¹ See Textual Proposal of the European Commission for the Chapter on “Regulatory Cooperation” in TTIP, art. 1, para. 3 (March 21, 2016), http://trade.ec.europa.eu/doclib/docs/2016/march/tradoc_154377.pdf; Eur. Comm'n, TTIP Initial Provisions for CHAPTER on Regulatory Cooperation, art. 1, para. 3 (May 2015), http://trade.ec.europa.eu/doclib/docs/2015/february/tradoc_153120.pdf.Google Scholar

² See Eur. Agency for Safety and Health Work Regulation No. 1907/2006, Dec. 18 2006 (EC) (concerning the Registration, Evaluation, Authorization and Restriction of Chemicals) [hereinafter REACH].Google Scholar

³ See Eur. Comm'n, Chemicals in TTIP–New Ideas for Working Together (Nov. 21, 2014), http://trade.ec.europa.eu/doclib/press/index.cfm?id=1204. The EU Chemicals Regulation REACH has been one of the main examples for how regulatory cooperation should operate within the framework of the TTIP.Google Scholar

⁴ See Eur. Comm'n, Position Papers Regulatory Cooperation, (Feb. 10, 2015), http://ec.europa.eu/trade/policy/in-focus/ttip/documents-and-events/index_en.htm#eu-position.Google Scholar

⁵ TTIP Leaks, Greenpeace, https://ttip-leaks.org/ (last visited June 10, 2017, 4:15 PM).Google Scholar

⁶ This is taking inspiration from the new institutionalisms in political science.Google Scholar

⁷ Eur. Comm'n, Communication: The Precautionary Principle (Feb. 2, 2000), http://ec.europa.eu/health/ph_determinants/environment/EMF/Conf24_26feb2003/belveze.pdf.Google Scholar

⁸ See Vogel, David, The Politics of Precaution: Regulating Health, Safety, and Environmental Risks in Europe and the United States (Princeton 2012); James Hammit et al., The Reality of Precaution: Comparing Risk Regulation in the United States and Europe (Routledge 2013). The questions concerning the kind of risks covered by precautionary approach have animated a rather lively academic or political debate in recent years. Does precaution encompass the regulation protecting us from deer running across streets or terrorism, or is its main concern the uncertain risks of business activity? Depending on the response to this question, we may see the EU and the US as more or less precautionary—influencing also the conclusion of whether we need to be concerned about the TTIP or not. These two citations are the most important contributions here.Google Scholar

⁹ See Sunstein, Cass, Laws of Fear: Beyond the Precautionary Principle (2005).Google Scholar

¹⁰ See José Luis Luján & Oliver Todt, Precaution: A Taxonomy, 42 Soc. Studies Sci. 143 (2012).Google Scholar

¹¹ See Treaty on the Functioning of the European Union, Oct. 26, 2012, 2012 O.J. (C 326) art. 121.Google Scholar

¹² Case T-521/14, Sweden v. Comm'n, ECLI:EU:T:2015:976 (2015). In one of the more recent decisions, the General Court has backed Sweden in its claim that the Commission's failure to prohibit certain endocrine disruptors in a time frame set by an EU regulation is a violation of EU law.Google Scholar

¹³ See Marjolein B. A. van Asselt & Ellen Vos, The Precautionary Principle and the Uncertainty Paradox, 9 J. Risk Research 313 (2006).Google Scholar

¹⁴ Textual Proposal of the European Commission for the Chapter on “Regulatory Cooperation” in TTIP, art. 1 para. 3 (Mar. 21, 2016), http://trade.ec.europa.eu/doclib/docs/2016/march/tradoc_154377.pdf.Google Scholar

¹⁵ See id. Google Scholar

¹⁶ REACH, supra note 2.Google Scholar

¹⁷ See Jasanoff, Sheila, The Fifth Branch: Science Advisers as Policymakers (2009) (distinguishing between regulatory science and innovative science).Google Scholar

¹⁸ For instance, the way in which we decide on the acceptable level of risk.Google Scholar

¹⁹ See Asselt & Vos, supra note 13.Google Scholar

²⁰ See Bartl, Marija & Fahey, Elaine, A Postnational Marketplace: Negotiating the Transatlantic Trade and Investment Partnership (TTIP), in A Transatlantic Community of Law: Legal Perspectives on the Relationship Between the EU and US Legal Orders 210 (Elaine Fahey & Deirdre Curtin eds., 2014). This is not to claim that science is not a fundamental source of invaluable information in regulation; rather, I am concerned here mainly with the use of science, which has more to do with law's framework than the substantive merits of science.Google Scholar

