1 Transatlantic Economic Council High Level Working Group on Jobs and Growth, “Final Report”, 11 February 2013, at p. 1; The White House, Office of the Press Secretary, “U.S., EU Announce Decision to Launch Negotiations on a Transatlantic Trade and Investment Partnership”, 13 February 2013.

2 To the contrary, the Commission now opines that “the TTIP could end up encouraging others to revive the WTO negotiations.” European Commission, “TTIP Questions and Answers”, available at <http://ec.europa.eu/trade/policy/in-focus/ttip/questions-and-answers/> (last accessed on 26 November 2013). On the other hand, Lamy has noted that, while “[a]greeing to regulatory standards at a bilateral or regional level could lead to deeper regional integration, it could also complicate the process of achieving a much more global agreement with ‘regulatory coherence’ and potentially raise new barriers to trade.” Shawn Donnan, “Pascal Lamy Questions US-led Regional Trade Talks”, 18 July 2013, Financial Times.

3 BusinessEurope, “Massive Scope for EU-US Trade Agreement to Drive Growth and Jobs Creation Across Europe”, Press Release of 14 June 2013. National Association of Manufacturers, “Public Comments Concerning the Proposed Transatlantic Trade and Investment Partnership”, 10 May 2013. Business Coalition for Transatlantic Trade, “BCTT Working Group Recommendations Concerning the Transatlantic Trade and Investment Partnership”, July 2013.

4 Russi, Luigi, “Economic Analysis of Article 28 EC after the Keck Judgment”, 7 German Law Review (2005), 479 et sqq, at p. 483Google Scholar.

5 Organization for Economic Cooperation and Development, “Trade and Regulatory Reform: Insights from Country Experience”, 2001, at p. 101.

6 This approach engenders an importing State's unilateral decision, whether or not voluntary, to recognize the standards and regulations of a more stringent regulatory system that generally meets its public policy objectives in order to avoid the costs, burdens and resources needed to establish its own measures.

7 European Commission, “Transatlantic Trade and Investment Partnership: The Regulatory Part”, September 2013.

8 DG Trade, <http://trade.ec.europa.eu/doclib/press/index.cfm?id=918> (last accessed on 26 November 2013).

9 Maine Government, “TTIP FAQ – Negotiation Phase (Transatlantic Trade and Investment Partnership)”, 12 July 2013, at p. 4.

10 European Parliament Resolution of 23 May 2013 on EU Trade and Investment Negotiations with the United States of America, (2013/2558(RSP)), at par. 17.

11 “Euro-MPs Back US Trade Talks, But With ‘Cultural’ Exceptions”, EU Business, 24 May 24 2013, available at <http://www.eubusiness.com/news-eu/us-trade-france.oqa> (last accessed on 26 November 2013).

12 Magda Stoczkiewicz, “Trading Away Citizen and Environmental Safeguards”, European Voice, 10 October 2013.

13 EU Green Party, Draft Resolution to be Voted on – Transatlantic Trade and Investment Partnership (TTIP), at p. 2,

14 BusinessEurope, “Correspondence to Members and Substitutes of the Internal Market & Consumer Protection Committee (IMCO)”, 24 September 2013, at p. 2.

15 National Association of Manufacturers, “Public Comments Concerning the Proposed Transatlantic Trade and Investment Partnership”, 10 May 2013, at p. 2 (“[m]anufacturers strongly urge that regulatory frameworks and outcomes not be based on the EU's so-called Precautionary Principle, which leads to regulatory outcomes that are contrary to basic science, risk assessment and cost-benefit principles.”).

16 NASDA, “Letter to Deputy National Security Advisor Mike Froman on TTIP”, May 2013, at p. 1. (“At the core, the EU's non-scientific notion of ‘precaution’ has led to the adoption of many trade-restrictive measures that have resulted in several highprofile WTO disputes in which the EU's defense of the precautionary principle has been ruled to be inconsistent with WTO rules. Such precautionary measures are often based on mere hazard identification – or worse, on public perception and political considerations – rather than proper, science-based risk assessments, as required by the WTO. And, even in cases where risk assessments are ultimately carried out, the EU has demonstrated an inability to lift unjustifiable measures because of domestic political pressures. ‘Precaution’ in the EU has become a pretext for import protectionism under the pretense of consumer safety. As a result, U.S. exports have repeatedly paid the price.”).

17 The Business Coalition for Transatlantic Trade (“BCTT”) developed a set of recommendations for the TTIP negotiating Parties’ use which emphasized that “[s]cience-based decision making and not the precautionary principle must be the defining principle in setting up mechanisms and systems that will address both today's SPS barriers and those of the future.” Business Coalition for Transatlantic Trade, BCTT Working Group Recommendations Concerning the Transatlantic Trade and Investment Partnership, July 2013, at p. 10.

18 Regulatory harmonization and regulatory compatibility are flip sides of the same coin. Regulatory convergence is the rate at which harmonization is achieved. Regulatory cooperation is a process aimed at achieving convergence.

19 DG Trade's website is the EU's primary source of information: <http://ec.europa.eu/trade/policy/in-focus/ttip/> (last accessed on 26 November 2013). The USTR's TTIP website can be found at <http://www.ustr.gov/ttip> (last accessed on 26 November 2013).

20 European Commission, “Member States Endorse EU-US Trade and Investment Negotiations”, MEMO/13/564, Brussels, 15 June 2013.

