The European Communities Biotech Dispute: How the WTO Fails to Consider Cultural Factors in the Genetically Modified Food Debate

Transcription

1 The European Communities Biotech Dispute: How the WTO Fails to Consider Cultural Factors in the Genetically Modified Food Debate LAYLAH ZUREK SUMMARY I. INTRODUCTION II. INTRODUCTION TO GENETICALLY MODIFIED FOODS A. Genetically Modified Foods B. Potential Risks and Benefits of Genetically Modified foods III. ATTITUDES ABOUT GENETICALLY MODIFIED FOODS A. United States B. Europe IV. CASE DISCUSSION A. Overview B. Governing WTO Agreements and International Law The General Moratorium Specific-Product Moratoria Member State Bans V. CASE ANALYSIS A. The Opinion Fails to Consider Other Values Bovine Spongiform Encephalopathy and the Distrust of Government Regulations The Precautionary Principle Food as a Distinct Cultural Value in Europe B. WTO Process Lacks the Institutional Capacity to Consider Non-Market Values J.D. Candidate, University of Texas School of Law. The author would like to thank Professor Thomas McGarity, Ken Ward, Chris Hammock, and Patricia Hudson for helpful comments and suggestions on various drafts. The author would also like to thank Ruth Karper and Skye Masson of the Texas International Law Journal. 345

2 346 TEXAS INTERNATIONAL LAW JOURNAL VOL. 42:345 C. Why Europeans Will Resist General Resistance to WTO Cultural Domination European Resistance to WTO Cultural Domination D. Labeling as an Alternative VI. CONCLUSION I. INTRODUCTION Tell me what kind of food you eat, and I will tell you what kind of man you are. 1 In 2003, the United States, joined by Canada and Argentina (the Complaining Parties), brought a claim to the World Trade Organization (WTO) that the European Communities (EC) strict regulation of genetically modified (GM) foods violated trade obligations. 2 In 2006, the WTO dispute settlement body agreed with the Complaining Parties that the EC had not adequately justified its restrictions on genetically modified foods. 3 However, unlike many international matters before the WTO, 4 decisions about food and food choice cannot easily be resolved, and it is likely that this dispute will not end with this decision. 5 Food has complex social and 1. JEAN-ANTHELME BRILLAT-SAVARIN, THE PHYSIOLOGY OF TASTE (1825). 2. See Reports of the Panel, European Communities Measures Affecting the Approval and Marketing of Biotech Products, at 1, WT/DS291/R (U.S.), WT/DS292/R (Can.), WT/DS293/R (Arg.) (Sept. 29, 2006) [hereinafter EC Biotech Reports of the Panel], available at (incorporating the Complaints by the United States, Canada, and Argentina). In this Comment, I use the term genetically modified (GM); the WTO employs the term biotechnology (biotech) rather than genetically modified or recombinant DNA. However, these terms are often used interchangeably. 3. Id. (issuing one report for the dispute but listing the respective dispute number for each complaint). 4. Many trade disputes do not involve, at least on the surface, deep disagreements about the nature of the product, its safety, or its desirability; as a result, compromises are easier to make, based on the agreed upon rules of the international trade regime and the WTO. For example, determining the regulation of specific electronic components is unlikely to create debate. However, as the disagreements move closer to issues involving conflicting values, making determinations becomes increasingly difficult. For example, agricultural tariffs are difficult to negotiate because agriculture and agricultural products have different values in different countries, and those values can come into conflict with the principles of a free market. We see similar problems when we consider negotiations over language. 5. Similar cases in front of the WTO have been difficult to resolve. A parallel case involves an EC ban on the importation of meat from the United States and Canada that may contain certain artificial hormones. The WTO found that the ban was in violation of trade rules and, eventually, authorized the United States and Canada to impose retaliatory trade tariffs. A key aspect of the decision was that the EC had not satisfied the requirements that they provide scientific proof of harm that could result from the use of the hormones in meat. See Recourse by the United States to Article 22.2 of the DSU, European Communities Measures Concerning Meat and Meat Products (Hormones), WT/DS26/19 (May 18, 1999) [hereinafter United States Recourse to Article 22.2, EC Hormones]; see also Recourse by Canada to Article 22.2 of the DSU, European Communities Measures Concerning Meat and Meat Products (Hormones), WT/DS48/17 (May 20, 1999) [hereinafter Canada Recourse to Article 22.2, EC Hormones]. The EC has subsequently modified the ban and conducted an independent scientific assessment of the danger; however the EC ban remains in place. Commission Background Paper (EU), The Hormone Case: Background and History, MEMO/00/27 (May 24, 2000), available at

