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THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE 7 July 2004 Dear friends and colleagues, This paper is the Executive Summary of the Norwegian Government’s written submissions to the WTO dispute settlement panel in the case of ‘European Communities: Measures Affecting the Approval and Marketing of Biotech Products’. Norway is one of a number of interested third Parties in this case brought by the US, Canada and Argentina against the EC. The paper contains a comprehensive and updated overview of the possible adverse effects of GE/GMOs, describing the main potential environmental effects outlined by scientists and the main scientific concerns raised in connection with human and animal health. It also addresses the Norwegian risk assessments on specific GMOs where certain EC Member States maintain national measures, and discusses the various WTO agreements in relation to biosafety regulation. With best wishes, Lim Li Lin and Chee Yoke Heong Third World Network 121-S Jalan Utama 10450 Penang Malaysia Email: twnet@po.jaring.my Website: www.twnside.org.sg
European Communities - Measures Affecting the Approval and Marketing of Biotech Products (DS291, DS292, DS293)
Executive Summary by Norway
Geneva 03 June 2004
1. INTRODUCTION 1. While recognising the many potential benefits from GM products, Norway underlines that GMOs have been used for a relatively short time and that important effects on health and the environment remain not fully understood. The approval of GMOs and GM products raise several complex issues of a scientific and factual nature. The process of risk assessment is therefore particularly time-consuming. A prudent approach to GMOs in WTO members’ regulatory frameworks is therefore warranted. 2. Norway restricts its third party submission to certain legal issues concerning Bt. 1761[1], MS1xRF12[2], and Topas 19/23[3]. These are three out of totally seven GMOs in relation to which national EC Member State measures are contested. 2. FACTUAL BACKGROUND, with emphasis on consequences of use of antibiotic resistance marker genes (ARMGs) 2.1 Overview 3. GMOs are one of the results of modern biotechnology. They are created by a particular set of techniques which are used to genetically modify (or “genetically engineer”) organisms. In short, they require a change of genetic material within an organism through genetic recombinant nucleic acid techniques. This is explained in more detail in chapter 2.1 of Norway’s first written submission. 4. Contrary to what has been claimed, there is no “proven safety record” 4[4] with regard to GMOs. National and international regulatory developments demonstrate that GMOs are not a mere continuation of traditional breeding. This is shown in Chapter 2.3 of Norway’s first written submission. GMOs should therefore not be treated as equivalent to non-GM products. Little is known about long-term effects of foods from transgenic crops. Moreover, little scientific agreement exists regarding their environmental impacts. New scientific evidence concerning environmental and health impacts is constantly emerging. 5. A prime concern is the potential spreading of genes through horizontal gene transfer from plants to micro-organisms in the environment, particularly in respect of antibiotic resistance marker genes (ARMGs) 6. As described in Chapter 2.4 and documented by risk assessments, these effects were the main reason for prohibiting the three GMOs in Norway. 7. Horizontal gene transfer is unknown. This means that intentional genetic modification of for example plants could lead to unintentional genetic modification of other organisms. Today no scientists deny the occurrence of horizontal gene transfer, and different mechanisms have been described for the process. An increasing amount of genes and traits in different species that most probably have been spread through horizontal gene transfer, have been reported. The consequences of such unintentional genetic modifications on human health and the environment, including possible long-term effects, are not well known. 8. ARMGs are used as a selection tool during the process of modification. In most cases they remain within the plant as an intact genetic trait5[5]. Resistance towards antibiotics is an increasing problem in therapeutic human and veterinary medicine. Most likely, this is a result of unwise use and spread of antibiotics in general. Two uncertainties exist: Firstly: When GM plants are digested, what possible increased spread of antibiotic resistance genes may occur through horizontal gene transfer to organisms in the environment and in the human and animal digestical tract? Secondly: What consequences may this have with regard to resistance development of pathogenic bacteria in the future? 9. Norway has explained the risks associated with Bt 176, MS1xRF1 and Topas 19/2 which led to their prohibition in Norway. The essence is described below: a) Maize Line Bt 176
Concerns are here related to risks associated with a possible horizontal transfer of the amp gene for resistance to the antibiotic ampicillin contained in the product, as well as with ecological effects of the insect toxin encoded by the cryIA (b) genes. A transfer of the amp gene to pathogenic bacteria in such a way that the gene is successfully incorporated and expressed would be highly undesirable. This is because it might impede clinical treatment. As is documented in the attached risk assessment, studies indicate that there is a risk for horizontal transfer of the amp gene. b) Oilseed rape line MS1 x RF1
