Wouter Zweers - Upholding the Precautionary Principle (Bachelor's Thesis)

Upholding the Precautionary Principle
A study on the roots and current application of the precautionary principle in the
EU and US, and its relevance to the standards-controversy of the Transatlantic
Trade and Investment Partnership (TTIP)
Wouter Zweers
Student Number: 10411720
E-mail Address: wtrzwrs@gmail.com
Bachelor's Thesis
Study: European Studies
Institute: University of Amsterdam
Thesis Supervisor: Mr Drs P.R. Teule

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Acknowledgments
Conducting this research has been more of a challenge than I initially expected. Keeping my
general narrative and interpretation consistent proved to be difficult from time to time.
However, thanks to my supervisor Mr Drs. P.R. Teule, whose expertise and advice have guided
me extensively, I have been able to produce this thesis. My sincere thanks go to him.
I would furthermore like to thank my parents, who have guided me my entire life and made
my studies possible in the first place, and whose support and encouragement has provided me
with the mindset necessary to conduct this research.
Special thanks go to my friends Kyle Storey and Paul Folten, who have helped me a lot by
proofreading this thesis and advising me on my English.

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Table of contents
Acknowledgments ..................................................................................................................................... 3
List of abbreviations...................................................................................................................................5
Introduction ............................................................................................................................................... 6
1. History of the precautionary principle in the EU and US............................................................ 8
1.1 The precautionary principle in the EU....................................................................................... 8
1.2 The precautionary principle in the US.......................................................................................11
1.3 Comparison.....................................................................................................................................13
2. Current judicial status and application of the precautionary principle in the EU and US ..15
2.1 The precautionary principle in the EU .....................................................................................15
2.2 The precautionary principle in the US.....................................................................................16
2.3 Comparison.................................................................................................................................... 17
3. The precautionary principle at work: GMO regulation in the EU and US.............................19
3.1 The EU's regulatory regime on GMOs .....................................................................................19
3.2 The US regulatory regime on GMOs ......................................................................................22
3.3 Comparison...................................................................................................................................23
4. TTIP: The end of European-style precaution?............................................................................26
4.1 The TTIP negotiations: a short overview ................................................................................26
4.2 Precaution and the TTIP negotiations.................................................................................... 27
4.3 Negotiations on divergent regulatory systems: influencing precaution? ............................31
4.4 Other factors influencing standards in the TTIP negotiations ...........................................33
Conclusion................................................................................................................................................ 35
Bibliography ............................................................................................................................................. 37
Appendix A: Definitions of the precautionary principle .................................................................41
Appendix B: Overview of provisional TTIP-chapters..................................................................... 43

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List of abbreviations
APHIS Animal and Plant Health Inspection Service
CAA Clean Air Act
CERCLA Comprehensive Environmental Response, Compensation, and
Liability Act
DG Directorate-General
EC European Commission
EC European Communities
EFA European Free Alliance
EFSA European Food Safety Authority
EPA Environmental Protection Agency
ESA Endangered Species Act
EU European Union
FDA Food and Drug Administration
FDCA Food Drug and Cosmetic Act
GHS UN Globally Harmonized System for classifying and labelling
substances
GM Genetically Modified
GMC Genetically Modified Crop
GMO Genetically Modified Organism
ICT Information and Communication Technology
NEPA National Environmental Policy Act
NTB Non-Tariff Barrier
OSPAR convention The Convention for the Protection of the Marine Environment of the
North-East Atlantic
PIP Plant-incorporated pesticide
SPS agreement The WTO Agreement on the Application of Sanitary and
Phytosanitary Measures
TBT Technical Barriers to Trade
TTIP Transatlantic Trade and Investment Partnership
TSCA Toxic Substances Control Act
UN United Nations
USDA U.S. Department of Agriculture
USTR United States Trade Representative
WTO World Trade Organization

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Introduction
In the past year public concerns on the Transatlantic Trade and Investment Partnership
(TTIP) between the European Union and the United States of America, of which the last
(ninth) round of negotiations took place in April 2015, have risen in various European Union
member states.1 Mainly major left-wing political groups and anti-TTIP activists fear that
European regulatory standards, which are considered to be higher than their American
counterparts, will be lowered as a result of the agreement.2 3 In an interview with Vrij
Nederland, Bas Eickhout, a member of the European Parliament for the Dutch party
Groenlinks (Greens/EFA) stated: ‘In the negotiations, rules that were established in a
democratic way are threatened to be given up. For example safety regulations, norms for food
quality and animal welfare, rules for the use of chemicals, you name it’.4
The European Commission has started a media campaign to tackle the public concerns.
For example, it published a factsheet under the header The top 10 myths about TTIP,
separating facts from fiction, which stated: ‘we're […] committed to protecting our high
standards, safeguarding EU regulators independence, upholding the precautionary principle.’5
There the Commission touches upon a very important difference between the European Union
and United States: the level of application of the precautionary principle. Internationally this
principle is subject to political and scholarly debate. Opponents criticise it for not being
effective and stimulating, and creating disguised protectionism.6 The EU has nevertheless, in
contrast to the US, fully embraced it.7
One definition that gives a clear insight at the principle's meaning, reads as follows:
Where an activity raises threats of harm to the environment or human health,
precautionary measures should be taken even if some cause and effect
relationships are not fully established scientifically. In this context the
proponent of an activity, rather than the public bears the burden of proof. The
process of applying the Precautionary Principle must be open, informed and
1 European Commission, tradoc 153437, ‘Report of the ninth round of negotiations for the
Transatlantic Trade and Investment Partnership (New York, 20–24 April 2015)’, as found at
http://ec.europa.eu/trade/policy/in-focus/ttip/documents-and-events/index_en.htm, accessed 27-05-
2015.
2 Author Unknown, ‘FAQS’, https://stop-ttip.org/what-is-the-problem-ttip-ceta/faqs/, accessed 27-05-
2015.
3 See for example: Author Unknown, ‘Questions & Answers’, http://ttip2015.eu/qa.html (initiative of
the Greens/EFA Political group of the European Parliament), accessed 27-05-2015.
4 T. Broer en M. Oberndorff, ‘Mister Chloorkip versus Mister Vrijhandel’, Vrij Nederland 13-05-2015.
5 European Commission, ‘The top 10 myths about TTIP, Separating fact from fiction’, as found at
http://ec.europa.eu/trade/policy/in-focus/ttip/documents-and-events/#economic-benefits, accessed 27-
05-2015.
6 See for example: G. Majone, ‘The Precautionary Principle and its Policy Implications’, Journal of
Common Market Studies, no. 1 (2002).
7 J. Tickner, C. Raffensperger, ‘The politics of precaution in the United States and the European Union’,
Global Environmental Change-Human And Policy Dimensions, no. 2 (2001), p. 175.

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democratic, and must include potentially affected parties. It must also involve
an examination of the full range of alternatives, including no action.8
Taking this definition as a guideline, four core tenets can be derived from the principle: ‘taking
preventive action in the face of uncertainty; shifting the burden of proof to the proponents of
an activity; exploring a wide range of alternatives to possibly harmful actions; and increasing
public participation in decision making’.9 The key element is thus that policy makers can take
regulatory measures to prevent or limit risks, even if scientific uncertainty on the scope of these
risks prevails. For example, although scientists do not agree on the effects of Genetically
Modified Organisms (GMOs) on the environment and human health, the European Union
has taken precaution by creating a regulatory regime where these GMOs are subject to approval
and monitoring measures.
The EU and US have different regulatory approaches to risk analysis, caused by a
different interpretation and level of application of the precautionary principle. As a result, EU
regulatory regimes highly differ from their US counterparts, leading to a difference in standards.
The TTIP-agreement, which seeks to enhance mutual trade and investment, aims to harmonise
the regulatory regimes, as their divergence acts as a Non-Tariff Barrier to trade (NTB). As it is
the fear of the European public, that the stringent European standards, of which precaution
forms the underlying principle, will be lowered as a result of TTIP, or are already being lowered
only by the negotiations on TTIP themselves, scientific research on whether these concerns are
justified is very much needed. Therefore, this paper researches the meaning of the
precautionary principle to both the EU and US and to what extent the principle is affected by
the TTIP negotiations, in order to clarify if European regulatory standards could be lowered
and if the fears of the European public are justified.
In order to do so, a first chapter will outline how and to what extent the precautionary
principle historically became a part of EU and US law and policy in an international context.
The second chapter describes how and to what extent it is currently applied in EU and US
domestic law and regulatory systems. A third chapter will take the form of a case study,
focussing on the regulatory regime on Genetically Modified Organisms of both powers,
highlighting their divergence and economic implications. A fourth chapter will research how
the TTIP negotiations are currently influencing the application of the precautionary approach,
and thereby regulatory standards in both the EU and US.
8 Various authors, Wingspread Statement on the precautionary principle (26-01-1998), as formulated
during the Wingspread Conference on the Precautionary Principle; A three-day conference convened
by the Science & Environmental Health Network (SEHN), where 32 scientists, philosophers, lawyers
and environmental activists gathered to define the precautionary principle and its role in (public
health and environmental) policy making. See: http://www.sehn.org/wing.html, accessed 27-05-2015.
A list of further relevant definitions is provided in Appendix A of this research.
9 Generally accepted derivation, for example: Various Authors, ‘The Precautionary Principle in
Environmental Science’, Environmental Health Perspectives, no. 9 (2001), p. 871.