21 Ibid.

22 European Commission, “Factsheet on Transparency in Trade Negotiations”, June 2013, at p. 4. It is the Commission's view that the public disclosure of its negotiating position would reveal “its entire strategy to [its] counterpart”, and thus, jeopardize its ability to “meet the objectives set out in the instructions from the Council.” Ibid.

23 Alex Hern and Dominic Rushe, “WikiLeaks Publishes Secret Draft Chapter of Trans-Pacific Partnership”, The Guardian, 13 November 2013.

24 Majone, Giandomenico, Dilemmas of European Integration: The Ambiguities and Pitfalls of Integration by Stealth (Oxford: Oxford University Press, 2005)CrossRefGoogle Scholar; Christian Engström, “EU Commissioner De Gucht Says No to Transparent TTIP Negotiations”, Christian Engström, Pirate MEP Blog, 23 May 2013.

25 Juan Mayoral, “Democratic Improvements in the European Union Under the Lisbon Treaty: Institutional Changes Regarding Democratic Government in the EU”, European University Institute – European Union Democracy Observatory, February 2011, pp. 7–8.

26 “Will the EU Parliament Let TAFTA Turn Into Another ACTA?”, 24 April 2013, Infojustice.org; Michael Carbone, “With ACTA Lessons Unlearned, An Uncertain Future for ‘21st Century’ Free Trade Agreements”, Bertelsmann Stiftung Future Challenges, 25 April 2013.

27 Corporate Europe Observatory, “Busting the Myths of Transparency Around the EU-US Trade Deal”, 25 September 2013; Trans-Atlantic Consumer Dialogue, “TACD Stakeholder Forum: The Transatlantic Trade and Investment Partnership: Can it Bring Benefits to the People?”, Summary Report, 29 October 2013, at pp. 2 and 4; Glyn Moody, “ISDS: ACTA by the Back Door?”, ComputerWorldUK, 17 October 2013.

28 DeLauro, “Miller Lead 151 House Dems Telling President They Will Not Support Outdated Fast Track For Trans-Pacific Partnership”, Congresswoman Rosa DeLauro Press Release, 13 November 2013; Tea Party, “Progressives Unite on Fast-Track Trade Authority”, Washington Times Communities, 13 November 2013; Paul Sracic, “The Odd Bipartisan Coalition That Could Sink Obama's Free-Trade Legacy”, The Atlantic, 18 June 2013.

29 Office of the United States Trade Representative, “Remarks by U.S. Trade Representative Michael Froman on the United States, the European Union, and the Transatlantic Trade and Investment Partnership”, 30 September 2013.

30 Karel De Gucht, “Speech – Transatlantic Trade and Investment Partnership (TTIP) – Solving the Regulatory Puzzle”, Europa Press Release (SPEECH/13/801), 10 October 2013.

31 Steve Suppan, “The Struggle for Transparency in the U.S.-EU Trade Deal”, Institute for Agriculture and Trade Policy Blog, 5 November 2013 (describing comments made by Neven Mimica regarding the PP).

32 Note, however, that Article 191(2),TFEU (ex Article 174 TEC) merely declares that the EU's environmental policy “shall be based on the precautionary principle.”

33 European Commission, “The Transatlantic Trade and Investment Partnership: The Regulatory Part”, September 2013, at p. 2. Cf. European Commission, “Trade, Growth and World Affairs: Trade Policy as a Core Component of the EU's 2020 Strategy”, 2010, p. 21. European Commission, “Transatlantic Trade and Investment Partnership: The Economic Analysis Explained”, September 2013.

34 For a quantitative assessment, see Centre for Economic Policy Research, “Reducing Transatlantic Barriers to Trade and Investment: An Economic Assessment”, Final Project Report, Brussels, March 2013, pp. 15–20.

35 Kogan, Lawrence A., “REACH and International Trade Law”, in Bergkamp, Lucas (ed.), The European Union REACH Regulation for Chemicals: Law and Practice (Oxford: Oxford University Press, 2013), pp. 309–334 Google Scholar.

36 Commission Implementing Regulation (EU) No 485/2013 of 24 May 2013 amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the use and sale of seeds treated with plant protection products containing those active substances, OJ L 139/12 (25.5.2013). Since Member State voting did not result in a qualified majority, the Commission was to decide whether to adopt the proposed regulation. Its decision to do so was based, in substantial part, on ‘data gaps’ as regards long term risk to honey bees and the absence of a regulatory impact assessment. For an analysis, see Alemanno, Alberto, “The Science, Law and Policy of Neonicotinoids and Bees: A New Test Case for the Precautionary Principle”, 4(2) European Journal of Risk Regulation (2013), pp. 191–208 CrossRefGoogle Scholar.

37 It has been suggested that a distinction should be made between the PP and the precautionary approach; the latter would be the Rio Declaration's ‘triple negative’ statement. We make no such distinction here.

38 European Commission. EU and US Conclude Second Round of TTIP Negotiations in Brussels Press Release (Nov. 15 2013)

39 Bradford, Anju, “The Brussels Effect”, 107 Northwestern University Law Review (2012), pp. 1–68 Google Scholar. For a discussion of the REACH Regulation's impact in the rest of the world, see Uyesato, Daniel et al., “REACH's Impact in the Rest of the World”, in Bergkamp, Lucas (ed.), The European Union REACH Regulation for Chemicals: Law and Practice (Oxford: Oxford University Press, 2013), pp. 335–370 Google Scholar.

