The international regulation of genetically modified organisms: Uncertainty, fragmentation, and precaution

European Environmental Law Review

Volumn 16, Issue 12, 2007, Pages 314-336

  Bevilacqua, Dario ^a  

^a SAPIENZA UNIVERSITY OF ROME   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ENVIRONMENTAL LEGISLATION; ENVIRONMENTAL PROTECTION; FRAGMENTATION; GENETICALLY MODIFIED ORGANISM; INTERNATIONAL LAW; PRECAUTIONARY PRINCIPLE; UNCERTAINTY ROLE;

BOLIVAR [COLOMBIA]; CARTAGENA; COLOMBIA; SOUTH AMERICA;

EID: 37549061803     PISSN: 09661646     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (207)

1. By the expression of "global regulatory framework" is meant that complex set of laws applying and interacting at a global scale in order to regulate certain transnational fields: not only treaty-based international law, but also direct-executing acts of regional organizations, transboundary-effect domestic regulations and that set of rules, which has its origin in extra-national institutions, has a binding effect over private individuals inside the States, and has been recently named "global law". On this issue see S. Cassese, Global Administrative Law. An introduction, available on line at http://www.e-italici.org/it_data/fil/ s_cassese_global_administrative_law.pdf, also published in Italian as 'Il diritto amministrativo globale: una introduzione' (2005) 2 Rivista trimestrale di diritto pubblico.
2. R. B. Stewart, Global Administrative Law, Lectio Magistralis Honoris causa, Conferimento della Laurea "Honoris Causa" in Giurisprudenza al Professor Richard B. Stewart, Università degli Studi di Roma "La Sapienza", Rome 13 June 2005;
3. R.B. Stewart, B. Kingsbury, N. Krisch, 'The Emergence of Global Administrative Law', (2005) 68 Law and Contemorary Problems 3-4.
4. Fragmentation is a typical problematic issue of the phenomenon of the legal globalization and it has been recently defined as "the breakdown of the substance of general international law into allegedly autonomous, functionally oriented, 'self-contained' regimes", M. Koskenniemi, 'Constitutionalism as Mindset: Reflections on Kantian Themes About International Law and Globalisation' (Berkley Press: Theoretically Inquires in Law, N. 1, Vol. 8, 2007) at http://www.bepress.com/til/default/vol8/iss1/art2/.
5. On the issue see also ID., Fragmentation Of International Law: Difficulties Arising From The Diversification And Expansion Of International Law. Report of the Study Group of the International Law Commission (Geneva: International Law Commission, Fifty-eighth session, 1 May-9 June and 3 July-11 August 2006), available at http://www.un.org/law/ilc/.
6. Cartagena Protocol on Bio-safety, signed at Montreal on 29 January 2000, entered into force on the 11 December 2003, available at http://www.biodiv.org/biosafety/protocol.asp. More in general a GMO is a product of the combination of genes from different organisms, through the recombinant DNA technology. The result of the combination is said to be "genetically modified", "genetically engineered" or "transgenic". However the three denominations imply different kinds of genetic modification. For instance, "although in popular parlance the term genetically modified (GM) often is used interchangeably with genetically engineered (GE) and biotechnology, (...) genetic modification refers to a range of methods used to alter the genetic composition of a plant or animal, including traditional hybridization and breeding. Genetic engineering is one type of genetic modification that involves making an intentional targeted change in a plant or animal gene sequence to effect a specific result through the use of recombinant deoxyribonucleic acid (rDNA) technology. Biotechnology refers to methods (including genetic engineering) other than conventional breeding used to produce new plants, animals, and microbes. Conventional breeding is used to describe traditional methods of breeding, or crossing, plants, animals, or microbes with certain desired characteristics for the purpose of generating offspring that express those characteristics".
7. On these issues see http://www.ornl.gov/sci/techresources/ Human_Genome/elsi/gmfood.shtml and Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health, 'Safety of Genetically Engineered Foods. Approaches to Assessing Unintended Health Effects' (The National Academies Press, Washington, D.C., 1 ff.), at www.nap.edu.
8. W. A. Kerr, 'International Trade in Transgenic Food Products: A New Focus for Agricultural Trade Disputed', (1999) 22 The World Economy 2, 247.
9. There has been established an ad hoc Intergovernmental Task Force on Foods Derived from Modem Biotechnology by the 27th Session of the Codex Alimentarius Commission. Its mandate is to elaborate standards, guidelines, or recommendations, as appropriate, for foods derived from modern biotechnology. The Task Force shall end its work within two years, submitting a full report in 2009. So, although the Task Force has actually produced some partial guidelines, there is still no complete official and legally approved statement to rely on for what concerns GMOs. On this see Codex Alimentarius Commission, Principles for the Risk Analysis of Foods derivedftom modern Biotechnology, Rome, CAC/GL 44-2003, 2, available at http://www.codex-alimentarius.net/download/ standards/10007/CXG_044e.pdf.
10. See also Mae-Wan Ho and Lim Li Ching, Independent Science Panel, The Case for a GM-free Sustainable World (London: Institute of Science in Society, 15 June 2003).
11. "There are many opinions but scarce data on the potential health risks of GM food crops", A. Pusztai, "Genetically Modified Foods: Are They a Risk to Human/Animal Health?" (American Institute of Biological Sciences, 2001, upaged), at http://www.freenetpages.co.uk/hp/a.pusztai/.
12. "Technologically based uncertainty stems from factors that include the inherent imprecision of currently employed rDNA techniques, the use of powerful, often viral, promoter sequences in genetic constructs, and the generation in GMOs of novel proteins to which humans and animals have never been exposed; scientific uncertainty also results from the still-considerable ignorance of the composition, and serious inadequacies in studies conducted to assess the potential health and environmental impacts of GMOs", EC - Measures Affecting the Approval and Marketing of Biotech Products (WT/DS/291, 292, and 293) (hereinafter EC-Biotech), Amicus Curiae Brief, June 1st, 2004, 4-5, available at http://www.trade-environment.org/page/theme/tewto/ biotechcase.htm.
13. "Chymosin", an enzyme used to make cheese is the first commercially approved (in 1990) genetically engineered food product. While "Flavr Savr" tomato is the first commercially approved (in 1994) genetically engineered food crop.
14. See Global Status of Biotech Crops in 2005, 'Report' (The International Service for the Acquisition of Agri-Biotech Applications), at: http://www.isaaa.org/kc/CBTNews/press_-release/images/briefs34/ figures/hectares/by%20country_hectares.jpg (last visited on March 28, 2007).
15. See C. James, Global Status of Commercialized Transgenic Crops, ISAAA Briefs n. 21, 24 and 30, Ithaca NY. For instance through the insertion of the genes derived from a bacterium, Bacillus thuringiensis (Bt), into crops, Bt-corn, Bt-cotton, Bt-potato, Bt-rice and Bt-tomato have been produced, in order to promote resistance to certain insects in these products. For what concerns herbicide, certain Glyphosate-tolerant soybeans (e.g. Roundup Ready ® by Monsanto) contain a gene that protects them from the herbicide glyphosate so that the fields can be sprayed with the herbicide, thus killing the weeds while leaving the soybeans standing.
16. On these issues see D. M. Strauss, 'The International regulation of Genetically Modified Organisms: Importing Caution Into the U.S. Food Supply', (2006) 61 Food and Drug Law Journal, 168.
17. Richard B. Stewart, The GMO Challenge to International Environmental Trade Regulation: Developing Country Perspectives (New York: unpublished, 2006) 5.
18. A complete report on risk and benefits from GMO has been produced by the World Health Organization: WHO, "Modern Food Biotechnology, Human Health and Development: An Evidence-Based Study", (Geneva: WHO, June 24, 2005), at http://www.who.int/foodsafety/pubblications/biotech/ biotech_en.pdf.
19. The scientific references hereinafter reported are also cited in EC-Biotech, First Submission of the US, April 21, 2004, 4-9, available at http://www.trade-environment.org/page/theme/tewto/ biotechcase.htm.
20. As a term of reference see also the very detailed analysis of R.B. Stewart, The GMO Challenge, cit., 8 ff.
21. "Modern biotechnology can significantly increase agricultural output by protecting plants from factors that reduce yields, such pests, diseases", Report of the National Academy of Medicine and National Academy of Pharmacology, How can genetic engineering contribute to the improvement of human health and food, and what are the obstacles to its application in this area?, 26 November 2002, 1.
22. "The power of genetic engineering to improve the nutritional quality of our food crop species is (...) immense", N.E. Bourlang, 'Ending World Hunger. The Promise of Biotechnology and the Threat of Antiscience' (2000) Zealotry, Plant Physiology, 487;
23. see also the "Golden Rice" case at M. McGloughlin, Why Safe and Effective Food Biotechnology is in the Public Interest, The Washington Legal Foundation Critical Legal Issues, Working Paper Series No. 99.
24. Washington, D.C., USA: The Washington Legal Foundation, 2000; against this view, on the same issue, see V. Shiva, Stolen Harvest: the Hijacking of the Global Food Supply (Research Foundation for Science, Technology and Ecology, 2000).
