Genetically Modified Trojan Horse
Will TTIP smuggle the United States’ GMOs past Europe’s Food-Safety wall?
By: Roeland Olthof 11154322
Chapter 1 4
Overview 4
1.1 Introduction 4
1.2 Research questions 5
Main research question:... 5
First sub question:... 5
Second sub question:... 5
Third sub question:... 5
Fourth subquestion:... 5
Fifth subquestion:... 5
1.3 Execution 5 Chapter 2 The Precautionary Principle 7 2.1 Introduction 7 2.2 The precautionary principle explained 7 2.3 Conclusion 8 Chapter 3 Trade Agreements 10 3.1 Introduction 10 3.2 SPS Agreement 11 Precaution in the SPS Agreement... 11
3.3 Trans-Pacific Partnership 12 Precaution in the TPP... 13
3.4 Comprehensive Economic and Trade Agreement 14 Precaution in CETA... 14
3.5 Findings 14 3.6 The Commission on TTIP 15 Textual proposal of TTIP’s SPS Chapter... 15
3.7 Conclusion 16 Chapter 4 18 Comparing standing GMO regulation 18 4.1 Introduction 18 4.2 History 18 4.3 United States GMO regulation 20 Federal agencies 21 United States Department of Agriculture...21
Environmental Protection Agency... 22
Food and Drug Administration... 22
4.4 European Union GMO regulation 24 General EU regulatory process... 24
European GMO regulation... 24
Deliberate Release into the Environment...25
Deliberate Release... 25
Placing on the market... 25
National prohibitions on cultivation... 26
Food and Feed... 26
Contained Use... 26
Transboundary Movements of GMOs... 27 4.5 Comparison of the regulations 27
4.6 Conclusion 29 Chapter 5 31
Possible actual impact of TTIP on standing EU GMO legislation 31 5.1 Introduction 31
5.2 International agreements 31
Regulatory cooperation... 33 The EU regulatory process... 33 5.3 Conclusion 35 Chapter 6 37 Conclusion 37 References 40 Books 40 Journals 40 Papers 42 Reports 43 Studies 43 Newspaper articles 43 Treaties 44 Agreements 44 Jurisprudence 44 ECJ... 44 WTO... 44 Communications 45 Policy Statements 45 Websites 45
Chapter 1
Overview
1.1 Introduction
The regulation of genetically modified organisms is a more and more dividing issue in our trade-oriented world. 1 One of the biggest, most recent, but at the same time long ongoing2
debates is between one of the largest GMO (Genetically Modified Organism) producers, the United States (US), and potentially one of their biggest clients to be, the European Union (EU).3 This dispute concerning the regulatory differences with respect to health and the
environment between the transatlantic adversaries evolves mostly around their disagreement on the implementation of the precautionary principle. Meaning that the EU regulates uncertain risk, as where the US demands scientific evidence afore moving on to regulating.4
Above that, as stated in the New York Times: “In Europe, the debate over genetically modified food is as much about passion as it is about science. British newspapers routinely call ingredients from genetically altered plants 'Frankenfood’”5
Several non-governmental organizations (NGOs) such as Greenpeace and Friends of the Earth Europe as well as a significant part of European citizens are therefore concerned about the implications that the Transatlantic Trade Investment Partnership (TTIP) might have for the EU’s food regulation. One of their greatest fears is that TTIP might affect the EU’s competence to take precautionary non-tariff measures against GMOs.6 This thesis examines
whether these fears are justified, by examining whether this trade agreement might indeed have the capacity to alter the EU’s GMO regulation.
1 Bridgers, M, “Genetically Modified Organisms and the Precautionary Principle: How the GMO Dispute
before the World Trade Organization Could Decide the Fate of International GMO Regulation”, Temple Journal of Science, Technology & Environmental Law Vol. 22, 2004, 171,172, Published online, Heinonline, 2004, pp. 171
2 The most recent debate of course evolves around TTIP, but as you will see in the History paragraph the debate
has already been going on for decades.
3 Lopez, R and J. Carrau, “The GMO Regulation in the EU and the Commercial Conflict with the United
States”,Xth EAAE Congress “Exploring Diversity in the European Agri-Food System”, 2002, Zaragoza, Published online, p. 2
4 Herrera, J. A, “International Law an GMOs: Can the Precautionary Principle protect Biological Diversity?”,
Boletín Mexicano de Derecho Comprado, Mexico City, UNAM, Vol. 118, 2007, p. 99
5McNeil, D. G. Jr. “Protests on New Genes and Seeds Grow More Passionate in Europe”, 2000, March, 14,
Published , The New York Times, A1, A10
6
1.2 Research questions
This thesis will therefore answer the following research questions:
Main research question:
What impact could TTIP have on standing EU GMO regulation? First sub question:
What does the precautionary principle encompass? Second sub question:
Can the fear that TTIP would be less facilitative towards the PP than other EU trade agreements be substantiated?
Third sub question:
What are the main differences of the EU’s and the US’s domestic GMO regulations?
Fourth subquestion:
Will TTIP amend standing EU GMO legislation?
Fifth subquestion:
Would it be possible to create a regulatory body under TTIP that has the capacity to make decisions that bypass formal European legislative procedures?
1.3 Execution
This thesis will first make a descriptive assessment of the precautionary principle. Then it will make a descriptive assessment of the WTO’s SPS chapter, The Transpacific Partnership and the Comprehensive Economic and Trade Agreement (CETA), after which it will comparatively assess all three together. It will also make a descriptive assessment of the European Commission’s (the Commission) textual proposal of TTIP’s SPS chapter, the EU’s negotiating position concerning TTIP and the results of public consultations. Then it will first make a historical assessment of how the differences in standing regulation have come into existence after which it will make a descriptive analysis of standing US and EU GMO regulation, which it will then comparatively assess. After that it will make a short descriptive
analysis of EU law concerning international agreements in order to make a predictive assessment on whether TTIP will alter standing GMO regulation.
Lastly, it will make a descriptive analysis of the EU’s regulation process. All assessments together will result in a final conclusion on the impact that TTIP could potentially have on standing EU GMO legislation.
Chapter 2
The Precautionary Principle
2.1 Introduction
In order to understand the rest of this thesis it is important to first know what the Precautionary Principle encompasses. All concerns surrounding TTIP regarding GMOs eventually come down to the fear that the EU might give away its ability to use the PP for the regulation of GMOs. Therefore this thesis starts of with a descriptive analysis of the PP.