40 Jeb Rubenfeld, “Two World Orders”, Wilson Quarterly, Autumn 2003, p. 26.

41 Industrial Union Department, AFL-CIO v. American Petroleum Institute, 448 U.S. 607, 639 (1980) (wherein the Supreme Court had decided that benzene could be regulated only if it posed a “significant risk of material health impairment”); Joseph C. Morelli, “The Benzene Case: Life, Liberty, and the Pursuit of Health — Industrial Union Department, AFLCIO v. American Petroleum Institute”, 3 W. New Eng. L. Rev (1980), p. 311 et sqq (discussing how the US Supreme Court “set up a two-part test for carcinogen regulation cases. The first prong…requires the Secretary to demonstrate the existence of a significant risk to employee health. The second prong deals with the existence of a cost-benefit test.”).

42 Executive Order 12866, “Regulatory Planning and Review”, 58 FR 51735, 4 October 1993; Circular No. A-4, “Regulatory Analysis”, Office of Management and Budget, 17 September 2003, (providing “guidance to Federal agencies on the development of regulatory analysis as required under Section 6(a)(3)(c) of Executive Order 12866 “Regulatory Planning and Review,” and also providing “guidance to agencies on the regulatory accounting statements that are required under the Regulatory Right-to-Know Act.”); Executive Order 13563, “Improving Regulation and Regulatory Review”, 76 FR 3821, 21 January 2011; Executive Order 13497, “Revocation of Certain Executive Orders Concerning Regulatory Planning and Review”, 74 FR 6113, 4 February 2009; White House, “Regulatory Impact Analysis: A Primer” (“providing a primer to assist agencies in developing regulatory impact analyses (RIAs), as required for economically significant rules by Executive Order 13563, Executive Order 12866, and OMB Circular A-4.”). Cf. Löfstedt, Ragnar and Vogel, David, “The Changing Character of Regulation: A Comparison of Europe and the United States”, 21(3) Risk Analysis (2001), pp. 399–405 (presenting the ‘flip-flop’ theory)CrossRefGoogle ScholarPubMed.

43 Anderson, Fred, Chirba-Martin, Mary Ann, Donald Elliott, E., Farina, Cynthia, Gellhorn, Ernest, Graham, John D., Boyden Gray, C., Holmstead, Jeffrey, Levin, Ronald M., Noah, Lars, Ryne, Katherine, and Wiener, Jonathan Baert, “Regulatory Improvement Legislation: Risk Assessment, Cost-Benefit Analysis, and Judicial Review”, 11 Duke Environmental Law & Policy Forum (2000), 89 et sqq, at p. 90–91Google Scholar (discussing how “[r]egulatory agencies use a variety of analytic tools, including comparative risk assessment, cost-benefit analysis, and cost-effectiveness analysis, to inform their decisions and provide a degree of credibility to the decisions that are made,” and [h]ow the 103rd, 104th, 105th and 106th Congresses demonstrated sustained interest in the passage of comprehensive legislation governing the employment of (…) analytic tools such as risk assessment and costbenefit analysis to improve the regulatory process” with respect to “public health, safety, and environmental problems”.). “Despite differences in terminology, it is well accepted that tools such as risk assessment and cost-benefit analysis offer insight and intellectual discipline to the decision-making process. They can help to identify and evaluate decision options, and achieve more benefits at less cost than otherwise would occur. However, it is also well recognized that use of these tools is not a substitute for human judgment in decision-making. Human judgment comes into play because the structure or findings of an analysis may not be adequate to inform a decision”. Ibid., at p. 93.

44 Consumer Product Safety Act, 15 U.S.C. § 2051.

45 Consumer Product Safety Act, 15 U.S.C. § 2056.

46 Executive Order 13563 of January 18, 2011, Improving Regulation and Regulatory Review, Federal Register, Vol. 76, No. 14 Friday, 21 January, 2011, at Sections, 1(a), 2(a)-(b).

47 5 USC § 553(c) (Rule making); 5 USC § 556 and 5 USC § 557 (When rules are required by statute to be made on the record after opportunity for an agency hearing).

48 Strauss, Peter, Smith, Turner and Bergkamp, Lucas, Rulemaking, Administrative Law of the European Union (New York: ABA Publishing, 2008)Google Scholar.

49 Article 114(3), TFEU.

50 Article 191(2),TFEU (ex Article 174 TEC) merely declares that the EU's environmental policy “shall be based on the precautionary principle.”

51 Craig, Paul, EU Administrative Law. Second Edition (Oxford: Oxford University Press, 2012), at p. 666 CrossRefGoogle Scholar.

52 Case C-180/96, UK v Commission (1998) ECR 1-2265, at 99(“When there is uncertainty as to the existence or extent of risks to human health, the institutions may take protective measures without having to wait until the reality and seriousness of those risks becomes fully apparent”).

53 Pieterman, Roel, Hanekamp, Jaap C. and Bergkamp, Lucas, “Onzekere voorzorg bedreigt de rechtszekerheid”, 1 Nederlands Juristenblad (2006),:pp. 2–8 Google Scholar.

54 For an overview of the case law, see Craig, Paul, EU Administrative Law. Second Edition (Oxford: Oxford University Press, 2012), pp. 641–667 CrossRefGoogle Scholar.

55 See, for instance, Case C-236/01, Monsanto Agriculturu ltaUa SpA v Presidenza del Consiglio dei Ministri (2003) ECR 1-8105. Case C-6/99, Association Greenpeace Frmice v Ministere de I’Agriculture et de la Peche (2000) ECR 1-1651. Case C-393/01, France v Commission (2003) ECR 1-5405.

