* Olivette Rivera-Torres graduated from the University of Puerto Rico-Rio Piedras (BA, 1995; JD, 1998) and Harvard Law School (LLM, 2002). She is currently Assistant Legal Counsel to the Governor of the Commonwealth of Puerto Rico. The author would like to thank Professor David Wirth for his insightful advice and encouragement throughout the process of writing this article. She would like to extend particular gratitude to her husband, Hiram Mel�ndez-Juarbe, for his helpful commentaries and constant support.
1 Cartagena Protocol on Biosafety to the Convention on Biological Diversity, Jan. 29, 2000, 39 I.L.M 1027 [hereinafter Biosafety Protocol]. I will use the terms “Biosafety Protocol” and “the Protocol” interchangeably throughout this article to refer to the Cartagena Protocol on Biosafety.
2 UN Conference on Environment and Development: Convention on Biological Diversity, June 5, 1992, 31 I.L.M. 818 (entered into force Dec. 29, 1993) [hereinafter CBD].
3 According to the Biosafety Protocol:
“Modern biotechnology” means the application of:
a. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or
b. Fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection . . . .
See Biosafety Protocol, supra note 1, art. 3(i).
4 See Cartagena Protocol on Biosafety: Signatures and Ratifications, at http://www. biodiv.org/biosafety/signinglist.asp (last visited Apr. 18, 2003).
5 Biosafety Protocol, supra note 1, art. 37(1).
6 For the definition of an LMO see infra text accompanying note 51.
7 General Agreement on Tariffs and Trade, Oct. 30, 1947, 61 Stat. A- 11, T.I.A.S. 1700, 55 U.N.T.S. 194 [hereinafter GATT].
8 See generally the following in which the authors have analyzed the Biosafety Protocol and have addressed the possibility of conflict: Aaron Cosbey & Stas Burgiel, International Institute For Sustainable Development, The Cartagena Protocol on Biosafety: An Analysis of Results: An IISD Briefing Note (2000), available at http://iisd1.iisd.ca/pdf/biosafety.pdf (last visited Feb. 4, 2003); Aarti Gupta, Framing “Biosafety” in an International Context: The Biosafety Protocol Negotiations (Harvard Univ., Kennedy Sch. of Gov’t Global Envtl. Assessment Project eds., 1999) [hereinafter Framing “Biosafety”]; Aarti Gupta, Creating a Global Biosafety Regime, 2 Int’l. J. Biotech. 205 (2000) [hereinafter Creating a Global Biosafety Regime]; Thomas J. Schoenbaum, International Trade in Living Modified Organisms, in Environment, Human Rights and International Trade 27 (Francesco Francioni ed., 2001); Thomas A. Cors, Biosafety and International Trade: Conflict or Convergence?, 2 Int’L J. Biotech. 27 (2000); Nathalie Bernasconi-Osterwalder, The Cartagena Protocol on Biosafety: A Multilateral Approach to Regulate GMOs, in Reconciling Environment and Trade 689 (Edith Brown Weiss & John H. Jackson eds., 2001); Simonetta Zarrilli, International Trade in Genetically Modified Organisms and Multilateral Negotiations, UNCTAD/DITC/TNCD/1 (July 5, 2000), available at http://www.unctad.org/en/docs/poditctncdd1.en.pdf; Paul E. Hagen & John Barlow Weiner, The Cartagena Protocol on Biosafety: New Rules for International Trade in Living Modified Organisms, 12 Geo. Int’l L. Rev. 697 (2000); Steve Charnovitz, The Supervision of Health and Biosafety by World Trade Rules, 13 Tul. Envtl. L.J. 271 (2000); Sean D. Murphy, Biotechnology and International Law, 42 Harv. Int’l L.J. 47 (2001); Sabrina Safrin, Treaties in Collision? The Biosafety Protocol and the World Trade Organization Agreements, 96 Am. J. Int’l L. 606 (2002); Gareth W. Schweizer, Note, The Negotiation of the Cartagena Protocol on Biosafety, 6 Envtl. L.J. 577 (2000); Gretchen L. Gaston & Randall S. Abate, The Biosafety Protocol and the World Trade Organization: Can the Two Coexist?, 12 Pace Int’l L. Rev. 107 (2000); Brett Grosko, Genetic Engineering and International Law: Conflict or Harmony? An Analysis of the Biosafety Protocol, GATT, and the WTO Sanitary and Phytosanitary Agreement, 20 Va. Envtl. L.J. 295 (2001); K. Mulongoy, Different Perceptions on the International Biosafety Protocol, 31 Biotech. & Dev. Monitor 16 (1997), available at http://www.biotech-monitor.nl/3106.htm (last visited Feb. 4, 2003); Deepa Badrinarayana, To Trade or Not to Trade . . . , 32 Envtl. L. Rep. 10512 (2002).
