Select Committee on European Communities Minutes of Evidence

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 of GMOs".

  3. One of the problems in implementing the Directive has been that "adverse effects" are not defined—it 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 account—the 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 indirect effects.

  4. It is in everyone's interest to clarify the scope of the Directive—the 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 issues—so 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 GMOs.

    —  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 remedying this.

    —  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 problem—individual 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 serious—they 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 addressed—by, 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 short—60 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 secret—it makes a nonsense of any claims to transparency.

    —  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 states—are 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 committees—indeed 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 States

  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 those impacts.

    —  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" basis—an 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 releases—herbicide 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 risk.

  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 unclear—a 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 in 1999.

June 1998

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