Table Of ContentEU
Policy-Making
on GMOs
The False Promise of Proceduralism
MIHALIS KRITIKOS
EU Policy-Making on GMOs
‘A critical analysis of the complex scientific, legal, and ethical challenges faced by
the decision-making bodies of the European Union in governing the planting of
GM crops, the book’s analytical sophistication and wealth of detail make[s] it into
a fascinating case-study of the politics of risk management in Europe.’
—David Vogel Solomon P. Lee Chair in Business Ethics, Haas Business
and Public Policy Group, University of California, Berkeley, USA
‘Mihalis Kritikos’ book shows an unparalleled knowledge of the technological fea-
tures of agricultural biotechnology, its legal debate and the wider theoretical
debates. It brings these seamlessly together in a way that will command the atten-
tion of policy-makers and academics not just in this field but of that of wider EU
risk regulation. It is a must-read.’
—Damian Chalmers the National University of Singapore and the
London School of Economics and Political Science, UK
‘This book goes to the heart of how the European Union agreed rules on GMO
crops. Inside the “box”, the institutional setting matters: it favours scientific exper-
tise and it leads the EU Commission into drawing false dichotomies, with conse-
quences for the effectiveness and legitimacy of the licensing regime. The analysis is
high quality: showing empirical rigour and conceptual relevance. It prompts a
more critical reflection on the EU regulatory model, with implications that go
beyond this sector.’
—Kevin Featherstone Head of the European Institute;
Eleftherios Venizelos Professor of Contemporary Greek
Studies and Professor of European Politics, the London
School of Economics and Political Science, UK
‘Agri-food biotechnology is a segment of risk politics of exemplary practical and
theoretical importance. The analyses offered are utmost care and in their discus-
sion of the multi-faceted policy debates, legal and transdisciplinary discussion
which have to cope with the intricacies of risk debates and the challenges of legiti-
mate transnational, in particular European governance.’
‘[This book] arrives at a time in which emotion trumps deliberation, facts are dis-
counted, expertise and practical reason meet with contempt. In that sense it is
untimely and outdated. Precisely for the same reason it is to be welcomed and
praised. This study explains the complexity of our products and their regulatory
domestication. It represents the type of argumentation which is at risk and deserves
to be defended.’
—Christian Joerges Professor of Law and Society,
Hertie School of Governance, Berlin
‘This book is a masterful analysis of how existing institutions shape the regulation
of new technologies. Its lessons are relevant for many other fields beyond agricul-
tural biotechnology. Its scholarly rigor and originality are matched by its practical
utility for policy makers. I highly recommend it for anyone perplexed by the
European Union’s complex biosafety regime.’
—Calestous Juma FRS, Belfer Center for Science and International Affairs,
Harvard Kennedy School, Harvard University, USA
‘Mihalis Kritikos has provided us with an insightful and timely portrayal and analy-
sis of the EU’s recent history of the evolution of EU Directives addressing the
regulation of the cultivation of GMO crops culminating in the recent 2015 direc-
tive. He exposes the EU’s reliance on a naïve classic separation of risk assessment
from risk management which allowed the EU Commission to fashion its regula-
tory policy based on traditional expert scientific opinion devoid of any application
of the precautionary principle which would have otherwise opened the determina-
tion of risk to alternative scientific interpretations, as well as consideration of
non-scientific input from important non-expert stakeholders. The treatise has
implications beyond the cultivation of GMO crops and is therefore a definite
“must read”. The EU Commission’s approach may well have long-term conse-
quences, as applied for example to other applications of genetic engineering or to
considerations of emerging technologies such as nanotechnology. The work is a
welcome addition to the literature on critical environmental policy discourse.’
—Nicholas A. Ashford Professor of Technology and Policy,
Massachusetts Institute of Technology (MIT), USA
‘Dr. Kritikos has written the most detailed and rigorous account to date that
unravels the European Union’s approach to developing a framework on behalf of
the EU federation of 28 nations, for regulating genetically engineered crops, which
the author rightly describes as “neither linear nor without contradictions”.’
