Select Committee on European Communities Second Report - Written Evidence


Memorandum by English Nature, Scottish Natural Heritage, Countryside Council for Wales and Joint Nature Conservation Committee

  The statutory nature conservation agencies are concerned with the effects of GMOs on our natural heritage of native species and habitats, and has no locus on issues of human health and safety.

  The UK has international obligations to safeguard its native biodiversity, through the EU Habitats and Species Directive, the EU Birds Directive, and the Convention on Biological Diversity. In the UK, biodiversity is often very closely associated with agricultural systems, and is already being affected significantly by agricultural intensification, with many formerly common farmland species having declined in numbers by up to 80 per cent. Use of GM crops has the potential to increase this pressure, and we believe there should be careful assessment of its implications on biodivesity.

POTENTIAL BENEFITS OF GENETICALLY MODIFIED ORGANISMS

  The statutory agencies are not fundamentally opposed to the development and marketing of GMOs, as genetic engineering has the potential to solve some of the environmental problems associated with conventional intensive agriculture. However, we are concerned that the thrust of GMO development and marketing is presently concentrated on agricultural intensification and the continued use of biocides. We believe that there is a need for a more cautious approach and greater regulation of releases of GMOs if the benefits rather than the potentially damaging impacts are to prevail.

KEY RECOMMENDATIONS

1. Crop management systems for growing GM crops differ significantly from those of conventional agriculture

  We recommend that the issue of GMO crop management and its effects on wildlife is addressed as a priority, both in terms of the need for more "forward look" research, and for the remit of the regulatory system to be extended to cover assessment of the ecological effects of crop management systems associated with growing GM crops.

2. Genetic modification of native plants and animals may increase the risk of gene introgression, and produce plants and animals which are capable of disrupting native ecosystems

  We strongly recommend that insertion of genes into native species (or those which are introduced and have become widespread) should be strictly controlled by the regulatory process, with a broader and deeper risk assessment being required for proposed releases.

3. Crops modified to produce pesticides in their tissues may pose significant risks to food chains in agricultural ecosystems

  We strongly recommend that throughout the EU all insect resistant (IR) crops which act by producing a biocide are subjected to statutory pesticide testing and monitoring. This testing should include an assessment of their potential ecological effects, and an assessment of risk to other species with which they might interact.

4. Some GMOs may have significant environmental benefits which need to be taken into account when assessing the potential overall effects of releasing them to the environment

  We recommend that the regulatory process is extended to encompass assessment of potential benefits of the GMO to the environment. It may be possible to achieve this by extending the expertise and remit of ACRE.

5. To reduce the risks of multiple tolerance development, and to maintain the ability for ecosystems to act as natural "early-warning" systems, closer regulation of GMO crop management systems is needed, particularly at the farm level

  We recommend that on-farm regulations are considered, aimed at ensuring that at least some sections of the crop are exposed to natural ecosystems during the growing season. It is difficult at this stage to see how this might be achieved for some crops other than by deliberately preventing the growing of crops with both IR and herbicide tolerant (HT) modifications together in the same crop. Further research into this area is needed.

6. Monitoring the environmental effects of growing GM crops is currently inadequate

  We recommend that there is a need for statutory regulation and monitoring of GM crop management systems at the on-farm level unless and until there is clear evidence that such systems are viable, safe and sustainable. The results of such monitoring would provide valuable feedback to future risks assessments.

7. Post-release monitoring of cross-pollination, and identifying spread of GMO organisms into the natural environment, would be more effective if easily identifiable markers were inserted into modified gene sequences.

  We recommend that consideration is given to a statutory requirement that easily detectable and safe markers enabling tracing of gene transfer to native plants are included in the GMO as a condition of its release.

8. No effective regulation of GM crop management is in place, and there is no provision for maintaining biodiversity by compensating for wildlife losses caused by more intensive GMO systems

  A crop management compliance system covering commercial use of GM crops is needed. This could contain provision for a "cross-compliance" system where environmental compensation for intensification on some parts of an individual holding is put in place.