2.2 The precautionary principle explained
The PP is laid down in Article 191 of the Treaty on the Functioning of the European Union (TFEU)7 and is therefore legally binding upon all Member States. Article 191(1) states
that the EU policy endeavors to: preserve, protect and improve the quality of the environment and to protect human health. Paragraph 2 of the same article most notably states that “Union policy on the environment shall aim at a high level of protection” and that it “shall be based on the precautionary principle.”8
Essentially the PP provides that the EU or the Member States can take action against a not yet scientifically proven or scientifically uncertain risk.9 The PP finds its basis in the notion
that to establish a high level of protection for health and the environment risks need to be averted before they are concretized and materialized or before they cause damage. The precautionary approach consists of three aspects: Risk assessment, risk management and risk communication.10
To conduct a risk assessment, one identifies and characterizes hazard and assesses exposure. Characterization of risk is conducted through constant assessment of available scientific data. While assessing the available data, it is essential to consider scientific uncertainty, meaning the insufficiency of information and to weigh this during each step of
7 European Union, Consolidated version of the Treaty on the Functioning of the European Union, 13 December
2007, 2008/C 115/0
8 http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:12016E191
9 Lynch, D., Vogel, D., “The Regulation of GMOs in Europe and the United States: A Case-Study of
Contemporary European Regulatory Politics”, 2001, Published online, Council on Foreign Relations Press, p. 26
10Douma, W. “The Precautionary Principle in the European Union”,2000, Reciel 9, Vol. 2, Oxford, Blackwell
the process. 11 Risk management is performed on the basis on this scientific assessment. Risk
management is basically the making of decisions whether or how measures are to be taken to get to the desired level of protection. The Commission stated in 2000 that recourse to the PP is taken when “a scientific evaluation of the risk which because of the insufficiency of the data, their inconclusive or imprecise nature, makes it impossible to determine with sufficient certainty the risk in question.”12 The management of the risks is inseparable from risk
communication. Good communication between stakeholders (experts, decision makers, political and social leaders, media, groups of interest and people involved) supports the risk management to a great extent. This part does however often form a lot of difficulties due to conflicts of interest, differences in values, languages etcetera.13
Another important aspect is that scientific developments should always be considered. This also means that while a precautionary measure is in effect, scientific research needs to continue to be conducted in order to re-evaluate the measure with new scientific evidence. The precautionary principle also forms the legal basis of several EU legislative acts.14
2.3 Conclusion
Generally the PP encompasses the right to take action against a not yet scientifically proven or scientifically uncertain risk and is laid down in Article 191 TFEU and is therefore legally binding upon all Member States. It furthermore finds its basis in the notion that to establish a high level of protection for health and the environment risks need to be averted before they are concretized and materialized or before they cause damage.
The precautionary approach consists of three aspects: Risk assessment, risk management and risk communication. A risk assessment is conducted through the identification and characterization of hazard and the assessment of exposure. Risk
management is then executed on the basis on this scientific assessment by making decisions whether or how measures should be taken to reach the desired level of protection. And lastly, risk communication is the conduction of communication between stakeholders in order to support risk management.
11 Stoll, P. and Douma, W. “CETA, TTIP and the EU precautionary principle”, 2016, published online,
Foodwatch, p. 9
12 EU Commission, Communication from the Commission on the Precautionary Principle, COM(2000) 1 final,
2000
13 Biocca, M.“Risk Communication and the Precautionary Principle”, 2005, Human and Ecological Risk
Assessment: An International Journal, Vol. 11, Issue 1, Published online, Taylor & Francis Online, p. 261
Chapter 3
Trade Agreements
3.1 Introduction
As stated in the general introduction, this thesis examines whether the fear for TTIP concerning GMOs is justified. This fear is mostly based on the supposed fact that US trade agreements -and therefore TTIP- would not explicitly facilitate the use of the PP, contrary to EU trade agreements supposedly. 15
In order to examine whether this fear is justified, this chapter is based on the
assumption that TTIP’s worst-case scenario in the eyes of its opponents would be a fully US-style trade agreement. One of the most recent US trade agreements: The
Transpacific-Partnership(TPP), will serve as a benchmark. The Comprehensive Economic and Trade Agreement (CETA) will serve as a benchmark for a contemporary EU-style agreement. This chapter will both descriptively and comparatively assess these agreements’ Sanitary and Phytosanitary (SPS) chapters16 against a background of the WTO Agreement on Sanitary and
Phytosanitary Measures (SPS Agreement), which will be descriptively assessed before the two earlier mentioned agreement’s SPS chapters. The reason for choosing this method is that the people whose fears are being questioned are very concerned with the fact that TTIP’s negotiations are supposedly in secret. This is actually not entirely valid, since the
Commission’s textual proposal for TTIP’s Sanitary and Phytosanitary chapter and the results of its public consultations are already available.17 But since these opponents are generally very
distrusting towards the government, this chapter will base its first answer on these two agreements, for they are already set in stone and could therefore by TTIP’s opponents own logic be the only evidence to substantiate the fear against a trade agreement with the US.
This chapter will also discuss the Commission’s actual negotiating positions to further argue whether these opponents’ concerns regarding TTIP are justified. Each paragraph will assess the facilitation of the PP of the concerning agreements’ SPS chapters by focusing on provisions that provide recourse to –or reflect precaution.
15
https://www.foeeurope.org/sites/default/files/press_releases/briefing_-_gm_food_and_the_eu-us_trade_deal.pdf
16 These chapters govern the trade agreements’ GMO regulation.
17 Commission, Textual Proposal TTIP, 2015, retrieved at http:// trade.ec.europa.eu/doclib
3.2 SPS Agreement
GMO regulation is multilaterally governed by two WTO agreements namely, the Agreement on Sanitary and Phytosanitary Measures and the Agreement on Technical Barriers to Trade. These Agreements prescribe situations in which non-tariff measures are allowed. These non-tariff measures include the rejection of genetically modified foods at the border as well as labeling requirements.18 This thesis will however on the SPS agreement, since it is the
WTO’s most relevant agreement concerning GMO regulation. This paragraph will discuss the main principles of the SPS agreement to serve as a background for the following comparative analysis.
Precaution in the SPS Agreement
Paragraph 6 of the preamble is the SPS Agreement’s first part of the agreement that reflects the PP. It namely states: “desiring to further the use of harmonized sanitary and phytosanitary measures between Members, on the basis of international standards, guidelines and recommendations” (…) “without requiring Members to change their appropriate level of protection of human, animal or plant life or health.” The right of the Members to maintain the level of protection that they deem appropriate is a reflection of the PP.19 Nevertheless, apart
from a preamble’s function to provide context for the purpose of interpretation of other provisions, this is still non-binding. It is notably also reflected in the WTO’s understanding of the SPS agreement, which states that the basic aim is: “maintain the sovereign right of any government to provide the level of health protection it deems appropriate, but to ensure that these sovereign rights are not misused for protectionist purposes and do not result in
unnecessary barriers to international trade.”2021
Members further oblige themselves to harmonize SPS measures as widely as possible. They will base these measures “on international standards, guidelines or recommendations, where they exist,” unless “there is a scientific justification, or as a consequence of the level of sanitary or phytosanitary protection a Member determines” a higher SPS measure “to be appropriate,” according to its risk assessment. 22 This article again has precautionary nature; it 18 Lampe, von, M. and H. Jeong, “Design and Implementation of Food-Import Related Regulations:
Experiences from Some Regional Trade Agreements”, OECD Food, Agriculture and Fisheries Papers, No. 62, 2013, Paris, OECD Publishing, pp. 4-7
19 WTO, Agreement on Sanitary and Phytosanitary Measures, preamble par. 6
20 WTO, “Understanding the WTO Agreement on Sanitary and Phytosanitary(SPS) Measures”, 2006,
online:http://www.wto.org/wto/goods/spsund.htm
21 Herrera, supra note 4, p. 115 22 Ibid. Article 3.3
comes with a few exceptions however, namely that there still needs to be a scientific justification or a justification through its own risk assessment.