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1. History of the precautionary principle in the EU and US
This chapter will point out to what extent the precautionary principle historically became a
part of EU and US policy. By outlining the differences between the EU and the US in a
historical context, the chapter will provide a solid basis to understand the current differences
in judicial status and application of the principle, such as those described in chapter two. It
should be noted that some developments described here not only mark the adoption of the
principle in either the EU or the US, but furthermore played a major role in the maturing of
the principle itself.10 Hence, international developments that are considered crucial in the
understanding of the evolvement of the principle are also covered in this chapter. This
international scope makes a comparison between both powers possible, since tipping points
can be distinguished where they chose a different direction in their interpretation of the
principle. The meaning of these differences will be examined at the end of the chapter.
1.1 The precautionary principle in the EU
The term precautionary principle is believed to originate from the Vorsorgeprinzip, which
came into use in German environmental law in the 1970s.11 Germany made the European
Community familiar with the principle during the North Sea Conferences in the 1980s.12 It
firstly entered EU law in the Treaty on the European Union (more commonly known as the
Treaty of Maastricht), that was signed in February 1992 and came into force the following year.
The treaty stated under Article 174 (ex-130R) paragraph 2 the following:
Community policy on the environment shall aim at a high level of protection
taking into account the diversity of situations in the various regions of the
Community. It shall be based on the precautionary principle and on the
principles that preventive action should be taken, that environmental damage
should as a priority be rectified at source and that the polluter should pay.
Environmental protection requirements must be integrated into the definition
and implementation of other Community policies.13
Naming the principle had some notable implications. Firstly, the treaty failed to provide a
definition of the principle, which made its implications on policy vague and susceptible to
10 For example: European Commission, COM(2000)1, ‘Communication from the Commission’.
11 G. Majone, ‘The Precautionary Principle and its Policy Implications’, p. 5.
12 The principle was firstly explicitly used in the Ministerial Declaration of the Second International
Conference on the Protection of the North Sea, London, 25-11-1987. See for a more extensive
introduction: W. Th. Douma, ‘The Precautionary Principle in the European Union’, Review of
European Community & International Environmental Law, no. 2 (2000), p. 133.
13 TFEU Article 191 paragraph 2, ex TEC Article 174 paragraph 2, ex SEA Article 130R (The
precautionary principle was only introduced in TEC)

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contradictory and/or multiple interpretations.14 Secondly, the scope of the principle in the treaty
was, in line with its origins, limited to the environmental policy area, although legal scholars
have argued that the principle applied beyond EC environmental policy as well via other
articles.15 Lastly, despite the principle being stressed in the treaty, member states of the EU had
no need to implement it into national policies, as the treaty only applied to the EC
institutions.16
During the 1990s the precautionary principle came into broader use internationally as
exemplified by a series of (environmental) international agreements and declarations that were,
among others, signed by the European Community.17 The 1992 Rio Declaration on
Environment and Development - also signed by the United States - for example described the
principle as follows:
In order to protect the environment, the precautionary approach shall be widely
applied by States according to their capabilities. Where there are threats of
serious or irreversible damages, lack of full scientific certainty shall not be used
as a reason for postponing cost-effective measures to prevent environmental
degradation.18
Another highly influential definition originates in the Convention for the Protection of the
Marine Environment of the North-East Atlantic (OSPAR). It reads:
[The precautionary principle is a principle,] by virtue of which measures are
taken when there are reasonable grounds for concern that substances or energy
introduced directly or indirectly into the environment may bring about damage
to human health, harm living resources, even where there is no conclusive
evidence of a causal relationship between the inputs and effects;19
Over the years, the EU has attached more value to the OSPAR definition, as will be discussed
later in the chapter. Also during the 1990s scholarly debate arose on the principle's definition,
its benefits and caveats, and how it should be implemented in policy making.20 Scholars stressed
the need for the refinement of the principle's definition in order to clarify its
14 G. Majone, ‘The Precautionary Principle and its Policy Implications’, p. 6.
15 See: Scott, J. and Vos, E., ‘The Juridification of Uncertainty: Observations on the Ambivalence of
the Precautionary Principle within the EU and the WT’. In Dehousse, R. and Joerges, Ch., Good
Governance in Europe's Integrated Market, Oxford: Oxford University Press (2002), p. 4.
16 W. Th. Douma, ‘The Precautionary Principle in the European Union’, p. 135.
17 Examples: The 1990 and 1991 Montreal Protocol Amendments, The Convention on Environmental
Impact Assesment in a Transboundary Context (Espoo, 1992), the 1990 Bergen Declaration on
Sustainable Development. See: W. Th. Douma, ‘The Precautionary Principle in the European
Union’, p. 133.
18 Rio de Janeiro Declaration on Environment and Development, 16-06-1992, Principle 15.
19 Convention on the Protection of the Marine Environment in the North-East Atlantic (OSPAR), 22-
08-1992, Article 2 paragraph 2a.
20 Such as in the Wingspread Conference on the Precautionary Principle, of which the definition of
the principle was covered in the introduction of this paper.

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operationalisation.21
However, the advance of the principle was slowed down by the World Trade
Organisation Agreement on the Application of Sanitary and Phytosanitary Measures (WTO
SPS Agreement), which was signed as a part of the Uruguay Round of Multilateral Trade
Negotiations in 1994. The agreement that established a policy framework on food safety and
plant and animal health, states under Article 2 paragraph 2:
Members shall ensure that any sanitary or phytosanitary measure is applied
only to the extent necessary to protect human, animal or plant life or health, is
based on scientific principles and is not maintained without sufficient scientific
evidence, except as provided for in paragraph 7 of Article 5.22
This paragraph states clearly that measures can only be taken based on scientific evidence,
thereby contradicting the precautionary principle. However, the exception of Article 5
paragraph 7 declares that ‘in cases where relevant scientific evidence is insufficient, a Member
may provisionally adopt Sanitary or Phytosanitary measures’.23 The WTO agreement thereby
does recognise the principle for provisional measures, but generally attaches more value to free
trade. As a result, the EU's broad application of the principle led to a series of disputes with
other countries that considered EU policy in breach with WTO free trade rules.24 Thus the
EU was urged to provide an explanation of its interpretation and implementation of the
principle. Therefore the Commission published a document named Communication from the
Commission on the precautionary principle in February 2000, in order to ‘avoid unwarranted
recourse to the precautionary principle, as a disguised form of protectionism’.25 The definition
used in the document is strongly influenced by the definition of the OSPAR convention.26 The
document states inter alia:
The precautionary principle is not defined in the Treaty, which prescribes it
only once - to protect the environment. But in practice, its scope is much
wider, and specifically where preliminary objective scientific evaluation,
indicates that there are reasonable grounds for concern that the potentially
dangerous effects on the environment, human, animal or plant health may be
inconsistent with the high level of protection chosen for the Community.
The Commission considers that the Community, like other WTO members,
has the right to establish the level of protection - particularly of the
environment, human, animal and plant health, - that it deems appropriate.
21 F.M. Fleurke, Unpacking precaution, Amsterdam 2012, p. 24.
22 WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS agreement),
1994, Article 2 paragraph 2.
23 Ibidem, p. 72.
24 For Example: Beef Hormone Dispute, WTO Appellate Decision WT/DS26/AB/R (16-01-1998), See:
F.M. Fleurke, Unpacking precaution, p. 26.
25 European Commission, COM(2000)1, Communication from the Commission, p. 2.
26 L. Krämer, ‘The Genesis of Environmental Principles’, in R. Macrory, European Principles of
European Environmental Law, Groningen: Europa Law Publishing (2004), p. 11.

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Applying the precautionary principle is a key tenet of its policy, and the choices
it makes to this end will continue to affect the views it defends internationally,
on how this principle should be applied.27
Hereby the Commission explicitly recognised that the scope of the precautionary principle in
EU policy is indeed far wider than just environmental protection. Hence the document
provided more clearance on the Commission's intended use of the principle. The
Commission's interpretation displayed in their communication however stretched the limits to
the application of the precautionary principle as set by the WTO SPS agreement. It therefore
caused controversy and criticism in international political and scientific circles, from among
others the United States.28 Some scholars found the Commission's explanation incomplete and
too vulnerable to arbitrary and discriminatory use.29 Others however regarded the document
as ‘a valuable start for further discussions on the need for applying the precautionary principle
in a way that ensures that protection is offered where necessary, both within and outside the
EU’.30
1.2 The precautionary principle in the US
Turning to the other side of the Atlantic, this section focuses on the history of the precautionary
principle in the United States. Traditionally policy-making in the United States has relied
heavily on cost-benefit analysis instead of the precautionary principle.31 Scholars have argued
that some preliminary form of the precautionary principle, albeit under different terminology,
has also existed in US policy since the 1960s, for example in the National Environmental Policy
Act (NEPA).32
In the decade after the principle came into use internationally, the Federal Government
of the United States took a negative approach towards the precautionary principle.33 For
example, Alan Larson, a former U.S. Under Secretary of State, stated in 1987:
For some in Europe, the ‘precautionary principle’ appears to mean that when
it suits European authorities, they may withhold approval until the risk
assessment process has convinced even the most irrational consumer of the
absence of even the most hypothetical risk of the most remote theoretical
28 F.M. Fleurke, Unpacking precaution, pp. 27 – 28.
29 For example: G. Majone, ‘The Precautionary Principle and its Policy Implications’, p. 7.
31 A. Sciascia, ‘Safe or Sorry: How the Precautionary Principle is Changing Europe's Consumer Safety
Regulation Regime and How the United States' Consumer Product Safety Commission Must Take
Notice’, p. 691.
32 S.C. Wood et al., ‘Whither the Precautionary Principle? An American Assessment from an
Administrative Law Perspective’, The American Journal of Comparative Law, nr: fall (2006), p. 585.
33 J. Tickner, C. Raffensperger, ‘The politics of precaution in the United States and the European
Union’, p. 176.

