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The TPP and Good Regulatory Practices: An Opportunity for Regulatory Coherence to Promote Regulatory Autonomy?

Published online by Cambridge University Press:  24 February 2016

ELIZABETH SHEARGOLD*
Affiliation:
Research Fellow, Melbourne Law School, University of Melbourne
ANDREW D. MITCHELL*
Affiliation:
Professor, Melbourne Law School, University of Melbourne

Abstract

Chapters relating to regulatory coherence or cooperation are likely to be significant features of new preferential trade agreements, including the Trans-Pacific Partnership (TPP). While the potential for harmonization of standards or institutional cooperation to impact on the regulatory autonomy of treaty parties has been well considered, this article focuses on those elements of regulatory coherence that relate to domestic processes for the development of regulations. It examines whether the adoption of ‘good regulatory practices’ in accordance with the TPP will help to ensure that measures states enact to protect non-economic interests (such as the environment or public health) are consistent with other key obligations of international trade and investment law. Although many elements of good regulatory practice mirror the criteria used to distinguish legitimate regulatory measures from disguised protectionism, there is no guarantee that a tribunal will come to the same conclusions as those reached during a domestic impact assessment.

Type
Review Article
Copyright
Copyright © Elizabeth Sheargold And Andrew D. Mitchell 2016 

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References

1 These include the United States’ ban of certain flavours of cigarettes, and Australia and Uruguay's regulations on tobacco packaging. See, e.g., Appellate Body Report, United States – Measures Affecting the Production and Sale of Clove Cigarettes, WT/DS406/AB/R, adopted 24 April 2012 (US–Clove Cigarettes); Request for Arbitration, Philip Morris Brands Sàrl, Abal Hermanos S.A. v. Uruguay, ICSID Case No. ARB/10/7 (19 February 2010); Written Notification of Claim by Philip Morris Asia Limited to the Commonwealth of Australia Pursuant to Agreement between the Government of Hong Kong and the Government of Australia for the Promotion and Protection of Investments, PCA Case No. 2012-12 (27 June 2011); Requests for Consultations by Honduras, Cuba, Dominican Republic and Indonesia, Australia – Certain Measures Concerning Trademarks, Geographical Indications and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging, WT/DS435 (4 April 2012), WT/DS441 (18 July 2012), WT/DS458 (3 May 2013), WT/DS467 (20 September 2013).

2 These include Canadian and European measures concerning feed-in tariffs, and Germany's phase out of its nuclear energy program. See, e.g., Notice of Arbitration, Mesa Power Group LLC v. Canada,  PCA Case No. 2012-17 (4 October 2011); Appellate Body Reports, Canada – Certain Measures Affecting the Renewable Energy Generation Sector/Canada – Measures Relating to the Feed-in Tariff Program, WT/DS412/AB/R, WT/DS426/AB/R (adopted 24 May 2013); Notice of Arbitration, Vattenfall AB and Others v. Federal Republic of Germany, ICSID Case No. ARB/12/12 (31 May 2012); Request for Consultations by China, European Union and Certain Member States – Certain Measures Affecting the Renewable Energy Generation Sector, DS452 (5 November 2012).

3 These include a European Union ban on seal products, and United States’ measures relating to ‘dolphin safe’ labels for tuna. See, e.g., Appellate Body Reports, European Communities – Measures Prohibiting the Importation and Marketing of Seal Products, WT/DS400/AB/R, WT/DS401/AB/R (adopted 18 June 2014) (EC–Seal Products); Appellate Body Report, United States – Measures Concerning the Importation, Marketing and Sale of Tuna and Tuna Products, WT/DS381/AB/R (adopted 13 June 2012).

4 These concerns have been particularly pronounced in relation to international investment law, and cases arising under investor–state dispute settlement mechanisms. See, e.g., European Commission, Investment Protection and Investor-to-State Dispute Settlement in EU agreements, Fact Sheet, November 2013.

