Does science speak clearly and fairly in trade and food safety disputes? the search for an optimal response of wto adjudication to problematic international standard-Making

Food and Drug Law Journal

Volumn 68, Issue 1, 2013, Pages 97-114

  Ni, Kllei Jung ^a  

^a NATIONAL CHIAO TUNG UNIVERSITY   (Taiwan)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL ASSESSMENT; CONFERENCE PAPER; CONSENSUS; EXPERT SYSTEM; FOOD SAFETY; HUMAN; INSTITUTIONAL REVIEW; INTERNATIONAL STANDARD UNIT; NATIONAL HEALTH ORGANIZATION; NUTRITIONAL SCIENCE; SCIENTIST; UNCERTAINTY; WORLD TRADE ORGANIZATION;

COMMERCE; FOOD INDUSTRY; FOOD SAFETY; HUMANS; INTERNATIONAL AGENCIES; INTERNATIONALITY; SCIENCE;

EID: 84892160677     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (108)

1. recitals 5 & 6 of the Preamble to the Agreement on the Application of Sanitary and Phytosanitary Measures [hereinafter the SPS Agreement]
2. The SPS Agreement, art. 3.1. Apart from harmonization, the SPS Agreement underlines several principles to be observed, including scientific principle, mutual recognition, transparency etc
3. E.g. Codex Alimentarius Commission (Codex), the International Office of Epizootics (OIE)and the International Convention on Plant Protection (IPPC) are explicitly recognized by the SPS Agreement as international standard-setters. Paragraph 3 of Annex A to the SPS Agreement
4. Part 3. A of this article
5. Part 3. B of this article
6. Ractopamine, a veterinary drug administered as a feed additive, is used to increase leanness in pork and beef. See Codex website: http://www.fao.org/ news/story/en/item/150953/icode/
7. At the previous Codex sessions, no consensus was reached concerning the approval of a residue standard for ractopamine. The U.S. and Canada favored the proposed draft standard, but European countries opposed the adoption of such a standard. Eventually, the Codex adopted a standard at the 35th session, held in Rome on July 6, 2012, by a very close vote: 69 in favor, 67 against, with seven abstentions
8. the Codex website: http://www.fao.org/news/story/en/item/150953/icode/. The move was seen as a triumph by countries that approve the use of the drug in meat production
9. http://www.foodsafetynews.com/2012/07/codex-votes-69-67-to-advance- ractopamine-limits-for-beef-and-pork/
10. the statement of the U.S. Trade Representative, at USTR Website: www.ustr.org (last visited Aug. 1, 2011). For the official statement of the U.S. government on the adoption of the standards, see:http://www.usda.gov/wps/ portal/usda/usdahome?contentid=2012/07/0222.xml&navid=NEWS- RELEASE&navtype=RT&parentnav=LATEST-RELEASES&edeployment-action= retrievecontent (last visited July 25, 2012)
11. Appellate Body Report, EC - Measures Concerning Meat and Meat Products (Hormones), WTO Doc. WT/DS26/AB/R,WT/DS48/AB/R(Jan. 16, 1998)[hereinafter Appellate Body Report, EC - Hormones]; Appellate Body Report, EC - Trade Description of Sardines, WT/DS231/AB/R(Sep. 26, 2002)[hereinafter Appellate Body Report, EC - Sardines]
12. Appellate Body Report, United States - Continued Suspension of Obligations in the EC - Hormones Dispute, WTO Doc. WT/DS320/AB/R (Oct. 16, 2008)[hereinafter Appellate Body Report, U.S. - Continued Suspension]
13. Id. paras.421, 422, 467, 472, 477, 479, 481, 482
14. The JECFA was established in 1956 under the auspice of FAO/WHO, which is run independently of Codex. See Codex website: http://www.codexalimentarius.org/ scientific-basis-for-codex/jecfa/en/
15. Jacqueline Peel, Science and Risk Regulation in International Law 294 (Cambridge, Cambridge U. P., 2010); Panel Report, United States - Continued Suspension of Obligations in the EC - Hormones Dispute, WTO Doc. WT/DS320/R, n. 377 to para. 7.78 (March 31, 2008)[hereinafter Panel Report, US - Continued Suspension]
