University of Amsterdam
Faculty of Law
International and European Law: International Trade and Investment Law 2014-2015
Master’s Thesis
The transatlantic legal debate on GMOs
in the TTIP Agreement –
Is it time to consider mutual
recognition?
Spyridoula K. Pratsa1
Supervisor: Dr. Ingo Venzke
Second supervisor: Dr. James M. Mathis
2
Acknowledgements
There are many people I must thank for the role they played while I was conducting this thesis. First and foremost, my supervisor, Dr. Ingo Venzke, for his guidance and always constructive comments and suggestions on the improvement of my work, even to its slightest detail. I would also like to thank my professor Dr. James Mathis for his valuable insight on the topic along with the information I acquired during his classes on International Trade Law and Domestic Regulation. I am also grateful to professor Laurence Boisson de Chazournes, whom I was lucky enough to meet during the summer courses in the Academy of International Law in the Hague, for the time she dedicated to introduce me to new notions on my topic and provide me with supplementary bibliography. I would also like to thank my friend, Kosmas Koteas, for all his support and encouragement and for making himself available to discuss my topic and relevant concerns. Last but not least, I would like to address a big thank to my beloved family and close friends for their love and support. I sincerely thank them all for being there when I needed them.
3 Table of contents Acknowledgements...2 Table of Contents...3 List of Abbreviation...4 Section I - Introduction……….……....5 A. Research question………...8 B. Structure………....9 C. Methodology………...………10
Section II - The GMOs controversy in the TTIP Agreement..………...11
Section III - The international legal framework for GMOs………14
Section IV – Moving towards transatlantic mutual recognition of GMOs……….17
A. Harmonization………...19
B. Mutual Equivalence………..…....20
C. Mutual Recognition………..…22
D. Concluding Remarks………...…..25
Section V - GMOs Regulatory Framework in the United States and Europe………....25
A. The Regulation of GMOs in the United States………26
B. The Regulation of GMOs in the European Union………...……29
C. New developments in the European GMO regime……….33
Section VI – Socio-economic impacts of mutual recognition on GMOs…………..….38
Section VII – Summary and Conclusions………...40
4
List of Abbreviation
CETA – (EU-Canada) Comprehensive Economic and Trade Agreement DSB – Dispute Settlement Body (WTO)
EC – European Community EU – European Union
EFSA – European Food Safety Authority FAO – Food and Agricultural Organization FTA – Free Trade Agreement
GATT – General Agreement on Tariffs and Trade GM – Genetically modified
GMO – Genetically modified organism GRAS - Generally Recognized As Safe
HLWG - High Level Working Group Report on Jobs and Growth ICJ – International Court of Justice
LMOs – Living Modified Organisms MRAs – Mutual Recognition Agreements MS – Member States
NAFTA – North American Free Trade Association NGOs – Non-Governmental Organizations
NTA - New Transatlantic Agenda (1995) NTB(s) – Non-tariff Barrier(s)
OECD – Organization for Economic Cooperation and Development RTA – Regional Trade Agreement
SPS – Sanitary and Phytosanitary TAFTA – Transatlantic Free Trade Area TBT – Technical Barriers to Trade
TEP - Transatlantic Economic Partnership (1998) TPP - Trans-Pacific Partnership
TTIP – Transatlantic Trade and Investment Partnership US/USA – United States of America
5
I. INTRODUCTION
In the dynamic and ever-evolving field of international economic law, a new development is eminent to change the state of the world trade as we know it. Pursuant to the general bilateral tendency that has been rising lately,2 contrary to the multilateralism that is wedded to the WTO system, since June 2013, the United States (US) and the European Union (EU) have been negotiating a transatlantic trade and investment deal, the TTIP Agreement.3 The new transatlantic agreement is expected to lead to remarkable reforms in international trade and investment law. The EU-US negotiations on the creation of a free trade agreement (FTA) pertain to the current proliferation of FTA and regional trade agreements (RTA);4 both negotiating parties have opted for negotiations with other countries in a bilateral trade environment, with the emergence of several FTAs.5 Indicatively,6 the EU-Canada Comprehensive Economic and Trade Agreement (CETA), the EU-Singapore FTA and the US Asia-Pacific trade agreement, known as the Trans-Asia-Pacific Partnership (TPP)7 are representative examples of a preference over the revival of bilateralism, especially on sectors that the stalemate of Doha Rounds, such as agriculture,8 environment and non-agricultural market access,9 has proved to be really challenging.
Notwithstanding the role of the Doha Rounds stagnation in the proliferation of the TTIP discussions,10 there were, undoubtedly, manifold reasons that paved the path for the US-EU negotiations and re-opened11 the bilateral discussions between the two actors. The global financial crisis that ended the age of neoliberal globalization (1990s-2008) for both the EU and the US and the ambition to compete with the simultaneously
2 See inter alia the speech of the DG Pascal Lamy, Multilateral and bilateral trade agreements: friends
or foes?, 2006 [online] ;
3 European Commission, What is TTIP about? [online]
4 Matsushita, A View on Future Roles of The WTO, 2014, pp. 702 and 705
5 Hartman, The WTO, the Doha Round Impasse, PTAs, and FTAs/ RTAs, 2013, pp. 421-422 “While the
Doha Rounds are basically in a stalemate, there has been a steadily increasing number of PTAs during the same period of time. At the time of this writing, there are over 300 PTAs and more than 500 FTAs/RTAs worldwide)”
6 See inter alia: EU Trade, European Commission, Overview of FTA and other Trade Negotiations
[online] ; European Commission, Free Trade Agreements, 2015 [online]
7 Office of the US Trade Representative, Free Trade Agreements, [online]
https://ustr.gov/trade-agreements/free-trade-agreements
8 Hartman, 2013, pp. 413-416 “The December 2011 Doha meeting was a stalemate, and basically nothing
was achieved in the agriculture area.”
9 Ibid, p. 416 “This is another major stumbling block for the WTO; some progress was made on the other
NAMA issues, but more needs to be done.”
10 See inter alia: Cottier, The Common Law of International Trade and the Future of the World Trade
Organization, 2015, p. 3
6
emerging trade powers, such as Brazil, Russia, China etc led the negotiators on the both sides of the Atlantic to reconsider the option of a US-EU FTA in order to address long-lasting and unprecedented issues; aiming at the economic growth and the creation of new jobs.12 At the time of drafting this contribution (April-June 2015), the ninth round of TTIP negotiations took place in New York, in April 20 – 24, 2015. Despite an opposing part of the public opinion on the matter, the negotiations of the TTIP Agreement are held behind closed doors and all the relevant information available to the public has become known through leaking drafts. This climate of secrecy that surrounds the negotiations combined with the trending topics covered by its agenda creates ambivalent emotions to the numerous interested stakeholders, who extent beyond the league of economic and legal counterparts and involve working parties, consumers, producers, retailers, investors etc.
