The meaningless pseudo-category of "GMOs": The trouble with the "new techniques" for genetically modifying crops demonstrates the illogical process-based definition of GMOs in EU regulation (original) (raw)
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The trouble with the "new techniques" for genetically modifying crops demonstrates the illogical process-based definition of GMOs in EU regulation Giovanni Tagliabue I 10. Miller H (2010) The regulation of agricultural biotechnology: science shows a better way. New Biotechnol 27: 628-634
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In this review, current EU GMO regulations are subjected to a point-by point analysis to determine their suitability for agriculture in modern Europe. Our analysis concerns present GMO regulations as well as suggestions for possible new regulations for genome editing and New Breeding Techniques (for which no regulations presently exist). Firstly, the present GMO regulations stem from the early days of recombinant DNA and are not adapted to current scientific understanding on this subject. Scientific understanding of GMOs has changed and these regulations are now, not only unfit for their original purpose, but, the purpose itself is now no longer scientifically valid. Indeed, they defy scientific, economic, and even common, sense. A major EU regulatory preconception is that GM crops are basically different from their parent crops. Thus, the EU regulations are "process based" regulations that discriminate against GMOs simply because they are GMOs. However current scientific evidence shows a blending of classical crops and their GMO counterparts with no clear demarcation line between them. Canada has a "product based" approach and determines the safety of each new crop variety independently of the process used to obtain it. We advise that the EC rewrites it outdated regulations and moves toward such a product based approach. Secondly, over the last few years new genomic editing techniques (sometimes called New Breeding Techniques) have evolved. These techniques are basically mutagenesis techniques that can generate genomic diversity and have vast potential for crop improvement. They are not GMO based techniques (any more than mutagenesis is a GMO technique), since in many cases no new DNA is introduced. Thus they cannot simply be lumped together with GMOs (as many anti-GMO NGOs would prefer). The EU currently has no regulations to cover these new techniques. In this review, we make suggestions as to how these new gene edited crops may be regulated. The EU is at a turning point where the wrong decision could destroy European agricultural competitively for decades to come.
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Because of the complexity of many environmental problems, we need their holistic assessment. That is why, in such a matter, a multidisciplinary approach is necessary. It has also been the guiding line for this present study on the European regulation of the GMOs, crossing the different points of view of a lawyer and a biologist. According to the European legislation, molecular biology and dissemination of genetically modified organisms are mainly regulated by two major directives of the European Parliament and of the Council: Directive 2009/41/EC on the contained use of genetically modified microorganisms, and Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms. Two different approaches are possible to analyse those directives and suggest possible improvements.
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The European Commission's assessment and approval process for genetically modified (GM) crops has resulted in only two GM crop varieties being licensed for cultivation in the European Union, one of which has been withdrawn. Unable to define GM crops satisfactorily, the European Commission has fallen back on a definition based on process. The shortcomings of this approach are all too clear as the Commission grapples with the advent of genome editing. This has led to a long and damaging delay in the Commission issuing an opinion on how genome-edited crops should be regulated. At the same time, national bans imposed by member states on GM crops without any evidence of safety concerns have been legalized. The Commission also faces the prospect of assessing an increasing number of GM and genome-edited crops with deliberately altered composition. In this article, the operation of regulations covering GM crops in the European Union and the effect they have had on the development of pla...
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The EU regulatory framework on GMOs has always been featured by a high degree of har-monisation and centralisation, resulting in a loss in its States' regulatory power. However, the EU harmonisation process has gone through several controversies over the years; as a consequence, the EU institutions have increasingly striven to support the pressing requests of Member States with a view towards granting the latter greater room to manoeuvre and decide as regards GMOs cultivation, starting from coexistence concerns. This article briefly analyses the changes recently introduced by means of Directive 2015/412/EU as regards the cultivation of GMOs, from the point of view of the evolution of the EU regulatory framework and national attitudes towards the risks and benefits linked to biotechnology derived products and their production. According to the new Directive 2015/412, amending Directive 2001/18/EC on the deliberate release into the environment of GMOs, Member States are entitled to enact measures restricting or banning the cultivation of GM crops on their territory complying with several so called " compelling grounds ". In the light of the diverse nature of such reasons, and considering the hostility expressed by Member States towards GMOs over the years, some doubts arise as to whether the exercise of the new regulatory powers by Member States will comply with the 'EU acquis'. What is certain is that today, after more than a decade since the big reform of 2001-2003, the EU GMO regime is still one of the much-contested policy sectors in the EU.
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