EU Authorization of GMOs—The Promise of Deliberation

Author(s):  
Maria Weimer

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.

Author(s):  
Anne Saab

This chapter examines comparative approaches to risk assessment and regulation of genetically modified organisms (GMOs). It first provides a brief background on the emergence, increased use, and controversy surrounding GMOs as well as the important legal questions and complexities they raise before discussing the legal approaches used to assess and regulate risks associated with GM foods, labelling of GM foods, and the application of intellectual property rights (IPRs) to GMOs. In particular, it considers risk assessment in the United States and in the European Union, focusing on the precautionary approach versus the permissive approach. It also compares process regulation and product regulation for regulating the risks posed by GMOs in the United States and the European Union, along with risk assessment and regulation in Brazil, China, and Costa Rica. Finally, it analyses the legal framework for IPRs as they apply to GMOs and comparative approaches to patenting GMOs.


Author(s):  
Maria Weimer

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.


Author(s):  
Maria Weimer

This book offers a topical inquiry into the legal and political limits of European Union regulation in the field of risk and new technologies surrounded by techno-scientific complexity, uncertainty, and societal contestation. It uses agricultural biotechnology as a paradigmatic example to illustrate the complex intersection between environmental, public health, economic, and social concerns in risk regulation. The text analyses the drawbacks of the European Union approach to agricultural biotechnology showing that its reductionism, that is, the narrow understanding of the risks associated with genetically modified organisms (GMOs) as well as the exclusion of broader societal concerns related to environmental and social sustainability, has undermined both the legitimacy and effectiveness of EU regulation in this area. Resistance to this approach, however, has also triggered legal innovations prompting us to rethink EU internal market law, including the way in which it manages the tensions between unity and diversity, and between social and economic concerns. This book examines how far the EU can go in harmonizing regulatory approaches to risk. At the same time, it proposes new ways of rethinking EU risk regulation to make it more responsive to different perspectives on risk and technology.


2020 ◽  
Vol 8 (5) ◽  
pp. 72
Author(s):  
Kai Liu

In a context of the emerging risks that may lead to the high speed rail accidents and so the deaths, the question is to know what the roles of different actors prescribed in the legal system and what instruments have been established, and whether the legal framework is sufficient to promote risk assessment. This research studied the European Union legal system and pointed out its experience that could be enlighting as well as its weaknesses.  


elni Review ◽  
2005 ◽  
pp. 22-37
Author(s):  
Lars Koch ◽  
Nicholas A. Ashford

This article analyzes the role of different kinds of information for minimizing or eliminating the risks due to the production, use, and disposal of chemical substances and contrasts it with present and planned (informational) regulation in the United States and the European Union, respectively. Some commentators who are disillusioned with regulatory approaches have argued that informational tools should supplant mandatory regulatory measures unflatteringly described as “command and control.” Critics of this reformist view are concerned with the lack of technology-innovation forcing that results from informational policies alone. We argue that informational tools can be made more technology inducing – and thus more oriented towards environmental innovations – than they are under current practices, with or without complementary regulatory mechanisms, although a combination of approaches may yield the best results. The conventional approach to chemicals policy envisions a sequential process that includes three steps of (1) producing or collecting risk-relevant information, (2) performing a risk assessment or characterization, followed by (3) risk management practices, often driven by regulation. We argue that such a sequential process is too static, or linear, and spends too many resources on searching for, or generating information about present hazards, in comparison to searching for, and generating information related to safer alternatives which include input substitution, final product reformulation, and/or process changes. These pollution prevention or cleaner technology approaches are generally acknowledged to be superior to pollution control. We argue that the production of risk information necessary for risk assessment, on the one hand, and the search for safer alternatives on the other hand, should be approached simultaneously in two parallel quests. Overcoming deficits in hazard-related information and knowledge about risk reduction alternatives must take place in a more synchronized manner than is currently being practiced. This parallel approach blurs the alleged bright line between risk assessment and risk management, but reflects more closely how regulatory agencies actually approach the regulation of chemicals. These theoretical considerations are interpreted in the context of existing and planned informational tools in the United States and the European Union, respectively. The current political debate in the European Union concerned with reforming chemicals policy and implementing the REACH (Registration, Evaluation and Authorization of Chemicals) system is focused on improving the production and assessment of risk information with regard to existing chemicals, although it also contains some interesting risk management elements. To some extent, REACH mirrors the approach taken in the U.S. under the Toxics Substances Control Act (TSCA) of 1976. TSCA turned out not to be effectively implemented and provides lessons that should be relevant to REACH. In this context, we discuss the opportunities and limits of existing and planned informational tools for achieving risk reduction.


2010 ◽  
Vol 1 (2) ◽  
pp. 123-135 ◽  
Author(s):  
Liana Giorgi ◽  
Annuradha Tandon

This article reviews the policy process of setting maximum levels for aflatoxins by the European Union and the Codex Alimentarius Commission. The differences between the two regulatory organizations and the difficulties entailed in the alignment of the two standards are illustrative of the problems inherent in risk analysis in the food sector. This case is also instructive with respect to the way in which scientific evidence is used when deciding on appropriate food safety standards.


2019 ◽  
Vol 26 (1) ◽  
pp. 92-115
Author(s):  
A. Aslı Bilgin

The foundation of European Integration is based on economic objectives from the beginning of the 1950s. The founding treaties did not include provisions regarding minority rights. Minority rights have been a foundational value since the entry into force of the Lisbon Treaty, but there is no legislation related to minority rights or internal minority policy at the European Union (eu) level, because of the absence of competence given to eu institutions. This study analyses how issues relating to minority protection are handled vis-a-vis internal market objectives under eu law in the light of primary, secondary and eu case-law. While determining the legal framework on minority rights in the eu, not only the impact of the case-law of the cjeu on minority protection, but also the possibility of the cjeu’s power to establish an internal minority policy and the Member States’ approaches to an internal minority policy have been taken into consideration.


Author(s):  
Maria Weimer

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.


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