3 2007 THE EUROPEAN COMMUNITIES BIOTECH DISPUTE 347 cultural meanings integral to the way legal decisions about food are made and enforced. After all, we are what we eat. This Comment contends that the decision in EC Biotech fails to account for the cultural significance of food and, therefore, will not resolve the controversy over GM food regulation. It identifies cultural factors that will make it difficult for the EC to comply with the WTO ruling. The Comment then proposes mandatory labeling as an alternative solution advancing free market principles while respecting cultural considerations. Part II provides an overview of GM foods, including potential risks and benefits. Part III lays out the respective United States and European Union regulation of GM foods, outlining the historical development of GM foods and the attitudes underlying the differences in regulation. Part IV discusses the EC Biotech decision. In particular, it looks at the Panel finding that the EC violated the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) 6 and at the EC s claim that it should be allowed to impose stricter measures on the regulation of GM foods. Part V evaluates the adequacy of the WTO s response to European arguments for stricter regulation of GM foods and considers the likelihood that the decision will resolve the dispute between the United States and the European Union. The section assesses the Report in light of the underlying cultural aspects of European regulation, and it contends that the WTO fails to adequately account for cultural values and therefore will have difficulty implementing the decision. The Comment concludes by defending labeling as an alternative resolution one that better accounts for cultural values while encouraging United States access to the European Market. II. INTRODUCTION TO GENETICALLY MODIFIED FOODS A. Genetically Modified Foods In order to understand the controversy, it is important to know how GM foods are created and why Europeans might be wary of them. Genetically modified foods are derived from organisms whose DNA has been altered through the insertion of genes from one organism into a second organism in order to suppress, encourage, or otherwise alter particular genetic traits in the second organism. 7 One example of a genetic modification is the creation of an herbicide-resistant cotton plant a gene increasing herbicide resistance is isolated in one plant, removed, replicated, and then 6. See generally EC Biotech Reports of the Panel, supra note 2. The SPS Agreement addresses food safety and animal and plant regulations among WTO member nations concerning measures necessary for the protection of human, animal or plant life or health, provided that such measures are not inconsistent with the provisions of this Agreement. Agreement on the Application of Sanitary and Phytosanitary Measures art. 2.1, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1A, Legal Instruments Results of the Uruguay Round, 1867 U.N.T.S. 493 (1994) [hereinafter SPS Agreement], available at see also Marrakesh Agreement Establishing the World Trade Organization, Apr. 15, 1994, Legal Instruments Results of the Uruguay Round, 1867 U.N.T.S. 154, reprinted in 33 I.L.M (1994) [hereinafter WTO Agreement], available at 7. Biotechnology can introduce genetic traits wholly different than those naturally occurring in the plant. See European Community Report, Harnessing the Potential of Modern Microbiology, at 4 (1999).

4 348 TEXAS INTERNATIONAL LAW JOURNAL VOL. 42:345 reinserted into the DNA of the target plant. 8 The process often uses bacteria to carry the selected DNA and antibiotic marker genes to identify altered cells. Genes can be transferred between plants, animals, or microorganisms both plants and animals have been genetically modified. 9 GM food comes primarily from four crops that dominate GM agriculture: soybeans, maize (corn), cotton, and canola. 10 Within commercial GM crops, the predominant modification is herbicide resistance, followed by insect resistance. 11 Other modifications include viral and fungal resistance, improved ability to resist environmental stresses, acceleration of growth time, and reduction in the maturation time of trees. 12 The above traits affect plant growth, or input, characteristics. 13 Traits affecting the characteristics of the food itself, or output characteristics, are less common 14 and have had less commercial viability. 15 B. Potential Risks and Benefits of Genetically Modified Foods Much of the debate over GM food regulation stems from the tension between the potential risks and benefits of GM foods. Concerns over human health and the environment have driven both sides of the argument: while GM foods may pose unknown risks to human health, they may also be the key to feeding a growing world population. 16 Because GM foods are relatively new and the techniques that create them are complex, fears abound that GM foods may carry serious risks both to human health and to the environment. Two human health risks associated with GM foods are potential allergies to novel proteins that appear in the GM food 17 and the risk that 8. See U.N. Food & Agriculture Organization [FAO], Electronic Forum on Biotechnology in Food and Agriculture Conference 9, Apr. 28-June 1, 2003, Background Document, 2(c) (2003) [hereinafter FAO Background Document], available at 9. Id Id. 11. GENETICALLY ENGINEERED FOOD METHODS AND DETECTION 31 (Knut J. Heller ed., 2d ed. 2006). 12. See id. at Id. at The Flavr Savr tomato was largely unsuccessful in the market due in part to a decline in quality related to the modification. U.N. FAO, GENETICALLY MODIFIED ORGANISMS, CONSUMERS, FOOD SAFETY AND THE ENVIRONMENT 12 (FAO Ethics Series 2001) [hereinafter FAO Ethics Series], available at ftp://ftp.fao.org/docrep/fao/003/x9602e/x9602e00.pdf. 15. See CONSUMER ACCEPTANCE OF GENETICALLY MODIFIED FOODS (R.E. Evenson & V. Santaniello eds., 2004) (stating that many consumers remain reluctant to use biotech products that primarily benefit agribusiness by reducing production costs; however, if biotech created products that directly benefited consumers, reluctance might be overcome, lessening both economic difficulties and the amount of regulation). 16. Rice that was genetically modified to produce vitamin A ( golden rice ) has been successfully created in the laboratory. There are currently plans to distribute the rice without charge when it serves humanitarian needs; however, there remain significant issues, including intellectual property challenges and concerns over how the rice will perform on a wide scale. See Quirin Schiermeier, Designer Rice to Combat Diet Deficiencies Makes its Debut, 409 NATURE 551 (2001), available at see also Nina Schnapp & Quirin Schiermeier, Critics Claim Sight-Saving Rice is Over-Rated, 410 NATURE 503 (2001), available at The risk of antibiotic resistance stems from the use of antibiotic-resistant genes that enable modified products to be identified by saturating cell samples with antibiotics. As a result, resistant genes