9. The GMO regulatory system is too narrowly focused on safety, and does not compare environmental audits of GMO systems compared with conventional crop management

  Risk assessments are based on partially informed deductive reasoning and judgment. There is little or no independent input into them; they are prepared by those who have vested interest in seeing the crops receive approvals. We recommend that the regulations require independent assessment and comparison of the present crop system with that based around the GMO, setting out the agricultural and environmental benefits of both crop systems, and the environmental (and human) risks of each. In this way, regulation can be used to re-establish the link between product design and use (in crop management terms).

10. The current regulatory system considers each application for release separately and on its own merits, and does not address the wider strategic issue of the cumulative effects of widespread use of GMOs

  Although we support the continuation of the case by case approach to the regulation of GMOs, we recommend that there should also be consideration of the cumulative environmental effects of widespread commercial and experimental releases. This is particularly topical in the case of GMHT crops, but should also be applied to other generic developments such as insect resistance.

11. Approval of a GMO by the EU regulatory process does not allow for differences in the environments and ecosystems of member states

  For pesticides to be marketed, even though an active ingredient is approved for use at EC level, individual products need approval within individual member states, taking account of individual conditions of use such as the ecosystems which those products may affect. We recommend that the same principle should apply to GMO releases, enabling member states to take account of individual ecological and agricultural circumstances. This would need more explicit enabling clauses in the review of 90/220 EEC.

12. The lack of ethical boundaries for the development and marketing of GMOs leads to high commercial and economic pressure on the regulation system

  A code of ethics is needed to set the framework for decision making and the domestic legislation delivering 90/220 EEC. It could set boundaries for research, development and marketing. This would help the industry to focus research, investment and development away from those areas which are unacceptable, and therefore reduce the economic pressures to gain approval for release.

13. In view of the concerns expressed above, and the fact that a number of research programmes have been commissioned by MAFF and DETR to investigate environmental effects of GM crops, regulatory improvements need to take account of the results of this work

  As research into the environmental effects of GMOs is not due to report for another three to five years, and there is a need for further research, English Nature has called for a period of restraint on commercial releases until more is known. There is a continuing need for experimental releases for the purposes of such research.

1. THE DUTIES OF THE STATUTORY NATURE CONSERVATION AGENCIES RELEVANT TO THE REGULATION OF GMO RELEASES

  1.1 English Nature is the statutory advisor to Government on nature conservation in England and was established by the Environmental Protection Act 1990. It promotes directly and through others the conservation of wildlife and natural features throughout the whole of England—the countryside, urban, coastal and maritime areas. Through the Joint Nature Conservation Committee (JNCC), English Nature works with equivalent organisations in Scotland, Wales and Northern Ireland. In fulfilling its duties English Nature advises Ministers on the development and implementation of policies for or affecting nature conservation; commissions and supports a wide range of research; and has a statutory duty when discharging its duties to take account of actual or possible ecological changes.

  1.2 In common with the other nature conservation agencies, Scottish Natural Heritage, Countryside Council for Wales, and the Environment and Heritage Service (Northern Ireland), English Nature is consulted by DETR Biotechnology Unit on applications to release GMOs, including marketing applications from other member states. Most applications for releases of GMOs are in England.

  1.3 The UK has international obligations to safeguard its native biodiversity, through the EU Habitats and Species Directive, the EU Birds Directive, and the Convention on Biological Diversity. In the UK, biodiversity is frequently very closely associated with agricultural systems and activities, and is already being affected significantly by agricultural intensification, with many formerly common farmland species having declined in numbers by up to 80 per cent. Use of GM crops has the potential to increase this pressure, and we believe there should be careful assessment of its implications on biodiversity.

2. POTENTIAL EFFECTS OF GMOS ON BIODIVERSITY AND GENETIC INTEGRITY OF NATIVE SPECIESRECOMMENDATIONS FOR FURTHER REGULATION.

2.1 Potential benefits of genetically modified organisms

  2.1.1. The conservation agencies are not fundamentally opposed to the development and marketing of GMOs, as genetic engineering has the potential to solve some of the environmental problems associated with conventional intensive agriculture. These range from potential reductions in the use of herbicides, fungicides and insecticides which harm wildlife, to the use of GMOs in pollution control. However, we are concerned that the thrust of GMO development and marketing is presently concentrated on agricultural intensification and the continued use of biocides. We believe that there is a need for a more cautious approach, and greater regulation of releases of GMOs, if the benefits rather than the potentially damaging impacts are to prevail.