5 See Council of the European Union, Directives for the Negotiation on the Transatlantic Trade and Investment Partnership between the European Union and the United States of America, 17 June 2013, 11103/13, DG C 1, p. 12 (TTIP Directives); full text of the Trans-Pacific Partnership Agreement (released 5 November 2015, not yet signed or entered into force), http://tpp.mfat.govt.nz/text, Chapter 25 (TPP Text).

6 Robert E. Hudec, The GATT Legal System and World Trade Diplomacy (Butterworth, 2nd edn, 1990) 232; Olivier Long, Law and its Limitations in the GATT Multilateral Trade System (M. Nijhoff, 1985) 25; Andrew Lang, World Trade Law after Neoliberalism (Oxford University Press, 2011) 169–170; Howse, Robert, ‘From Politics to Technocracy – and Back Again: The Fact of the Multilateral Trade Regime’ (2002) 96 American Journal of International Law 94, 101Google Scholar.

7 UNCTAD, Expropriation: A Sequel (UNCTAD, 2011), p. xii.

8 See Consolidated CETA Text (published 26 September 2014, not yet signed or entered into force), http://trade.ec.europa.eu/doclib/docs/2014/september/tradoc_152806.pdf, Chapter 26 (CETA Text); TPP Text, above n. 5, Chapter 25.

9 See TTIP Directives, above n. 5, p. 12; Enhancing Trade and Investment, Supporting Jobs, Economic Growth and Development: Outlines of the Trans-Pacific Partnership Agreement, 12 November 2011 (Honolulu, Hawaii), https://ustr.gov/tpp/outlines-of-TPP (TPP Outline).

10 Rodrigo Polanco, ‘The Trans-Pacific Partnership Agreement and Regulatory Coherence’, in Tania Voon (ed.), Trade Liberalisation and International Co-operation: A Legal Analysis of the Trans-Pacific Partnership (Edward Elgar, 2013) 231, 231.

11 TTIP Directives, above n. 5, p. 12.

12 TPP Outline, above n. 9.

13 TPP Text, above n. 5, art. 25.2(1).

14 See, e.g., OECD, APEC–OECD Integrated Checklist on Regulatory Reform (OECD Publishing, 2008), http://www.oecd-ilibrary.org/governance/apec-oecd-integrated-checklist-on-regulatory-reform_9789264051652-en APEC, ‘Information Notes on Good Practice for Technical Regulation’ (APEC, September 2000).

15 OECD, above n. 14, 2.

16 Thomas J. Bollyky, ‘Better Regulation for Freer Trade’ (Council on Foreign Relations, June 2012) 2, http://www.cfr.org/trade/better-regulation-freer-trade/p28508.

17 In addition to these, regulations that are discriminatory to foreign goods, services, or investment, either in law or fact, are a form of protectionism, and will necessarily impact on trade and investment. See Thomas J. Bollyky, ‘Regulatory Coherence in the TPP Talks’, in C. L. Lim, D. K. Elms and P. Low (eds.), The Trans-Pacific Partnership: A Quest for a Twenty-first-Century Trade Agreement (Cambridge University Press, 2012) 171, 172.

18 See Council of the OECD, ‘Recommendation of the Council on Regulatory Policy and Governance’ (22 March 2012) 4, http://www.oecd.org/gov/regulatory-policy/49990817.pdf.

19 OECD, ‘Introductory Handbook for Undertaking Regulatory Impact Analysis (RIA)’ (October 2008) 3, http://www.oecd.org/gov/regulatory-policy/44789472.pdf.

20 See, generally, Council of the OECD, above n. 18; OECD, above n. 14; Improving Regulation and Regulatory Review, Executive Order 13563, 76 Fed. Reg. 3821 (18 January 2011).

21 OECD, above n. 14, 16.

22 On how regulatory reform can improve prospects for international trade and investment, see generally: OECD, Enhancing Market Openness through Regulatory Reform (OECD Publishing, 2008), http://www.oecd-ilibrary.org/governance/enhancing-market-openness-through-regulatory-reform_9789264051478-en.

