Regulatory cooperation in TTIP : challenges for the EU food safety regulatory framework

R

EGULATORY

C

OOPERATION IN

TTIP:

C

HALLENGES FOR

THE

EU

F

OOD

S

AFETY

R

EGULATORY

F

RAMEWORK

Written by Marie Vanderheyden

Student n° 10732624

Under the supervision of dr. Maria Weimer

LL.M. European Union Law Thesis in Risk Regulation Academic year 2014-2015

T

Introduction………p. 3 1. The Concept of Regulatory Cooperation……….p. 4 1.1. Definition and Modes of Regulatory Cooperation………p. 5 1.2. The Emerging Phenomenon of Horizontal Regulatory Cooperation: Definition and Applications in the EU-US Partnership………..p. 8 2. International, EU and US Food Safety Regimes: Procedures, Precautionary

Principle and Divergences……….p. 10 2.1. Brief Overview of the WTO Rules: the TBT and SPS Agreements……...p. 10 2.2. European and US Approaches to Precaution in Food Safety Regulations..p. 12

2.2.1. Overview of EU and US Legislative and Regulatory Processes……p. 12 A. Comparison of EU and US Legislative Processes………...p. 13 B. Comparison of EU and US Regulatory Processes………...p. 15 C. EU and US Approaches to Impact Assessment ………..p. 18 2.2.2. EU and US Diverging and Evolving Attitudes towards Precaution in Food Safety Regulations: Precautionary Principle, Risk Assessment and Cost-Benefit Analysis………...p. 20 2.2.3. The Reasons behind Food Safety Regulatory Divergence in the EU and the US………...p. 23 3. Regulatory Cooperation in TTIP’s Horizontal, SPS and TBT Chapters: Challenges

for EU Food Safety Regulatory Framework………..p. 26 3.1. Which Type of Regulatory Cooperation is Envisaged in TTIP?...p. 26 3.1.1. The Horizontal Provisions on Regulatory Cooperation……….p. 28 3.1.2. “TBT-plus” and “SPS-plus” Frameworks………..p. 31 3.2. Challenges for EU Food Safety Regulatory Framework……….p. 33 Conclusion………p. 41 Bibliography……….p. 46

“Acceptable risk is a matter of judgment and…judgments differ” Mary Douglas & Aaron Wildavsky1

I

The Transatlantic Trade and Investment Partnership (TTIP) is a free trade agreement under negotiation since July 2013 between the EU and the US which aims at tackling unnecessary impediments to the flow of goods and services between the two trading partners2. Since the vast majority of trade barriers nowadays flow from regulatory divergences, making EU and US regulations more compatible will be at the heart of TTIP3. The Commission presents regulatory cooperation as a tool for generating jobs, stimulating economic growth and increasing consumer choice on either side of the Atlantic4.

The purpose of this thesis is to assess the challenges the transatlantic regulatory cooperation envisaged in TTIP could raise for EU food safety regulations. Indeed, among the numerous concerns raised by the TTIP negotiations, one of the most invoked is the risk that EU food safety standards would be weakened by the agreement due to a convergence with US conflicting standards. The great majority of environmentalist and anti-capitalist NGOs, citizens and political parties denounce the threat represented by the “Trojan horse treaty” for public health, consumer rights and environmental standards5, although the Commission asserts that this idea is a pure misconception6. Beyond the lowering of EU standards, some actors also fear a move towards deregulation and privatisation7. In this controversial context, we have chosen to look at TTIP’s regulatory part in order to assess what difficulties the planned regulatory cooperation could pose for EU food safety standards.

First of all, since regulatory cooperation is at the core of TTIP, a definition of this key concept is a necessary foundation to this analysis. The first chapter defines the notion and the various modes it can take, and then focuses on the emerging tendency of horizontal regulatory cooperation by giving an overview of how it is

2 _{Gerstetter et al, Legal Implications of TTIP for the Acquis Communautaire in ENVI Relevant}

Sectors, 2013, [online], p. 8.

3

European Commission, Transatlantic Trade and Investment Partnership: The Regulatory Part, September 2013, [online], p. 2; European Commission, TTIP and Regulation: An Overview, 10-02-2015, [online], p. 3. Regulations are laws covering risks in the areas of health, food safety, environment and financial security.

4

European Commission, TTIP and Regulation: An Overview, op. cit., p. 3.

5 _{Friends of the Earth Europe, EU-US Trade Deal Threatens Food Safety, 04-02-2015, [online];}

Joumard, Traités de libre-échange: citoyens bafoués, multinationales souveraines, Attac Rhône, 18-02-2015, [online]; Ducourtieux, La galaxie hétéroclite des anti-TTIP, Le Monde 11-10-2014, [online].

6 _{European Commission, The top 10 myths about TTIP, April 2015, [online], p. 5.} 7 _{Ducourtieux, op. cit.}

applied in the transatlantic relationships. After having made a brief description of the technical barriers to trade (TBT) and the sanitary and phytosanitary (SPS) measures at the World Trade Organisation level (WTO), the second chapter makes a comparison of EU and US legislative and rule-making processes and then looks at the difference in attitudes towards precaution on each side of the Atlantic and its explanatory factors. This step, highlighting procedural divergences between the EU and the US, in particular as regards risk assessment and management criteria, makes sense insofar as these divergences may complicate the reinforcement of transatlantic regulatory cooperation envisaged in TTIP and, in that respect, may constitute a challenge for EU food safety rules. Finally, the third chapter assesses the mode of regulatory cooperation provided in TTIP’s draft proposals on horizontal regulatory cooperation, SPS and TBT measures, and evaluates the arguments advanced by TTIP’s opponents concerning the leveling down of EU food safety standards, with a view to pinpointing the difficulties TTIP may create for these standards.

As regards methodology, this thesis adopts an analytical approach, aiming at answering the research question on the basis of the available documents, including former free trade agreements, TTIP draft proposals, case law and academic literature. In order to provide this answer, the second chapter consists of a comparative analysis of EU and US legislative and regulatory processes, first assessing the level of transparency and public participation on both sides and then highlighting the EU-US differing precautionary approaches and the explanatory factors behind it.

1.

T

C

R

C

In order to analyse the form of regulatory cooperation envisaged in TTIP and the difficulties it may raise for the EU food safety framework, the first section of this chapter defines the notion of regulatory cooperation and the various shapes it can take. Moreover, since TTIP is aimed, inter alia, at further developing the horizontal regulatory cooperation existing between the US and the EU, the second section describes this type of cooperation and gives an overview of how it has materialised in the transatlantic partnership since the early 1990s.

1.1. Definition and Modes of Regulatory Cooperation

As we know, non-tariff barriers, emerging from regulatory divergences across countries, represent the major obstacle to trade exchanges nowadays8. As a result, whereas rule-making used to be confined to the domestic sphere, cross-border cooperation between regulators is today crucial to limit and remove regulatory disparities9.

Although TTIP is a free trade agreement, its objective is to remove regulatory obstacles to transatlantic trade in various sectors, such as food safety. In order to understand the methods put forward by TTIP draft proposals to achieve this objective, the notion of international regulatory cooperation and the various forms it can take have to be defined.

According to the general definition given by the Organisation for Economic Cooperation and Development (OECD), international regulatory cooperation refers to “any agreement or organisational arrangement, formal or informal, between

countries (at the bilateral, regional or multilateral level) to promote some form of cooperation in the design, monitoring, enforcement, or ex-post management of regulation, with a view to support the converging and consistency of rules across borders”10. This broad definition includes WTO multilateral treaties, bilateral agreements and more informal regulatory cooperation.