9 On the MEA/WTO debate see generally, Chris Wold, Multilateral Environmental Agreements and the GATT: Conflict and Resolution?, 26 Envtl. L.J. 841 (1996); Edith Brown Weiss & John H. Jackson, The Framework for Environment and Trade Disputes, in Reconciling Environment and Trade, supra note 8, at 1; P. K. Rao, The World Trade Organization and the Environment (2000); Kenneth P. Ewing & Richard G. Tarasofsky, The “Trade & Environment” Agenda: Survey of Major Issues and Proposals: From Marrakesh to Singapore (1997); Annick Emmenegger Brunner, Conflicts Between International Trade and Multilateral Environmental Agreements, 4 Ann. Surv. Int’l & Comp. L. 74 (1997); Kevin C. Kennedy, Why Multilateralism Matters in Resolving Trade-Environment Disputes, 7 Widener L. Symp. J. 31 (2001); Steve Charnovitz, A Critical Guide to the WTO’s Report on Trade and Environment, 14 Ariz. J. Int’l & Comp. L. 341 (1997) [hereinafter Critical Guide to WTO’s Report].
10 Weiss & Jackson, supra note 9, at 2–3.
11 Id. at 25.
12 Biosafety Protocol, supra note 1, art. 1.
13 See, e.g., Zarrilli, supra note 8, para. 75.
14 Some treaties that ban trade with non-parties include: The Montreal Protocol on Substances That Deplete the Ozone Layer; the Convention on International Trade in Endangered Species; and the Basel Convention on the Transboundary Movement of Hazardous Wastes. Weiss & Jackson, supra note 9, at 31. These treaties all include some sort of “escape hatch” which would allow for trade with non-parties under certain circumstances. Id.
15 See Bernasconi-Osterwalder, supra note 8, at 698–99.
Unlike the Convention on International Trade in Endangered Species of Fauna and Flora (CITES), the Montreal Protocol on Substances That Deplete the Ozone Layer, and the Basel Convention on the Control of Transboundary Movement of Hazardous Waste and Their Disposal, the Biosafety Protocol does not contain a provision requiring Parties to ban trade with non-parties . . . .
Id. (emphasis omitted).
16 See Gaston & Abate, supra note 8, at 142–44 (arguing that what is being regulated by the Biosafety Protocol are the final product’s characteristics and not the process and production measures through which the LMO was created).
17 See generally Charnovitz, supra note 8; Bernasconi-Osterwalder, supra note 8; Gaston & Abate, supra note 8; Cosbey & Burgiel, supra note 8.
18 GATT, supra note 7, at 1154. The GATT 1947 and 1994 are available at the World Trade Organization website, http://docsonline.wto.org(last visited Feb. 25, 2003).
19 Agreement on Technical Barriers to Trade, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1A, Legal Instruments--Results of the Uruguay Round vol. 1 (1994), 18 I.L.M. 1079 (1979), available at http://docsonline.wto.org [hereinafter TBT Agreement].
20 Agreement on the Application of Sanitary and Phytosanitary Measures, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1A, LEGAL Instruments--Results of the Uruguay Round vol. 1 (1994), available at http://docsonline.wto.org [hereinafter SPS Agreement].
21 This framework builds upon the analysis conducted by Professor David Wirth in Trade Implications of the Basel Convention Amendment Banning North-South Trade in Hazardous Waste, 7 Rev. Eur. Community and Int’l Envtl. L. 237 (1998).
22 See generally Cosbey & Burgiel, supra note 8; Gaston & Abate, supra note 8; Mulongoy, supra note 8; Cors, supra note 8; Framing “Biosafety,” supra note 8; Creating a Global Biosafety Regime, supra note 8; Zarrilli, supra note 8; Schweizer, supra note 8. Most of these sources refer to the Earth Negotiation Bulletin produced by the International Institute for Scientific Development (IISD) covering many of the meetings leading to the approval of the Biosafety Protocol. These documents can be found at http://www.iisd.ca/biodiv/excop/ (last visited Feb. 25, 2003).
23 See generally Martina McGloughlin, Ten Reasons Why Biotechnology Will Be Important to the Developing World, 2 AgBio F. 163 (1999); C.S. Prakash, Feeding a World of Six Billion, 2 AgBio F. 223 (1999).
24 See generally Miguel A. Altieri & Peter Rosset, Ten Reasons Why Biotechnology Will Not Ensure Food Security, Protect the Environment and Reduce Poverty in the Developing World, 2 AgBio F. 155 (1999); Miguel A. Altieri & Peter Rosset, Strengthening the Case for Why Biotechnology Will Not Help the Developing World: A Response to McGloughlin, 2 AgBio F. 226 (1999).
25 For a list of some of the concerns that have been voiced regarding the risks that biotechnology products could present to biodiversity, see Vicente Paolo B. Yu III, Compatibility of GMO Import Regulations with WTO Rules, in Reconciling Environment and Trade, supra note 8, at 575, 582-85. See also Secretariat Of the Convention on Biological Diversity, Global Biodiversity Outlook 67 (2001), available at http://www.biodiv.org/ doc/publications/gbo/gbo-ch-01-en.pdf.
26 Secretariat Of the Convention on Biological Diversity, Sustaining Life on Earth: How the Convention on Biological Diversity Promotes Nature and Human Well-being 2 (2000), available at http://www.biodiv.org/doc/publications/cbd-sus-tain-en.pdf.