16. Antonia Eliason, Science Versus Law in WTO Jurisprudence: The (Mis)Interpretation of the scientific Process and the (In)Sufficiency of Scientific Evidence in EC - Biotech, 41 N.Y.U. J. Int'l L. & Pol. 342, 353 (2009)
17. Peel, supra note 13, at 98-103 (elaborating works of social scientists regarding uncertainty in science)
18. The case of E. Coli raised by the EC provides a good example. See Panel Report, EC - Measures Concerning Meat and Meat Products, WTO Doc. WT/DS48/R/CAN, para. 4.213 (Aug. 18, 1997)[hereinafter Panel Report, EC - Hormones]
19. Marielle D. Masson-Matthee, The Codex Alimentarius Commission and Its Standards 69, n. 91. (The Hague: TMC Asser, 2007)(explaining the lacking of national regulations for field test requirement and the reluctance of many local industry to accept the requirement)
20. Cf It is argued that every product implies differential risk. To require a zero risk is impracticable. However, according to the ruling on Australia-Salmon case, the Appellate Body recognizes the right of WTO members to use zero risk as an appropriate level of protection. See Appellate Body Report, Australia-Measures Affecting Importation of Salmon, WTO Doc. WT/DS18/AB/R, para. 125 (Oct. 20, 1998)
21. Statements of Principles Concerning the Role of Science," in Codex Procedural Manual, at 209-10 (20th ed. 2011), available at ftp://ftp.fao.org/ codex/Publications/ProcManuals/Manual-20e.pdf (last visited July 31, 2011)[hereinafter Codex Procedural Manual]
22. According to Codex Procedural Manual, the procedure to conclude a food standard consists of eight steps. See "Uniform Procedure for the Elaboration of Codex Standards and Related Texts," id., at 31-32
23. See Peel, supra note 13, at 294
24. Masson-Matthee, supra note 17, at 68; Ravi Afonso Pereira, Why Would International Administrative Activity be Any Less Legitimate?- A Study of the Codex Alimentarius Commission, 9 German L. J. 1693, 1701 (2008)
25. Masson-Matthee, supra note 17, at 68
26. G.G. Moy and J.R. Wessel, Codex Standards for Pesticides Residues, in International Standards for Food Safety 215 (N. Rees and D. Watson eds., Aspen, 2000)
27. Masson-Matthee, supra note 17, at 68
28. David G. Victor, The Sanitary and Phitosanitary Agreement of the WTO: An Assessment After Five Years, 32 N. Y. U. J. Int'l L. & Pol. 865, 899 (2000)(explaining the determination of MRLs relies on "no effect" level in tested animals, but questioning "how it translates to human effects has not been rigorously defined or quantified")
29. It is observed that there are only s9 test persons that have been studied concerning ractopamine's effect. See European Food Safety Authority's scientific opinion on Safety Evaluation of ractopamine, the Scientific Opinion of the Panel on Additives and Products or Substances Used in Animal Feed, adopted on Apr. 2, 2009, The EFSA Journal (2009) 1041, at 24, 28, available at http://www.efsa.europa.eu/en/efsajournal/pub/1041.htm (last visited May 1, 2012)
30. Many Asians preferentially consume the organs of livestock. China has raised concerns about the higher concentrations of ractopamine residues in pig organs. See Food Safety News website: http://www.foodsafetynews.com/2012/07/ codex-votes-69-67-to-advance-ractopamine-limits-for-beef-and-pork/
31. Codex Procedural Manual, supra note 20, at 25
32. Masson-Matthee, supra note 17, at 172
33. steps 4, 5 of Uniform Procedure for the Elaboration of Codex Standards and Related Texts, Codex Procedural Manual, supra note 20, at 31, 32