25. National Academy of Sciences, Transgenic Plants and World Agriculture, July 2000, 487.
26. D. B. Whitman, "Genetically Modified Foods: Harmful or Helpful?" (CSA, April 2000, unpaged), at http://www.csa.com/ discoveryguides/gmfood/overview.php.
27. Ibid.
28. "Champions of GMO technologies claim that, in addition to economic benefits, GMO technologies can provide a range of important social and health, environmental, and social benefits: boosting the ability of developing countries to feed undernourished and growing populations; enhancing small farmer incomes and rural economic development; providing consumers with more nutritious and safer foods (for example, by developing non-allergenic peanuts); preserving forests and biodiversity by enhancing agricultural productivity and thereby reducing the need for agricultural clearing" (see Reports by Council for Biotechnology Information; AgBio World, available at: www.agbioworld.com, (last visited 28 March 2007)); reducing the need for chemical pesticides and the associated risks to agricultural workers and non-target species; reducing fertilize use (for example, by enhancing more rapid crop rotation) and the ecological problems associated with nitrogen and phosphate runoff; and, enhancing carbon sequestration in soils by engineering crop varieties adapted to low-till farming", R.B. Stewart, The GMO Challenge, cit., 9.
29. Some of the references hereinafter reported are also cited in EC-Biotech, First Submission of the European Communities, Geneva, 17 May 2004, pp. 14-24, available at http://www.trade-environment.org/page/ theme/tewto/biotechcase.htm.
30. As a term of reference see also R.B. Stewart, The GMO Challenge, cit., 10 ff.
31. "Through genetic manipulation, plants which do not naturally contain toxins may become toxic or capable of inherent toxin production", R. M. Russel, "The vitamine A spectrum: from deficiency to toxicity" (2000) 71 American Journal of Clinical Nutrition, 878. For instance, in herbicides-resistant plants the new gene allows the plant to absorb more herbicide than a sensitive one, so that the residues of chemical products might be found in big quantities in food.
32. S. L. Hefle, J. A. Nordlee and S. L. Taylor, "Allergenic Foods" (1996) 36 Critical Review of Food Science and Nutrition. "More than 90% of food allergies occur in response to specific proteins in milk, eggs, wheat, fish, tree nuts, peanuts, soybeans, and shellfish (3). The risk for allergic reaction stems from a protein from one of these foods incorporated into a food that does not cause a known allergic reaction",
33. S. H. Dresbach, H. Flax, A. Sokolowski, J. Allred, "The Impact of Genetically Modified Organisms on Human Health" (2001) Family and Consumer Sciences, Ohio University 1, at http://ohioline.osu.edu.
34. For instance, in 1998 the Rowett Institute of Aberdeen, Scotland, released a research followed by a researcher, Arpad Pusztai: the administration of modified potatoes to rats had caused damages to the growth of the animals, affecting, in particular, the immune system. On this see http://www.global-reality.com/biotech/articles/ othernews013.htm.
35. "Foreign and transgenic DNA has been shown to persist in the stomach and intestine of animals after ingestion of GM products and can be taken up into the cells and nuclei of the receiving organism", R. Schubbert, U. Hohlweb, D. Renz, and W. Doerfler, "On the fate of food ingested foreign DNA in mice: chromosomical associations and placental transmission to the fetus" (1998) 259 Molecular and General Genetics. In addition anybody who eats the modified plant also eats the antibiotic-resitant DNA, which is the marker, used to check the result of the genetic modification. This new DNA is not absorbed by man, but can be incorporated by bacteria present in our organism, which might become resistant to antibiotics,
36. on this see M. Buiatti, Le biotechnologie (Bologna: Il Mulino, 2001), 81 e ss. Another example can be seen in the Glyphosate-tolerant soybeans quoted in footnote n. 9: although the plant does not absorb the herbicide, it goes into the soil, contaminating it. This might affect other plants, or find other vehicles to be absorbed by man.
37. "The critics argue that GMOs pose great uncertainties and potential for harm, because the expression of the inserted transgene may result in unexpected characteristics in the modified organism, and those characteristics in turn may interact in unexpected ways with the surrounding environment or consumer", R.B. Stewart, The GMO Challenge, cit., 10.
38. The inserted toxins could harm and kill insects which are not pests, damaging biodiversity. See A. Hillbeck et al., "Toxicity of Bacillus thuringiensis Cry 1 Ab Toxin to the Predator Chrysoperla carnea" (1998) 27 Environmental Entomology, 1255.
39. "The resistance-gene may outcross into other plants", FDA Talk Paper, FDA Action on Corn Bioengineered to Produce Pharmaceutical Material, U.S. Food and Drug Administration, T02-46, 19 Nov. 2002.
40. "The use of GM crops as opposed to conventional crops may lead to a change in agricultural and management practices. Such changes, based on the specific GM crop in question, may have adverse effects on the agro-ecological environment and biodiversity" EC-Biotech, First Submission of the European Communities, cit., 21.
41. The centre of origin of a species is an invaluable and irreplaceable source of genetic material for plant breeding and the genetic modification could harm it, ibid., 23-24.
42. "The principal contemporary concerns (regarding GMOs) may be placed in six general categories: (...) A) equitable concerns regarding the patenting of GM products (...); B) the level of transparency for exports of GM products (... ); C) import bans on GM products (...); D) liability for damage by GM products (...); E) liability for damage for extraterritorial damage by GM products (...); F) long-term decline in global biological diversity", S.D. Murphy, "Biotechnology and International Law", (2001) Harvard International Law Journal, 6-17;
43. According to some, the market restriction to GM products, while being a trade barrier potentially decreasing consumers' choices, might, on the contrary, increase their protection from the risk of a biotechnological monopoly, which would as well affect their freedom of choice. On the opposite, "critics argue that a widespread LMO technology in agriculture will benefit a few large multinational companies and allow them to establish a global cartel to the detriment of the world's consumers and farmers. An antitrust suit has already been filed on this ground in the US (B. Picket, et al. v. Monsanto Co., Case No 1:99)", T.J. Schoenbaum, "International Trade in LMOs: The New Regimes" (2000) International and Comparative Law Quarterly, 857.
44. Agriculture represents "a major source of income for the estimated 2.6 billion people who depend on agriculture for their livelihoods (FAOSTAT 2004)", World Resource Institute, "Millennium Ecosystem Assessment" (Washington D.C., 2005, 749) at http://www.wri.org/biodiv/Pubs_description.cfm?pid=3927.
45. In the biotech agriculture few species occupy the most of the cultivated fields of the world's surface. That is because they are so intensive that they need several thousands of hectares to be productive. In the developing Countries, instead, the agricultural system is mainly based on families, which dispose of small land, and on the diversity of the cultivations. In the latter, the main problem is in lack of cultivable land, which is always in the hands of few people. Introducing GM crops in those systems would thus not solve the problem of starvation and poverty, as it would not redistribute the land and it would deprive people of the advantages of biodiversity. On these issues see I. Verga, Per decidere il futuro, in G. Celli (ed.), I semi della discordia. Biotecnologie, agricoltura e ambiente (Milano: Ambiente, 2000) 71 ff.
46. For a divergent approach, citing the cultivation of GMOs in small farms, see R.B. Stewart, The GMO Challenge, cit., 8 ff.
47. Check C. Modonesi, S. Masini, I. Verga (eds), Il gene invadente. Riduzionismo, brevettabilità e governance dell'innovazione biotech (Consiglio dei Diritti Genetici, Roma: Baldini e Castoldi, 2006).
48. See R.B. Stewart, The GMO Challenge, cit., 8 ff, 16 ff. and 73 ff.
49. S. Chaturvedi - L. Chawii, Biosafety, Biosafety Protocol, International Trade and Agricultural Biotechnology: Policy Inferences for India, RIS woking paper, RIS-DP # 99, New Delhi, September 2005, 18.
50. M. K. McDonald, "International Trade Law and the U.S.-EU GMO Debate: Can Africa Weather This Storm?" (2004) 32 Georgia Journal of International & Comparative Law 501, 504, 522.
51. See, R.W. Herdt, "Biotechnology in Agriculture", (2006) 7 Annual Review of the Environment 18, 266 ff.
52. As the Africa - Europe Faith and Justice Network (AEFJN) notes: "Among other problems causing food insecurity and hunger in the world are: the structure of global food production, the increasing control of the food chain (from land to dish) by a handful of multinationals of the agro-food sector and problems with distribution. To address the problem of hunger in the world one needs to address structural problems at the global, regional, national and local levels of food production and distribution." AEFJN: "Statement on the Use of GMO Food and Seeds in Africa", 12 November 2004, at: http://aefjn.org/Documents/aefjn%20statement%20on%20gmo.doc, (last visited on March 28, 2006).
53. J.M. Migai Akech, "Developing Countries at Crossroads: Aid, Public Participation, and the Regulation of Trade in Genetically Modified Foods", (2006) Fordham International Law Journal, 270.