Regulatory cooperation can be achieved through various modes. While informal mechanisms, such as exchange of information, unilateral harmonisation and delegation to non-governmental organisations may be used, more institutionalised modes also exist11.

First, it can be dealt with regulatory convergence through harmonisation, that is to say alignment of regulations in order to make them identical12. Substantive harmonisation, by requiring a joint regulation based on a complete consensus,

8 _{Alemanno, International Regulatory Cooperation and its discontents: What is really at stake in}

TTIP?, 04-02-2015, [online], p. 1.

9

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, 2011, [online], p. 249.

10 _{OECD, What is international regulatory co-operation?, [online].} 11

Meuwese, op. cit., p. 251.

12 _{Lester & Barbee, The Challenge of Cooperation: Regulatory Trade Barriers in the Transatlantic}

necessarily limits the sovereignty of the states who want to cooperate13. This explains why the latter usually opt for procedural harmonisation, meaning that they agree on a set of shared procedures and methodologies rather than on substantive regulatory requirements, as it is the case at WTO level14. While offering more flexibility, it remains that, according to some authors, procedural harmonisation does not address regulatory divergences as effectively as substantive harmonisation since disparities cannot be fully removed via this method15.

The second and most used method to achieve regulatory cooperation is mutual recognition, which can take the form of mutual recognition agreements (MRAs) or acknowledgements of regulatory equivalence16.

MRAs aim at allowing goods produced and marketed in conformity with one party’s legal regime to be traded in the territory of another party without facing duplicative requirements17. Mutual recognition concerns either the substantive technical regulations or the results of testing and certification processes (conformity assessment procedures)18. The second option is traditionally chosen in MRAs concluded between the EU and its trading partners19. By way of illustration, the 2011 EU-Korea Free Trade Agreement states that the results of EU tests to show compliance with EU standards in the sector of motor vehicles shall be recognised by Korea20. Besides, the EU-Canada CETA, of which legal review and ratification have still to be carried out, applies the same system of mutual recognition for various types of goods, such as electronical and radio equipment, machinery and toys21.

Regulatory equivalence means that the parties recognise that their regulations, although different, can be considered as functionally equivalent22. While MRAs refer

13 _{Lester & Barbee, op. cit., p. 857; Alemanno, The Transatlantic Trade and Investment Partnership}

and the Parliamentary Dimension of Regulatory Cooperation, April 2014, [online], p. 30.

14 _{Alemanno, The Transatlantic Trade and Investment Partnership and the Parliamentary Dimension}

of Regulatory Cooperation, op.cit., p. 30.

15

Ibid., p. 31.

16 _{Lester & Barbee, op. cit., p. 857.}

17 _{Ibid., p. 857-858; Alemanno, The Transatlantic Trade and Investment Partnership and the}

Parliamentary Dimension of Regulatory Cooperation, op.cit., p. 31.

18 _Ibid.

19 _{Ibid., p. 32; Meuwese, op. cit., p. 252.}

20 _{European Commission, The EU-Korea Free Trade Agreement in Practice, 2011, [online], p. 13. The}

Agreement tackles, inter alia, non-tariff barriers in four specific sectors : consumer electronics, motor vehicles and parts, pharmaceuticals/medical devices and chemicals.

21 _{European Commission, Consolidated Comprehensive Economic and Trade Agreement (CETA)Text,}

26-09-2014, [online], Chapters 13 (Mutual Recognition of Professional Qualification), 26 (Regulatory Cooperation) & 27 (Protocol on the Mutual Acceptance of the Results of Conformity Assessment).

to the recognition of the validity of foreign technical requirements for the fulfilment of national objectives, regulatory equivalence applies to the technical aspects of the regulations23. The already mentioned EU-Korea Agreement implements this method by obliging Korea to acknowledge that international and EU standards for motor vehicles are equivalent to Korean major technical regulations24. Another example is the 2012 EU-US Organic Equivalence Arrangement, whereby the parties agreed that their certification processes for organic products were equivalent, except for the prohibition on the use of antibiotics25.

Beyond these more or less institutionalised regulatory cooperation modes, a third mechanism may be used, which can take varying degrees of formality: transnational regulatory networks, taking the form of associations or committees in various sectors26.

In choosing the most suitable one to address a specific problem of regulatory divergence, it must be looked at the causes of this divergence27. Minor and unintentional differences in regulations can be tackled through harmonisation measures since they only constitute random variations of achieving the same policy objective28. By contrast, differences resulting from divergent preferences require a more flexible approach like mutual recognition or equivalence29. These methods may nevertheless show their limitations when states have antagonistic policy preferences30. In such a case, the latter can rely on international dialogue to understand the roots of the divergences and cooperate on how they put regulations into practice31. As regards transatlantic cooperation, genetically modified organisms (GMOs) belong to this third category since the EU and the US have strongly conflicting policy views on the matter32. Therefore, it has been decided that basic EU law on GMOs will not be included in the negotiations so that it will not be subject to

23 _{Alemanno, The Transatlantic Trade and Investment Partnership and the Parliamentary Dimension}

of Regulatory Cooperation, op.cit., p. 32.

24

European Commission, The EU-Korea Free Trade Agreement in Practice, op. cit., p. 12.

25 _{Alemanno, The Transatlantic Trade and Investment Partnership and the Parliamentary Dimension}

of Regulatory Cooperation, op.cit., p. 33.

26

Meuwese, op. cit., p. 252.

27 _{Lester & Barbee, op. cit., p. 858.} 28 _Ibid.

29 _Ibid. 30

Ibid.

31 _{Ibid.; , Transatlantic Trade and Investment Partnership: The Regulatory Part, op. cit., p. 3.} 32 _{Lester & Barbee, op. cit., p. 858.}

modifications33. The idea is rather to reinforce the information exchange between the EU and US on policy, regulations and technical issues regarding GMOs34.

As regards the form of regulatory cooperation, it should be noted that besides the integration in free trade agreements, other options can be imagined. A recent example is the US-Canada Regulatory Cooperation Council (RCC), which has been established in 2011 outside the context of a trade agreement35. Co-chaired by high-level representatives from US and Canadian regulatory oversight agencies, the RCC promotes bilateral and horizontal cooperation between the lead agencies of both countries36. The objective is to limit inefficiencies in existing regulations, without the RCC being entitled to adopt common rules37.

1.2. The Emerging Phenomenon of Horizontal Regulatory Cooperation: Definition and Applications in the EU-US Partnership

Nowadays, the tendency is to set up horizontal rather than sectoral regulatory cooperation38. The adjective “horizontal” refers to the general analytical basis of regulations, meaning that such a cooperation focuses on the tests carried out in the elaboration phase of regulations, such as risk assessment, impact assessment or cost-benefit analysis39. The underlying idea of horizontal cooperation is that a methodological convergence may help in shaping compatible substantive standards40. If regulators apply a set of shared best practices aimed at making better and more rational regulations, it may play a decisive role in the elimination of non-tariff barriers41.

The EU and the US are the most advanced in the development of this method, as evidenced by the current horizontal dialogue between the Secretariat General of the

33 _{European Commission, Transatlantic Trade and Investment Partnership: The Regulatory Part, op.}

cit., p. 8.

