EXECUTIVE SUMMARY Our concerns 1. The issues surrounding genetically modified (GM) crops and food have been intensely controversial across the world. Yet the risks from GM crops and food are serious, likely to be irreversible and have health, environmental, social, cultural and ethical dimensions – all of which may be legitimately protected under WTO rules. No regulatory systems can be foolproof and many of the wider social and ethical dimensions are completely neglected in conventional risk assessments.1 Therefore, it is crucial that countries have the ability to determine their own approaches on GM crops and food, and that citizens are able to engage fully in these processes, without pressure from large economic interests. 2. As the European Communities, its Member States and other governments struggle to resolve the conflicts between the demands of industry and those of consumers in relation to GM crops and food, the timing of this challenge by the Unites States, Canada and Argentina is difficult to understand – more hostility from the public seems the only outcome.2 This challenge has been driven by the interests of biotech and large-scale, intensive farming corporations in the countries involved with no regard for the interests of the broader community.3 In whatever way this dispute is resolved, it will inevitably send a very clear signal to the world beyond the European Communities: to try to protect either the environment or the health of their citizens from the potentially serious impacts of GM crops and food could result in a punishing response from the US and other Members of the World Trade Organisation (WTO) in defence of the interests of their biotech companies. 3. As the First US submission shows in its Statement of Facts,4 there are complex political and social interests at stake in this challenge. It is not simply a matter of examining bureaucratic or administrative procedures. How the Panel arbitrates these disputes will have far reaching implications for all governments, communities and the environment. We request that, in its recommendations, the Panel upholds the right of governments to protect their citizens’ health, the environment and consumer interests, and that it will take account of the broad range of interests, concerns and expertise relevant to these disputes. Our claims 4. The US, Canada and Argentina (the ‘complainants’) have challenged the European Communities (the ‘EC’) over three categories of ‘measures’: (1) the ‘suspension’ of GM approvals (EC’s general de facto moratorium), (2) the failure to consider applications for GM approvals (EC’s specific de facto moratoria), and (3) EC Member States’ ‘safeguard’ actions on approved GM products under the Deliberate Release Directive and the Novel Foods Regulation.5 5. The Amicus Coalition respectfully submits that the ‘general’ de facto moratorium is not a ‘measure’ subject to the World Trade Organisation’s Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), the Agreement on Technical Barriers to Trade (TBT Agreement), or the 1994 General Agreement on Tariffs and Trade (GATT). The ‘general’ de facto moratorium, as recorded in the minutes of a meeting of the Council of the European Union and in statements of Member State officials, is an expression of political intent. It is not legislation of a general nature and it is not mandatory in its effect. The governance structures of the EC are very different from a single national system and a complex procedure must be followed before mandatory laws or guidance can be put into effect. A sovereign entity’s expression of political intent is not subject to WTO scrutiny (see section 3.1.1). In our submission, we do not address the question of whether the relevant WTO Agreements apply to the EC’s specific de facto moratoria or the EC Member States’ safeguard actions.6. If the Panel finds that the three categories of measures’ are subject to the SPS Agreement, the TBT Agreement and/or the GATT, the Amicus Coalition respectfully submits that the three categories of measures are consistent with the EC’ obligations under those Agreements.In particular, the Amicus Coalition respectfully submits that: a) Precaution: The ‘measures’ are an exercise of the WTO right of the EC and its Member States to establish their domestic health and environmental standards in accordance with their respective environmental conditions, needs and priorities (see section 3.2). The measures are based on the precautionary principle and, as such, they are based on international standards. The precautionary principle – recognised in many international agreements and instruments including the Cartagena Protocol on Biosafety – warrants measures aimed at preventing irreversible health and environmental damage even in the absence of full scientific certainty as to the risk of damage (see section 3.2.2). b) Necessity: The challenged ‘measures’ restrict trade only to the extent necessary to fulfill their objectives within the meaning of SPS Articles 2.2 and 5.6, TBT Articles 2.2 or 5.1.2, and GATT Article XX. In particular, the challenged measures are necessary to protect human, animal and plant life and health, and to protect the environment, against the risks associated with GM products, and to prevent deceptive practices through appropriate labels on GM products. There were no ‘alternative’ less trade-restrictive measures reasonably available to the EC which would have provided the EC’s desired level of high protection. A global appreciation of the risks associated with GM technology, and the need for appropriate regulation to guard against the risks, is evidenced by the international efforts to agree rules and implement national strategies to avoid harm to people and the environment from genetically modified organisms and GM products (see section 3.2.1). c) Risk Assessment: The challenged ‘measures’ are based on scientific principles and have not been maintained without sufficient scientific evidence within the meaning of SPS Article 2.2. In particular, there is a ‘rational relationship’ between the measures and the assessment of risks to human, animal or plant life or