Memorandum by the Green Alliance
1. The Green Alliance (GA) is one of the UK's
leading environmental policy organisations. The Green Alliance
biotechnology programme has been active since 1987, and the GA
has played an important role in raising awareness about the potential
environmental consequences of releasing GMOs, as well as campaigning
for greater transparency of the regulatory system. Julie Hill,
former Director of The Green Alliance and now Programme Advisor
to the organisation, has since 1990 been a member of the UK Government's
Advisory Committee on Releases into the Environment (ACRE). The
GA thus has considerable experience of the development and operation
of the EU regulatory system, its implementation in UK law and
associated policy, and the concerns of non-governmental organisations.
1. The appropriateness and efficacy of current
regulation of release into the environment at European Level
The scope of 90/220 must be clarified
to ensure that indirect effects are considered
2. Directive 90/220 requires that "Member
States shall ensure that all appropriate measures are taken to
avoid adverse effects on human health and the environment which
might arise from the deliberate release or placing on the market
3. One of the problems in implementing the Directive
has been that "adverse effects" are not definedit
is left up to member states to decide what constitutes an adverse
effect. This has led to considerable differences in interpretation
among member states, culminating in fierce disagreement as to
whether particular products should be allowed to enter the market.
One of the main disagreements has been over how far "indirect"
environmental effects should be taken into accountthe most
prominent of these being the effects of the use of a chemical
in conjunction with a GMO, as happens with herbicide tolerant
crops. The UK has been one of the Member States arguing for a
relatively narrow interpretation of the Directive, one that excludes
4. It is in everyone's interest to clarify the
scope of the Directivethe delays caused by these disputes
have been time-consuming and costly, not least for the applicants.
In the most recent draft of the proposed revision of the Directive,
"indirect" as well as "direct risks" are included
in the definition of what environmental risk assessment should
cover, but there is no guidance as to how this should be interpreted.
It should be made clear that the Directive regulates "indirect"
as well as "direct" effects and these should be defined,
so far as is possible.
5. By recognising the importance of indirect
efforts, the Directive will be moving towards ensuring a fuller
environmental "audit" of the applications of the technology
in agriculture. Biotechnology companies are presenting their products
as more "environmentally friendly" and arguing that
they will lead to a decrease in the use of damaging pesticides,
but as yet they have provided very little independent evidence
that this is the case. The public is looking to the regulatory
authorities to provide a judgment on these issuesso far
they have abrogated this responsibility.
There should be guidance in the
Directive as to what constitutes an unacceptable risk from GMOs
6. The revised Directive attempts to set up
principles for risk assessment (Annex II). This gives guidance
on the kind of questions that should be asked in order to assess
the risks posed by a GMO, but gives no guidance on how the answers
should be judged. As noted above, in the absence of any definition
of "adverse effects", member states are left to come
to their own views as to what constitutes an unacceptable effect
from a GMO, and have already tended to disagree.
7. The Directive should provide guidance on
the acceptability of impacts. In order to do so, the Commission
and Member States will have to engage in a very broad debate about
the value we place on the natural environment, and what should
be considered an unacceptable burden on it. It should also be
debated whether GMOs should be judged by reference to other agricultural
practices, for instance the spraying of chemical controls, or
whether there should be an independent standard for damage by
The Directive should require that
risk assessments explicitly acknowledge areas of uncertainty before
coming to a general conclusion about risk.
8. One of the problems for risk assessment in
this area is the large degree of uncertainty about long-term effects
of releases. The Principles for Risk Assessment in Annex II of
the draft revised Directive give no guidance as to how to handle
uncertainty, and uncertainties are rarely acknowledged by the
Member States when they give their verdicts on an application
for a consent. The effect of this, particularly for marketing
consents, has been a severe lack of confidence in the way political
systems are using science, and diminishing credibility of scientific
experts. Acknowledging uncertainty is an important step towards
The Directive should require Member
States to consider the cumulative impacts of GMO releases
9. The Directive provides for risk assessment
and consent procedures for individual applications for release
or marketing. Although not specifically prohibited by the Directive,
this framework tends to limit the ability of Member States to
consider the cumulative impacts of a variety of GMOs, released
at increasing scale, over time. Herbicide tolerant oil-seed rape
has provided a potent illustration of this problemindividual
applications for a single type of tolerance, used on a small scale
at trial stage are judged not to be a problem. However, there
is an increasing feeling that the cumulative effects when the
crops reach commercial stage could be very seriousthey
include the possibility of volunteers with multiple tolerance
and dramatic changes to patterns of chemical use. The same problem
is posed by different types of insect-resistant crops.
10. A more strategic view, considering cumulative
effects, would provide important context for individual consents,
which otherwise tend to be seen in isolation from each other.
The Directive should require that Member States periodically review
the releases already in progress in their country, and identify
any cumulative impacts that should be addressedby, for
instance, discontinuing consents for certain types of release.