Article 5 states that SPS measures shall be based on an appropriate risk assessment. Members oblige themselves to take relevant scientific as well as economic factors into account, while bearing in mind the objective of minimizing negative trade effects.23 It is
nevertheless allowed for a Member to adopt measures “provisionally” where “scientific evidence is insufficient.” This is again a reflection of the PP. It does however again come with some with a few limitations. The provisional measure has to be on the basis of available pertinent information. Members have to gain “additional information necessary for a more objective assessment of risk” and review the measure “within a reasonable period of time.”24
3.3 Trans-Pacific Partnership
The TPP is one of the US’s most recent trade agreements and is one of three recent major US trade agreements that the opposing media likes to refer to as “the three terrible Ts” or just as “the three Ts.”25 TTIP is also named as one of these “three Ts” and it is therefore
conceivable that the TTIP opponents’ concerns are partially based on the text of the TPP. “The three Ts” would namely consist of the TPP, TTIP and The Trade in Services Agreement (TiSA). The TPP is a multilateral trade agreement between the US and several other
countries. TPP is the only one of “the three Ts” that has already been finalized. It has even already been signed by Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam and it has already been ratified by Japan. The US was also a signatory, however President Trump has withdrawn the US from the agreement. It will still however give a good insight on what the opponents of TTIP presumably base their concerns regarding TTIP’s GMO regulation on.26
Precaution in the TPP
Surprisingly, TTIP’s Preamble also includes a paragraph that contains precautionary language. Namely, in paragraph 9 the Parties recognize “their inherent right to regulate and
23 Ibid. Article 5.1-5.4 24 Ibid. Article 5.7
25 http://www.infosource.london/featured/the-three-ts-that-could-reshape-the-world
resolve to preserve the flexibility of the Parties to set legislative and regulatory priorities” (…) “and protect legitimate public welfare objectives, such as public health, safety, the
environment, the conservation of living or non-living exhaustible natural resources.”27 This
statement is of course also non-binding. Remarkably, the TPP does not have a paragraph on harmonization. It therefore also does not have an equivalent of the SPS Agreements’
provision that most explicitly facilitates the PP, namely article 3.3 SPS.28
The risk analysis chapter of the SPS Agreement under Article 5.7 SPS allows Members to adopt provisional measures where relevant scientific evidence is insufficient temporarily and therefore reflected a very limited version of the PP.29 The TPP’s counterpart
of that chapter first of all acknowledges that it is important that SPS measures are based on scientific principles. The parties also commit themselves to ensuring that their SPS measures are in conformity with “relevant international standards, guidelines or recommendations,” and if not that they ensure that the measures are “based on documented and objective scientific evidence that is rationally related to the measures.” This does not seem to allow for
precautionary measures to be taken. However, while acknowledging their obligations under article 5 of the SPS agreement.
The Parties maintain the right to:
Establish the level of protection they deem appropriate;
Establish or maintain a procedure requiring risk analysis before granting access to its market; or
Adopt or maintain a provisional SPS measure.30
This means that just like all Members of the WTO, the Parties to the TPP may also -under circumstances- adopt provisional measures where relevant scientific evidence is insufficient.
3.4 Comprehensive Economic and Trade Agreement
The Comprehensive Economic and Trade Agreement between Canada and the EU is Europe’s most recently approved trade agreement. The European Parliament has already signed it, but the State parliaments have yet to approve. This paragraph will assess whether
27 Trans-Pacific Partnership, Preamble, par. 9 28 SPS, Supra Note 19, Article 3.3
29 Ibid. Article 5.7 SPS
CETA contains any reflections of the PP while comparing it against this chapter’s previous findings.
Precaution in CETA
CETA’s Preamble also has a paragraph that reflects the PP, namely that Parties preserve the right to “regulate within their territories” (...) “to achieve legitimate policy objectives.” This is however, as stated earlier, a non-binding policy statement.31
Remarkably, CETA, just like the TPP, does not have a paragraph on harmonization. It therefore also does not have an equivalent of the SPS Agreements’ provision that most explicitly facilitates the PP, namely article 3.3 SPS.32 Also remarkably, CETA does not
contain a separate chapter on risk analysis. It therefore also does not have an equivalent of the TPP’s and the SPS Agreements’ provisions on provisional measures that reflect the PP.33
3.5 Findings
Ironically, it seems that CETA contains less precautionary language than both the SPS Agreement and the TPP. Only the preamble contains a non-binding policy statement that Parties preserve the right to “regulate within their territories” (...) “to achieve legitimate policy objectives.”34 This paragraph however also has an equivalent in both the other
agreements’ preambles.35 CETA does not even provide for an equivalent of the SPS
agreement’s and TPP’s extremely restrictive provisional measures that can only be applied temporarily.36
It seems that -at least since CETA- EU trade agreements contain even less precautionary language than US trade agreements and do not contain any other provisions that might provide any other safety net to stop GMOs from accessing the European market.
3.6 The Commission on TTIP
The previous paragraphs have determined whether the concerns regarding TTIP are justified from the point of view of its opponents who have been largely influenced by the media and therefore believe that all of the TTIP negotiations are in secret, which has largely created these –thus far- seemingly unjustified concerns. How about the Commission’s actual
31 Comprehensive Economic and Trade Agreement, Preamble, par. 6 32 SPS, Supra Note 19, Article 3.3; CETA, Supra Note 32
33 TPP, Supra Note 27, Article 7.9; SPS, Supra Note 19, Article 5.7 34 CETA, Supra Note 32, par. 6
35 TPP, Supra Note 27, Preamble, par. 9; SPS, Supra Note 19, Preamble, par. 6
negotiating standpoints then? Should those indeed cause concern? This chapter will briefly discuss whether this is the case.
Textual proposal of TTIP’s SPS Chapter
The Commission’s textual proposal of TTIP’s SPS Chapter does not yet include a preamble, therefore it is not possible to determine whether it will or will not include a paragraph that reflects the PP.37 Just like CETA TTIP’s textual proposal of its SPS Chapter
also does not contain a separate harmonization paragraph. It therefore also does not have an equivalent of the SPS Agreements’ provision that most explicitly facilitates the PP, namely article 3.3 SPS.38 And also just like CETA, TTIP’s textual proposal does not have a separate
chapter on risk analysis. It therefore also does not have an equivalent of the TPP’s and the SPS Agreements’ provisions on provisional measures that reflect the PP.39
All in all, due to the absence of a preamble it can’t be said whether the proposal is more, or less facilitative towards the PP than CETA. However it can still be concluded that this proposal, even if the preamble omits a non-binding reference to the PP, still should not cause any more concern than CETA.
