title: New GMO regulations for old: Determining a new future for EU crop biotechnology.
abstract: 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 We advise that theECre-writes it outdated regulations and moves toward such a product based approach.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.
authors.affiliation: a Research Director (retired), Institut National de la Recherche Agronomique (INRA) , Versailles , France.
authors.forename: John
authors.initials: J
authors.lastname: Davison
authors.affiliation: b Former Director of the Botanical Garden, University of Bern , Bern , Switzerland.
authors.forename: Klaus
authors.initials: K
authors.lastname: Ammann
mesh_terms: D001709:Biotechnology / Q000379:methods / Q000639:trends; D002170:Canada; D018556:Crops, Agricultural / Q000235:genetics*; D005062:European Union; D059022:Food Safety; D030841:Food, Genetically Modified / Q000592:standards*; D005544:Forecasting; D033161:Government Regulation; D006801:Humans; D030821:Plants, Genetically Modified
keywords: GMOs; NBTs; anti-GMO; gene editing; new breading methods; regulation