The high importance of the TTIP Agreement lies in the covered topics under negotiation which are expected to be comprehensive, covering virtually all aspects of EU-US trade.13 According to the Report of the US-EU High Level Working Group (HLWG),14 these include, among others, the liberalization of agricultural products, public procurement, investment and the regulation of intellectual property rights. A key factor to the liberalization process is the reduction of regulatory or non-tariff barriers (NTBs)15 that occur through diverging domestic regulations. While past trade negotiations have dealt with domestic regulation as a trade barrier in only narrow and limited ways, within the TTIP framework, the reduction of regulatory barriers constitutes a signature issue.16
Without undermining the importance of the rest of the objectives of the TTIP under negotiation and as it could not be feasible to extend the scope to the whole range of the TTIP chapters, in the present analysis the focus will be on one of the most sensitive and illustrative examples of divergent visions between the negotiators within the TTIP framework: the regulation of genetically modified organisms (GMOs)17 as an
12
See inter alia: European Commission, Transatlantic Trade and Investment Partnership - The Economic Analysis Explained, 2013, p. 6 [online]
13 Lester & Barbee, The Challenge of Cooperation, 2013, p. 852
14 The HLWG was established in November 2011 by the US and EU political leaders to identify options
for strengthening the US–EU trade and investment relationship, see inter alia: Lester & Barbee, p. 850
15 See inter alia: European Commission, Transatlantic Trade and Investment Partnership - The
Regulatory Part, 2013, p. 2 [online]
16 Lester & Barbee, p. 848 17
For the definition of GMOs see inter alia: European Commission, Biotechnology: Genetically Modified Organisms (GMOs) in agriculture [online] “GMOs are organisms such as plants, animals and
micro-7
objective pertaining to the reduction of domestic regulatory barriers.18 It is well-known that, since the appearance of GM products in the early 80s, the US and the EU have developed diverging regimes regarding the GMOs regulation, with the US being more flexible and open to new technologies and the EU upholding a more restrictive and cautious approach.19 The scientific uncertainty and the absence of a definitive answer that even today accompanies the effect of GM cultivation and use on human health and on the environment have accordingly influenced the position of the two trade blocs that is well-established and deeply entrenched.20 The two diverging regimes have not only constituted a topic of academic discussion, but the two parties were confronted before the dispute settlement system of the World Trade Organization, in 2003, in the (in)famous EC-Biotech case,21 setting the actual trade-related dimensions of the regulatory divergence on GMOs between the two legal frameworks.
Even before the initiation of the TTIP negotiations, stakeholders from both sides of the Atlantic shared the opinion that the negotiations on the regulation of GMOs and the intention to achieve a conciliatory solution would constitute one of the stumbling blocks of the TTIP conclusion. Notwithstanding the benefits emanating from a successful TTIP conclusion, the negotiators from both economic zones appeared to quite categorical on the extent of mutual compromises; with the US supporting the acceptance of the less restrictive American GM policies and the EU insisting on the maintenance of the precautionary principle22 without compromising health standards and its high level of health protection.
However, and this is the one of the reasons why this topic was interesting to further examine, the reality has come to prove otherwise; at the beginning of 2015, the
organisms (bacteria, viruses, etc.), the genetic characteristics of which have been modified artificially in order to give them a new property (a plant's resistance to a disease or insect, increased crop productivity, a plant's tolerance of a herbicide, etc.)”
18 See inter alia: Gerstetter, Regulatory cooperation under TTIP, 2014, p. 7
19 Boisson de Chazournes & Mbengue, International legal aspects of the co-existence between GM and
non-GM products, 2005, p. 17 ; Lively, The ABCs and NTBs of GMOs, 2002, p. 240
20
Grueff, Achieving a Successful Outcome for Agriculture in the EU-U.S. Transatlantic Trade and Investment Partnership Agreement, 2013, p. 4
21 See inter alia: Conrad, The EC–Biotech dispute and applicability of the SPS Agreement, 2007, pp.
233-234 “[…] the requests and arguments of the complainants in EC–Biotech did not lead to a substantive discussion or to findings on the general permissibility of restrictive national regulations of biotech products. Indeed, the dispute focused on the implementation of administrative approval procedures and delays, as well as on the simple need to base decisions on scientific principles and risk assessments. Future panels may nevertheless have to decide upon the ultimate question of the permissibility of restrictive national regulations of biotech products.”
8
EU, in the process of putting an end to a four-year dispute between “pro- and anti-GMO Member States”,23 adopted a new legislation that allows EU member states to ban or restrict the cultivation of GMOs in their territory.24 In addition, recently, a new proposal was announced by the Commission that would allow EU members states to prohibit the imports of GM products. These developments cannot be seen separately from the on-going TTIP negotiations. Thus, it is obvious that while the TTIP discussion is still evolving, one of the most controversial topics covered by the said negotiations and capable of contributing in the postponement of the deal conclusion, saying the GMOs regulation, is the sector where substantial developments have been noted recently that cannot be seen away from the developments with the TTIP Agreement.
However, albeit these developments may alter the current state of affairs the main controversy remains making the question of regulatory cooperation most topical than ever before, in front of the potential of a uniform transatlantic market. Whether regulatory effectiveness can be achieved in the GM regulation is unclear and convergence will not be easy.25 However, in the present thesis, I wish to illustrate that the TTIP negotiations provide for a basis to tackle and further negotiate potential converging points with respect to the regulation of GMOs on both sides of the Atlantic. There is an optimistic view that the negotiations could result in mutual recognition and global standards for GM regulation and unravel a range of issues that are currently stalling the multilateral negotiations within the World Trade Organization (WTO).26 Since the alternatives, such as harmonization, are hard to be achieved on a transatlantic level, given the absence of a harmonized regime even among the EU Member States on GMOs, the mutual recognition appears to be a viable solution for the current inhomogeneity.
A. Research question
The present contribution outlines the current legal framework of GMOs in the US and the EU. By presenting the two diverging regimes, I aim at delineating the main opposing elements of the two regimes that constitute the potential of convergence in the GMOs regulation a rather onerous procedure. The GM regulatory divergence was one of the parameters that allegedly blocked the successful outcome of previous attempts of
23 Randour, Janssens & Delreux, 2014, pp. 1312-1313
24 See inter alia: EU Parliament Research Service, New GMO Legislation, 2015 [online] ; European
Parliament, 13/01/2015 Text adopted by Parliament, [online]
25
Lester & Barbee, 2013, p. 852
9
transatlantic cooperation;27 together with the unbridged opposition on the hormone-beef dispute.28 In this thesis, I seek to illustrate whether, after almost 20 years of communications between the two trading blocs and developments on GM regulation, the current GMO regimes could constitute, once again, a blockage of the on-going TTIP negotiations. Moreover, acknowledging the emergence of significant opportunity for both parties and pursuant to an imperative to gradually overcome the perennial deadlock over GMOs, I argue that the TTIP provides for a conducive framework to promote the transatlantic cooperation on GMOs through mutual recognition.29 The current inability of the WTO/SPS framework to govern biotechnology provides for valuable incentives for both the US and the EU to engage in an effective regulatory cooperation exercise.
