UNITED KINGDOM ENVIRONMENTAL LAW ASSOCIATION (UKELA) BIOTECHNOLOGY WORKING GROUP Submissions to the Environment, Food and Rural Affairs Committee regarding the Terms of Reference of its Inquiry into the implications of the Government's recent decision to agree to the limited cultivation of GM maize in the UK Introduction The UK Environmental Law Association (UKELA) is the UK forum which aims to make the law work for a better environment and to improve understanding and awareness of environmental law. UKELA's members are involved in the practice, study or formulation of Environmental Law in the UK and the European Union. It attracts both lawyers and non-lawyers and has a broad and growing membership. UKELA is the network for those interested in environmental law in the UK and key issues including GMOs/biotechnology, insurance and liability, climate change, IPPC, environmental impact assessment, waste, contaminated land, water and planning. It includes a working party on Environmental Law in Scotland and is particularly concerned that all countries within the UK have the best quality environmental legislation and adequate resources for implementation. UKELA was formed in 1987 and has around 1,000 members. They include both corporate and individual members, based mainly in the UK but also overseas. This submission has been prepared on behalf of UKELA by Daniel Lawrence and Martha Grekos, Joint Convenors of the UKELA Biotechnology Working Group. Submissions The Committee’s Terms of Reference and our submissions in response thereto are set out below: 1. In relation to co-existence, what physical separation will be required between GM and non-GM crops in order to guard against cross-contamination? The EC Commission Recommendation of 23 July 2003, on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming (the July 2003 Recommendation), recognises that farmers should be able to cultivate the types of agricultural crops they choose – be it GM crops, conventional or organic crops – and that none of these crops should be excluded in the EU. It further recognises that, in order to be cultivated in the EU, GMOs must first have been authorised for cultivation under Directive 2001/18/EC; the authorisation procedures under Directive 2001/18/EC involve a comprehensive health and environmental risk assessment1 and, to the extent needed, specific co-existence measures to protect the environment and human health are included in the final authorisation given under Directive 2001/18/EC. The July 2003 Recommendation emphasises that, since only authorised GMOs can be cultivated in the EU, “the pending issues still to be addressed in the context of co-existence concern the economic aspects associated with the admixture of GM and non-GM crops” and, in particular, “the most appropriate management measures that can be taken to mimimise the admixture”.2 According to the July 2003 Recommendation the issue of physical separation distances needs to be assessed on a crop-specific basis depending on a range of factors, including: the outcrossing potential of specific crops (for example, larger distances may be needed for crops and plants which are open-pollinating, such as oilseed rape, than for those which are self-pollinating or where the harvested product is not a seed, such as beet and potatoes); crop-specific forms of cross-pollination; crop-specific potential to form volunteers, and the time seeds remain viable in the ground; the species- and variety-specific cross-pollination potential with close relatives, whether farmed or wild; the flowering time of the pollen source and the receiving population, and the degree of overlap of the respective flowering periods; the duration of pollen viability, which depends on the plant species, the variety, and on environmental conditions (such as humidity); 1 The methodology of the risk assessment includes: identification of any characteristics of the GMO(s) which may cause adverse effects; evaluation of the potential consequences of each adverse effect; evaluation of the likelihood of the occurrence of each identified potential adverse effect; estimation of the risk posed by each identified characteristic of the GMO(s); application of management strategies for risks from the deliberate release or placing on the market of GMO(s); and determination of the overall risk of the GMO(s). 2 It is submitted that the term “admixture” is preferable to “contamination” as the latter term connotes rendering the crop with which the undesirable element is mixed unwholesome, which is inappropriate given that the GM crop (by virtue of having been authorised under Directive 2001/18/EC) will already have been determined to be safe for consumption and the environment. Page 2 the competition among pollen, which is influenced by the production of pollen in the receiving population and the pollen pressure generated by the pollen source; differences between farming systems and the relative lengths of the cultivation process; and the degree to which genetic exchange through pollen flow influences the admixture rate in the harvested crop. The July 2003 Recommendation states that: “The conditions under which European farmers work are extremely diverse. Farm and field sizes, production systems, crop rotations and cropping patterns, as well as natural conditions, vary enormously across Europe. This variability needs to be taken into account when devising, implementing, monitoring and coordinating co-existence measures. The measures that are applied must be specific to the farm structures, farming systems, cropping patterns and natural conditions in a region.” It follows that the only sensible approach to determining appropriate separation distances for GM and non-GM