The Deadlock in European GM Crop Authorisations as a Wicked Problem by Design A need for Repoliticisation of the Decision-making Process Ruth Mampuys The Deadlock in European GM Crop Authorisations as a Wicked Problem by Design A need for Repoliticisation of the Decision-making Process Ruth Mampuys Colofon Sociology, Theory and Methodology | Erasmus School of Law | 2020 Author: Ruth Mampuys Thesis design & layout: Bart Erkamp Cover design: Matteo Bettoni The Deadlock in European GM Crop Authorisations as a Wicked Problem by Design A need for Repoliticisation of the Decision-making Process Thesis To obtain the degree of Doctor from the Erasmus University Rotterdam By command of the rector magnificus Prof.dr. F.A. van der Duijn Schouten and in accordance with the decision of the Doctorate Board. The public defence shall be held on Thursday 28 january 2021 at 15:30 hrs by Ruth Mampuys born in Enschede, the Netherlands Doctoral Committee Promotors: Prof. dr. W. van der Burg Prof. dr. F.W.A. Brom Other members: Prof. dr. A. Arcuri Prof. dr. K. Millar Prof. dr. J.E.J. Prins Copromotor: Dr. L.M. Poort CONTENTS PREFACE 1 LIST OF ABBREVIATIONS AND ACRONYMS 5 CHAPTER 1 Biotechnology governance: why, how and by whom? 9 1. Introduction 11 2. Varying definitions of biotechnology and GMOs 14 3. Recurring themes in discussions about biotechnology 17 3.1 Fundamental moral perspectives 18 3.2 Attitudes on risks/benefits 19 3.3 Broader issues 20 4. Regulatory framework for GMOs in Europe 21 4.1 Prerequisite: an environmental risk and food safety assessment 24 4.2 Regulatory decision-making: Comitology 25 4.3 Decision-making in practice 30 5. Alarming studies: a case of conflict on science? 36 5.1 The Séralini case 37 5.2 EU funded research to solve the discussion 39 5.3 Regulations remain unchanged and the debate continues 42 6. Biotechnology as a wicked problem 44 6.1 Rittel & Webbers’ Wicked problems 44 6.2 Wicked problems: consequences for problem mitigation 49 7. Problem definition 53 CHAPTER 2 Technocratic, participatory and regulatory mitigation 57 strategies 1. Introduction 59 2. Mitigating the biotechnology conflict 60 2.1 Technocratic strategies 63 2.1.1 Reducing uncertainties 64 2.1.2 Use of scientific expertise 68 2.1.3 Search for technological solutions 71 2.1.4 Implications of technocratic strategies 73 2.2 Participatory strategies 74 2.2.1 Inclusion and engagement 76 2.2.2 Consensus building 77 2.2.3 Acknowledging controversies 78 2.2.4 Implications of participatory strategies 80 2.3 Regulatory strategies 81 2.3.1 An objective science-based regulatory framework 83 2.3.2 A precautionary and inclusive regulatory framework 85 2.3.3 Comitology reform: changing the rules of the game 89 2.3.4 Implications of regulatory strategies 90 3. Research question 92 4. Outline 93 CHAPTER 3 GM crop authorisations: undecisiveness caused by political 99 conflict 1. Introduction 101 2. Decision-making on GM crops 102 2.1 A brief overview of characteristics of decision-making 102 2.2 Contributions and limitations of decision-making in a scientific, 103 societal and regulatory context 2.2.1 Science does not compel action 10 6 2.2.2 Public opinion compels various and conflicting actions 107 2.2.3 Regulations do not determine the outcome: law in books # law in action 108 3. Undecisiveness about GM crops as a political conflict 110 3.1 Politics = decision-making in cases of conflict 110 3.2 Indicators of political conflict in biotechnology 112 4. Hypothesis 115 CHAPTER 4 Ethics of dissent: a plea for restraint in the scientific debate 117 about the safety of GM crops 1. Introduction 119 1.1 Alarming studies challenge the current risk governance 119 1.2 Alarming studies 12 0 1.3 Attempts to separate facts and values fuel the debate 12 2 2. Argument analysis 123 2.1 Specific arguments 125 2.1.1 Methodological arguments; the experimental design 125 2.1.2 Peer review arguments: scientific quality 12 6 2.1.3 Early-warning arguments: seriousness of the findings 12 6 2.1.4 Data availability arguments: transparency 12 7 2.1.5 Long-term effect arguments: unquestioned 12 7 2.2 Contextual arguments 12 8 2.2.1 Generalisation arguments: beyond the detail 12 9 2.2.2 Risk-benefit arguments; broader context 13 0 2.2.3 Burden-of-proof arguments: independent research 13 0 2.3 Arguments about personal credibility 131 2.3.1 Tu quoque arguments: you too 131 2.3.2 Authority arguments: expert opinion 132 2.3.3 Ad hominem arguments: playing the man 132 2.3.4 Conspiracy theory arguments: distrust the system 133 3. Dynamics of the discussion about alarming studies 134 3.1 A hotchpotch of arguments 134 3.2 Contextual arguments hamper decision making 135 3.3 Governance should acknowledge both facts and