34 _Ibid. 35

Canada-United States Regulatory Cooperation Council, Progress Report to Leaders, December 2012, [online], p. 3.

36 _{Ibid. The US lead agency is the Office of Information and Regulatory Affairs (OIRA), which is part}

of the US Office of Management and Budget (OMB) and falls under President’s direction.

37

Ibid.

38 _{Alemanno, Is There a Role for Cost-Benefit Analysis Beyond the Nation-State?, in: The}

Globalization of Cost-Benefit Analysis in Environmental Policy, 2013, [online], p. 6; Meuwese, op. cit., p. 249.

39

Meuwese, op. cit., p. 252.

40 _{Alemanno, Is There a Role for Cost-Benefit Analysis Beyond the Nation-State?, op. cit., p. 6.} 41 _Ibid.

EU Commission and the US Office of Management and Budget (OMB) on cross-cutting issues of regulatory cooperation – the OMB overseeing the performance of US federal agencies42.

The transatlantic horizontal regulatory cooperation process has been built in successive stages over the last two decades. Involving mainly US agencies and Directorates-General of the EU Commission, it has been initiated in 1990 with the Transatlantic Declaration on EC-US Relations, which provided for information exchanges and consultations between the parties on important issues of common interest43. Various initiatives have contributed to further develop this cooperation, such as the establishment of the Transatlantic Economic Partnership (1998), which set up a New Transatlantic Marketplace and aimed, inter alia, at reinforcing the cooperation in the area of biotechnology and sanitary and phytosanitary regulation through MRAs, scientific dialogue and consultations, and the creation of the High-Level Regulatory Cooperation Forum (2005), which gathers EU and US regulatory authorities, administrations and stakeholders in order to share ideas, experiences and good regulatory practices, including methods of regulatory analysis such as impact assessment, for improving regulatory approaches44. The most recent step of this process is the establishment of the Transatlantic Economic Council (2007), which set up a common understanding of best regulatory practices and succeeded in enhancing cooperation in some respects, such as electric cars or mutual recognition of organic products labelling45. All these initiatives, while they considerably improved transatlantic cooperation in some areas, remained nevertheless below expectations, mostly because of a lack of political will46. Consequently, the EU and US engaged in

42 _{Meuwese, op. cit., p. 250.}

43 _{European Commission, Bulletin of the European Communities, 1990/11, point 1.5.3., cited in:}

Meuwese, op. cit., p. 254.

44 _{Alemanno, The Transatlantic Trade and Investment Partnership and the Parliamentary Dimension}

of Regulatory Cooperation, op. cit., p. 27-28; Meuwese, op. cit., p. 255-260. The High-Level Regulatory Cooperation Forum significantly influenced the EU’s adoption of Impact Assessment Guidelines in 2005, 2006 and 2009, as well as the establishment of the Impact Assessment Board in 2006.

45 _{Alemanno, The Transatlantic Trade and Investment Partnership and the Parliamentary}

Dimension of Regulatory Cooperation, op. cit., p. 29-30; Meuwese, op. cit., p. 260.

46 _{Peterson et al, Review of the Framework for Relations between the European Union and the United}

States, 2004, [online], p. 79-80. Besides the low political profile of the EU-US dialogue, the study cites several obstacles to the establishment of a real transatlantic partnership : “the complexity of legislative processes, the independence of regulatory agencies, and basic differences of view about how to achieve security in a post 9/11 world” ; Takács, Transatlantic regulatory coperation in trade, in : A Transatlantic Community of Law : Legal Perspectives on the Relationship between the EU and the US Legal Orders,2014, [online], p. 184.

TTIP negotiations in order to go beyond the WTO traditional treaty-making approach and further develop the existing transatlantic dialogue by creating a new form of regulatory cooperation, embedded in a free trade agreement47. While the initiative to institutionalise the transatlantic partnership with TTIP reveals political commitment to address regulatory divergence, it remains to be seen whether it will be sufficient to reach a consensus on sensitive issues such as GMOs or endocrine disrupting chemicals48.

2. I

,

EU

US

F

S

R

:

P

,

P

P

D

Now that the concept of (horizontal) regulatory cooperation has been delineated, this chapter looks at international, EU and US food safety rules which might be affected by the future TTIP. Since the free trade agreement, along with the approach used in CETA49, aims at going beyond the measures provided in WTO TBT and SPS Agreements, a brief overview of their content is given in the first section. Furthermore, understanding the extent to which an enhanced transatlantic regulatory cooperation can involve challenges for EU food safety rules requires to examine the divergences between EU and US rules in that area. On that background, the second section compares European and American legislative and regulatory systems as well as the criteria used in risk regulation making on each side of the Atlantic and the invoked reasons as to why they differ. This comparative analysis, focusing on transatlantic procedural divergences (processes and criteria), is crucial insofar as the type of regulatory cooperation discussed in TTIP’s negotiations, at least as regards food safety rules, primarily concerns procedural regulatory cooperation50.

47 _{Alemanno, International Regulatory Cooperation and its discontents: What is really at stake in}

TTIP?, op. cit., p. 1.

48

Takács, op. cit., p. 185. The author mentions the “substantive step forward in transatlantic economic relations” that the creation of a “permanent, transparent and effective” institution would represent. The Regulatory Cooperation Body envisaged in TTIP proposals (cf infra) could be considered as such an institution. The adoption of a chapter on horizontal regulatory cooperation in TTIP, combined with the creation of this body, insofar as it would allow EU and US regulators to reinforce regulatory cooperation in the future without requiring to agree on every regulatory convergence issue in TTIP, might make it possible to overcome previous divisions.

49 _{European Commission, Consolidated Comprehensive Economic and Trade Agreement (CETA)Text,}

26-09-2014, op. cit., Chapters 6 (TBT), 7 (SPS) & 26 (Regulatory Cooperation).

50 _{Alemanno, Presentation on TTIP’s Regulatory Convergence before the Committee on Legal Affairs}

2.1. Brief Overview of the WTO Rules: the TBT and SPS Agreements

As regards first the TBT Agreement, it applies to technical regulations, standards and conformity assessment procedures which govern the marketing of products with a view to ensure their safety and quality51. Technical regulations and standards both apply to product characteristics and related processes and production methods, but the former are legally binding, while the latter are not52. Besides, conformity assessment procedures correspond to the testing required to ensure that products comply with technical regulations or standards53. These procedures can take various forms, such as sampling, testing, verification, evaluation or accreditation54.

The problem relating to these three types of rules lies in the fact that divergent technical requirements or conformity assessment procedures between two markets, such as the EU and the US, may hinder trade due to the extra costs they place on businesses willing to export their products55. The TBT Agreement, as a crucial instrument of international regulatory cooperation, therefore requires that technical requirements, standards and testing procedures are non-discriminatory and limited to what is necessary to protect human and animal health and ensure environmental and consumer protection56.

More specific than the TBT Agreement, the SPS Agreement regulates WTO members’ freedom to adopt SPS measures, namely laws and regulations protecting human and animal health (sanitary) and plant health (phytosanitary)57. It must be noted that SPS measures are expressly excluded from the scope of application of the TBT Agreement58. However, in the same vein as the TBT Agreement, the SPS Agreement states that national SPS measures must be limited to the extent required to achieve their legitimate objectives, so that they do not constitute unnecessary or disguised trade restrictions59. Following a procedural harmonisation approach60, the

51

WTO TBT Agreement, 15-04-1994, recitals 5-9 & Annex 1.1-1.3; European Commission, TTIP and Regulation: An Overview, op. cit., p. 9.