54. On the relationship between agricultural economy and environmental degradation in India see R.N. Chakraborty, " Linkages between Income Distribution and Environmental Degradation in Rural India, in S.T. Madsen (ed.), State, Society and the Environment in South Asia, (New Delhi: Nordic Institute of Asian Studies, 1999), 165 ff.
55. On these see A. Gupta, Governing Biosafety in India: The Relevance of the Cartagena Protocol, Belfer Center for Science and International Affairs (BCSIA), Discussion Paper 2000-24, Environment and Natural Resources Program, Kennedy School of Government, Harvard University, 2000, available at http://environment.harvard.edu/gea, pp. 18 - 19 and 27
56. and D. Bevilacqua, "The Precautionary Principle in GMO Regulations: a vertical and horizontal comparison", (2006) Poros project 2005-2007: Eu-India Economic Cross Cultural Programme, European Public Law Series, Vol. LXXXIV, 132 ff.
57. "The agricultural biotechnology industry has expanded in India in a major way. The number of agricultural firms engaged in the agricultural biotechnology sector has gone up from 85 in 2001 to 132 in 2003. There were in total 176 biotechnology firms in India, of which almost 48 per cent were agriculture based companies, 24% with an interest in health related medical activities and 28 per cent were with varied interests, including in environmental biotechnology. In 2003, the number of biotechnology firms was 401, with healthcare firms showing the largest increase, overtaking the number of agricultural biotechnology companies", S. Chaturvedi - L. Chawii, Biosafety Protocol, International Trade and Agricultural Biotechnology: Policy Inferences for India, RIS woking paper, RIS-DP # 99, New Delhi, September 2005, 13;
58. "Though India established the bio safety guidelines way back in 1989, till now no commercial trials of GM crops have been allowed", S. Chaturvedi, Status and Development of Biotechnology in India: An Analytical Overview, RIS working paper, RIS-DP # 28, New Delhi, September 2002, 31.
59. See also A. Gupta, Governing Biosafety, cit., 13-14.
60. The Agreement establishing the World Trade Organization was assigned at Marrakesch in 1994 and entered into force on 1 January 1995. Besides regulating the organisation it establishes the disciplines for all the sectors, contained in four Annexes. For more information, see http://www.wto.org/english/docs_e/legal_e/ legal_e.htm#wtoagreement.
61. The regulation focuses on the process through which the GM products are obtained, rather than on the final product and on its physical analogies with traditional ones.
62. "The focus is exclusively on the end product of GM technology, rather than on the fact that the process of genetic modification is used", E. Marden, "Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture", (2003) 44 Boston College Law Review, 734.
63. "Products developed through biotechnology processes do not per se pose risks to human health and the environment; risk depends instead on the characteristics and use of the individual products", Exercise of Federal Oversight Within Scope of Statutory Authority: Planned Introductions of Biotechnology Products into the Environment, 57 Fed. Reg. 6753 (proposed 27 February 1992), note 25, at 6760.
64. "As far as the system for assessing GMO risks is concerned, there are two separate and distinct blocks on the global level. The first, with the USA in the lead, is based on the concept of "familiarity" and of "substantive equivalence", considering the GMO equal to the organism that has been transformed, apart from what concerns the characteristic modified. Risk assessment is thus limited to analysis of the effects of the new characteristic. The second, most prevalent in Europe is based on a more prudent view of innovation in the agriculture/ food sector, assessing the individual GMOs on a case-by-case basis, taking into consideration how they were created, the results of the modification at the genomic level and the possible consequences of such modification", M. Lener, "The European Union and GMOs: Democracy, Participation and Information in Decision-Making Processes", Abstract in the International Workshop "The Frontier of Invisible: Biosciences, Quality of Information and Decision-Making Processes; GMOs, Famine and the Future; Biotechnological Innovation: from Governance to Government, Consiglio dei Diritti Genetici, Rome, November - December 2006, proceedings, 10.
65. On the comparison see also J.S. Applegate, "The Prometeus Principle: Using the Precautionary Principle to Harmonize the Regulation of Genetically Modified Organisms", (2001) Indiana University School of Law, Indiana Journal of Global Legal Studies, 209 ff.;
66. and R.B. Stewart, The GMO Challenge, cit., 12 ff.
67. S. D. Murphy, Biotechnology, cit., 2.
68. EC - Measures Affecting the Approval and Marketing of Biotech Products (WT/DS/291, 292, and 293), Reports of the Panel, Geneva, 29 September 2006 (hereinafter EC-Biotech) Available at http://www.wto.org/english/ news_e/ news06_e/291R_e.htm, §§ 4.748 ff., 7.147 ff.
69. According to S. Zarrilli, "International Trade in GMOs and Multilateral Negotiations: A New Dilemma for Developing Countries", in (2000) 5 UNCTAD/DITC/TNCD/1, 71 ff., "GMOs are not covered by the SPS if we consider the text of the Agreement, but they fall within its 'spirit'".
70. However the Panel excluded the defensive argument of the EU, holding that the European measures fell under the regulation of the SPS Agreement, see EC-Biotech, (WT/DS/291, 292, and 293), Reports of the Panel, Geneva, 29 September 2006, available at http://www.wto.org/english/news_e/news06_e/291R_e.htm, § 7.147 ff.
71. The Ad Hoc Task Force of the Codex will complete its work only in 2009. See footnote n. 5.
72. The phenomenon of globalization, mainly consisting in the development of common socio-economic views, rules, and tendencies around the world meant as a whole, has been followed by an evolving attempt to create a legal globalization, i.e. a shared global law binding individuals and authorities of the world: "we are witnessing the emergence of a 'global administrative space': a space in which the strict dichotomy between domestic and international has largely broken down, in which administrative functions are performed in often complex interplays between officials and institutions on different levels, and in which regulation may be highly effective despite its predominantly nonbinding form", N. Krisch and B. Kingsbury, "Introduction: Global Governance and Global Administrative Law in the International Legal Order", (2006) 17 European Journal of International Law, 1.
73. On this issue see also: E. Benvenisti, "Welfare and Democracy on a Global Level: The WTO as a case study", 04 November 2002, 1, file:/// c/puah/benvenisti _globalizationdemocracy.htm;
74. J. Ladeur, Public Governance in the Age of Globalization, Aldershot, 2004;
75. and http://www.iilj.org/publications/wp_globadminlaw.htm.
76. Following Niklas Luhman's theory of the social systems, on which see N. Luhman, Communication About the Law in Interaction Systems. Advances in Social Theory and Methodology (London: Routledge, 1981);
77. ID., "Operational Closure and Structural Coupling: The Differentiation of The Legal System" (1992) Cardozo Law Review, 13.
78. For an application of the Systemic theory on the legal issues of Trade and Environment see O. Perez, Ecological Sensitivity and Global Legal Pluralism: Rethinking the Trade and Environment Conflict (Oxford: Hart, 2004), 18 ff.
79. Under the regulation established by the Directive 90/220/EC and now by the Directive 2001/18/EC (together with Regulations 258/97/EC; 1829/ 2003; and 1830/2003, mainly related to food products).
80. This kind of genetic modified variety of corn is one of the most significant approbation of GMO in Europe. "B.t., or Bacillus thuringiensis, is a naturally occurring bacterium that produces crystal proteins that are lethal to insect larvae. B.t. crystal protein genes have been transferred into corn, enabling the corn to produce its own pesticides against insects such as the European corn borer. For two informative overviews of some of the techniques involved in creating GM foods, visit Biotech Basics (sponsored by Monsanto) http://www.biotechknowledge.monsanto.com/biotech/bbasics.nsf/ index or Techniques of Plant Biotechnology from the National Center for Biotechnology Education http://www.ncbe.reading.ac.uk/NCBE/GMFOOD/ techniques", D. B. Whitman, Genetically Modified, cit. unpaged.
81. EC-Biotech, n. 46 above.
82. "The US submits that the EC's adoption of the moratorium is inconsistent under the WTO Agreement (...). While members are allowed to maintain approval systems, the procedures under that system must be undertaken and completed without undue delay" EC-Biotech, First written submission by the USA, Geneva, April 21, 2004, 1; "Argentina is consistently not questioning the Community directives and regulations per se, but their implementation", EC-Biotech, First written submission of Argentina, Geneva, April 2004, § 195, available at http://www.trade-environment.org/Page/theme/ tewto/biotechcase.htm.
83. For instance the proceeding of Falcon oilseed rape (EC-62), of MS8/RF3 oilseed rape, of Bt 531 cotton (EC-65), of transgenic potato (EC-67), and so on. See EC-Biotech, n. 46 above, cit., § 7.1792 ff.
84. "The Panel emphasised that its report did not examine the safety of the biotech products and that it had not examined the legitimacy of current EC legislation", N. Bernasconi-Osterwalder and M. J. Oliva, "EC-Biotech: Overview and Analysis of the Panel's Interim Report" (Center for International Environmental Law (CIEL), March 2006, 5) at http://www.ciel.org/Publications/EC_Biotech_Mar06.pdf.
