Select Committee on European Communities Second Report - Written Evidence


APPENDIX 1

COMMENTS ON THE PROPOSAL FOR A DIRECTIVE AMENDING THE COUNCIL DIRECTIVE

ON THE DELIBERATE RELEASE INTO THE ENVIRONMENT OF GENETICALLY MODIFIED

ORGANISMS (90/220/EEC)

1. THE CONCEPT OF ENVIRONMENTAL HARM IN THE DIRECTIVE MUST BE ENLARGED

  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 BE IN THE PUBLIC INTEREST

  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 OF GMOS SHOULD FORM PART OF THE REVISED DIRECTIVE

  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 consumer choice.

4. SHORTCOMINGS OF THE CASE-BY-CASE APPROACH MUST BE ADDRESSED

  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 ARE TOO DANGEROUS TO PUT IN PLACE AT THIS TIME

  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 Union—to 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 OF GMOS UNDER PRODUCT REGULATIONS WILL COMPROMISE SAFETY

  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 agencies.

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.



 
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