52 _{WTO TBT Agreement, op. cit., Annex 1.1 & 1.2.} 53

Ibid., Annex 1.3.

54 _Ibid.

55 _{European Commission, TTIP and Regulation: An Overview, op. cit., p. 9.} 56 _{WTO TBT Agreement, op. cit., art. 2.2. & 5.1.-5.2.}

57

WTO Agreement on the Application of SPS measures, 15-04-1994, preamble & art. 1 & 2.

58 _{WTO TBT Agreement, op. cit., art. 1.5.}

Agreement promotes the use of international food safety standards by covering their use by a presumption of necessity61. Furthermore, the Agreement states that WTO members must ensure that SPS measures are based on regularly updated scientific evidence and create no arbitrary and unjustifiable discrimination between countries62. Finally, WTO importing members are obliged to accept the SPS measures of exporting members where they objectively achieve the importer’s level of health protection63. To be noted that the first dispute involving the SPS Agreement arose between the EU and the US and concerned the import ban decided by the EU on US hormone-treated beef64. In this case, the WTO Appellate Body ruled that the EU ban was not based on scientific evidence and was inconsistent with the SPS Agreement65. With TTIP, the EU’s objective is to go beyond TBT and SPS Agreements principles and further reduce unnecessary trade barriers created by TBT or SPS measures, while maintaining a high level of safety for products66. However, as observed in this section, TBT and SPS measures adopted by the EU during the last two decades have at several occasions been successfully challenged by the US before the WTO Dispute Settlement Body. This tendency, revealing a tension between EU approach to food safety and WTO principles invoked by the US, is a key to understand the challenges that TTIP could raise for EU food safety standards. The next section complements this overview of international rules by focusing on the tension existing between EU and US approaches to precaution.

2.2. European and US Approaches to Precaution in Food Safety Regulations

2.2.1. Overview of EU and US Legislative and Regulatory Processes

60 _{Alemanno, The Transatlantic Trade and Investment Partnership and the Parliamentary Dimension}

of Regulatory Cooperation, op.cit., p. 31.

61

WTO Agreement on the Application of SPS measures, op. cit, art. 3.2. As regards food safety, members are to base their measures on standards, guidelines and recommendations issued by the Codex Alimentarius Commission (CAC).

62

Ibid., art. 2.2 & 2.3.

63 _{Ibid., art. 4.}

64 _{WTO, EC Measures Concerning Meat and Meat Products (Hormones) – Complaint by the United}

States: Report of the Panel, 18-08-1997, [online], § II.1.

65

WTO, EC Measures Concerning Meat and Meat Products (Hormones) – Complaints by the United States: Report of the Appellate Body, 16-01-1998, § XIV.253 (esp. h & l).

TTIP negotiations seem to move towards an innovative procedural regulatory cooperation system under which EU and US regulatory authorities would exchange information and coordinate their legislative and rule-making processes and methodologies67. In order to see which synergies can be created, a thorough understanding of both systems and methodological tools is therefore required.

According to the February 2015 EU draft proposal on TTIP, regulatory cooperation would apply to regulatory acts at central (US Federal State and the EU) and non-central levels (US States and EU Member States)68. The proposal elaborates only on the central regulatory acts, which include Regulations, Directives, Delegated and Implementing Acts for the EU and Federal Statutes and Administrative Acts for the US69. Since both legislative and executive acts can constitute regulatory acts, both legislative and regulatory processes have to be analysed. It should be noted, however, that regulatory barriers to transatlantic trade are not of the same nature on both sides of the Atlantic: while they usually take the form of legislative acts in the EU, they very often consist of rules in the US – non-legislative acts executing statutes adopted by the Congress70.

A. Comparison of EU and US Legislative Processes

In the US, the main legislative body is the Congress, composed of the House of Representatives (members elected from equally populated districts) and the Senate (two senators from each state)71. In the EU, three actors play a role in the legislative process: the Commission, which represents Union’s interests and has the right of legislative initiative72, the Council and the Parliament, which have the role of co-legislators, the former representing the interests of Member States, the latter speaking

67 _{European Commission, European Union’s initial proposal for legal text on “Regulatory}

Cooperation” in TTIP, 10-02-2015, [online], Section III.

68

Ibid., art. 2.

69 _{Ibid., art. 2(a).}

70 _{Alemanno, Presentation on TTIP’s Regulatory Convergence before the Committee on Legal Affairs}

and the Committee on International Trade of the European Parliament, op. cit., at 2:06; Bergkamp & Kogan, Trade, the Precautionary Principle, and Post-Modern Regulatory Process: Regulatory Convergence in the Transatlantic Trade and Investment Partnership, EJRR 2013/4, [online], p. 497-498.

71

Parker & Alemanno, Towards Effective Regulatory Cooperation under TTIP, 13-05-2014, [online], p. 1.

for EU citizens73. Furthermore, since the Maastricht Treaty, the European Parliament is entitled to request the Commission to put forward a proposal74. This institutional triangle, by combining actors representing various interests, aims at complying with the EU principle of “institutional balance”75.

As regards the legislative process strictly speaking, two stages can be distinguished on both sides of the Atlantic: the formative stage, where issues which may be subject to legislation are discussed and incorporated in draft bills, and the deliberative stage, where debates, amendments and votes take place76.

European and US law-making processes, while they bear similarities with each other, differ in several respects.

First, the formative stage takes a different form in each jurisdiction. In the EU, the elaboration of a legislative proposal by the Commission is typically based on numerous preliminary consultations with experts and interested parties77. The most important Commission initiatives, before being transmitted to the European Parliament and Council, are subject to an extensive administrative process, including early warnings through public Commission Roadmaps, comprehensive stakeholders consultations, reports by national experts, consultation of international organisations and/or NGOs, developed Impact Assessment, Impact Assessment Board review, Inter-Service Consultation between the departments of the Commission, and, lastly, adoption of the legislative proposal by the College of Commissioners78. In the US on the contrary, the pre-legislative process only exceptionally entails such extensive consultations79. In the vast majority of cases, legislative proposals come from a Member of the House of Representatives or the Senate, assisted by his or her staff80. In addition, outside stakeholders and the Congress’s Office of Legislative Counsel may help in drafting the proposal81. However, neither impact assessment, nor stakeholder consultation constitute mandatory steps for submitting a draft bill to the

73 _{TEU, art. 14(1) & (2); art. 16(1) & (2).} 74

TFEU, art. 225.

75

Parker & Alemanno, op. cit., p. 1.

76 _{Ibid., p. 1-2.}

77 _{For the guidelines to be complied with in the framework of these consultations, see European}

Commission, Communication on the collection and use of expertise by the Commission: principles and guidelines, 11-12-2002, COM(2002)713 final, [online].

78 _{Parker & Alemanno, op. cit., p. 2; European Commission, Ordinary Legislative Procedure “Step by}

Step”, 31-01-2012, [online], p. 1.

79

Parker & Alemanno, op. cit., p. 2.

80 _Ibid. 81 _Ibid.

House or the Senate82. Consequently, EU and US formative stages are not characterised by the same level of transparency to the public.