Lastly, maybe the results of public consultations and negotiating positions can
substantiate opponents concerns regarding TTIP’s future SPS chapter. However, results of the public consultations are also very clear stating that: “Growing genetically modified organisms is subject to an authorization process in line with EU law. TTIP will not change this law. EU countries must also agree to any growing of GM plants. This will not change through TTIP.”40
Commissioner Cecilia Malmström has also reaffirmed this view in a statement on the 2nd of May 2016 that said: “It begs to be said, again and again: No EU trade agreement will
ever lower our level of protection of consumers, or food safety, or of the environment. Trade agreements will not change our laws on GMOs, or how to produce safe beef, or how to protect the environment.”41
37 Commission Proposal TTIP, Supra Note 17
38 3.3 SPS; Commission Proposal TTIP, Supra Note 17
39 7.9 TPP; 5.7 SPS; Commission Proposal TTIP, Supra Note 17 40 Commission Proposal TTIP, Supra Note 17
3.7 Conclusion
This chapter has examined whether TTIP’s opponents’ fear that TTIP’s future SPS Chapter would not facilitate the PP. Since the opponents of TTIP generally distrust the government and since the media is constantly pointing out how the meetings are supposedly in secret, this chapter has assumed that the fear against TTIP can -following that logic- only be based on recent US trade agreements, which would mean that a fully US-style TTIP would be the worst-case scenario. Therefore this chapter firstly assessed the differences between a recent US trade agreement, TTIP, and a contemporary EU trade agreement, CETA, against a background of the WTO SPS Agreement, focusing on recourse to precaution.
The SPS Agreement contains most references to precaution, namely three in total. It is also is the only one that explicitly facilitates the PP, although quite restrictively. The TPP also has one provision on provisional measures that reflects the PP through a reference to the SPS Agreement.
CETA however, is the only agreement that does not contain a provision on provisional measures and is therefore also the only agreement that has not one provision that reflects the PP. CETA’s only reflection of the PP is a general non-binding policy statement in the preamble that also has an equivalent in all three agreements. This means that, ironically, CETA is the least facilitative agreement towards the PP.
Since the earlier mentioned supposed fact that no information on TTIP would be available is unfounded; this chapter has also examined whether the Commission’s textual proposal and negotiating positions and results of public consultations might be a reason for concern. Since the proposal does not yet have a preamble, it cannot be estimated whether TTIP’s preamble will refer to the PP. However we do know that both the proposal and CETA hardly facilitate the PP and even if TTIP eventually omits a reflection in the preamble it would still -irrespective of its function to provide context for the purpose of interpretation of other provisions- be non-binding and it would therefore not make that much of a difference. This means that at least since CETA TTIP would not be a step back. Furthermore the results of public consultations and a personal confirmation from Commissioner Cecilia Malmström confirm that TTIP would never lower the level of protection or change any existing laws.
What can be concluded from all this, is that the concerns surrounding TTIP’s future SPS Chapter are somewhat of a hype. Indeed it will probably not expressly facilitate the use of the PP, but at least since CETA that will be nothing new under the sun.
Chapter 4
Comparing standing GMO regulation
4.1 Introduction
This chapter will assess the differences is standing domestic GMO regulation. It will therefore first historically assess how the differences have come into existence. After that it will descriptively assess the US’s GMO regulation. And then the same assessment will be applied to the EU’s GMO regulation. After that a comparative assessment of the standing regulations will follow in order to conclude what the main differences in standing GMO regulation are and what their origin is.
4.2
History
We now know that the biggest contradiction in regulation lies in the EU’s supposed precautionary approach while regulating, where the US applies a more reactive approach.42
The question now is how did this contraposition come into existence? It can be explained by both history and cultural and legal differences. 43 First of all I would like to point out that as
much as it is true when it comes to the EU being more precautionary when it comes to GMO regulation, the precautionary approach is still relative. Namely where the EU takes more precaution in areas such as GMOs, hormones in beef4445 and climate policy, the Unites States
takes more precaution in areas such as drug approval, bovine spongiform encephalopathy (BSE) –to which I will come back later, teen drinking and nuclear energy. Another remarkable fact and also paradoxically one of the main explanations for the present day’s situation is that the United States actually used to be more precautionary (even in the area of food safety) than the EU. 46 This was before an enormous outbreak of BSE, better known as
‘mad cow disease’, in the UK in the 80s continuing to well in the 90s.47 The cause of BSE was 42 Wiener, J. B., Rogers, M. D., “Comparing precaution in the United States and Europe”, Journal of Risk
Research, Vol. 5, Issue 4, 2002, Published online, Taylor and Francis Ltd, p. 317
43 Levy, D.l. and Newell, P. “Oceans Apart? Business Responses to Global Environmental Issues in Europe and
the United States”, Environment: Science and Policy for Sustainable Development Vol. 42 , Iss. 9, 2000, Published online, Taylor an Francis, pp. 11-16
44WTO, European Communities — Measures Concerning Meat and Meat Products (Hormones)- Report of the
Appellate Body, (1998) WT/DS26/AB/R and WT/DS48/AB/R
45Levy, Newell, Supra Note 47, pp. 11-16 46 Wiener, Rogers, Supra Note 46, p. 317 47 Downes, Supra Note 51, pp. 14-15
that the cattle were fed remnants of dead sheep that contained infected protein. 48 Even though
there were assumptions that infected meat might also inflict a human SE by the name of Creutzfeldt-Jakob, the UK asserted that the meat would not harm humans. This was based on scientific evidence. It was only after young people started developing a new form of
Creutzfeldt-Jakob that the EC decided to ban all beef and cattle originated in the UK in 1996.49 And it was only then, that when the UK challenged the measure, the EU relied on the
Precautionary Principle in its defense. 50,51 Where it gets especially interesting is that the US,
the United States Department of Agriculture (USDA) to be more precise, had already started a working group on the matter in 1988 and in 1989 the Animal and Plant Health Inspection Service (APHIS) of the USDA banned almost all cattle products originated in the UK. 52
This incident has of course -rightfully so- had a significant impact on the public opinion in Europe, creating a distrust of government when it comes to health risks emanating from food safety issues, which in turn has provoked a regulatory response by the EU resulting in the appreciation of the precautionary principle.53 Another cultural factor might be lobbying,
which is far more deeply entrenched in the United States’ political system than in Europe’s, due to the winner-takes-it-all form of election, making it easier for lobbyists to approach the one and only winner. 54
What also might significantly contribute to the different approaches are the different legal systems of the United States and the EU. For one the availability of United States Law to citizens, advocacy groups, judicial review and science-based opposition make the possible enforcement of the precautionary provisions more probable. 55 Another sensible explanation
might be the arguably inherent interplay between ‘ex ante’ precaution and ‘ex post’ remedies. US tort law is commonly seen as ‘stronger’ than European tort law. It therefore seems less necessary for the US to adopt strict ‘ex ante’ precautionary provisions, since the ‘ex post’ post remedies are deemed to be sufficient to achieve the same safety standards. This counts vice
48 Prusiner, S, "Novel Proteinaceous Infectious Particles Cause Scrapie", Science 216, Vol. 4542, 1982, Boston,
AAAS, p. 136
49 Commission Decision of 27 March 1996 on emergency measures to protect against bovine spongiform