27 CBD, supra note 2, art. 2.
28 See Secretariat of the Convention on Biological Diversity, Parties to the Convention on Biological Diversity/Cartagena Protocol on Biosafety, at http://www.biodiv.org/world/parties. asp (last visited Feb. 4, 2003).
29 There are no signs this fact will change any time soon. It is also interesting to note that the commitment to promulgate a Biosafety Protocol is one of the reasons put forth for the United States not signing the CBD. See Henry I. Miller, Is the Biodiversity Treaty a Bureaucratic Time Bomb? 2–6 (1995).
30 See Zarrilli, supra note 8, para. 60 (stating that the proposal for provisions dealing with the safe transfer, handling, and use of LMOs was already being discussed during the negotiations of the CBD but “there was neither time nor a wholehearted willingness to . . . include them into the Convention . . . .”); see also Cors, supra note 8, at 29.
31 Framing “Biosafety,” supra note 8, at 4.
32 Creating a Global Biosafety Regime, supra note 8, at 208.
33 Id.
34 Id.
35 Id.
36 Framing “Biosafety,” supra note 8, at 6.
37 Id.; Creating a Global Biosafety Regime, supra note 8, at 208–09.
38 Biosafety has been commonly defined as the “safe use of biotechnology.” Creating a Global Biosafety Regime, supra note 8, at 206.
39 Framing “Biosafety,” supra note 8, at 7.
40 Id.
41 Second Conference of the Parties to the Convention on Biological Diversity, Decision II/5: Consideration of a Need for Modalities of a Protocol for the Safe Transfer, Handling and Use of Living Modified Organisms, UNEP/CBD/COP/2/19 (Nov. 1995), available at http://www.biodiv.org/decisions/default.asp?1g=0&m=cop-02&d=05 (last visited Feb. 4, 2003).
42 Id.
43 Framing “Biosafety,” supra note 8, at 9.
44 Schweizer, supra note 8, at 585–86.
45 Charnovitz, supra note 8, at 298; Cosbey & Burgiel, supra note 8, at 2.
46 Creating a Global Biosafety Regime, supra note 8, at 217-18.
47 Id. at 218.
48 Id.
49 Zarrilli, supra note 8, para. 64.
50 Biosafety Protocol, supra note 1, art. 4.
51 Id. art. 3(g).
52 Id. art. 3(h)-3(i).
53 Id. art. 3(h).
54 Id. art. 3(i).
55 On the ongoing controversy of GMO product labeling see generally Mathew Franken, Fear of Frankenfoods: A Better Labeling Standard for Genetically Modified Foods, 1 Minn. Intell. Prop. Rev. 153, 158–59 (2000); Karen A. Goldman, Labeling of Genetically Modified Foods: Legal and Scientific Issues, 12 Geo. Int’l Envtl. L. Rev. 717 (2000); Diane Thue-Vasquez, Genetic Engineering and Food Labeling: A Continuing Controversy, 10 San Joaquin Agric. L. Rev. 77 (2000); Lara Beth Winn, Special Labeling Requirements for Genetically Engineered Food: How Sound Are the Analytical Frameworks Used by FDA and Food Producers?, 54 Food & Drug L.J. 667 (1999).
56 Biosafety Protocol, supra note 1, art. 4.
57 Id. art. 2(5). Article 2(5) indicates that “the parties are encouraged to take into account, as appropriate, available expertise, instruments, and work undertaken in international forums with competence in the area of risks to human health.” Id. It is important to note that this might also be a recognition of the fact that there are other international forums with particular expertise and competence in the issue of human health. See id.
58 Id. art. 2(5).
59 Id.
60 Creating a Global Biosafety Regime, supra note 8, at 211.
61 It must be pointed out that the fact that a risk to human health could or could not be addressed as an independent ground for a measure under the Biosafety Protocol would not impede a country from limiting the entrance of a product that in fact poses such a risk.
62 Biosafety Protocol, supra note 1, art. 5 (emphasis added).
63 Murphy, supra note 8, at 77.
64 See id. The significance of this interpretation might be limited. But one can imagine, for example, an imported seed for a medicinally enhanced fruit, which, for its hybrid nature (pharmaceutical/fruit), were not addressed by other international agreements. In this case, these seeds’ impact on biodiversity should be analyzed under the Protocol’s provision.
65 Hagen & Weiner, supra note 8, at 702.
66 See id. One could conceive, for example, feed in the form of seeds or grain engineered to deliver medicinal benefits to animals falling under this category as long as the seeds are “living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.” Id. art. 3(g). But if the seed in this example is grown elsewhere and intended to be used directly as seed the AIA procedure would still not apply. See id.
67 Hagen & Weiner, supra note 8, at 702 n.28.
68 Biosafety Protocol, supra note 1, art. 6(1).
69 Id. art. 6(2).”’Contained use’ means any operation, which undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment.” Id. art. 3(b).
70 Id. art. 6(2).
71 Id. art. 7(2).
72 Id. art. 7(4). This provision would seem to have been included to attract LMO exporting countries which could arguably manage exclusions for several of their products.