34. Pereira, supra note 23, at 1700-01. A risk assessment as observed is to decide what level of risk is acceptable, which usually subjects to non-science factors. Although risk managers are expected to base their judgment on risk assessments, they needs to consider other factors relating to the protection of consumers' health and the promotion of fair food trade. See id
35. Michael A. Livermore, Authority and Legitimacy in Global Governance: Deliberation, Institutional Differentiation and the Codex Alimentarius, 81 NYU L.Rev. 766, 784-85 (2006); Lucinda Sikes, FDA's Consideration of Codex Alimentarius Standards in Light of International TradeAgreements, 53 Food & Drug L.J. 327, 330 (1998)
36. Livermore, supra note 35, n. 90
37. The voice of consumer groups remains less influential than that of groups of industry. Id. at 785-86
38. Lori M. Wallach, Globalization and Sovereignty: Accountable Governance in the Era of Globalization: The WTO, NAFTA, and International Harmonization of Standards, 50 Kan. L. Rev. 823, 836 (2002)
39. It has been rightly pointed out that "industry representatives [who] are seeking to use the international harmonization process as a vehicle for global deregulation." See B. A. Silverglade, The Impact of International Trade Agreements on U.S. Food Safety and Labelling Standards, 53 Food & Drug L. J. 537, 540 (1998)
40. Alan Boyle & Christine Chinkin, The Making of International Law 101 (Oxford: Oxford U. P., 2007);Jan Klabbers, Anne Peters and GeirUlfstein, The Constitutionalization of International Law 55(Oxford, Oxford UP, 2009)
41. Boyle & Chinkin, supra note 40, at 101-102
42. The United Nations Convention on the Law of the Sea, UN Doc. A/CONF.62/122 (1982), 21 ILM 1261, in force Nov. 16, 1994, Art. 161
43. Boyle & Chinkin, supra note 40, at 158
44. Agreement for the Implementation of the Provisions of the United Nations on the Law of the Sea of 10 December 1982 relating to the Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks, UN Doc. A/CONF.164/37 (1995), 34 ILM 1542, in force Nov. 11, 2001
45. Boyle & Chinkin, supra note 40, at 158
46. For instance, the 2007 UN Declaration on the Rights of Indigenous Peoples was adopted by voting. The UN Declaration was adopted by a majority of 143 states in favor, with 4 votes against (Australia, Canada, New Zealand and the United States) and 11 abstentions (Azerbaijan, Bangladesh, Bhutan, Burundi, Colombia, Georgia, Kenya, Nigeria, Russian Federation, Samoa, and Ukraine). See Office of the United Nations High Commissioners for Human Rights, at http://www2.ohchr.org/english/issues/indigenous/declaration.htm (last visited Aug. 10, 2009)
47. Barry Buzan, Negotiating by Consensus: Developments in Technique at the UN Conference on the Law of the Sea, 75 Am. J. Int'l L. 324, 329 (1981)
48. Since the inception of the WTO in 1995, the trade regime has constantly engaged in negotiation and decision-making based on consensus. The WTO never resorts to a voting process. Otherwise, the major members that are of developing countries would have dominated the decision of the regime. Yet, it is also true that the current Doha negotiation almost collapses mainly because no consensus could be reached among WTO members
49. Livermore, supra note 35, at 787
50. The SPS Agreement, supra note 1, art. 3.2
51. Terence P. Stewart & David S. Johanson, The SPS Agreement of the World Trade Organization and International Organizations: the Roles of the Codex Alimentarius Commission, the International Plant Protection Convention, and the International Office of Epizootics, 26 Syracuse J. Int'l L. & Com. 27, 45 (1998)
52. Victor, supra note 28, at 931; Livermore, supra note 35, at 789. Countries like America and the European nations have adopted a differential policy on growth promoting hormones. The use of hormones would be legal in North America if farmers comply with regulations. By contrast, the EC directives prohibit the use of hormones as veterinary drugs