encephalopathy, 96/239/EC
50 ECJ, UK v. CEC, Case C-180/96, 1998 51 Wiener, Rogers, Supra Note 46, p. 329 52 Idem. p. 331
53 Lynch, D. Vogel, D. “The Regulation of GMOs in Europe and the United States: A Case-Study of
Contemporary European Regulatory Politics”, 2001, Published online, Council on Foreign Relations Press, pp. 22-27
54 Levy, Newell, Supra Note 47, pp. 15-16 55 Wiener, Rogers, Supra Note 46, p. 340
versa for EU. 56 What might also be of importance is the fact that the European Commission
(EC) works as a representative for the EU’s Member States and therefore the elected domestic parties. Contrary to the US, where the representative might have to address an unfavorable Congress. This might make the US representative more reserved in conveying precautionary agreements back to the US in order for them to be ratified. 57
The last legal difference that might cause these different approaches concerning
precaution I would like to discuss is that in the EU the PP is believed to go hand in hand with the proportionality principle. 58 United States law however has no general proportionality
principle (except for exceptions regarding self-defense and a few other areas). Therefore US regulators might fear that the implementation of the precautionary principle would allow for disproportional regulation, where the EU trusts in the proportionality principle to even this out. 59
4.3 United States GMO regulation
The overarching framework for US biotech regulation is called the “Coordinated Framework for the Regulation of Biotechnology Products,” 60 61 which has recently been
updated. 62 It was federally registered in 1986 when the concerns evolving GMOs where
relatively new. Therefore there were quite some arguments concerning two major difficulties, namely whether regulation of this new, unfamiliar subject demanded its own laws and
agencies (horizontal regulation) and whether the regulation ought to cover the process or the products of biotechnology. 63
Over the first difficulty it was decided that GM products did not require specific
regulation (vertical regulation). Instead it was decided to adapt existing regulatory law to fit the requirements for biotech regulation, to which I will come back later. 64
56 Ibid. p. 341 57 Idem 58 Idem 59 Idem
60 51 Fed. Reg. 23303
61Cadot, O. and Suwa-Eisenmann, A. “trade-related issues in the regulation of genetically modified organisms”,
2001, Published online, ResearchGate, p.19
62 Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the
Coordinated Framework for the Regulation of Biotechnology
63 Lynch, Vogel, Supra Note 57, pp. 5-6
64 Belson, N. A, “US REGULATION OF AGRICULTURAL BIOTECHNOLOGY: AN OVERVIEW”, 2000, The
Journal on Agrobiotechnology Management and Economics, Vol. 3, issue 4, Published online, AgBioForum, p. 269
Concerning the second question, it was argued -with the premise that a longer lasting tomato would still be somewhat identical to a tomato- that the process should be regulated, with especially the Environmental Protection Agency (to which I will also come back later) vowing for these new risk assessment procedures. 65 However after it was decided that the
Coordinated Framework had sufficient statutory power for regulating biotechnology, a following research by the National Research Council (NRC) decided, “the product of genetic modification and selection should be the primary focus for making decisions about the environmental introduction of a plant or microorganism and not the process by which the products were obtained.” This has become the foundation for US GMO regulation.6667
Federal agencies
Under the Coordinated Framework three agencies are responsible for the regulation of biotechnology, namely: the Food and Drug Administration (FDA), the United States Department of Agriculture (USDA) and the US Environmental Protection Agency (EPA).68
The FDA is in charge of food safety (and also drugs, human biologics and medical devices.) The USDA is responsible for crop safety (and also veterinary biologics and also for a substantial part for meat and poultry.) And lastly EPA regulates broader risks to the
environment (pesticides or new chemicals.)69
United States Department of Agriculture
The main USDA institution concerned with biotech regulation is the Animal and Plant Health Inspection Service (APHIS). Operating through the agency of Biotechnology
Regulatory Services (BRS) the APHIS is mainly responsible for the protection of agriculture and the environment against threats from pests. 70 Almost all genetically modified plants fall
under the category “regulated articles.” Before shipping these regulated articles to another state or before field testing one must always notify APHIS. Genetically modified plants can
65 Lynch, Vogel, Supra Note 57, p. 6
66 National Research Council, “Field Testing Genetically Modified Organisms: Framework for Decisions”,
1989, Washington DC, National Academy Press
67 Lynch, Vogel, Supra Note 57, p. 6
68 Amaru, S. “A Natural Compromise:A Moderate Solution to the GMO& "Natural" Labeling Disputes”, Food
and Drug Law Journal vol. 69, 2014, Published online, Heinonline, pp. 582-583
69 Lopez, R and J. Carrau, “The GMO Regulation in the EU and the Commercial Conflict with the United
States”,Xth EAAE Congress “Exploring Diversity in the European Agri-Food System”, 2002, Zaragoza, Published online, pp. 3-4
70McHughen, A. and Smyth, S. “US regulatory system for genetically modified [genetically modified organism
(GMO), rDNA or transgenic] crop cultivars”, Plant Biotechnology Journal, Vol. 6, Issue 1, 2008, Published, Wiley Online Library online, pp. 4-5
be ‘deregulated.’ In order for that to happen APHIS must approve the so-called ‘petition for deregulation’, which encompasses information on genetics, possible environmental impact etcetera. Once approved the deregulated genetically engineered plant open for interstate restriction-free distribution. 71
The statute that gives APHIS the authority to regulate is the Federal Plant Protection Act.72 It was the replacement for the Federal Plant Pest Act, which has been modified for the
regulation of genetically modified plants. The ratio behind it was that regulation prevents the genetically modified plants from becoming ‘plant pests.’ 73
Environmental Protection Agency
EPA has extensive regulatory authority over substances that characterize as pesticides. EPA however claims it does not exactly regulate genetically modified plants themselves, but the ‘pesticidal properties’ related to GM plants. 74
Three federal statutes give EPA the regulatory authority it enjoys, namely: the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA),75 the Federal Food, Drug and Cosmetic
Act (FFDCA),76 and the Toxic Substances and Control Act (TSCA).77
Food and Drug Administration
The main statute concerning the regulation of food and drug safety is the earlier mentioned Federal Food, Drug and Cosmetic Act and the FDA is its main enforcer. In
addition, certain other statutes make the FDA responsible for the regulation of several specific products. The FDA for instance regulates several biologics through the Public Health Service Act, 78 even though many now also fall under drugs regulated by the FFDCA.79
71 Belson, Supra Note 68, p. 269
72 U.S.C. (United States Code) Article 7 §§ 7701 et seq.
73 McHughen, A. and Smyth, S. “US regulatory system for genetically modified [genetically modified organism
(GMO), rDNA or transgenic] crop cultivars”, Plant Biotechnology Journal, Vol. 6, Issue 1, 2008, Published, Wiley Online Library online, pp. 5
74 McHughen, A. and Smyth, S. “US regulatory system for genetically modified [genetically modified organism
(GMO), rDNA or transgenic] crop cultivars”, Plant Biotechnology Journal, Vol. 6, Issue 1, 2008, Published, Wiley Online Library online, p.9
75 U.S.C. Supra Note 76, Article 7 §§ 7701 et seq. 76 U.S.C. Supra Note 76, Article 21 §§ 301 et seq. 77 U.S.C. Supra Note 76, Article 15 §§ 2601 et seq. 78 U.S.C. Supra Note 76, Article 42 §§ 201 et seq. 79 Belson, Supra Note 68, p. 271-274
The FDA regulates food mainly through three key provisions that govern three food related categories. The first one is section 402 of the FFDCA, which regulates “adulterated foods.”80 The second main provision through which the FDA regulates food and thus food
biotechnology is section 403 of the FFDCA. This section concerns “misbranded Foods.”81
Lastly the FDA’s third important provision concerning the regulation of food is section 409 of the FFDCA. This section concerns “food additives.”