B. Structure
In the process of clarifying the main controversy of GMOs within the TTIP framework, covered by the present research, I address, separately, the following topics: the Section II starts with a general overview of the TTIP Agreement providing for some general information on the biggest deal ever negotiated and continues with an insight in the GMOs related provisions within the TTIP context. For this analysis to be illustrative, it is indispensable to briefly present the existing international framework and international instruments that address the GM regulation (Section III) that could provide for the necessary stepping stone for the initiation of a converging policy between the two parties, concluding pursuantly in favor of the principle of mutual recognition as the most adequate option (Section IV). Moreover, as it will be exposed below, in the absence of international standards thoroughly harmonizing or aligning the regulation of GMOs, this regulatory field belongs mainly to the domestic regulation.30 Thus, it is essential in order to have the whole picture of the current deadlock to present the two diverging regimes, focusing mostly on the fundamental elements and principles that - until now - have aggravated the regulatory convergence (Section V). As it was
27
Alons, 2014, p. 65
28 European Communities — Measures Concerning Meat and Meat Products (Hormones)
29 See inter alia: Todhunter, The US-EU Trans-Atlantic Free Trade Agreement (TAFTA), 2014 “One of
the key aspects of the negotiations is that both the EU and US should recognise their respective rules and regulations, which in practice could reduce regulation to the lowest common denominator. The official language talks of ‘mutual recognition’ of standards or so-called reduction of non-tariff barriers. For the EU that could mean accepting US standards in many areas, including food and agriculture, which are lower than the EU’s.”
30
See inter alia: Cottier, Genetic engineering, trade and human rights, in Wüger & Cottier, Genetic engineering and the world trade system, 2008, p. 17
10
stated above, the present thesis introduces the idea of mutual recognition as the most effective mechanism to overcome the current divergence, with a prospect of multilateral extension. Undoubtedly, the likelihood of this solution to be achieved seems rather distant and especially challenging, while it is accompanied with variant socio-economic implications that are concisely stated in Section VI. An overview of the findings and relevant conclusions are presented in the final section (Section VI).
C. Methodology
The importance and controversial nature of each of the main elements in the present research, the GMOs per se, the TTIP negotiations and the legal dispute between the EU and the US over GMOs explains the plethora of relevant articles and bibliography as well as the demand for an articulated legal framework to regulate the application of biotechnology. Both legal and non-legal sources, as the topic pertains to manifold fields of interest, have been taken under consideration and contributed as building blocks for the structure of the present thesis. Undoubtedly, emphasis was given mostly to the legal aspects of the controversy as an integral part of the international trade law.
Clearly, primary and secondary law could not but constitute the foundation of the research; both EU law; the EU treaties, regulations, directives, decisions and recommendations, and the relevant US legislation on the regulation of GMOs were the primary source of information. In addition, the international legal instruments addressing the GMOs, i.e. the WTO Agreements, the Cartagena Protocol on Biosafety31 and the Codex offered valuable background information on the regulation of GM products and modern biotechnology, albeit the GMOs are not directly addressed and regulated on the international plane, but fall under the domestic regulation. Moreover, communications of the trade representatives of both countries and negotiators of the TTIP referring to the topic of GMOs under the TTIP contributed to a great extend in the understanding of the two parties position in the current state of negotiations.
The thesis is written based on a comprehensive literature review and internet research mostly through the databases available through the Law Library of UvA32 and the Peace Palace Library in the Hague.33 Following the doctrinal method, the above mentioned sources were analysed, described and when possible evaluated, while the
31 See inter alia: Boisson de Chazournes & Mbengue, Trade, Environment and Biotechnology, in Wüger
& Cottier, Genetic engineering and the world trade system, 2008, pp. 208-210
32
http://databases.uba.uva.nl/en
11
relevant chapters of the US/EU legal framework are presented in a comparative approach to further illustrate the controversy over GMOs between the two economies. Finally, the present thesis suggests that mutual recognition constitutes an effective way out of the current transatlantic blockage on GMOs.
Section II
The GMOs controversy in the TTIP Agreement
The present thesis is thoroughly developed within the context of the Transatlantic Trade and Investment Partnership. The TTIP is a transatlantic free trade area and trade and investment deal currently under negotiation between the US and the EU. The two negotiating parties are among the world’s biggest trading blocs: together they account for one half of all global trade, making the TTIP the biggest deal ever negotiated. The TTIP constitutes the latest attempt of the two parties to address long-lasting topics and bring in light new issues.34 Recently, the ninth round of negotiations was held in New York and the 10th round is scheduled for 13-17 July 2015.35 The final agreement is expected to contain 24 chapters that are grouped into three basic areas: market access, regulatory cooperation36 and new trade rules addressing common global challenges,37 covering a range of crucial public-interest sectors; labour standards, the licensing of medicines, digital privacy and public procurement constitute just an indicative list.
The size and areas of interest of the TTIP indicate that this agreement is deemed to have important implications for stakeholders in the negotiating blocs and beyond; investors, working parties, medical community, consumers and producers are just a few examples. Undoubtedly, this trade deal is expected to be prosperous and beneficial for both parties; it bears the hopes of supporting the economy by eliminating the already low tariffs and reducing the non-tariff barriers and by opening up the markets on both sides of the Atlantic. Nevertheless, these benefits are not expected to occur at no cost. Especially in the EU, where the policy is affected largely by the NGOs, sensitive areas
34
Buonanno, Cuglesan & Henderson, The New and Changing Transatlanticism, 2015, p. 126
35 ETUCE, General Information on the TTIP, 2015 [online]
36 European Commission, Now online - EU negotiating texts in TTIP, 2015 [online]: Regulatory
Cooperation includes the “cutting of red tape and costs – without cutting corners”; Regulatory coherence, technical barriers to trade (TBTs), sanitary and phytosanitary measures (SPS), regulations on chemicals, cosmetics, medical devices, textiles and vehicles are among the subjects that fall within the scope of regulatory cooperation in the negotiating process.
37 Ibid: This part of the TTIP involves new rules that will make exports, imports and investment easier; it
includes provisions on sustainable development, energy and raw materials, competition, intellectual property and geographical indications, investment protection and investor – state dispute settlement etc.
12
under negotiation, such as food safety and environment cannot but bring preoccupation and concerns38 to the stakeholders that get aggravated in the absence of transparency.39
Since the tariff barriers between the EU-US are already low, the focus of the TTIP negotiations is mainly set on the non-tariff barriers (NTBs). Within the TTIP framework, the discussions over the GM products fall under the NTBs pertaining to the SPS Agreement. As explained above, the regulation of GM products is one of the main diverging elements between the negotiating parties that extends beyond the politically interesting comparative review of the two regulatory regimes and has actual impact on trade40 that led to the EC-Biotech case in front of the WTO dispute settlement system. This restrictive policy reflects the priorities set in forth in the EU; human health, environment and to that extent food safety, having the main role. This attitude in relation to the more tolerant policy from the part of the US constitutes a major issue during the negotiations, setting the GMOs controversy - once again - under scrutiny. The big chasm between the GM policies was proven to be definitive and insuperable obstacle to the conclusion of previous US-EU deals. Almost 20 years later, with only recent developments in the GMOs sector by the EU that will be discussed below, the crucial question remains; is still possible and to what extent for the diverging GM regimes in the territory of the two negotiating parties to compromise the future of the TTIP negotiations,41 by postponing the attainment of a conclusion?42
Aiming at the substantial reduction of NTB and at the alliance of the way the GMOs are regulated, the TTIP negotiations are expected to introduce negotiable terms
38
See inter alia: Ignatius, A free-trade agreement with Europe? 2012 [online] “[…] long-standing barriers to trade and market access” that would have to be removed to make any such deal possible, such as the European Union’s protectionist agricultural rules.”