73 Zarrilli, supra note 8, para. 69.
74 Biosafety Protocol, supra note 1, arts. 20, 22. The Biosafety Clearing-House offers a mechanism for information sharing between countries providing the opportunity for exchange of scientific technical and environmental information that will aid an importing Country in its decision-making processes. Id. Capacity building, on the other hand, aims at more directly improving a developing country’s capacity to assess the desirability or potential hazards of importing an LMO, taking into consideration its own environmental and ecological realities. Both of these efforts by the Protocol should be seen as important contribution primarily to developing countries if they are adequately carried out. Id.
75 Id. art. 17.
76 Id. art. 21.
77 Id. art. 23.
78 Id. art. 25.
79 Biosafety Protocol, supra note 1, art. 11.
80 Id. art. 2(2) (emphasis added).
81 Id. art. 16(1).
82 Id. art. 16(4).
83 Id. Annex II(j). Annex II(j) of the Protocol specifically requires a risk assessment report consistent with Annex III. Id. Annex II(j).
84 Biosafety Protocol, supra note 1, art. 11(8).
85 Cosbey & Burgiel, supra note 8, at 8; see also David J. Schnier, Genetically Modified Organisms & The Cartagena Protocol, 12 Fordham Envtl. L.J. 377, 410 (2001).
86 Biosafety Protocol, supra note 1, art. 11(6).
87 Cosbey & Burgiel, supra note 8, at 7.
88 Bernasconi-Osterwalder, supra note 8, at 693.
89 Biosafety Protocol, supra note 1, art. 7.
90 Id.
91 Id.
92 Id. art. 7(3).
93 Id. art. 8(1).
94 Biosafety Protocol, supra note 1, Annex I(e).
95 Id. Annex I(f).
96 Id. Annex I(g).
97 Id. Annex I(h).
98 Id. Annex I(i).
99 Biosafety Protocol, supra note 1, Annex I(m).
100 Id. art. 9. It is interesting to note that among the information that the acknowledgment of receipt must include is whether to proceed according to the domestic regulatory framework of import or according to the AIA procedure as specified in Article 10. See id. art. 10. This presents another opportunity for the scope of the AIA procedure to be limited.
101 Id. art. 10(4).
102 Id.
103 Id. art. 15(2).
104 Biosafety Protocol, supra note 1, art. 15(2), (3).
105 Id. art. 15(1).
106 Id. Annex III(2), (9).
107 Id. art. 10(6).
108 Although the Miami Group as a whole also resisted the inclusion of the precautionary principle, at least one member to that group, Australia, presently invokes the precautionary principle in its regulation relating to GMO labeling. See generally Denise M. Lietz, A Precautionary Tale: The International Trade Implications of Regulating Genetically Modified Foods in Australia and New Zealand, 10 Pac. Rim L. & Pol’y J. 411 (2001).
109 James Cameron refers to the debate surrounding the principle’s meaning in the following way:
Much of the confusion surrounding the principle’s interpretation stems from a failure to distinguish between precautionary and preventative measures. Preventive standards may be precautionary or non-precautionary in certain degrees, but precautionary standards, while able to vary the degree of prevention, cannot be non-preventative. This is because, regardless of the particular language used by an instrument, a key element in defining the core of precaution is a lack of certainty about the cause and effect relationships or the possible extent of a particular environmental harm. If there is no uncertainty about the environmental risks of a situation, then the measure is preventive, not precautionary. In the face of uncertainty, however, the precautionary principle, like the Vorsorgeprinzip, allows for the state to act in effort to mitigate the risks. Put best, “the precautionary principle stipulates that where the environmental risks being run by regulatory inaction are in some way uncertain but non-negligible, regulatory inaction is unjustified.”
James Cameron, The Precautionary Principle in International Law, in Tim O’Riordan, James Cameron & Andrew Jordan, Reinterpreting the Precautionary Principle 116 (2001) (emphasis added). Various books and articles have been written on the subject of the precautionary principle. Some of these are: The Precautionary Principle and International Law: The Challenge of Implementation (David Freestone & Ellen Hey eds., 1994); Interpreting the Precautionary Principle (Timothy O’Riordan & James Cameron eds., 1994).
110 Timothy O’Riordan & James Cameron, The History and Contemporary Significance of the Precautionary Principle, in Interpreting the Precautionary Principle, supra note 109, at 12, 20–22; United Nations Development Programme, Human Development Report 2001: Making New Technologies Work for Human Development: Ch. 3 Managing the Risks of Technological Change 70 (Box. 3.3) (2001), available at http:// www.undp.org/hdr2001/ (last visited Feb. 4, 2003) [hereinafter UN Human Development Report].
111 UN Human Development Report, supra note 110, at 70 (Box. 3.3).
112 Report of the United Nations Conference on Environment and Development, U.N. GAOR, 47th Sess., Annex I, Agenda Item 21, at Principle 15, U.N. Doc. A/CONF.151/26 (vol. I) (1992) [hereinafter Rio Declaration].
113 Cosbey & Burgiel, supra note 8.
114 James Cameron, The Precautionary Principle in International Law, in Reinterpreting the Precautionary Principle, supra note 109, at 113, 141; Creating a Global Biosafety Regime, supra note 8, 221–23. Admittedly the precautionary principle as formulated in Articles 10(6) and 11(8) could be interpreted as a stronger formulation of the Principle if compared to the Rio Declaration Principle 15, because it does not seem to require a threat of serious or irreversible damage, or impose a cost-benefit analysis. See Biosafety Protocol, supra note 1, arts. 10(6), 11(8); Rio Declaration, supra note 112, Principle 15. Additionally, it is not contingent on the capabilities of the State. See Biosafety Protocol, supra note 1, arts. 10(6), 11(8); Rio Declaration, supra note 112, Principle 15.