85. EC-Biotech, n. 46, above, § 7.1290. The European moratorium was not found in violation of substantive norms of the SPS Agreement (Arts 2.2, 2.3, 5.1, 5.2, 5.5, and 5.6 ), but it was considered unlawful under the procedural norm of Art 8 and Annex C(1)(a), requiring to complete the operational and approval procedures "without undue delay". The Panel thus questioned the inertial behaviour of the European institutions and of the Member States and it found it to integrate a violation of WTO law, through inaction and omissions.
86. EC-Biotech, n. 46, above, § 7.1466 ff.
87. It is to be born in mind that the obligations embodied by the provisions of the Marrakesch Agreements, which created the WTO framework of law, have demonstrated to possess an effective binding force for the member States, supported by the enforcement system of Arts 21-22 of the Dispute Settlement Understanding. If members do not conform to the decision of the Dispute Settlement Body (DSB) the winning Parties are entitled, in accordance with Arts 21 and 22 of the DSU, to apply tariffs or trade barriers, which are normally prohibited by the general provisions, in order to obtain a restoration for the loss, due to the market restriction of the losing Parties. As the States which ratified the WTO Agreement in 1995 agreed on following the objective of the free market in order to favour general wealth and to gain economic advantages, they are factually compelled to obey DSB's decision or they would nullify those advantages. More significantly national authorities are constrained by international law also for what concerns their internal and secondary level policy as far as it might produce trade-restrictive effects towards foreign producers and traders. So that the law is supported by an authoritative enforcement and therefore it can be seen as properly effective, as "a wish conceived by one and expressed or intimated to another with an evil to be inflicted and incurred in case the wish be disregarded", J. Austin, The Province of Jurisprudence Determined, in W. E. Rumble (ed.), Cambridge Texts in the History of Political Thought (New York: Vassar College, 1995), 24.
88. The described model consists of an enforcing mechanism, which, although based on retaliation, has much stronger effect than the obligations required by Art. 26 and Art. 27 of the Vienna Convention on the Law of Treaties, which inevitably rely on States' "good faith" and on their sovereignty. Finally we can assume that the main lack of international law, indicated by Max Weber (The Theory of Social and Economic Organization, translated by A.M. Hendersson and T Parsons, Oxford, Oxford University Press, 1947, p. 128) as a "legal authority above the state capable of enforcing it" seems to have been adequately compensated.
89. For instance this was invoked, by the EC, in order to justify its delay in the authorization procedure. In that case, however, the Panel excluded its application, assessing that the precautionary principle should have been applied to a concrete and definitive measure and not to a procedural iter as the EU asserted, using it as a justification to the de facto moratoria, EC-Biotech, Interim Report of the Panel, Geneva, 7 February 2006, § 7.1505 ff.
90. On this issue see S. Poli, "The EC and the Adoption of International Food Standards within the Codex Alimentarius Commission", (2004) 10 European Law Journal 5, 616;
91. A. Herwig, Transnational Governance Regimes for Food derived from Bio-Technology and their Legitimacy, in C. Joerges, I. J. Sand and G. Teubner (ed.), Transnational Governance and Constitutionalism (Oxford and Portland Oregon: Hart, 2004), 210 ff..;
92. D. Bevilacqua, "The Codex Alimentarius Commission and its Influence on European and National Food Policy (2006) 1 European Food and Feed Law Review, 3 ff.;
93. ID,"The Codex Alimentarius Commission: increasing accountability
94. "The SPS Agreement is the only WTO instrument that imposes on WTO members the obligation to base their measures on scientific evidence, regardless of whether the measures are discriminatory or violations of other basic provisions of GATT. This extra obligation in fact imposes a higher justificatory burden on all WTO member states wishing to protect themselves from GMOs and the same time makes it easier for potential complaining parties to challenge them", R. Howse - P. Mavroidis, "Europe's evolving regulatory strategy for GMOs - The Issue of Consistency with WTO Law: of Kine and Brine", (2000) 24 Fordham International Law Journal 317, 4-5 (also available at http://www.worldtradelaw.net/articles/howsemavroidisgmos.pdf). According to the described mechanism, in the disputes among WTO members, the DSB does not consider the logical reasonability, the logical proportionality or the internal legitimacy of a Country's decision, but only the affordability of the scientific reports on which it bases it.
95. The trade-oriented approach of the SPS Agreement has a considerable spill-over on fundamental rights, such as health or food safety, which have been considered merely as "interest(s) worth protecting. Food safety is a fundamental right that is clearly derived from other fundamental rights such as right to life, human dignity, the right to health protection and the right of consumers to protection", M.A. Recuerda Girela, "Law and Obesity" (2006) 4 European Food and Feed Law Review, 114-115.
96. "When states have consented to delegate some of their sovereign power to the WTO to act in the domain of international trade, the consent has, in fact, spilled over to a far wider range of social concerns, such as health and safety issues", P.M. Gerhart, "The two constitutional visions of the World Trade Organization" (2003) 20 University of Pennsylvania Journal of International Economic Law 101, 3.
97. "Among the most common critiques of globalization is that it increasingly constrains the ability of democratic communities to make unfettered choices about policies that affect the fundamental welfare of their citizens, including those of health and safety, the environment, and consumer protection. Traditionally, free trade rules were about constraining border measures such as tariffs and quantitative restrictions on imports. Increasingly, however, such rules include requirements and constraints addressed directly to domestic regulation", R. Howse, "Democracy, Science, and Free Trade: Risk Regulation on Trial at the World Trade Organization", (2000) 7 Michigan Law Review 98, 2329.
98. The demonstration of a scientific relationship between a risk assessment and an adopted measure, as requested by the AB in its precedent legal doctrine, is a very high burden to be proven when national and environmental provisions are part of prudent and long-period oriented policies. On the opposite, it seems easier to bring a case, on the accusation that a health measure is restricting trade, as it is based on a self-proving factual evidence.
99. A. Stirling, "On Science and Precaution in the Management of Technological Risk", SPRU University of Sussex, European Science and Technology Observatory, European Commission - JRC, Institute Prospective Technological Studies, EUR 19056/EN/2, Seville 2001, 9.
100. In EC-Hormones (Appellate Body Report, EC - Measures Concerning Meat and Meat Products (1998), WTO Appellate Body 1998, WT/DS 48/AB/R, available at http://www.wto.org/english/tratop_e/dispu_e/ dispu_subjects_index_e.htm (hereinafter EC-Hormones)), at §§ 124-125, the Appellate Body admitted the inclusion of the precautionary principle into the SPS Agreement, although not explicitly recalled by the Treaty, but excluded the application of the principle at the case at issue, stating that it could not override the science-based risk assessment of Art 5.1: "The precautionary principle indeed finds reflection in Article 5.7 of the SPS Agreement.
101. We agree, at the same time, with the European Communities, that there is no need to assume that Article 5.7 exhausts the relevance of a precautionary principle. It is reflected also in the sixth paragraph of the preamble and in Article 3.3. These explicitly recognize the right of Members to establish their own appropriate level of sanitary protection, which level may be higher (i.e. more cautious) than that implied in existing international standards, guidelines and recommendations. Thirdly, a panel charged with determining, for instance, whether "sufficient scientific evidence" exists to warrant the maintenance by a Member of a particular SPS measure may, of course, and should, bear in mind that responsible, representative governments commonly act from perspectives of prudence and precaution where risks of irreversible, e.g. life-terminating, damage to human health are concerned. Lastly, however, the precautionary principle does not, by itself, and without a clear textual directive to that effect, relieve a panel from the duty of applying the normal (i.e. customary international law) principles of treaty interpretation in reading the provisions of the SPS Agreement. 125. We accordingly agree with the finding of the Panel that the precautionary principle does not override the provisions of Articles 5.1 and 5.2 of the SPS Agreement". On this see also R. D. Thomas, "Where's the Beet? Mad Cows and the Blight of the SPS Agreement" (1999) 32 Vanderbilt Journal of Transnational Law, 4: "footnote 2, of Art 3.3, defines 'scientific justification' as being based on 'an examination and evaluation of available scientific information'. This definition seemingly endorses an implied precautionary approach as it does not require 'conclusive' scientific justification for a particular measure, but only a risk assessment based upon current science".
102. The most problematic element regards "the interpretation of the term available pertinent information (...). [P]erhaps the cornerstone of the whole article: since it is by definition less authoritative than scientific evidence, we need to know how much less is necessary for the precautionary principle to be invoked in the first place", R. Howse and P. C. Mavroidis, Europe's evolving, cit., 16.
103. Appellate Body Report, Japan - Measures affecting the Importation of Apples, WT/DS45/AB/R, 10 December 2003, available at http://www.wto.org/english/tratop_e/dispu_e/ dispu_subjects_index_e.htm (hereinafter Japan - Apples).