56 Pieterman, Roel and Hanekamp, Jaap C., The cautious society? An essay on the rise of the precautionary culture (Amsterdam: HAN Foundation, 2002)Google Scholar. Stark, Barbara, “Sustainable Development and Postmodern International Law: Greener Globalization?”, 27 Wm. & Mary Envrtl. L. & Pol’y Rev. (2002), 137 et sqq, at pp. 156–157Google Scholar; Sustainable Development Education Panel First Annual Report 1998, Annex 4 – Submission to the Qualifications and Curriculum Authority, at p. 13; Royden Somerville QC, “Legal Opinions: Managing Risks Associated with Outdoor Use of Genetically Modified Organisms”, January 2013, at p. 24; de Chazournes, Laurence Boisson, “Precaution in International Law – Reflection on its Composite Nature”, in Ndiaye, Tafsir Malick, Wolfrum, Rüdiger and Kojima, Chie (eds), Law of the Sea, Environmental Law and Settlement of Disputes: Liber Amicorum Judge Thomas A. Mensah (Amsterdam: M. Nijhoff, 2007), at pp. 21–24 CrossRefGoogle Scholar; “The Many Facets of Precautionary Logic”, Introduction, 2 Erasmus Law Review (2002), pp. 97 et sqq, at p. 102; Hanekamp, Jaap C., “Neither Acceptable nor Certain – Cold War Antics for 21st Century Precautionary Culture”, 2 Erasmus Law Review (2009), pp. 242–244 Google Scholar; Ravetz, Jerry, “The Post-Normal Science of Precaution”, 36 Futures (2003), pp. 347 et sqq, at p. 350CrossRefGoogle Scholar; Vogel, David, The Politics of Precaution: Regulating Health, Safety, and Environmental Risks in Europe and the United States, (Princeton: Princeton Univ. Press 2012), at p. 27 CrossRefGoogle Scholar.

57 A founder of post-modernism, Foucault denies that there is universal rationality, and suggests that any knowledge, including scientific knowledge, reflects specific interests and serves as an instrument for domination. “The theme that underlies all Foucault’s work is the relationship between power and knowledge, and how the former is used to control and define the latter. What authorities claim as ‘scientific knowledge’ are really just means of social control.” Stokes, Philip, Philosophy: 100 Essential Thinkers (London: Arcturus, 2004), at p. 157 Google Scholar (discussing the theories of Michel Foucault). See also Foucault, Michel, The Birth of Biopolitics: Lectures at the Collège de France, 1978–1979, Translated by Burchell, Graham, (London: Palgrave Macmillan, 2008)Google Scholar.

58 For a discussion of the various versions of the PP, see Bergkamp, Lucas, EC Law for the New Economy (Antwerpen: Intersentia, 2003), pp. 157–231 Google Scholar.

59 REACH Recitals 9 and 69; Art. 1(3).

60 Sunstein, Cass R., “The Paralyzing Principle”, Regulation (Winter 2002–2003), pp. 32–37 Google Scholar.

61 Stone, Christopher D., “Is There A Precautionary Principle?”, 31 ELR (2001)Google Scholar.

62 European Commission. Communication from the Commission on the Precautionary Principle. COM(2000) 1 final, Brussels, 2.2.2000.

63 See, for instance, Majone, Giandoemnico, “What Price Safety? The Precautionary Principle and its Policy Implications”, 40 JCMS (2002), p. 89 et sqqGoogle Scholar; Ladeur, K-H., “The Introduction of the Precautionary Principle into EU Law: A Pyrrhic Victory for Environmental and Public Health Law?”, 40 CMLRev (2003), p. 1455 et sqqGoogle Scholar. Forrester, “The Dangers of too much Precaution”, in M. Hoskins and W. Robinson (eds), A True European, Essays for Judge David Edward (Oxford: Hart, 2003) ch 16. Marchant, G. and Mossman, K., “Arbitrary and Capricious: The Precautionary Principle”; 11 The European Union Courts (AEI Press, 2004)Google Scholar.

64 Peter Saunders, “The Precautionary Principle”, in Organization for Economic Cooperation and Development, Policy Responses to Societal Concerns in Food and Agriculture, Proceedings of an OECD Workshop (2010), at pp. 47, 52. Federal Republic of Germany, Federal Institute for Risk Assessment, Evaluation of Communication on the Differences Between ‘Risk’ and ‘Hazard’, (E. Ulbig et al. eds., 2010), at pp. 7–8 (defining and distinguishing between the terms “hazard” and “risk”).

65 Hazard-based restrictions can be found in EU regulation of chemicals, cosmetics, medical devices, plant protection products, biocides, toys, food contact materials, etc. If no derogations are available under the particular regulation, the absence of risk is completely irrelevant and does not affect the restriction. In addition to hazard-based restrictions, the EU also regulates on the basis of proxies or surrogates for exposure and risk, and assumed exposure and risk. Bergkamp, Lucas (ed.), The European Union REACH Regulation for Chemicals: Law and Practice (Oxford: Oxford University Press, 2013), pp. 420–422 Google Scholar (“Hazard and Risk Revisited”).

66 Peter Saunders, The Precautionary Principle, in Organization for Economic Cooperation and Development, Policy Responses to Societal Concerns in Food and Agriculture, Proceedings of an OECD Workshop (2010), at p. 55.

67 Joel Tickner, “Putting Precaution into Practice: Implementing the Precautionary Principle”, in Integrating Foresight and Precaution into the Conduct of Environmental Science, Report of the International Summit on Science and the Precautionary Principle (Sept. 20–22, 2001).