23 See Polanco, above n. 10, 242.

24 Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 UNTS 3 (entered into force 1 January 1995) (Marrakesh Agreement), annex 1A, Agreement on the Application of Sanitary and Phytosanitary Measures, art. 3.3 (SPS Agreement).

25 Marrakesh Agreement, annex 1A, Agreement on Technical Barriers to Trade (TBT Agreement).

26 See, e.g., Promoting International Regulatory Cooperation, Executive Order 13609, 77 Fed. Reg. 26413 (1 May 2012).

27 Some examples are discussed below, in section 3.

28 Claude Barfield, ‘The Trans-Pacific Partnership: A Model for Twenty-First Century Trade Agreements?’ (International Economic Outlook No. 2 of 2011, American Enterprise Institute, 1 June 2011) 7, https:// www.aei.org/publication/the-trans-pacific-partnership/; Lester, Simon and Barbee, Inu, ‘The Challenge of Cooperation: Regulatory Trade Barriers in the Transatlantic Trade and Investment Partnership’ (2013) 16 Journal of International Economic Law 847, 857858 Google Scholar.

29 We note that Hoekman and Mavroidis distinguish between regulatory coherence and regulatory cooperation. In their taxonomy, regulatory coherence refers to provisions requiring the adoption of good regulatory practices, while regulatory cooperation refers to measures that may reduce divergence between jurisdictions. Bernard M. Hoekman and Petros C. Mavroidis, ‘Regulatory Spillovers and the Trading System: From Coherence to Cooperation’ (E15 Intiative, ICTSD and World Economic Forum, April 2015) 2–3, http://e15initiative.org/publications/regulatory-spillovers-and-the-trading-system-from-coherence-to-cooperation/.

30 See, e.g., US Model BIT (2012).

31 For further details on these transparency requirements and their interpretation, see Mitchell, Andrew D., Sheargold, Elizabeth, and Voon, Tania, ‘Good Governance Obligations in International Economic Law: A Comparative Analysis of Trade and Investment’ (2016) 17 Journal of World Investment and Trade 7 CrossRefGoogle Scholar.

32 Korea–United States Free Trade Agreement, signed 30 June 2007 (entered into force 15 March 2012).

33 See, e.g., Trans-Pacific Strategic Economic Partnership Agreement, signed 18 July 2005 (provisionally entered into force 1 May 2006; officially entered into force 28 May 2006), chapter 14; China–New Zealand Free Trade Agreement, signed 7 April 2008 (entered into force 1 October 2008), chapter 13; Singapore–Peru Free Trade Agreement, signed 29 May 2008 (entered into force 1 August 2009), chapter 15; Malaysia–Australia Free Trade Agreement, signed 22 May 2012 (entered into force 1 January 2013), chapter 17.

34 Bollyky, above n. 16, 176–177.

35 Steger, Debra P., ‘Institutions for Regulatory Cooperation in “New Generation” Economic and Trade Agreements’ (2012) 39 Legal Issues of Economic Integration 109, 114115 Google Scholar.

36 Ibid. 115.

37 See Council of Australian Governments, The Trans-Tasman Mutual Recognition Arrangement, https:// www.coag.gov.au/the_trans-tasman_mutual_recognition_arrangement.

38 See, generally, Food Standards Australia and New Zealand, About FSANZ, http://www.foodstandards.gov.au/Pages/default.aspx.

39 ASEAN Framework Agreement on Mutual Recognition Arrangements, signed 16 December 1998.

40 Bollyky, above n. 16, 176.

41 See, Hoekman and Mavroidis, above n. 29, 2–3.

42 Krstic, Stanko S., ‘Regulatory Cooperation to Remove Non-Tariff Barriers to Trade in Products: Key Challenges and Opportunities for the Canada–EU Comprehensive Trade Agreement (CETA)’ (2012) 39 Legal Issues of Economic Integration 3, 56 Google Scholar; Lester and Barbee, above n. 28, 849–852.

43 CETA Text, above n. 8, Chapter 26, Articles X.4, X.5, and X.6, Chapter 27. See also Hoekman and Mavroidis, above n. 29, 8.