Concerns are here related to the risks associated with a possible horizontal transfer of the nptII gene for resistance to the antibiotics neomycin and canamycin contained in the product, as well as with the consequences of gene flow from the genetically modified oilseed rape to wild plants and crops. Transfer of this gene to pathogenic bacteria could contribute to worsening the problem of development of antibiotic resistance. When the risks of this particular genetically modified oilseed rape were assessed, some results indicated a risk of horizontal transfer of the nptII gene. As with Bt 176, further studies were needed. A further concern was documented in the above-mentioned risk assessment. This was related to hybridisation between genetically modified oilseed rape and several wild and domesticated plant species in Norway. Introgression of the gene conferring gluphosinate-tolerance into cross-compatible species could lead to the development of gluphosinate-resistant weeds. In addition, hybridisation with other crop plants could have undesirable effects. These may include future agricultural problems connected to weed management. c) Oilseed rape line Topas 19/2
It contains the npt II gene encoding resistance to the antibiotics kanamycin and neomycin. The assessments and comments with regard to ARMGs in oilseed rape MS1xRF1 above are also applicable to oilseed rape line Topas 19/2. 3. Legal Discussion 3.1 Overview 10. Norway submits that risks related to ARMGs are not covered by the SPS Agreement, or by Article 2 of the TBT Agreement. The applicable WTO Agreement is thus the GATT. The Member State measures are not in breach of GATT Article III: 4, and are at any rate justified under GATT Article XX. 11. If the Panel nevertheless were to consider that such bans should to be addressed under the SPS Agreement, Norway argues in the alternative that the national EC Member States bans conform to Article 5.7 under the SPS Ag. 3.2 The SPS Agreement is not applicable to measures against ARMGs 12. The definitions in Annex A point 1 are quite precise. The application of the SPS Agreement will depend on the purpose of each particular measure, and more specifically which risks the measure is intended to protect against. If a particular objective is not covered by the SPS Agreement, a decision which invokes this particular risk shall not be assessed under SPS, but rather under the TBT Agreement or the GATT. Should the Panel decide that only one objective falls under the SPS, the remaining part of the decision must be assessed under the other Agreements. 13. The protection from risks arising from GMOs or GM products, is not mentioned per se in the wording of Annex A. Whether a measure falls under Annex A, point 1 will therefore be decided by the objective(s) of a measure in relation to the concrete risk(s). 14. The concern with ARMGs is that the antibiotic resistant trait in the GM crop or product DNA might be transferred to bacteria, particularly in the digestive tract of humans or animals. This might have negative impact on clinical and veterinary medicine, which relies heavily on antibiotics (and therefore on the absence of resistance to antibiotics). As explained by the EC6[6], plant DNA is in itself not an organism. Even if it were, it would however not be the plant DNA that caused the disease. The disease would have to arise from other sources. Therefore, plant DNA is not covered by the definitions set out in Annex A point 1. Accordingly, the SPS Agreement is not applicable. 3.3 Alternative argument in respect of SPS Agreement Article 5.7 15. Should the Panel, nevertheless, decide to assess Member States’ national measures regarding any of the three GMOs under the SPS Agreement, Norway will argue, in the alternative, that the measures against the risks of ARMGs fully conform with the SPS Agreement, in particular Article 5.7 thereof. 16. The EC has convincingly shown that the national measures of Member States - if they are to be assessed under the SPS agreement - are “provisionally adopted”. 7[7] This follows inter alia from the legal basis in internal EC law. We refer to the EC’s first submission for further details.8[8] Since these Member States’ measures are provisional, any evaluation of the conformity of the bans with the SPS agreement must be made under Article 5.7 and not under Article 5.1. 17. Norway argues that the four cumulative requirements set out in Article 5.7 are satisfied and accordingly that there is legal basis for adopting and maintaining the provisional phytosanitary measures. 18. Firstly, Norway argues that we are faced with a situation where “relevant scientific evidence is insufficient”. Biotechnology is still in its infancy. Many of the scientific findings are inconclusive or ambiguous. GMOs are exceedingly complex to analyse. It may take years before one may find reliable evidence, which allows to conclude as to their possible harmful impact on health and/or the environment. 