seven year review is equated with safety.
31. However, as well as these basic problems
with the principles of monitoring and re-evaluation as safety
management tools, they will be completely unable to identify even
gross harm unless mandatory segregation of GMOs is put in place.
Without this, it will prove impossible to track and evaluate their
effects at any stage, be it on consumers, the environment or agriculture.
32. The proposed Directive must be amended
to include the provision for mandatory segregation of GMOs and
their tracking through the environment and food chain. Such a
system would also allow for full labelling to take place and facilitate
4. SHORTCOMINGS OF
33. Under both the current and proposed revision
to the Directive, case-by-case assessment is the only approach
envisaged. By looking at each GMO in isolation, the possibility
of cumulative effects is neglected. For example, many crops are
being engineered to include a insecticidal toxin (Bacillus
thuringensis toxin in particular) so they can resist insect
attack. Because the toxin is present throughout the growing cycle
rather than intermittently, beneficial insects and birds which
normally feed on the pest species may lose their food supply completely.
When considered on a crop-by-crop basis, the likelihood of this
occurring or having any serious effect may seem remote, but if
the majority of crops planted carry such a toxin, there could
be serious impacts on some species.
34. The Directive should be amended to allow
for the review of the potential for cumulative impacts of classes
of genetic modification. This could include, for example, insect
and herbicide resistance and should be undertaken before approvals
for individual products are given.
5. SIMPLIFIED PROCEDURES
35. Articles 18 and 19 of the Commission's proposed
revision contemplate the introduction of simplified procedures
for the placing on the market of GMOs. The Commission or Member
States can make proposals and, if accepted, would lead to a fast
track approval process with much shorter times for evaluation
and public scrutiny. The real danger is that the types of GMOs
that would be recommended for this simplified procedure would
be similar to those already approved. Whilst this sounds a sensible
approach, it would mean even less attention being given to the
issue of cumulative impacts (see above). There is also very limited
knowledge about the commercial use of GMOs in the European Unionto
date there have been no crops grown on a commercial scale at all.
36. Simplified procedures for the marketing
of GMOs should not be allowed at this stage. Knowledge about their
impacts may go undetected if fast tract approvals are allowed.
Therefore, Articles 18 and 19 should be deleted.
6. PLACING EVALUATIONS
37. Under Article 14 of the Commission's proposed
revision, GMOs to be marketed could be assessed under product
regulations. In practice this means that a GMO intended to be
used as a pesticide (a virus engineered to kill insects for example)
could be assessed under pesticides regulations if this included
a "similar" risk assessment process to that laid
down in the Directive. Although superficially this seems like
streamlining, it could result in GMOs being considered by authorities
ill-equipped to evaluate the risks of the genetic modification
because their normal work involves the assessment of more conventional
pesticides. Thus important safety considerations may be overlooked.
38. Evaluations of GMOs must be undertaken
by those with the specialised knowledge required. Article 14 of
the proposed revision should be deleted to avoid the erosion of
safety standards through less rigorous scrutiny by less experienced
Liability for harm
39. To encourage companies to make a realistic
assessment of the risks and to ensure that should harm arise it
will not be left to public funds to pay any costs arising, a system
of strict liability should be put in place.
40. The proposed revision of 90/220 should
include an article which puts in place strict liability for environmental
or other harm arising from the release of a GMO.