68 Cranor, Carl, “Scientific Inferences in the Laboratory and the Law”, 95 American Journal of Public Health (2005), at S-121, S-123CrossRefGoogle Scholar.

69 Caroline Foster, Scientific Evidence and the Precautionary Principle in International Courts and Tribunals, 2010 Salmon Lecture (hereinafter referred to as “Caroline Foster, Salmon Lecture”) (Sept. 2, 2010) at p. 6.

70 Ibid, at pp. 7, 20.

71 We treat the “other legitimate factors” as inherent in, albeit not exclusive to, PP-based regulatory procedure.

72 Alemanno, Alberto, “Risk vs. Hazard and the Two Souls of EU Risk Regulation: A Reply to Ragnar Löfstedt”, 2(2) European Journal of Risk Regulation (2011), pp. 169–171 CrossRefGoogle Scholar. “Therefore it is no surprise that today the resulting tension between the necessity for a rational, evidence-based decision-making and the wider demand for a flexible, precautionary-oriented regulatory approach stands as the defining feature of the EU risk regulation. In particular, by allowing restrictive regulatory action in situations of documented scientific uncertainty, the precautionary principle embodies the uneasy coexistence between the two souls.”

73 European Environment Agency, “Late lessons From Early Warning: Science, Precaution, Innovation”, EEA Report No. 1/2013, at p. 644.]

74 “EU chief scientist calls for debate on precautionary principle”, Chem Watch, 7 November 2013.

75 Lawrence Kogan, “Revised U.S. Deep Seabed Mining Policy Reflects UNCLOS and Other International Environmental Law Obligations”, Emerging Issues (2013), 6893.

76 US House of Representative, Committee on Natural Resources. Oversight Hearing on “Transparency and Sound Science Gone Extinct?: The Impacts of the Obama Administration's Closed-Door Settlements on Endangered Species and People”, 1 August 2013.

77 Alan Sokal, “Transgressing the Boundaries: Toward a Transformative Hermeneutics of Quantum Gravity”, Social Text 46/47, pp. 217–252 (Spring/Summer 1996). (the original “parody” article). See also Alan Sokal, “A Physicist Experiments with Cultural Studies”, Lingua Franca, May/June 1996, pp. 62–64 (the article in which the parody is revealed). Cf. Sokal, Alan, Beyond the Hoax: Science, Philosophy and Culture (Oxford: Oxford University Press, 2008)Google Scholar.

78 Under various Framework Programmes, the European Commission provides very substantial amounts of funding for research intended to support policy making. See <http://ec.europa.eu/research/environment/index_en.cfm> (last accessed on 26 November 2013). For instance, “European Union (EU)-funded research was instrumental in substantiating the plausibility that endocrine disrupters might lead to serious, irreversible human and wildlife health effects.” (emphasis supplied) The 2013 Berlaymont Declaration on Endocrine Disrupters.

79 Dietrich, R., Aulock, S.v., Marquardt, H., Blaauboer, B., Dekant, W., Hengstler, J., Kehrer, J., Collier, A., Gori, G.B., Pelkonen, O., Nijkamp, F.P., Lang, F., Stemmer, K., Li, A., Savolainen, K., Wallace, Hayes, A., Gooderham, N., Harvey, A., “Scientifically unfounded precaution drives European Commission's recommendations on EDC regulation, while defying common sense, wellestablished science and risk assessment principles”, Toxicology in Vitro (2013), doi: <http://dx.doi.org/10.1016/j.tiv.2013.07.001> (last accessed on 26 November 2013).

80 Office of the Chief Scientific Adviser, European Commission, Meeting on endocrine disruptors, Brussels, 24.10.2013. The reasoning represents a non sequitur: “There was agreement that the existence of thresholds cannot be determined experimentally. For this it would be necessary to look at much smaller doses, with correspondingly smaller effects, beyond the resolving power of toxicological experiments. It is therefore uncertain whether there are thresholds at all, at least for some endpoints.”

81 The comparison with genotoxic chemicals made in the minutes is not applicable, unless it has been established that the endocrine effect results from the genotoxic effect. Office of the Chief Scientific Adviser, European Commission, Meeting on endocrine disruptors, Brussels, 24.10.2013.

82 Lindzen, Richard, “Science in the Public Square: Global Climate Alarmism and Historical Precedents”, 18(3) Journal of the American Physicians and Surgeons (2013), pp. 70–73 Google Scholar.

83 Conversely, the sound studies are more likely to produce negative results. The end result may be that the meta-analysis will find a correlation.

84 Sheldon Krimsky, “The Weight of Scientific Evidence in Policy and Law,” 95 American Journal of Public Health, Supplement 1 (2005), at S-129 (distinguishing between the ‘weight-of-the evidence’ and ‘strength-of-evidence’ approaches); Jack Weinberg and Joe Thornton, “Scientific Inference and the Precautionary Principle”, in International Joint Commission, “Applying Weight of the Evidence – Issues and Practice: A Report From the Workshop Held October 24, 1993”, (Michael Gilberston and Sally Cole-Misch, Eds. June 1994) at pp. 20–21, 24–26 (explaining the need to employ the “weight-of-the-evidence” approach to implement the precautionary principle).

85 Sokal, Alan and Bricmont, Jean, Fashionable Nonsense (St. Martin’s Press, 1998)Google Scholar. Goldstein, Bernard D. and Carruth, Russellyn S., “Implications of the Precautionary Principle for Environmental Regulation in the United States: Examples from the Control of Hazardous Air Pollutants in the 1990 Clean Air Act Amendments”, 66 Law and Contemporary Problems (2003), p. 247 et sqq, at p. 249Google Scholar.

