Maria Weimer

The Regulatory Challenge of Animal Cloning for Food: The Risks of Risk Regulation in the European Union

In this article I describe and analyse the current regulatory developments at EU level concerning the marketing of foods produced from cloned animals. As they are on the verge of commercialisation in countries outside the EU, especially in the United States, foods from cloned animals are likely to reach the European consumers in the foreseeable future. Yet at the moment there is no specific legal framework that regulates such products in the EU. The European institutions have, however, opened up a debate to determine the appropriate European policy approach towards animal cloning. The recent discussion reveals that the variety of potential yet very uncertain risks associated with animal cloning renders the drafting of suitable legislation difficult. At the same time, Europe’s regulation of food risks also entails certain regulatory risks of its own (e.g. risks of political, economic, and legal conflicts within the EU as well as with EU’s trade partners). By considering the discussion on animal cloning in the broader context of EU’s regulation of genetically modified organisms and of nanotechnology, I identify the legal and political problems of current regulatory options. I argue that such problems should be openly addressed in the regulatory discussion; it is possible for them to be minimised if lessons are drawn from previous regulatory experience.

A Crisis of Executive Managerialism in the EU: No Alternative?

Against a backdrop of rapidly evolving crisis management in the European financial and sovereign debt crisis this essay aims both to explore and to re-consider the role of law in the EU integration process: What did law accomplish? Where did it fail? What is law going to endure? What kind of future can it envisage? The essay traces back the evolution of the law-politics relationship in both EU legal scholarship and practice from the foundational period of ‘integration-through-law’ to the advent of ‘new governance’ in the EU, and finally to the current deep transformations of EU law in new economic governance and the financial crisis. The centrality of law as ‘both the object and the agent’ of European integration, and the legal enshrinement of EU’s economic constitution has recently neglected the weight of ‘the social’ in the societies of post-war Europe, a failure which was to become detrimental to both domestic social stability and the legitimacy of integration. Attempts to cure Europe’s social deficit by re-conceptualizing the notion of law as new governance have widened the theoretical perspective of EU legal scholarship. Yet new governance has not delivered more social democracy and justice in Europe in practical terms, and continues to suffer from the methodological problems of its ‘definition-by-contrast.’ These problems re-emerge in current new economic governance, which Europe’s crisis management is generating. This hybrid arrangement of hard and soft law instruments has, to date, been economically unsuccessful and socially disastrous, especially in the South of Europe. Equally disquieting, the notion of democratic law (either in traditional or experimentalist understandings) has been replaced by a praxis of authoritarian executive managerialism. The essay concludes by sketching out an alternative understanding of law-mediated legitimacy in the integration process, namely ‘conflicts-law constitutionalism’. This approach stresses the normative value of conflicts and pluralism in the process of European integration. Instead of ‘ever more Europe’ it aims to secure the existing democratic credentials of EU law, namely its ability to correct the democratic deficit of the Member States while respecting their constitutional integrity.

The Role of Law in Managing the Tension between Risk and Innovation : Introduction to the Special Issue on Regulating New and Emerging Technologies

Technological innovations are crucial drivers of economic, social, and environmental progress. While innovations lead the evolution of our societies and permeate all domains of human life, they also pose significant risks both to humans and the environment. Law and regulation are expected to enable innovation, while at the same time protecting society from unintended consequences. However, assessing new technological risks confronts deep uncertainty and limited knowledge. In contrast to simple risks (e.g. car accidents), technological risks (such as risks stemming from new health technologies, nanotechnology, biotechnology, or robotics as discussed in this special issue) cannot be calculated according to traditional technocratic models, namely as a statistically foreseeable function of probability and effects. It is widely recognised that regulating new and emerging technologies is challenging for law due to problems of uncertainty and limited knowledge in the assessment and management of technological risks. To address this challenge it is crucial to study the ways in which law and regulation can successfully respond and adapt to technological progress.

Risk Regulation and Deliberation in EU Administrative Governance — GMO Regulation and its Reform

The article analyses the problems of EU risk regulation of genetically modified organisms (GMOs) through the lens of deliberative theories of EU law and governance, such as deliberative supranationalism and experimentalist governance. Previous research had suggested that the GMO issue is not conductive to deliberation within EU institutions because of its high politicisation. This article argues that another equally salient factor is the scientification of the GMO authorisation process. Scientification stands for the Commissions overreliance on epistemic legitimacy as the basis for risk management. Given the deadlock of comitology in this field, scientification is exacerbated by a reversion to top-down regulation by the Commission. As a result, political responsibility for GMO authorisations gets lost. This article argues that both scientification and politicisation are mutually accelerative processes ultimately leading to a break down of dialogue at the EU level. This contradicts the assumption that deliberation is fostered by technocratic ‘behind closed door’ decision-making. In the GMO case, the top-down imposition of epistemic authority has only increased politicisation contributing to the de-legitimation of all EU institutions involved in GMO regulation. The recent EU reform on national opt-outs is not sufficient to address this problem. A successful reform should mitigate the negative effects of both politicisation and scientification.