5 2007 THE EUROPEAN COMMUNITIES BIOTECH DISPUTE 349 antibiotic resistance could be spread through GM organisms. 18 In addition, there are serious environmental concerns regarding the release of genetically modified organisms (GMOs) into the environment. 19 These concerns include negative and unintended consequences to the biosphere, as demonstrated in U.S. field trials. 20 Balanced against the risks are the potential benefits of GM foods, 21 including reduced usage of pesticides and herbicides, better yields, foods with better nutritional value, foods altered to be less allergenic, production of vaccines within foods, and even the production of alternative fuels. 22 These potential benefits offer strong justifications for further research by biotechnology companies. 23 However, the difficulty remains in determining how to assess the potential benefits and risks and whether regulation can adequately manage the risks. 24 As a result, two approaches to GM food regulation have emerged from the different opinions concerning the role science should play in determining food safety. The first approach assumes that GM foods are safe after limited testing because they are equivalent to foods that have not been genetically altered. The modified genes survive. If the resistance could be transferred from the biotech food to other organisms it encounters, particularly microorganisms in digestive systems of stock or humans, the efficacy of antibiotics could be threatened. See ANDREW ROWELL, DON T WORRY, IT S SAFE: THE TRUE STORY OF GM FOOD, BSE AND FOOT AND MOUTH , (2004). But see ALAN MCHUGHEN, PANDORA'S PICNIC BASKET: THE POTENTIAL AND HAZARDS OF GENETICALLY MODIFIED FOODS 186 (2000) (arguing that resistance is as likely to develop by natural means as from biotech use of antibiotic marker genes). A key concern is that altered food could reach the market with no warning of potential food allergies, either because the gene had unknowingly spread to other crops, or because the protein was not identified as present in the biotech foods. The risk of allergy is best illustrated by the StarLink corn incident, where corn approved for crop use was found to be present in Taco Bell taco shells. Another allergy scare occurred when DNA from Brazil nuts, a common allergen, was used in biotech experiments. See Saturday Morning News: Kraft Recalls Taco Bell Shells (CNN television broadcast Sept. 23, 2000) (transcript available at MCHUGHEN, supra, at See MCHUGHEN, supra note 17, at The environmental risks of living modified organisms (LMOs) play an important role in European regulation. LMOs are regulated under the Convention on Biological Diversity (CBD); in EC Biotech, the European Union raised the protocol as an alternative forum for the debate over GM food regulation. See generally Convention on Biological Diversity, opened for signature June 5, 1992, 1760 U.N.T.S. 142, reprinted in 31 I.L.M. 818 (1992) [hereinafter CBD], available at see also MCHUGHEN, supra note 17, at 249 (discussing conflicts that arise from differing regulatory bodies applying intellectual property law to biotechnology). 20. This occurred in the United States where biotech corn pollen, containing B.t. (Bacillus thuringiensis), a common pesticide used in traditional organic farming, produced by the modified plants, killed the larvae of Monarch butterflies. Sharon Guynup, Homeless Butterflies - Destruction of Habitat for Monarch Butterfly in Mexico; Concerns of Bioengineered Plants on Butterflies, SCIENCE WORLD, Nov. 27, But see MCHUGHEN, supra note 17, at (arguing that B.t. would have the same effect). In the EC, there is a concern that biotech crops will negatively influence bird populations if GM crops become common, since a large percentage of European land is farmed. McHughen contends that the reduction in bird population is due to the intensification of land use, and that the affects of GMOs on bird populations is unknown but could provide a solution by improving crop yield and thus reducing the total land needed for production. Id. at NUFFIELD COUNCIL ON BIOETHICS, GENETICALLY MODIFIED CROPS: THE ETHICAL AND SOCIAL ISSUES 3 (1999) (stating that concern over risks may distract both the public and governments from giving proper attention to the benefits they could bring ). 22. Id. at Id. 24. Id. at 6.

6 350 TEXAS INTERNATIONAL LAW JOURNAL VOL. 42:345 second approach assumes that more extensive testing on a broader scale is required to prove the safety of GM foods. These competing approaches to regulation underlie the different positions in EC Biotech. III. ATTITUDES ABOUT GENETICALLY MODIFIED FOODS A. United States Within the United States, GM foods have met with comparatively little opposition because trust in the government s regulation of food is strong, although not absolute. 25 In general, there has been limited response to GM foods in the marketplace. The United States is the largest producer of GM foods, and estimates of the amount of GM food in the domestic food supply are quite high. 26 Canada and Argentina also produce significant percentages of GM food. 27 None of the three nations requires any traceability 28 or specific labeling 29 for GM foods. Instead, the modified foods are treated in the same manner as unmodified foods on the basis that they are substantially similar to unmodified products. 30 In the United States, the adaptation of existing regulatory rules to biotechnology has resulted in gaps that allow GM foods to pass into the food supply: once GM food has left the grower, no regulation exists requiring identification of the GM food, nor is there any traceability of the food. 31 The StarLink corn 32 incident demonstrated weaknesses in the U.S. regulatory system providing an example of the unexpected migration of GM foods into the human food supply, even when a scientific basis exists for a regulatory decision to keep the GM food from human consumption. 33 Due to questions about the 25. Thomas O. McGarity, Seeds of Distrust: Federal Regulation of Genetically Modified Foods, 35 U. MICH. J.L. REFORM. 403, (2002). 26. FAO Background Document, supra note 8, 2(a). 27. Id. 28. Traceability of food means that each step in the food's history can be traced in order to determine the origin and subsequent handling of the food. See generally EUROPEAN COMMISSION, FROM THE FARM TO THE FORK (2005), available at (stating that each step of production should record where the food came from and where it goes); see also EC Biotech Reports of the Panel, supra note 2, at D4-6 (discussing U.S. regulation of GM foods). 29. Labeling would require that any food or feed containing genetically modified food or processed from genetically modified food, would have to disclose that information on the label; labeling depends on traceability. See generally Farm Foundation, Food Traceability & Assurance in the Global Food System (Traceability and Assurance Panel Report July 2004), available at see also EC Biotech Reports of the Panel, supra note 2, at D See FAO Ethics Series, supra note 14, at The United States has not established GM-specific requirements; rather, modified foods are regulated under the existing framework of the FDA, EPA and USDA. See Rebecca M. Bratspies, The Illusion of Care: Regulation, Uncertainty, and Genetically Modified Food Crops, 10 N.Y.U. ENVTL. L.J. 297, (2002). For an overview of the roles of U.S. agencies in the regulation of GM foods, see the United States Regulatory Agencies Unified Biotechnologies Website, (last visited Apr. 7, 2007). 32. Starlink corn was engineered by Aventis CropScience to contain an insecticidal protein. Starlink Official Website, Starlink History, (last visited Apr. 7, 2007). 33. See Rebecca M. Bratspies, Myths of Voluntary Compliance: Lessons from the StarLink Corn Fiasco, 27 WM. & MARY ENVTL. L. & POL'Y REV. 593, 596 (2003).