The FDA declared that its genetically modified food regulation policy does not need separate regulatory legislation only because they are produced by means of genetic modification. Instead the FDA looks at the food’s components and its characteristics. 82
Another remarkable feature is that the FDA has also determined that genetically modified food does not require special labeling if the food’s composition is not substantially different from its original counterpart. Food only requires special labeling if it contains a transgenic protein from a source that is known to cause allergic reactions, such as lactose, peanuts, and almonds, although the FDA would usually consider labeling insufficient and just stop it from being marketed. So bio technically added substances such as fats and proteins are generally recognized as safe and are not subjected to pre-market review. Developers are only
encouraged to get consultations by the FDA voluntarily.83
Somewhat peculiar seems the fact that the evaluation of transgenic plant pesticides like for instance Bt toxins is assigned to be EPA’s responsibility under FIFRA. The division of safety review of genetically modified crops between two agencies has already raised questions on the desirability of this situation, compared to a situation where full responsibility is given to one agency. It is however claimed to be a success by proponents. They claim that even though it might not be compulsory, all bio engineers still consult the FDA before commercial
distribution.84
On the other hand critics claim that due to this informal process no public record is being created and can therefore not be reviewed by the general public. Also with this policy
companies can just decide not to consult the FDA, even though there is a lot of commercial
80 U.S.C. Supra Note 76, Article 21 § 342 81 U.S.C. Supra Note 76, Article 21 § 343
82 FDA, Food for human consumption and animal drugs, feeds, and related products:
Foods derived from new plant varieties; policy statement, 57 Fed. Reg. 22984
83 Belson, Supra Note 68, pp. 274-275
84 Dahl, R. “To Label or Not to Label: California Prepares to Vote on Genetically Engineered Foods”, 2012,
Environmental Health Perspectives, Vol. 120, Issue 9, Published online, National Institute of Environmental Health Sciences, pp. 360-361
pressure for them to still follow the FDA’s recommended process. Moreover it of course gives them a far stronger position in case of a future liability claim.8586
4.4 European Union GMO regulation
General EU regulatory process
First of all, legally binding regulations in the EU need to be created through directives or regulations. This requires involvement of the Commission, the Council and the European Parliament.87 The Commission is the politically independent executive arm and consists of
one commissioner of each Member State.88 The Council, or in full, the Council of the
European Union (not to be confused with the European Council or the Council of Europe) consists of government ministers from each Member State and is the EU’s primary decision-making body together with the European Parliament.89 The European Parliament is the EU’s
legislator. The members are elected every five years and their main responsibilities are passing laws and reviewing all EU institutions.90
European GMO regulation
The European Union’s legal framework that governs GMOs is primarily laid down in two directives, namely: Directive 2001/18/EC, which governs the deliberate release into the environment9192 and Directive 2009/41/EC, which governs the contained use of ‘genetically
modified microorganisms.’93 Both are second carnations of 1990’s directives.94 Regulation
(EC) No 1946/2003 on transboundary movements of GMOs, Regulation (EC) No 1829/2003
85 McHughen, Smyth, Supra Note 74, p. 3 86 Belson, Supra Note 68, p. 276
87 TFEU, Supra Note 7, Article 289 and 294
88 https://europa.eu/european-union/about-eu/institutions-bodies/european-commission_en 89 https://europa.eu/european-union/about-eu/institutions-bodies/council-eu_en
90 https://europa.eu/european-union/about-eu/institutions-bodies/european-parliament_en
91 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate
release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC [2001] OJ L 106/1
92 Sella-Villa, D. E. “Gently Modified Operations: How Environmental Concerns Addressed through Customs
Procedures Can Successfully Resolve the US-EU GMO Dispute”, 2009, William & Mary Environmental Law and Policy Review, Vol. 33, Issue 3, pp.985-988
93Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of
genetically modified micro-organisms [2009] OJ L 125/75
on genetically modified food and feed, 95 and Regulation (EC) No 1830/2003 concerning the
traceability and labeling of GMOs and the traceability of food and feed products produced from GMOs96 complement the two directives. 97
Deliberate Release into the Environment
Directive 2001/18/EC governs not only GMO’s introduction into the environment, but also their placing on the market. Looking at the preamble -which states that living organisms, either commercially marketed or released into the environment, may cross borders and reproduce98- it actually makes a lot of sense for both to be regulated at EU level. 99
Directive 2001/18/EC is divided in four sections. Section A lays down the general rules. Procedures for the deliberate release of genetically modified organisms for all purposes except placing on the market are laid down in section B. Sections C consists of rules
specifically for the placing on the market of GMO products and section D contains the final provisions. 100 The procedure regarding the placing of genetically modified organisms on the
market appoints the authority to make decisions on this subject for the larger part to the EU. The procedure for deliberate release is rather an informative one, leaving the decision-making powers with the Member States.101
Deliberate Release
The standard authorization procedure for the “deliberate release of GMOs for any other purpose than for placing on the market” has a few requirements. Before conducting a deliberate release, one must first inform the competent authority of the Member State in whose territory the release will take place, by way of notification.102
95 Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on
transboundary movements of genetically modified organisms [2003] OJ L 268/1.
96Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003
concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC [2003] OJ L 268/24
97 Langlet, D. and Mahmoudi, S. “EU Environmental Law and Policy”, 2016, Published online, Oxford
Scholarship Online, p. 339-340
98 Directive 2001/18/EC, preamble paragraph 4 99 Langlet, Mahmoudi, Supra Note 101, p. 341 100 Idem
101 Idem
Placing on the market
Part C of the Directive that governs the placing on the market of GMOs is the most detailed part, since the decision-making procedure for placing GMOs on the market is more extensive and leaves the final decision to the EU rather than the Member States.103 GMOs, as
or in products that satisfy all the requirements in the Directive are subject to free circulation, meaning that their placing on the market cannot be prohibited, restricted or impeded.104
However there is also a safeguard clause through which the use and/or sale can still be restricted or prohibited after initial consent..105106
National prohibitions on cultivation
In 2015 through Directive 2015/412 (EU), Directive 2001/18/EC was amended. This amendment enables Member States to require the adjustment of the geographical scope of consent, in order to exclude all or part of its territory from cultivation, during the
authorization procedure or during the renewal of consent.Afterwards it is allowed for the notifier to adjust its notification to the geographical scope. If not then the alteration will still be implemented in the written consent. 107108109 And since April 3rd of this year, The Member
States that do allow for cultivation on their territories must take appropriate measures at their border areas in order to avoid cross-border contamination.110
Food and Feed
A lot of applications for authorization of GMOs are made conform the procedure laid down in Regulation 1829/2003 on genetically modified food and feed. This is because that procedure is applicable to GMOs that may in any form be used as food or as a source for food. The authorization procedure is almost identical except for a few different requirements and the option to prohibit the cultivation also applies.111 The only big difference is that the
103 Ibid. Art. 12 104 Ibid. 22 105 Ibid. 23
106 Langlet, Mahmoudi, Supra Note 101, pp. 342-343
107 Directive (EU) 2015/412 of the European Parliament and of the Council amending Directive 2001/18/EC as
regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory [2015] OJ L 68/1.