53. 33 votes in favor, 29 against, 7 abstentions.Report of the 21st Session of the Joint FAO/WHO Codex Alimentarius Commission, Rome, July 3-8, 1995 ALINORM 95/37, para. 45 [hereinafter Codex 21st Session Report]
54. Rules of Procedure, Rule V3, para.5, in Codex Procedural Manual (20th ed., 2010), supra note 20, at 11
55. Codex 21st Session Report, supra note 58, para. 46; Stewart & Johanson, supra note 56, at 42
56. 33 votes in favor, 31 against and 10 abstentions.Report of the 22nd Session of the Joint FAO/WHO Codex Alimentarius Commission, Geneva, June 23-28, 1997 ALINORM 97/37, para. 69 [hereinafter Codex 22nd Session Report]
57. Victor, supra note 28, at 887
58. The U.S. objected the standard by stating that "[this] standard ignores public health protection by prohibiting any antimicrobial treatment and creates a barrier to international trade by including unnecessary and inappropriately restrictive requirements which are contrary to the General Principles of Codex Alimentarius, adopted by the Commission to protect public health and facilitate international trade. Codex 22nd Session Report, supra note 61, para. 91
59. Id. para. 93; According to an evaluation initiated by the FAO in 2002, the majority of Codex members objected an increase of resorting to vote in standard-making. W. Bruce Trail et al., Report of the Evaluation of the Codex Alimentarius and Other FAO and WHO Food Standards Work (2002), at (2002), at § 4.4.3.7
60. Rule of Procedure, Rule 12, para. 2, in Codex Procedural Manual (20th ed., 2010), supra note 20, at 14
61. Masson-Matthee, supra note 17, at 233
62. Annex 2 to the Marrakesh Agreement Establishing the World Trade Organization, in The Legal Texts: The Results of the Uruguay Round of Multilateral Trade Negotiations 354 (1999)
63. Masson-Matthee, supra note 17, at 185
64. The SPS Agreement, supra note 1, art. 3
65. Panel Report, EC - Hormones, supra note 16, para. 9.72
66. Panel Report, EC - Trade Description of Sardines, WTO Doc. WT/DS231/R, para. 4.34 (May 29, 2002)[hereinafter Panel Report, EC - Sardines]
67. Decision of The Committee On Principles For The Development of International Standards, Guides and Recommendations With Relation to Articles 2, 5 and Annex 3 of The Agreement, Committee on Technical Barriers to Trade, WTO Doc. G/TBT/9, adopted November 13, 2000, para. 9
68. Panel Report, EC - Sardines, supra note 76, para. 4.33
69. Appellate Body Report, EC - Sardines, supra note 9, para. 227
70. Henrik Horn and Joseph H.H. Weiler, European Communities- Trade Description of Sardines: Textualism and its Discontent, in The WTO Case Law of 2002 255 (Henrik Horn and Petros C. Mavroidis eds., Cambridge, Cambridge U. P., 2005)
71. For instance, Chile worried the adverse effect of the Appellate Body ruling. See Dispute Settlement Body, WTO Doc. WT/DSB/M/134, at 12, para. 41 (Oct. 23, 2002)
72. Klabbers et al, supra note 40, at 64
73. Questions of Interpretation and application of the 1971 Montreal Convention arising from the Aerial Incidents at Lockerbie, (preliminary objections) ICJ Rep. 9 (1988)[hereinafter Lockerbie]
74. Application of the Convention on the Prevention and Punishment of the Crime of genocide (provisional measures), ICJ Rep. 3 (1993)
75. Lockerbie, supra note 87, at 15
76. Livermore, supra note 35, at 790
77. Id.at 790-96; Joanne Scott, International Trade and Environmental Governance: Relating Rules (and Standards) in the EU and the WTO, 15 Euro. J. Int'l L. 307, 330-33 (2004); Pereira, supra note 23, at 1711-12
78. Livermore, supra note 35, at 790-91
79. Masson-Matthee, supra note 17, at 190-91
80. Id. at 190. (For instance, Masson-Matthee observes that the Lome Convention had been reviewed in the WTO Banana case.)