104. Ibid., § 1-79.
105. Ibid., § 184.
106. "We use the term uncertainty, if we mean the general inability to make reliable predictions of events of damages (comp. Bonß, 1996). Uncertainty is a fundamental characteristic of risk, whereas the certainty of assessment varies between extremely high and extremely low. Even if it is not possible to make objective predictions about single events of damage on the basis of risk assessment, results of the assessment are not arbitrary", A. Stirling, On Science and Precaution, cit., 12.
107. On this dichotomy Richard B. Stewart presents four conceptions of the precautionary principle, two belonging to a strong version of the principle, and the other ones to a soft conception: 1) "scientific uncertainty should not automatically preclude regulation of activities that pose a potential risk of significant harm (...); 2) regulatory controls should incorporate a margin of safety, activities should be limited below the level at which non adverse affect has been observed or predicted (...); 3) activities that present an uncertain potential for significant harm should be subject to best technology available requirements to minimize the risk of harm, unless the proponent of the activity shows that they present no appreciable risk of harm (...); 4) activities that present an uncertain potential for significant harm should be prohibited, unless the proponent of the activity shows that they present no appreciable risk of harm", R. B. Stewart, "Environmental Regulatory Decision Making under Uncertainty", in Research in Law and Economics, vol. 20, An Introduction to the Law and Economics of Environmental Policy: Issues in Institutional Design, ed. by Swanson, 2002, UK, 76.
108. "The core purpose of the precautionary principle is the management of uncertainty" J. Applegate, The Prometheus, cit., 20; "the precautionary principle is the natural child of the uncertain union between law and science", B Mathieu, "Le future du principe de precaution" (2001) 45 La semaine juridique, 2025.
109. Consult also Commission of the European Union, Communication on the precautionary principle, Brussels, 02.02.2000, COM (1) 2000, 3 ff.; " Uncertainty is an essential component of the precautionary principle", in EC-Biotech, Amicus Curiae, cit., 18.
110. In the Environmental Declaration of Rio de Janeiro, at Art 15, there is a clear phrase: "lack of certainty". Par. 9 Cartagena Convention on Biosafety states: "...where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty..." and this view has been kept also for the CBP: "Lack of scientific certainty...", Art 10. On the issue check also F. De Leonardis, Il principio di precauzione nell'amministrazione di rischio, (Milano: Giuffrè, 2005) 3 ff..;
111. F. Bruno, Principio di precauzione e organismi geneticamente modificati, in Rivista di diritto agrario, 2000, III, 223;
112. J. Tickner, C. Raffensperger, and N. Myers, The precautionary principle in action. A handbook, First Edition (Science and Environmental Health Network, 2005), 2 ff.;
113. P. Harremoes & oth., The Precautionary principle in the 20th Century. Late lessons from Early Warnings (London: Earthscan, 2002), 3 ff.;
114. T. O'Riordan, J. Cameron, A. Jordan, Reinterpreting the precautionary Principle (London: Cameron May, 2001), 10 ff.
115. The interpretation of the AB in Japan - Apples excludes the concept of uncertainty and quantifies insufficiency by limiting the impossibility of risk assessment to the evaluation of a likeable risk. In doing so, it excludes all the cases in which the uncertainty about the likelihood itself is related to the inadequacy of science to guarantee a minimum amount of safety; and, more generally, the ones in which a risk assessment is still possible while being not yet objectively reliable as univocal. An opposite (to the one of the AB) view can be found in Howse and Mavroidis, Europe's evolving, cit., 362, where the two authors point out that "the only threshold for scientific certainty required by the SPS is the threshold of not being maintained without 'sufficient scientific evidence' contained in SPS Art 2.2. Therefore national regulators are able to act to adopt a cautious approach towards serious harm even where a risk assessment is uncertain so long as the uncertainty was based on sufficient scientific evidence and further examination was unwarranted".
116. A. Stirling, On Science and Precaution, cit., 21.
117. On these issues see ibid., 15.
118. The issue of uncertainty, as appears evident, is highly controversial. There is a hypothetical possibility to find uncertainty over every kind of products and this might be aberrant as well as dangerous for the development of free trade. However, the rationale of Art. 5.7 is that of an exemption to the general rule of Art. 2.2, giving a qualified right to the members of the WTO to temporary neglect the access of products for which the assessment is so vague and undetermined to produce a double-sensed uncertainty: the cited article might cover situations in which risk is only possible, but also safety is not only unproven, but also nonprobable, as far as it stays among an open range of theoretical possibilities. In such combination of events, according to the words of the mentioned provision, States would be entitled to temporary close their markets, as a right to demand more accurate demonstration, at least in order to provide "a more objective assessment of risk" (Art. 5.7, SPS Agreement) and so demonstrate an adequate, thus sufficient, amount of results to justify one of the alternatives: safety- or risk-probability.
119. According to such orientation, if scientific reports are uncertain about the effect of a product, there is enough to have scientific uncertainty and therefore to claim the insufficiency of demonstration to exclude a risk: "scientific uncertainty can itself reflect risk. Risk is measured not only by positive knowledge of a quantifiable likelihood, but also by the degree of uncertainty or lack of knowledge about a possible hazard (...). Within that zone, the risk of harm is real so long as safety is unproven", V. R. Walter, "Keeping the WTO from becoming the World Trans-Science Organisation: scientific uncertainty, Science Policy and Fact-finding in the Growth Hormones Dispute" (1998) 2 Cornell International Law Journal 31, 305.
120. The proportionality principle of Art 5.6 SPS would have the effect to limit member states' precaution to a reasonable level, entailing the DSB to perform a control limited to the reasonability and proportionality of the decision: "for purposes of paragraph 6 of Article 5, a measure is not more trade-restrictive than required unless there is another measure, reasonably available taking into account technical and economic feasibility, that achieves the appropriate level of sanitary or phytosanitary protection and is significantly less restrictive to trade", Note 3, Art 5.6, SPS Agreement.
121. In this sense also Richard B. Stewart, who, whilst criticizing the strong versions of the precautionary principle agrees that "where the risk of harms and/or regulatory costs are uncertain, decisions and societal welfare can be improved by reducing uncertainty through the development of new information. The additional information can help ensure that regulatory decisions are made on the basis of more accurate estimations of costs and benefits, which will in turn make it more likely that such decisions will enhance social welfare", R. B. Stewart, Environmental Regulatory Decision Making, cit., 106.
122. In the Biotech case the EC and the experts who delivered the Amicus Curiae Brief to the Panel considered the first sentence of Art. 5.7 as implying the possibility to invoke the precautionary principle on the base of scientific uncertainty upon a possible risk. About the words of Art. 5.7, the Amicus Curiae stresses that even if that provision does not recall scientific uncertainty, it relies on insufficient scientific evidence to provide a risk assessment (EC-Biotech, Amicus Curiae Brief, cit., 15). This reasoning finds confirmation in the fact that the article provides for a measure adopted "on the basis of available pertinent information". It is implicit thus that if the available information consists of data that state a theoretical possibility of risks brought by certain products, which cannot be considered safe with sufficient certainty, the measure at issue falls under the words of Art. 5.7.
123. EC-Biotech, n. 46, above, § 7.2986 ff. Annex A defines the procedure of risk assessment as "the evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of a Member State". The mentioned interpretation of Art. 5.7 follows the previous ruling of the AB in Japan-Apples (n. 67, above) and, as noted before, it takes for granted the likelihood of risk as a base for precaution, while excluding its possibility due to scientific uncertainty.
124. lbid., § 7.3056.
125. In the Biotech case the Panel did not need to specify much, as, for what concerns the national bans, they were exceptions to a positive risk assessment performed by the Community.
126. The AB has repeatedly affirmed the insufficiency of a precautions risk management act not supported by an adequate risk assessment to justify a SPS measure, see footnote 65.
127. Japan - Apples, n. 67, above, § 182.
128. EC-Biotech, n. 46, above, § 7.3226.
129. "Further the use of harmonized sanitary and phytosanitary measures between Members, (...), without requiring Members to change their appropriate level of protection of human, animal or plant fife or health" (Preamble); "Members shall accept the sanitary or phytosanitary measures of other Members as equivalent, even if these measures differ from their own or from those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member's appropriate level of sanitary or phytosanitary protection" (emphasis added) (Art 4, Equivalence).
130. "As language such as 'based on' and 'take into account' suggests, the SPS Agreement brings science in as one necessary component of the regulatory process, without making it decisive. Thus 'sufficient scientific evidence' arguably refers to the evidence that is needed if science is to play this democratic role in risk regulation, not to some threshold of scientific proof or certainty below which democratic judgements about risk are illegitimate", R. Howse, Democracy, cit., 2336.
131. "When there are reasonable grounds for concern that potential hazards may affect the environment or human animal or plant health, and when at the same time the available scientific and technological data preclude a detailed risk evaluation, the precautionary principle has been politically accepted as a risk management strategy in several fields", Commission of the European Union, Communication, cit., 9.