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uncertainty.34
Since then, the US have nevertheless been a party in some WTO and United Nations
declarations and treaties that (implicitly) included precaution.35 The 1990 Amendment to the
Montreal Protocol, ratified by the US in 1991, stated that the participants were ‘determined to
protect the ozone layer by taking precautionary measures […]’.36 Even a decade earlier, when
the causes of ozone depletion were still unclear, the US had taken various precautionary
measures to protect the ozone layer.37 It is of importance to note that the amendment stressed
precautionary measures instead of principle, as a principle universally applies, whereas
measures are applied in individual cases. The Protocol was furthermore only aimed at one
specific environmental goal: the protection of the ozone layer.
This is not the case in the aforementioned Rio Declaration, which had a broader scope
and intended to set guidelines for sustainable development in general. However, this
declaration did not regard precaution as a principle, but speaks of a precautionary approach
instead.38 The use of the term approach instead of principle is believed to be heavily influenced
by the US.39 It is this definition that the United States have since held on to, thereby denying
that precaution is to be regarded as a legal principle. Another significant aspect of the Rio
Declaration is that it states that ‘[a] lack of full scientific certainty shall not be used as a reason
for postponing cost-effective measures to prevent environmental degradation’.40 The word cost-
effective was added to the declaration on the insistence of US negotiators.41 This indicates that,
while accepting the declarations text, the US did not fully embrace precaution and held on to
their tradition of cost-benefit analysis.42
Another agreement that has been highly influential to the US perception of the principle is the
aforementioned WTO SPS agreement. The US have strongly argued that the WTO agreement
set clear limitations on the precautionary principle. The country often interprets the principle's
34 Quoted in D. Vogel, The Politics of Precaution: Regulating Health, Safety, and Environmental
Risks in Europe and the United States, Princeton: Princeton University Press 2012, p. 9.
35 Examples: The 1990 and 1991 Montreal Protocol Amendments, United Nations Framework
Convention on Climate Change 1992, The Convention on Environmental Impact Assessment in a
Transboundary Context (Espoo, 1992)
36 The amendment to the Montreal Protocol agreed by the Second Meeting of the Parties (London, 29
-06-1990), Preambular paragraph 6.
37 E. Fabry, G. Garbasso, Synthesis of The Reality of Precaution, Comparing Risk Regulation in the
United States and Europe, RFF Press: Washington 2010, as found at
http://www.delorsinstitute.eu/011-19897-The-reality-of-precaution.html, accessed 01-06-2015., p. 5.
38 Rio Declaration, Principle 15.
39 L. Krämer, ‘The Genesis of Environmental Principles’, p. 10.
40 Rio Declaration, Principle 15.
41 J.D. Graham, S. Hsia, ‘Europe's precautionary principle: promise and pitfalls’, Journal of Risk
Research, no. 4 (2002), p. 380.
42 Some scholars have argued that by signing and ratifying the Rio Declaration the United States have
bound themselves to the precautionary principle. See for example: J. Tickner, C. Raffensperger, ‘The
Precautionary Principle in Action, A Handbook, Science and Environmental Health Network’, as
found at www.sehn.org/rtfdocs/handbook-rtf.rtf, accessed 03-06-2015, pp. 2-3. As the experience has
shown, this viewpoint isn’t shared by the US.

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implications as being an unjustified barrier to free trade. It does not come as a surprise that
government experts on commerce and trade in the most part formulated the US position on
the principle.43 Not only the US government, but also US corporations have vehemently
opposed the principle due to its costs and in their view its consequences to free trade.44
The US reaction to the European Commission's communication on the precautionary
principle provides further clarity on their viewpoint. The US government commented that ‘a
clear definition has not been provided and […] political decisions will determine its use.’45 It
furthermore expressed its concern that ‘the precautionary principle could be used to justify
trade-restricting action based on a public fear alone.’46 This view is also frequently taken in
scholarly debate, where convictions exist that political decisions are vulnerable to ‘public
hysteria, industrial influence, and activist lobbies […]’, thereby making the principle highly
arbitrary.47 After the communication from the Commission the US have continuously opposed
the value accredited to the precautionary principle by the EU.
This section has shown that the precautionary principle was initially opposed by the
United States. Although being a party to the Rio Declaration, the country has held on to its
tradition of cost-benefit analysis instead of embracing the precautionary principle. The US have
systematically attached more value to free trade rules than to precaution in their interpretation
of the WTO SPS agreement, displaying their deeper general attitude.
1.3 Comparison
As this chapter has outlined, many international treaties in the 1990s, in which the
precautionary principle was represented, were signed by both the EU and US. This suggests
that both powers equally (implicitly) acknowledged the principle. However, three major
differences that can be distinguished between the two powers challenge this assertion.
Firstly, though signing the same treaties, the EU and US have had a very divergent
notion of the meaning of these treaties and their definitions of the precautionary principle. The
OSPAR definition for example notes that precautionary measures can be taken ‘when there
are reasonable grounds for concerns […]’48. What grounds are ‘reasonable’ is of course strongly
43 J. Tickner, C. Raffensperger, ‘The politics of precaution in the United States and the European
Union’, p. 176.
44 P.L. DeFur, M. Kaszuba, ‘Implementing the precautionary principle’, The Science of the Total
Environment, no. 1-2 (2002), p. 156.
45 Food and Drug Administration (FDA) U.S. Department of Agriculture (USDA), A US government
submission to the Committee on General Principles of the Codex Alimentarius Commission (2000),
quoted in: F.M. Fleurke, Unpacking precaution, p. 27.
46 C. Button, The power to Protect: Trade, Health and Uncertainty in the WTO, London:
Bloomsbury Publishing: 2004, p. 129.
47 J.D. Graham, S. Hsia, ‘Europe's precautionary principle: promise and pitfalls’, p. 385.
08-1992, Article 2 paragraph 2a.

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subject to interpretation. Therefore, the definitions in the treaties have enabled both powers to
defend their position on the precautionary principle, despite using the same texts. Tensions
between these interpretations furthermore display their divergent (and clashing) reference
frameworks and underlying attitudes.
Secondly, the EU and US have disagreed on the meaning of the WTO SPS agreement.
The EU regards the agreement as a confirmation of the precautionary principle, in contrast to
the US, according to which it set clear limitations on the principle's use. As a consequence, a
considerable amount of WTO disputes between the two, such as WTO Dispute EC Biotech,
have been caused, in which the US often consider the EU's precautionary policy to be a form
of disguised protectionism. 49 50 Although the communication from the Commission searched
to explain the EU's interpretation of the principle, the US upheld their objections,
systematically attaching more value to free trade.
Thirdly, besides the different interpretations of the treaties and the SPS agreement, the
EU has followed the OSPAR definition, whereas the US took the Rio definition as a standard.51
The Rio definition describes precaution not as a principle, but as an approach. This definition
is clearly softer, as a principle universally applies, whereas an approach is practised in individual
cases. This brings forth a very important difference in the interpretation of the precautionary
principle. Whereas the European Commission regards it as a general customary principle of
international law, the United States strongly disagree, above all because no single agreed
formulation of the principle exists.52
Internationally the two Atlantic powers have thus taken a differing stance on the rise of
the precautionary principle, displaying their underlying divergent attitudes. Consequently, the
meaning of the principle in their domestic laws and policies differs. This will be outlined by
the next chapter that focuses on the current judicial status and application of the precautionary
principle in both the EU and US.
49 WTO, EC — Approval and Marketing of Biotech Products Dispute WT/DS291-293 (29-09-2006).
50 A. Sirinskiene, ‘The Status of the Precautionary Principle: Moving towards a Rule of Customary
Law’, Mykolas Romeris University periodical reviewed research papers "Jurisprudence", no. 4
(2009), pp. 351-352.
51 L. Krämer, ‘The Genesis of Environmental Principles’, p. 11.
52 A. Sirinskiene, ‘The Status of the Precautionary Principle’, pp. 351-352.

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2. Current judicial status and application of the precautionary
principle in the EU and US
This chapter will focus on how the precautionary principle is currently expressed in primary,
secondary and case law in the EU and US. It will also demonstrate in what policy areas the
principle is applied. The EU and US are dealt with separately. A comparison is drawn at the
end of the chapter.
2.1 The precautionary principle in the EU
The Communication from the Commission on the precautionary principle was, although very
influential, not a legally binding document. The principle is however widely expressed in EU
primary, secondary and case law. This paragraph will provide a brief overview of how the
principle is judicially represented in the EU.
Primary law in the European Union is mainly formed by the founding-, amending-
and accession treaties of the EU, that, as the Eur-lex website states, ‘contain formal and
substantive provisions, which frame the implementation of the policies of the European
institutions’.53 The precautionary principle is found explicitly only in the aforementioned
TFEU Art. 191 (2) sentence 2 (ex TEC Art. 174 (ex 130R)) concerning environmental issues.
However, the Court of Justice has argued (just like the communication from the Commission
and various scholars) that via Article 11 TFEU (ex Art. 6 TEC), the principle in fact applies to
all EU policies.54 In areas where secondary law is absent, the principle doesn't apply to member
states policies, since the article addresses the EU institutions.55
In EU secondary law, the principle is expressed in several regulations and directives
that form the source of EU regulatory regimes in various (environmental) policy areas.
Especially chemicals and food safety policies are founded on the precautionary principle. The
regulatory regime on chemicals is established by Regulation (EC) No 1907/2006 of 18 December
2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals
(REACH), establishing a European Chemicals Agency. It explicitly states in Article 1 paragraph
3 that ‘Its provisions are underpinned by the precautionary principle’.56 Regulation 178/2002
establishes the institutional and judicial framework by laying down the general principles and
requirements of food law, establishing the European Food Safety Authority and laying down
53 Eur-Lex, Primary Law, http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=URISERV:l14530,
accessed 19-06-2015.
54 F.M. Fleurke, Unpacking precaution, p. 25.
55 Ibidem, p. 59.
56 Regulation (EC) No 1907/2006 of 18 December 2006, Article 1 paragraph 3.

