EU Authorization of GMOs—The Failure of Deliberation

2019 ◽  
pp. 115-142
Author(s):  
Maria Weimer
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Genetically Modified Organisms ◽  
The European Union ◽  
Discretionary Power ◽  
Top Down ◽  
Risk Regulation ◽  
Administrative Process ◽  
Gmo Risk Assessment

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

2019 ◽  
pp. 86-114
Author(s):  
Maria Weimer
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Risk Management ◽  
Genetically Modified Organisms ◽  
Legal Framework ◽  
Internal Market ◽  
The European Union ◽  
Risk Regulation ◽  
Legal Rules ◽  
Unity In Diversity

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.

Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU

BioTech ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. 10
Author(s):  
Michael F. Eckerstorfer ◽  
Marcin Grabowski ◽  
Matteo Lener ◽  
Margret Engelhard ◽  
Samson Simon ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Genome Editing ◽  
Genetically Modified Organisms ◽  
Unintended Effects ◽  
The European Union ◽  
Gm Plants ◽  
European Court ◽  
Assessment Approach ◽  
Deliberate Release ◽  
Specific Assessment

An intensely debated question is whether or how a mandatory environmental risk assessment (ERA) should be conducted for plants obtained through novel genomic techniques, including genome editing (GE). Some countries have already exempted certain types of GE applications from their regulations addressing genetically modified organisms (GMOs). In the European Union, the European Court of Justice confirmed in 2018 that plants developed by novel genomic techniques for directed mutagenesis are regulated as GMOs. Thus, they have to undergo an ERA prior to deliberate release or being placed on the market. Recently, the European Food Safety Authority (EFSA) published two opinions on the relevance of the current EU ERA framework for GM plants obtained through novel genomic techniques (NGTs). Regarding GE plants, the opinions confirmed that the existing ERA framework is suitable in general and that the current ERA requirements need to be applied in a case specific manner. Since EFSA did not provide further guidance, this review addresses a couple of issues relevant for the case-specific assessment of GE plants. We discuss the suitability of general denominators of risk/safety and address characteristics of GE plants which require particular assessment approaches. We suggest integrating the following two sets of considerations into the ERA: considerations related to the traits developed by GE and considerations addressing the assessment of method-related unintended effects, e.g., due to off-target modifications. In conclusion, we recommend that further specific guidance for the ERA and monitoring should be developed to facilitate a focused assessment approach for GE plants.

INTRODUCTION: HEALTH TECHNOLOGY ASSESSMENT AND THE EUROPEAN UNION

2000 ◽  
Vol 16 (2) ◽  
pp. 299-302 ◽  
Author(s):  
David Banta ◽  
Wija Oortwijn
Keyword(s):  
Public Health ◽  
Decision Making ◽  
European Union ◽  
Health Technology Assessment ◽  
European Commission ◽  
Technology Assessment ◽  
Health Technology ◽  
The European Union ◽  
European Level

Health technology assessment (HTA) has become increasingly important in the European Union as an aid to decision making. As agencies and programs have been established, there is increasing attention to coordination of HTA at the European level, especially considering the growing role of the European Union in public health in Europe. This series of papers describes and analyzes the situation with regard to HTA in the 15 members of the European Union, plus Switzerland. The final paper draws some conclusions, especially concerning the future involvement of the European Commission in HTA.

The terroir of bureaucratic practice: Everyday life and scholarly method in the study of policy

2018 ◽  
Vol 37 (4) ◽  
pp. 617-633 ◽  
Author(s):  
Merje Kuus
Keyword(s):  
Decision Making ◽  
Everyday Life ◽  
Lived Experience ◽  
Cultural Geography ◽  
The European Union ◽  
Policy Studies ◽  
Policy Practice ◽  
Michel De Certeau ◽  
Do So

This article seeks to connect political geographic scholarship on institutions and policy more firmly to the experience of everyday life. Empirically, I foreground the ambiguous and indeterminate character of institutional decision-making and I underscore the need to closely consider the sensory texture of place and milieu in our analyses of it. My examples come from the study of diplomatic practice in Brussels, the capital of the European Union. Conceptually and methodologically, I use these examples to accentuate lived experience as an essential part of research, especially in the seemingly dry bureaucratic settings. I do so in particular through engaging with the work of Michel de Certeau, whose ideas enjoy considerable traction in cultural geography but are seldom used in political geography and policy studies. An accent on the texture and feel of policy practice necessarily highlights the role of place in that practice. This, in turn, may help us with communicating geographical research beyond our own discipline.