44 EU Textual Proposal for TTIP Regulatory Cooperation Chapter, April 2015 (publicly released 4 May 2015), http://trade.ec.europa.eu/doclib/docs/2015/april/tradoc_153403.pdf (EU TTIP Proposal).

45 For greater detail about some of these differences, see Bernard M. Hoekman and Petros C. Mavroidis, ‘Regulatory Spillovers and the Trading System: From Coherence to Cooperation’ (E15 Intiative, ICTSD and World Economic Forum, April 2015) 8, http://e15initiative.org/publications/regulatory-spillovers-and-the-trading-system-from-coherence-to-cooperation/.

46 CETA Text, above n. 8, Chapter 26, Article X.3.

47 EU TTIP Proposal, above n. 44, section 2.1.

48 Ibid., Article 7.

49 See TPP Text, above n. 5.

50 Ibid. art. 25.4.

51 Ibid. art. 25.5.

52 Ibid. art. 25.6.

53 Ibid. art. 25.7.

54 Ibid. art. 25.7(1)(b) and art. 25.8.

55 Ibid. art. 25.3.

56 Cf. EU TTIP Proposal, above n. 44, art. 10(2)(a); CETA Text, above n. 8, Chapter 26, Article X.4(18).

57 The relationship between regulatory coherence and regulatory autonomy is discussed in greater detail below, in Sections 4 and 5.

58 APEC Leaders Declaration, Annex D, Strengthening Implementation of Good Regulatory Practices, 12–13 November 2011, http://www.apec.org/Meeting-Papers/Leaders-Declarations/2011/2011_aelm/2011_aelm_annexD.aspx.

59 See TPP Text, above n. 5, Chapter 25. This focus on regulatory practice, rather than substantive harmonisation, was anticipated by many commentators. See, generally, Bollyky, above n. 16, 181–182; Polanco, above n. 10, 254–256.

60 Bollyky, above n. 16, 181.

61 TPP Text, above n. 5, art. 25.4(1)–(2).

62 Ibid. art. 25.5(1).

63 Ibid. art. 25.5(2) (emphasis added).

64 Polanco, above n. 10, 251–252.

65 These documents are: OECD, above n. 14; APEC, above n. 14. See Trans-Pacific Partnership Agreement Regulatory Coherence Chapter, Dated 4 March 2010, available from Citizens Trade Campaign, http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificRegulatoryCoherence.pdf (Draft TPP Regulatory Coherence Chapter).

66 OECD, ‘Introductory Handbook for Undertaking Regulatory Impact Analysis (RIA)’, above n. 19, 10.

67 Ibid.

68 Ibid.

69 TPP Text, above n. 5, art. 25.5(2)(b).

70 Ibid.

71 Cost-efficiency analysis takes the benefits of a proposed regulation as given, and focuses only on comparing the costs of different alternatives. It may be useful when there is limited technical expertise or resources for a full CBA. Partial CBA refers to a cost–benefit analysis where some of the costs or benefits are not able to be included, either because of insufficient information or an inability to quantify. In these circumstances, a partial CBA may still be of use when assessing the available alternatives. See OECD, ‘Introductory Handbook for Undertaking Regulatory Impact Analysis (RIA)’, above n. 19, 10.

72 TPP Text, above n. 5, art. 25.11.

73 Polanco, above n. 10, 254; Bollyky, above n. 16, 180.

74 OECD, above n. 14, 3.

75 TPP Text, above n. 5, art. 25.2(2)(b)–(c).

76 For example, see Corporate Europe Observatory, Regulatory Cooperation in TTIP: United in Deregulation (8 April 2015), http://corporateeurope.org/international-trade/2015/04/regulatory-cooperation-ttip-united-deregulation.

77 See, generally, Alemanno, Alberto, ‘The Regulatory Cooperation Chapter of the Transatlantic Trade and Investment Partnership: Institutional Structures and Democratic Consequences’ (2015) 18 Journal of International Economic Law 625 Google Scholar.