2.2 Gene introgression or hybridisation

  2.2.1 Conventional plant and animal breeding may, over time, produce organisms which show similar characteristics (such as herbicide tolerance and insect resistance) to some GMOs. These traits are selected from the range of genes present in the gene pool of the native (or domesticated) organisms from which the breeding line is derived. As such, the selected genes have already been exposed to natural selection in the wild. If the selected line then back-crosses to the original line, there is no net addition to the existing gene pool. GMOs are different in that they contain genes which are derived from other, often very different, organisms. The genes within them do not occur normally in the gene pools of the original unmodified organism. These genes have not been exposed to selective pressures in the habitat of the original organism, and may have unpredictable effects if they outcross into wild relatives. Genetic modification also allows more rapid and radical modification of organisms than conventional breeding. We are therefore sceptical of the argument that GMOs are no different to conventionally bred organisms.

  2.2.2 Work by Chèvre et al. (1997) in France [see Appendix 1 for references] has clearly demonstrated that gene flow between genetically modified (GM) oilseed rape (modified to express the bar gene) and native wild radish not only takes place, but that the hybrids are fertile and transfer the gene through successive generations. It is highly likely that similar gene introgression will be found for all releases of GM crops which are capable of out-crossing to native species. These would include sugar beet which crosses with native beet species. Sugar beet modified for herbicide tolerance (HT) is currently the subject of intensive commercial development.

  2.2.3 Out-crossing to native species is likely to be a rare event, but with increasing acreages of GM crops, will occur more often. We are concerned not only about the possibility of HT hybrids becoming persistent weeds, and insect resistant hybrids having adverse effects on farmland insect biodiversity, but also that outcrossing risks harm to biodiversity in other semi-natural habitats. It is also possible that insect resistance in GM crops could transfer to native species, putting at risk species of insect which depend solely on that species. Some very rare insects are entirely dependent on a single plant species. One example is a small, endangered species of beetle which feeds only on the Lundy Cabbage, a rare wild brassica related to oilseed rape. We are also concerned about the possibility of other, as yet unknown, genetic modifications becoming incorporated into the genomes of other native species, mostly plants. The effects of these genes are not entirely predictable and pose an as yet unquantifiable risk to the genetic fitness (ability to reproduce) of native plant populations.

  2.2.4 There is already gene flow from crops (and other plants including horticultural and decorative plants) produced by conventional plant breeding, to native plants, but the genes involved are of plant origin and produce traits found in natural plants. GM crops and other species contain genes of bacterial, viral and fungal origin, whose effects in plants other than the crop have not been considered.

  2.2.5 There are existing experimental methods of genetically modifying plants which significantly reduce the risk of gene transfer, but these are not being developed as a commercial priority. The methods involve manipulation of genes conferring male sterility, and the insertion of genes into chloroplast DNA, which is inherited through the female line and not carried in pollen. They are not generally applicable to crops which rely on pollination for their commercial value, but it is possible that research into pollen compatibility systems will generate methods of reducing gene introgression even for these crops. The statutory nature conservation agencies would prefer such methods to be used in commercial systems whenever possible.

  2.2.6 If the regulatory process required that the risks of gene transfer were minimised during the developmental stage of the product, it would stimulate further research and development of these safeguards in many crops.

2.3 Crop management changes and potential effects of biodiversity

  2.3.1 There is no evidence that the new crop management systems associated with growing genetically modified herbicide tolerant (GMHT) crops will reduce overall herbicide use in the countryside. Even though GMHT crops may require fewer herbicide applications, there will probably be a large increase in the total area being sprayed, because certain broad spectrum herbicides would be used for the first time on growing crops like sugar beet and oilseed rape which were previously damaged by herbicides. The timing of herbicide applications may also shift to the growing season, when insects are in the larval or adult stages and require weed plant material to complete their life-cycles. Overall, we believe that the use of GM crops will further intensify arable agriculture, resulting in fewer wild plants and invertebrates within arable cropping systems. This will have huge impacts upon ecological food webs, and is likely to reduce further the already diminished and threatened populations of farmland birds, as well as species of arable plants which were previously common but are now rare. Increase in the use of broad spectrum herbicides would also have damaging effects on hedgerows, ditches and farmland trees, as a result of drift during spraying operations.

