i V.R. Krishna Iyer. The Majesty of the Judiciary. Universal; New Delhi, 2007 pp 27-28. ii Dhananjoy Das v District Magistrate, Darrang AIR 1982 SC 1315 iii Termes de la ley; West Ham v Lles 8 App cas 388. iv Understanding Common Law Legislation- Francis
Keywords:
EUROPEAN COURT, GENE EDITING, JUSTICEAbstract
Science and the law have been in a fight over which one should lead the people. On July 25, 2018, the European Court of Justice interpreted 2001 European Union directive language and its scope about organisms obtained by means of technique/methods of mutagenesis. However, within 17 years scientists have invented new genome manipulation techniques. Environmentalists and anti-OGM claim that the result of NPBTs is the same as genesis techniques in which DNA is inserted or deleted. On the other hand, in the US deletion mutagenesis, in which leaves no evidence behind, is treated different from insertion mutagenesis, which is considered in the same manner as traditional genetic engineering. However, the benefits such as more quantity of GMO food in less time and fewer costs outweigh the environmental damages stemming from the overuse of herbicides. Furthermore, the use of herbicide is unavoidable even with the organisms obtaining from the mutagenesis, which the EU excludes from regulation. This note will elaborate on the narrow concept of ECJ on the mutagenesis technique and considering them as GMOs with respect to EU regulation. The note concludes that most of the experts agree that gene editing techniques pose no important risk to the environment and human health; therefore, the ECJ opinion of 2018 is likely a step back for biotechnology science and the profits that it brings to society, especially to GMOs and NPBTs.
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References
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ii CRISPR stands for clustered regularly interspaced short palindromic repeats is a technique, which edits DNA
sequences in the genomes, also named as cut-paste-replace technique. See generally Anthony King, What the ECJ
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an ensemble of innovative genetic technologies which include gene editing tools that allow mutation, insertion,
deletion, or substitution of DNA at targeted sites and the most famous is CRISPR.)
iv Unlike transgenesis, mutagenesis is a set of techniques that make it possible to alter the genome of a living
species without the insertion of foreign DNA. Mutagenesis techniques have made it possible to develop seed
varieties that are resistant to selective herbicides. See generally Court of Justice of the European Union, PRESS
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vi Court of Justice of the European Union, PRESS RELEASE No 111/18, Luxembourg, July 25, 2018
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xiii Nina Federoff, former President AAAS says, "This is probably the safest technology that human beings have
ever invented," however, I think that nothing is absolute in science and that would be a faulty logic.
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xv See also Arango Isaza et al., Combating a Global Threat to a Clonal Crop: Banana Black Sigatoka Pathogen
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xvi Pursuant to Article 3(1) of the directive: “This Directive shall not apply to organisms obtained through the
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xvii Paula Fernandez-Wulff, Why and How Spain Became the EU’s Top Grower of GMOs, OUR WORLD, UNITED NATIONS
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xviiiArticle L. 531-1 of the French Environmental Code defines a genetically modified organism as an “organism
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xix Opinion of Advocate General, Case C-528/16 (January 18, 2018) at 2.
xxId. at 15.
xxiId. at 5.
xxii Article of this Directive provides: (2) “genetically modified organism (GMO)” means an organism, with the
exception of human beings, in which the genetic material has been altered in a way that does not occur naturally
by mating and/or natural recombination. Within the terms of this definition: (a) genetic modification occurs at
least through the use of the techniques listed in Annex I A, part 1; (b) the techniques listed in Annex I A, part 2,
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their contact with and to provide a high level of safety for the general population and the environment.”
xxiii GMO Directive regulates the GMOs' release into the environment and into the EU market. Also, the Directive
regulates the traceability, labeling, and monitoring of all GMOs in EU members. However, this Directive treats
mutagenesis differently as organisms obtained from specific techniques of GMOs.
xxiv Article 4(4) of Directive 2002/53 provides, "In the case of a genetically modified variety within the meaning
of Article 2(1) and (2) of Directive 90/220/EEC, the variety shall be accepted only if all appropriate measures
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xxviii Id. at 20.
xxix “This Directive should not apply to organisms obtained through certain techniques of genetic modification
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xxxviii See supra note 2.
xxxix Except they will need to be plant molecular biologists and not farmers.
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lviId.
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lxv See supra note 48 at 6.
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