16
procedures in matters of food safety. It ties itself to the precautionary principle in Article 6
paragraph 3 and in Article 7.57 EU secondary law has also put in place a precautionary
regulatory regime on fisheries and other (environmental) policy areas.58 In other areas, such as
cars, pharmaceuticals, medical devices, engineering, textiles and Information and
Communication Technology (ICT) the principle is not explicitly named. However, via the
aforementioned Article 11 TFEU the principle applies here as well.
In EU case law, discussion used to focus on whether the precautionary principle was
enforceable or not. Where some scholars argued it is only a general guideline, others regarded
it as a legally binding norm.59 The principle has over time proven to be of importance to
agriculture, public health and environmental issues by influencing and sometimes determining
the European Court of Justice's decisions.60 Although it was only explicitly mentioned first in
2000 (Case C/352-98 P Bergaderm), the court referred to the principle implicitly in earlier
cases.61 The Court of Justice regards precaution nowadays as a general principle of EU law.
Decisions of the Court in a considerable amount of cases have made clear that the principle
directly applies to member states through secondary legislation. Member states have however
also utilized the principle, whether or not with judicial success, to break with EU law in order
to put in force more stringent regulations than the Commission's.62
One could conclude that the principle has evolved into a mature principle of EU law,
which is highly influential in several policy areas, above all in food safety, chemicals- and
environmental policy.
2.2 The precautionary principle in the US
The first chapter has outlined that the US do not attribute the same value to the precautionary
principle as the EU in international affairs. Turning to the domestic representation of the
principle, a similar conclusion can be drawn. In written US law there are no explicit references
to the precautionary principle, one study concluded in 2006.63 The assumption that precaution
thus does not play a role at all in the US is nevertheless incorrect. Precautionary approaches
are to a certain level adopted in practice by courts, administrative agencies and Congress.64
57 Regulation (EC) No 178/2002 of 28 January 2002, Article 6 paragraph 3, Article 7.
58 Fisheries: the Common Fisheries Policy (CFP), (EU) Regulation No 1380/2913 of 11 December 2013.
Article 2 paragraph 2, Article 4 paragraph 1 sentences 8 and 19, and Article 9 paragraph 2 all speak of
the precautionary approach.
60 Ibidem, p. 140.
61 F.M. Fleurke, Unpacking precaution, p. 45.
62 See for examples and a more extensive coverage: F.M. Fleurke, Unpacking precaution, pp. 49-50.
63 S.C. Wood et al., ‘Whither the Precautionary Principle?’, p. 583.
64 H.G. Anker, M.R. Grossman, ‘Authorization of Genetically Modifed Organisms: Precaution in US
and EC law’, European Food and Feed Law Review, no. 1 (2009), p. 7.

17
There are examples of domestic US law that share characteristics with precaution (without
explicitly mentioning it).65 To name a few: the Endangered Species Act (ESA), the Clean Air
Act (CAA), the Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA), the Toxic Substances Control Act (TSCA), the Food Drug and Cosmetic Act
(FDCA) and the National Environmental Policy Act (NEPA). The latter created the
Environmental Protection Agency (EPA), responsible for protecting human health and the
environment, thereby often taking diluted forms of precautionary approaches.66 The FDCA,
which is about the authorisation of biotech-foods, takes a precautionary approach for example
in its Delaney clauses, where it prevents the use of carcinogens, substances that are suspected
of causing cancer.67 The ESA has been described by the US Supreme Court as institutionalized
caution, which has the same connotation as precautionary principle.68 However, in US case
law federal courts presented with the principle have generally rejected it.69
In general, it is possible to conclude that the precautionary principle is hardly at work
in US law. The US see precaution as a preference or an approach, in which many of the
principle's characteristics are represented only partially.70 It thus appears only in an adulterated
and implicit form. As one scholar describes it: ‘the United States seemed to be happier
endorsing specific actions that could be seen to be precautionary—rather than endorsing the
principle per se.’71
2.3 Comparison
In the domestic judicial representation of the precautionary principle of the EU and US, two
major differences can be distinguished. The foremost is that the EU has explicitly acknowledged
the principle in its treaties and secondary law, whereas US law, albeit featuring its
characteristics, hasn't. Although some sort of precaution is at times taken in US policy, the
principle practiced as a whole is absent. It appears regularly in an adulterated and implicit form.
Case law furthermore shows that the EU attributes substantially more value to the
precautionary principle than the US.
A second difference is in what policy areas the principle is applied. The EU regulatory
65 J.S. Applegate, ‘The precautionary Preference: An American Perspective on the Precautionary
Principle’, Human and Ecological Risk Assessment: An International Journal, no. 3 (2000), p. 420.
66 P.M. Kannan, ‘The precautionary principle: more than a cameo appearance in United States
environmental law?’, William and Mary Environmental Law and Policy Review, no. 2 (2007), p.
458.
67 H.G. Anker, M.R. Grossman, ‘Authorization of Genetically Modified Organisms’, p. 8.
68 J.S. Applegate, ‘The precautionary Preference’, p. 420.
69 P.M. Kannan, ‘The precautionary principle’, p. 419.
70 J.S. Applegate, ‘The precautionary Preference’, p. 438.
71 D. Freestone, ‘Chapter 8: The Marine Environment’, in: Jonathan B. Wiener et al. (eds.), The
Reality of Precaution: Comparing Risk Regulation in the United States and Europe, London: RFF
Press 2011, p. 177.

18
regimes on chemicals, food safety and fisheries reflect the principle the best. In other areas it
mainly applies via Article 11 TFEU. In the US, the principle's scope, as marked by the acts
where precaution implicitly plays a minor role, is mainly limited to environmental issues.72
As we have seen in the first two chapters the United States and European Union take
quite a different stance regarding the precautionary principle. The two powers don't agree on
its definition and its international legal status and thus give a very different meaning to it in
their domestic law and policy. Hence, the conclusion can be drawn that both powers general
attitudes are highly divergent. Consequently, their regulatory regimes are rather different, as the
next chapter will show. It takes the form of a case study on both power's regulatory regimes on
Genetically Modified Crops.
72 One study did not find a difference in relative precaution between the EU and US in a quantitative
analysis using a random selection of 100 risks. However, by taking a closer look at the list of risks
assessed, one can conclude that there exist major differences in the policy areas where more
precaution is taken. In food safety and other environmental issues the EU proved to be more
precautious. See: E. Fabry, G. Garbasso, Synthesis of The Reality of Precaution, p. 2-3.

19
3. The precautionary principle at work: GMO regulation in the EU
and US
The different meaning that is given to precaution in the EU and US has led to distinctive
regulatory regimes in various policy areas. It would take a book to describe all different
regulatory regimes, so this chapter, which can be regarded as a case study, will only outline how
the different meaning given to precaution by the US and EU is expressed in their regulatory
systems on Genetically Modified Organisms (GMOs), and more specifically on Genetically
Modified Crops (GMCs, GM-crops or biotech-crops). The reason behind choosing this
particular policy area is threefold. Firstly, the policies of the EU and US on biotech-crops show
great divergence in the level of application of the precautionary principle. Secondly, as one
scholar puts it, ‘GMOs are currently perceived as one of the main examples of new
technological risks with potentially irreversible and unforeseen consequences […] [and]
therefore the classic case for applying precaution’.73 Thirdly, biotechnology is one of the main
areas where the TTIP negotiations have caused European public concerns. The chapter focuses
firstly on the EU, subsequently on the US, and concludes with a comparison of both regimes.
For both powers the chapter will provide a very brief history and legal basis of the regulatory
regime, an overview of the authorisation process of GMOs, the outcomes of this process and
an analysis of where precaution is to be found in the regulatory regime.
3.1 The EU's regulatory regime on GMOs
In the 1990s, opposition to GMOs from environmentalists, consumer groups, organic farmers
and the general public arose rapidly in the EU as a result of various controversies.74 Member
states, picking up the public concerns, blocked all new approvals of GMOs in the Council,
which resulted in a moratorium on all GMO approvals from 1998 until 2004. This led to the
aforementioned WTO dispute EU Biotech between the EU and the US.75 After heated
negotiations new regulatory frameworks were introduced by the Commission in 2001 through
Directive 2001/18/EC on the Deliberate Release into the Environment of Genetically Modified
Organisms and Regulation 172/2002 laying down the general principles of food law, including
73 M. Weimer, ‘Applying Precaution in EU Authorisation of Genetically Modified Products –
Challenges and Suggestions for Reform’, European Law Journal, no. 5 (2010), p. 625.
74 BSE case: although this has nothing to do with GMOs, public perception linked the two together
due to events that occurred simultaneously in both the BSE case and the introduction of GMOs.
See: D. Vogel, The Politics of Precaution: Regulating Health, Safety, and Environmental Risks in
Europe and the United States, Princeton: Princeton University Press 2012, p. 77.
75 WTO, EC — Approval and Marketing of Biotech Products Dispute WT/DS291-293 (29-09-2006).