115 Cameron, supra note 114, at 141; Creating a Global Biosafety Regime, supra note 8, at 221–23.
116 Biosafety Protocol, supra note 1, arts. 10(6), 11(8).
117 Id.; Cameron, supra note 114, at 141.
118 Biosafety Protocol, supra note 1, art. 15(2); see also Cameron, supra note 114, at 141.
119 Cameron, supra note 114, at 141.
120 Biosafety Protocol, supra note 1, art. 10(6).
121 See Charnovitz, supra note 8, at 301.
122 Biosafety Protocol, supra note 1, art. 16(2).
123 Charnovitz, supra note 8, at 299; see also infra text accompanying note 276–280.
124 The notification must include the information specified in Annex I. Biosafety Protocol, supra note 1, art. 13(2–3).
125 Biosafety Protocol, supra note 1, art. 14(1).
126 Id. art. 14(3).
127 Id. art. 18.
128 Id. art. 18(1).
129 Id. arts. 18(1-10).
130 Biosafety Protocol, supra note 1, art. 18(2).
131 Id. art. 18(2)(a).
132 Id. art. 18(2)(b).
133 See Badrinarayana, supra note 8, at n. 85.
134 Similarly, see Bernasconi-Osterwalder, supra note 8, at 698, stating that “[i]t should be noted that these labeling requirements do not concern consumer product labeling but shipping documentation only.”
135 Biosafety Protocol, supra note 1, art. 1.
136 Id. art. 18(2)(c).
137 Id.
138 Id. art. 18(3).
139 See Rafe Pomerance, The Biosafety Protocol: Cartagena and Beyond, 8 N.Y.U. Envtl. L.J. 614, 620 (2000).
140 Biosafety Protocol, supra note 1, art. 18(2)(a).
141 See Hagen & Barlow, supra note 8, at 705; Shweizer, supra note 8, at 594.
142 Stephen Tomans, Promise, Peril, Precaution: The Environmental Regulation of Genetically Modified Organisms, 9 Ind. J. Global Legal Stud. 187, 203 (2001); Thomas P. Redick & Christina G. Bernstein, Nuisance Law and the Prevention of “Genetic Pollution”: Declining a Dinner Date with Damocles, 30 Envtl. L. Rep. 10328, � 1 (2000).
143 Biosafety Protocol, supra note 1, art. 24(1). The fact that the specific obligations of the protocol relating to transboundary movements of LMOs are only applicable as between parties to the protocol is also affirmed by Article 3(k) which states: “Transboundary movement” means the movement of a living modified organism from one Party to another Party, save that for the purposes of Article 17 and 25 transboundary movement extends to movement between Parties and non-Parties.”Id. art. 3(k).
144 Id. art. 24(1).
145 Id.
146 Id. pmbl.
147 Cosbey & Burgiel, supra note 8.
148 WTO, World Trade Organization: A Training Package, available at http://www.wto.org/ english/thewto_e/whatis_e/whatis_e.htm (last visited Feb. 25, 2003).
149 Id.
150 Id.
151 GATT, supra note 7, art. I; WTO, GATT and the Goods Council, available at http://www.wto.org/english/tratop_e/gatt_e/gatt_e.htm (last visited Feb. 25, 2003).
152 GATT, supra note 7, arts. I, II, XI.
153 Id. arts. I, III.
154 WTO Appellate Body Report on European Communities--Measures Affecting Asbestos and Asbestos-containing Products, WT/DS135/AB/R (Mar. 12, 2001), 40 I.L.M. 1193 (2001), available at http://www.wto.org/english/tratop_e/dispu_e/distab_e.htm# 1998 [hereinafter Asbestos Appellate Body Report].
155 Id. � 101.
156 Id.
157 Id. � 112.
158 Id. � 113. In the Asbestos case, the particular health threat was the known carcinogenic nature of the chrysotile asbestos fibers. Id. � 114. Interestingly, the Appellate Body also established that the use of health risks in determining the physical properties of a product does not nullify the effect of article XX(b). Id. � 113.
159 Asbestos Appellate Body Report, supra note 154, � 121.
160 David M. Driesen, What Is Free Trade?: The Real Issue Lurking Behind the Trade and Environment Debate, 41 Va. J. Int’l L. 279, 293 (2001) (citing WTO Dispute Settlement Panel Report on India—Quantitative Restrictions on Imports of Agricultural, Textile, and Industrial Products, 1999 WTO DS Lexis 5, para. 5.142 (Apr. 6, 1999)).
161 GATT, supra note 7, art. XX. The phrase “exhaustible natural resources” has been interpreted to include dolphins, salmon fisheries and clean air. David Hunter et al., International Environmental Law and Policy 1166 (2002).