7 2007 THE EUROPEAN COMMUNITIES BIOTECH DISPUTE 351 allergenicity of an altered protein in the corn, GM corn was approved for animal feed but not for human consumption. 34 However, subsequent testing by an anti-gm organization found the GM corn to be present in Kraft taco shells on grocery store shelves. 35 Aventis voluntarily withdrew the corn, 36 but it had already been consumed domestically and shipped abroad. 37 While subsequent research failed to show any allergic reaction, the fact remains that the product had not been proven safe or approved for human consumption. 38 Mistakes such as these cast doubt on the ability of the U.S. government to properly regulate GM foods. 39 Outside the United States, such events have led to calls for labeling and traceability of GM products, particularly from trade partners that regulate GM products more stringently. 40 B. Europe Since the late 1990s, GM food regulation by the European Union, and many Member States, has become increasingly stringent. Thus, the European Union has been caught between domestic pressure to regulate and international trade pressure not to regulate at the same time. The regulatory scheme for approval of GM foods for sale within the European Union has always been much stricter than in the United States. 41 However, the gap has widened since an authorization process for GM foods was established by the European Union. 42 In addition, political pressure from citizens of Member States subsequently led the EU to reevaluate its procedures for accepting GM foods in an attempt to harmonize different regulatory regimes within the EU. 43 The EU did not 34. Id. at Id. at The U.S. government exerted significant effort controlling damage to trade; additionally, the costs of trying to remove Starlink corn from the food supply were very high. Aventis Corporation was also found liable for damages to Taco Bell, the name under which the taco shells were marketed, for damages to the company s reputation and lost sales. See id. at Id. at Andrew Pollack, Study Raises Doubt About Allergy to Genetic Corn, N.Y. TIMES, Nov. 10, 2003, at C10, available at Bratspies, supra note 33, at David Barboza, As Biotech Crops Multiply, Consumers Get Little Choice, N.Y. TIMES, June 10, 2001, at A1, available at spon=&partner=permalink&exprod=permalink. 41. See Genetically Modified Food and Feed (GMOs) (2006), (summarizing EU regulations of GM foods). 42. Council Regulation (EC) 258/97, Concerning Novel Foods and Novel Food Ingredients, art. 7, 1997 O.J. (L 43) 1, available at Joanne Scott, European Regulation of GMOs and the WTO, 9 COLUM. J. EUR. L. 213, 226 (2003). For further discussion of member state regulations, see Franz Xaver Perrez, Taking Consumers Seriously: The Swiss Regulatory Approach to Genetically Modified Food, 8 N.Y.U. ENVTL. L.J. 585 (2000), which provides a good case study on one of the first nations to require labeling on GM foods, where the concern over GM foods is based on social and environmental concerns, including a concern for the dignity of creation.