20
the precautionary principle, and establishing the European Food Safety Authority (EFSA).
These intended to create high standards and a single European GMO market. Failing to satisfy
certain member states, including Denmark, Germany and France, who continued to block
GMO approvals and demanded higher standards, it was complemented by regulation
1829/2003 on Genetically Modified Food and Feed, and regulation 1830/2003, which requires
traceability and labelling of GMOs and GM food and feed products. Several member states
refused to comply with the European laws – Austria and Ireland for example declared they
intend to stay GM-free – and thereby undermined their effectiveness. As such, pressure on the
Commission to adjust the framework arose.76 Therefore Directive 2015/412/EU was adopted in
2015, amending the original Directive 2001/18/EC, creating the possibility for member states to
restrict or prohibit GMO cultivation in their territory. This means the Commission's intention
to create a single European GMO market has failed, although in order to ban GMOs member
states have to provide valid argumentation.77
Authorisation for new GMOs works as follows: applicants apply by submitting a dossier
with a risk assessment and experimental data in one member state. One can apply for either
cultivation, or marketing of food and feed and derived products of GMOs, or both. The
national authority forwards the application file to the EFSA that carries out a scientific risk
assessment, covering both environmental risks and human health safety risks. The EFSA then
forms its opinion, upon which the Commission decides whether to approve the GMO
provisionally or not. Next to decide is a regulatory committee consisting of member state
representatives that approves the variety or not. If not, the proposal is forwarded to the Council.
If the Council doesn't oppose the proposal, the Commission authorises the GMO for 10 years.78
Although the EFSAs opinion is often positive, the authorisation process allows other factors
such as consumer concerns to affect decision-making. An authorisation is always accompanied
by a post-market monitoring plan.79
The question that naturally follows is how many GMOs are currently approved in the
EU and if they are actually cultivated and on the market. The EU register of authorized GMOs
currently contains 59 different GMO varieties. It comprises maize (30 varieties), soybean (12
varieties) and cotton (10 varieties) and to a lesser extent oilseed rape (4 varieties),
microorganisms (2 varieties) and sugar beet (1 variety).80 However, two factors have prevented
the GMO market from growing. Firstly, several member states continue to refuse the cultivation
of GMCs on their territory. Cultivation of GMCs in the EU is limited to GM-maize and only
takes in place in five countries. Total acreage comprised 143,016 hectares in 2014, of which Spain
76 D. Vogel, The Politics of Precaution, pp. 77 – 81.
77 European Commission, ‘EU Register of authorised GMOs’,
http://ec.europa.eu/food/plant/gmo/new/legislation/index_en.htm, accessed 11-06-2015.
78 F.M. Fleurke, Unpacking precaution, pp. 156 – 158.
80 European Commission, ‘EU Register of authorised GMOs’.

21
accounted for 92%, the remainder being divided among Portugal, Czech Republic, Slovakia and
Romania.81 Of the EU member states, only Spain appears in the global top 20 of GMC-
cultivating countries, at a 17th place.82 Secondly, food producers and retailers refrain from using
or selling GM foods due to a fear of public opposition (consumer boycotts) and the stringent
EU labelling and traceability requirements.83
The precautionary principle can be applied in three different phases of risk analysis;
risk assessment, risk management and risk communication.84 In the whole regulatory
framework on GMOs in the EU, precaution is clearly found at four levels, namely: the
establishment of the regulatory principle as a whole, in the risk assessment phase, in the risk
management phase, and on member state level. The precautionary principle served as a
structural principle by establishing and underlying the regulatory framework on GMOs.85
Precaution functioned as a normative principle (applying directly) in the other three levels. In
its risk assessment, The EFSA searches not only to determine risks but also to identify the
degree of scientific uncertainty. It thereby creates the conditions for the institutions to decide
whether there are, as the OSPAR definition reads, ‘reasonable grounds for concern that
substances or energy introduced directly or indirectly into the environment may bring about
damage to human health, harm living resources, even where there is no conclusive evidence of
a causal relationship between the inputs and effects’.86 It thus provides a condition for the phase
where precaution manifests itself the most clearly, namely the phase of risk management,
formed by the institutions political responsibility to judge what is an ‘acceptable’ level of risk
for society (and thus authorising a GMO or not).87 By taking into account not only the EFSA's
opinion, but other factors such as public concerns, the fourth key tenet of the precautionary
principle, ‘public participation in decision making’, is lived up to. Further precaution in the
risk management phase is taken by requiring monitoring plans, traceability and labelling.88 The
fourth level where the precautionary principle is at work is at the member state level. Member
state's prohibitions of and/or restrictions on GMOs imply the adoption of two of the
Wingspread definition features of the precautionary principle: taking preventive action in the
face of uncertainty and increasing public participation in decision making (by taking into
account public concerns).89
81 C. James, ‘Global Status of Commercialized Biotech/GM Crops: 2014’, International Service for the
Acquisition of Agri-biotech Apllications (ISAAA) report, p. 11.
82 Ibidem, p. 4.
83 D. Vogel, The Politics of Precaution, p. 81.
84 European Commission, COM(2000)1, ‘Communication from the Commission on the precautionary
principle’ (02-02-2000), p. 2.
85 H.G. Anker, M.R. Grossman, ‘Authorization of Genetically Modifed Organisms’, p. 4.
08-1992, p.3.
88 H.G. Anker, M.R. Grossman, ‘Authorization of Genetically Modifed Organisms’, p. 21.
89 Various authors, Wingspread Statement on the precautionary principle.

22
3.2 The US regulatory regime on GMOs
When GMOs became commercially exploitable, the US reacted by establishing The
Coordinated Framework for the Regulation of Biotechnology in 1986 aimed at promoting the
domestic GMO industry, which, apart from minor changes, is still in place today. It divided
regulation among the Food and Drug Administration (FDA), the U.S. Department of
Agriculture (USDA), and the U.S. Environmental Protection Agency (EPA). US Congress has
however never produced legislation on GMOs.90 During the 1990s, the US adopted GMOs
rapidly. However, in 1999 public concerns over GMOs arose due to the controversy
surrounding a GM corn variety that was held responsible for killing butterfly colonies. These
concerns were furthermore influenced by European public perceptions of GMOs. Domestic
political pressures arose and as a result the US strengthened its regulations for the authorisation
of GMOs.91
For the introduction of new GMOs for cultivation the authorisation process starts with
a field test under control of the USDA's Animal and Plant Health Inspection Service (APHIS).
If a GMC release is considered safe the process is relatively simple, and only a notification to
APHIS is needed. If it's more experimental and carries higher risks, a permit (which includes
an environmental assessment) has to be obtained. If a GM variety proves to be safe, the USDA
grants the application. It's then ready for commercial cultivation (as long as it also meets EPA
and FDA requirements), and no further monitoring plan is required.92 93. The EPA regulates
only those GMCs that feature plant-incorporated pesticides (PIPs) through experimental use
permits. GMCs are registered after proving to be of no harm to the environment. The EPA
furthermore regulates pesticide residues in food through establishing tolerance-levels. The FDA
is responsible for the safety of non-pesticidal GM foods. It focusses not on the process but on
the product. It considers GM foods substantially equivalent to conventional foods. Hence,
neither pre-market approval nor labelling of GM foods is required. Only foods with higher
risks (for example new substances) require pre-market approval. However, the three agencies
work together with food producers in voluntary consultations, where food safety data are
assessed.94
The regulatory regime as a whole contributes to a business friendly environment
90 D. Vogel, The Politics of Precaution, pp. 73–74.
91 Ibidem, pp. 82 – 85.
92 H.G. Anker, M.R. Grossman, ‘Authorization of Genetically Modified Organisms’, pp. 12-21.
93 APHIS proposed stricter regulations (banning the simple notification process) in 2008, but
withdrew this in 2015 after opposition from the agricultural sector, see: USDA APHIS, ‘stakeholder
announcement’,
http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/biotechnology/sa_news/ct_news_340/!ut/p/a0/04
_Sj9CPykssy0xPLMnMz0vMAfGjzOK9_D2MDJ0MjDzd3V2dDDz93HwCzL29jAyMTPULsh0V
AU1Vels!/, accessed 11-06-2015.

23
instead of confining the market, marked by the United States' unremitting growth in GMO
planting and consumption.95 In 2014, regulatory approvals of biotech-crops totalled 171 (not
including gene stacked events).96 The US are absolute global market leader in the biotech-
sector. Acreage of GM-crops matched 73.1 million hectares in 2014 and comprised maize,
soybean, cotton, canola, sugarbeet, alfalfa, papaya and squash. Thereby the US grow almost
twice as many GMOs as the second-biggest global market player, Brazil, which accounts for
42.2 million hectares.97 In the US, 85 up to 95 percent of all produced soybeans, cotton, corn,
and sugar beets come from GM seeds. Due to the business-friendly climate, most leading
agricultural biotechnology companies, like Monsanto or Dow Agrosciences, are based in the
US.98 In some states, mainly in Vermont and California, various bills have been filed to ban
GM-crops and food or to introduce labelling, but so far without success.99
On what levels and to what extent do we find precaution in the US regulatory system?
In the establishment of The Coordinated Framework for the Regulation of Biotechnology
precaution did not play a significant role, as the main purpose was to guide the agricultural
biotechnology industry by creating an advantageous business climate. By undertaking risk
assessments for more experimental GM varieties the APHIS shows precaution. However, a
substantial part of GM varieties only requires notification, which doesn't match with the
precautionary principle. Precaution is completely absent in the FDAs concept of substantial
equivalence (the conviction that GM foods are substantially equivalent to their traditional
counterparts).100 The most important feature of the precautionary principle, that is, taking
preventive action in the face of uncertainty, is absent in the US regulatory system. If the
authorities find scientific data incomplete, and uncertainty on the safety of a GM variety
remains, they simply request more data from the applicant. Therefore, in practice the
authorities will always eventually find the data sufficient, hence no scientific uncertainty
remains. This nevertheless means that the regulatory system, as the precautionary principle
comprises, does shift the burden of proof to the proponents of the activity.101
3.3 Comparison
This chapter has outlined how, as a result of the different judicial status of the precautionary
principle, the way it is expressed in regulatory regimes differs, taking the case study of
96 C. James, ‘Global Status of Commercialized Biotech/GM Crops: 2014’, p. 11.
97 Ibidem, p. 4.
99 Organic Consumers Association, ‘Countries & Regions With GE Food/Crop Bans’,
https://www.organicconsumers.org/old_articles/gefood/countrieswithbans.php, accessed 11-06-2015.
100 H.G. Anker, M.R. Grossman, ‘Authorization of Genetically Modifed Organisms’, p. 14 – 15.
101 Ibidem, p. 15.