86 Joe A. Oppenheimer, “Rational Choice Theory”, in The Sage Encyclopedia of Political Theory (2008).

87 European Commission, “Impact Assessment Guidelines”, SEC(2009) 92, Brussels,15 January 2009.

88 Cavan O’Connor Close and Dominic J. Mancini, “Comparison of US and European Commission Guidelines on Regulatory Impact Assessment/Analysis”, 3 Industrial Policy and Economic Reforms Papers (2007), Enterprise and Industry Directorate-General, European Commission, Brussels, April 2007.

89 John F. Morrall III, “Determining Compatible Regulatory Regimes between the U.S. and the EU, US Chamber of Commerce”, 2012.

90 Magda Stoczkiewicz, “Trading Away Citizen and Environmental Safeguards”, European Voice, 10 October 2013.

91 BEUC and TACD, EU-US Trade Talks Resume, Consumer Concerns Continue, PR 2013/024, 12 November 2013.

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93 The WTO dispute resolution bodies, in first instance and on appeal, found the EU import ban on meat that contains artificial hormones trade-illegal, but the EU has failed to comply with these rulings. In the Appellate Body's opinion, “the European Communities did not actually proceed to an assessment (…) of the risks arising from the failure of observance of good veterinary practice combined with problems of control of the use of hormones for growth promotion purposes. The absence of such risk assessment, when considered in conjunction with the conclusion actually reached by most, if not all, of the scientific studies (…), leads us to the conclusion that no risk assessment that reasonably supports or warrants the import prohibition embodied in the EC Directives was furnished to the Panel.” WTO Appellate Body, EC Measures Concerning Meat and Meat Products (Hormones), AB-1997-4 (16 January 1998). Following this ruling, the EU mandated a risk assessment, amended the relevant legislation, but upheld the ban, claiming it complied with its international law obligations. The US retaliated. In 2009, the USTR and the European Commission entered into an agreement that provides for an increase of EU import quota for beef produced from cattle that have not been treated with growth-promoting hormones. The deal was approved by the European Parliament in March 2012. European Parliament News, Win-win ending to the “hormone beef trade war,” available at <http://www.europarl.europa.eu/news/en/news-room/content/20120314IPR40752/html/Win-win-ending-to-the-hormonebeef-trade-war> (last accessed on 26 November 2013). Cf. Chang, Howard F., “Risk Regulation, Endogenous Public Concerns, and the Hormones Dispute: Nothing to Fear but Fear Itself”, 77 S. Cal. L. Rev. (2003–2004), p. 743 et sqqGoogle Scholar. Lusk, Jayson L., Roosen, Jutta, and Fox, John A., “Demand for Beef from Cattle Administered Growth Hormones or Fed Genetically Modified Corn: A Comparison of Consumers in France, Germany, the United Kingdom, and the United States”, 85(1) Am. J. Agr. Econ. (2003), pp. 16–29 CrossRefGoogle Scholar. The trade dispute over poultry treated with chlorine is still pending. WTO Dispute Settlement, European Communities — Certain Measures Affecting Poultry Meat and Poultry Meat Products from the United States, DS389. Cf. Congressional Research Service, U.S.-EU Poultry Dispute on the Use of Pathogen Reduction Treatments (PRTs), 7-5700, R40199 (November 19,2012).

94 European Commission, “TTIP Questions and Answers”, available at <http://ec.europa.eu/trade/policy/in-focus/ttip/questions-andanswers/> (last accessed on 26 November 2013).

95 Graham, John D. and Wiener, Jonathan Baert (eds), Risk vs. Risk: Tradeoffs in Protecting Health and the Environment (Cambridge: Harvard University Press, 1995)Google Scholar.

96 The problem of “junk science” however, has plagued litigation in US courts. Huber, Peter, Galileo's Revenge: Junk Science In The Courtroom (New York: Basic Books, 1993)Google Scholar. For a comparison of European and US product liability litigation, see Bergkamp, Lucas and Hunter, Rod, “Product Liability Litigation in the US and Europe: Diverging Procedure and Damage Awards”, 3 Maastricht Journal of International and Comparative Law (1996)Google Scholar. When it proposed the REACH Regulation, the Commission suggested that stringent ex ante precautionary regulation of chemicals would be required due to the insufficient incentives generated by European civil liability regimes. “Liability is usually based on the principle that those who cause damage should pay compensation for that damage. However, in order to be held liable, it is generally required that a causal connection be proven between the cause and the resulting damage. This is often virtually impossible for injured parties if cause and effect occur far apart in time and if adequate test data on the effects of substances are not available. Even if a causal connection can be established, compensations awarded by courts of EU Member States are generally not as high as, for example, in the US, and hence have a limited deterrent effect. In order to improve this situation and to make producers assume responsibility for their products, the Commission has announced its intention to propose Community legislation in this field.” European Commisison, WHITE PAPER Strategy for a Future Chemicals Policy, COM(2001) 88 final, Brussels, 27.2.2001, pp. 6–7.

97 Vogel, David, The Politics of Precaution: Regulating Health, Safety, and Environmental Risks in Europe and the United States, (Princeton: Princeton Univ. Press 2012), at p. 255 CrossRefGoogle Scholar, quoting Shapiro, Martin, “The Frontiers of Science Doctrine: American Experiences with the Judicial Control of Science-Based Decision-Making” in Joerges, C., Ladeur, K.M., and Voss, Kim (eds), Integration Scientific Expertise into Regulatory Decision- Making (Baden-Baden: Nomos Verlagsgesellschaft 1997), pp. 332–333 Google Scholar.