crops is for management measures for co-existence to be considered in the context of the particular specific circumstances which pertain to the immediate locality where the relevant crops are to be grown. The principles outlined under section 2.1 of the July 2003 Recommendation should serve as a base for formulating a set of best practice guidelines for coexistence. In particular, guidelines for co-existence management measures should: reflect the best available scientific evidence on the probability and sources of admixture between GM and non-GM crops; take into account the additivity of measures including as a result of already existing segregation practices/methods and agricultural experience about handling of identity preserved crops and seed production practices; be efficient, cost-effective and proportionate (not going beyond what is necessary to keep adventitious presence of GMOs below the tolerance thresholds set out in Community legislation, and not imposing unnecessary burdens for farmers, seed producers, cooperatives, etc); take account of regional and local situation and the specific nature of the crop concerned; and ensure an equitable balance between the interests of farmers of all production types and encourage cooperation between farmers. In keeping with the objective of ensuring an equitable balance between the interests of farmers of all production types, the best practice guidelines should operate so as not to discriminate against GM farmers. That is to say that the guidelines should apply not only to GM growers but also growers of non-GM crops (e.g. to prevent the adventitious presence of non-GM crops in GM crops where such presence is economically undesirable to the GM grower). Page 3 The Advisory Committee on Releases to the Environment (ACRE) should be required to establish scientifically-sound “best practice guidelines on coexistence” for the UK, based on the principles outlined under section 2.1 of the July 2003 Recommendation. As discussed below, in response to the second question in the Committee’s Terms of Reference, a failure to comply with the (ACRE established) best practice guidelines on co-existence might result in a grower incurring civil liability as a result of not being able to rely on the suggested best practice defence of compliance with an authorisation under Directive 2001/18/EC and the (ACRE established) best practice guidelines for the specific crop in question. An alternative would be for the commercial growing of GM crops to be required to take place in accordance with binding codes of practice. Such a system would involve legally enforceable crop management protocols (designed to achieve at least the 0.9% threshold). These would require authority in primary legislation to establish the regulatory framework, although the scheme would need to be flexible enough to ensure that the detailed measures in protocols could be varied not only as a result of voluntary agreement among farmers3 (for example taking account of local conditions) but also in the light of new evidence without having to revise the law. We would agree with the Agriculture and Environment Biotechnology Commission’s (AEBC) recommendation that “the main aim of Government policy on coexistence of GM and other crops must be to facilitate consumer choice to the greatest possible extent, while allowing UK farmers to respond to present and future national and international market demand.”4 2. If cross-contamination occurs, how liability will be established and responded to, who should be legally responsible and what the limits of that responsibility should be and what role Government should play in determining these matters? The issue of how liability should be established in the case of adventitious admixture of GM and non-GM crops should be left for the UK courts to determine on a case-by-case basis with reference to relevant civil, criminal and administrative law.5 Also, international and European obligations need to be borne in mind e.g. the EU Proposals for a Directive on Liability for Environmental Damage and The Cartagena Protocol on Biosafety. 3 The July 2003 Recommendation advised Member States “to set up mechanisms to favour coordination and voluntary arrangements between neighbouring farmers, and to specify procedures and rules in cases of disagreements between farmers on the implementation of the measures in question.” 4 “GM Crops? Coexistence and Liability”, report by the Agriculture and Environment Biotechnology Commission, November 2003, page 36, 5 For an analysis of the various heads of civil, criminal and administrative liability see Annex D to “GM Crops? Coexistence and Liability”, report by the Agriculture and Environment Biotechnology Commission, November 2003. Page 4 Bearing in mind that any GMOs commercially cultivated in the UK must first have been authorised for cultivation under Directive 2001/18/EC, responsibility should rest with farmers to ensure they cultivate only authorised GMOs and that cultivation is carried out in accordance with any specific co-existence measures to protect the environment and human health that are included in the final authorisation given under Directive 2001/18/EC.6 Compliance with such specific co-existence measures would be a defence in terms of determining whether or not the authorisation has been complied with. Compliance with the (ACRE established) best practice guidelines on co-existence (to the extent these go beyond the co-existence measures contained in an authorisation under Directive 2001/18/EC) should not be mandatory but could be relevant in determining the extent of a person’s liability under civil law. For example, legislation could provide for a best practice defence to the effect