EU 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 In that sense it is untimely and outdated.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 © The Editor(s) (if applicable) and The Author(s) 2018 The author(s) has/have asserted their right(s) to be identified as the author(s) of this work in accordance with the Copyright, Designs and Patents Act 1988. This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the pub- lisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institu- tional affiliations. Printed on acid-free paper This Palgrave Macmillan imprint is published by Springer Nature The registered company is Macmillan Publishers Ltd. The registered company address is: The Campus, 4 Crinan Street, London, N1 9XW, 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 xi