24
Genetically Modified Crops. This section will make some final remarks and provide a
comparison between the EU and US.
Historically, two divergent regulatory frameworks on GMOs have, due to different
public concerns, emerged in the US and the EU. The regulatory regime in the US was installed
by proponents of the agricultural biotechnology sector who searched to enhance it. The
foundation of the EU regime came as a reaction on public and member state concerns and was
thus aimed at establishing high environmental and health standards. It was explicitly based on
the precautionary principle. Also, unremitting opposition of GMOs has continued to alter the
framework's stringency. The differences become clear when looking at the authorisation
procedures of both the EU and US.
The authorisation procedure of the EU for GMOs is significantly stricter than its US
counterpart. In the risk assessment phase the EU covers all GMO food products containing
GMOs. In contrast the US regard the bulk of GMO foods substantially equivalent to traditional
foods and no risk assessment is conducted. A considerable amount of new GMO varieties
tested for cultivation in the US are only subject to notification (to the APHIS), whereas in the
EU full authorisation is required. In the risk management phase, The EU explicitly takes into
account the precautionary principle, when authorising a GMO variety, which is not the case in
the US. Therefore, when dealing with scientific uncertainty, the EU will, in contrast to the US,
be willing to turn down GMO applications. This is demonstrated by the amount of current
approvals in both powers (EU 59 vs. US 171). The EU approval method via the Commission,
a regulatory committee consisting of member state representatives and if needed the Council,
reflects transparent and democratic decision making, thereby living up to the fourth key tenet
of the Wingspread definition of the precautionary principle. Furthermore, in practice,
precaution in risk management in the EU is taken by the requirement of monitoring plans,
traceability and a strict labelling regime (albeit regarding the requirement of labelling as a
precautionary measure is subject to scholarly debate). These precautionary measures of risk
management are completely absent in the US.
The divergence in market outcomes as a result of the differing regulatory regimes is
overwhelming. Acreage of biotech-crops in the US comprises 73.1 million hectares versus
143,017 in the EU, the latter thereby being 540 times smaller. Whereas the US account for
42.62% of global acreage of GM-crops, the EU only forms 0.079%. However, it should be noted
that the differences in the magnitude of the GMO market do not just reflect the divergent
regulatory systems caused by the deviating meaning given to precaution. Other factors have
influenced the economic importance of the agricultural biotechnology sector as well. An
example for the EU is that food producers and retailers refrain from the use and sale of GM
foods due to a fear of consumer boycotts.
The case study of GMOs provides a striking insight of how a different application of

25
the precautionary principle leads to divergent regulatory regimes, which have a sharp influence
on market outcomes. As outlined in this chapter, a considerable gap exists between the US and
the EU when it comes to GMO regulation and the GMO market. The TTIP negotiations that
currently take place are nevertheless aimed at harmonising standards in various sectors such as
the biotechnology sector. What sectors and regulatory regimes are up for negotiation and where
precaution plays a role in the negotiations is outlined in the next chapter.

26
4. TTIP: The end of European-style precaution?
This chapter will highlight how the process of the TTIP negotiations is currently influencing
precaution in the EU. Firstly the chapter will provide a short overview of how the TTIP
negotiations work, who are involved and what progress has been made so far. Secondly, the
chapter focuses on precaution in the negotiations: where and when is it specifically addressed,
what statements have been made on it etcetera. Subsequently, the impact of the negotiations
on regulatory regimes like that on GMOs, which was discussed in the previous chapter, will be
highlighted. It will become clear in what sectors the negotiations could lower regulatory
standards and affect precaution. Finally, the chapter will outline other factors that are believed
to have an influence on the level of application of the precautionary principle and regulatory
standards.
4.1 The TTIP negotiations: a short overview
On the 13th of February 2013 United States President Barack Obama, European Council
President Herman Van Rompuy and European Commission President José Manuel Barroso,
issued a joint statement reading:
We, the Leaders of the United States and the European Union, are pleased to
announce that, based on recommendations from the U.S.-EU High Level
Working Group on Jobs and Growth […], the United States and the European
Union will each initiate the internal procedures necessary to launch
negotiations on a Transatlantic Trade and Investment Partnership.102
After these internal procedures, such as the EU member states giving approval to start the
negotiation (14-06-2013) and the formation of a negotiating team, the first round of negotiations
took off in July 2013. Currently the 10th round of negotiations is coming up, starting on the
13th of July 2015.103
For the EU, the negotiations are conducted by the Directorate-General Trade
Commission of the European Commission, headed by Commissioner Cecilia Malmström. The
Chief Negotiator is Ignacio Garcia Bercero, who works as a director within DG Trade. He
coordinated the work of the EU High Level Working Group on Jobs and Growth that preceded
102 European Commission, MEMO/13/94, ‘Statement from United States President Barack Obama,
European Council President Herman Van Rompuy and European Commission President José
Manuel Barroso’, 13-02-2013, as found at http://europa.eu/rapid/press-release_MEMO-13-94_nl.htm,
103 European Commission, ‘how TTIP started’, as found at http://ec.europa.eu/trade/policy/in-
focus/ttip/documents-and-events/index_en.htm, accessed 18-06-2015.

27
the TTIP negotiations.104 For the US, the negotiations are conducted by chief negotiator Dan
Mullaney, who works for the United States Trade Representative Michael Froman. Both the
EU and US have a team of additional negotiators specialising in various negotiating areas.105
These can be divided under three pillars: a) market access, b) regulatory issues and Non-Tariff
Barriers, c) rules. Of special importance to this paper is the second pillar, which is about
regulatory cooperation in general, SPS measures, Technical Barriers to Trade (TBTs), and
specific industries. For an overview of all provisional TTIP-chapters, see Appendix B.106
The EU negotiators obtained a mandate from the Council (and thereby from the
member states) that set directives for the negotiations in June 2013.107 The European
Parliament also committed to follow the negotiations closely, and is currently preparing a
recommendations report to the TTIP negotiators. Due to a considerable amount of
amendments, a plenary vote on the draft report as a whole has been postponed to July.108 The
TTIP negotiations are scheduled to be completed by the end of 2015, although some delay can
be expected. After a legal revision and translation of the final text, the European Council and
Parliament will vote on approval, thereby, as the website of the European Commission states,
providing a ‘double democratic guarantee’.109 Recent attempts from President Barack Obama
to side-track the US Congress in the final decision on Trade agreements have failed for the
time being (although new attempts are expected in the coming months), thus the final
agreement provisionally has to be adopted by the US Congress as well.110
4.2 Precaution and the TTIP negotiations
After a rise of public concerns on TTIP, resulting in, among other things, a European Citizens
Initiative against TTIP as a whole, the Commission hurried to improve the transparency of
104 European Commission, tradoc 151669, ‘Mr Ignacio Garcia Bercero’, as found at
http://trade.ec.europa.eu/doclib/press/index.cfm?id=950, accessed 18-06-2015.
105 For the US: ‘List of Lead Negotiators for the Transatlantic Trade and Investment Partnership
(TTIP)’, as found at https://ustr.gov/ttip, accessed 16-06-2015.
For the EU: ‘List of Lead Negotiators for the Transatlantic Trade and Investment Partnership
(TTIP)’, as found at http://trade.ec.europa.eu/doclib/press/index.cfm?id=950, accessed 16-05-2015.
106 European Commission, ‘The EU's position in the negotiations’, http://ec.europa.eu/trade/policy/in-
focus/ttip/documents-and-events/index_en.htm#eu-position, accessed 18-06-2015.
107 Council of the European Union, ST 11103 2013 DCL 1, ‘Directives for the negotiation on the
Transatlantic Trade and Investment Partnership between the European Union and the United
States of America’, as found at http://ec.europa.eu/trade/policy/in-focus/ttip/documents-and-
events/index_en.htm#eu-position, accessed 16-06-2015.
108 European Commission INTA committee, ‘New TTIP timeline: Trade Committee to decide fate of
116 amendments on 29 June’, http://www.europarl.europa.eu/news/en/news-
room/content/20150615IPR66489/html/New-TTIP-timeline-Trade-Committee-to-decide-fate-of-116-
amendments-on-29-June, accessed 27-06-2015.
109 European Commission, ‘The three main stages in the negotiating process’,
http://ec.europa.eu/trade/policy/in-focus/ttip/about-ttip/process/#_main-stages, accessed 18-06-2015.
110 RussiaToday, ‘Obama's fast-track authority stuck in House slow lane’, http://rt.com/usa/267652-fast-
track-slow-lane/, accessed 18-06-2015.

28
the negotiations.111 It therefore published various factsheets and a document named The top 10
myths about TTIP, Separating fact from fiction. As I already cited in the introduction of this
paper, it states that ‘we're committed to upholding the precautionary principle’.112 This section
will examine if the negotiations appear to be in line with this assertion, by examining where
precaution is explicitly or implicitly mentioned in the various negotiation documents of the
EU. These include the mandate from the Council and the EU's proposed legal TTIP-texts of
the chapters on SPS measures (under which GMO regulation falls) and regulatory coherence.
The negotiation mandate from the Council does not explicitly contain the
precautionary principle as a guideline for the negotiations.113 However, the document does state
the following:
The Agreement should recognise that sustainable development is an
overarching objective of the Parties and that they will aim at ensuring and
facilitating respect of international environmental and labour agreements and
standards while promoting high levels of protection for the environment, labour
and consumers, consistent with the EU acquis and Member states' legislation.
The Agreement should recognise that the Parties will not encourage trade or
foreign direct investment by lowering domestic environmental, labour or
occupational health and safety legislation and standards […].114
Since the precautionary principle definitely falls under the EU acquis, as we have seen in
chapter two, in combination with the phrase on ensuring standards, this line can be regarded
as an implicit referral to the precautionary principle. The document furthermore states on
regulatory issues and specifically on SPS measures, that:
Provisions of the SPS chapter will build upon the key principles of the WTO
SPS Agreement, including the requirement that each side's SPS measures be
based on science and on international standards or scientific risk assessments,
while recognising the right for the Parties to appraise and manage risk in
accordance with the level of protection that each side deems appropriate, in
particular when relevant scientific evidence is insufficient, but applied only to
the extent necessary to protect human, animal, or plant life or health, and
developed in a transparent manner, without undue delay.115
The key tenet of the precautionary principle, taking preventive action in the case of scientific
uncertainty, is clearly described here. Therefore this phrase can also be regarded as an implicit
reference to the principle.
111 See: ‘Self-Organised European Citizens' Initiative against TTIP and CETA’, https://stop-ttip.org/,
112 European Commission, The top 10 myths about TTIP.
113 A search conducted in the document using the terms ‘precaution’ and ‘precautionary’ yielded zero
results.
Transatlantic Trade and Investment Partnership’, p. 4.
115 Ibidem, p. 11.

