GMO authorisations and the Aarhus Regulation: Paving the way for precautionary GMO governance?
| Author | Giulia Claudia Leonelli |
| Published date | 01 August 2019 |
| DOI | 10.1177/1023263X19855081 |
| Date | 01 August 2019 |
| Subject Matter | Articles |
Article
GMO authorisations and the
Aarhus Regulation: Paving the
way for precautionary GMO
governance?
Giulia Claudia Leonelli*
Abstract
This article endeavours to assess whether existing case law under the Aarhus Regulation has
opened up any opportunities for civil society to challenge the decision that, in the face of
scientific uncertainty, genetically modified organism risks meet the intended European Union
levels of health and environmental protection. Against this backdrop, it seeks to establish
whether the actions of non-governmental organizations under the Aarhus Regulation have
resulted in any meaningful review of the Commission’s exercise of its discretion, in accor-
dance with the overarching tenets of the precautionary principle and the aim of a high level of
health and environmental protection. Upon an in-depth analysis of the recent TestBioTech
cases, the article puts forward an argument for different evidentiary rules and a different
standard of review in Aarhus Regulation case law, advocating a clearer distinction between
‘standard’ action for annulment and annulment of a decision to reject a request for internal
review. This is argued to be the only way forward to breathe some life into the Aarhus
Regulation’s provisions, ensuring some scrutiny of the level of protection achieved and
nudging the Commission to take the precautionary principle seriously in the genetically
modified organi sm field.
Keywords
Judicial review, Aarhus Regulation, GMOs, precautionary principle
* Lecturer in Law, Birkbeck College, University of London,London, United Kingdom; Research Fellow at the Transnational
Law Institute, School of Law, King’s College London, London, United Kingdom.
Corresponding author:
Giulia Claudia Leonelli, Birkbeck College, University of London,London, United Kingdom.
E-mails: giuliaclaudia.leonelli@gmail.com; g.leonelli@bbk.ac.uk
Maastricht Journal of European and
Comparative Law
2019, Vol. 26(4) 505–523
ªThe Author(s) 2019
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DOI: 10.1177/1023263X19855081
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MJ
1. The Aarhus Regulation, the notion of socially acceptable risk
and genetically modified organisms
An evidence-based and a socially acceptable risk approach coexist under European Union (EU)
risk regulation.
1
Under the former approach, the results of technical risk assessment directly feed
into risk management; little or no room for man oeuvre is thus left for risk managers to take
scientific uncertainty, the precautionary principle
2
or any of the other legitimate factors at stake
3
into consideration. The specific values at issue, the pervasiveness of the potential effects, the
intended level of protection in the field, public opinion or the availability and efficacy of risk
management measures have no role to play; factors such as the advantages and disadvantages
associated with the decision to run uncertain risks and their distribution across different constitu-
encies are equally irrelevant.
4
Evidence-based risk regulation in the EU draws on the dominant
transnational legal narrative, whereby uncertain risks ought to be run as long as they have not been
scientifically proven and established.
5
Under a socially acceptable risk approach, in contrast, the decision to run uncertain risks and the
enactment of risk management measures result from an iterative evaluation of all factors at stake.
6
At the heart of this approach is the question of whether uncertain risks are worth running in the
light of scientific uncertainty, the intende d level of protection pursued, the public healt h and
environmental values at issue as well as all relevant advantages, disadvantages and distributional
stakes.
7
Under this approach, the presumption that uncertain risks ought to be run unless they have
been positively proven does not apply. Rather, risk managers are called upon to make a convincing
case that a product or process meets the intended level of protection and is safe enough for the
ensuing risks to be socially acceptable and worth running, taking all factors into due consideration.
1. G.C. Leonelli, ‘The Fine Line Between Procedural and Substantive Review in Cases Involving Complex Technical-
Scientific Evaluations: Bilba´ına’, 55 Common Market Law Review (2018), p. 1217-1250; G.C. Leonelli, ‘The Gly-
phosate Saga and The Fading Democratic Legitimacy of European Union Risk Regulation’, 25 Maastricht Journal of
European and Comparative Law (2018), p. 1-25. For a different perspective on the coexistence of an ‘evidence-based’
and ‘precautionary’ soul under EU risk regulation see A. Alemanno, ‘Risk Versus Hazard and The Two Souls of EU
Risk Regulation: A Reply to Ragnar Lofstedt’, 2 European Journal of Risk Regulation (2011), p. 169-172.
2. See first and foremost Article 191(2) TFEU and Communication from the Commission on the Precautionary Principle,
COM(2000) 1 final, p. 12, 13 and 16.
3. On the role of other legitimate factors (‘OLFs’) in EU risk regulation, see for instance Recital 19 and Articles 5, 6(2),
6(3) and 7(2) of the General Food Law (‘GFL’), Regulation No. 178/2002/EC of the European Parliament and of the
Council of 28 January 2002 Laying Down the General Principles and Requirements of Food Law, Establishing the
European Food Safety Authority and Laying Down Procedures in Matters of Food Safety [2002] OJ L 31/1(The General
Food Law). Article 6(3) maintains that ‘risk management shall take into account the results of risk assessment ( ...),
other factors legitimate to the matter under consideration, and the precautionary principle where the conditions laid
down in article 7(1) are relevant ( ...)’.
4. More specifically, under evidence-based approaches to risk regulation, cost-benefit analysis (CBA) heuristics apply to
the phase of risk management. Any detailed analysis of this aspect would go beyond the limited scope of this article; for
more information see G.C. Leonelli, ‘GMO Risks, Food Security, Climate Change and the Entrenchment of Neo-Liberal
Legal Narratives’, 9 Transnational Legal Theory (2013), p. 302-315.
5. In this perspective see M. Lee, ‘Beyond Safety? The Broadening Scope of Risk Regulation’, 62 Current Legal Problems
(2009), p. 242-285; G.C. Leonelli, 9 Transnational Legal Theory (2013); and G.C. Leonelli, The Transnational Law and
Governance of GMOs (forthcoming), under peer review, on file with author.
6. On ‘linear’ and ‘iterative’ approaches to risk regulation see E. Fisher, ‘Framing Risk Regulation: A Critical Reflection’,
4European Journal of Risk Regulation (2013), p. 125-132.
7. See G.C. Leonelli, 25 Maastricht Journal of European and Comparative Law (2018).
506 Maastricht Journal of European and Comparative Law 26(4)
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