78 Ibid. 629.

79 Jane Kelsey, ‘Preliminary Analysis of the Draft TPP Chapter on Domestic Coherence’ (23 October 2011) 2, http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacific_RegCoherenceMemo.pdf.

80 See TPP Text, above n. 5, art. 25.11.

81 Alberto Alemanno, ‘Is There a Role for Cost–Benefit Analysis Beyond the Nation-State?: Lessons from International Regulatory Co-operation’, in Michael A. Livermore and Richard L. Revesz (eds.), The Globalization of Cost–Benefit Analysis in Environmental Policy (Oxford University Press, 2013) 105.

82 On the link between regulatory process and outcomes, see , generally, OECD, above n. 14; APEC, above n. 14; OECD, ‘Introductory Handbook for Undertaking Regulatory Impact Analysis (RIA)’, above n. 19.

83 Mattoo, Aaditya and Subramanian, Arvind, ‘Regulatory Autonomy and Multilateral Disciplines: The Dilemma and a Possible Resolution’ (1998) 1 Journal of International Economic Law 303, 304Google Scholar.

84 See, generally, OECD, above n. 14; OECD, above n. 22.

85 This is considered in greater detail below, in section 3.

86 Interestingly, in at least two investment cases that we know of, the claimant alleged that the conduct of an RIA process itself (in both cases, an environmental impact assessment), contributed to a breach of the fair and equitable treatment obligation. In one of these cases, the tribunal held that the conduct of an environmental assessment in accordance with domestic law could not constitute a violation of fair and equitable treatment. See Emilio Augustin Maffezini v. Spain (Award), ICSID Case No. ARB/97/7 (13 November 2000) [67]–[71]. The second case found that the conduct and findings of the environmental assessment process did constitute a violation of fair and equitable treatment. See discussion below n. 134–139 and accompanying text.

87 See, e.g., the measures at issue in Clatyon and Bilcon v. Canada (Award on Jurisdiction and Liability), PCA Case No. 2009–04 (17 March 2015) (Bilcon v. Canada); Appellate Body Report, US–Clove Cigarettes. It is noteworthy that the US, which has well regarded regulatory practices, has recently had a number of its regulations found to be inconsistent with the WTO Agreements, particularly the TBT Agreement.

88 We note that the trade provisions considered in this section are those of key WTO Agreements, particularly the GATT 1994, the SPS Agreement, and the TBT Agreement, rather than those in PTAs. However, comparable provisions are found in virtually all PTAs.

89 TPP Text, above n. 5, art. 25.5(2)(a).

90 Marrakesh Agreement, annex 1B (GATS).

91 See GATT 1994, art. XX(b) and GATS art. XIV(b).

92 SPS Agreement, annex A, para. 5.

93 TBT Agreement, art. 2.1. Article 2.2 of the TBT Agreement also clearly demands consideration of the regulatory purpose of a measure, as it requires that ‘technical regulations shall not be more trade-restrictive than necessary to fulfil a legitimate objective, taking account of the risks non-fulfilment would create. Such legitimate objectives are, inter alia: national security requirements; the prevention of deceptive practices; protection of human health or safety, animal or plant life or health, or the environment’.

94 Appellate Body Report, US–Clove Cigarettes [174].

95 Ibid.

96 See, e.g., Australia–Japan EPA, annex 12, para. 3(c).

97 See, e.g., Methanex Corporation v. United States of America (Final Award), NAFTA Chapter 11 Arbitral Tribunal, UNCITRAL (3 August 2005), Part IV, Chapter D [15] (Methanex); Saluka Investments BV v. Czech Republic, UNCITRAL, Partial Award (17 March 2006) [255]; LG&E Energy Corp. and Others v. Argentina (Decision on Liability) (2007) 46 ILM 36 [195]. In contrast, a small number of cases considering indirect expropriation disregarded regulatory purpose entirely, employing a doctrine known as the ‘sole effects’ test. See, e.g., Metalclad Corporation v. United Mexican States (Award), ICSID Case No. ARB(AF)/97/1 (30 August 2000) [110]–[111] (Metalclad); Compañia de Aguas v. Argentina (Award), ICSID Case No. ARB/97/3 (20 August 2007) [7.5.21].