—Sheldon Krimsky Lenore Stern Professor of Humanities
and Social Sciences, Tufts University, USA
Mihalis Kritikos
EU Policy-Making
on GMOs
The False Promise of Proceduralism
Mihalis Kritikos
Law
Vrije Universiteit Brussel
Brussels, Belgium
Disclaimer
The author is publishing this book in a personal capacity and the views expressed
constitute his personal opinion.
ISBN 978-0-230-29994-8 ISBN 978-1-137-31446-8 (eBook)
DOI 10.1057/978-1-137-31446-8
Library of Congress Control Number: 2017947190
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United Kingdom
For my parents for making me what I am; their devotion, support and
guidance has always been quiet and assure.
For Sonia, my everything, and Ioannis, Iasonas and Sofia, who taught me
to love and be loved.
F
oreword
The distinguishing characteristic of this intellectually provocative and fas-
cinating work is its capacity to surprise. Very much in the logic of a Russian
doll, or matyroshka, Kritikos’s account manages to operate simultaneously
at the level of two discrete, in many ways conflicting, but ultimately com-
plementary realities, which he systematically and with impressive consis-
tency juxtaposes with one another. The reader is intrigued and delighted
to find numerous intellectual arguments challenging the dominant para-
digm underpinning the European Union’s (EU’s) decision-making sys-
tem, as it applies to a specific policy sector, and the regulatory schemes
issuing from it. These are hidden within a thorough and compelling analy-
sis of a highly technical subject—the regulation of genetically modified
organisms (GMOs) in the EU.
To be properly understood and appreciated, however, the study should
be read at multiple levels of analysis. At the initial, more ‘technical’ level,
the author’s core argument, shorn to its essentials, raises two central issues
or questions. The first concerns whether and under what conditions GMO
crops are to be grown and supplied to consumers. The author’s central
point here is that, in relevant decision-making contexts, the role of sci-
ence, as exemplified by expert knowledge, needs to be carefully examined
and properly balanced with broader considerations, capable of taking into
account social, political, and ethical parameters affecting the decision-
making process.
The second question arises from the way the regulatory scheme con-
cerning the issue at hand has been set up. In the author’s view, the scheme
contains two distortions: (a) decision-making has been structured as
vii
viii FOREWORD
case-by-case authorisation, in which only scientific data are relevant; and
(b) the accuracy of the scientific data cannot be tested adequately because
of the information asymmetry resulting from the fact that the relevant data
are supplied by enterprises seeking to obtain authorisation.
Structuring the argument in such a fashion facilitates the transition to a
second level of analysis, in which the author argues that, ‘contrary to its
defined objectives, the apparently proceduralised model of Community
regulation, based on a decentralised and open-ended risk analysis struc-
ture, is in fact limited in [its capacity to] accommodat[e] “alternative”
conceptualisations of what constitutes “acceptable risk” in the field of
genetic engineering’.
What Kritikos refers to as ‘“alternative” conceptualisations of what con-
stitutes “acceptable risk”’ introduces an epistemological dimension into
his analysis centring on the very definition and understanding of risk, the
demarcation of the conceptual boundaries separating risk assessment from
risk management, as well as, more broadly, the entire decision-making
process linked to risk employed by the Commission and its agencies. In
this context, which constitutes a third level of analysis, the author engages
in some of his more trenchant criticisms of the existing arrangements and
sets forth his own proposals for moving the procedural and regulatory
platforms for shaping regulatory policies beyond the dominant paradigm
of what he terms ‘one-dimensional’ approaches to risk, based on ‘transna-
tional, standardised and homogeneous views concerning the safety and
compatibility of GM crops in favour of more context-specific approaches’
and interpretations capable of taking into account, and of being more
sensitive to, local conditions, ‘subnational concerns, regional particulari-
ties and non-expert judgments’ that would enhance the Commission’s
capacity to reflect ‘upon the limitations of science as a novel and uncertain
regulatory field’.