108Weimer, M. “Risk Regulation and Deliberation in EU Administrative Governance-GMO Regulation and Its
Reform”, 2015, European Law Journal, Vol. 21, Issue. 5, UK, John Wiley & Sons Ltd, p. 623
109 Langlet, Mahmoudi, Supra Note 101, p. 344 110 Idem
European Food Safety Authority (EFSA) is responsible for some of the functions that are carried out by the competent authority under Directive 2001/18/EC.112
Contained Use
The contained use of genetically modified microorganisms (GMMs)113 is regulated
through Directive 2009/41/EC, which is based on the predecessor of Article 192(1) TFEU. The Directive stipulates measures for the contained use of GMMs in order to protect human health and the environment.114 Already placed on the market GMMs in conformity with
Directive 2001/18/EC or through other relevant EU legislation falls outside of the scope of this Directive.115 The objective of each measure is avoidance of adverse effects on human
health and the environment that might occur through the contained use of GMMs. Therefore the user is obligated to conduct an assessment of these risks.116117
Transboundary Movements of GMOs
Regulation 1946/2003 on transboundary movements of GMOs118 implements the
Cartagena Protocol on Biosafety.119 It is based on the predecessor of Article 192(1) TFEU and
even provides for extra measures on top of those stipulated in the protocol. The regulation for example, quite strikingly, is also applicable to shipments from the EU to any other states and not just between the parties to the Protocol.120
4.5 Comparison of the regulations
What is first noticeable is the hodgepodge of intertwined regulations and agencies on the US side. Under the coordinated framework the FDA, the USDA, and EPA are all
responsible for the regulation of GMOs in certain -sometimes overlapping- areas.121 EPA for
instance gets its regulatory authority through three federal statutes, namely the FIFRA, the
112 Langlet, Mahmoudi, Supra Note 101, p. 345
113 Microorganisms that have been genetically altered in a way “that does not occur naturally by mating and/or
natural recombination.”
114 Directive 2009/41/EC Article 1 115 Ibid. Articles 2 and 3
116 Ibid. Articles 4 and 5
117 Langlet, Mahmoudi, Supra Note 101 p. 346 118 Regulation (EC) No 1946/2003, Supra Note 99
119 Cartagena Protocol on Biosafety to the Convention on Biological Diversity 120 Langlet, Mahmoudi, Supra Note 101, p. 345
FFDCA and the TSCA. 122 Also they are all concerned with several statutes that also
intertwine or even conflict. For instance the FDA is the main enforcer of the FFDCA that also gives EPA its regulatory power in certain areas. 123124 Also the safety review of genetically
modified crops is both EPA’s and the FDA’s responsibility.125 They furthermore often operate
through several sub agencies, such as BRS and APHIS.126
On the EU side on the other hand, the legal framework that governs GMOs consists of primarily two directives, namely Directive 2001/18/EC on deliberate release 127128 and
Directive 2009/41/EC on the contained use of genetically modified microorganisms. They are complemented by three regulations, namely: Regulation (EC) No 1946/2003 on
transboundary movements of GMOs, Regulation (EC) No 1829/2003 on genetically modified food and feed, 129 and Regulation (EC) No 1830/2003 concerning the traceability and labeling
of GMOs and the traceability of food and feed products produced from GMOs.130 What is
peculiar on the EU side though is that the deliberate release of GMOs is regulated at the EU level, but leaves the decision-making with the Member States where the placing on the market of GMOs is left with the EU for the bigger part. 131 And concerning GMOs in food and feed
the EFSA is responsible for certain tasks.132 Most importantly, since 2015 EU Members can
even decide to prohibit the cultivation of GMOs on their territory. This is not possible for separate States in the US.133
Another more important difference is that the US has chosen to regulate GMOs vertically, meaning that the US does not create new legislation for the regulation of GMOs, instead it chooses to adapt standing regulation to fit the requirements for the regulation of GMOs.134 For instance APHIS, regulates through the Federal Plant Protection Act, which is
actually a modification of the Federal Plant Pest Act and has been modified for the purpose of regulating GMOs.135
122 U.S.C. Supra Note 76, Article 15 §§ 2601 et seq. 123 Idem
124 Langlet, Mahmoudi, Supra Note 101, pp. 271-274 125Dahl, Supra Note 88, pp. 360-361
126McHughen, Smyth, Supra Note 74, pp. 4-5 127 Directive 2001/18/EC, Supra Note 95 128 Sella-Villa, Supra Note 96, pp.985-988 129 Regulation (EC) No 1946/2003, Supra Note 99 130Regulation (EC) No 1830/2003, Supra Note 100 131 Langlet, Mahmoudi, Supra Note 101, p. 341 132 Ibid. p. 345
133 Ibid. p. 344
134 Belson, Supra Note 68, p. 269
The EU on the other hand regulates horizontally, which means that it adopts rules to specifically address matters such as GMO regulation. All five of the abovementioned
directives and regulations are brought into existence with the purpose of regulating GMOs. 136
Another one of the fundamental differences is the basis on which the US and the EU regulate. The US regulates GMOs based on their end result, so on their characteristics, such as the product’s safety and quality and effectiveness. Genetically modified food for instance does not even require special labeling if the composition is not substantially different from its original counterpart.137 The EU on the other hand regulates based on the process through
which the product is made.138
Lastly, the most important difference is the fact that the US uses a preventive approach, meaning that the US regulates when the harm is already caused or scientifically proven.139 The EU on the contrary, can regulate before the threat has come into existence and
before it has been scientifically proven to cause harm.140
4.6 Conclusion
This chapter has shown how the diversions in regulation have come into existence, due to a long history of events as well as cultural and legal differences between the US and the EU. For example, several events such as an outbreak BSE in Europe have caused for Europeans to distrust of government when it comes health, which risks resulted in the
appreciation of the precautionary principle. Also Europe’s weaker ‘ex post’ remedies increase the need for stronger ‘ex ante’ precaution.
The differences in regulating that cause friction today mainly come down to three fundamental contradictory aspects in regulating. The first and most important one is whether the philosophy behind the regulation is precautionary or preventive. As we have concluded we cannot label a country’s entire regulation philosophy as being precautionary or preventive, since it is relative and it should be determined for each field separately whether the approach is precautionary or preventive. In the case of GMO regulation however we can say that Europe applies a precautionary approach, that is to say a proactive approach; meaning that the EU can introduce measures to remedy threats to health or the environment before the threat
136 Langlet, Mahmoudi, Supra Note 101, p. 339-340 137 Lynch, Vogel, Supra Note 57, p. 6
138 Langlet, Mahmoudi, Supra Note 101, p. 339-340 139 Wiener, Rogers, Supra Note 46, p. 341
has come into existence and that is not solely based on scientific principles, due to the precautionary principle. The US on the other hand uses a more preventive regulatory approach, that is to say a reactive approach; meaning that the US takes measures after the threat has already come into existence or after it has been scientifically proven to cause harm.
