GMO Reform—The Internal Market as a Site of Diversity

This chapter examines the legal and policy changes brought about by the 2015 reform of the regulatory framework for genetically modified organisms (GMOs). It considers the extent to which Directive 2015/412, introduced to make the 2015 regulatory reform possible and to allow for national opt-outs from GMO cultivation, helps overcome the legitimacy problems of EU risk regulation. The chapter first analyses the new EU approach to GMO cultivation via Directive 2015/412 before discussing the scope of EU harmonization in the field of GMO regulation after the adoption of this Directive. It then explains the constitutional limits of Article 114 TFEU in granting Member States the right to restrict GMO cultivation and concludes by assessing the implications of the 2015 reform for free movement of GMO products as well as highlighting the reform’s shortcomings.

Differentiation through Derogations—Contesting Internal Market Discipline

This chapter examines attempts to accommodate diversity and disagreement on issues of agricultural biotechnology in the European Union through derogation mechanisms, such as those contained in Article 114 TFEU. More specifically, it considers whether derogations can lead to differentiation in EU harmonization to regulate risk in the internal market. The chapter begins with a discussion of pathways of differentiation available under EU harmonized legal frameworks, with particular emphasis on opt-out clauses under Article 114(4) and (5) TFEU and safeguard clauses in EU secondary legislation. It then explores the practical application of these clauses in the field of GMOs, showing that their strict interpretation by both the Commission and the CJEU leaves little room for differentiation and decentralized governance after GMO authorization. Finally, the chapter analyses the contestation by Member States of such strict interpretation. By continuously invoking opt-outs and safeguards, Member States have achieved de facto differentiation through disobedience.

Introduction

This book examines the legal and political context of European Union regulation of agricultural biotechnology, using the case of genetically modified organisms (GMOs) as a classic example of the challenges and convoluted problems that public regulators in general, and EU regulators in particular, face when confronted with technological risks in a globalized risk society. Focusing on the GMO reform of 2015, the book explores possible ways forward in EU risk regulation, their legitimacy, effectiveness, and their very legality under the current framework of EU internal market law. It discusses the evolution and challenges of EU risk regulation in the internal market, the administration of GMO risks, the EU legal framework for GMO authorization and its implementation in practice, and exit options from EU harmonized rules, including the 2015 opt-out reform of GMO legislation.

Conclusions

The concluding chapter to this book provides a summary of the discussions in the text thus far, which were centred around trying to reveal the broader constitutional implications of EU regulation of agricultural biotechnology as a paradigmatic example of the challenges and wicked problems that public regulators encounter when regulating technological risks in globalized risk societies. The concluding chapter also looks at lessons learned from the controversy surrounding genetically modified organisms (GMOs) and GMO failures. It finishes with the view that there is a need for a societal debate about modern agri-food production.

EU Authorization of GMOs—The Failure of Deliberation

This chapter examines the extent to which epistemic, political, and diversity challenges arising from the authorization of genetically modified organisms (GMOs) are actually met in practice. It first considers how the European Commission defines the boundaries of its discretionary power as the risk administration of the internal market by contrasting Commission decision-making with two ideal models of administrative legitimation, the control, and the deliberative model. It then looks at two controversial cases of GMO authorization that illustrate the role of the European Food Safety Authority (EFSA) in GMO risk assessment, as well as the scientification of the Commission’s risk management and the politicization of comitology decision-making. It also discusses the European Union General Court's responses to the administrative process of GMO authorizations. The chapter shows that top-down decision-making combined with scientification has contributed to the failure of deliberation in GMO risk regulation.

EU Authorization of GMOs—The Promise of Deliberation

This chapter examines epistemic and political challenges of risk regulation in the internal market of the European Union, with particular emphasis on how EU legal rules governing authorization of genetically modified organisms (GMOs) accommodate divergent national views on GMOs. It first considers the EU legal framework aimed at ensuring a safe internal market for GMOs through harmonization of national laws and the implementation of a pre-market authorization procedure through direct EU administration. It then describes two main stages of GMO authorization, both governed by decentralized transnational networks—risk assessment and risk management—and the roles of the European Food Safety Authority (EFSA) and the comitology network, respectively. The chapter concludes with an analysis of the promise of deliberation in terms of legally enabling ‘unity in diversity’ in EU authorization of GMOs.

Risk Regulation in the EU Internal Market

This chapter examines the evolution of risk regulation in the European Union since the Single European Act, with particular emphasis on how the legal and institutional context of the internal market has shaped the EU approach to risk. It first traces the emergence of supranational risk regulation in the EU with the ‘1992 project’ before discussing treaty reforms in the 1990s which strengthened the function of risk regulation as a justification of EU internal market regulation. It then considers the legitimacy dilemma faced by the EU with regard to risk regulation, focusing on the debate over the scope of political discretion that the precautionary principle should provide. It also analyses the application of the principles of risk and cost-benefit analysis to control discretion through science and economics, respectively. Finally, it explores risk regulation challenges arising from the legal-institutional, socio-economic, and cultural diversity in the Member States.

Risk as a Regulatory Idea

This chapter discusses the ideational foundations of risk and its implications for regulation. It begins with an overview of the risk discourse, focusing in particular on the ‘bright’ and ‘dark’ sides of risk. On its ‘bright’ side, risk is viewed as an achievement of modernity; on its ‘dark’ side, it is described as a new technological and potentially uncontrollable hazard. The chapter then considers the roles played by risk in regulation and explains the distinction between regulation and risk regulation, along with the challenges posed by risk to public regulation. It also examines the contestability of risk and how risk differs from uncertainty, as well as the role of science and risk management principles in stabilizing risk regulation, taking into account the use of the precautionary principle and cost-benefit analysis. Finally, it analyses the rational–instrumental model of evidence-based regulation that distinguishes epistemic authority from governance authority in risk regulation.