39 For the issue of confidentiality and the negotiations behind closed doors, see inter alia: European
Commission, Factsheet on Transparency in Trade Negotiations, 2013, p. 4. [online] 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.
40
Grueff, 2013, p. 8 “[…] the most devastating commercial impact in terms of lost EU-U.S. agricultural trade resulting from policy conflicts has probably been that suffered by the U.S. soybean industry. The current annual value of U.S. soybean and soymeal exports to the EU is more than one billion dollars below the corresponding figure for the late 1990s.”; Akhtar & Jones, Transatlantic Trade and Investment Partnership (TTIP) Negotiations, 2014 [online] p. 22 “U.S. producers of certain agricultural products assert that continuing EU labeling and traceability regulations and lack of timelines and transparency in the EU process for admitting GMO products have caused U.S. exports of certain crops, such as soybeans, to decline over time.”
41
See inter alia Alons, 2014, p. 66
42 Akhtar & Jones, 2014, p. 22 “EU officials argue that the number of GMO product approval requests is
increasing, but some agriculture industry stakeholders assert that the time for processing (close to 3.5 years in the EU, in contrast to an average of 1.5 years in the United States) and the attendant backlog remain a major trade barrier. These stakeholders suggest that legally prescribed timelines, transparency, and risk assessment, among other things, could be established to address these issues.”
13
under which the restriction of imports of GMOs constitutes an unfair trade policy.43 So far the leaking drafts of the TTIP agreement do not provide for clear answers on the SPS-related questions, addressed mainly by consumers44 and NGOs during the negotiating rounds.45 Nevertheless, it is known already that the EU and US HLWG, before the limited possibilities provided for by the SPS Agreement together with the incapacity of the Doha Round to successfully address the food safety related issues, suggested the expansion of the TTIP upon the SPS with the creation of “SPS-plus”.46 In this context, the two parties discuss the establishment of an on-going mechanism for improving cooperation and dialogue47 on the protection of human, animal and plant health and the environment.48 However, once again the success of the relevant attempt depends on the willing of the participants to reform adequately their regimes and find a common basis of the scientific understanding of the GM products49 under the auspices of relevant international legal frameworks on GMOs that will be exposed in the following section.
Section III
The international legal framework for GMOs
It has been made clear from the introduction of this paper that the regulation of biotechnology, subsequently of the GMOs, belongs mainly to domestic regulation.50 The resulting regulatory divergence among national orders, such between the EU and
43
Baker, The Risks of the Transatlantic Trade and Investment Partnership, 2014 [online]
44 Knoll, Zinke & Jaksche Safeguarding Consumer Rights and Protection in the TAFTA | TTIP in: The
Transatlantic Colossus, p. 28 [online] “Consumer groups are concerned that the agreement would roll back important regulations. This is primarily because with tariffs on transatlantic trade at historic lows, the joint negotiators will seek to remove “regulatory issues and non-tariff trade barriers” with the focus being on protection and labelling rules, safety and regulatory standards in order to achieve regulatory convergence. This concerns a range of economic sectors at both national and international levels which will affect all aspects of citizens’ daily lives.”
45
Suppan Analysis of the draft Transatlantic Trade and Investment Partnership (TTIP) chapter on food safety, and animal and plant health issues, 2014 [online]
46 See inter alia: Gerstetter, Regulatory cooperation under TTIP, 2014, p. 10
47 See inter alia: Alemanno, The Transatlantic Trade and Investment Partnership and Parliamentary
Regulatory Cooperation, 2014 [online] p. 42
48 See below, p. 26 on Regulatory Council
49Alemanno, The Transatlantic Trade and Investment Partnership (TTIP) and Parliamentary Regulatory
Cooperation, 2014 [online] p. 36 “However, because the EU and US have not shifted their positions on scientifically proven risk or whether the precautionary principle or cost benefit analysis approach should prevail, it is unclear how the TTIP could be more successful than the recent inconclusive disputes brought under the WTO SPS Agreement. Thus, without a common basis of scientific understanding and with continued EU deference to consumer preference, the food sector is likely to remain an area of regulatory divergence”
14
the US, when it comes to regulating GMOs should not cause surprise.51 The regulatory response of each country towards the GMOs reflects its principles and attitudes vis-à-vis genetic engineering and its potential risks.52 This divergence inevitably creates a polyphony over a similar if not identical normative question; the GMOs. Allegedly, in the absence of international trade, this divergence could not cause adverse effects.53 However, the impact of this polyphony extends beyond the national boundaries of each country, primarily in the area of international trade law where regulatory differences are mostly felt and contradict to the aimed non-discriminatory and unrestricted market access.54 Respectively, international trade law from the one hand, encourages the exercise of the sovereign rights of the states to regulate the cultivation and marketing of GMOs, one the other hand, trading blocs must ensure that their GM-related rules are in conformity with their international obligations, notably, their obligations under the WTO law55 and its legal regime on standards and conformity assessment procedures.56
Notwithstanding their long presence57 in the legal reality and their high controversial nature, GMOs are not specifically addressed in any WTO provision,58 albeit a number of provisions of the TBT, SPS and GATT Agreements59 could – and did60 – find grounds of application on GM related measures.61 Indicatively, under the
51
Alemanno, How to Get Out of the Transatlantic Regulatory Deadlock over GMOs?, 2009, p. 9
52
See inter alia: Boisson de Chazournes & Mbengue, International legal aspects of the co-existence between GM and non-GM products, 2005, p. 15
53 See inter alia: Cottier, Genetic engineering, trade and human rights, 2008, p. 22
54 Alemanno, 2009, p. 9: “Yet, since regulatory divergence may lead to the creation of obstacles to the
free movement of factors of production and of unfair conditions of competition for like products, international law - notably international trade law - is expected to step in to ensure market access.”
55 See inter alia: Fauchald, Flexibility and predictability under the World Trade Organization's
non-discrimination clauses, 2003 pp. 446-447
56
See inter alia: Zúñiga Schroder, 2011, p. 1
57 See inter alia: Wüger, The many faces of Biotechnology, in Wüger & Cottier, Genetic engineering and
the world trade system, 2008, p. 4
58 Ibid, p. 6 “There has often been criticism that the science-centric approach of the WTO’s Agreement
on Sanitary and Phytosanitary Measures (SPS Agreement) adopted for this purpose fails to properly address the specific concerns with modern biotechnology.”
59 See inter alia: Zarrilli, International trade in GMOs and GM products, 2005, p. 24 [online] “Since
biotechnology is by and large proprietary technology, the rules of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) may also have a bearing on international trade in GMOs.”