8 352 TEXAS INTERNATIONAL LAW JOURNAL VOL. 42:345 approve genetically modified food from 1999 to 2003, while they were determining the risks and benefits of such food. 44 Finally, the EU passed a directive that made labeling mandatory for all GM foods that contain more than 0.9% of GM ingredients and GM foods that contain more than 0.5% of GM ingredients from GMOs not approved by the EU. 45 In addition, Regulation 1829/2003 centralized authorization of GM food and crops in the European Food Safety Authority (EFSA), which is responsible for the scientific assessment of genetically modified food and feed. 46 These labeling and traceability requirements allow for increased citizen choice, and, this in turn, may alleviate some of the pressure to ban GM foods, although it is still unclear how easy it will be for GM foods to be approved in practice. 47 The EC s policies reflect an uncertain compromise between the concerns of its citizens and those of its trading partners, such as the United States, and now the WTO. Resistance to GM foods continues, accompanied by claims that the EC was motivated by market concerns to push the regulations on Member States without having satisfactorily resolved health concerns. 48 A. Overview IV. CASE DISCUSSION In 1998, the European Communities responded to political pressure for stricter regulation of GM foods by reviewing their approval processes; no approvals of biotech products were completed during the review and six individual Member States implemented restrictions on certain GM foods already approved by the EC. 49 On May 13, 2003, the United States and Canada requested WTO consultations with the European Communities, claiming that the EC and individual Member State actions regarding GM foods were inconsistent with WTO trade agreements. 50 The 44. Request for Consultations by the United States, European Communities Measures Affecting the Approval and Marketing of Biotech Products, WT/DS291/1 (May 13, 2003) [hereinafter U.S. Request for Consultations], available at Council Regulation No. (EC) 1829/2003, On Genetically Modified Food and Feed, arts. 12, 47, 2003 O.J. (L 268) 11, 22, available at Id. at For a discussion on food labeling reform in the EU, see generally Ignacio Carreño, The New European Community Rules on the Labeling of Allergen Ingredients in Foodstuffs, 60 FOOD & DRUG L.J. 375 (2005). 48. European Member States still had domestic restrictions on GM foods at the end of See EC Biotech Reports of the Panel, supra note 2, at 31, Id. 50. In particular, the United States claimed the following violations: Articles I, III, X, and XI of GATT; Article 4 of the Agricultural Agreement; Articles 2 and 5 of the TBT Agreement; and Articles 2, 5, 7, 8 as well as Annex B and Annex C of the SPS Agreement. See U.S. Request for Consultations, supra note 44. Canada claimed the following violations: Articles I:1, III:4, X:1, XI:1 and XXIII:1(b) of GATT; Articles 2.1, 2.2, 2.8, 5.1 and 5.2 of the TBT Agreement; Article 4.2 of the Agricultural Agreement; and Articles 2.2, 2.3, 5.1, 5.6, 7, and 8 as well as Annex B and C of the SPS Agreement. See Request for Consultations by Canada, European Communities Measures Affecting the Approval and Marketing of Biotech Products, WT/DS292/1 (May 13, 2003) [hereinafter Canada Request for Consultations], available at Argentina claimed the following violations: Articles I, III, X,XI of GATT; Articles 2, 5, and 12 of the TBT Agreement; Article 4 of the Agricultural Agreement; and Articles 2, 5, 7, 8, and 10, as well as Annex B and Annex C of the SPS Agreement. See Request for

9 2007 THE EUROPEAN COMMUNITIES BIOTECH DISPUTE 353 United States and Canada, joined by Argentina, brought a complaint claiming that: 1) the EC s failure to approve any GM food for five years was a de facto moratorium violating obligations under WTO Agreements; 51 2) a moratorium on approvals of specific products also existed, in violation of WTO Agreements; 52 3) certain EC Member States had imposed limits on specific biotech products already approved by the EC, violating EC obligations under the WTO Agreements. 53 On August 29, 2003, after consultations failed to resolve the issues, 54 the WTO established a panel to consider the complaints. 55 This Panel issued an interim decision in February 2006, after extended delays due to the complexity of the case. 56 In late 2006, the final Panel decision was circulated and then accepted by the members of the WTO. 57 B. Governing WTO Agreements and International Law The United States, Canada, and Argentina (the Complaining Parties) alleged that the EC general moratorium, product-specific moratorium, and Member State bans of GM products were inconsistent with the SPS Agreement which requires measures be based on scientific principles and supported by scientific evidence. 58 Canada and Argentina also alleged that the moratoria and bans were inconsistent with the Agreement of Technical Barriers to Trade (TBT Agreement) and the General Agreement on Tariffs and Trade (GATT). 59 In response, the EC asserted that the general moratorium did not exist and argued that the lack of approvals did not qualify as a formal or informal measure Consultations by Argentina, European Communities Measures Affecting the Approval and Marketing of Biotech Products, WT/DS293/1 (May 14, 2003) [hereinafter Argentina Request for Consultations], available at U.S. Request for Consultations, supra note 44; see also Canada Request for Consultations, supra note 50; see also Argentina Request for Consultations, supra note U.S. Request for Consultations, supra note 44; see also Canada Request for Consultations, supra note 50; see also Argentina Request for Consultations, supra note U.S. Request for Consultations, supra note 44; see also Canada Request for Consultations, supra note 50; see also Argentina Request for Consultations, supra note Request for the Establishment of a Panel by the United States, European Communities Measures Affecting the Approval and Marketing of Biotech Products, at 2, WT/DS291/23 (Aug. 8, 2003), available at Request for the Establishment of a Panel by Canada, European Communities Measures Affecting the Approval and Marketing of Biotech Products, at 1, WT/DS292/17 (Aug. 8, 2003) [hereinafter Canada Request for the Establishment of a Panel], available at Request for the Establishment of a Panel by Argentina, European Communities Measures Affecting the Approval and Marketing of Biotech Products, at 2, WT/DS293/17 (Aug. 8, 2003) [hereinafter Argentina Request for the Establishment of a Panel], available at EC Biotech Reports of the Panel, supra note 2, at Id. at Id. 58. U.S. Request for Consultations, supra note 44; see also Canada Request for Consultations, supra note 50; see also Argentina Request for Consultations, supra note 50; see also SPS Agreement, supra note 6, arts. 1-2 (allowing signatories to regulate products as necessary to protect human, plant, and animal health, provided that the regulations are based on scientific principles and supported by scientific evidence); see also, infra note 73 and accompanying text. 59. Canada Request for the Establishment of a Panel, supra note 54; Argentina Request for the Establishment of a Panel, supra note 54.