29
We can examine if the negotiators indeed persecute the level of precaution implicitly
mentioned in the mandate by looking at the provisional legal texts the EU has proposed.
Two chapters are especially relevant for this research, the chapter on SPS measures and that
on Regulatory Cooperation, of which an EU proposal was submitted during the 9th Round of
negotiations.116 An accompanying detailed explanation on the EU proposal for a Chapter on
Regulatory Cooperation states:
The EU text clearly states that the two parties would continue to regulate in
accordance with their regulatory framework, procedures and principles. This
means that the well-established precautionary approach to regulation in the EU
would not be affected by the provisions of the Regulatory Chapter. The EU
would retain the ability to maintain and develop its own approach with respect
to e.g. risk assessment or risk management.117
By digging into the actual proposed chapter, this statement appears to be true. In particular
Article 1 paragraph a) and paragraph 3, Article 10 paragraph 1, and Article 12 paragraph 3
disseminate the principle implicitly. Especially Article 1 paragraph 3 is worth mentioning:
The provisions of this Chapter do not restrict the right of each Party to
maintain, adopt and apply timely measures to achieve legitimate public policy
objectives, such as those mentioned in paragraph 1 [Pursuing a high level of
protection of inter alia: the environment; consumers; public health; working
conditions; social protection and social security; human, animal and plant life;
animal welfare; health and safety; personal data; cybersecurity; cultural diversity;
and preserving financial stability], at the level of protection that it considers
appropriate, in accordance with its regulatory framework and principles. […].118
One of the regulatory principles meant is undoubtedly the precautionary principle, especially
since the paragraph is mentioned in the explanation document as being precautionary.
In the EU's textual proposal of the chapter on Sanitary and Phytosanitary measures,
one of the objectives stressed is to:
Facilitate trade between the Parties to the greatest extent possible while
preserving each Party's right to protect human, animal or plant life and health
in its territory and respecting each Party's regulatory systems, risk assessment,
risk management and policy development processes;119
116 European Commission, tradoc 153437, ‘Report of the ninth round of negotiations for the
117 European Commission, tradoc 153431.1.1, ‘Detailed Explanation on the EU proposal for a Chapter
on Regulatory Cooperation’, as found at http://trade.ec.europa.eu/doclib/press/index.cfm?id=1230,
accessed 18-06-2015, p. 11. ‘precautionary approach to regulation in’ is bold in the original document.
118 European Commission, tradoc 153403, ‘TTIP – Initial Provision for CHAPTER [ ] – Regulatory
Cooperation’, as found at http://trade.ec.europa.eu/doclib/press/index.cfm?id=1230, accessed 18-06-
2015, p. 3.
119 European Commission, ‘Textual proposal for legal text on the chapter of Sanitary and
Phystosanitary Measures (SPS)’, as found at

30
As the precautionary principle plays a key role in the EU's regulatory systems and risk
management, assessment and policy development processes, the line hereby implicitly
dedicates itself to upholding the principle. It indicates that no changes will occur in the
application of the precautionary principle in the EU's regulatory regimes on Sanitary and
Phytosanitary measures, such as the GMO regulation, that was discussed in chapter three.
Where the precautionary principle is (implicitly) named in the EU texts, the context is
that it should be upheld to maintain regulatory standards. When we turn to the United States,
this is clearly different. Although no official legal text proposals from the US are available, the
website of the US Trade Representative gives a clear insight to the US view on the principle,
which is not mentioned explicitly.120 On regulatory issues the website states:
We seek to build on key principles and disciplines of the World Trade
Organization (WTO) Agreement on the Application of Sanitary and
Phytosanitary Measures (SPS) to achieve meaningful market access, including
commitments to base SPS measures on science and international standards or
scientific risk assessments, apply them only to the extent necessary to protect
human, animal, or plant life or health, and develop such measures in a
transparent manner, without undue delay; and to establish an on-going
mechanism for improved dialogue and cooperation addressing bilateral SPS
issues.121
At first sight it forms a striking resemblance to the mandate from the Council. However, the
mandate added ‘while recognising the right for the Parties to appraise and manage risk in
accordance with the level of protection that each side deems appropriate, in particular when
relevant scientific evidence is insufficient’.122 Hence the precautionary principle is only at work
in the Mandate, not in the US text. The latter thus rejects the idea of precaution (in line with
the US interpretation of the SPS agreement). The two citations perfectly show the positions of
the US and EU on the principle. As these positions are rather divergent, negotiations on the
topic will be difficult.
As we have seen, the precautionary principle is not mentioned explicitly in the EU
mandate or in the legal texts of the treaty that the EU proposed. If the EU would've mentioned
it explicitly, the negotiations would be unfeasible, as the divergence between the two powers on
the principle is substantial. The proposed legal texts from the EU do contain some important
paragraphs that can be regarded as an implicit appearance of the precautionary principle.
http://trade.ec.europa.eu/doclib/press/index.cfm?id=1230, accessed 19-06-2015, p. 1.
120 A search conducted in the website using the terms ‘precaution’ and ‘precautionary’ yielded zero
results.
121 Office of the United States Trade Representative, ‘Non-Tariff Barriers and Regulatory Issues’,
https://ustr.gov/trade-agreements/free-trade-agreements/transatlantic-trade-and-investment-
partnership-t-tip/t-tip-2, accessed 18-06-2015.

31
Furthermore, in accompanying (explanatory) documents, the principle is mentioned explicitly.
As the top 10 Myths-document promises, the negotiators do indeed appear to be committed to
upholding the precautionary principle. It should be noted however that some of the documents
stressed in this section are provisional, as the final text will be the result of the negotiations with
the US. Since the US take a very different stand on the issue, it is not clear to what extent the
principle will appear (implicitly) in the final agreement. How the precautionary principle and
its corresponding regulatory regimes will be affected in practice by the negotiated
harmonisation in various specific industries and regulation on Sanitary and Phytosanitary
Measures, will be the topic of the next paragraph.
4.3 Negotiations on divergent regulatory systems: influencing precaution?
This section will outline what sectors are being negotiated and how these negotiations aim at
harmonizing their regulatory frameworks. As already touched upon in chapter three, the US
and EU know divergent regulatory regimes in various specific industries. Since market access
is as a consequence strongly hindered, the EU and US aim at harmonisation. Under pillar two
of the TTIP negotiations, the following industries are being negotiated (in separate chapters,
see Appendix B): Chemicals, Cosmetics, Engineering, Medical devices, Pesticides, Information
and Communication Technology (ICT), Pharmaceuticals, Textiles, and Vehicles. For these
industries factsheets are available online on the European Commission's TTIP-website and for
the bulk of them also EU position papers.123
The regulatory regimes can be divided among two categories. In the first category,
regulatory regimes between the EU and US differ, but the outcome (standards on consumer
and environmental protection) is more or less uniform. The regulatory regimes for example
comprise different testing methods that approximately lead to the same level of protection.
These differences can be described as ‘horizontal’. Precaution is in this category rather equally
applied. This is partially the case in most of the specific industries, and for some industries it
almost applies to the regulatory regime as a whole. The industries that mainly fall in this
category are Vehicles, Engineering and Textiles. For example in the vehicles industry EU and
US standards match to a large extent and the overall level of safety can be regarded equivalent.124
These industries fall mainly outside of the classic scope of the precautionary principle
(environment, consumer health and safety).
In the second category, regulatory regimes are not only divergent, but furthermore lead
123 See: European Commission, ‘EU negotiating texts, chapter by chapter’,
http://trade.ec.europa.eu/doclib/press/index.cfm?id=1230, accessed 18-06-2015. The documents
stressed in this section can all be founded here.
124 European Commission, tradoc 153168.4.9, ‘Second Test Case on Recognition of Equivalence in
relation to US and EU lighting and vision standards’, p. 1.