The second regulatory difference is the basis of the regulation. In the EU regulation is based on the product’s production process. Whereas the US has decided to base its regulation on the end result, so on the product’s safety and quality and effectiveness, irrespective of the process through which it was produced.
The third key difference is the adoption of the regulation, and the contradiction is between horizontal and vertical regulation. The EU uses horizontal regulation, which means that it has adopted several rules to specifically address matters such as food safety. Whereas the US regulates vertically, meaning that the US modifies existing regulation to fit matters such as food safety.
One last important difference that should be mentioned is that the EU Member States, as opposed to the US separate States, are allowed to prohibit cultivation on their territory.
Chapter 5
Possible actual impact of TTIP on standing EU GMO legislation
5.1 Introduction
This chapter will assess whether a trade agreements in general could have the capacity to amend standing EU legislation and whether it would be possible to create a regulatory body under TTIP that has the capacity to make decisions that bypass formal European legislative procedures. It will do so by first making a descriptive analysis of EU law concerning
international agreements, which will constitute a predictive analysis on the possible impact of TTIP. After that it will make a descriptive analysis of EU legislative procedures and also of regulatory cooperation as it is proposed for TTIP, in order to draw a conclusion on the two matters in the last paragraph.
5.2 International agreements
First of all, which regulations would the US like to see changed? One of the aspects of EU law that irritates the US is the so called ‘zero tolerance rule’, which purports that only authorized GMOs can be placed on the market in the EU and it also lays the burden of proof with the producer.141 The US claims that this rule is actually used as a barrier to trade.142143
Also the EU’s labeling requirements are a thorn in the side of the US. They claim it is
‘commercially unfeasible’ and that labeling requirements144 are only justified if there is a risk
to health.145146
The authorization system is based on the precautionary principle, which is deeply embedded in EU legislation147 and also the labeling requirements that find their basis in the
TFEU148 cannot be changed through a trade agreement. The precautionary principle and TTIP
are and will be primary law respectively; international agreements are namely incorporated
141 COMMISSION REGULATION (EU) No 619/2011 142 US SPS report 2013 p. 58
143 FOE, Supra Note 15
144 Article 169(1) TFEU and Article 12 and 24 of regulation 1829/2003 145 SPS 2013 US report p.35
146 FOE, Supra Note 15
147 TFEU, Supra Note 7, Article 191 148 Ibid. Article 169
into the EU legal system and are directly applicable.149150 The TFEU however will still be
higher in hierarchy than international agreements. Worse still, if TTIP would be incompatible with the EU agreements, then it may not enter into force.151
Furthermore, since TTIP will become primary legislation through incorporation, it will have supremacy over secondary EU legislation. However, paragraph 1 of Article 218 TFEU, which governs the conclusion of international agreements, refers to Article 207 TFEU. It states that the agreements shall be negotiated and concluded, “Without prejudice to the specific provisions laid down in Article 207.” Article 207 paragraph 3 in its turn states that: “the Council and the Commission shall be responsible for ensuring that the agreements negotiated are compatible with internal Union policies and rules.” Therefore it seems impossible that TTIP would be incompatible with the EU’s GMO regulation in the first place.152
However “internal Union policies and rules” is not further specified, nonetheless one would think that that includes secondary EU legislation. What also brings up the question: what if a trade agreement appears to be incompatible with secondary EU law afterwards? If there is no recourse for a violation of secondary law, then the agreement becomes static. It looks as if the legislator did not want touch this subject and just left it this way for others to figure out. Since the Commission keeps on reassuring that TTIP cannot change the rules that govern GMOs153, it can only be concluded that a trade agreement that is incompatible with
secondary EU law would indeed be impossible to conclude due to Article 207 paragraph 3 TFEU.
Does this mean that all worries surrounding TTIP are just based on absolutely nothing? Well usually there is no smoke without a fire, as might be the case here. Namely, TTIP’s supposed endeavor to start ‘regulatory cooperation’ might cause legitimate concerns and maybe support the earlier named worries.154 The next paragraph will discuss the content of
regulatory cooperation and analyze its feasibility.
149Martines, F. “Direct Effect of International Agreements of the European Union”, 2014, The European Journal
of International Law Vol. 25 Issue. 1, Published online, Oxford University Press, pp. 130-131
150 ECJ, Van Gend en Loos, Case 26/62, 1963 151 TFEU, Supra Note 7, Article 218(11) 152 Ibid. Articles 218(1) and 207(3)
153 http://ec.europa.eu/trade/policy/in-focus/ttip/about-ttip/questions-and-answers/index_en.htm; Supra Note 17 154 Parker, R and Alemanno, A, “Towards Effective Regulatory Cooperation under TTIP: A Comparative
Overview of the EU and US Legislative and Regulatory Systems”, 2014, Published online, European Commission p. 2
Regulatory cooperation
One of the US’s main goals concerning TTIP is to remove non-tariff measures such as GMO authorization processes and GMO labeling requirements through regulatory
cooperation. The idea is to harmonize both legal orders regarding import regulation, which would facilitate trade because only one set of legal rules needs to be complied to. However as we have seen in previous chapters, this would mean from a European perspective that it would have to shift its policy from health and environmental protection towards economic interests. The question now remains: is this possible regarding EU law? Or would the proposed cooperation break constitutional rules and affect the Member States’ national democratic decision making? Would a regulatory cooperation council possibly get the authority to take actions that surpass the European Parliament and the Council? 155
The next paragraph will discuss the feasibility of such extensive regulatory cooperation, by checking how much space European entities have to make decisions autonomously.
The EU regulatory process
As established in the previous chapter, legally binding regulations in the EU usually need to be created through directives or regulations. This requires involvement of the
Commission, the Council and the European Parliament. And in the normal course of business the creation of EU regulation starts of with the Commission making an ‘impact assessment’ of the possible economic, social and environmental impact that the legislative act might have.
The Commission however can be mandated to adopt delegated or implementing acts.156157 These delegated acts can adapt standing legislation in ‘non essential’ manners. The
Treaty itself does not define ‘non-essential,’ the European Court of justice however did formulate that “political choices falling within the responsibility of the EU legislature cannot be delegated, in particular where conflicting interests at issue must be weighed.”158159 For the
Commission to be able to adopt implementing or delegating acts, the original legislative act must have a provision that authorizes the Commission to adopt such acts. The drafts of delegated acts are subjected to the European Parliaments and the Council’s review and can be rejected by either one of them. Implementing acts are made in cooperation with Member
155 Gerstetter, C. “Regulatory cooperation under TTIP – a risk for democracy and national regulation?”, 2014,
Published online, Ecologic Institute, pp. 7-9
156 TFEU, Supra Note 7, Article 290
157 Lee, M. “EU Evironmental Law, Governance and Decision Making”, 2014, Oxford, Hart Publishing Ltd, p.
48
158 CJEU, Judgment of 5 September 2012, Council of the European Parliament vs. European Council, Case
C-355/10, para. 65.