The deliberative phase, on the other hand, is rather similar in both jurisdictions, taking the form of a debate and amendment process between two co-legislating institutions83. In the US however, before being formally submitted to the Congress, a bill normally goes through a hearing and “mark-up” process in one or several relevant committees in the House and the Senate84. This preliminary step, though not necessarily carried out, compensates for the absence of impact assessment and Inter-Service Consultation procedures in the formative stage. On both sides of the Atlantic, a draft bill becomes a law only after an identical text is approved by the co-legislators – European Parliament and Council in the EU, the House and Senate in the US – and then signed by the Presidents of the European Parliament and Council or by the US President85. The only difference lies in the fact that the US President has the discretion to veto a bill, whereas the signature of his EU counterparts is largely ceremonial86. It must nevertheless be noted that a veto can be overcome by a two-thirds vote of the House and Senate, although this rarely occurs87.

Besides the formative and deliberative stages, it is noteworthy that both the EU and the US committed, through WTO agreements, to notify their trading partners of laws and rules in preparation that could affect trade88. For instance, under the WTO TBT Agreement, the EU shall notify draft TBT-relevant regulations and directives to the WTO once adopted by the College of Commissioners89.

B. Comparison of EU and US Regulatory Processes

European and US central regulatory bodies, namely the EU Commission and US agencies, are endowed with identical powers.

In the EU, the Commission has the power to adopt two types of non-legislative acts: implementing acts, which are used where uniform conditions for 82 _Ibid. 83 Ibid., p. 2-3. 84 _{Ibid., p. 2.} 85 _{Ibid., p. 3.} 86 _Ibid. 87 Ibid. 88 _Ibid.

implementing legally binding Union acts are necessary90, and delegated acts, through which the Commission may “supplement or amend certain non-essential elements” of EU legislative acts91. US agencies, by contrast, are not entitled to exercise delegated powers to modify congressionally enacted laws92.

This difference in attributions implies that the Commission is subject to a stricter oversight than US agencies. First, draft delegated acts, since they involve the exercise of a quasi law-making power by the Commission, are reviewed by the European Parliament and Council, which may reject them within a two months period, possibly extendable to four months93. Implementing acts, although merely consisting in the practical implementation of rules already existing in the original legislation, cannot be enacted by the Commission before an Examination Committee consisting of Member States representatives issues a formal opinion94. In that respect, two procedures may be used: the examination procedure, in which the Examination Committee may, acting by a qualified majority, vote against the adoption of the implementing act95, and the less commonly used advisory procedure, in which the Committee gives a mere advisory opinion to the Commission96. Furthermore, when the implementing act relates to a sensitive policy issue, such as food safety, consumer health or environmental protection, it has to be approved by the Committee at qualified majority vote97. If not, then the draft is submitted to the Appeals Committee, which may adopt, amend or reject it via qualified majority vote98.

The review system applying to both implementing and delegated acts in the EU has no counterpart in the US, where regulations adopted by agencies cannot be amended or vetoed by the Congress unless the latter adopts a new statute, starting the ping-pong process between the House and the Senate over from the beginning99. Nevertheless, although US regulations are not subject to an ex ante legislative control,

90 _{TFEU, art. 291(2).} 91 _{TFEU, art. 290(1).} 92

Parker & Alemanno, op. cit., p. 4.

93

Council of the European Union, Common Understanding on Delegated Acts, 10-04-2011, 8753/11 PE 164 INST 195, [online], points 4 & 10.

94 _{Regulation (EU) No 182/2011 of the European Parliament and Council of 16 February 2011 laying}

down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers, OJ L55/13, art. 3.

95 _{Ibid., art. 5.} 96 _{Ibid., art. 4.} 97

Ibid., art. 5.4.a.

98 _{Ibid., art. 6.4.}

they are more likely to be challenged in court than EU delegated and implementing acts because, inter alia, of the less strict rules governing legal standing in the US100.

Beyond US and EU regulatory bodies’ attributions and review modalities, it is appropriate, in the light of the procedural regulatory cooperation approach envisaged in TTIP draft proposals, to compare the level of transparency and public participation in the formative and deliberative stages of rulemaking in both jurisdictions.

As regards the formative stage of rulemaking, in which proposals are analysed and weighted with alternatives, the situation is broadly similar in the EU and the US: informal and non-regulated consultations take place between regulators and stakeholders101. In the US, agencies may decide to take counsel from stakeholder groups and advisory boards, hold public hearings and issue notices to inform about their current discussions, but the publication of a Notice of Proposed Rulemaking is not conditional upon the compliance with legally binding requirements102. Indeed, nothing in US law prevents contacts between stakeholders and agencies’ staff at this stage and, as a corollary, there is no requirement of disclosing or transcribing their content103. In the same way, no procedural requirements prohibit informal contacts between EU regulators and stakeholders regarding a proposed delegated or implementing act104.

At the deliberative stage however, EU and US processes slightly differ105. In the US, after the publication of the Notice of Proposed Rulemaking, all agency rules are subject to a notice-and-comment process, which, even though variations of practice exist among US agencies, includes the publication of the draft regulation, the opening of a comment period, the reviewing of the comments, the revision of the draft in the light of the comments, and the issuance of the final regulation106. Furthermore, it must be noted that a large number of agencies restrict or require disclosure of communications between their staff and the stakeholders after the close of the comment period107. In the EU, while the transparency offered by the US notice-and-comment process can be achieved via Impact Assessment, it remains that this process 100 _{Ibid., p. 7.} 101 Ibid., p. 5. 102 _Ibid. 103 _Ibid. 104 _Ibid. 105 Ibid. 106 _{Ibid., p. 5-6.} 107 _{Ibid., p. 6.}

applies only to acts likely to have significant economic, environmental or social impacts108. Nevertheless, tools exist at EU level to intensify transparency for delegated and implementing acts. As regards the former, a Register of Expert Groups and Other Similar Entities established by the Commission provides information about the advisory entities that play a role in the preparation phase (inter alia group’s composition, missions and links with the Commission)109. A similar system exists for implementing acts: the Comitology Register, which lists all comitology committees and provides summary records of their meetings, draft implementing acts submitted to them, results of voting, final draft implementing acts and information about the adoption of final draft implementing acts by the Commission110.

Finally, as it is the case for legislative acts, the EU and the US are obliged under WTO SPS and TBT Agreements to notify other members of draft regulations and conformity assessment procedures likely to affect trade exchanges111.

C. EU and US Approaches to Impact Assessment

Impact assessment (IA) is used on both sides of the Atlantic in order to evaluate various options to regulation and consider the environmental, social and economic impacts of the latter on the society112. The EU procedure is known as Impact Assessment, while it is called Regulatory Impact Assessment (RIA) in the US113. In spite of a similar denomination, the EU and US processes differ in various respects.

First, IA is not carried out for all legislative and regulatory acts in both jurisdictions. Indeed, while it is mainly applied to legislative acts and only rarely to delegated and implementing acts in the EU, it is almost never used in the US pre-legislative phase114. By contrast, all “significant” US rules are to be subject to a RIA115. 108 _Ibid. 109 _Ibid. 110 Ibid.

111 _{WTO Agreement on the Application of SPS measures, op. cit., art. 7 & Annex B, points 5-6; WTO}

TBT Agreement, op. cit., art. 2.9.2. & 2.10.1.

112 _{Meuwese, op. cit., p. 252.} 113

Parker & Alemanno, op. cit., p. 7; Meuwese, op. cit., p. 252-253.

