Genetic Alterations That Do or Do Not Occur Naturally; Consequences for Genome Edited Organisms in the Context of Regulatory Oversight

Custers, René; Casacuberta, Josep M.; Eriksson, Dennis; Sági, László; Schiemann, Joachim

doi:10.3389/fbioe.2018.00213

Cited by 27 publications

(17 citation statements)

References 15 publications

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“…Some of these aspects have been also pointed out, before and after the Judgment, by other scholars [see, eg, New Techniques Working Group (2012); Vives-Vallés (2016) or Purnhagen et al (2018a;2018b)]. Therefore, according to the Court, how natural those techniques may be is not determinant (Custers et al, 2019) and the techniques listed in Annex I A Part 1 do not exhaust the notion of (nonexempted) GMO of art 2(2)(a) Directive 2001/18/ EC. It is instead the inability of those techniques to fit in Annex I A Part 2 and Annex I B Directive 2001/18/EC, that matters the most (see Table 1).…”

Section: The Judgment On "Nbt"mentioning

confidence: 99%

“…Therefore, considering that a reform of Directive 2001/18/EC would be probably a lengthy process (Eriksson et al, 2018), and that such delay would have a negative impact on plant breeding (Eriksson et al, 2018), this proposal could likely work as a suitable transitory solution until a deeper reform of the EU legal regime on GMO comes. In the absence of further guidance by the CJEU on the concept of "mutagenesis" as well as of the requirements contained in Annex I B Directive 2001/18/EC, choices among the different possible interpretations (Krämer, 2015;Spranger, 2015;Jorasch, 2016;Sprink et al, 2016;Eriksson, 2018;Eriksson et al, 2018;Custers et al, 2019) will have to be made by the EU legislature. Defining in detail these choices falls completely out of the scope of the present paper; but, in the following section, the status of the most well-known breeding techniques (see Table 2) in the light of the aforementioned criteria from Directive 2001/18/EC interpreted according to the Judgment (see Table 1) is shown, further illustrating the potential reach of a limited legislative proposal like the one outlined.…”

Section: Static Interpretation Of Lawmentioning

confidence: 99%

“…Each plant breeding technique is placed on the graph according to the category it belongs to, and to its history of use: black triangles and circles represent respectively techniques that are currently under the scope of Directive 2001/18/EC and exempted according to the present study, while white triangles represent techniques which could be exempted by means of a limited legislative proposal (see Table 1 and preceding sections). Legend of the x-axis: "New Combination": creation of a genetic variation (sequence, location) that was not present initially in the genome (see Custers et al (2019); "Beyond nature": genetic "[a]teration beyond what does occur naturally by mating and/or natural recombination" (Custers et al, 2019); "[U]se" lato sensu of recNA: "use of recombinant nucleic acid molecules" (lato sensu), i.e., introduction in the plant of DNA or RNA sequences, but not insertion of heritable recombinant NA sequences into the genome (related to question "6)" from Table 1); "[U]se" stricto sensu of recNA: "use of recombinant nucleic acid molecules" (stricto sensu), i.e., stable insertion of heritable DNA sequences into the genome (related to question "6)" from Table 1).…”

Section: Analysis Of the Impact Of The Judgment On The Breeding Technmentioning

confidence: 99%

See 2 more Smart Citations

The Judgment of the CJEU of 25 July 2018 on Mutagenesis: Interpretation and Interim Legislative Proposal

Vives-Vallés

Collonnier²

2020

Front. Plant Sci.

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was optimistically awaited by breeders and supporters of agricultural biotechnology, but shortly after the press release advancing the Judgment, hope turned into frustration. Opinions on how to frame the New Breeding Techniques (NBT) in the context of Directive 2001/18/EC were issued before the Judgment, while proposals to assist the EU legislator to amend the regime driven by the Directive have been also provided afterwards by scientists and institutional bodies around the EU. However, they do not seem to have paid so much attention to the Judgment itself. This paper focuses on the Judgment. It finds out that while the impacts of the Judgment on the NBT might have been slightly overvalued, its potential negative effects on techniques of random mutagenesis and varieties breed through them have been generally underestimated if not absolutely overlooked. The analysis also shows that the Judgment does not preempt the possibility to exempt certain applications of some NBT from the scope of Directive 2001/18/EC, 2 and, in fact, ODM, SDN1, and SDN2 might be, under certain conditions, easily exempted from its scope without the need of a deep legislative revolution nor even the amendment of Directive 2001/18/EC. As regards techniques of random mutagenesis and mutant varieties bred by means of those techniques, until action is taken by Member States (if finally taken), no real limitations upon them are to be feared. However, if Member States start to consider the path opened by the CJEU, then their regulation at an EU level should be readily explored in order to avoid further negative effects on plant breeding as well as on the free movement inside the EU of those varieties and the products thereof.