Knowledge-Intensive Entrepreneurship in the Economy of the European Union

2014 ◽  
pp. 43-52
Author(s):  
G. Olevsky
Keyword(s):  
Decision Making ◽  
Knowledge Production ◽  
The European Union ◽  
Quality Of Information ◽  
The Matrix ◽  
Knowledge Intensive ◽  
Knowledge Intensive Entrepreneurship ◽  
The Eu

The article studies role of knowledge in business and analyzes tendencies of the formation of knowledge-intensive entrepreneurship (business) in the EU. It is shown that for small and medium-sized enterprises prospects of expansion of knowledge production and sales of products and services are associated with the internationalization of business. The author proposes the matrix of decision-making entrepreneurs, depending on the completeness and quality of information at their disposal on the market.

A Brief Comment on Science-based Risk Regulation Within the European Union

2012 ◽  
Vol 3 (1) ◽  
pp. 86-91 ◽  
Author(s):  
Barbara Stibernitz
Keyword(s):  
Decision Making ◽  
European Union ◽  
Central Position ◽  
The European Union ◽  
Risk Regulation ◽  
General Acceptance ◽  
Scientific Experts ◽  
Democratic Control ◽  
The One

Nowadays as political decision making involves such a huge range of complex matters, scientific experts have become more and more involved in European risk regulation. The support by so-called independent experts may, on the one hand, be seen as a guarantee of rational decision making, increasing the quality of decisions as well as the general acceptance of all people affected. On the other hand, the number of expert groups, scientific committees and agencies helping the Commission in fulfilling its duties is vast and confusing.In addition, scientific advisory bodies often face the burden of unrealizable independence, as well as a lack of transparency and democratic control. This article sums up the central position of science-based risk regulation within the European Union (EU), referring to the necessity for expert opinion as well as to consequent problems concerning the involvement of these experts in risk regulatory actions.

From Mad Cows to GMOs: The Side Effects of Modernization

2016 ◽  
Vol 7 (3) ◽  
pp. 517-531 ◽  
Author(s):  
Patricia A. Stapleton
Keyword(s):  
Side Effects ◽  
Cultural Context ◽  
Genetically Modified Organisms ◽  
Risk Society ◽  
The Political ◽  
The European Union ◽  
Risk Regulation ◽  
Social Reaction ◽  
Subsequent Response ◽  
The Impact

Ulrich Beck's Risk Society: Towards a New Modernity provides a lens through which we can analyze contemporary debates over risk regulation of agricultural biotechnology. This article establishes the political and cultural context into which genetically modified organisms (GMOs) were introduced in the European Union, by reviewing the HIV-contaminated blood scandal, mad cow crisis, and dioxin contamination episode. These public health and food safety scandals exemplify the side effects of modernization as outlined by Beck. Beck also predicted the development of a solidarity arising from the public's anxiety over the global distribution of modernization's risks. The impact of these cases on risk regulation illustrates the political and social reaction to the invisible, global risks of late modernity. The subsequent response to this reaction in European risk regulation further demonstrates the tension between a globalizing market and public anxiety in risk society.

When Science Meets Responsibility: The Major Risks Commission and the L’Aquila Earthquake

2014 ◽  
Vol 5 (2) ◽  
pp. 146-158 ◽  
Author(s):  
Marta Simoncini
Keyword(s):  
Risk Assessment ◽  
Risk Communication ◽  
Future Development ◽  
Seismic Activity ◽  
Research Question ◽  
L’Aquila Earthquake ◽  
Civil Protection ◽  
Risk Regulation ◽  
Main Research

This article aims to analyse the role of law in the identification of the responsibility domain of ‘regulatory science’ (Jasanoff, 1990) within the risk regulatory process. The main research question is therefore,what kindof relationshipbetween science andpolicy-making lawshould design in risk regulation.In order to address this issue, this contribution focuses on the recent verdict of the Tribunal of L’Aquila. After the earthquake occurred in L’Aquila on the 6th April 2009, six Italian scientists that had participated in the Major Risks Commission's meeting have been condemned for the multiple manslaughter of 29 people who were among the 309 victims of the earthquake, ‘for having assessed the risks related to seismic activity in the L’Aquila territory in an inaccurate, generic and ineffective way’ and for having provided ‘information which was imprecise, incomplete and contradictory as to the nature, the causes and the hazardousness and on the future development of the seismic activity’.As far as risk assessment and risk communication are concerned, firstly the tasks of the Major Risks Commission under the Italian Civil Protection law will be analysed. Against this backdrop, the issues related to this expert body's responsibility will be addressed and the gaps in the current accountability regime will be pointed out.

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