60 WTO, European Communities — Measures Affecting the Approval and Marketing of Biotech
Products (DS291, 292, 293): the EU measures were found to be inconsistent with the SPS Agreement Art. 5.1 (risk assessment) and 2.2 (sufficient scientific evidence), Annex C (1): (a) and Art. 8 (control, inspection and approval procedures) and Art. 5.7 (provisional measure) [online]
61 See inter alia: Cottier, Genetic engineering, trade and human rights, 2008, p. 25; For the inability to
fully address all the GM related topics under the WTO Agreement see inter alia: Alemanno, 2009, pp.10-11: “The GATT regime though, by merely requiring Member States not to discriminate between domestic and imported products and recognising exceptional departures from this principle, falls short in
15
GATT, a Panel reviewing biotech regulations would face some fundamental and unsolved questions of WTO law; for instance, do comparatively small physical differences, such as those between biotech and conventional products, suffice to justify different treatment and in case the disputed regulation violates a GATT obligation, what would be the requirements for justifying such a measure under Article XX?62 The only relevant case on GMOs, the EC-Biotech case, however, does not discuss any of these legal questions. The Panel found the SPS Agreement to be applicable, and under this agreement these questions were irrelevant. Consequently, the panel’s decision to rest its review on the SPS Agreement was of highest importance for the dispute, and it has set the course for future disputes in similar cases.63
Although public health and food safety issues are addressed by a number of WTO Agreements, such as the GATT and TBT, the WTO regulation of food and subsequently, of the GMOs, is mostly contained within the SPS Agreement.64 In particular, under the SPS Agreement, a SPS measure that seeks to regulate the production/marketing of a GM product must be based on scientific evidence. Moreover, albeit the SPS Agreement does not establish international standards for biotechnology or other food-safety questions,65 the Member States are deemed to adopt international standards (i.e. standards set up by Codex Alimentarius and the International Office of Epizootics).66 Pursuantly, the WTO/SPS legal framework offers a presumption of legitimacy when a members’ regulations implements an international standard. So far, this outcome is not feasible in the GM sector due to the absence of international standards that thoroughly regulate the GM products.
For the sake of brevity, the present contribution does not contain an extensive presentation of the international instruments that refer to GMOs. As it has been already stated, there are no such instruments to fully regulate biotechnology and its products.
addressing the underlying issues related to the GM phenomenon, such its food safety, environmental and public perception implications.”
62 Conrad, The EC–Biotech dispute and applicability of the SPS Agreement, 2007, p. 235 63 Ibidem
64 See inter alia: Alemanno, Trade in Food: Regulatory and Judicial Approaches in the EC and the WTO,
2007, p. 227
65 Shaffer & Pollack, Reconciling (or Failing to Reconcile) Regulatory Differences in: The Future of
Transatlantic Economic Relations, 2006, p. 188
66 Broude, Genetically modified rules: the awkward rule–exception–right distinction in EC–Biotech,
2007, p. 222 ; Howse & Horn, European Communities – Measures Affecting the Approval and Marketing of Biotech Products 2009, p. 57
16
The Cartagena Protocol on Biosafety67 is the only international regulatory instrument which deals specifically with the potential adverse effects of genetically modified organisms on the environment, taking also into account effects on human health.68 I basically covers transboundary movement of “living modified organisms” (LMOs).69 The Protocol establishes a harmonized set of international rules and procedures designed to ensure that countries are provided with the relevant information on LMOs.70 While the Protocol is the key basis for international regulation of LMOs, it does not deal specifically with GM foods. Moreover, the scope of its consideration of human health issues is limited, given that its primary focus is biodiversity, in line with the scope of the Convention itself. Consequently, the Protocol alone is not sufficient for the international regulation of GM foods.71
The same can be said about the Codex Alimentarius that essentially deals with food-safety issues,72 but do not thoroughly address GM-related concerns. Despite their promising initiatives, both instruments cannot constitute legal basis for uniform regulation of GMOs, as the former has not been ratified by important actors of GM-industry, among them, the US; and the latter, has unfortunately been unable to solve several long-standing issues at the regulatory level, including the problem of defining the roles of the precautionary principle and of “other factors” in risk assessment.73
The above delineation further illustrates the imperative for the initiation of a transatlantic dialogue and cooperation aiming at the GM standardization. Inevitably, the absence of regulatory harmonization of GM products intrigues the emergence of conflicts in the international trade law.74 Although harmonization of principles and practices among states would represent the most effective answer to this challenge, regulatory harmonization has not occurred yet in the GM sector and, given the existing differences between the two sides of the Atlantic, is a rather challenging task to
67
See also Hahn, Food security and Agricultural production with genetically modified products, 2008, pp. 197-198
68 Boisson de Chazournes & Mbengue, International legal aspects of the co-existence between GM and
non-GM products, 2005, p. 18
69
Zarrilli, 2005, p. 24
70 Boisson de Chazournes & Mbengue, 2005, p. 18 71 Ibidem
72 Ibid, p. 21 73
Ibid, p. 13
74 Alemanno, 2009 “Although harmonization of principles and rules among countries would represent the
most effective answer to this challenge, regulatory harmonization has not occurred yet in the GM sector and, given the existing differences between the two sides of the Atlantic, is not likely to occur in the near future. Indeed, the existence of largely different views and approaches vis-à-vis GM products is difficult to overcome, being essentially based on beliefs rather than scientific evidence.”
17
achieve. In the section that follows, an overview of possible ways to achieve trade facilitation on GMOs will be exposed, only to conclude with the imperative of mutual recognition as the most adequate and viable means out of the current deadlock.
Section IV
Moving towards transatlantic mutual recognition of GMOs
Before the idea of mutual recognition between the EU and the US on the GM regulation is fully introduced, some initial remarks should take precedence. In general, there are three trade facilitation tools that can be used to achieve regulatory convergence;75 these are harmonization, mutual equivalence and mutual recognition. The SPS Agreement encourage all the above trade promotion devices to facilitate trade76 by at the same time implementing a “presumption of consistency” derived from the use of international standards.77 There is a big part of scholarship arguing that the regulatory convergence of GM policies between the two trading parts is a rather recalcitrant and demanding task. The two diverging regimes between the US-EU that will be outlined in the following sections constitute well-established regulatory frameworks surrounding the GMOs, while the relevant companying principles, for instance, the precautionary principle is enshrined in the EU Treaty.78 Undoubtedly, the endeavour of bringing the two regimes closer is challenging and most likely, the outcome of long-lasting negotiations.
At this point, it should be noted that the two trading blocs have a history of previous regulatory cooperation and communications in the field of GMOs.79 It is further worth noting that the emergence of the transatlantic biotechnology dispute coincided with the establishment of the New Transatlantic Agenda (1995) and the Transatlantic Economic Partnership (1998), both of which reflect the efforts by Washington and Brussels to deepen their economic ties and to address longstanding
75 According to Boisson de Chazournes and Mbengue, there is also the concept of mutual supportiveness
that could tackle fragmentation: Boisson de Chazournes & Mbengue, A “footnote as a Principle”. Mutual Supportiveness and its Relevance in an era of Fragmentation, 2013, p. 1618: “One may wonder why the ILC has not further explored the concept of mutual supportiveness and declined to consecrate it among the bulk of rules or principles susceptible of harnessing and tackling fragmentation.”