10 354 TEXAS INTERNATIONAL LAW JOURNAL VOL. 42:345 under the SPS Agreement regulations on how measures can be applied. 60 Next, the EC argued that failure to complete product-specific applications did not qualify as measures either. 61 As to the Member State bans, the EC argued that because they were temporary, they did not violate WTO obligations. 62 Additionally, the EC claimed that the contested moratoria and bans primarily addressed environmental, and not health, concerns; consequently, they fall outside of the SPS Agreement. 63 According to the EC, the Cartagena Protocol on Biosafety (Cartagena Protocol) applies instead. 64 It further contended that even if WTO agreements apply, they should be interpreted in conjunction with, rather than separate from, other sources of international law. Finally, the EC argued that the appropriate WTO agreement is the TBT Agreement, not the SPS Agreement. 65 The decision found that the de facto moratoria and bans were measures as defined by the WTO and that the measures fell within the SPS Agreement. 66 The Panel did not consider the EC claim that Cartagena Protocol should govern. 67 Additionally, the Panel considered only one of the GATT claims by Canada and Argentina, and none of the TBT claims was successful The General Moratorium The Complaining Parties alleged that the EC maintained a general moratorium on biotech products between June 1999 and August 2003 (the latter being the date the Panel was established), in violation of the SPS Agreement. 69 While under the SPS Agreement WTO Members are allowed to maintain independent approval procedures for biotech products, these procedures must be conducted without undue delay, which the Complaining Parties claim the EC failed to do in creating a de facto moratorium on approvals of GM foods First Written Submission by the European Communities, European Communities Measures Affecting the Approval and Marketing of Biotech Product, at 64, DS/291, DS/292, DS/293 (May 17, 2004) [hereinafter First Written Submission by the European Communities], available at Id. 62. Id. 63. Id. 64. Id.; see also Cartagena Protocol on Biosafety to the Convention on Biological Diversity, adopted Jan. 29, 2000, 1760 U.N.T.S. 9, reprinted in 39 I.L.M (2000) [herinafter Cartagena Protocol], available at The Cartagena Protocol is a supplementary agreement to the Convention on Biological Diversity, which established international environmental standards, including the protection of species and environmental preservation across borders. CBD, supra note See EC Biotech Reports of the Panel, supra note 2, at An alternative defense was made by the EC: its actions were not measures because they were not explicit or official decisions but rather informal inaction. See id. at See id. at Id. at 866. The Panel did not assess the overall safety of GM food and did not rule as to whether GM products were substantially similar to other products. Further the Panel did not address whether the EC had a right to require pre-marketing approvals, whether the EC approval procedures violated WTO Agreements, whether the EC evaluations of the safety of biotech products were correct, or whether the EC regulatory scheme was in accordance with WTO obligations. Id. at , See id. at See EC Biotech Reports of the Panel, supra note 2, at 624.

11 2007 THE EUROPEAN COMMUNITIES BIOTECH DISPUTE 355 The EC claimed that the moratorium did not exist and would not constitute a measure under the SPS Agreement if it did exist. 71 The Panel disagreed, finding that a moratorium on the approval of biotech products did indeed exist between June 1998 and August 2003, and that the moratorium violated Article 8 and Annex C(1)(a) of the SPS Agreement. 72 Because the moratorium had ended by the time the Panel issued its Reports, the Panel did not make a recommendation regarding the moratorium Specific-Product Moratoria The Complaining Parties also claimed that undue delays in approval of specific GM products violated the SPS Agreement. 74 The Panel found that EC actions violated Article 8 and Annex C(1)(a) of the SPS Agreement by allowing unnecessary delays in the approvals of two of the twenty-seven products specified by the Complaining Parties. 75 As a result, the Panel recommended that the Dispute Settlement Understanding (DSU) ask the EC to bring the relevant product-specific measures into conformity with its obligations under the SPS Agreement. 76 The Complaining Parties were less successful in their claim that the EC s product-specific moratoria were not based on risk assessment and thus did not satisfy WTO obligations. 77 As was the case with their challenge to the general moratorium, 78 the Complaining Parties failed in their challenge to the productspecific moratoria under other SPS provisions; the Panel rejected all claims other than those under the SPS Agreement See id. 72. See generally Interim Reports of the Panel, European Communities Measures Affecting the Approval and Marketing of Biotech Products, at 2, WT/DS291/Interim, WT/DS292/Interim, WT/DS293/Interim (Feb. 7, 2006) [hereinafter Interim Reports of the Panel], available at (discussing the United States, Canadian, and Argentinian complaints). 73. See Understanding on Rules and Procedures Governing the Settlement of Disputes [Dispute Settlement Understanding] art. 3.8, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 2, Legal Instruments Results of the Uruguay Round, 33 I.L.M (1994), available at ( where there is an infringement of the obligations assumed under a covered agreement, the action is considered prima facie to constitute a case of nullification or impairment ). 74. Each country had a separate list of products, including twenty-five U.S. products, four Canadian products, and ten Argentinean products. See U.S. Request for Consultations, supra note 44; see also Canada Request for Consultations, supra note 50; Argentina Request for Consultations, supra note See EC Biotech Reports of the Panel, supra note 2, at Id. at , 1078, SPS Agreement, supra note 6, arts (requiring that all measures follow appropriate scientific protocols, including scientifically supportable risk assessments). 78. Relevant provisions include, Annex C(1)(a) (forbidding any undue delay in processing applications), Article 8 (requiring that applicants be kept informed of the progress of their applications), Annex C(1)(b), and Annex B(1) (requiring that SPS measures be promptly published). Id. art. 8 & Annexes C(1)(a), C(1)(b), B(1). 79. EC Biotech Reports of the Panel, supra note 2, at

