Towards a new regulatory framework for GM crops in the European Union - Scientific, ethical, social and legal issues and the challenges ahead

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DOI: 10.3920/978-90-8686-845-2
Isbn: 978-90-8686-30-0
Publisher: Wageningen Academic Publishers
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Abstract
Aware of the significant potential of nascent biotechnologies, the European Economic Community (the predecessor to the European Union) was one of the first regions in the world to develop a regulatory framework for them. Back in the 1980s, the objective of Community member countries was to strengthen the standards of consensus and collaboration, and of environmental and health safety, as well as to promote an industrial sector of enormous potential. In spite of all effort, towards the end of the 1990s it was a widely accepted fact that a number of political and economic factors were blocking the development of biotechnology in Europe. From that crisis emerged what in some aspects is probably the most comprehensive and rigorous body of regulations for biotechnology in the world today. However, the very high technical level of those regulations did not prevent a new crisis which EU institutions aim to solve with a new regulatory framework. Thus, since March 2015, the way towards the third regulatory framework for Biotechnology in the EU has been open. Will this third regulatory framework finally offer sufficient guarantees to allow a healthy and sustainable development of biotechnology in the EU? What do we need to do so that 'third time is lucky'? In this work, a group of European and non-European experts, from different disciplines and approaches, discuss the past and the present, as well as the various possible futures, of Genetically Modified Crops in the EU.
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Aware of the significant potential of nascent biotechnologies, the European Economic
Community (the predecessor to the European Union) was one of the first regions in the world
to develop a regulatory framework for them. Back in the 1980s, the objective of Community
member countries was to strengthen the standards of consensus and collaboration, and of
environmental and health safety, as well as to promote an industrial sector of enormous
potential. In spite of all effort, towards the end of the 1990s it was a widely accepted fact that a
number of political and economic factors were blocking the development of biotechnology in
Europe. From that crisis emerged what in some aspects is probably the most comprehensive and
rigorous body of regulations for biotechnology in the world today. However, the very high
technical level of those regulations did not prevent a new crisis which EU institutions aim to
solve with a new regulatory framework. Thus, since March 2015, the way towards the third
regulatory framework for Biotechnology in the EU has been open. Will this third regulatory
framework finally offer sufficient guarantees to allow a healthy and sustainable development of
biotechnology in the EU? What do we need to do so that ‘third time is lucky’? In this work, a
group of European and non-European experts, from different disciplines and approaches,
discuss the past and the present, as well as the various possible futures, of Genetically Modified
Crops in the EU.
Keywords: biotechnology, regulatory framework, European Union, genetically modified crops
See more at: http://www.wageningenacademic.com/doi/abs/10.3920/978-90-8686-845-2
Table of contents
● Front Matter
pp. 1–15
● Three decades later, what has become of the EU Regulation of GMOs?
L. Escajedo San-Epifanio
pp. 17–22
● 1. Decision-making on genetically modified crops in the EU: finding the way out or going
even deeper into the maze?
A. López-Basaguren
pp. 23–45
● 2. Directive (EU) 2015/412 in the EU Acquis: its scope and significance
L. González Vaqué
pp. 47–59
● 3. Restrictions on GM crops in the European Union: between legislative unity and the
diversity of national positions
F.J. Romero-Caro
pp. 61–75
● 4. Labelling requirements of GM food as compared to those of other foods
A. Arroyo Aparicio
pp. 77–85
● 5. A scientific view of the current status of genetically modified crops, foods and feed in the
European Union
M. De Renobales
pp. 87–110
● 6. Franken-food or techno-fix? – Ethical issues of GMOs in Europe
M. Kaiser
pp. 111–122
● 7. Genome editing: does it move the goalposts on the GM playing field?
D.M. Bruce
pp. 123–129
● 8. Genetically modified crops in India: some observations
G. Pakky Reddy
pp. 131–140
● 9. GMO risk assessment in the EU: interplay between science, policy and politics
J.M. Casacuberta, F. Nogué, P. du Jardin
pp. 141–154
● 10. Substituting a fictional ‘science’ for public accountability: legitimacy problems of the EU’s
regulatory framework for GM products
L. Levidow
pp. 155–166
● 11. EFSA’s role as an independent authority: a comparative perspective
M. Salvador Martínez
pp. 167–182
● 12. Towards a new regulatory framework for GMOs in the EU: will it be third time lucky?
L. Escajedo San-Epifanio
pp. 183–210
  • Regulation of genome edited technologies in India
    Article
    In India, genetically modified organisms and products thereof are regulated under the "Rules for the manufacture, use, import, export and storage of hazardous microorganisms, genetically engineered organisms or cells, 1989" (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986. These Rules are implemented by the Ministry of Environment, Forest and Climate Change, Department of Biotechnology and State Governments though six competent authorities. The Rules, 1989 are supported by series of guidelines on contained research, biologics, confined field trials, food safety assessment, environmental risk assessment etc. The definition of genetic engineering in the Rules, 1989 implies that new genome engineering technologies including gene editing technologies like CRISPR/Cas9 and gene drives may be covered under the rules. The regulatory authorities if required, may also review the experiences of other countries in dealing with such new and emerging technologies.
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