76 See Art. 3 of the SPS Agreement on harmonization and Art. 4 on equivalence and agreements of
recognition. Note that mutual recognition is only ‘expressly’ incorporated with the TBT Agreement, albeit exclusively for conformity assessment procedures (Art. 6.3 TBT Agreement): Zúñiga Schroder, 2011, p. 3
77 Zúñiga Schroder, 2011, pp. 22-23 78
Article 191 of the TFEU
18
trade tensions. In the context of the NTA and the TEP, biotechnology was quickly identified as a regulatory area in which a structured dialogue among regulators might build mutual understanding and cooperation, provide early warning of disputes and even contribute to a gradual convergence of regulatory approaches to GM foods and crops.80 By and large, however, the outcome of these working groups was considered disappointing by both sides. Despite years of regular dialogue, the US and the EU never progressed to a formal cooperation agreement in the biotech sector; nor was there any clear sign of convergence in the views of US and EU regulators as a result of their dialogue.81
What is being argued in the present analysis is that the TTIP negotiations provide a promising environment for the two trading blocs to re-open a dialogue for cooperation on the GM related policies and - if feasible - reach the stage of mutual recognition. As it has been already stated above, seemingly, the time is right for both the US and the EU to consider the possibility of mutual recognition, since the multilateral Doha Round has never specifically addressed the GMOs topic and the relevant international instruments cannot adequately regulate all the aspects of GMOs.82 What is more, lately, the world trade witnesses the emergence of new trading powers from the part of Brazil, Russia, China etc that are also expected to develop activities in the field of GMOs, making the future of GM-related topics appear more complex and the need of standardization more topical than ever.83
As it was mentioned above, there are practically three methods to overcome the GMOs controversy. All of them are introduced in the HLWG Report as adequate mechanisms to achieve regulatory convergence.84 However, the HLWG report, while asking for provisions that provide an ‘institutional basis for future progress’, is not clearly suggesting one or even an outline.85 Supposedly, this absence allows for a certain extent of discretion to the negotiating parties and dictates the imperative to take all these regulatory methods under consideration when it comes to the effective regulation of GM products on a transatlantic level and beyond.86 In the paragraphs that
80 Shaffer & Pollack, pp. 183-184 81 Ibid, p. 185
82 See above, Section III 83
See above, supra note. 69
84 High Level Working Group on Jobs and Growth Regulatory Issues and Non-Tariff Barriers, 2013 pp.
3-4, [online]
85 Mathis, Addressing transatlantic regulatory barriers, in: A Transatlantic Community of Law, 2014, p.
188
19
follow, the three methods of regulatory convergence will be presented with direct reference to their applicability on the matter of GMOs and the potential of a successful outcome or not.
A. Harmonization
To start with, harmonization constitutes a policy tool of the WTO system, regional trade agreements and national legislation.87 It implies the alignment of regulations, principles and policies to a single best practice, until they are the same88 or substantially similar.89 Usually a voluntary agreement, harmonization can be based on a reference to international standards from a standard-setting body, or simply involve coordination among nations. As exposed in the relevant sector of the present thesis, each WTO member is allowed to adopt its food safety measure, under the prerequisite that there is scientific justification. In the context of the SPS Agreement and from the initiation of the Uruguay Round, there was general consensus that harmonization could have significantly contributed to the fight against those trade obstacles stemming from diverging regulatory regimes.90 Accordingly, the SPS Agreement, in Art. 3.1, encourages the adoption of international standards, guidelines and recommendations.91 However, at the same time, provides for derogation from this article,92 since members may introduce or maintain sanitary or phytosanitary measures, such as GM-related measures that, allegedly, result in a higher level of protection than would be achieved by measures based on international standards.93
Nevertheless, in the absence of international standards fully addressing the GM-related issues, the option of harmonization seems reasonably not applicable. To the same extent, harmonization requires complete consensus and agreement on a common regulation;94 a rather onerous situation, even when it refers to regional regulatory harmonization, i.e. in the EU internal market that has not been fully achieved.95 One
87 Zúñiga Schroder, 2011, p. 21 88 TACD Briefing Paper, p. 4 89
Zúñiga Schroder, 2011, p. 22
90 Alemanno, Trade in Food: Regulatory and Judicial Approaches in the EC and the WTO, 2007, p. 259 91 Ibidem
92 See Art. 3.3 of the SPS Agreement 93
Alemanno, 2007, p. 259
94 See inter alia: Zúñiga Schroder, 2011, p. 97
95 See inter alia: Bernauer & Aerni, Trade conflict over genetically modified organisms, 2010, p. 187. For
the US internal market, see inter alia: Mathis, p. 190 “The USA has no constitutional mandate for the removal of non-tariff barriers between the States, and thus no court interpretation mandating a minimum form of harmonization across the US internal market”
20
can safely conclude that harmonization does not appear to be the most appropriate vehicle to address GMOs regulatory divergence that inherently reflects differences in constituent preferences and different regulatory strategies.96 It is argued that “in an environment characterized by high numbers, complexity, rapidly changing technology and indeterminacy between regulatory strategies and outcomes, harmonization policies can be inappropriately rigid, not permitting for needed experimentation and learning”.97
B. Mutual Equivalence
Having exposed the reasons for the unsuitability of harmonization to overcome the GMOs divergence, we move on to the second trade facilitating tool available: the mutual equivalence. The equivalence concept is based on the acknowledgment that different foreign technical regulations can still achieve the same objectives or outcomes of the importing country, including in relation to health and food quality.98 Unlike harmonization, equivalence does not necessarily involve the adjustment of any standard; it rather involves a determination that two standards or procedures each sufficiently address similar regulatory objectives or achieve similar outcomes, despite not being identical.99 In doing so, the two regimes should be treated as equivalent.100 However, from the perspective of health, safety and environmental protection, equivalence suffers from considerable flaws.101 The primary flaw stems from the incompatibility of its flexible nature with the inflexible nature of standards in a regulatory context.102 A mandatory substantive standard, such as the mandatory labelling regime that applies with a minimum threshold provision,103 serves as a positive line that divides everything above it from everything below it. Depending upon how loosely equivalence is defined in a particular situation, the lower of two standards may be significantly lower, thereby “eviscerating the higher standard”.104 Furthermore, a second flaw of equivalence, with allegedly significant importance in the EU, especially when it refers to GMOs, is that it deprives consumers and other interested
96
See also: Cottier, Genetic engineering, trade and human rights, 2008, p. 22
97 Shaffer, Reconciling Trade and Regulatory Goals, 2002, p. 3
98 Tarimo, Equivalence and Mutual Recognition in International Food Trade, 2013, p. 4 99 TACD Briefing Paper, p. 4
100
Lester & Barbee, Tackling Regulatory Trade Barriers in the Transatlantic Trade and Investment Partnership, 2014, p. 87 [online]
101 TACD Briefing Paper, pp. 4-5 102 Ibid, p. 5
103
See footnote 112
21
stakeholders of their right to participate in decisions about the regulation of the products that they consume.105 Because an equivalence agreement allows products to gain admission to an importing country by going through the regulatory system of the exporting country, it removes those products from direct regulation and oversight by consumers in the importing country.106
In the case of the regulatory divergence regarding GMOs, equivalence is highly unlikely to be achieved for reasons inherent to the “problematic” nature that was described above and directly affects the GM regulation. In addition, the EU stretches that the US system fails to take under consideration “other legitimate factors”, i.e. cultural parameters. This attitude requires for more steps to be taken rather than acknowledging that the US GM regime can still achieve the same objective. In connecting the various divergences with the possible solutions, the reason for the regulatory difference matters.107 Divergent preferences are more difficult to resolve, but can often be bridged through mutual recognition, thus allowing consumers to decide which products they prefer by increasing their access to items which otherwise would not be available.
