EU Regulation of GMOs

EU Regulation of GMOs

Author: Maria Lee

Publisher: Edward Elgar Publishing

Published: 2009-01-01

Total Pages: 297

ISBN-13: 184844396X

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Lee s book is a valuable addition to the literature for those wishing to broaden their understanding of the range of legal disciplines involved in GMO regulation. Tracey Epps, European Review of Agricultural Economics Maria Lee s work is a successful attempt to illustrate the big legal issues behind the regulation of genetically modified organisms (GMOs). This study, which is thorough and well documented, is particularly welcomed in view of the need for a dialogue between different legal specialisms for which GMOs are a relevant area of research. . . [The] book provides a very interesting and insightful examination of the legal problems raised by GMOs. I would warmly recommend its reading to academics and practitioners who are interested in European risk regulation law, environmental law, biotechnology and trade law. Sara Poli, European Law Review Genetically modified organisms (GMOs) are an extraordinary innovation. They raise great expectations of economic prosperity and improved capacity to address pressing problems of poverty and environmental degradation, whilst simultaneously raising great concerns about the type of social and physical world they promise. Finding space in regulation to consider the full range of issues provoked by GMOs is a huge challenge. This book explores the EU s elaborate regulatory framework for GMOs, which extends far beyond the process of their authorisation (or not) for the EU market, embracing disparate legal disciplines including intellectual property, consumer protection and civil liability. The regulation of GMOs also highlights questions of EU legitimacy in a context of multi-level governance, both internally towards national and local government, and externally in a world where technologies and their regulation have global impacts. This book will be of interest to academics and students in both law and social sciences, as well as practising lawyers and policy makers. It addresses questions that are significant for those involved in environmental or food issues, as well as specialists in GMOs.


Biotechnology Regulation and GMOs

Biotechnology Regulation and GMOs

Author: Naveen Thayyil

Publisher: Edward Elgar Publishing

Published: 2014-03-28

Total Pages: 285

ISBN-13: 1783473886

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This thoughtful book explores how EU law treats serious disagreements about the development and use of a radically new technology like genetic modification. Relevant EU laws are examined to analyse the room available, or possible, for public participat


EU Policy-Making on GMOs

EU Policy-Making on GMOs

Author: Mihalis Kritikos

Publisher: Springer

Published: 2017-11-02

Total Pages: 352

ISBN-13: 113731446X

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This book examines the development and implementation of the EU’s legislative framework on the commercial release of GMO products as a case study of social regulation operating within a predominantly technical framework. The analysis and findings are based on an extensive documentary analysis and interviews with regulators, risk assessors, public interest groups and biotechnology experts at the national and European levels. It argues that in the case of the EU biotechnology framework, the particular institutional settings created for the formulation and interpretation of its provisions have been of decisive importance in elaborating a proceduralised ‘science-based’ prior authorization scheme as the preferred framework for granting commercial permits. This interdisciplinary work will appeal to EU lawyers, decision-makers and risk managers as well as academics working in the fields of EU studies, politics, law, risk governance sociology of science/risk and technology assessment. The book is based on a PhD thesis that was awarded with the 2008 UACES Prize for the Best Thesis in European Studies in Europe and with the EPEES 1st Prize for the Best Thesis written by a Greek Researcher between 2004 and 2008.


Risk Regulation in the Internal Market

Risk Regulation in the Internal Market

Author: Maria Weimer

Publisher: Oxford University Press

Published: 2019-03-19

Total Pages: 360

ISBN-13: 019104718X

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This book offers a topical inquiry into the legal and political limits of EU 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 intertwinement between environmental, public health, economic and social concerns in risk regulation. Weimer analyses the drawbacks of the EU approach to agricultural biotechnology showing that its reductionism, i.e. the narrow understanding of GMO risks 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 re-think EU internal market law, including the way in which it manages the tensions between unity and diversity, and between social and economic concerns. This text offers fresh and original insights into how far the EU can go in harmonizing regulatory approaches to risk. At the same time, it proposes new ways of re-thinking EU risk regulation to make it more responsive to different perspectives on risk and technology. A unique feature of this book is that it contributes to various strains of scholarship including risk regulation, internal market law, public administration, and studies of governance and regulation, as well as connecting these themes to broader debates about the legitimacy of European integration and new ways of differentiated integration. As a result it assists in re-imagining the EU internal market and its regulation as a site of diversity.


Genetically Modified Food

Genetically Modified Food

Author: Marie Kreipe

Publisher: Diplomica Verlag

Published: 2010

Total Pages: 97

ISBN-13: 3842850131

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The controversial issue of genetically modified (GM) food is discussed in this book. While the United States (US) is a strong supporter of GM technology having adopted a rather lax regulation of trade with GM products, the European Union (EU) is representing a sceptical position towards this new technology and has even imposed a de facto moratorium on further approval of GM products from 1998 to 2004. The purpose of this book is an extensive analysis of the current status on risks and benefits of genetically modified organisms (GMOs) and a suggestion on how an appropriate regulation of GM products could be derived. Potential guidelines are provided for policy formulation both in a qualitative and in a quantitative dimension. The US is applying the principle of substantial equivalence, which means that GM products are in their substance identical to products produced by conventional methods. Therefore, no new regulations are necessary for the trade with GM products. In contrast, the European Union (EU) disagrees that GM products are equivalent to their conventional counterparts due to the different production process. Instead, the EU refers to the precautionary principle in its GMO policy, meaning that trade with GM products should be restricted until it will be proven that no additional risks are implied by the use of these products. The divergence of opinions about the right policy to regulate GM products has significant impacts on trade flows and welfare effects. The US and the EU have already tried to resolve their dispute before the World Trade Organization (WTO). Relevant laws of the General Agreement on Tariffs and Trade (GATT) and the WTO are presented as well as indications for a potential consensus.