  2.3.2 The known effects of intensive agriculture on farmland bird populations are documented by Campbell et al. in the 1996 review of the indirect effects of pesticides on birds, prepared for the Joint Nature Conservation Committee and the Department of the Environment by a consortium of experts, including the Oxford University BBSRC-NERC Ecology and Behaviour Group, The Royal Society for the Protection of Birds, and the Institute of Terrestrial Ecology. It is clear from this work that the crop management systems associated with intensive farming have serious adverse effects on 17 resident species of birds using farmland. We see changes in crop management associated with GM crops as having a greater potential effect on biodiversity than gene introgression. There is little, if any, research currently taking place on this issue, and the regulatory process does not include assessment of the ecological risks of GMO release.

  2.3.3 The above discussion deals with the current wave of GM crop development, but we understand that there may be other novel GMOs already being developed by the Industry. These include modification of tolerances to adverse climatic factors, such as frost and drought, and soil conditions such as waterlogging, salt content and acidity. The introduction of these traits commercially may result in radical changes in farming practice, and further loss of wildlife. Conversely, GMOs may be developed to alleviate damage to wildlife in intensive farming systems whilst also increasing yield. This would release land for low intensity farming and nature conservation. We believe the regulatory system should positively encourage these latter developments.

  2.3.4 We recommend that this issue of changing farming practice and the effects on wildlife is addressed as a priority in terms of the need for more "forward look" research, and also that the remit of the regulatory system should be extended to cover assessment of the ecological effects of crop management systems associated with growing GM crops.

  2.3.5 In some European countries (e.g., Sweden, Norway, Austria and Denmark (Levidow 1997)) it appears that the remit of the Competent Authority already covers this issue. These countries have rejected approval of GMHT crops on the grounds that there would be significant adverse effects on the ecology of agricultural land, and that growing GMHT crops would be inconsistent with their goals of introducing integrated and environmentally friendly pest control.

  2.3.6 A number of research programmes have been commissioned by DETR and MAFF to investigate some of the effects on biodiversity which may result from gene introgression and changes in crop management. The projects are listed in Appendix 2. Of 31 projects on GMOs commissioned by government bodies, 13 relate to potential environmental effects. These projects do not address all the concerns outlined above, and more field-scale research is needed to compare conventional with GMO crop management systems. It would, for example, be desirable to identify possible changes in weed density and insect biodiversity, and to investigate changes in crop rotation used in GMO management systems.

  2.3.7 Even if the current research programme was broad enough, which we do not consider it is, the existing projects would not report until 2000 at the earliest. It may take another two years for this research to be integrated into other projects in Europe and elsewhere, and for the knowledge acquired from this effort to be used to inform the regulatory system. Applying the precautionary principle defined in the government's statements on sustainable development, it is difficult to see justification for the commercial release of GM crops until sufficient knowledge of their effects on the environment is understood.

  2.3.8 As current research into the environmental effects of GMOs is not due to report for another three to five years, and as additional research is also needed, English Nature has called for a period of restraint on commercial releases until more is known. There is a continuing need for experimental releases for the purposes of such research.

2.4 Genetic modification of native plants and animals

  2.4.1 Although it is difficult to obtain information about commercially sensitive research, we believe there is already advanced research on the insertion of high yield and HT genes into forage grasses such as rye-grass Lolium perenne. If these GM crops were released, even experimentally, there would be a risk that the genes might spread to native grasses by cross-pollination. The crosses (hybrids) and the original GM grass could be more competitive than native grasses if they invaded natural grasslands, and could not be controlled by the herbicides to which they are resistant. There is also the risk that use of HT grasses and other forage crops would lead to monocultural forage crops, with the use of broad-spectrum herbicides removing other grasses and herbs from diverse agricultural grasslands which currently harbour important populations of insects and birds.

  2.4.2 There might also be other, unpredictable, effects of inserting genes into native plants, particularly if the GM plant could hybridise with a wide range of related native species. We are not aware of any current research programme specifically looking at the effects of gene introgression on the phenotypes of native species.

  2.4.3 In a review of environmental risks posed by GMOs, Crawley (1996) considered that GMO perennials such as grasses and trees, rather than annuals, carried a high risk of invasiveness. We are concerned that applications for release of GM trees (e.g., poplar modified for lignin content) are already being received, and that research into genetic modification of other trees and shrubs is reported from several sources. Williamson et al (1996) argue that weediness (invasiveness) is very difficult to predict, and that the information used by the regulatory system in the EU is inadequate for risk assessment of invasiveness of transgenic hybrids.