C. Mutual Recognition
That brings us closer to the imperative of mutual recognition108 as an adequate mechanism to homogenously regulate GMOs between the EU and US. The principle of mutual recognition means that a product lawfully put on the market in one state can and should be allowed access to the market in the other state, since it has already satisfied home state controls.109 Compared to the mechanism of equivalence, the mutual recognition appears to have an obvious advantage. The principle of mutual recognition goes beyond the equivalency check, as merely requiring an equivalent level of protection might sometimes be considered disproportionate and lesser to the protected interest in question110 – and that is the case with GMOs. Some scholars argue that “mutual recognition regimes are not simply one option among many available in the palette of global administrative law, but rather a core element of any global governance
105
TACD Briefing Paper, p. 5
106 Ibidem
107 Lester & Barbee, p. 87
108 See also: Gerstetter, 2014, p. 14 109
Barnard, The substantive Law of the EU, 2013, p.656
22
regime that eschews global government”.111Essentially, mutual recognition means that two parties mutually accept each other’s rules112 and standards or the results of conformity assessment procedures.113 Mutual recognition regimes set the conditions governing the recognition of the validity of foreign regulations, standards and certification procedures among states in order to assure the regulatory officials and citizens of the other country that their application within their borders is “compatible” with their own regime and that the imported products are recognised as safe.114 To be more specific, according to the principle of mutual recognition, a state should allow in its territory the free circulation of GMOs produced or marketed in conformity with the rules, standards and tests set in another state, as long as it offers an equal level of protection to its own rules and standards.115 Thus, mutual recognition is a vehicle for regulatory cooperation, and it may be based on harmonization, equivalence or external criteria such as the importing party’s standards or international standards.116
Nevertheless, regulators remain accountable to domestic legislators for the product standards that are applied both to domestic and foreign products.117 Accordingly, the EU retains separate standards for internally-produced products118 but accepts the rules and standards of the fellow jurisdiction, and vice versa, conditionally upon the adoption of a “core” of common provisions or principles.119 Common provisions may refer to each countries conformity assessment results, test reports, certificates, product standards, regulations, quality assurance system standards etc; either because they are harmonized or found to be equivalent, or because they satisfy other agreed upon external criteria.
Accordingly, these criteria may involve the acceptance of consumer protection as a core objective or “other legitimate factors” that extend beyond the protection of health and currently are only taken into consideration in the EU.120 This concrete
111
Nicolaidis & Shaffer, Transnational Mutual Recognition Regimes, 2005, p. 263
112 Tarimo, Equivalence and Mutual Recognition in International Food Trade, 2013, p. 5 113 Zúñiga Schroder, 2011, p. 3
114 According to Alemanno in Trade in Food: Regulatory and Judicial Approaches in the EC and the
WTO, (2007), the mutual recognition principle that was formulated by the ECJ in the 1979 case Cassis de Dijon, has systematically been endorsed by the ECJ, holding that “the protection of the consumers cannot be a legitimate ground upon which a Member State may prohibit the marketing in its territory of
foodstuffs that are compositionally different from those generally sold there.” See respectively p. 55
115
Alemanno, Trade in Food: Regulatory and Judicial Approaches in the EC and the WTO, 2007, p. 54
116 TACD Briefing Paper, p. 1
117 Nicolaïdis & Steffenson, Managed Mutual Recognition in the Transatlantic Marketplace, pp. 144-145 118 Shaffer, 2002, p. 4
119
Messerlin, Negotiating Mega-Agreements: Lessons from the EU, 2014, p. 10
23
objective could be achieved for instance by the inclusion of additional information on the labelling of products121 that have undergone some sort of genetic modification, indicating differences in production methods and composition existing in the exporting country. Hence, consumers would be able to make informed choices.122 This option indicates that the US would have to adopt mandatory labelling regimes, corresponding at the same time to the American consumers concerns.123 In general, it can be said that regulatory change is a key variable in this process;124 the US-EU should probably need to abandon highly diverging policies allowing place to a core of principles, for instance, adoption of product-related assessments,125 the protection of consumer’s right for information and appropriate official controls126 is just an indicative list.127 Moreover, the adoption of strictly science-based risk assessment128 that excludes protectionist motivation and influence could contribute in dealing with risk uncertainties.129 Going a step further, risk assessment should be entrusted to appropriate international organisations which would coordinate the research activities of domestic institutions and accordingly, the assessment outcomes should be mutually recognised.130 Similarly, the US should consider the idea of abstaining from the one-size-fits-all presumption of “substantial equivalence” between biotech products and their unmodified
121 Alemanno, Trade in Food: Regulatory and Judicial Approaches in the EC and the WTO, 2007, p. 55 122 See inter alia: Boisson de Chazournes & Mbengue, International legal aspects of the co-existence
between GM and non-GM products, 2005, p. 19 ; Cottier, Genetic engineering, trade and human rights, 2008, p. 50
123 For the increasing concerns of American consumers regarding the labelling of GMOs see inter alia:
Lipsky, Will European Requirements for Labeling GMO Foods Survive New Trade Negotiations?, 2013 ; Shaffer & Pollack, p. 208 “Within both the US Congress and in various state assemblies, legislators have introduced dozens of bills with a potential impact on the regulation of biotechnology […] that would introduce mandatory labelling for all GM foods.”