²¹ See Organization for Economic Cooperation and Development, Recommendation of the Council on Regulatory Policy and Governance (2012), http://www.oecd.org/gov/regulatory-policy/49990817.pdf.Google Scholar

²² See Peel, Jacqueline, Of Apples and Oranges (and Hormones in Beef): Science and the Standard of Reviewiln WTO Disputes Under the SPS Agreement, 61 Int'l & Comp. L.Q 2 (2012).Google Scholar

²³ See Hansen, Steffen Foss, Lars Carlsen & Tickner, Joel A., Chemicals Regulation and Precaution: Does REACH Really Incorporate the Precautionary Principle, 10 Envtl. Sci. & Pol'y 395, 404 (2007); Luján & Todt, supra note 10; Lucas Bergkamp & Lawrence Kogan, Trade, the Precautionary Principle, and Post-Modern Regulatory Process, 4 Eur. J. Risk Reg. 493, 507 (2013).Google Scholar

²⁴ See Hansen, Carlsen & Tickner, supra note 23; see also Luján & Todt, supra note 10.Google Scholar

²⁵ See Hansen, Carlsen & Tickner, supra note 23; Luján & Todt, supra note 10.Google Scholar

²⁶ Eur. Comm'n, supra note 7.Google Scholar

²⁷ See Arrow, Kenneth J. et al., Is There a Role for Benefit-Cost Analysis in Environmental, Health, and Safety Regulation?, 272 Sci. 221, 222 (1996). For instance, within the context of US chemical law (TSCA), only a few substances have been phased out in its almost 40 years of existence. This also includes asbestos, which was finally phased out after several judicial reversals (on the grounds of lack of “sound scientific evidence”) only at the end of 90s.Google Scholar

²⁸ See Weber, Max, 1 Economy and Society (2003); Oliver Williamson, The Economics of Organization: The Transaction Cost Approach, 87 Am. J. of Soc. (1978).Google Scholar

²⁹ See Ackerman, Frank & Heinzerling, Lisa, Pricing the Priceless: Cost-Benefit Analysis of Environmental Protection, 150 U. Pa. L. Rev. 5 (2002).Google Scholar

³⁰ See Bergkamp, Lucas & Kogan, Lawrence, Trade, the Precautionary Principle, and Post-Modern Regulatory Process, 4 Eur. J. Risk Reg. 493, 507 (2013).Google Scholar

³¹ See Susan Rose-Ackerman, Precaution, Proportionality, and Cost/Benefit Analysis: False Analogies, 4 Eur. J. Risk Reg. 281 (2013); See Ackerman & Heinzerling, supra note 29.Google Scholar

³² See Rose-Ackerman, supra note 31.Google Scholar

³³ See id. Google Scholar

³⁴ Eur. Comm'n, Better Regulation “Toolbox” (June 25, 2015), http://ec.europa.eu/smart-regulation/guidelines/toc_tool_en.htm. The Commission, in its last guidelines, while still acknowledging this fundamental problem of cost benefit analysis provides a large tool-kit to estimate such monetary values.Google Scholar

³⁵ See Textual Proposal of the European Commission on TTIP Initial Provisions for Chapter on Regulatory Cooperation, art. 7(3)(b) (May 4, 2015).Google Scholar

³⁶ See Sunstein, supra note 9.Google Scholar

³⁷ See Ackerman & Heinzerling, supra note 29; Duncan Kennedy, Cost-Benefit Analysis of Entitlement Problems: A Critique, 28 Stan. L. Rev. 387 (1981).Google Scholar

³⁸ An additional important feature that distinguishes the US from the EU system is the possibility to enforce their version of better regulation in courts. The US courts have been eager to enforce a strict standard of review with regard to scientific evidence that need to be met by any regulator who wants to regulate. See Vogel, supra note 8. The standards for the engagement with stakeholders need to be met as well. See Wagner, Wendy, Administrative Law, Filter Failure, and Information Capture, 59 Duke L.J. 1321 (2010) (causing a significant regulatory chill). Usually it has been enough that the industry threatens with court action for regulators to water down the proposal. Id. The EU experience has been different, whereby the courts have both endorsed precautionary principle (EU treaties, case law) as well as given some deference to administration to assess what is the right way to implement it. Vogel, supra note 8.Google Scholar

³⁹ See Rose-Ackerman, supra note 31.Google Scholar

⁴⁰ The operationalization of this principle works, then, by attributing values trying to establish how much people are ready to pay or would be ready to pay for certain non-market goods, such as environmental safety or nature. These revealed preferences are aggregated in two forms as willingness to pay or willingness to accept, both without factoring in distributional concerns such as capability to pay.Google Scholar