12 356 TEXAS INTERNATIONAL LAW JOURNAL VOL. 42: Member State Bans Finally, the Complaining Parties challenged the EC-approved restrictions that maintained import or marketing bans for GM products in six Member States Austria, France, Germany, Greece, Italy, and Luxemburg. 80 Each of the countries had justified the measures as protecting human health; consequently, the Complaining Parties argued that the SPS Agreement, governing human safety issues within measures, be justified by scientific risk assessments as defined by the SPS Argreement. 81 The SPS Agreement requires that restrictions in the name of human health be based on scientifically supportable risk assessment following appropriate procedures. 82 The Complaining Parties argued that the bans did not meet this standard. 83 The EC contended that the actions were justified by environmental concerns, and therefore should be allowed regardless of the SPS requirements. 84 Further, the EC argued that each ban fell under the Article 5.7 exception, which allows for temporary precautionary measures when there is insufficient scientific information to adequately assess the risk. 85 Finally, the EC argued that because the measures were based on some scientific knowledge, the requirements of Article 5.1 were satisfied. 86 The United States claimed that the bans did not qualify for the Article 5.7 exception because the scientific information available was in fact sufficient to show that GM foods were safe. It contends that rather than consider this information, the six countries attempted to justify their bans by using non-human studies that do not meet the standards for scientific assessment established in the SPS Agreement. 87 The Panel found that the bans fell under the SPS Agreement and failed to satisfy the risk assessment requirements under that Agreement, violating Articles 2.2 and The Panel further found that because there was sufficient information with which to assess risk, the temporary exception under Article 5.7 was not applicable. 89 It also found that the available information did not establish that the restrictions protected human health or the environment and were therefore not justified. 90 The 80. Article 12 of Council Regulation 258/97 allows Member States to institute a measure to restrict or ban a product if the Member State has a justifiable reason for considering it a danger to human health or the environment. Council Regulation 258/97, supra note 42, art U.S. Request for Consultations, supra note 44; see also Canada Request for Consultations, supra note 50; Argentina Request for Consultations, supra note SPS Agreement, supra note 6, art. 5.1 ( Members shall ensure that their sanitary or phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations. ). The risk assessments must consider, based on sufficient scientific data, whether the likelihood and severity of potentials dangers exceed what member States determine to be an adequate level of protection of human health; this consideration must allow for a sufficient margin of error and the level of protection must not be more trade-restrictive than necessary. See id. arts 5.1, 5.5 & Annex EC Biotech Reports of the Panel, supra note 2, at 75 (containing the First Oral Statement of the United States). 84. Id. at Id. at Id. at Id. at Id. at EC Biotech Reports of the Panel, supra note 2, at Id. at 1069.

13 2007 THE EUROPEAN COMMUNITIES BIOTECH DISPUTE 357 Panel determined that the bans must be lifted in order to comply with WTO trade obligations; if the EC or more likely an individual Member State unreasonably delayed, the Complaining Parties would be able to impose retaliatory tariffs. 91 The EC has already asked for more time to determine how to bring Member States and EC law into compliance with the WTO trade obligations as established in Reports of the Panel. 92 In conclusion, the Panel found that the EC acted inconsistently with its obligations under specific articles of the SPS Agreement but not under any of the other WTO trade agreements. The moratoria against GM foods existed and created unnecessary delays inconsistent with the SPS Agreement. The Panel found that Member State measures were not adequately justified by a scientifically based risk assessment as defined in the SPS Agreement. Of particular interest, the Panel read the Article 5.1 exception narrowly, rejecting the EC s claim that precaution was justified because of insufficient scientific information. 93 V. CASE ANALYSIS A. The Opinion Fails to Consider Other Values The Panel decision did not consider legal authority beyond the WTO, reflecting the WTO s commitment to preserve market access and free trade. This is especially apparent in its treatment of scientific evidence about risk. The Panel narrowly defines an acceptable risk assessment, following the requirements of the SPS Agreement. 94 The Panel read the Article 5.1 exception as placing the burden on the EC to prove GM foods unsafe and rejected the EC claims that risk assessments were not adequate in the face of insufficient scientific data. 95 It also failed to consider the EC s claims of environmental safety brought under alternative Environmental treaties, such as the Convention on Biological Diversity (CBD). 96 In so doing, the Panel s process did not respect the cultural values that underlie the EC s actions and will likely lead to difficulties in the implementation of the Panel s decision. The EC s actions were not based solely on market considerations. The moratoria responded to political pressure resulting from citizen mistrust of biotech foods and demands for more stringent oversight. 97 This citizen reaction was rooted in cultural considerations existing outside the market and helped structure the EC s determination that GM products were not proven safe. 98 Given its unwillingness to 91. Id. at See WTO Summary of the Dispute DS291, European Communities Measures Affecting the Approval and Marketing of Biotech Products, (last visited Apr. 8, 2007) [hereinafter EC Biotech Summary]. 93. See EC Biotech Reports of the Panel, supra note 2, at Id. 95. Id. 96. See id. at See generally Theofanis Christoforou, The Precautionary Principle and Democratizing Expertise: A European Legal Perspective, 30 SCI. & PUB. POL Y 205 (2003) (discussing the process of European risk assessment). 98. Culture is not an aspect of markets; rather, culture defines markets and preferences. Culture