114 _{Parker & Alemanno, op. cit., p. 7.} 115 _Ibid.

Second, the EU and the US make use of different methodologies of assessment. In the EU, IA is carried out according to an integrated approach, mixing the characteristics of regulatory impact assessment, sustainable impact assessment and other assessment methods, such as cost-benefit analysis or cost-effectiveness analysis116. The US approach, on the contrary, focuses on quantitative and, though to a lesser extent, qualitative cost-benefit analysis117.

A third divergence existing between the two systems relates to the public consultation process. In the EU, the public is given the opportunity to comment various envisageable policy options and their impacts in the framework of each IA118. The consultation is organised by the Directorates-General in charge of carrying out the IA within the Commission119. Only then occurs the publication of the draft proposal and the IA accompanying it, after the approval of the College of Commissioners120. In the US, by contrast, public comments are directly made on the draft RIA and the Notice of Proposed Rulemaking121.

A last distinction existing between the two systems is the influence of the IA on the political decision-making. The IA carried out in the EU does not prescribe a decision criterion, leaving thus decision-makers free to depart from it122. In the US, on the contrary, RIA system tends to impose a decision criterion, since one of the ideas behind RIA is to exercise control on delegated standard-setting procedures123. The diverging place occupied by IA on each side of the Atlantic is thus described by the American Chamber of Commerce to the EU as follows: “European impact

assessments appear to be a tool for informing legislators about, and legitimising, the Commission’s choices in formulating legislative proposals. However, in the US – even though impact assessments may be carried out in preparing for legislative measures – impact analysis is mainly understood as a means by which executive action may be disciplined and influenced”124.

116 Ibid., p. 8. 117 Ibid. 118 _Ibid. 119 _{Ibid., p. 25.} 120 Ibid., p. 8. 121 _Ibid.

122 _{Meuwese, op. cit., p. 253.} 123 _Ibid.

124

American Chamber of Commerce to the EU, AmCham EU’s comments on the EC-OMB Joint Draft Report on the Review of the application of EU and US regulatory impact assessment guidelines on the analysis of impacts on international trade and investment, 29-02-2008, [online], p. 2.

2.2.2. EU and US Diverging and Evolving Attitudes towards Precaution in Food Safety Regulations: Precautionary Principle, Risk Assessment and Cost-Benefit Analysis

Now that we have depicted the EU and US legislative and rule-making processes in general, the purpose of this sub-section is to describe the EU and US conflicting approaches to precaution, since this aspect plays a crucial role in food safety law- and rule-making. Understanding this divergence is necessary to evaluate the challenges that TTIP’s procedural regulatory cooperation process could raise for EU food safety regulatory framework.

First and foremost, it is important to explain what is meant by precaution. Since time immemorial, human beings have faced risks that compromised their survival125. In order to maintain themselves and prosper, humans have developed their ability to efficiently assess and manage risks126. The late 1960s, in particular, mark the beginning of the establishment of comprehensive risk regulation regimes in Europe and in the US in order to address risks to the environment, health, safety and security127. From the outset, the creation of these regimes raised the issue of the level of stringency and anticipation that should characterise regulations applying to new and uncertain risks, in other words which precautionary approach should be preferred128.

When observing food safety risk regulations adopted from the 1960s on both sides of the Atlantic, 1990 is often presented as a pivotal year in the sense that European and American attitudes towards precaution have reversed in that year129. Prior to 1990, while food safety risk regulations enacted in the US tended to follow a more precautionary approach, especially for suspected carcinogens in food, European standards, by contrast, used to reflect less risk-averse policy views130. After 1990

125 _{Wiener, The Rhetoric of Precaution, in: The Reality of Precaution, 2011, p. 3.} 126

Ibid.

127 _{Ibid., p. 4.} 128 _Ibid.

129 _{Vogel, The Politics of Precaution, op. cit., p. 2, 18-20 & 43 ; Wiener, The Rhetoric of Precaution,}

op. cit., p. 4-5, citing the “flip-flop” in the 1990s as one of the basic accounts that define attitudes to precaution in the history.

nevertheless, a shift in regulatory stringency occured, whereby EU food safety risk regulations have tended to be more risk-averse than their US counterparts131. As a matter of fact, the EU has not merely replaced the US as the world leader of risk regulation, but it also has adopted more stringent and comprehensive regulations, in particular concerning risks that became more significant in the 1990s, such as GM food and agriculture, antibiotics in animal feed and milk and beef hormones132. This flip-flop move, although comprehensively challenged by Wiener133, dissipates the conception of a “risky, reckless and violent America” opposed to a “careful, safe and

civilised Europe” advanced by some observers134. All the more since many EU risk regulations have been inspired by US regulations enacted between the 1960s and 1990s135.

Risk assessment and management criteria applied on each side of the Atlantic played a major role in this regulatory shift. For its part, the EU has included the precautionary principle (PP) in the 1992 Maastricht Treaty, enabling by that European regulatory officials to regulate and impose restrictions on businesses that presented scientifically uncertain or disputed risks136. The PP, elaborated in the 1960s, can indeed be summarised under the quote “It’s better to be safe than sorry”137, insofar as it is based upon the idea that “the lack of clear evidence of harm is not evidence of the

absence of harm”138. No clear unified denifition of the principle has been established at EU level, but the Commission considers that it allows to take regulatory action despite scientific uncertainty because of the harm that inaction could cause139. According to the 2000 Commission Communication, if EU risk managers decide to adopt measures based on the PP, they have to ensure that the latter are, inter alia, non-discriminatory, proportional, consistent with similar existing measures and subject to review in the light of new scientific data140.

131 _Ibid.

132 _{Ibid., p. 4, 6 & 25. For details, see p. 66-96.} 133

Wiener, Symposium on David Vogel’s The Politics of Precaution, Regulation & Governance 2013/2, [online], p. 258-259; Wiener, The Rhetoric of Precaution, op. cit., p. 13-23.

134 _{Wiener, Whose Precaution After All?, Duke J. Comp. & Int’l L.2003/3, [online], p. 214-215.} 135 _{Vogel, The Politics of Precaution, op. cit., p. 11-12.}

136

Ibid., p. 9 & 35. At present, the PP is incorporated in TFEU, art. 191(2).

137 _{Wiener, The Rhetoric of Precaution, op. cit., p. 4; Vogel, The Politics of Precaution, 2012, p. 19.} 138 _{Vogel, The Politics of Precaution, op. cit., p. 19.}

139 _{Rose-Ackerman, Precaution, Proportionality, and Cost/Benefit Analysis: False Analogies, EJRR}

2013/2, [online], p. 282.

140 _{European Commission, Communication on the precautionary principle, 02-02-2000, COM2000(1),}

By contrast, American policy makers started to use scientific risk assesments in the 1980s, after a landmark judgment issued by the US Supreme Court141. The method of scientific risk assessment, since it requires that a risk is “significant” according to relevant scientific data and expert reports to be regulated, often has the effect to strengthen the level of scientific evidence requested for enacting new risk regulations142. Besides the performance of a science-based risk assessment, the adoption of a risk regulation in the US is conditional upon a cost-benefit analysis143. Introduced in 1981 by President Reagan, this technique, applied by federal regulatory agencies, consists of considering alternative approaches to a given risk regulation issue and evaluating whether the benefits outweigh the costs144.