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Section: The Judgment On "Nbt"mentioning

confidence: 99%

Section: Static Interpretation Of Lawmentioning

confidence: 99%

Section: Analysis Of the Impact Of The Judgment On The Breeding Technmentioning

confidence: 99%

See 1 more Smart Citation

The Judgment of the CJEU of 25 July 2018 on Mutagenesis: Interpretation and Interim Legislative Proposal

Vives-Vallés

Collonnier²

2020

Front. Plant Sci.

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“…The transfer of genes from other species has a major role in the evolution of bacteria and other unicellular organisms. It is less common in multicellular organisms, but it is known to have taken place in some crops: from Agrobacterium to sweet potato and between rice and millet [10][11][12][13][14].…”

Section: A Moratorium With a Long Shadowmentioning

confidence: 99%

A Science-Informed Ethics for Agricultural Biotechnology

2019

Crop Breed Genet Genom.

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This overview of ethical issues in plant breeding and agricultural biotechnology puts emphasis on the scientific consensus as the basis for ethical studies and discussions. An introduction is given to major ethical issues in plant breeding, including the selection of socially important breeding goals such as environmental and nutritional improvements, the measures needed to ensure that sufficient priority is given to such breeding goals, potential risks and how they should be weighed against benefits, the interpretation of the precautionary principle, intellectual property rights, and the construction of a labelling system for biotechnological products. Some of the common arguments against agricultural biotechnology are also discussed, among them arguments referring to negative effects of yield increases, the dominance of big companies, and the alleged unnaturalness of biotechnology.

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“…Besides, genetic technologies are being increasingly used in forensics (Arenas et al 2017). Recent developments in gene editing (Knott and Doudna 2018) and gene drive technologies (Collins 2018) have raised great concern about ethical and moral dimensions of genetics based technologies (Brossard et al 2019;Custers et al 2019). Thus, knowledge of genetics is essential for all citizens as it touches every individual in one or more ways.…”

Section: Introductionmentioning

confidence: 99%

Genetics on a maize cob: A teaching tool for schools

Hossain¹,

Bhat²,

Mohapatra³

et al. 2019

IJGPB

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Genetics occupies central position in biology and directly connects with all its branches. In fact, ‘life’ and ‘non-life’ meet each other in viruses and genes. Technologies emanating from genetics have had immense impact in various areas such as healthcare, agriculture, environment etc. Recent developments in stem cell biology and gene editing technologies not only promise cures for several ailments which were hitherto unthinkable but also raise concerns of irreparable harm that can result from unbridled use of these technologies. Therefore, basic understanding of genetics is necessary for all sections of society. Hence, genetics is now introduced at the school level. However, at least in the Indian context, genetics teaching in classrooms relies largely on blackboard or chart-based explanations. Unlike physics, chemistry and to some extent basic botany and zoology where models or live/preserved specimens are available to demonstrate fundamental concepts under classroom conditions, there is a dearth of material resources for teaching genetics. Maize has a long history of basic and applied genetics where a large number of well-characterized mutant stocks are available. To make learning experience interesting and engaging, we have developed maize genetic resources for use under classroom conditions. In particular, maize cob with seeds segregating for various clearly identifiable phenotypes presents unique opportunity to demonstrate basic genetic principles including statistical and population genetic concepts. In this article we describe these resources and explain how they can be used to demonstrate different concepts.

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Genetic Alterations That Do or Do Not Occur Naturally; Consequences for Genome Edited Organisms in the Context of Regulatory Oversight

Cited by 27 publications

References 15 publications

The Judgment of the CJEU of 25 July 2018 on Mutagenesis: Interpretation and Interim Legislative Proposal

The Judgment of the CJEU of 25 July 2018 on Mutagenesis: Interpretation and Interim Legislative Proposal

A Science-Informed Ethics for Agricultural Biotechnology

Genetics on a maize cob: A teaching tool for schools

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