When Cooperation Fails

When Cooperation Fails

Author: Mark A. Pollack

Publisher: OUP Oxford

Published: 2009-05-21

Total Pages: 464

ISBN-13: 0191568902

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The transatlantic dispute over genetically modified organisms (GMOs) has brought into conflict the United States and the European Union, two long-time allies and economically interdependent democracies with a long record of successful cooperation. Yet the dispute - pitting a largely acceptant US against an EU deeply suspicious of GMOs - has developed into one of the most bitter and intractable transatlantic and global conflicts, resisting efforts at negotiated resolution and resulting in a bitterly contested legal battle before the World Trade Organization. Professors Pollack and Shaffer investigate the obstacles to reconciling regulatory differences among nations through international cooperation, using the lens of the GMO dispute. The book addresses the dynamic interactions of domestic law and politics, transnational networks, international regimes, and global markets, through a theoretically grounded and empirically comprehensive analysis of the governance of GM foods and crops. They demonstrate that the deeply politicized, entrenched and path-dependent nature of the regulation of GMOs in the US and the EU has fundamentally shaped negotiations and decision-making at the international level, limiting the prospects for deliberation and providing incentives for both sides to engage in hard bargaining and to "shop" for favorable international forums. They then assess the impacts, and the limits, of international pressures on domestic US and European law, politics and business practice, which have remained strikingly resistant to change. International cooperation in areas like GMO regulation, the authors conclude, must overcome multiple obstacles, legal and political, domestic and international. Any effective response to this persistent dispute, they argue, must recognize both the obstacles to successful cooperation, and the options that remain for each side when cooperation fails.


Genetically Engineered Crops

Genetically Engineered Crops

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-01-28

Total Pages: 607

ISBN-13: 0309437385

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Genetically engineered (GE) crops were first introduced commercially in the 1990s. After two decades of production, some groups and individuals remain critical of the technology based on their concerns about possible adverse effects on human health, the environment, and ethical considerations. At the same time, others are concerned that the technology is not reaching its potential to improve human health and the environment because of stringent regulations and reduced public funding to develop products offering more benefits to society. While the debate about these and other questions related to the genetic engineering techniques of the first 20 years goes on, emerging genetic-engineering technologies are adding new complexities to the conversation. Genetically Engineered Crops builds on previous related Academies reports published between 1987 and 2010 by undertaking a retrospective examination of the purported positive and adverse effects of GE crops and to anticipate what emerging genetic-engineering technologies hold for the future. This report indicates where there are uncertainties about the economic, agronomic, health, safety, or other impacts of GE crops and food, and makes recommendations to fill gaps in safety assessments, increase regulatory clarity, and improve innovations in and access to GE technology.


EU Food Law and Policy

EU Food Law and Policy

Author: Debra Holland

Publisher: Kluwer Law International B.V.

Published: 2004-01-01

Total Pages: 254

ISBN-13: 9041121242

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To all appearances, Europe is at present undergoing a crisis of consumer confidence with respect to the food industry. Recent food scares, the genetically-modified food controversy, a growing public awareness of the environmental footprint of intensive farming methods, and a perceived threat to the deeply-held European cultural values surrounding diet and cuisine all have combined to expose the vulnerability of consumers in the very ordinary activity of purchasing food. Although the creation of the European Food Safety Authority (EFSA) in February 2002 can be viewed as an EU response to this crisis, it in fact represents an inevitable milestone in a body of food-specific European legislation and case law that has been growing for many years. The EFSA does, however, clearly establish food law as an autonomous branch of EU law. This is the first book to survey and analyse this body of law in depth, drawing together the relevant laws and cases and taking stock of the trends and likely future developments in this dynamic and emotive area of law and policy. elucidates the scope of European food law by investigating several avenues and facets of the subject, including the following: its underpinnings in Article 3 of the EC Treaty, on the free movement of goods;the principle of mutual recognition among Member States;case law developments concerning composition of foodstuffs, labelling, sales promotion, advertising, and other aspects of food production and distribution;aims and policies of the January 2000 White Paper on Food Safety issued by the European Commission;appropriate hygiene standards; andauthorisation and labelling of GMOs. Because food is such a central and essential element in society, food law has far-reaching economic, social, and environmental consequences. And because Europe's new food safety regime is intended, by an extraordinary unanimity of Member States and major political groups, to be the most up-to-date and effective in the world, a broad range of legal practitioners and scholars, social scientists, and policymakers will greatly appreciate this thoroughgoing and insightful analysis.


Regulation of Genome Editing in Plant Biotechnology

Regulation of Genome Editing in Plant Biotechnology

Author: Hans-Georg Dederer

Publisher: Springer

Published: 2019-08-16

Total Pages: 372

ISBN-13: 3030171191

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This book provides in-depth insights into the regulatory frameworks of five countries and the EU concerning the regulation of genome edited plants. The country reports form the basis for a comparative analysis of the various national regulations governing genetically modified organisms (GMOs) in general and genome edited plants in particular, as well as the underlying regulatory approaches.The reports, which focus on the regulatory status quo of genome edited plants in Argentina, Australia, Canada, the EU, Japan and the USA, were written by distinguished experts following a uniform structure. On this basis, the legal frameworks are compared in order to foster a rational assessment of which approaches could be drawn upon to adjust, or to completely realign, the current EU regime for GMOs. In addition, a separate chapter identifies potential best practices for the regulation of plants derived from genome editing.