This, finally, ushers us to the fourth and final level of analysis, which,
by uncovering the last matyroshka hidden inside the author’s overall
argument, brings to the forefront his conviction that, far from being a
technical matter capable of being addressed and resolved at the level of
experts and of science, the policy issues revolving around the regulation
of GMOs constitute a deeply political matter, which needs to be addressed
at the political level and not be confined to the administrative one. As he
puts it, ‘[d]irectly addressing the inherent inadequacies of science to
offer all-encompassing, objective information for regulatory purposes
FOREWOR D ix
can, potentially, lead to the formulation of more transparent and account-
able risk analysis practices’.
By insisting on the political dimension of the issue at hand, and by call-
ing for the establishment of an alternative culture of governance capable
of providing space for complementing and reinforcing existing arrange-
ments by means of enhanced public participation and deliberation, the
author deliberately inscribes his argument in the logic exemplified by the
Treaty of Lisbon, which, in its relevant provisions, seeks to enhance
the role of citizens in the formulation of policy at the level of the EU.
In this context, the ultimate value of this work and the substantive ser-
vice it offers its potential audiences—lay and expert—lies not so much in
the accuracy or non-accuracy of the solutions proposed or of the recom-
mendations put forward, but rather in the very questions raised and in the
quality of its argumentation—a quality, let it be added, which earned the
author the United Kingdom University Association for Contemporary
European Studies Award for best PhD dissertation in European Studies for
the year 2008. In framing his subject in this way, the author succeeds in
shifting the ground of the relevant policy debates by steering them in the
direction of enhanced transparency and accountability. In this era of the
Lisbon Treaty and of heightened concerns regarding how to promote,
enhance, and maintain relations of trust with citizens, it behoves the
Commission and Parliament to seize on the opportunity thus provided and
to actively as well as genuinely engage with the arguments put forward by
Kritikos in favour of a new paradigm for the EU’s decision-making process
that, in addition to science-based findings, will be able to take account of
the political, social, and ethical parameters of policy formulation.
In putting forward such an alternative vision, the author has creatively
combined his role as a policy expert with that of an active citizen. For that
alone we are all very much in his debt.
European Ombudsman 2003–2013 P. Nikiforos Diamandouros
A
cknowledgements
Many days have been spent daydreaming about writing these words.
During this long journey of research, I have incurred many debts. As the
book was based on my doctoral work, I must firstly thank the Greek State
Scholarships Foundations (IKY) and the Department of Law of the
London School of Economics (LSE) for their generous support.
The book would never have started without the encouragement and
inspiration from several people who ‘forced’ me to fill in the book pro-
posal form and bring this piece of work into light: Nicola Countouris,
Giorgos Evangelopoulos, Nikos Farantouris, Maria Gavouneli, Panagiotis
Grigoriou, Marios Haintarlis, Assimakis Komninos, Panos Koutrakos,
Vassilis Monastiriotis, Efthymios Papastavridis, Glykeria Sioutis and George
Terzis, stood by me in different ways during this long route, sometimes
beyond the call of duty.
Looking back, I remain immensely grateful to Damian Chalmers and
Veerle Heyvaert, who guided me through the process of conceptualizing,
researching, and organizing this piece of work. Without their critical read-
ing, combined with their inspiring trust in the project, it would have many
more defects. While reworking major parts of the book, Dorian Karatzas
as a mentor and friend (more like a brother) offered me valuable advice,
provided with abundance, when needed, and took a keen and genuine
interest in my academic development. I cannot forget friends who went
through hard times together, cheered me on, and celebrated each accom-
plishment: Leonidas, Akis, Thodoris, George and Konstandinos.
I am most grateful to all the academic scholars who warmly endorsed
this work for their time and generosity, and especially to Professor
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