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2019 | OriginalPaper | Buchkapitel

1. Introduction: Regulation of Plants Derived from Genome Editing—What Lessons To Be Learned from Other Countries?

verfasst von : Hans-Georg Dederer, David Hamburger

Erschienen in: Regulation of Genome Editing in Plant Biotechnology

Verlag: Springer International Publishing

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Abstract

The advent of genome editing in plant breeding and the resulting blurring of the boundaries between natural and artificially induced genetic modifications present regulators worldwide with new challenges. In such a time of regulatory uncertainty, or dispute over how to regulate genome edited plants, legislators are well advised to seek external guidance on how this issue could be addressed appropriately. Since genome edited organisms pose similar challenges to regulatory systems around the world, it seems sensible to study the practices of other jurisdictions in order to draw lessons for one’s own regulatory efforts. To be able to choose from a diverse selection of regulatory approaches, countries with differing attitudes towards genetically modified plants were chosen as research objects. Broadly speaking the studied jurisdictions can be divided into those which embrace the cultivation of GMOs (Argentina, Canada and the USA), those which are reluctant adopters of GMOs (Australia and Europe) and a de facto absolute abstainer from GM crop cultivation (Japan). Based on a comparative analysis of the regulatory frameworks and an identification of possible best practices, the conclusion is made that a consistent regulatory regime should be product-based, i.e. the risk regulation should be triggered by a plant’s traits. From a procedural point of view, an obligatory upstream procedure should be used for channelling the respective plant into the relevant regulatory framework. This process can be further catalysed by a voluntary early consultation procedure. Within such a framework the one-door-one-key principle should apply, which means that all relevant authorizations are granted upon a single application.
Fußnoten
1
Cf. Sprink et al. (2016), p. 1497; Voigt and Klima (2017), p. 321; Schenkel and Leggewie (2015), p. 265.
 
2
Cf. Sprink et al. (2016), pp. 1494–1495; Globus and Qimron (2018), pp. 1293–1294.
 
3
As is the case in the European Union (EU) with regard to the Court of Justice of the European Union’s judgment of 25 July 2018 (CJEU, C-528/16, Confédération paysanne et al.). Cf. European Court of Justice (2018).
 
4
For a detailed illustration of those countries’ varying attitude towards GM cultivation see Chap. 8, Sect. 8.​2.​1.
 
5
Ministerio de Agricultura, Ganadería y Pesca (2015). For detailed information on the content and working of this decree see Chap. 2, Sect. 2.​3.​2.
 
6
The situation seems at a first glance similar to the European approach. However, since the EU has the competence to shape the legal framework for marketing of GMO based on its own volition, the European situation is in this concrete instance more comparable to that of a federal state—even though the EU is not a state entity in legal terms.
 
7
Directive 94-08, Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits, Sec. 1.
 
8
European Court of Justice (2018).
 
9
European Court of Justice (2018), para. 29.
 
10
Cf. Chap. 5, Sect. 5.​3.​2. The same view is held by Seitz (2018), p. 763.
 
11
See for example Lappin (2018), Neslen (2018), Callaway (2018), Stokstad (2018) and Science Media Centre (2018).
 
12
See Chap. 8, Fig. 8.​5.
 
13
Cf. for this paragraph Sato (2015), 6, 15–16.
 
14
There does not exist a uniform definition of “best practices” which is agreed upon. For different definitions see for example Bretschneider et al. (2005), p. 309; Bendixsen and de Guchteneire (2003), pp. 678–679.
 
15
“Emerging best practices” describes a process or method for which there is only a low degree of scientific evidence to qualify as a best practice. In the case of a “promising best practice” the existing quantitative and qualitative data is elevated to a moderate level. An “evidence-based best practice” is supported by a convincing and strong set of scientific evidence regarding its general effectiveness and efficiency. For a more detailed illustration of different best practice categories and sources of best practice evidence see Spencer et al. (2013); Bhatta (2002), p. 102; Moore and Browne (2017), p. 385; Canadian Homelessness Research Network (2013), p. 7; Myers et al. (2006), p. 374.
An example for a widely adopted and well-regarded best practice in the realm of GMO regulation are the international frameworks for risk assessment. Cf. Cartagena Protocol on Biosafety to the Convention on Biological Diversity, 2226 U.N.T.S. 208, 39 ILM 1027, UN Doc. UNEP/CBD/ExCOP/1/3 42; UNEP International Technical Guidelines for Safety in Biotechnology; OECD Safety Considerations for Biotechnology 1992. See also the OECD Consensus Documents on Safety Assessment of Transgenic Organisms.
 
16
Overman and Boyd (1994), p. 69.
 
17
Bardach and Patashnik (2016), p. 125.
 
18
For an overview see Hamburger (2018).
 
19
See Chap. 8, Table 8.​5.
 
20
Purnhagen and Wesseler (2016), p. 151.
 
21
Purnhagen and Wesseler (2016), p. 151.
 
22
For a detailed illustration of that principle’s application in the EU see van der Meulen and Yusuf (2014).
 
23
For more on this issue see Voigt and Klima (2017), p. 335.
 
24
Dederer (1998), pp. 32–49.
 
25
Herring (2008), p. 459; Herring and Paarlberg (2016), p. 398.
 
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Metadaten
Titel
Introduction: Regulation of Plants Derived from Genome Editing—What Lessons To Be Learned from Other Countries?
verfasst von
Hans-Georg Dederer
David Hamburger
Copyright-Jahr
2019
DOI
https://doi.org/10.1007/978-3-030-17119-3_1

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