32
to different standards. For example, divergent testing methods lead to different viewpoints on
what substances are considered safe, and therefore one power approves these while the other
doesn't. These differences can be described as ‘vertical’. A different level of application of the
precautionary principle leads in this category to divergent standards, such as we have seen in
the case study on GMOs. In some specific industries this is the case only to a small extent, but
especially in Chemicals, Cosmetics, Pesticides, and Pharmaceuticals the regulatory regimes
vertical differences prevail, as well as in SPS-regulation (that includes GMO regulation). These
industries show more affection with areas where precaution is traditionally applied, such as
environment and consumer health and safety.
The TTIP negotiations aim at harmonisation in four different ways, each described
below and complemented by an example. The first is achieving mutual recognition of (parts
of) one another's regulatory regimes. For example in the vehicles-industry, ‘the EU wants both
sides to recognise as many as possible of their respective requirements as equivalent to each
other’.125 The second method of harmonisation is by converging the divergent regulatory
regimes. The two powers for example seek to set up a common regulatory regime for textile-
standards and testing methods.126 A third way of achieving harmonised regulatory systems is
by upgrading both regimes to international standards (such as established by the United
Nations). In the chapter on the Chemicals-industry a good example can be found. The EU
wants to ‘promote the use of relevant international standards such as the UN Globally
Harmonized System (GHS) for classifying and labelling substances’.127 A fourth harmonisation
measure is harmonising approval-forms while maintaining the divergent regulatory regimes.
Although this does not actually harmonise the regimes themselves, the outcome is the same:
improving a company's access to both the EU and US market. For example, in the medical
devices-industry, the EU wants to ‘harmonise forms for getting new medical devices approved,
so EU and US regulators can work on approvals at the same time’.128 In reality harmonisation
of the regulatory regime as a whole will, in each specific industry, comprise a combination of
these methods.
For the previously described first category of regulatory regimes, these harmonisation
measures are not likely to lead to different outcomes in levels of standards or application of the
precautionary principle, since mainly horizontal differences prevail. This applies principally to
the Vehicles, Engineering and Textiles industries. Regarding the second category, under which
the greater part of the regulatory regimes on SPS measures, Chemicals, Cosmetics, Pesticides,
and Pharmaceuticals falls, the situation is different. Different levels of precaution leading to
different levels of protection are likely to clash in the negotiations. If harmonisation of these
125 European Commission, tradoc 153012.4.9, ‘Factsheet Vehicles in TTIP’, p. 1.
126 European Commission, tradoc 153011.4.8, ‘Factsheet Textiles in TTIP’, p. 1.
127 European Commission, tradoc 153005, ‘Factsheet Chemicals in TTIP’, p. 1.
128 European Commission, tradoc 153008, ‘Factsheet Medical Devices in TTIP’, p. 1.

33
regulatory regimes, where vertical differences prevail, is agreed on in the final TTIP-agreement,
either one or both powers standards and level of application of the precautionary principle will
be influenced. This implies that in practice a lowering of standards for the EU could be possible.
However, this notion has its limitations, which will be outlined in the next paragraph.
4.4 Other factors influencing standards in the TTIP negotiations
Although the conclusion drawn from the last paragraph sounds alarming, the risk that a
lowering of standards will actually take place is determined by various factors other than the
level of application of the precautionary principle. This section will provide a brief overview of
the most relevant ones.
Most importantly, The EU has excluded the majority of those parts of regulatory
regimes where public sensitivity is the highest from the negotiations, thereby preventing
standards from being influenced. For example, the authorisation process for GMOs, such as
described in chapter three, is not under negotiation.129 In areas like this one (SPS measures),
where major ‘vertical’ differences exist, the negotiations only aim at closer cooperation through
exchange of information, thereby creating transparency, minimization of the effects of
regulation on trade by working together, and removing unnecessary trade barriers.130 However,
the question remains what parts of regulations are regarded as being ‘unnecessary’ trade
barriers, and if these do not partially overlap with areas where vertical differences prevail. This
will only become clear in the final text of the agreement, as the outcome is subject to the
negotiations. For example, as stated in paragraph 4.2, if the implicit appearance of the
precautionary principle in the EUs proposed legal text on the SPS chapter will be maintained
in the final text, remains uncertain.
A second possibility is of course that the negotiators won't come to an agreement on
certain controversial topics that are under negotiation. In that case, standards and the
application of the precautionary principle won't be affected as these topics will not be covered
by the final agreement, i.e., these parts of the regulatory regimes will stay the way they were
before. However, the outcome of the agreement is not fixed. A dialogue will be established, for
example in the EU proposed Joint Management Committee for SPS Measures, where new
initiatives will continue to be discussed after the agreement.131
As already touched upon in paragraph 4.1, the final text of the agreement has to be
approved by the Council and the European Parliament. As we have seen, these bodies have set
129 European Commission, tradoc 153004.3, ‘Food Safety and animal and plant health in TTIP’, p. 2.
130 Ibidem, p. 1.
131 European Commission, ‘Textual proposal for legal text on the chapter of Sanitary and
Phystosanitary Measures (SPS)’, p. 12.

34
directions for the negotiations on, among other things, SPS measures. In the mandate, the
Council has expressed the value it attaches to precaution and upholding safety, health and
environmental standards. Although the Parliament hasn't succeeded in bringing about a final
recommendations report, the draft report implies that the parliament takes the same or even a
stricter position as expressed in the Council's mandate.132 Therefore, if standards or the
application of the precautionary principle will be excessively undermined in the final
agreement, it is not likely this will be accepted either one or both of the two bodies.
External factors (outside the official negotiations) could furthermore play a role in
affecting standards and precaution. These factors are not covered in this research and their
actual effects require further research. Fears exist that current revisions of EU regulation are
already affected by the TTIP negotiations. For example, when the Commission approved 19
new GMO varieties in May, it was accused of lowering standards in order to make the TTIP
negotiations easier. These would thus indirectly lead to a lowering of standards.133 Other factors
outside of the official negotiations could be corporate and government lobby and involvement
of other (higher) political levels, such as the recent G7-summit.134
The notion that standards and precaution can be undermined in some specific
industries and (parts of) regulatory regimes, as outlined in the previous paragraph, thus has
limitations. As this section has shown, various other factors have an influence as well.
132 European Parliament, Committee INTA Draft Report, procedure 2014/2228(INI), PE549.135v01-
00, as found at
http://www.europarl.europa.eu/oeil/popups/ficheprocedure.do?reference=2014/2228(INI)&l=en,
133 Greens/EFA, ‘GMO approvals’, http://www.greens-efa.eu/gmo-approvals-13878.html, accessed 19-06-
2015.
134 See: White House Office of the Press Secretary, ‘G-7 Leaders' Declaration (08-06-2015)’,
https://www.whitehouse.gov/the-press-office/2015/06/08/g-7-leaders-declaration, accessed 19-06-2015.

35
Conclusion
As this thesis has outlined, the meaning of the precautionary principle to the EU is very
different from the meaning of the principle to the US. Historically, the two powers have dealt
with the principle very differently. In the 1980s only the EU took a positive stance on the
emergence of the precautionary principle, whereas the US rejected it. As both powers became
party to a number of international agreements in which the principle was represented, most
importantly the Rio Declaration and OSPAR convention, they implicitly acknowledged it.
Their (partial) adoption of the principle should be viewed upon in light of its international
development. Whereas the EU has mainly held on to the OSPAR definition, the US followed
the softer Rio definition. A different interpretation of the WTO SPS agreement created further
divergence in the value the powers attached to the principle.
Through the years this has led to a stark difference in the domestic judicial
representation of the principle, as discussed in chapter two. The EU explicitly acknowledged
the principle in the Treaty on the European Union and its secondary law. US law on the other
hand, albeit featuring the principles characteristics in an adulterated form, hasn't. In the EU
the precautionary principle is applied in a wide range of policy areas, whereas in the US its role
is mainly limited to environmental issues. The two powers hence deviate in the level of
application of the principle, but also in the areas it applies to. Overall, the EU embraced the
precautionary principle to a much greater extent than the US did.
Chapter three outlined that as a result of the different judicial status of the
precautionary principle in the two powers, the extent to which it is expressed in their regulatory
regimes differs. The chapter took the case study of the EU and US regulatory regimes on
Genetically Modified Organisms, since these are highly divergent, as marked by the resulting
WTO disputes. The case study provided a clear insight of how the precautionary principle is
applied in regulatory regimes in practice, and of what importance this can be for market
outcomes. Due to precaution (and minor other factors), the EUs regulatory regime on GMOs
has showed to be highly more stringent than its US counterpart, resulting in the GMO industry
only playing a minor role on the European market.
Taking the different pathways both powers have followed in their interpretation and
application of the precautionary principle under consideration, the fourth chapter shifted its
focus to the TTIP negotiations. It showed that although the precautionary principle is not
explicitly mentioned in the Council's mandate or the legal texts of the treaty that the EU
proposed as of yet, it does appear in an implicit form. Furthermore, accompanying explanatory
documents do mention the principle explicitly. Therefore, the statement of the Commission
that it is committed to upholding the precautionary principle, appears to be true.
However, when looking at the intended harmonization in various specific industries

36
and regulation on Sanitary and Phytosanitary Measures, it seems that the precautionary
principle and its corresponding regulatory regimes in practise can possibly be affected. This is
only the case in the regulatory regimes on SPS measures, Chemicals, Cosmetics, Pesticides,
and Pharmaceuticals falls, where different levels of precaution leading to different levels of
protection are likely to clash in the negotiations. If harmonisation of these regulatory regimes,
where ‘vertical’ differences prevail, is agreed on in the final TTIP-agreement, either one or both
powers standards and level of application of the precautionary principle will be influenced. In
theory a lowering of standards for the EU could therefore be possible. However, the EU has
excluded the majority of those parts of regulatory regimes where public sensitivity is the highest
from the negotiations, thereby preventing standards from being influenced. Also various other
factors can have an influence on a lowering of standards and precaution such as negotiators
failing to come to an agreement, thereby excluding regulatory regimes and standards from being
influenced. Also the Council, European Parliament, and/or US Congress not approving the
final TTIP-agreement, and various external factors as corporate/government lobby and
involvement of other (higher) political levels, can affect the outcomes. In order to determine
how relevant and/or influential these factors are, more scientific research is required.
Taking these conclusions into account makes clear that public fears that TTIP will
lower EU standards are only partially justified, as the TTIP-agreement could only affect the
EU's application of the precautionary principle in certain sectors. Various other factors have
their influence as well. Therefore, only after the TTIP-agreement is ratified, will its implications
for EU standards and the precautionary principle become fully clear.

37
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