162 See Hunter et al., supra note 161, at 1163–65. Only one WTO Panel report actually determined that a measure that violated GATT disciplines was permissible under Article XX(b), but the WTO Panel decision was reversed by the Appellate Body. See generally Asbestos Appellate Body Report, supra note 154.
163 WTO Appellate Body Report on United States—Standards for Reformulated and Conventional Gasoline, WT/DS2/AB/R (May 20, 1996), 35 I.L.M. 603 (1996).
164 WTO Appellate Body Report on United States—Import Prohibition of Certain Shrimp and Shrimp Products, WT/DS58/AB/R (Oct. 12, 1998), 38 I.L.M. 118 (1999).
165 Hunter et al., supra note 161, at 1168.
166 Id.
167 See Thomas J. Schoenbaum, International Trade and Protection of the Environment: The Continuing Search for Reconciliation, 91 Am. J. Int’l L. 268, 276 (1997).
168 GATT, supra note 7, art. XX.
169 Kristina Kloiber, Removing Technical Barriers to Trade: The Next Step Toward Freer Trade, 9 Tul. J. Int’l & Comp. L. 511, 517 (2001).
170 TBT Agreement, supra note 19, art. 1.3.
171 Id. annex 1(1).
172 Asbestos Appellate Body Report, supra note 154, � 76.
173 TBT Agreement, supra note 19, art. 2.1.
174 Id. art. 2.2.
175 Id. art.
176 Id. art. 2.3.
177 WTO, Application of the Necessity Test: Issues for Consideration (Oct. 8, 1999), at http:// www.wto.org/english/tratop_e/serv_e/serv_reg_secretariatnot_e.htm.
178 Id.
179 TBT Agreement, supra note 19, art. 2.4. This article gives examples of reasons why a certain international standard could be ineffective or inappropriate because of “fundamental climatic or geographical factors or fundamental technological problems.” Id.
180 TBT Agreement, supra note 19, Annex 1(4).
181 SPS Agreement, supra note 20, pmbl.
182 WTO Appellate Body Report on European Community Measures Concerning Meat and Meat Products, WT/DS26/AB/R; WT/DS48/AB/R (Jan. 16, 1998) [hereinafter Beef Hormones Appellate Body Report].
183 WTO Appellate Body Report on Australia—Measures Affecting Importation of Salmon, WT/DS18/AB/R (Oct. 20, 1998) [hereinafter Australian Salmon Appellate Body Report].
184 WTO Appellate Body Report on Japan—Measures Affecting Agricultural Products, WT/DS76/AB/R (Feb 22, 1999) [hereinafter Japan Agricultural Products Appellate Body Report].
185 SPS Agreement, supra note 20, art. 1, � 1.
186 Id. Annex A, � 1.
187 Id. art. 2, � 2.
188 Id. art. 2, � 3.
189 Id. art. 3, � 1.
190 SPS Agreement, supra note 20, art. 3, � 2.
191 Id. Annex A, � 3(a)–(c).
192 Id. Annex A, � 3(a).
193 Id. Annex A, � 3(b).
194 Id. Annex A, � 3(c).
195 SPS Agreement, supra note 20, Annex A, � 3(d).
196 Id. art. 3, � 3.
197 Id. In paragraphs 174 to 176 of the Beef Hormones Case the Appellate Body concluded that the disjunctive “or” created a distinction that may be more apparent than real, basically equating both requirements as entailing a risk assessment. Beef Hormones Appellate Body Report, supra note 182, �� 174–76.
198 SPS Agreement, supra note 20, art. 3, � 3.
199 Id. art. 5, � 1.
200 Id. art. 5, � 2.
201 Beef Hormones Appellate Body Report, supra note 182, � 187.
202 SPS Agreement, supra note 20, Annex A, � 4.
203 Australian Salmon Appellate Body Report, supra note 183, � 121 (emphasis added).
204 Beef Hormones Appellate Body Report, supra note 182, � 190; Australian Salmon Appellate Body Report, supra note 183, � 122 n.68.
205 Australian Salmon Appellate Body Report, supra note 183, � 200. “The ‘appropriate level of protection’ established by a Member and the ‘SPS measure’ have to be clearly distinguished. They are not one and the same thing. The first is an objective, the second is an instrument chosen to attain or implement that objective.” Id. (referring to Beef Hormones Appellate Body Report, supra note 182, � 214).
206 Id. � 125. In the Australian Salmon Case the Appellate Body clarified some expressions made by the WTO Panel with regard to a country’s determination on level of protection by stating in � 125:
The statement by the Panel quoted above is not appealed, and we merely note that it is important to distinguish—perhaps more carefully than the Panel did—between the evaluation of “risk” in a risk assessment and the determination of the appropriate level of protection. As stated in our Report in European Communities-Hormones, the “risk” evaluated in a risk assessment must be an ascertainable risk; theoretical uncertainty is “not the kind of risk which, under Article 5.1, is to be assessed. This does not mean, however, that a Member cannot determine its own appropriate level of protection to be “zero risk.”
Id. (emphasis added).
207 At least one commentator has drawn attention to the fact that the language in this article through the use of the word “should” instead of “shall” seems to “denote a lesser degree of obligatory force.” Robert Howse, Democracy, Science, and Free Trade: Risk Regulation on Trial at the World Trade Organization, 98 Mich. L. Rev. 2329, 2356 (2000).