⁴¹ See Ackerman, Frank & Heinzerling, Lisa, Priceless: On Knowing the Price of Everything and the Value of Nothing (2005).Google Scholar

⁴² See Renda, Andrea, Too Good to Be True? A Quick Assessment of the European Commission's New Better Regulation Package, A Quick Assessment of the European Commission's New Better Regulation Package, CEPS Special Report No. 108 (2015).Google Scholar

⁴³ See Andrea Renda et al., Assessing the Costs and Benefits of Regulation, Economisti Associati, Study for the Eur. Comm'n (2013), http://www.economistiassociati.com/files/cba_study_sg_final_0.pdf. The multiple criteria analysis distinguishes between various objectives and groups affected by regulation, thus giving more space for considering distributive consequences or other normative concerns along with efficiency.Google Scholar

⁴⁴ Eur. Comm'n, Commissionaires (2014), https://ec.europa.eu/commission/2014-2019/timmermans_en. Currently, this is the agenda of one of the most prominent vice-president of the European Commission—Mr. Timmermans.Google Scholar

⁴⁵ See Jean-Claude Juncker, A New Start for Europe: My Agenda for Jobs, Growth, Fairness and Democratic Change, at 5–6, 18 (July 15, 2014).Google Scholar

⁴⁶ See Eur. Comm'n, Better Regulation Guidelines (2015), http://ec.europa.eu/smart-regulation/guidelines/docs/br_toolbox_en.pdf.Google Scholar

⁴⁷ See id. For instance, the ‘quality-adjusted life year’ matrix is placed under the rubric of non-monetary valuations, because they concern years saved instead of money saved. Yet the value of years is calculated in monetary terms. The usefulness of the regulation—its benefits—are given monetary value which is correlated to how many years of life the regulation will save: the younger the person saved, the more money will be saved, and the more efficient the regulation is.Google Scholar

⁴⁸ See Ferdi De Ville & Gabriel Siles-Brügge, TTIP: The Truth about the Transatlantic Trade and Investment Partnership (2015).Google Scholar

⁴⁹ See Anne CM Meuwese, EU—US Horizontal Regulatory Cooperation: Mutual Recognition of Impact Assessment?, in Transatlantic Regulatory Cooperation: The Shifting Roles of the EU, the US and California 249 (David Vogel & David Swinnen eds., 2011).Google Scholar

⁵⁰ See Vogel, supra note 8.Google Scholar

⁵¹ See id. Google Scholar

⁵² See Renda, supra note 42; Cavan O'Connor Close & Mancini, Dominic J., Comparison of US and European Commission Guidelines on Regulatory Impact Assessment/analysis, Indus. Pol'y & Econ. Reforms Papers no. 3 (European Commission, Enterprise and Industry Directorate General 2007), https://infoeuropa.eurocid.pt/files/database/000047001-000048000/000047484.pdf.Google Scholar

⁵³ See Rose-Ackerman, supra note 31.Google Scholar

⁵⁴ See Impact Assessment Board / Regulatory Scrutiny Board, 2015 Activity Statistics (2016), http://ec.europa.eu/smart-regulation/impact/key_docs/docs/iab_rsb_stats_2015.pdf.Google Scholar

⁵⁵ See Aseeva, Anna, Global Good Process Standards and World Trade Law: A Study of Norms and Normativity in Global Law and Governance perspective (2015) (unpublished manuscript) (on file with author).Google Scholar

⁵⁶ See Centre for Int'l Envtl. Law Report, Lowest Common Denominator 11 (Jan. 7, 2015), http://www.ciel.org/lowest-common-denominator/ (last visited June 18, 2017). For illustration, I reproduce here the table concerning the levels of permitted residue for apples, carrots and cabbage. The first number indicates the US permitted levels, the second Codex Alimentarius permitted levels, and the third number indicates the EU permitted levels, in comparable units (usually in mg).Google Scholar

Apple (Captan 25.0 / 15.0 / 3.00, Clothianidin 1.00 / 0.40 / 0.40, Diazinon 0.50 / 0.30 / 0.01, Diphenylamine 10.0 / 10.0 / 0.01, Malathion 8.00 / 0.05 / 0.02, Methomyl 1.00 / 0.03 / 0.02, Tebuconazole 0.05 / 1.00 / 0.30, Ziram 7.00 / 5.00 / 0.10).Google Scholar

Carrot (Deltamethrin 0.20 / 0.02* / 0.05, Difenoconazole 0.50 / 0.20 / 0.40, Iprodione 5.00 /10.0 /0.50, Mancozeb 1.00 / 1.00 / 0.20)Google Scholar