132. The precautionary principle is triggered by uncertainty, which implies the possibility of risk, whilst the preventive one consists of a prudent measure based on a risk which is at least probable. On this see D. Bevilacqua, "The EC-Biotech Case: Global v. Domestic Procedural Rules in Risk Regulation: The Precautionary Principle", (2006) 6 European Food and Feed Law Review, 333 and 337-340.
133. As concerns customary law, the Panel refused the European reasoning, noting the lack of demonstration of such assertion and motivating its reasoning by affirming that there was no evidence of a common opinio juris and of a common legal practice of the principle at stake: "the European Communities has not explained exactly what it means by the term 'general principle of international law'. We note that this term may be understood as encompassing either rules of customary law or the recognized general principles of law or both. Given this, we are prepared to consider whether the precautionary principle fits within either of these categories. This approach is consistent with the position taken by the European Communities in EC - Hormones where the European Communities contended on appeal that the precautionary principle was a general customary rule of international law or at least a general principle of law", EC-Biotech, n. 46, above, § 7.86 ff.
134. EC-Biotech, First written submission of the European Communities, cit., § 457.
135. The Parties (among which all the three complaining Parties of the Biotech dispute) which signed the Convention on Biological Diversity in 1993, adopted, after long and difficult negotiations, the Cartagena Protocol on Bio-safety in 2000 (103 signatories including Canada and Argentina, as at July 2005 the Countries are 122). The Protocol, which entered into force on 11 September 2003, without Canada's and Argentina's ratifications, addresses the safe transfer, handling and use of living modified organisms that may have adverse effect on biodiversity.
136. Article 1, CBP: "Objective: in accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on trans-boundary movements".
137. EC-Biotech, n. 46, above, § 4.330 ff.
138. "The European Communities would like to stress the importance of international regulatory acts in the field, in particular the Cartagena Biosafety Protocol. According to the Appellate Body, the rules of customary law "call for an examination of the ordinary meaning of the words of a treaty, read in their context, and in the light of the object and purpose of the treaty involved". The Biosafety Protocol can assist the Panel in the process of interpreting WTO rules, in accordance with the Appellate Body findings in US - Shrimp", ibid., § 4.358.
139. The Convention was adopted on 22 May 1969 and opened for signature on 23 May 1969 by the United Nations Conference on the Law of Treaties. The Conference was convened pursuant to General Assembly resolutions 2166 (XXI) of 5 December 1966 and 2287 (XXII) of 6 December 1967. The Conference held two sessions, both at the Neue Hofburg in Vienna, the first session from 26 March to 24 May 1968 and the second session from 9 April to 22 May 1969. In addition to the Convention, the Conference adopted the Final Act and certain declarations and resolutions, which are annexed to that Act. Entry into force on 27 January 1980, in accordance with Article 84(1). Official Publication in United Nations, Treaty Series, vol. 1155, 331.
140. United States - Standards for Reformulated and Conventional Gasoline, Appellate Body Report, WT/DS2/AB/ R, 1996, available at http://www.wto.org/english/tratop_e/dispu_e/ dispu_subjects_index_e.htm, 621.
141. The Convention is an international Agreement, which was signed in June 1992, and entered into force in December 1993. It counts 188 members, and established and prepared the preparation and ratification of the CBP.
142. In Europe, where the precautionary approach has reached the highest level of implementation, it is interpreted as a principle of action which entitles competent authorities to act prudently only after the scientific test has proven unsatisfying and in combination with proportionality and reasonability. Such interpretation seems to be confirmed into institutional Reports ("The decision to act or not to act, based on the precautionary principle, is essentially a problem of political interpretation", European Parliament Resolution on the Communication on the precautionary principle, A5-0352/2000), and by the recent legal doctrine: "the precautionary principle represents ... a principle of action in cases where a risk may eventually emerge", Case C-236/01, Monsanto, Opinion of AG S. Alber, 2003, pt. 108; "in so far as there are uncertainties in the present state of scientific research with regard to the harmfulness of a certain additive, it is for the Member States, in the absence of full harmonisation, to decide what degree of protection of the health and life of humans they intend to assure, in light of the specific eating habits of their own population", Case 174/82, Sandoz BV [1983] ECR 1-2211, § 16. Finally also the legal science convened on this soft conception of the principle: "The principle's essential purpose is to scientifically frame a decision-making procedure. In no instance does it determine the decision itself. (...). Advocate General Mischo makes clear (...) that the distinction made between evaluation of and dealing with risk fulfils a double requirement: 'on one hand to introduce science into the policy, and on the other, that of maintaining the autonomy of the policy with regard to the science'", J. Cazala, "Food Safety and the Precautionary Principle: The Legitimate Moderation of Community Courts", (2004) 5 European Law Journal 10, 545;
143. "the decision about whether matters have gone beyond the acceptable level of risk must be based on as thorough a scientific risk assessment as possible. It is on that same basis that the competent authority must also decide, as part of 'risk management', whether preventive measures are called for and which measures appear to be necessary and appropriate to prevent the risk from materializing", J. L. da Cruz Vilaça, "The Precautionary Principle in EC Law", (2004) 2 European Public Law 10, 387.
144. See Arts 1 and 10(6) of the Bio-safety Protocol.
145. On the relationship between the two agreements see B. Eggers and R. Mackenzie, "The Cartagena Protocol on Biosafety (2000) 3 Journal of International Economic Law 3, 542;
146. see also N. Bernasconi-Osterwalder, The Cartagena Protocol on Biosafety: a multilateral approach to regulate GMOs, in E. Brown Weiss and J. H. Jackson (eds.), Reconciling Environment and Trade (Ardsley, N.Y.: Transnational Publishers, 2001), 716-719;
147. R. A. Neff, "The Cartagena Protocol and the WTO: Will the EU Biotech Products Case leave Room for the Protocol?" (2005) 3 Fordham Environmental Law Journal 16.
148. P. Malanczuk, Modern Introduction to International Law, 7th edn (London - New York: Routledge, 1997), 49 and 56.
149. "When a treaty specifies that it is subject to, or that it is not to be considered as incompatible with, an earlier or later treaty, the provisions of that other treaty prevail. 3. When all the parties to the earlier treaty are parties also to the later treaty but the earlier treaty is not terminated or suspended in operation under article 59, the earlier treaty applies only to the extent that its provisions are compatible with those of the latter treaty. 4. When the parties to the later treaty do not include all the parties to the earlier one: (a) as between States parties to both treaties the same rule applies as in paragraph 3; (b) as between a State party to both treaties and a State party to only one of the treaties, the treaty to which both States are parties governs their mutual rights and obligations" On the issue see W. Karl, Treaties, Conflicts between, in R. Bernhardt (ed.), Encyclopedia of Public International Law, vol. 7 (1984), IV, 935 ff.
150. "The special norm is the more effective or precise norm, allowing for fewer exceptions and because of this, the special norm reflects most closely, precisely and/or strongly the consent or expression of will of the states in question", J. Pauwuelyn et al., Conflict of Norms in Public International Law. How WTO Law relates to Other Rules International Law (Cambridge: Cambridge University Press, 2003), 387.
151. On "lex specialis" and fragmentation of international law see also M. Koskenniemi, Fragmentation Of International Law, cit., 34 ff.
152. The issue of temporality of the measure, for instance, is instead out of question, as the CBP allows a permanent precautionary approach and the SPS only a provisionary one. Therefore, over such issue the two texts are incompatible.
153. The Convention on Biological Diversity entered into force on 29 December 1993.
154. "The mere fact that the United States has signed the Convention on Biological Diversity does not mean that the Convention is applicable to it. [... [ [I]f a rule of international law is not applicable to one of the Parties to this dispute, it is not applicable in the relations between all WTO Members", EC-Biotech, n. 46, above, § 7.74.
155. Ibid., § 7.74, footnote 251.
156. Ibid., §§ 7.67-7.68.
157. Ibid., § 7.94.
158. The European Communities refers to the Preamble and Art. 8(g) of the Convention on Biological Diversity and Arts 1, 8, 10, 11, 15, 23, 26 and Annex III of the Biosafety Protocol.
159. EC - Biotech, n. 46, above, § 7.95.
160. "Bearing in mind the unlikeliness of a precise congruence in the membership of most important multilateral conventions, it would become unlikely that any use of conventional international law could be made in the interpretation of such conventions. This would have the ironic effect that the more the membership of a multilateral treaty such as the WTO covered agreements expanded, the more those treaties would be cut off from the rest of international law. (...). This approach would maintain the "generality" of at least some multilateral treaties. But it would have an inappropriately restrictive effect in two situations: (a) It could preclude reference to treaties which have very wide acceptance in the international community (including by the disputing States) but which are nevertheless not universally ratified and which are not accepted in all respects as stating customary international law (such as UNCLOS); (b) It could also preclude reference to treaties which represent the most important elaboration of the content of international law on a specialist subject matter, on the basis that they have not been ratified by all the parties to the treaty under interpretation", M. Koskenniemi, "Fragmentation Of International Law", cit., 237-238.
161. M.J. Trebilcock and R, Howse, The Regulation of International Trade, 2nd edn (London & New York: Routledge, 2002), 75.