98 Ibid., at p. 255 (emphasis added).

99 Vogel, David, “The Politics of Risk Regulation in Europe and the United States”, 3 The Yearbook of European Environmental Law (2003), at pp. 50–54 Google Scholar.

100 Ibid., at p. 67; Vogel, David, The Politics of Precaution: Regulating Health, Safety, and Environmental Risks in Europe and the United States, (Princeton: Princeton Univ. Press 2012), at p. 30 CrossRefGoogle Scholar.

101 Wiener, Jonathan B., Rogers, Michael D., Hammitt, James K., and Sand, Peter H., The Reality of Precaution (Washington DC: Resources for the Future, 2010)Google Scholar.

102 Attali Commission, An Ambition for Ten Years – Report of the Committee for the Liberation of Growth, Chaired by Jacques Attali (October 2010), at pp. 21–23, 34–35, 157, 175–177.

103 Louis Gallois, “Compact for the Competitiveness of French Industry, Report to the Prime Minister”, 5 November 2012, at p. 39.

104 It is hard to pinpoint the PP as he sole cause for such adverse impacts, as other trends (such as ‘risk society’ politics) and arguments may also push towards ever stringent regulation. It is clear, however, that the PP, being a constitutional policy principle, provides substantial power to proponents of such regulation.

105 ERF, The Innovation Principle – Letter to the Presidents of the European Commission, the Europe Council, and the European Parliament. European Risk Forum – Communication 12, Brussels, October 2013.

106 Epstein, Richard A., “Why The Modern Administrative State is Inconsistent With the Rule of Law”, 1 NYU Journal of Law & Liberty (2008), at pp. 491–492 and 505–515Google Scholar; Mantel, Jessica, “Procedural Safeguards for Agency Guidance: A Source of Legitimacy for the Administrative State”, 61 Administrative Law Review (2009),p. 343 et sqq, at p. 347Google Scholar.

107 Executive Order 13563, supra at Sec. 1(c) (“In applying [the] principles [set forth in 1(a)-(b)], each agency is directed to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible. Where appropriate and permitted by law, each agency may consider (and discuss qualitatively) values that are difficult or impossible to quantify, including equity, human dignity, fairness and distributive impacts.”).

108 On-going and closed public consultations by the Commission are listed on the ‘Your Voice’ website at <http://ec.europa.eu/your-voice/consultations/index_en.htm> (last accessed on 26 November 2013).

109 Strauss, Peter, Smith, Turner and Bergkamp, Lucas, Rulemaking, Administrative Law of the European Union (New York: ABA Publishing, 2008)Google Scholar.

110 John Graham, “The Role of Precaution in Risk Assessment and Management: An American's View”, remarks prepared for the January 11–12, 2002 conference on Europe, Precaution and Risk Management: A Comparative Case Study Analysis of the Management of Risk in a Complex World, pp. 1–4.

111 European Parliament Resolution 2012/2024(INL) – 15/01/2013 recommending to the Commission a Law of Administrative Procedure of the European Union. Cf. European Law Institute, Towards Restatement and Best Practices Guidelines on EU Administrative Procedural Law.

112 The EU has adopted a document access regulation, but it excepts “[a]ccess to a document, drawn up by an institution for internal use or received by an institution, which relates to a matter where the decision has not been taken by the institution (…) if disclosure of the document would seriously undermine the institution’s decision-making process, unless there is an overriding public interest in disclosure.” Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, OJ L L 145/43 (31.5.2001). There is also a webbased ‘comitology register,’ which provides access to draft measures subject to adoption through the comitology procedure, at <http://ec.europa.eu/transparency/regcomitology/index.cfm> (last accessed on 26 November 2013).

113 5 U.S.C. § 553(c), which is Section 4(b) of the Administrative Procedure Act (APA), provides as follows: “After notice required by this section, the agency shall afford interested persons an opportunity to participate in the rule making through submission of written data, views, or arguments with or without opportunity to present the same orally in any manner; and, after consideration of all relevant matter presented, the agency shall incorporate in any rules adopted a concise general statement of their basis and purpose. Where rules are required by statute to be made on the record after opportunity for an agency hearing, the requirements of sections 7 and 8 shall apply in place of the provisions of this subsection.” 5 U.S.C. § 556(e), which is Section 7(d) of the APA, on the record of hearings, provides as follows: “The transcript of testimony and exhibits, together with all papers and requests filed in the proceeding, shall constitute the exclusive record for decision in accordance with Section 8 and, upon payment of lawfully prescribed costs, shall be made available to the parties.” Cf. Attorney General's Manual on the Administrative Procedure Act, Prepared by the United States Department of Justice Tom C. Clark, Attorney General, 1947. ACUS, Administrative Conference Recommendation 2013-4: The Administrative Record in Informal Rulemaking, 14 June 2013.

114 See, for instance, for a recent case Case T-456/11, International Cadmium Association (ICdA) et al. v European Commission, 14 November 2013 (holding that “[t]he procedure culminating in the amendment of Annex XVII to Regulation No 1907/2006 and that relating to the request for access to the Commission's documents under Regulation No 1049/2001 are separate procedures which are not mutually interdependent.”).