There must be post-commercialisation
monitoring of GMO products
11. In the recent draft revision of the Directive,
those applying for a consent to market a GMO product must submit
plans for monitoring "to identify any relevant direct, indirect,
immediate or delayed effects of the GMOs on human health and/or
the environment" (Article 15.2). This is linked to a proposal
that consents are limited to seven years. We welcome these proposals,
although we are firmly of the view that monitoring should not
be seen as a substitute for thorough risk assessment when the
application is first processed.
12. We acknowledge that finding scientifically
credible and practicable methods of monitoring the long-term environmental
impact of GMOs will be challenging not impossible. The Green Alliance
is planning a pan-European workshop for the end of 1998 which
will bring together representatives of non-government groups and
scientific experts to debate options for monitoring.
The transparency of the Directive
should be improved
13. In the recent draft revision of the Directive,
there are new provisions for public consultation. For applications
for marketing consents, a summary will be made available to the
public by the Commission, and a period of 30 days allowed for
comment. Copies of the assessment report, which is the report
made by the Member State Competent Authority to which the notification
is first made, and copies of opinions from any scientific committees
consulted, will only be made available after a decision has been
made. There is also provision for releasing some information about
experimental releases (Article 26). Article 19 of the original
Directive (now Article 28) that requires that commercially sensitive
information is not disclosed, remains in place. There is a further
public consultation measure in Article 18.3, which requires the
Commission to make available to the public any proposals for "simplified
procedures" i.e., proposals from Member States to administer
the consent system in a more streamlined way. The public will
have 60 days to comment on these. This means that the public will
be able to express views not just on individual applications but
also on procedures.
14. We welcome these developments. However,
we consider that the comment time on summary marketing consents
is too short60 days is more realistic. Further, the assessment
reports should be made available before a final decision is made,
to enable the public to comment on these. There is no case for
keeping these secretit makes a nonsense of any claims to
The relationship between the central
scientific committees and those giving advice to the Competent
Authorities in Member States must be clarified.
15. The draft revised Directive provides that
"The relevant Scientific Committee(s) shall be consulted
by the Commission on any matter . . ." It is assumed that
this refers to the committees set up under the auspices of DGXXIV,
and which have recently been asked to provide opinions on applications
for marketing consents where the Member States have not been able
to reach an agreement. This includes the case of the Ciba-Geigy
(now Novartis) Maize, with the ampicillin resistance genes, which
the UK Government, on the advice of one of its scientific committees,
initially voted against being given commercial consent. The Commission
sought advice from three of its scientific committees who found
no grounds for refusing the consent, and the Commission pressed
ahead with a positive recommendation.
16. This raises questions about the role of
the Brussels-based scientific committees vis-a-vis the committees
in individual member statesare they there only to comment
on differences of scientific opinion, or to re-rehearse all the
arguments? Do Member States have a right to give opinions on their
opinion, or are they the final recourse for advice? How are members
appointed to them? Do concerned citizens in the member states
have sufficient access to the Brussels-based committeesindeed
do they mean that the whole focus of risk assessment procedures
shifts to Brussels? These questions must be answered if the system
is to recover any credibility.
There should be clarification
of financial liability
17. It is not clear that there is adequate provision
for compensation for damage caused by GMOs in the national legal
systems put in place to implement directive 90/220. Civil liability
regimes also vary from country to country. Ideally there should
be specific provision in the Directive for strict liability for
damage caused by GMOs.
2. The appropriateness and efficacy of current
regulation at the level of the United Kingdom and other Member
18. These remarks are confined to the UK situation.
19. All the points above are relevant to regulation
in the UK, since its structure and operation are conditioned by
the Directive and by on-going discussions between Member States
about how it should be implemented (through regular Competent
Authorities meetings and specific sub-groups such as the Risk
Assessment Group). All the problems cited above are mirrored in
the UK. The UK Government should make maximum effort to resolve
them at the EU level by taking the opportunities presented by
re-negotiation of the Directive, but should at the same time look
for UK-based solutions.
The UK Government must research
"indirect" effects of GMOs on UK biological diversity,
and must decide on appropriate controls.
20. As noted above, the UK is one of the Member
States taking a relatively narrow interpretation of the Directive,
so there has also been a relatively narrow interpretation of the
UK's legislation, and indirect effects are not deemed to be covered.
However, The Department of Transport, Environment and the Regions
has recently announced the intention to consult on these indirect
effects. We have welcomed this initiative, and have been involved
in discussions about how it should be framed. Once the results
of the consultation have been analysed, which we hope will be
by the end of this year at the latest, the Government must move
quickly to put in place appropriate controls. If agreement cannot
be reached in Europe to regulate indirect effects through the
Directive, the UK Government must find unilateral means of control.
The UK Government must develop
more detailed guidance on what is "harm" under the legislation.