values 135 3.4 Structuring multi-level disagreements 135 4. Discussion & concluding remarks 137 4.1 Additional scientific assessment no remedy 137 4.2 Addressing wider issues of biotechnology 13 8 CHAPTER 5 Governance strategies for responding to alarming studies on 141 the safety of GM crops 1. Introduction 143 1.1 Alarming studies reignite discussion 14 4 1.2 Biotechnology debate characterised by multi-level disagreements 14 5 2. Alarming studies 14 7 3. Governance options 151 3.1 Monitoring (I) 152 3.2 Timing and opening gambit (II) 152 3.2.1 Initial response 153 3.2.2 Moratorium 154 3.3 Expertise and data (III) 15 5 3.3.1 Choice of advisory bodies 15 5 3.3.2 Coordination with national and european advisory bodies 15 7 3.4 Communication and follow-up actions (IV) 15 8 3.4.1 Communicating about the assessment of alarming studies 15 8 3.4.2 Follow-up actions 15 9 4. Discussion & concluding remarks 161 CHAPTER 6 Controversy first: factors limiting the success of Directive (EU) 169 2015/412 for national decision-making on the cultivation of GM crops 1. Introduction 171 2. The European struggle on GM crop cultivation authorisation 173 2.1 Historical overview of the legislative struggle 175 2.2 Diverging viewpoints of and within EU member states 176 3. New regulation GM crop cultivation 180 3.1 Regulatory aims of the new regulation 181 3.2 Disappointing initial results 183 4. The interactive legislative approach: An ethos of controversies 184 4.1 The Interactive legislative approach 185 4.2 An ethos of controversies 187 4.2.1 Three stages 188 5. The new Directive in light of an ethos of controversies 19 0 5.1 User factors limiting the potential success of the Directive 19 0 5.2 Design factors and the Directive as a window of opportunity 19 3 6. Conclusion 19 8 CHAPTER 7 Socio-economic Considerations in Regulatory Decision- 201 making on GM Crops 1. Introduction 203 2. Legal basis. Article 26, Cartagena Protocol on biosafety 204 3. Specifying socio-economic considerations 205 3.1 Farm-level Impacts 206 3.1.1 Income-related aspects 207 3.1.2 Health aspects 208 3.1.3 Social aspects 209 3.2 Impact of Coexistence Measures 209 3.3 Environmental Impacts 212 3.4 Impact Along the Supply Chain 213 3.5 Food Security and Consumer Level Impacts 214 4. Using SECs in regulatory frameworks 216 4.1 Measuring Socio-economic Impacts 216 4.1.1 Ex post or ex ante? 217 4.1.2 Data availability and quality 218 4.1.3 Uncertainties and limitations 219 4.2 Implementing SECs in Regulatory Frameworks 221 4.3.Harmonisation of Regulatory Frameworks 222 4.3.1 International differences 223 4.3.2 Ongoing efforts to harmonise sec implementation 224 5. Conclusions & discussion 225 CHAPTER 8 Emerging crossover technologies; how to organise a 229 biotechnology that becomes mainstream? 1. Introduction 231 2. Expansion and refinement of biotechnological techniques 231 3. Biotechnological developments accompanied by a multitude of challenges 234 4. Stimulating, regulating and debating biotech 236 5. Preparing policy: from reaction to foresight 237 6. Conclusion 240 CHAPTER 9 European decision-making on GM crop authorisations: 243 repoliticisation is evaded but needed 1. Introduction 245 2. Adjusting expectations from and within science, participatory activities 247 and regulations 2.1 Science informs expectations 247 2.2 Participation highlights values, hopes and threats of technologies 250 2.3 Regulations assign responsibilities 251 3. Political responsibilities, motivations and decision-making at EU level 253 3.1 Indicators of evasion of political conflict 253 3.2 Glyphosate authorisation: similar case, different outcome 258 3.3 The need for political decision-making on GM crops 262 3.4 Factors affecting the likelihood of repoliticisation 268 4. Conclusions & recommendations 271 SUMMARY 277 SAMENVATTING 289 PORTFOLIO 303 BIBLIOGRAPHY 309 1 PREFACE 2 3 When I started working at the Netherlands Commission on Genetic Modification (COGEM), I was aware that controversial technologies were not simply resolved through more scientific knowledge. But as with most problems, it is easier to identify what doesn’t work than to come up with strategies that might prove effective. Working for a scientific advisory body, I have experienced throughout the years how resilient certain patterns in discussions and problem solving have become. But it wasn’t until the ‘alarming study’ published by Séralini, that the apparent unresolveability really started to dawn on me. And this is where I got fascinated by the entanglement and dynamics of different factors in science, society and regulations. This dissertation analyses the role and limits of decision-making in each of these fields, with GM crops as a case study.