162. The precautionary principle is enforced by many states ("at the domestic level it informs environmental policy and law in Australia, Germany, the UK, the USA, the EU and certain other states", P. Byrnie and A. Boyle, International Law and the Environment, 2nd edn (Oxford: Oxford University Press, 2002), 118) and it is included in a large number of international agreements (Preamble to the 1985 Vienna Convention; Preamble to the 1987 Montreal Protocol; Preamble to the Ministerial Declaration of the International Conference on the Protection of the North Sea; Art. 4 (3) (f) of the Bamako Convention; Art. 2 (5) (a) of the 1992 Biodiversity Convention; The 2000 Biosafety Protocol); "There is certainly sufficient evidence of state practice to support the conclusion that the principle (...) has now received sufficiently broad support to allow a strong argument to be made that it reflects a principle of customary law, and that within the context of the European Union it has now achieved customary status, without prejudice to the precise consequences of its application in any given case",
163. P. Sands, Principles of International Environmental Law, 2nd edn (Cambridge: Cambridge University Press, 2003), 279.
164. European Communities - Measures Affecting Asbestos and Asbestos-Containing Products, WT/DS135/AB/R (AB-2000-11), Appellate Body Report, 68 and 70.
165. In the case at issue it must be held that while the two risk assessment procedures are different (the CBP implies a precautionary approach and includes risk management), the precautionary approach of Art. 10.6 CBP ("Lack of scientific certainty due to insufficient relevant scientific information and knowledge") is very similar to the provision held in article 5.7 SPS Agreement ("relevant scientific evidence is insufficient ... on the basis of available pertinent information"), with the only difference that the latter measure must be provisory, while the former can be permanent. In addition "the Biosafety protocol could be a relevant international organization within the meaning of Article 5.7 of the SPS Agreement", B Eggers and R. Mackenzie, "The Cartagena Protocol", cit., p. 542;
166. check also N. Bernasconi-Osterwalder, "The Cartagena Protocol", cit., 716-719.
167. It does not cause "a change in the rights and obligations of a Party under any existing international agreements" and it does not "subordinate this Protocol to other international agreements".
168. It is well known that that European integration and the evolution of the European Law is due to the constructive job of the judges of the ECJ. On this issue see, in particular, T.C. Hartley, Constitutional Problems of the European Union (Oxford and Portland, Oregon: Hart, 1999), 22 - 66.
169. At the same time it is also agreed that in the US the judicial bodies have continuously shaped and developed traditional administrative law, as well as its reformations, so that, for instance, "judges have greatly extended the machinery of the traditional model to protect new classes of interests", R. B. Stewart, "The Reformation of American Administrative Law" (1975) 8 Harvard Law Review 88, 1670.
170. In such cases as the one recalled the judge makes a decision according to the applicable law, rather than to its jurisdiction: judges exploit this difference to all the non incompatible international laws. On this see S. Cassese, "La funzione costituzionale dei giudici non statali. Dallo spazio giuridico globale all'ordine giuridico globale" (Lecture helld by the French Cour de Cassation, Paris, unpublished, 11 June 2007, 25-26) at http://www.irpa.eu.
171. According to some commentators, by the description of the main provisions and objectives of the CBP, it appears to be in conflict with some WTO ones: "they answer to rather different logic: to facilitate trade on one hand, and, on the other, to make it safe, if necessary by restricting it" (Boisson de Chazournes and M. M. Mbengue, "GMOs and Trade: Issues at Stake in the EC Biotech Dispute", (2004) 3 Review of European Community & International Environmental Law 13, 298).
172. However, this is not completely correct. The Preamble of WTO includes, among the general objectives of the organization, the "optimal use of the world's resources in accordance with the objective of sustainable development" and the protection of the environment. And besides that, the general purpose of WTO law is to spread and develop economic welfare around the world, not to protect trade per se. "Trade is not a value, it is only an instrument...to increase the economic welfare of all states" (J. Pauwuelyn, "Conflict of Norms in Public International Law" (2004) 3 Nordic Journal of International Law 73, 88). The aim and the rationale to have the WTO is to find a balance between the different interests at stake and even if the law of the organization is above all trade-related and - oriented it must aim at a fair and effective trade. In order to reach this last objective in particular, the WTO institutions should take in consideration the evolution of general international law, the environmental and social limits, and the effects they could have on trade. That is why the DSB needs, as the applier of an abstract framework of rules, to find a balance "between fixed textual understanding (positivism) on the one hand, and predetermined functional objectives (naturalism) on the other", M. Koskenniemi, "Constitutionalism", cit., 12.
173. For the way the WTO is conceived it would be difficult to demonstrate that certain values are constitutionally superior to others, like it happens internally in the individual states or in the EU ("In trade disputes dealing with environmental or public health issues, the WTO's one-dimensional quality - in contrast to the EU's multi-dimensional approach - is painfully apparent", S. Dillon, International Trade and Economic Law and the EU (Oxford - Portland: Hart, 2002), 119). In most of the members of WTO health protections is considered as a fundamental right and as a value that must be protected by the state. It cannot be said the same for what concerns trade. However, at the international level the situation is different. The lack of harmonization in fields like the protection of the environment or health has the consequence to put these values in a weaker position towards the most harmonized sector of trade, so that in case of contrast between the two interests, trade will prevail. Nonetheless the WTO Preamble does exclusively refer to trade, which is a means, rather than a value, in order to reach general welfare, but also to sustainable development, which is one of the general objectives of the organization: "optimal use of the world's resources in accordance with the objective of sustainable development".
174. Considering the DSB as an adjudicative organ with a constitutional nature and the Marrakech Agreements as the text of reference it is to stress on what kind of interpretation the former should have towards the latter after more than ten years and with so many factual and legal evolutions surrounding it. In the legal sciences there are at least two literatures concerning constitutional interpretation. One states that a constitutional text should be interpreted in accordance to the original meaning at the moment of entry into force (on this, see for instance A. Scalia, A Theory of Constitution Interpretation, speech held on the 18th of October 1996 by the Catholic University of America, Washington D.C., available at www.courttv.com). In that perspective it is denied that the interpretation of the Constitution by lawyers and legal scientists should follow the evolution of society, a duty which should be left, instead, to the legislature, also in regard of the constitutional reforms. A different doctrine recognizes, particularly to the constitutional court, an active role of constitutional and systemic revision and reinterpretation, based on its technical and cultural legitimacy and on its function of guaranty of pluralism. Therefore, such doctrine emphasizes the evolutionary character of constitutional interpretation, in virtue of the continuous change of society (See, e.g., P. Häberle, Stato costituzionale, in Enc. Giur., XXX, Roma, 2000: "sistemi costituzionali variano e i loro equilibri interni si ricompongono continuamente proprio per opera di fattori esterni rispetto alla logica dei singoli sistemi": "il giurista che consideri realisticamente i rapporti tra diritto costituzionale e società sarà portato a considerare il mutamento dell'idea di costituzione muovendo dall'esame dei dati reali, dei conflitti tra interessi e visioni del mondo"; thus the principles of a legal order cannot be crystallized one time for all, but are alway open to new proposals of innovation).
175. The fragmentation of the GMO regulatory framework results inadequate to provide a proper and effective global regulation of the matter. This happens either for what concerns environmental issues (until countries as USA, Canada and Argentina do not ratify the CBP, it will be more difficult to prevent eventual risks due to genetically engineered products), or for what concerns trade and economic issues (WTO law seems inadequate to face a trade-restrictive regulation of GMOs, so that it is difficult to promote the wide spread of safe biotechnological products). This breach, which involves either developed or developing Countries, also reflects the discrepancy between biodiversity and biotechnology.
176. The European legislation on GMOs, based on precaution and compulsory labeling might be overcome by the American regime, informed by substantial equivalence, and vice versa.
177. An interesting example of this trend can be found in US environmental and health regulations, where, with some peculiar and famous difference from the EU, a precautionary approach is getting more and more frequent in several sectors. For a detailed analysis of those see J. B. Wiener, "Whose Precaution After All? A comment on the Comparison and Evolution of Risk Regulatory Systems", (2003) 13 Duke Journal of Comparative & International Law, 227 ff.
178. Here impartiality is considered in conjunction with the principle of good administration and as a criterion to perform the general interest rather than maintain in balance private or corporate conflicting interests. This means, interalia, that when the public administrations are called to issue a decision, they are required not only to avoid any sort of privilege or favoritism, but also to balance all the interests involved, to consider the main purpose of the act they are required to issue and to choose for the most effective, economic and fair solution. The principle at stake implies a discretional evaluation made by the competent authorities. This is thus not arbitrary, but it is limited by the rule of law and by a reasoned motivation which the administration is compelled to provide.
179. P. Guggenheim, Traite de Droit International Public, Geneva, 1967, 1.
180. "It is widely asserted, often with reason, that global regulatory bodies disregard or give inadequate consideration to a range of important social, economic, cultural environmental and values (... social interests) impacted by their decisions", R.B. Stewart, "Accountability and the Discontents of Globalization: US and EU Models for Regulatory Governance", Discussion Draft, Viterbo II GAL Seminar, June 9-10, 2006, 4.