health, for the purposes of SPS Article 5.1 (see section 3.2.2(i)). d) Provisional measures: Alternatively, the challenged ‘measures’ are provisional and based on available pertinent information. The EC has continued to seek additional information and has been reviewing the ‘measures’ within a reasonable time within the meaning of SPS Articles 2.2 and 5.7 (see section 3.2.2(ii)). e) Discrimination: GM crops and products are not ‘like’ their conventional counterparts for the purposes of TBT Article 2.1 and GATT Article III. Moreover, the challenged ‘measures’ do not arbitrarily or unjustifiably discriminate between Members or constitute a disguised restriction on international trade for the purposes of SPS Article 2.3 and GATT Article XX. In particular, a comparison of the challenged measures and the EC’s regulation of GM processing aids, or novelnon-GM crops or food derived from novel non-GM crops, does not show an arbitrary or unjustifiable distinction in levels of protection in different situations which amount to discrimination or a disguised restriction on trade (SPS Article 5.5) (see section 3.2.3). f) Transparency: The ‘measures’ were published in accordance with SPS Article 7 and Annex B.1, TBT Articles 2.9,2.10 or 2.11 and GATT Article X.1. If the Panel applies a broad interpretation to the types of ‘measures’ that can be the subject of a WTO challenge and assessed for compliance with the WTO Agreements, it must also take a broad interpretation of what constitutes ‘publication’ for the purposes of WTO rules (see section 3.3.1). g) Fairness: There was no ‘undue delay’ in the administration of the measures for the purposes of SPS 8 and Annex C; TBT 5.2; GATT X.3(a). The time taken since 1998 to further assess the risks and develop appropriate regulatory controls is a reasonable time frame within which to review the challenged ‘measures’ in the EC. The EC is a unique WTO Member, representing a union of formerly 15 and now 25 Member States and an assessment of ‘undue delay’ must take account of the EC’s complex decision-making procedures (see section 3.3.2). 7. Finally, we respectfully submit that if the Panel limits its recommendations to the consistency of the challenged ‘measures’ with the SPS Agreement, those recommendations would apply only to the extent that the ‘measures’ serve SPS objectives to protect humans, animals, plants and territory from pests or disease, or to protect humans and animals from certain food-borne risks (see section 3.1.2). Our submission does not address the question of whether, if the general and specific de facto moratoria are ‘measures’, they have, as of 18 April 2004 or as of any other time, been discontinued, and whether this would have a bearing on the disputes (see section 3.1.1). However, by way of a general observation, the Amicus Coalition questions whether it is possible for the complainants to have acted in good faith in assessing their challenge to be ‘fruitful’ within the meaning of Article 3.7 of the WTO’s Understanding on Rules and Procedures Governing the Settlement of Disputes (‘DSU’) where the biotech companies affected by the specific de facto moratoria might have a right of action in the EC which they have not explored and have instead voluntarily agreed with at least one EC Member State not to not to proceed with the commercialisation of GM crops until the results of large-scale field trials were known (Farm-Scale Evaluations) (see section 3.1.1).1 See e.g. Mayer, S. & Stirling, A. (2002) ‘Finding a precautionary approach to technological developments – lessons for the evaluation of GM crops’. Journal of Agricultural and Environmental Ethics. Journal of Agricultural and Environmental Ethics 15 (1) 57-71. 2 See Kinderlerer, J. (2003) ‘The WTO complaint – why now?’ Nature Biotechnology 21: 735-736; see also Busch, M. and Howse, R., A. (September 2003) (Genetically Modified) Food Fight: Canada’s WTO Challenge to Europe’s Ban on GM Products CD Howe Institute Commentary 186. Available at http://www.cdhowe.org/pdf/commentary_186.pdf. 3 See e.g. FB Urges ‘Immediate Action’ on EU Biotech Ban. American Farm Bureau Federation, 18th December 2002 http://www.fb.com/news/nr/nr2002/nr1218a.html; Inside US Trade Bush Set for Decision on WTO Biotech Challenge 31st January 2003; The American Soybean Association is even reported to be ‘taking the lead’ in drafting a subsequent challenge to Europe on GM food labeling, Inside US Trade: Likely new WTO challenge on EU GMO policy, March 12th 2004. 4 First Submission of the United States (‘First US submission’) 21 April 2004, para 64. Available at http://www.ustr.gov/enforcement/2004-04-21-ecbiotech-usfirst.pdf. 5 See the three categories of ‘measures’ as set out in the Requests for the Establishment of a Panel by the United States (WT/DS291/23), Canada (WT/DS292/17), and Argentina (WT/DS293/17). See also Directive 90/220/EEC, of 23 April 1990, on the deliberate release into the environment of genetically modified organisms, OJ L 117 of 8 May 1990 (‘Deliberate Release Directive’), replaced by Directive 2001/18/EC, of 12 March 2001, on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, OJ L 106 of 17 April 2001 (‘Revised Deliberate Release Directive’); Regulation 258/97/EC, of 27 January 1997, concerning novel foods and novel food ingredients, OJ L 43 of 14 February 1997 (‘Novel Foods Regulation’).——————————————————————————————Submission made by the following groups:(a) GeneWatch UK (b) Foundation for International Environmental Law and Development (FIELD) (c) The Five Year Freeze (d) The Royal Society for the Protection of Birds (RSPB), UK (e) The Center for Food Safety (CFS), USA (f) The Council of Canadians, Canada (g) Polaris Institute, Canada (h) Grupo de Reflexión Rural Argentina (GRR), Argentina(i) The Center for Human Rights and Environment (CEDHA), Argentina(j) Gene Campaign, India(k) The Forum for Biotechnology & Food Security, India(l) Fundación Sociedades Sustentables (Sustainable Societies Foundation), Chile(m) Greenpeace International(n) Californians for GE-Free Agriculture (o) The International Forum on Globalization (IFG), USAThe full submission is attached.