21. The UK legislation implementing the Directive
(Environmental Protection Act 1990 Part VI) has the purpose of
"preventing or minimising any damage to the environment which
may arise from the escape or release from human control of genetically
modified organisms". "Damage to the environment"
is caused by the "presence in the environment of genetically
modified organisms . . . which are capable of causing harm to
the living organisms supported by the environment" and "harm"
means harm to the health of humans or other living organisms or
other interference with the ecological systems of which they form
part and, in the case of man, includes offence caused to any of
his senses or harm to his property". As with the Directive,
these very broad definitions leave open the detailed interpretation
of environmental damage.
22. There is some guidance on what would constitute
severe, moderate or low levels of harm to natural populations,
but this has not been widely debated or agreed. There should be
a UK debate on what might be considered unacceptable impacts on
the UK environment, covering both the nature and the scale of
The UK regulatory system must
formalise examination of the cumulative effects of GMO releases.
23. As framed by the Directive, UK regulation
proceeds on a "case-by-case" basisan application
is judged according to the environmental risks it poses as it
stands, and consideration is not extended to what would happen
if the development was used on a larger scale, or over a long
period of time. This is the only practical way to grant individual
consents, but it limits the ability of ACRE to take a more strategic
view of developments, which may provide a helpful context for
individual consents. However, ACRE has taken the initiative to
examine the possible cumulative effects of certain types of releasesherbicide
tolerant crops were the first to be subject to such a discussion,
and insect resistant crops are beginning to come under scrutiny.
This initiative should be formalised, so that regular discussions
are held about the possible cumulative impact of the releases
being undertaken, or planned, for the UK at a given time.
Judgments made by the Advisory
Committee on Releases into the Environment should explicitly acknowledge
areas of uncertainty before coming to a general conclusion about
24. ACRE has a range of tools for communicating
with those outside Government about how its advice has been arrived
at. These include comments on the public register, newsletters
and the Annual Report, news releases, and there will shortly be
reports of each meeting. These tools should be used to acknowledge
areas of scientific uncertainty in the risk assessment process.
There must be post-commercialisation
monitoring of GMO products.
25. UK systems for monitoring the environmental
impact of commercial releases should be developed and should not
be delayed until agreement on monitoring is reached in Europe.
Transparency must be promoted
in the UK.
26. The transparency of the UK regulatory system,
including the accessibility of the Advisory Committee on Releases
into the Environment, has improved a great deal. It is now possible
to have access to most of the information in the application (bar
that agreed by the Secretariat as being commercially sensitive);
comments by ACRE following discussion of the application; agendas
of ACRE meetings; and there will shortly be reports of ACRE meetings.
27. However, it is clear that still relatively
few people know about the role and day-to-day operation of ACRE,
and more proactive measures are needed to ensure that concerned
organisations and members of the public can transmit their views
to the Committee and to the system of which it forms a part. This
would be facilitated by public meetings, with widely publicised
agendas, in different parts of the country. ACRE should also consider
meeting in public.
There should be clarification
of financial liability in the UK.
28. In the absence of specific provision in
Directive 90/220, it is left to individual countries' legal systems
how far compensation would be available for damage caused by GMOs.
The Environmental Protection Act 1990 provides that if damage
is the result of the law being breached, and remedy is possible,
steps may be taken to remedy the damage and recover costs. However,
to our reading, this relies on a successful prosecution being
brought. The civil liability situation is also uncleara
key defence in civil liability for environmental damage is whether
the damage was "reasonably foreseeable"which
it may not be for damage caused by a GMO. In our view, a form
of strict liability is appropriate, and if agreement cannot be
reached on this at European level it should be considered how
it can be applied at UK level.
3. The most appropriate jurisdictions for
decisions on genetically modified organisms
The UK Government must consider
how to cater for the wide range of concerns articulated in relation
to GMOs, consider innovative institutional arrangements, and involve
a wider spectrum of people in the decision-making process.
29. A wide range of concerns has been brought
forward about the application of GMO technology. These include
ecological concerns and the cumulative impact of GMOs on biological
diversity; concerns about the future direction of agriculture
and whether GM technology will or will not contribute to more
"sustainable" practice of agriculture; health concerns
from the growing and consumption of GM crops; concerns that consumer
choice is being progressively eroded by global trade in agricultural
products and the unsegregated presence of GMOs in those products;
scepticism about the benefits of the technology and concern that
it should be justified in social terms; concerns about the ethical
implications of transferring genes between species; concerns about
the domination of agriculture by a few very large companies.
30. Most of these concerns have been at some
time laid at the door of the systems for scrutinising the environmental
and food safety of GMOs, and these systems are not designed to
deal with most of them. At the same time, trust in official processes
of risk assessment and decision-making has been eroded by other
crises over food. The net effect is a sense that the regulatory
and policy machinery is unresponsive to people's concerns about
GMOs, both nationally and internationally. Worse, it is on some
issues, such as segregation, powerless to intervene in the practice
of global trade in agricultural products.
31. This situation requires innovative solutions.
As a first step towards this, we recommend the formation of a
working group, with representation from a wide range of interest
groups, to look at the technology "in the round" and
recommend appropriate forms of control. Such a group could build
on the work of the Nuffield Council on Bioethics, which is currently
examining the issues around GM plants, and which is due to report