2.2.3. The Reasons behind Food Safety Regulatory Divergence in the EU and the US

Having noted the existence of such a regulatory shift, the central issue is to understand the reasons underpinning the transatlantic regulatory divergence since 1990. According to Vogel, regulatory decisions are influenced by three aspects: the risk assessment and risk management criteria, the public demands and the preferences of policy makers145. In order to explain regulatory divergences between the EU and the US, in particular in the area of food safety, these three factors have thus to be considered.

As regards, first, the criteria used to elaborate risk regulations, different paths have been adopted on either side of the Atlantic around 1990: while the EU adopted the PP, the US placed the emphasis on scientific risk assessment and cost-benefit analysis. Although the criteria applied by the US do not preclude, in principle, the enactment of stringent risk regulations, it remains that, in practice, they involved a

141 _{US Supreme Court, Industrial Union Department, AFL-CIO v. American Petroleum Institute,}

02-07-1980, 448 U.S. 607, [online], 639.

142

Vogel, The Politics of Precaution, op. cit., p. 35, 44, 256 & 259.

143

Ibid., p. 257; Bergkamp & Kogan, op. cit., p. 497.

144 _{Vogel, The Politics of Precaution, op. cit., p. 257; Alemanno, Is There a Role for Cost-Benefit}

Analysis Beyond the Nation-State?, op. cit., p. 7.

145

Vogel, The Politics of Precaution, op. cit., p. 3. For further details, see Ibid., Chapter 7 (Public Risk Perceptions and the Preferences of Policy Makers), p. 219-251. Besides these three factors, Vogel examines alternative explanations to EU-US conflicting approaches, such as differences in actual risks, links between economic performances and regulatory stringency, economic interests of EU and US firms, traditionally divergent attitudes towards interventionism, differences of political systems and cultural values, but concludes that none of them is satisfactory for justifying US-EU regulatory divergences since 1990 (Ibid., Chapter 2, p. 23-42).

decrease in the adoption of risk-averse regulations by federal agencies146. Furthermore, insofar as they require quantitative risk assessments, the two US requirements limited the adoption of regulations in case of scientific uncertainty147. In the light of these considerations, it appears that the transatlantic regulatory divergence has been shaped by the risk assessment and risk management criteria used on each side of the Atlantic.

More fundamentally, one might wonder why the EU has adopted the PP whereas the US have not done so. In that respect, some authors have invoked the role of deeply rooted cultural values148. In their view, Europeans are more concerned about the need to preserve the environment for future generations, more collectivist and afraid of technological developments, and therefore more likely to adopt a precautionary approach than Americans, who are said to be more individualistic, technologically optimistic, risk-taking and antiregulatory149. However, Vogel considers that cultural values are not the cause of all regulatory divergences between the EU and the US150. Wiener, for his part, sees this cultural opposition as a stereotype, which does not match with empirical studies151. Indeed, since the existence of a regulatory shift in 1990, advocated by Vogel and the majority of scholars, provides evidence that attitudes towards risks and regulation are not permanent on either side of the Atlantic, the fact that Wiener strongly nuances this “flip-flop” and rather envisages variations in regulatory stringency as “particular

differences on particular risks” necessarily involves an even higher skepticism

regarding these claimed conflicting cultural values152. Nevertheless, both authors acknowledge that cultural roots have sometimes played a role in shaping public’s risk perceptions – for instance, the fact that Europeans are less open to agricultural biotechnology than Americans may originate from their historically strong preference for “natural” food processes153.

146

Ibid., p. 260.

147

Ibid.

148 _{Levy & Newell, Ocean’s Apart?, Environment 2000/9, [online], p. 10-11; Kempton & Craig,}

European Perspectives on Global Climate Change, Environment 1993/3, [online], p. 16-20 & 41-45; Bodansky, Transatlantic Environmental Relations, in: Europe, America, Bush, 2003, p. 64.

149 _Ibid.

150 _{Vogel, The Politics of Precaution, op. cit., p. 34.} 151 _{Wiener, The Rhetoric of Precaution, op. cit., p. 8.} 152

Ibid., p. 8-9.

153 _{Vogel, The Politics of Precaution, op. cit., p. 34; Wiener, The Rhetoric of Precaution, op. cit., p.}

If attitudes towards precaution are not intrinsically cultural, why, then, did the EU and the US adopt different risk assessment and management criteria around 1990? In our view, the choice of criteria, although presented as one of the three explanatory factors of the 1990 regulatory shift, is actually the consequence of the evolution of both public risk perceptions and policy makers preferences. Understanding the reasons underpinning the change in method therefore requires to look at the rationale behind these two remaining factors.

While public pressures within the EU for more stringent food safety regulations had already largely contributed to the 1980s EU bans on growth hormones for livestock154, they have been reinforced by the fact that, in the mid-1990s, European policy makers experienced a series of food safety policy failures: the mismanagement of the mad-cow disease (BSE) caused vivid health concerns, as did the discovery of dioxin in animal feed and the contamination of Coca-Cola by chemicals155. These failures have been attributed to insufficiently stringent regulations at EU level156. By contrast, American food safety regulations enacted before 1990, mostly focusing on carcinogens in food, such as cyclamates, DES, pesticides and Alar157, were more risk-averse than those adopted in Europe158. This has led to publicised examples of “over-regulation” in the US, of which the Alar controversy constitutes a prominent case159. These contrasting situations, having involved opposite policy failures across the Atlantic, have triggered a change in EU and US public’s risk perceptions160. In the 1990s, whereas Europeans perceived food safety risks as credible and politically unacceptable, the American public was less concerned by the same issues161. In the US, this situation was reinforced by the fact that the multiplicity of political points of view expressed on new risks limited their

154 _{Vogel, The Politics of Precaution, op. cit., p. 58 & 62.} 155 _{Ibid., p. 62-65.}

156 _{Ibid., p. 17.} 157

Ibid., p. 40 & 48-51. Cyclamates are artificial sweeteners, DES, or dimethyl stilbenes, is a growth promoter, and Alar is a type of plant-growth regulator usually sprayed on apples to make them look better and fall from trees only when ripe.

158 _{Ibid., p. 40, 45 & 48-51. The Delaney Clause, adopted in 1958, played a major role in the adoption}

of highly risk-averse US food safety regulations.

159 _{Ibid., p. 17 & 53-54. In spite of conflicting scientific studies on the safety risks caused by the}

ingestion of Alar-treated apples, strong opposition from activists groups, relayed by the media, contributed to scare the public and triggered a ban decision for all food products by the US Environmental Protection Agency.

160 _{Ibid., p. 25 & 37.} 161 _{Ibid., p. 41.}

political impact, which prevented the persuasion of the public162. This change in public’s preferences, contributing to the emergence (EU) or the attenuation (US) of a “precautionary risk culture”, in turn increased the pressure exercised on policy makers for more or less stringent regulations163. As a result, after 1990, EU risk regulations put the emphasis on the avoidance of false negatives – insufficiently risk-averse regulations –, whereas US regulators placed priority on reducing false positives – unnecessarily risk-averse regulations164. For instance, EU regulatory policies for milk hormones and GMOs have been strongly influenced by consumer concerns165.