208 Beef Hormones Appellate Body Report, supra note 182, � 211. Two of the cases examined have referred to this last requirement: The Beef Hormones Case at �� 210–46, where no violation was found; and the Australian Salmon Case at �� 139–78, where the Appellate Body found a violation of Article 5.5. Beef Hormones Appellate Body Report, supra note 182, �� 210–26; Australian Salmon Appellate Body Report, supra note 183, �� 139–78.
209 See Beef Hormones Appellate Body Report, supra note 182, �� 192–94.
210 See Japan Agricultural Products Appellate Body Report, supra note 184, � 84.
211 SPS Agreement, supra note 20, art. 5, � 7.
212 Beef Hormones Appellate Body Report, supra note 182, �� 120–25.
213 Id. � 124.
214 Id. � 125.
215 Japan Agricultural Products Appellate Body Report, supra note 184, � 89.
216 Id.
217 Id. � 92.
218 Id. � 93.
219 Weiss & Jackson, supra note 9, at 14.
220 Id. at 16.
221 See Gregory C. Shaffer, The World Trade Organization Under Challenge: Democracy and the Law and Politics of the WTO’s Treatment Of Trade And Environment Matters, 25 Harv. Envtl. L. Rev. 1, 1–2 (2001).
222 See Charnovitz, supra note 8, at 271.
223 Philippe Sands, Treaty, Custom and the Cross-Fertilization of International Law, 1 Yale Hum. Rts. & Dev. L.J. 85, 90 (1998).
224 See GATT, supra note 18, pmbl.; Biosafety Protocol, supra note 1, pmbl.
225 SPS Agreement, supra note 20, Annex A, � 1.
226 Id. Thus, for example, threats to human health or life from a pharmaceutical or from toxins and contaminants not contained in food, beverages, plants, or animals are not included under the scope of the SPS.
227 Id.
228 Id.
229 TBT Agreement, supra note 19, art. 1.3.
230 See, e.g., Environmental Protection Agency, Bt Plant-Pesticides Biopesticides Registration Action Document � IID1, � 1 (recognizing the possibility of certain Bt Crops increasing insect resistance to pesticides), available at http://www.epa.gov/ oscpmont/sap/2000/october/brad4_ irm.pdf (last visited Mar. 26, 2003).
231 WTO, The WTO Agreements Series 4 Sanitary and Phytosanitary Measures 9 (1998).
232 Id. at 13-15. The examples given of measures include: “plant . . . quarantine”; “regulation on treatment of imported fruit to prevent pests spreading.” Id.
233 See generally Soil Association, Soil Biodiversity: Briefing Paper, (Jan. 2002), at http:// www.soilassociation.org/web/sa/saweb.nsf/home/index.html (discussing the importance of biodiversity for soil organisms) (last visited Apr. 4, 2003).
234 It is significant to note that the International Animal Health Code prepared by the IOE—referred to in the SPS as the recognized international standard-setting body with regard to animal health—applies only to mammals, birds and bees. A separate IOE code refers to aquatic animals. See David G. Victor, The Sanitary and Phytosanitary Agreement of the World Trade Organization: An Assessment After Five Years, N.Y.U. J. Int’l & Pol. 865, 892 (2000). Since none of the IOE standards seem to apply to microorganisms, or insects for than matter, a situation like the one mentioned in this example would have no recourse to a set international standard.
235 Biosafety Protocol, supra note 1, Annex II.
236 TBT Agreement, supra note 19, Annex I.
237 Id.
238 Biosafety Protocol, supra note 1, art. 1.
239 In fact, whether the SPS is the agreement that applies or should apply to measures concerning LMOs in general is also a disputed matter. See Charnovitz, supra note 8, at 276–77 (citing U.S. Statute, Trade and Development Act of 2000, Pub. L. No. 106–200, which contains a provision in section 409(b)(4) establishing as one of the U.S. objectives in WTO trade negotiations to affirm that SPS applies to new technology, including biotechnology); see also Cors, supra note 8, at 30.
240 CBD, supra note 2, art. 2.
241 See discussion supra Part II.
242 Biosafety Protocol, supra note 1, art. 26.
243 But see Article 12.4 of the TBT, which appears to provide an alternative to some developing countries concerned with the economic dependence that could arise from the introduction of certain types of LMOs into their existing agricultural arrangements. TBT Agreement, supra note 19, art. 12.4.
244 Article 24(1) of the Protocol, referring to non-parties, states: “Transboundary movements of living modified organisms between Parties and non-Parties shall be consistent with the objective of this Protocol. The Parties may enter into bilateral, regional and multilateral agreements and arrangements with non-Parties regarding such transboundary movements.” Biosafety Protocol, supra note 1, art. 24(1).
245 See supra text accompanying note 12.
246 Biosafety Protocol, supra note 1, art. 24(1).
247 It would be hard for a party to argue that compliance with the specific provisions of the Protocol is the only way to comply with the Protocol’s objective because this interpretation would render Article 24, an operative provision of the Protocol, superfluous. In fact, the recognition of alternative ways of achieving the objectives of the protocol can be found in various provisions of the Protocol allowing parties to agree to or inform that an alternative procedure than that provided by the protocol will be used. See id. arts. 2(4), 9(2)(c), 9(3), 11(4), 13, 14.