115 OMB, Final Information Quality Bulletin for Peer Review, Washington DC, 2004 (issued under the Information Quality Act, this bulletin establishes government-wide guidance aimed at enhancing the practice of peer review of government science documents). Treasury and General Government Appropriations Act for Fiscal Year 2001, Pub. L. No. 106–554, 114 Stat. 2763 (2000), § 515 (“Information Quality Act”); OMB, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 FR 8452, 22 February 2002; Office of Management and Budget (“OMB”), Administrator, Office of Information and Regulatory Affairs (“OIRA”), Memorandum, Information Quality Guidelines – Principles and Model Language, 5 September 2002; Office of Management and Budget (“OMB”), Final Information Quality Bulletin for Peer Review, 16 December 2004.

116 Administrative Conference of the United States, Recommendation 2013-3, Science in the Administrative Process (Adopted 14 June 2013). Pursuant to this recommendation, at an early stage in their decision making processes, agencies should “identify the specific policy questions that may be informed by science; describe the design of the assessments needed to characterize risks and inform policy decisions; and describe the criteria to be used in reviewing and weighing existing studies.” They should explain “how they ensured rigorous review of the scientific information underlying each science-intensive regulatory project.” To the extent practicable, agencies are to “make publicly available (…) references to the scientific literature, underlying data, models, and research results that it considered” and “ensure that members of the public have access to the information necessary to reproduce or assess the agency's technical or scientific conclusions.” Further, agencies are to “encourage vigorous debate among agency scientists and should explore ways of incorporating the diversity of that debate in any resulting work product.” ACUS Recommendation 2013-3, at pp. 4–7.

117 Consistent with the President's Memorandum for the Heads of Executive Departments and Agencies, “Scientific Integrity” (March 9, 2009), and its implementing guidance, each agency shall ensure the objectivity of any scientific and technological information and processes used to support the agency's regulatory actions.” Executive Order 13563, supra at Sec. 5. See also The White House, President's Memorandum for the Heads of Executive Departments and Agencies, “Scientific Integrity” (March 9, 2009); Director of the Office of Science Technology and Policy, Memorandum for the Heads of Executive Departments and Agencies, “Scientific Integrity” (Dec. 17, 2010) (providing guidance on how to implement Administration scientific integrity policies).

118 European Commission. Communication on the Collection and Use of Expertise by the Commission: Principles and Guidelines . Improving the knowledge base for better policies. COM(2002) 713 final, Brussels, 11.12.2002. (“There are three components. The core principles of quality, openness and effectiveness should underpin all activities of the Commission in this domain. The set of guidelines should be used to help departments implement the principles. Finally, a series of practical questions should help departments design methods for collecting and using expert advice appropriate to the circumstances of specific cases.”).

119 European Parliament Resolution 2012/2024(INL) – 15/01/2013 recommending to the Commission a Law of Administrative Procedure of the European Union. Cf. European Law Institute, Towards Restatement and Best Practices Guidelines on EU Administrative Procedural Law.

120 Karel De Gucht, “Speech – Transatlantic Trade and Investment Partnership (TTIP) – Solving the Regulatory Puzzle”, Europa Press Release, SPEECH/13/801, 10 October 2013.

121 Davis Guggenheim, An Inconvenient Truth (film), <http://www.takepart.com/an-inconvenient-truth/film> (last accessed on 26 November 2013). An English court denied a request to prohibit, as ‘promotion of partisan political views,’ the distribution of this film to state secondary schools, subject to an appropriate guidance note being included in the information pack for the schools. Dimmock v Secretary of State for Education & Skills [2007] EWHC 2288 (Admin) (10 October 2007)

122 Bergkamp, Lucas (ed.), The European Union REACH Regulation for Chemicals: Law and Practice (Oxford: Oxford University Press, 2013), p. 414 Google Scholar.

123 “All truth passes through three stages. First, it is ridiculed. Second, it is violently opposed. Third, it is accepted as being self-evident.” This quote has been attributed to Arthur Schopenhauer, but this attribution is doubtful. Shallit, Jeffrey, Science, Pseudoscience, and The Three Stages of Truth (Waterloo: University of Waterloo, 2005)Google Scholar.

* The authors wish to thank Prof. Alberto Alemanno, HEC Paris and New York University, who provided very helpful comments on an earlier draft of this article. Any errors or omissions remain the sole responsibility of the authors.

124 The prospect for mutual recognition of transatlantic regulatory decisions was extensively addressed in 2011 by the Administrative Conference of the United States (ACUS). The ACUS is “an independent federal agency dedicated to improving the administrative process through consensus-driven applied research.” Administrative Conference of the United States, About Us, available at: <http://www.acus.gov/about/the-conference/> (last accessed on 26 November 2013). The ACUS had been commissioned to review the extent of federal agency progress that had been made in implementing 1991 ACUS recommendations to improve the international regulatory cooperation process, and to evaluate and recommend how to overcome new regulatory cooperation challenges that have since emerged. ACUS Recommendation 91–1, Federal Agency Cooperation with Foreign Government Regulators (Adopted 13 June 1991). Administrative Conference, Recommendation 2011–6 International Regulatory Cooperation (Adopted 8 December 2011), 77 FR 2259-2260 (17 January 2012). Three 2011 ACUS recommendations are aimed at improving such cooperation with respect to chemicals regulation. Administrative Conference, Recommendation 2011–6 International Regulatory Cooperation (Adopted 8 December 2011); 77 FR 2259-2260 (17 January 2012). These recommendations became official US policy upon the issuance of Presidential Executive Order 13609, the objective of which is the “reduc[tion], eliminat[ion] or prevent[ion of] unnecessary differences in regulatory requirements in order to promote international trade.” Executive Order 13609, Promoting International Regulatory Cooperation (1 May 2012), 77 FR 26413.