* This article has been written by an international team of researchers working as part of a Concerted Action of the European Commission (B104-CT95-0043) administered on behalf of Directorate General XII by Andreas Klepsch. For details see box overleaf. Address for correspondence: G Gaskell, Department of Social Psychology, London School of Economics, Houghton Street, London WC2A 2AE, UK (e-mail: [email protected]). 1 Evans, G and Durrant, J, Public Understand Sci. 4, 57-74 [1995].

2 Biotechnology and Genetic Engineering: What Europeans Think About it in 1993 (INRA (Europe), Brussels, 1993).

3 Bauer, M (ed.) Resistance to New Technology: Nuclear Power. Information Technology: Biotechnology (Cambridge Univ Press, 1995).

  2.4.4 We are equally concerned about reports that the US Department of Agriculture is sponsoring research in Florida which involves the release of predatory mites genetically modified to be resistant to insecticides. Modifications of native insects could carry risks of multiple resistance to insecticides being conferred on non-target species, and there is also the significant risk that they could be imported to other countries on crops with unpredictable and uncontrollable consequences.

  2.4.5 We strongly recommend that insertion of genes into native species (or those which are introduced and have become widespread) should be strictly controlled by the regulatory process, with broader and deeper risk assessments, and more detailed post-release monitoring, being required for proposed and licenced releases.

2.5 Effects of toxins produced by GM crops on food webs

  2.5.1 Recent research (Birch et al 1997, Hillbeck et al 1998, and Chèvre et al 1997) has demonstrated that the Bt insecticidal toxin inserted into insect resistant (IR) GM crops has adverse effects on non-target species, including ladybirds, lacewings and bees within farmland ecosystems. The magnitude of these effects, and their risks compared to conventional insecticide treatments, is unknown. We know little about the potential ecological effects of these genes in hybrids with native plants. It is possible that insect resistant hybrids would be fitter than native species and would spread in ecosystems, having deleterious effects on dependent insects (including those which are rare).

  2.5.2 In view of the known effects of insect-resistant GM crops, and the fact that unlike most conventionally bred IR plants they produce chemicals which are highly toxic to insects, the regulatory authorities in the USA treat IR crops as pesticides, and subject them to the same rigorous testing that applies to chemical biocides.

  2.5.3 We strongly recommend that the same approach is adopted in the UK and throughout the EU, and that all IR crops which act by producing a biocide are subjected to statutory pesticide testing and monitoring. This should include an assessment of their potential ecological effects, and an assessment of risk to other species with which they might interact.

2.6 Incentives to develop crops benefiting the environment

  2.6.1 Besides the risks outlined above, GMOs have the potential to alleviate some of the more serious adverse effects of intensive agriculture on wildlife. Insect resistant GM crops, for example, offer a real prospect of reducing insecticide use on arable crops. Altering the growing characteristics of crops, e.g., shortening the growing season or changing the timing of harvests, offers the prospect of allowing more fallow land and less autumn planting. These developments could benefit bird and insect populations of farmland, whilst maintaining yields at current levels. However, present development and marketing is concentrated on those crops which yield high monetary returns, with little or no incentive delivered through the regulatory system favouring environmentally sound GMOs.

  2.6.2 The remit of ACRE appears not to cover consideration of potential environmental benefits when assessing whether a GMO should be released. We recommend that the regulatory process is extended to encompass assessment of potential and deliverable benefits of the GMO to the environment. It may be possible to achieve this by extending the expertise and remit of ACRE.

2.7 Importance of intact farmland ecosystems

  2.7.1 One of the arguments for maintaining viable ecosystems in direct contact with farmland is that species within these ecosystems can act as indicators giving early warning of potentially far-reaching environmental problems. Problems with the crop itself, or with its management, often manifest themselves before the system impacts on human health. Examples of this can be found in the impact of DDT on vertebrate reproduction which became apparent from effects on peregrine falcons and sparrowhawks (Ratcliffe 1970, Moore 1974), and the effects of aldrin and dieldrin on otter populations, where the pesticide (used in sheep dip and to control eelworm in potatoes) caused tumours and effectively prevented the animals from reproducing. This "early-warning" system has served agriculture well over the past 40 years. With the introduction of GM crops which are capable of IR and HT, crops may be managed out of contact with natural food chains, preventing any early warning of problems with either the crop or the management system.