248 Schoenbaum, supra note 8, at 37.
249 Bernasconi-Osterwalder, supra note 8, at 712 (pointing out that she had found no evidence that the negotiating parties to the Protocol expressed any concern that the AIA procedure as such was WTO inconsistent).
250 Biosafety Protocol, supra note 1, Annex C(1).
251 Id. art. 10(1), 15(1).
252 Id. art. 10(4).
253 SPS Agreement, supra note 20, art. 12(3).
254 It is interesting to note that with regard to food derived from biotechnology, a task force of the Codex has recently agreed on a final draft of principles for the risk analysis of foods derived from biotechnology. The agreement is also said to mark a breakthrough in international negotiations concerning the use of tracing systems in relation to food in international trade. Joint Press Release, Food and Agriculture Organization of the United Nations, Codex Task Force Agrees on Final Draft of Principles for the Evaluation of GM Foods (Mar. 8, 2002), available at http://www.fao.org/WAICENT/OIS/PRESS_NE/english/2002/3060-en.html.
255 See Office International des Epizooties, To Guarantee the Sanitary Safety of World Trade by Developing Sanitary Rules for International Trade in Animals and Animal Products (last updated Apr. 22, 2002), at http://www.oie.int/eng/OIE/en_securite.htm.
256 See International Plant Protection Convention, Apr. 3, 1952, 23 U.S.T. 2767, 150 U.N.T.S. 67, art. 1, � 1 (as amended Nov. 17, 1997) [hereinafter IPPC].
257 Cors, supra note 8, at 34–35. This limited scope of the international organizations referred to in the SPS could also be significant in the analysis about scope carried out in Part IV of this article.
258 SPS Agreement, supra note 20, art. 12.1.
259 See Food & Agricultural Organization of the UN (FAO), FAO Helping the Consumer and Protecting the Environment Through Food Quality Control and Plant Protection: Codex Alimentarius/ International Plant Protection Convention, at http://www.fao.org/WorldFoodSummit/ sideevents/papers/Y6823e.htm (last visited Apr. 18, 2003) (“Many components of the IPPC are directly related to elements of the Convention on Biological Diversity (CBD) and the Cartagena Protocol, including work on invasive species and genetically modified organisms. As a consequence, the CBD and IPPC are establishing a close collaborative relationship to ensure consistency.”); see also International Centre for Trade & Sustainable Development (ICTSD), FAO Plant Health Commission to Build Bridges Between WTO and CBO, ICTSD Bridges: Weekly Trade News Digest, Apr. 10, 2001, at http://www.ictsd.org/ html/weekly/10-04-01/story5.htm (last visited Apr. 18, 2003).
260 SPS Agreement, supra note 20, art. 3.3.
261 See supra text accompanying note 203.
262 Biosafety Protocol, supra note 1, Annex III(8)(a).
263 Id. Annex III(8)(b).
264 Id. Annex III(8)(c).
265 Id. Annex III(8)(e).
266 See supra note 206.
267 See supra text accompanying note 215.
268 Bernasconi-Osterwalder, supra note 8, at 720.
269 TBT Agreement, supra note 19, Annex 1(4).
270 Biosafety Protocol, supra note 1, Annex 3.
271 See supra text accompanying note 156.
272 Asbestos Appellate Body Report, supra note 154, �23.
273 GATT, supra note 7, art. XX(g).
274 See supra note 161.
275 GATT, surpra note 7, art. XX.
276 Gaston & Abate, supra note 8, at 145.
277 Gaston & Abate state:
[T]he Biosafety Protocol, through its AIA process, not only requires notification from the exporting countries of certain LMO transactions, but also requires “acknowledgement of receipt of notification” from the importing country. Moreover, the Biosafety Protocol establishes a “decision procedure,” which lays out a structure for accepting or denying imports. Once a decision is made, or anytime thereafter, an importing country may change its decision “in light of new scientific information on potential adverse effects on . . . biodiversity” and an exporting country may, at any time, request that the importer review its prior decision.
Id. at 146.
278 Id. at 145-46.
279 Biosafety Protocol, supra note 1, art. 20.
280 Gaston & Abate, supra note 8, 147-48.
281 Vienna Convention on the Law of Treaties, May 22, 1969, 1155 U.N.T.S. 332, 81 I.L.M. 679.
282 Wirth, supra note 21, at 242.
283 Schoenbaum, supra note 8, at 36.
284 Cosbey & Burgiel, supra note 8, at 11–12.
285 Id.
286 Id.
287 See, e.g., Documento de Antecedentes sobre Acuerdos Internacionales Existentes sobre Seguridad de la Biotecnolog�a (revisi�n del documento UNEP/CBD/BSWG/2/3) (Background Document on Existing International Agreements Related to Biosafety (revision of UNEP/CBD/BSWG/2/3)), UNEP/CBD/BSWG/3/Inf.2 (June 28, 1997).
288 Critical Guide to WTO’s Report, supra note 9, at 351 (emphasis supplied).