Cabbage (Carbaryl 21.00 — 0.01, Fluopicolide 5.00 / 7.00 / 0.20, Glyphosate 0.20 — 0.10, Mancozeb 9.00 / 5.00 / 3.00, Metalaxyl 1.00 / 0.50 / 1.00, Novaluron 0.50 / 0.70 / 0.01, Permethrin 6.00 / 5.00 / 0.05). The table is based on the information provided by the United States Department of Agriculture Foreign Agricultural Service, FAS Online, International Maximum Residue Level Database.Google Scholar

⁵⁷ See Eur. Comm'n, supra note 35, at art. 8–12.Google Scholar

⁵⁸ See Christiane Gerstetter et al., Regulatory Cooperation under TTIP–A Risk for Democracy and National Regulation?, Heinrich Böll Stiftung TTIP Series (2014); Marija Bartl, Internal Market Rationality, Private Law and the Direction of the Union: Resuscitating the Market as the Object of the Political, 21 Eur. L.J. 572 (2015).Google Scholar

⁵⁹ See Eur. Comm'n, supra note 35, arts. 14–16.Google Scholar

⁶⁰ Eur. Comm'n, TTIP—EU Proposal for Chapter: Regulatory Cooperation (Mar. 21, 2016), http://trade.ec.europa.eu/doclib/docs/2016/march/tradoc_154377.pdf.Google Scholar

⁶¹ See id. at 9.Google Scholar

⁶² Eur. Comm'n, TTIP Initial Provisions for CHAPTER on Regulatory Cooperation, art. 16 (May 4, 2015) http://trade.ec.europa.eu/doclib/docs/2015/april/tradoc_153403.pdf.Google Scholar

⁶³ See Eur. Comm'n, supra note 60, at annex.Google Scholar

⁶⁴ See Eur. Comm'n, supra note 62. By regulatory affairs officials, I mean those members of the governments who are responsible for what is called by the European Commission “regulatory analytics.” This includes the administration of impact assessments, and regulation review. In the US, these are the representatives of the Office of Regulatory Affairs (OIRA) and in Europe, the members of the Secretariat General of the European Commission. The cooperation among those officials has already been taking place for years.Google Scholar

⁶⁵ See Daniel Carpenter & Moss, David A., Preventing Regulatory Capture: Special Interest Influence and How to Limit It (Cambridge University Press 2013); James Kwak, Cultural Capture and the Financial Crisis, in Preventing Regulatory Capture, (Daniel Carpenter & Moss, David A. eds., 2013); Andrew Baker, Restraining Regulatory Capture? Anglo-America, Crisis Politics and Trajectories of Change in Global Financial Governance, 86 Int'l Affairs 647 (2010).Google Scholar

⁶⁶ Compare Martti Koskenniemi, The Politics of International Law–20 Years Later, 20 Eur. J. Int'l L. 7 (2009), with Andrew T.F. Lang, Legal Regimes and Professional Knowledges: The Internal Politics of Regime Definition (Young, Margaret A. ed., 2012).Google Scholar

⁶⁷ Greenpeace, Eur. Comm'n: Chapter on Sanitary and Phytosanitary Measures, Consolidated Proposals, art. X 15 (2016), https://ttip-leaks.org/andromache/doc11.pdf.Google Scholar

⁶⁸ Id. Google Scholar

⁶⁹ See id. art. X 5, para. 6.Google Scholar

⁷⁰ See id. at US art. X 12, para. 8.Google Scholar

⁷¹ See id. at US art. X 16.Google Scholar

⁷² See id. at EU art. X 17.Google Scholar

⁷³ See Wagner, supra note 38; Baker, supra note 65; Maria Green Cowles, The Transatlantic Business Dialogue and Domestic Business-Government Relations, in Transforming Europe: Europeanization and Domestic Change (Maria Green Cowles, James Caporaso & Thomas Risse eds., 2001); Beate Kohler-Koch, Governing with the European Civil Society, in De-Mystification of Participatory Democracy: EU Governance and Civil Society 105 (Beate Kohler-Koch & Christine Quittikat eds., 2013).Google Scholar

⁷⁴ See Scharpf, Fritz W., The Asymmetry of European Integration, or Why the EU Cannot Be a “Social Market Economy”, 8 Socio-Econ. Rev. 211 (2009). This argument will sound familiar to European scholars. The lack of political capacity at the side of the EU political institutions has made the negative integration a main driver of the EU project, with ensuing problems and assymetries.Google Scholar