98 See, e.g., Glamis Gold Ltd v. United States (Award), NAFTA Chapter 11 Arbitral Tribunal (8 June 2009) [805]–[806] (Glamis Gold); Alex Genin, Eastern Credit Limited, Inc. and A.S. Baltoil v. Estonia (Award), ICSID Case No. ARB/99/2 (25 June 2001) [370]–[371].

99 See, e.g., Methanex, Part IV, Chapter D [12]–[15]. In that case, the tribunal used evidence that the measure had a legitimate purpose (which was backed by scientific evidence), to rebut an allegation by the claimant that the measure was designed to favour domestic producers.

100 Appellate Body Report, United States – Measures Affecting the Cross-Border Supply of Gambling and Betting Services, WT/DS285/AB/R (adopted 20 April 2005) (US–Gambling) [304]. See also Appellate Body Report, EC–Seal Products [5.144]; Appellate Body Report, India – Measures Concerning the Importation of Certain Agricultural Products, WT/DS430/AB/R (adopted 19 June 2015) [5.221]–[5.222].

101 Appellate Body Report, Korea – Measures Affecting Imports of Fresh, Chilled and Frozen Beef, WT/DS161/AB/R, WT/DS169/AB/R (adopted 10 January 2001) (Korea – Various Measures on Beef) [175] [178]. See also Ming Du, Michael, ‘Autonomy in Setting Appropriate Level of Protection under the WTO Law: Rhetoric or Reality?’ (2010) 13 Journal of International Economic Law 1077, 10971098 Google Scholar.

102 See Metalclad [90]–[98]; Tecnicas Medioambientales Tecmed S.A. v. The United Mexican States (Award), ICSID Case No. ARB (AF)/00/2 (29 May 2003) [157]–[158] and [164]. For a similar example in the WTO context, see Panel Report, US–Clove Cigarettes [7.289].

103 See, e.g., TBT Agreement, art. 2.2; SPS Agreement, art. 5.6.

104 See Appellate Body Report, Korea – Various Measures on Beef [162]–[164]; Appellate Body Report, Brazil – Measures Affecting Imports of Retreaded Tyres, WT/DS332/AB/R (adopted 17 December 2007) (Brazil–Retreaded Tyres) [156]; Appellate Body Report, China – Measures Affecting Trading Rights and Distribution Services for Certain Publications and Audiovisual Entertainment Products, WT/DS363/AB/R (adopted 19 January 2010) [242]; Appellate Body Report, US–Gambling [305]–[308].

105 Bilcon v. Canada [590]–[591] (in which the majority of the tribunal held that a failure by a panel reviewing an environmental impact statement (EIS) to consider alternatives to its recommended course of action constituted a violation of the international minimum standard of treatment).

106 TPP Text, above n. 5, art. 2.5(2)(b).

107 Ibid.

108 Appellate Body Report, Brazil–Retreaded Tyres [171].

109 TPP Text, above n. 5, art. 2.5.(2)(b).

110 For a more detailed discussion of what may constitute ‘trade-restrictiveness’, see Voon, Tania, ‘Exploring the Meaning of Trade-Restrictiveness in the WTO’ (2015) 14 World Trade Review 451 Google Scholar.

111 OECD, above n. 14, 28.

112 OECD, ‘Introductory Handbook for Undertaking Regulatory Impact Analysis (RIA)’, above n. 19, 10.

113 Draft TPP Regulatory Coherence Chapter, above n. 65, art. X.3(1)(b)(2) and (b)(3).

114 TPP Text, above n. 5, art. 2.5(2)(b).

115 Ibid. art. 25.5(2)(c).

116 See sources cited above n. 104.

117 See, e.g., Glamis Gold [803]–[805]; Methanex Part IV, Chapter D [12]–[15]. In contrast, one tribunal upheld a measure which it had found to be ‘misguided’ and ineffective to achieve its stated purpose. In spite of this, the Tribunal found held that the measure was ‘plausibly connected with a legitimate goal of policy’ and that it was therefore not discriminatory. GAMI Investment, Inc. v. Mexico (Award), NAFTA Chapter 11 Arbitral Tribunal, UNCITRAL (15 November 2004) [114].