81. Livermore, supra note 35, at 792. Cf From a general perspective of international law, Klabbers submits that the scope of matters to be reviewed should also cover the content of the decisions as so to ensure respect of general international law, of course including ergaomnes. Klabbers, supra note 40, at 67
82. Livermore, supra note 35, at 794-95
83. The Appellate Body considered that the lack of a proper appeal mechanism provided for importing countries as such was of arbitrary discrimination, and thus violated U.S. obligations under the chapeau of Article XX of the GATT 1994. Appellate Body Report, United States - Import Prohibition of Certain Shrimp and Shrimp Products, WTO Doc. WT/DS58/AB/R, paras. 177-83 (Oct. 12, 1998)[hereinafter Appellate Body Report, U.S. - Shrimp]. For a discussion on the principle of due process in the WTO dispute settlement proceedings, see Andrew Mitchell, Legal Principles in WTO Disputes 145-76 (Cambridge: Cambridge U.P., 2008)
84. Livermore, supra note 35, at 795
85. The SPS Agreement, supra note 1, art. 3.5
86. It should be understandable that a Codex member will oppose such review if a presumed Codex standard favoring its position would be so applied as to push the lift of trade restrictions of other countries
87. Richard H. Steinberg, Judicial Lawmaking at the WTO: Discursive, Constitutional, and Political Constraints, 98 Am. J. Int'l L. 257 (2004)(addressing concerns about expansive judicial lawmaking at the WTO); Boyle & Chinkin, supra note 40, at 263-311(providing a general discussion on law-making activities of international courts)
88. It is proposed that a structure of international judicial review should encompass issues of scope, matters to be covered, standing and effects etc. Klabbers et al, supra note 40, at 66-67
89. Marrakesh Agreement Establishing the World Trade Organization, art.9, para. 2
90. Jan Klabbers, Straddling Law and Politics: Judicial Review in International Law, in Towards World Constitutionalism: Issues in the Legal Ordering of the World Community 833 (Ronald St J MacDonald and Douglas M Johnston eds.,MartinusNijhoff 2005)
91. According to article 22.6 of the DSU, the U.S. was authorized to terminate its concessions and obligations towards the EC by imposing higher tariffs on the importation of EC products. See Appellate Body Report, U.S. - Continued Suspension, supra note 10, paras. 8-9
92. Article 11 of the DSU requires the Panel to conduct an objective assessment of the matter before it
93. Appellate Body Report, U.S. - Continued Suspension, supra note 10, paras. 10. 11
94. Id. para. 11
95. The SPS Agreement, supra note 1, art. 11.2
96. Append9 4 to the DSU
97. Rules of Conduct for the Understanding on Rules and Procedures Governing the Settlement of Disputes, WT/DSB/RC1
98. Panel Report, U.S. - Continued Suspension, supra note 13, para. 6.22
99. Id. paras. 7.84
100. Id. paras. 7.85
101. The Appellate Body considered due process protection covers the selection and consultations with experts. See Appellate Body Report, U.S. - Continued Suspension, supra note 10, para. 436
102. The two doctors were not only members of the JECFA, but played a significant role in hormone discussions by serving Chairman, Vice-Chairman, and Joint-Rapporteur. See id. para. 460
103. Id. paras.462-68, 477
104. Id. para. 469
105. Id. paras. 458, 477, 479 (The EC argued the limitations in JECFA's assessments and pointed out the data used by JECFA was outdated)
106. Id. para. 481
107. See Sungjoon Cho, Case Report on United States - Continued Suspension of Obligations in the EC - Hormones Dispute, 103 Am. J. Int'l L. 299, 303 (2009)
108. JoostPauwelyn, U.S.-EU Hormone Case Limits WTO Role in Reviewing SPS Measures, INSIDE U.S. TRADE (Oct. 24, 2008); Michael M. Du, Standard of Review under the SPS Agreement after Hormones II, 59 Int'l & Com. L. Q 441, 459 (2010)