that a farmer had complied with the authorisation under Directive 2001/18/EC and the (ACRE established) best practice guidelines for the specific crop in question. No liability should arise for economic losses arising from admixture of GM and non-GM crops to the extent the loss was due to any fault on the part of the party suffering the loss or would have been avoidable had the party suffering the loss complied with the (ACRE established) best practice guidelines. No liability should be allowed for economic losses where the loss was attributable to adventitious presence of GMOs within the tolerance thresholds set out in Community legislation. Cultivators of GM crops should be entitled to economic losses where they incur loss as a result of the undesired adventitious presence of non-GM crops in their GM crops. Special arrangements might be devised for allowing compensation to farmers suffering financial loss as a result of their produce exceeding statutory thresholds through no fault of their own, with a view to an insurance market developing in due course. Another option would be to establish an indemnity or a fund to cover the types of economic loss for which insurance would later become available.7 Further, there is the question of redress for damage to the environment more generally. Government should use the general approach of the Draft EU Liability Directive to develop the UK’s liability regime for any damage caused by the release of GMOs to the environment. In addition, it needs to be borne in mind that there are inherent limits to any system of liability, which need to be understood from the start. Even a heavily modified regime will fail to cover risk completely. Where liability fails, environmental damage either goes unremedied, or responsibility rests, by default, with the state. 6 Thus, for example, a farmer who cultivated a particular “authorised” GMO variety but not in compliance with any specific coexistence measures contained in the relevant authorisation would commit an offence under section 111(1) of the Environmental Protection Act 1990. 7 See further “GM Crops? Coexistence and Liability”, report by the Agriculture and Environment Biotechnology Commission, November 2003, pages 89-93. Page 5 3. What processes will be involved in determining how GM-free zones will be established at both a regional and local level and what role Government should play in this development? The Advisory Committee on Releases to the Environment (ACRE) should be required to address this issue, in the context of establishing scientifically-sound best practice guidelines on co-existence for the UK, based on the principles outlined under section 2.2.6 of the July 2003 Recommendation. These include: the crop-specific GMO share in the region; the number and type of crop varieties (GM and non-GM) that have to co-exist in a particular region; the shape and size of the fields in a region; the fragmentation and geographical dispersion of fields belonging to individual farms; regional farm management practices; crop rotation systems and cropping patterns in a region; the likely activity, behaviour and population size of pollinators; climatic conditions; topography; and surrounding structures, such as the prevalence of hedges, forests, uncultivated areas, and the spatial arrangement of fields. It should not be open for a particular region or locality to declare itself “GM free” where to do so would not be consistent with the (ACRE established) best practice guidelines. In addition, compulsory regional zoning of GM crops would be contrary to EU law (except on grounds of a particular environmental risk to the area in question). Compulsory zoning would significantly limit some farmers’ freedom of choice, and it would not be straightforward to operate (requiring the establishment of buffers between zones, and the monitoring of volunteers from long-distance transport of seed and of unauthorised growing within the non-GM zone). There is the possibility of encouraging voluntary zoning agreements, and this is something that needs to be explored further.8 4. What changes to legislation will be required to allow GM crops to be grown? The existing authorisation procedures that exist under Directive 2001/18/EC are sufficient to allow GM crops to be grown in the UK. Measures on co-existence may be dealt with without changes to the legislation by means of (ACRE established) best practice guidelines on co-existence. However, if binding codes of practice are established as well as legally enforceable crop management protocols (see the responses in section 2 above), these would require authority in primary legislation to establish the regulatory framework. 8 See further “GM Crops? Coexistence and Liability”, report by the Agriculture and Environment Biotechnology Commission, November 2003, page 46, and the European Commission’s coexistence guidelines. Page 6 Changes to UK legislation would be needed to ensure that a best practice defence were available for growers of GM and non-GM crops (see the responses in section 2 above). The Environmental Protection Act 1990 should be amended to allow the competent regulatory authority to require environmental remediation in respect of environmental harm caused by the release of GMOs where failure to require such remediation would be inconsistent with the EU Directive on Environmental Liability, irrespective of criminal liability. 5. What will be the scope and scale of the 2006 re-licensing procedures? These should follow the procedure referred to in Article 17 of Directive 2001/18/EC. Daniel Lawrence Martha Grekos Joint Convenors of the UKELA Biotechnology Working Group 19 April 2004 Page 7
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