Applying Precaution in EU Authorisation of Genetically Modified Products—Challenges and Suggestions for Reform

• Date: 01 September 2010
• DOI: http://doi.org/10.1111/j.1468-0386.2010.00526.x
• Author: Maria Weimer
• Published date: 01 September 2010

eulj_526624..657

Applying Precaution in EU Authorisation

of Genetically Modified

Products—Challenges and Suggestions

for Reform

Maria Weimer*

Abstract: In this article, I endeavour to examine concrete challenges that arise with

regard to implementation of the precautionary principle in the field of European Union

regulation of genetically modified organisms (GMOs). Developed by the European courts

into a general legal principle, precaution requires EU regulators to strike a balance

between scientific and political legitimacy when taking decisions on risk-entailing prod-

ucts. Following this understanding, the current GMO legislation creates precautionary

governance structures that allow for a broad input into the authorisation process, not only

of scientific, but also of ‘other legitimate factors’. At the same time, it can be criticised for

narrowly defining precaution as a decision rule, which, if applied correctly, will lead the

decision maker to the ‘right’ decision. I argue that this misconception is one of the reasons

why, in the current authorisation practice, the EU institutions fail to apply the principle in

a balanced way, falling into the extremes of either purely science-based decision making

or a highly politicised precautionary rhetoric. I suggest that in order not to be paralysing,

precaution should be understood as a procedural principle that provides for precautionary

governance, thus enabling regulators to make appropriate risk choices.

I Introduction

In forcing public decision makers to think carefully about the scientific uncertainties involved in health

and environmental decision making, the precautionary principle is perhaps one of the most significant

principles of the contemporary era.1

The existing academic literature on the meaning and possible interpretations of the

precautionary principle is abundant and covers various academic disciplines.2The

* PhD candidate, Department of Law, European University Institute.

1E. Fisher, J. Jones and R. von Schomberg, ‘Implementing the Precautionary Principle: Perspectives and

Prospects’, in E. Fisher, J. Jones and R. von Schomberg (eds), Implementing the Precautionary Principle

(Edward Elgar, 2006) 1, at 11.

2See R. Harding and E. Fisher (eds), Perspectives on the Precautionary Principle (Federation Press, 1999);

T. O’Riordan, J. Cameron and A. Jordan (eds), Re-Interpreting the Precautionary Principle (Cameron

May, 2001); J. Morris (ed), Rethinking Risk and the Precautionary Principle (Butterworth-Heinemann,

2001); I. Forrester and J. C. Hanekamp, ‘Precaution, Science and Jurisprudence: a Test Case’, (2006) 9(4)

European Law Journal, Vol. 16, No. 5, September 2010, pp. 624–657.

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and 350 Main Street, Malden, MA 02148, USA

objective I pursue in this article is not to contribute to this discussion by providing for

yet another abstract definition of the principle, or for another argument either in favour

or against its application. Despite the ongoing controversy surrounding it,3the precau-

tionary principle has become a reality of public regulation all over the world.4In the

EU, it is today an established principle of EU environmental and health law, and, as

such, has been implemented in many concrete regulatory frameworks of risk regula-

tion. Under European law, the question is, therefore, not whether to implement the

precautionary principle, but how to implement it. It is with regard to these concrete

challenges arising from the application of precaution in particular areas of risk regu-

lation that I hope to make a useful contribution.5

EU regulation of genetically modified organisms (GMOs) provides an interesting

field for such a case study. GMOs are currently perceived as one of the main examples

of new technological risks with potentially irreversible and unforeseen consequences,

the occurrence of which has motivated Ulrich Beck to proclaim the advent of the risk

society.6It is, therefore, the classic case for applying precaution. At the same time, in no

other field of EU regulation do the shortcomings of the practical use of the principle in

regulatory decisions become more apparent than currently in the authorisation of

GMOs.

Although the current regulatory framework, which was officially based on the pre-

cautionary principle,7was overhauled not long ago,8it is now under further criticism

and is once more being reviewed for reform.9In the summer of 2008, the French EU

presidency established a working group including Member State representatives with

the objective of reflecting upon possibilities of improving the authorisation procedures

for GM products in the EU and, if necessary, of inducing a new reform of the legislative

Journal of Risk Research 297; A. Wildavsky, But is it True? A Citizen’s Guide to Environmental Health and

Safety Issues (Harvard University Press, 3rd edn, 1997); E. Fisher, ‘Opening Pandora’s Box: Contextu-

alising the Precautionary Principle in the European Union’, in E. Vos and M. Everson (eds), Uncertain

Risks Regulated (Routledge-Cavendish, 2008); C. R. Sunstein, Risk and Reason (Cambridge University

Press, 2002); C. R. Sunstein, Laws of Fear: Beyond the Precautionary Principle (Cambridge University

Press, 2005); G. Majone, ‘What Price Safety? The Precautionary Principle and its Policy Implications’,

(2002) 40 Journal of Common Market Studies 89; I. S. Forrester, ‘The Dangers of too Much Precaution’,

in M. Hoskins, D. Edward and W. Robinson (eds), A True European (Hart Publishing, 2003); N. de

Sadeleer, Environmental Principles: From Political Slogans to Legal Rules (Oxford University Press, 2002);

T. Christoforou, ‘The Origins and Content of the Precautionary Principle in European Community Law’,

in C. Leben and J. Verhoeven (eds), Le Principe de Precaution: Aspects de Droit International et Com-

munautaire (Pantheon Assas, LGDJ Diffuseur, 2002).