19. Secondly, the measures in question were adopted “on the basis of available pertinent information”. The EC Member States could collect information from open sources and they could depend on risk-assessments delivered by other Member States due to internal transparency mechanisms within the EU. They could also depend on the Norwegian risk-assessment due to the same kind of mechanisms within the European Economic Area. On the whole, there exists a presumption that sufficient information was at hand for the EC Member states to identify the risks posed by GMOs. 20. Thirdly and fourthly, the EC fulfils the requirement of seeking “to obtain the additional information necessary for a more objective assessment of risk and will review the measure within a reasonable period of time”. In order to gain better insight a considerable amount of research is continuously carried out world-wide. An expert panel recently established under the European Food Safety Authority has recently assessed ARMGs, and a working group within the EC is currently considering the use of ARMGs in GMOs. In conclusion, the requirements under SPS Article 5.7 are thus met in relation to the three GMOs. 3.4 The TBT Agreement is not applicable to measures against ARMGs. 21. Canada and Argentina argue that to the extent that the SPS Agreement is not applicable, the Member State national measures could be reviewed under various subparagraphs of Article 2 to the TBT agreement9[9]. In Norway’s view the arguments of Canada and Argentina do not correctly reflect the content of Article 2.2. The reason is that EC Member State national measures are not “technical regulations” within the meaning of the TBT Agreement.10[10] They do not contain general descriptions of a normative nature applicable to an undetermined number of producers. In the case in EC - Asbestos, the Appellate Body inter alia held that since the national measure “lays down “characteristics” for all products that might contain asbestos”11[11] (underlining added), the measure was covered by the TBT Agreement Article 2.2 In our dispute, however, the national measures do not apply to all GMOs or even all GMOs coding for antibiotic resistance. Rather, each measure contains a single ban on one particular GMO. Each measure is addressed to one specific manufacturer or right holder and creates legal rights and obligations only upon this addressee. Therefore, they fall outside the scope of Article 2 of the TBT Agreement. 3.5 The GATT 1994 22. Canada and Argentina claim that [some] of the Member State national measures violate Article III: 4 of GATT 1994. 12[12]These allegations are unfounded. 23. In order for a violation of Article III: 4 to occur, several conditions have to be fulfilled. A main requirement is that imported products are treated less favourably than domestic products. In this dispute, the national origin of the manufacturers are not a relevant issue. As shown throughout this submission, quite different concerns have led to these national measures. Indeed, most of the GMOs subject to Member State national measures have in fact been notified by companies incorporated in the EC and belong to such companies.13[13] Thus, the national measures do not distinguish on the basis of nationality. Moreover, there is no evidence that the national measures are in particular addressed at the imported GMOs. This is also the case with the Greek national measure, which according to its intended legal effects applies erga omnes. 24. Moreover, in order to be caught by Article III: 4 of GATT 1994, the Complainants must show that these GMOs are “like” products. Several factors will contribute to deciding whether these are “like” products or not. As demonstrated in Chapter 2.3, most WTO member distinguish between GMOs and its conventional counterparts as regards regulatory regimes. This is because GMOs in fact may have different effects on health and environment than their conventional counterparts. Also, as shown in Chapters 2.4.2.2 and 2.4.3.2, international organisations are increasingly viewing products containing GMOs with genes coding for antibiotic resistance as distinct from conventional products. Also, the growing requirement for labelling of GMOs, which come as a respond to consumer demands, indicate that GMOs should not be treated as “like” products. 25. In conclusion, the Member State measures in relation to the three GMOs are not in breach of GATT 1994 Article III: 4. 26. Even if there should be a breach, other Articles of the GATT 1994, the GATT Article XX, in particular sub-paragraph (b), provide a defence with respect to the three GMOs discussed here. 4. CONCLUDING REMARKS 27. Norway respectfully requests the Panel to take the facts and arguments presented above fully into consideration when making its findings and recommendations. 1[1] Subject to safeguard in Austria, Luxembourg and Germany. 2[2] Subject to safeguard in France. 3[3] Subject to safeguard in France and Greece. 4[4] As stated in the first written submission by the US, ref. heading preceding paragraph 27. 5[5] Droege M. et al., 1998 (Exhibit NOR-105); Nielsen K. M. et al., 2000 (Exhibit NOR-106), 2003 (Exhibit NOR-76). 6[6] Ibid paras 431-432 7[7] At least Canada does not seem to contest that these are provisional measures, see Canada’s First Submission para 379 8[8] EC first written submission para 589 9[9] Canada first written submission paras 473-505 and Argentina first written submission paras. 547-592 10[10] EC first written submission para 642 11[11] Appellate Body in EC- Asbestos WT/DS135/AB/R para 75 12[12] Canada first written submission para 444. Argentina first written submission paras 338 13[13] See EC first written submission paras 632-633
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