124 Nicolaidis & Shaffer, 2005, p. 294
125 See inter alia: Shaffer & Pollack, p. 195 “Many American observers hoped that the EU might move
towards a more “science-based” and less “politicized” system of regulation, which would, in turn, facilitate the resumption of approvals for new GM varieties Many European observers, by contrast, hoped that the European Union’s stricter standards would prompt a process of “trading up” in the United States, which might become more precautionary in its own regulations”
126
Alemanno, 2007, p. 56
127 See also: Grosz & Portas, Environmentally Sound Management – Towards a Coherent Framework
Bridging the Basel, The Rotterdam and the Stockholm Conventions, 2008, p. 33 ; Gerstetter, Regulatory cooperation under TTIP, 2014, pp. 10-11
128
See inter alia: Thomas, The International Management of Risk, 2008, p. 3 “At the scientific level one might perhaps assume that the understanding of the potential risks to public health and to the
environment which is generated by trade in hazardous chemicals and wastes is relatively well understood in comparison for instance to genetically modified organisms and biodiversity”
129
See inter alia: Cottier, Genetic engineering, trade and human rights, 2008, p. 48
24
counterparts131 and instead focusing on the characteristics, use and risks of each biotech product in a casuistic approach.132
The size and impact of both economies - encompassing almost 30% of world trade - provides for the promotion of “positive integration”133 on the field of GMOs as a main core that would be further supported by regulations enjoying mutual recognition.134 Mutually recognized principles and practices might henceforth evolve in international standards, i.e. standardization of assessment procedures135 that contain conformity assessment procedures (e.g. testing or certification) and as such enjoy a presumption of legitimacy (the methodology has the weight of the international community behind it).136 Respectively, mutual recognition of GMOs between the US-EU could potentially enhance the multilateral trading system as third countries,137 in order to boost their exports, will have a strong incentive to adopt standards and regulations that have the advantage of being recognized on both sides of the Atlantic.138
D. Concluding Remarks
Notwithstanding the positive outcomes of mutual recognition of GMOs between the two contracting parties, regulators on both sides of the Atlantic are expected to be reluctant to transfer authority to a foreign body and previous negotiations for mutual recognition agreements (MRAs)139 have demonstrated that some regulatory bodies are more reluctant than others.140 At this point, it should be useful to refer to the role of the institutional mechanism for regulatory cooperation,141 the Regulatory Cooperation Council142 that brings together the heads of the most important EU and US regulatory agencies on this matter.143 As an institutional structure, an “oversight
131 See also: Boisson de Chazournes & Mbengue, International legal aspects of the co-existence between
GM and non-GM products, 2005, pp. 21-22
132 See inter alia: Peck, Leveling the Playing Field in GMO Risk Assessment, p. 280 133
Alemanno, 2007, p. 56
134 For the multilateral impact of the transatlantic negotiations see also: Mathis, p. 209 135 Nicolaidis, & Shaffer, p. 274
136 Wijkström & McDaniels, 2013, p. 1034 137
See inter alia: Boisson de Chazournes & Mbengue, 2005, pp. 17-18
138 See inter alia: European Commission, Transatlantic Trade and Investment Partnership - The
Regulatory Part, 2013, p. 2 [online] ; Pardo, The Transatlantic Trade and Investment Partnership, A long hard road to multilateralism?, 2014 [online]
139
On MRAs see inter alia: Zúñiga Schroder, 2011, p. 130-133
140 Nicolaïdis & Steffenson, p. 145 141 Gerstetter, 2014, p. 10
142 See inter alia: Ermert, TTIP Leak Illustrates Depth Of “Enhanced Regulatory Cooperation” As NGOs
Sound Off, 2013 [online]
25
body”, into the agreement, mostly referred to as an EU-US “Regulatory Council”, it would enable the parties to deal with their differences in a more long-term fashion. It was also stated above that regulatory cooperation is a long term project. It is meant to deal with differences that could not be settled at the negotiating table at the highest level, that could also be the case with the GMOs regulation; and also to respond to new regulations as they occur. In the course of the negotiations, the parties will see to what extent they can agree on common standards or recognize each other’s standards as basically similar. That raises the prospect of the parties reaching a conclusion on even the most difficult issues, such as food safety.144
Section V
GMOs Regulatory Framework in the United States and Europe
The regulation of GMOs has been, and continues to be, one of the most difficult and intractable disputes in the US-EU economic relationship.145 As Alemanno interestingly sets it albeit the presence of GM foods and crops has been posing common regulatory challenges to the EU and the US, they have adopted two rather diverging regimes vis-à-vis agricultural technology.146
There are various reasons that contributed and still set apart the two regimes; related to consumer preferences, cultural configurations and different risk perceptions. As an extensive analysis of the relevant parameters is not feasible, at this point suffice it to say that one of the main contributing factors is the differentiated risk management conducted in the US in comparison with the EU, with the former being more tolerant and receptive to new technologies and risks and the latter, applying the precautionary principle147 that underlines a more risk-averse and suspicious stance towards the GM products.148 According to the precautionary principle, the potential risks of adverse effects of GMOs on human health and environment constitute adequate legal basis in order to justify differentiated regulation regarding the non-GM counterparts.
Whichever their causes may be, the diverging regulatory policies carry a double peril; first, the potential to escalate again into a blockage of the on-going transatlantic negotiations between the EU-US and second, adversely affect both the negotiating
144 Corporate Europe Observatory, Regulation - none of our business?, 2013 145 Shaffer & Pollack, 2006, p. 220
146 Alemanno, 2009, p. 3
147 See inter alia: Crawford-Brown, Pauwelyn & Smith Environmental Risk, Precaution, and Scientific
Rationality in the Context of WTO/NAFTA Trade Rules, 2004, p.466
26
parties and third countries outside the framework of TTIP. To elaborate, the threat of access denial to highly lucrative developed-country markets, such as the EU market, largely defines developing countries’ approach towards GMOs. In addition, when setting up their own regulatory frameworks, most of these countries tend to choose between US or EU approaches to GM products. However, as it was mentioned before, the rise of new powers, i.e. China, India and Brazil, in the world trade in general and in the field of GM industry specifically, may significantly change the polarity of the current status quo in GMOs. It is thus likely that the future of biotechnology will be influenced by the new emerging trading powers rather than by the US and the EU.149
All the above make the outline of the relevant US and EU legal frameworks and prevailing principles an imperative part of the present discussion so as to give an insight to the legal reality surrounding the GMOs on both sides of the Atlantic.
A. The Regulation of GMOs in the United States
In the United States there is no comprehensive federal legislation that specifically addresses the regulation of GMOs. Following the general principle of substantial
equivalence150 that prevails in the US, the GM products are considered like151 their non-modified counterparts and consequently, the GMOs are rather regulated pursuant to health, safety and environmental legislation governing conventional products.152 A policy statement published in 1986, entitled the Coordinated Framework for Regulation of Biotechnology constitutes, until today, the legal basis for the regulation of the GMOs.153 The basic ideas running through the Coordinated Framework are the following: (i) product-based approach instead of process itself;154 (ii) scientifically
149
Alemanno, 2009, p. 4
150 Sheldon, Regulation of biotechnology, 2001 [online] “The objective of such an approach is not to
establish absolute safety, but to consider whether a GM food (ingredient) is as safe as its conventional counterpart. In other words, the focus is on identifying intended and unintended differences between the two types of food (ingredient), which are then analyzed in a pre-market safety assessment. This
regulatory approach […] is consistent with recommendations made by the WHO/FAO (1995, 1996, 2000), and the Codex Alimentarius Commission (2001a) for assessing the safety of GMOs, and the principles for evaluation of GM foods put forward by the OECD (1993).”
151
Emphasis added
152 Acosta, Restrictions on Genetically Modified Organisms: United States, 2014, [online] “Rather,
GMOs are regulated pursuant to health, safety, and environmental legislation governing conventional products. The US approach to regulating GMOs is premised on the assumption that regulation should focus on the nature of the products, rather than the process in which they were produced.”
153 See inter alia: Peck, Leveling the Playing Field in GMO Risk Assessment, 2010, pp. 250-251 154 See inter alia: Lynch &Vogel The Regulation of GMOs in Europe and the United States, 2001
[online] “[…] the White House, through its Office of Science and Technology Policy (OSTP), along with the US Department of Agriculture (USDA) and the Food and Drug Agency (FDA). OSTP and the USDA were interested in promoting the economic potential of biotechnology and accordingly only wanted to