The third explanatory factor of transatlantic regulatory divergence refers to the preferences of influential policy makers166. Although the mentioned policy failures have affected these preferences, the dissimilar composition of the governments and parliamentary assemblies across the Atlantic has also contributed to shape them167. In the US, where, up until 1990, Democrats and Republicans had supported strong consumer and environmental regulations, risk regulation has started to be subject to a strong polarisation between the members of the two parties, Republicans objecting to the adoption of more stringent risk regulations168. The combination of a Republican-led Congress between 1995 and 2006 and the presidency of George W. Bush until 2008 had the consequence of slowing down the amount of new and more stringent risk regulations enacted, in particular in the form of legislative acts169. An opposite process occurred in Europe, where Green political parties increased their influence from 1994, both in the European Parliament and in national assemblies170. Moreover, in 1995, this movement has been reinforced by the accession to the EU of new Member States in favour of green policies (Sweden, Finland and Austria)171.

162 Ibid. 163 _{Ibid., p. 25 & 38-39.} 164 _{Ibid., p. 17.} 165 Ibid., p. 72 & 75-77. 166 _{Ibid., p. 34-35.} 167 _{Ibid., p. 35.} 168 _{Ibid., p. 34-35.} 169 Ibid. 170 _{Ibid., p. 35.} 171 _Ibid.

3. R

C

TTIP’

H

,

SPS

TBT

C

:

C

EU

F

S

R

F

While it is difficult to predict the impact of TTIP’s negotiations on EU food safety regulations, it is nevertheless worthwile to address issues the TTIP’s regulatory cooperation approach presents for these EU rules. For that purpose, the first section of this chapter attempts to assess the modes of regulatory cooperation considered in the horizontal chapter as well as the TBT and SPS chapters of TTIP, acknowledging the limitation of available information. The second section then considers criticism raised against TTIP, in particular regarding the threat the TTIP’s regulatory cooperation approach represents for EU food safety rules and the precautionary principle, given the differences between the EU and the US identified in the second chapter.

3.1. Which Type of Regulatory Cooperation is Envisaged in TTIP?

With TTIP, the EU and the US want to adopt an innovative approach to international regulatory cooperation172. The purpose is to build upon the WTO regime and the transatlantic dialogue existing from the 1990s173.

Regulatory cooperation in TTIP will be organised on the basis of horizontal and sectoral or vertical provisions174. Among the numerous areas covered by risk regulation, we have chosen to focus in this thesis on food safety. Since this area of law is not specifically dealt with in the sectoral provisions – applying to chemicals, cosmetics, engineering, medical devices, motor vehicles, pharmaceuticals, services, textiles and clothing175 –, we will look at the first part of TTIP’s regulatory pillar, namely horizontal provisions. The latter include a chapter on horizontal regulatory cooperation as well as “TBT-plus” and “SPS-plus” frameworks176. Horizontal

172

Alemanno, International Regulatory Cooperation and its discontents: What is really at stake in TTIP?, op. cit., p. 1.

173 _{Alemanno, The Transatlantic Trade and Investment Partnership and the Parliamentary Dimension}

of Regulatory Cooperation, op. cit., p. 32-34.

174

European Commission, TTIP and Regulation: An Overview, op. cit., p. 8.

175 _{Ibid., p. 12-17.} 176 _{Ibid., p. 8-12.}

provisions are analysed separately according to this subdivision in points 3.1.1. and 3.1.2. It is noteworthy that, even though “TBT-plus” and “SPS-plus” frameworks will be included in the horizontal chapter of TTIP, they are more specified than general horizontal regulatory cooperation provisions, which can be applied to any regulatory matter177. In that light, these frameworks can be considered as sectoral provisions aimed at achieving regulatory convergence in the area of SPS and TBT measures. The combined analysis of general horizontal regulatory cooperation provisions and “SPS-plus” and “TBT-“SPS-plus” frameworks is justified in this thesis insofar as the former could apply to food safety rules on the basis of their non-specified scope of application, while the latter, especially SPS measures, are directly related to food safety.

To the end of assessing the regulatory cooperation approach adopted in TTIP as regards horizontal convergence and TBT and SPS measures, this section focuses on two types of documents.

The first of these is the Final Report of the High-Level Working Group on Jobs and Growth (HLWG), issued in February 2013178. The HLWG has been established in November 2011 with a view to setting up measures boosting trade exchanges between the EU and the US and, in turn, stimulating economic growth, job creation and competitiveness179. In its June 2012 Interim Report, the HLWG concluded that this objective would be best achieved through the conclusion of a comprehensive transatlantic trade and investment agreement, addressing a broad range of trade and investment issues, including regulatory convergence issues180. The Final Report, which has served as the reference document for TTIP negotiations, further elaborates the form of regulatory cooperation which should be considered.

The second set of documents is composed of the draft EU proposals on horizontal regulatory cooperation, TBT and SPS measures. While the EU committed to achieve greater transparency concerning TTIP negotiations, the US nevertheless decided not to share their consolidated texts181. As a result, the draft EU proposals on TTIP, published after each round of negotiations, are the only documents that can

177

European Commission, European Union’s initial proposal for legal text on “Regulatory Cooperation” in TTIP, 10-02-2015, op. cit., art. 3.

178 _{High-Level Working Group on Jobs and Growth, Final Report, 11-02-2013, [online].}

179 _{European Commission DG Enterprise and Industry, EU-US High-Level Working Group on Jobs}

and Growth, [online].

180 _{High-Level Working Group on Jobs and Growth, Interim Report, 19-06-2012, [online].}

give indications as to the path taken. The discussion focuses on the latest proposals, published in January and February 2015.

3.1.1. The Horizontal Provisions on Regulatory Cooperation

As regards horizontal regulatory cooperation, the Final Report of the HLWG called for the establishment of new means to address non-tariff barriers to trade between the EU and the US, while at the same time “achieving the levels of health,

safety and environmental protection that each side deems appropriate, or otherwise meeting legitimate regulatory objectives”182. The processes proposed by the HLWG in order to remove existing regulatory divergences include equivalence, mutual recognition or other agreed methods183. As regards future regulatory compatibility, the report even referred to harmonisation of regulations184. In particular, the HLWG recommended the application of common regulatory methodologies, including early consultations, use of best regulatory practices and impact assessments185. The idea behind this procedural convergence was to make EU and US regulations “efficient,

cost-effective and more compatible”186.

The methodological rapprochement suggested by the HLWG in 2013 has been taken over in the February 2015 EU draft proposal on horizontal regulatory cooperation187. More concretely, according to the proposal, the horizontal part would provide a framework for cooperation including, for the first time in a trade agreement188, good regulatory practices such as early information on planned acts, early regulatory cooperation, stakeholder consultation, transparency on impact assessments189. Furthermore, a bilateral cooperation mechanism aiming at fostering information exchanges and increasing regulatory compatibility between EU and US frameworks would be set up190. Finally, a Regulatory Cooperation Body composed of representatives of EU and US regulatory bodies would be established with a view to

182 _{High-Level Working Group on Jobs and Growth, Final Report, op. cit., p. 3.} 183 Ibid., p. 3-4. 184 Ibid., p. 3. 185 _{Ibid., p. 4.} 186 _Ibid. 187

European Commission, European Union’s initial proposal for legal text on “Regulatory Cooperation” in TTIP, 10-02-2015, op. cit., Section II & III.

188 _{Alemanno, The Transatlantic Trade and Investment Partnership and the Parliamentary Dimension}

of Regulatory Cooperation, op. cit., p. 44.

189

European Commission, European Union’s initial proposal for legal text on “Regulatory Cooperation” in TTIP, 10-02-2015, op. cit., Section II.