181. N. Perdikis, W.A. Kenand, and J.E. Hobbs, "Reforming the WTO to defuse Potential Trade Conflicts in GM Goods" (2001) The World Economy, 383.
182. One idea is, for instance, "renegotiating the SPS to permit trade restrictions for reasons of consumer preference", ibid., 392 ff.;
183. J.M. Wagner, "The WTO's interpretation of the SPS Agreement has undermined the right of Governments to establish appropriate levels of protection against risk" (2000) 3 Law and Policy in International Business 31, 2000, 858.
184. "As part of this effort, the Bush Administration's OSTP released a draft policy statement on GM foods titled "Exercise of Federal Oversight Within Scope of Statutory Authority: Planned Introductions of Biotechnology Products into the Environment" ("Proposed Scope") in 1992. The document was to provide ongoing direction to federal agencies on the implementation of federal policy as outlined in the Coordinated Framework. It specifically stated that federal over-sight under the Coordinated Framework should be limited to science-based risk assessment to " ensure the safety of planned introductions of organisms into the environment while not unduly inhibiting these introductions." In another document, "Four Principles of Regulatory Review for Biotechnology" ("Principles of Regulatory Review"), the Bush Administration re-emphasized that the end product would be the focus of regulatory attention: Federal regulatory over-sight should focus on the characteristics and risks of the biotechnology product-not the process by which it is created",
185. E. Marden, "Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture" (2003) 44 Boston College Law Review, 741.
186. It is known that the European political system is far from being perfect and far from being properly democratic. However, in the case at issue the reference concerns namely the European area, or better, the sum of the European legal orders, which all shared, until now, the same view of precaution towards GMOs.
187. "The difference between the European and the American and WTO regulations of GMOs goes beyond the mechanical one of process versus product. The two regulatory systems see GMOs in entirely different ways, reflecting not merely a technical divergence, but rather a fundamental epistemiological difference in the knowability and assessability of risks", A. Gupta, "Governing Trade in Genetically Modified Organisms: The Cartagena Protocol on Biosafety" (2000) 4 Environment 42, 23, 32-33.
188. C. Joerges, "Re-Constitutionalising Transnational Governance Through Conflict of Laws: The Example of International Trade - An Outline", The New International Law Conference, Oslo, 15-18 March 2007, unpublished, 17 and 19.
189. M. Matsushita, "Governance of International Trade under World trade Organization Agreements - Relationships between WTO Agreements and Other Trade Agreements" (2004) 2 Journal of World Trade Law 38, 210.
190. J. Cameron - K. Campbell, Challenging the Boundaries of the DSU throughout Trade and the Environment Disputes, in J. Cameron - K. Campbell (eds.), Dispute Resolution in the WTO (London: Cameron/ May, 1998), 227-229.
191. This would have a significant impact, as the judges will have a general competence and will be able to decide the case on the basis of an equal balancing between the interests involved. Against this proposal check N. Notaro, Judicial Approaches to Trade and Environment. The EC and the WTO (London: Cameron May International Law and Policy, 2003), 265: "the feasibility of such an institution is uncertain as it is very difficult to find a global consensus about the creation of a global environmental organization".
192. J. Cameron - K. Campbell, Challenging the Boundaries of the DSU, cit., 227-229.
193. M. Matsushita, T. J. Schoenbaum, and P. C. Mavroidis, The World Trade Organization. Law, Practice, and Policy (Oxford: Oxford University Press, 2002), 45.
194. Paper (Global Administrative Law Series), 2004/4, 22 ff.), at http://www.iilj.org/papers/2004/2004.4%20Cassese.pdf.
195. D. Esty, "Good Governance at the Supranational Scale: Globalizing Administrative Law" (2006) 115 Yale Law Journal, 1547.
196. M. Matsushita, T. J. Schoenbaum, and P. C. Mavroidis, The World Trade Organization., cit., 45.
197. N. Krisch, "The Pluralism of Global Administrative Law" (2006) 1 European Journal of International Law 17.
198. As said in precedence it is not correct to say that the principle is not applied in the US, to the contrary, it is used in many regulations, although not always equivalent to the European ones: "Europeans are not more averse to risks than Americans. They are more averse to particular risks, such as the risks associated with global warming; but Americans have their own preoccupations as well. In the early twenty-first century, for example, many Americans have been highly 'precautionarý about the risks associated with aggressive regulation itself - fearing that costly steps, designed to combat global warming and other environmental problems, will lead to unemployment and excessive prices of energy, including gasoline. Whether or not that fear is justified, it is, in its own way, highly precautionary", C.R. Sunstein, Laws of Fear (Cambridge: Cambridge University Press, 2005), 14.
199. There are many areas, among which environment or health administration, which fall under the scope of «risk regulation»: a general expression, which covers a set of policies to face, regulate and minimize risk on behalf of public authorities: risk analysis, precautionary principle, principle of prevention, notice and comment procedures, public debates, and so on. Risk regulation has gained an increasing popularity, due to the development of technological discoveries, which have entitled the administration with the task to monitor and regulate all the progresses of science, in order to avoid or limit all the possible dangers which the former could cause. This regulatory activity has been described as proper of the " Risikogesellschaft" ("Risk society"), on which see U. Beck, Risikogesellschaft. Auf dem Weg in eine andere Moderne, (Frankfurt am Main: Suhrkamp, 1986), 14, In english as Risk Society - Towards a New Modernity (London: Sage, 1992).
200. "The precautionary principle is particularly relevant to the management of risk", although it "should not be confused with the element of caution that scientists apply in their assessment of scientific data", Commission of the European Union, Communication, cit., 3.
201. "However, as the CFI rightly emphasized [in Pfizer, para. 143], it is also clear from the case law that a preventive measure cannot properly be based on a purely hypothetical approach to the risk, founded on mere conjecture that has not been scientifically verified", J. L. da Cruz Vilaga, "The precautionary", cit., 382.
202. "What if, because of the inadequate nature of the available scientific data, it is impossible to carry out a full risk assessment, which may require long and detailed scientific research? The answer of the Court [in Pfizer, § 160] is, first, that in such situation the competent authority cannot be prevented from taking preventive measures, when they appear necessary given the level of risk, which the authority deemed unacceptable for society", ibid., 387.
203. The concept of reasonability is central either in the regulation of risk or in the precautionary principle. In the former it is to be seen as the administration's approach to act in accordance with a legitimate and justified (by the reasonability of the risks expected) discretion, rather than through a free (and so potentially arbitrary) discretion. In the second the reasonalbility is required to demonstrte that the precautionary decision has been made on a reasonable evaluation of the risk involved, an "appréciation raisonable" (N. De Sadeller, Les principles du polluer-payeur, de prevention et de précaution (Bruxelles: Bruylant, 1999), 155), which considers and gives reasons of all the involved facts and interests, on the issue see also F. De Leonardis, Il principio, cit., 129 ff.
204. Precaution is in intimacy connection with the principle of proportionality, mainly because it implies a cost-benefits analysis and a balanced evaluation between risk and prudence. In addition legal science considers the precautionary principle to be derived by the proportionality one, in a parental-kind relationship: according to F. Ewald, Philosophie politique du principe de précaution, in F. Ewald, C. Golliers, N. De Sadeleer, Le principe de précaution, Colecciòn Que sais-je?, (Paris: PUF, 2001), 56: "le principe de precaution est indissociable du principe de proportionnalitè. Il repose sur un art des pondérations". But proportionality, as seen, is above the limit of precaution, as the other face of the same coin: "The principle of proportionality limits the discretion of the competent authorities when deciding what is the level of protection they deem necessary to pursue. Indeed, such level of protection should be proportionate to the perceived risk as defined under risk assessment. But it is at the level of risk management, in particular when they have to decide which concrete measures should be taken, that the institutions are typically bound to respect such principle", J. L. da Cruz Vilaga, "The precautionary", cit., 396.
205. "Starting in 1999, there has been a subtle but noticeable change in the policy agenda surrounding biotechnology issues in the U.S., signifying movement (but not a drastic change) toward some sort of convergence with EU standards, especially regarding labeling and segregation of GM crops. Further, as the passage of the revised EU rules for releasing GMOs into the environment demonstrates, the Europeans are likely to keep updating and strengthening the regulations controlling the use of agricultural GMOs", A. Prakash - K. 1. Kollman, "Biopolitics in the EU and the U.S.: A Race to the Bottom or Convergence to the Top?" (2003) 47 International Studies Quarterly, 629.
206. Finding a balance between two important objectives: establish a protection of health and environment and favoring the process of harmonization in consideration of supra-national interests over member states' ones ("protect human health and the environment" and "to approximate the laws of the member states", Preamble, recitals 5 and 7 and Art. 1, Dir. 18/2001/EC).
207. A. Prakash - K. I. Kollman, "Biopolitics in the EU and the U.S.", cit., 617 ff.