  2.7.2 We recommend that on-farm regulations are considered, aimed at ensuring that at least some sections of crop are exposed to natural ecosystems during the growing season. Without further research, it is difficult at this stage to see how this might be achieved for some crops other than by deliberately preventing the growing of crops with both IR and HT modifications together in the same crop.

3. THE APPROPRIATENESS AND EFFICACY OF CURRENT REGULATION

3.1 Research

  3.1.1 We are concerned about the efficacy of the present system for the regulation of experimental releases. This is not a criticism of ACRE, but derives from legislative constraints on their remit. There is little direct consultation with neighbouring interests (which may include nature conservation) of the land concerned, and several examples of failure to keep to cultivation and research protocols specified in the consent. In some cases, reported in various ACRE Reports and Newsletters, farmers and research stations were found by the Health and Safety Executive (HSE) to be disregarding the experimental protocols required in the release consent.

  3.1.2 ACRE point out in their 1996-97 Annual Report that prevention of gene introgression and the development of multiple resistance to herbicides can only take place at farm level. For example, there would need to be minimum separation distances between crops with tolerance to different herbicides, to reduce the risk of hybridisation; any hybrids could be resistant to more than one herbicide and therefore be very difficult to control if volunteer plants became weeds. ACRE consider that this could be avoided by goodwill and good communication between farmers and seed merchants. On the evidence of non-compliance with conditions, set out in the previous paragraph, we have doubts about the efficacy of this recommendation.

  3.1.3 We therefore recommend that there is a need for statutory regulation and monitoring of GM crop management systems at the on-farm level, unless and until there is clear evidence that such systems are viable, safe and sustainable. The results of such monitoring would provide valuable feedback to future risk assessments. A crop management compliance system covering commercial use of GM crops needs to be put in place. This could contain provision for a "cross-compliance" system where environmental compensation for intensification on some parts of an individual holding is put in place.

  3.1.4 It is possible that future GMO development will produce entirely safe crops where gene introgression cannot occur. There is promise in the work of Daniell (1998) in Alabama, who reports that he has inserted an HT gene into chloroplasts which do not pass genes into pollen and therefore cannot be transferred to hybrids.

3.2 Release into the environment

  3.2.1 We are concerned that the quality of risk assessments submitted by applicants is not adequate to allow a reliable judgment to be made as to whether the GMO should be released into the environment. In particular, there is rarely a detailed assessment of the likely effects on other organisms, despite mounting evidence that such effects exist and are potentially harmful to ecosystems. All assessments seen so far (over 50) have concluded, without real evidence(certainly not experimental evidence), that the risk to other organisms is effectively zero. This ignores recent research (Birch et al. 1997, Hillbeck et al. 1998) which demonstrates that the insertion of the Bt gene into crops has adverse effects not just on target organisms but also on their predators. Although these risks are clearly emerging from the few research studies specifically targeted at the effects of GMOs on ecosystems, risk assessments contain no comparison with the known risks from present intensive use of insecticides and herbicides.

  3.2.2 Risk assessments are therefore based on partially informed deductive reasoning and judgment. There is little or no independent input into them; they are prepared by those who have a vested interest in seeing the crops receive approval.

  3.2.3 We recommend that the regulations should require an independent assessment and comparison of the present crop system with that based around the GMO, setting out the agricultural and environmental benefits of both crop systems, and the environmental (and human) risks of each. This system, in effect an environmental audit, should be incorporated within the regulatory process required by Directive 90/220. There is sufficient expertise in UK and European research institutes to co-ordinate and prepare such assessments, using evidence from research and monitoring on a global basis, and commissioning, or carrying out new research if necessary. In this way, regulation can be used to re-establish the link between product design and use (in crop management terms). Domestic legislation has been interpreted by ACRE to mean that the link between design and use is not part of their remit.