118 Joost Pauwelyn, ‘Does the WTO Stand for “Deference to” or “Interference with” National Health Authorities When Applying the Agreement on Sanitary and Phytosanitary Measures (SPS Agreement)?’, in Thomas Cottier, Petros Constantinos Mavroidis, and Patrick Blatter (eds.), Role of the Judge in International Trade Regulation: Experience and Lessons for the WTO (University of Michigan Press, 2003) 175, 184.

119 Regan, Donald H., ‘The Meaning of “Necessary” in GATT Article XX and GATS Article XIV: the myth of cost–benefit balancing’ (2007) 6 World Trade Review 347 Google Scholar. See also Robert Howse and Elisabeth Türk, ‘The WTO Impact on Internal Regulations’, in George A. Bermann and Petros C. Mavroidis (eds.), Trade and Human Health and Safety (Cambridge University Press, 2006) 116.; Federico Ortino, ‘From Non-Discrimination to Reasonableness: A Paradigm Shift in International Economic Law?’, Jean Monnet Working Papers 01/2005.

120 Regan, above n. 119, 348–349.

121 See Section 907(a)(1)(A) of the Federal Food, Drug and Cosmetic Act (FFDCA).

122 Panel Report, US–Clove Cigarettes [2.26]–[2.2.7].

123 Appellate Body Report, US–Clove Cigarettes [224]–[225].

124 Ibid. [216].

125 Ibid. [225].

126 We do not suggest that the Appellate Body should have performed a cost–benefit analysis of the measure at issue in Clove Cigarettes, as a detailed consideration of the appropriateness of cost–benefit analysis (or other RIA methodologies) as an appropriate analytical tool for a given type of regulatory measure is beyond the scope of this paper. For a critique of cost–benefit analysis, see Rose-Ackerman, Susan, ‘Putting Cost–Benefit Analysis in Its Place: Rethinking Regulatory Review’ (2011) 65 University of Miami Law Review 335 Google Scholar.

127 EU TTIP Proposal, above n. 44, Article 7.

128 For detailed discussion of some of these requirements (in the US, Canada, Australia, and EU), see Alemanno, above n. 81, 110–112.

129 Ibid. 111–112.

130 EU TTIP Proposal, above n. 44, Article 7.

131 TPP Text, above n. 5, art. 25.5(2)(d).

132 On the methodology for assessing including qualitative findings within CBA, see OECD, ‘Introductory Handbook for Undertaking Regulatory Impact Analysis (RIA)’, above n. 19, 10.

133 In contrast to the GATT, TBT, or SPS Agreements, which do not require deference to the findings of domestic authorities, Article 17.6(i) of the WTO's Anti-Dumping Agreement does provide for deference to national authorities, if their findings were objective and unbiased. See Pauwelyn, above n. 118, 185. For a consideration of how this question has been approached by domestic courts in constitutional adjudication, see Petersen, Niels, ‘Avoiding the Common-Wisdom Fallacy: The Role of Social Sciences in Constitutional Adjudication’ (2013) 11 International Journal of Constitutional Law 294 Google Scholar.

134 North American Free Trade Agreement (1993) 32 ILM 289 and (1993) 32 ILM 605.

135 Bilcon v. Canada [502]–[547]. This can be compared to the dissenting opinion of Professor Donald McCrae: Clayton and Bilcon v. Canada (Dissenting Option of Professor McCrae), 17 March 2005 [8]–[26] (Bilcon Dissent).

136 Bilcon v. Canada [591]–[594].

137 Ibid. [508].

138 Ibid. [530].

139 On the possible implications of this for regulatory decision-making in the future, see Bilcon Dissent [44]–[55].

140 TPP Text, above n. 5, art. 25.5(2)(d).