The EU adventures of 'Herculex': Report on the EU authorization of the genetically modified maize 1507

The EU authorization process of the insect-resistant maize 1507, branded by its developer company Pioneer-DuPont as ‘Herculex’, is perhaps the most interesting and emblematic example of the current regulatory crisis of GMO regulation in Europe.1 The case is particularly controversial, because it concerns the first risk assessment regarding the cultivation of a GMO issued by the European Food Safety Authority (EFSA) since its establishment in 2005.2 It involves a long and complicated authorization process marked by persistent contestation of both the EFSA’s risk assessment and the Commission’s risk management; a total of six EFSA opinions; administrative delay; and ultimately a judicial condemnation of the Commission’s behavior by the EU General Court. This case is of particular relevance, because it registers a slight yet meaningful change in the EFSA’s approach to GMO risk assessment including the way the EFSA has dealt with competing scientific opinions, risks and uncertainty involved in GMO regulation. Moreover, in the field of GMO authorizations under the new legislative framework, the European Parliament (EP) has actively intervened in the administrative authorization process. It should be noted that the outcome of this process remains unclear at the moment, given that at the time of writing the Commission has not yet taken its final decision on Maize 1507. The present report aims to offer an overview of this year-long and controversial process including the approaches taken by the relevant institutions involved therein.

Reconciling Regulatory Space with External Accountability through WTO Adjudication – Trade, Environment and Development

This paper argues in favor of broadening the trade and environment debate in the WTO to include a developmental perspective. It takes the US-Tuna II dispute between the United Sates and Mexico as an example to show the complex intertwinement between economic, environmental and developmental issues. WTO litigation involving environmental regulation also touches upon the issue of global justice and the power asymmetries structurally embedded in the global economy. The recognition of the WTO as a legitimate global institution depends on its ability to reconcile respect for the right to regulate with the need to give due regard to the interests and concerns of foreign constituencies affected by domestic regulation, thereby ensuring external accountability. The paper applies this framework by analyzing the legal reasoning of the Appellate Body in US-Tuna II (in both the original and the compliance report). It shows that the Appellate Body deferred to a stringent and unilateral standard of the United States while imposing only minimal accountability vis-a-vis Mexico by requiring that the US standard be applied ‘even-handedly.’ The paper criticizes that ‘even-handedness’ does not necessarily improve regard for affected foreigners. A comparison with the Appellate Body’s reasoning in US-Shrimp shows that reflexivity-inducing other-regarding obligations require a higher burden of justification from the regulating state, especially in disputes between developed and less developed states.

Differentiated Integration or Uniform Regime? National Derogations from EU Internal Market Measures

The EU has most frequently resorted to harmonisation as a model to achieve its in-ternal market. This contribution examines the dynamics of legal differentiation in EU’s internal market law laid down in Article 114 TFEU and secondary laws. It con-cludes that there has been a modest number of invocations of the derogation possibili-ties under Article 114 (4) and (5) TFEU and the safeguard clauses. The low number may be due to the fact that may both the Commission and the Courts have a very rig-id reading of the procedure whilst the grounds for invocation are very limited. This low number nevertheless does not automatically imply that Member States agree with the level of protection laid down in the EU’s harmonisation measures or that the opt out mechanisms are not relevant. Derogation mechanisms may play an important role in the negotiations of the level of protection in the draft legislative acts. This study moreover reveals that the derogation mechanisms may be important devices of regulatory adjustment and learning in the fields of public health and environmental protection in the EU. They ultimately may rather strengthen the uniformity of regula-tory requirements in the EU internal market instead of leading to regulatory diversity.

It's the politics, stupid. Or is reality more complex?

Reality is complex, and often does not lend itself to generalization or simplifying explanations. Yet at the same time, explaining reality often requires the shaping of notions and concepts of it through generalization and the reduction of complexity. This tension between complexity and particularity on the one hand and generalization and the search for abstracting explanatory patterns on the other is beautifully illustrated by two recently released publications on precaution and risk regulation in the United States and Europe, namely “The Politics of Precaution” by David Vogel and “The Reality of Precaution” edited by Jonathan Wiener, Michael Rogers, James Hammitt, and Peter Sand. This essay first reviews both books in isolation, and then juxtaposes them, while discussing their relation, relative merits and achievements.

The Right to Adopt Post-Market Restrictions of Genetically Modified Crops in the EU – A Shift from De-Centralised Multi-Level to Centralised Governance in the Case of GM Foods

Case Note on Court of Justice of the European Union, Joined Cases C-58/10 to C-68/10 Monsanto Sas and Others.