3See all criticism raised by Sunstein, Risk and Reason and Laws of Fear,ibid.

4See examples in Fisher et al,op cit n1supra, and in Harding and Fisher, op cit n2supra.

5Other scholars have already paved the way for this type of research on the precautionary principle. See

Fisher et al,op cit n1supra.

6SeeU.Beck,Risk Society: Towards a New Modernity (Sage, 1992).

7See analysis below at IV.

8Between 2001 and 2003.

9The European Commission announced that it would present a new proposal by the middle of July 2010,

which aims at changing the current EU framework for GMO cultivation and allowing for more Member

State autonomy to prohibit cultivation on national territories. See Commission Press Release, 2 March

2010, available at http://europa.eu/rapid/pressReleasesAction.do?reference=IP/10/222. This paper could

not consider the announced change as it went into print before the announcement of the Commission

proposal.

September 2010 Precaution in Authorisation of GM Products

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© 2010 Blackwell Publishing Ltd.

framework.10 In December 2008, following tough negotiations, the Environmental

Council presented first results of this reflection process by identifying several problem

areas in the implementation of the GMO legal framework.11 Many Member States have

issued national bans on GMOs,12 and some have even demanded a halt on authorisa-

tions until the current framework has been reformed. In a latest bid to overcome

national resistance to the EU authorisation system, the European Commission is

currently seeking to modify the legislative framework in order to grant Member States

more freedom in prohibiting GMO cultivation on their territories on grounds other

than safety or environmental concerns.13 The conditions under which the precautionary

principle is applied in these procedures are, therefore, highly politicised. Political

deadlock and delays concerning decision making are almost a daily occurrence. This

situation nourishes the criticism often voiced to reject precaution as a meaningful

concept to guide administrative decisions, namely that it just offers no guidance at all,

is paralysing and leading to the stagnation of technological innovations.14 By studying

the application of precaution in the GMO framework, I will examine the pertinence of

such criticism and, thus, contribute to the ongoing reflection process on the reform of

the framework.

The research interest to guide this examination is to determine how the precaution-

ary principle is defined under the current legal framework for GMO authorisation; and,

subsequently, to look at the way this definition is applied by EU institutions in the

practice of authorisation. The main hypothesis to be confirmed is that the GMO

legislation establishes a notion of the precautionary principle closely following the

precedent interpretation of the principle by the European Commission, which has also

been confirmed in the jurisprudence of the European Court of First Instance. Under

this interpretation, public decision making on risk-entailing products needs to have a

strong scientific basis. However, it also recognises the limitations of scientific assess-

ment when faced with new technological innovations. In situations of scientific uncer-

tainty, therefore, the EU institutions can apply the precautionary principle, which

allows them to exercise their political responsibility in taking other factors than science

into account. Understood in this way, precaution under EU law combines both a

scientific and a political rationality, and it grants the EU institutions a wide discretion

in balancing them in case-by-case decision making. Nonetheless, in the administrative

practice of GMO authorisation, the institutions fail to find such a balance. Above all,

the Commission does not seem to follow a coherent approach to precaution, falling

into the extremes of either a purely science-based decision making or a highly politi-

cised precautionary rhetoric. The failure to use the precautionary principle in a

10 See French Presidency Proposal, available at http://66.102.9.132/search?q=cache:mOddKHsaDR4J:

register.consilium.europa.eu/pdf/en/08/st07/st07128.en08.pdf+7128/08+GMOs:+Exploring+the+way+

forward&hl=en&ct=clnk&cd=1&gl=be&client=firefox-a. Another parallel reflection group was set up by

Commission President Jose Barrosso; see press article on EurActiv, available at http://www.euractiv.com/

en/environment/france-propose-concrete-solutions-eu-gmo-muddle/article-174002.

11 See the ‘Environment’ Council Conclusions on Genetically Modified Organisms from 5 December 2008,

available at http://register.consilium.europa.eu/pdf/en/08/st16/st16882.en08.pdf.

12 For lists of national measures see the Directorate General Environment website, available at http://

ec.europa.eu/environment/biotechnology/safeguard_measures.htm.

13 See Euractiv, EU to Overhaul GM Crop Approval System, 4 June 2010, available at http://

www.euractiv.com/en/cap/eu-overhaul-gm-crop-approval-system-news-494896; J. M. Barroso, Political

Guidelines for the Next Commission, 3 September 2009, p 39, available at http://ec.europa.eu/

commission_2010-2014/president/about/political/index_en.htm.

14 See Sunstein, Laws of Fear,op cit n2supra.

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