14 358 TEXAS INTERNATIONAL LAW JOURNAL VOL. 42:345 incorporate the broader scope of international law regarding biotech decisions or to separately consider non-market values, the WTO decision will not resolve the biotech debate between the EC and the producers of biotech products (primarily the United States, followed by Canada, Argentina, and China). This section outlines three cultural variables motivating the EC regulations variables the opinion fails to consider. 1. BSE and the Distrust of Government Regulations European consumers do not trust their governments to regulate food safety. A series of incidents in the 1990s, involving foot and mouth disease, food-borne illnesses, and, most significantly, BSE (Mad Cow Disease), undermined consumers trust in their governments. 99 BSE is a lethal disease in cattle that, if transmitted through certain meat consumption, can cause a related disease in humans. 100 When the first mad cow cases were discovered, the British government downplayed the significance and denied that there was a connection between the diseased cows and a human health threat. 101 This was later determined to be untrue BSE had spread from cows to humans who had eaten tainted meat. 102 The revelation created a panic, and British beef was rejected throughout Europe. 103 Public trust in the British government eroded. 104 The British resumed eating beef, but the distrust of the British government remained. 105 In a recent poll, more than half of Europeans were still concerned about BSE. 106 Further, more than one in three Europeans polled thought that the government should do more to regulate food, expressing particular concern that regulation favored industry over the protection of human health. 107 The initial risk assessments of BSE were based on scientific information incorrectly thought to be sufficient at the time. 108 This failure of science eroded confidence in governmental regulations, as illustrated by the public reaction to the potential threat caused by artificial hormone use in American beef. 109 The uncertainty of the hormones safety has resulted in enormous political pressure on the EU to support a ban on beef from cattle treated with hormones. 110 determines what goods are valuable, and thus what goods are offered for sale. For an illustration of the role of culture in shaping preferences, see Theodore Bestor's discussion of the recent emergence of sushi in Western markets. Theodore C. Bestor, How Sushi Went Global, FOREIGN POLICY, Nov.-Dec. 2000, at 54, available at MARION NESTLE, SAFE FOOD: BACTERIA, BIOTECHNOLOGY, AND BIOTERRORISM 250 (2003) NICOLS FOX, SPOILED: WHY OUR FOOD IS MAKING US SICK 291 (1998) See NESTLE, supra note 99, at See id. at See id. at See id See Claude Fischler, The Mad Cow Crisis: A Global Perspective, in FOOD IN GLOBAL HISTORY, 207, (Raymond Grew ed., 1999) EUR. COMM N, SPECIAL EUROBAROMETER 225: SOCIAL VALUE, SCIENCE AND TECHNOLOGY 99 (June 2005) [hereinafter SPECIAL EUROBAROMETER 225: SOCIAL VALUE, SCIENCE AND TECHNOLOGY], available at Id FOX, supra note 100, at Id. at Id. at 101.

15 2007 THE EUROPEAN COMMUNITIES BIOTECH DISPUTE The Precautionary Principle The European attitude about food safety is characteristic of Europe s broader concern with risk and safety issues, as expressed in the precautionary principle. While there is no single definitive statement of the precautionary principle, the Rio Declaration on Environment and Development s definition is widely considered an expression of the principle: In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation. 111 Europe has wholeheartedly embraced the principle and played a large part in its creation. The principle originated in German domestic law, emerging internationally at the 1987 London Conference of the North Sea under the term precautionary principle. 112 The precautionary principle is in the treaty forming the EU and is employed both in EU law and in European domestic law. 113 The precautionary principle has gained acceptance in the area of environmental protection during the last few decades. Yet the principle has not taken hold in the WTO, where it justifies only a temporary exception that allows a nation to impose stricter measures protecting health and safety only when significant uncertainty exists. 114 The exception is quite limited: it must be temporary in nature, based on a lack of sufficient information, and new information must be sought actively during the time the exception is in place. 115 Therefore, the differences between the WTO precautionary approach and the EU precautionary principle are significant United Nations Conference on Environment and Development, June 3-14, 1992, Rio de Janeiro, Brazil, Rio Declaration on Environment and Development, U.N. Doc. A/Conf.151/5/Rev.1 (June 14, 1992), reprinted in 31 I.L.M. 876 (1992), available at Michael Pollan, The Year in Ideas: A to Z; Precautionary Principle, N.Y. TIMES, Dec. 9, Treaty Establishing the European Community, arts. 130r-130t, Nov. 10, 1997, 1997 O.J. (C 340) 3, reprinted in 31 I.L.M See generally Theofanis Christoforou, The Precautionary Principle in EC Law and the WTO Legal System, in THE PRECAUTIONARY PRINCIPLE 99, 116 (Georges Kremlis, Yiorgos Balias & Antonis Sifakis eds., 2004) SPS Agreement, supra note 6, art The SPS Agreement defines the limits of the exception in Article 5.7: In cases where relevant scientific evidence is insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary measures applied by other Members. In such circumstances, Members shall seek to obtain the additional information necessary for a more objective assessment of risk and review the sanitary or phytosanitary measure accordingly within a reasonable period of time. Id Id.