4. THE APPROPRIATENESS AND EFFICACY OF CURRENT REGULATION AT UK LEVEL AND IN OTHER MEMBER STATES

  4.1 Unilateral regulation of GMO releases to the environment at member state level is perceived as a restriction on competition and free trade. Approval for release and marketing in the EU is given by a qualified majority vote among member states. In effect this means that a GM crop which receives marketing approval for use in Southern Spain would have approval for marketing in Scotland. Clearly the crop would be grown among different ecosystems in each state, and therefore potential effects of gene introgression and crop husbandry systems would be different.

  4.2 For those crops which rely on the use of biocides (e.g., herbicide tolerant crops), approval has to be given for the use of the biocide on the new GM crop before that crop can be used in the particular member state. Although this procedure might delay approval at member state level, it has little effect on the eventual approval of the new crop. There is provision under Directive 90/220 for member states to reject approval but they would need to be able to prove that the GMO has particularly high risks within the special circumstances of the member state. With the current paucity of research results on environmental effects, this would be very difficult to prove for the majority of GM crops.

  4.3 Detailed proposals to review 90/220 EEC have recently been published by the EC as COM (1998)85. These proposals include provisions for:

    (a)  approval of a new GMO by simple majority vote with member states playing a greater role;

    (b)  an improved system of consulting Scientific Committees before approval;

    (c)  common principles for risk assessment;

    (d)  Seven years mandatory monitoring of GMOs after they receive marketing consent;

    (e)  Better definition of the scope and provisions of 90/220, particularly by including consideration of all potential direct and indirect effects on the environment.

  4.4 Whilst many of these proposals are welcome, in our view there are serious shortcomings:

  4.4.1 The central principle that each GMO application should be assessed on its own merits remains unchanged. The "fast-track" procedure for approval of crops with generic modifications which have already been approved would also remain. These principles do not address possible cumulative ecological effects of multiple releases, each of which may appear to be relatively harmless. If the majority of agricultural crops were to carry the Bt gene, for example, there could be a much greater reduction in farmland birds and insects than that caused by current crop management systems. Similarly, widespread adoption of HT crops would have similar cumulative effects.

  4.4.2 Although we support the continuation of the case by case approach to the regulation of GMOs, we recommend that there is also consideration of the cumulative environmental effects of widespread commercial and experimental releases. This is particularly topical in the case of GMHT crops, but should also be applied to other generic developments such as insect-resistance.

  4.4.3 The risk assessment and information requirements still concentrate on the genetic modification itself and direct risks of release. There is no specific provision for Competent Authorities to assess the wider, indirect, risks to the environment.

Our views on these aspects of regulation are dealt with in previous sections

  4.4.4 Criteria for selecting suitable monitoring regimes for the statutory seven year period are not set out. This is a difficult area, where the risks from new technology are ill understood, but it should be possible to define a minimum set of monitoring procedures which should be applied to GMOs after release. Williamson (1997) and others also point out that escape of GM genes may be irreversible, so even if monitoring detects ecological and environmental harm, it may not be possible to remedy every situation. However, it may be possible to build easily detectable markers into GMOs to facilitate detection and eradication. These would need to be quite different from the antibiotic-resistance markers currently used to develop GMOs, which are left in the final product.

  4.4.5 We therefore recommend that consideration is given to a statutory requirement that such markers are included in the GMO as a condition of its release.

  4.4.6 There is still the presumption that marketing approval given in one member state should apply throughout the EU.

  4.4.7 For pesticides to be marketed, even though an active ingredient is approved for use at EC level, each product needs approval within each member state, taking account of individual conditions of use such as the ecosystems which those products may affect. We recommend that the same principle should apply to GMO releases, enabling member states to take account of individual ecological and agricultural circumstances. This would need more explicit enabling clauses in the review of 90/220 EEC.

5. THE MOST APPROPRIATE JURISDICTIONS FOR DECISIONS ON GENETICALLY MODIFIED ORGANISMS

  5.1 Given the current situation on GMO regulation, where each proposal for release is considered separately and on its own merits, a code of ethics is needed to set the framework for decision making and the domestic legislation delivering 90/220 EEC. This could operate in a similar way to codes on the development of human genetic research and development. It could set boundaries for research, development and marketing. It could, for example, discourage the high risk practice of inserting alien genes into native forage plants, but encourage research into GMOs which might have significant environmental benefits. This would help the industry to focus research, investment and development away from those areas which are controversial, and therefore reduce the economic pressures to gain approval for release.

8 June 1998



 
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