The Swedish policy approach to directed mutagenesis in a European context

Abstract

This review describes the Swedish approach to directed mutagenesis in plants and puts it in a comparative European perspective. Directed mutagenesis is accomplished by a number of genome editing techniques; however, the legal status of these techniques and their resulting products is uncertain in the European Union (EU) as there is no political consensus on whether or not these should be regulated as genetically modified organisms (GMOs). A number of cases have developed over the past few years, putting the GMO regulatory framework to the test. These include oilseed rape developed by oligonucleotide-directed mutagenesis, Arabidopsis developed by clustered regularly interspaced short palindromic repeat-Cas9, and the case on mutagenesis for which the French Court requested a preliminary ruling from the Court of Justice of the EU. In this review, the involvement of the Swedish Government and governmental authorities in these cases is described and compared with that of other EU member states and/or EU entity statements and reports. Various approaches to the definition of recombinant nucleic acids are also discussed, as this is crucial for the EU GMO definition thus affecting the legal status of products developed by directed mutagenesis.

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

“…Indeed, after the positive expectations created by the Opinion of Advocate General Bobek (Callaway, 2018;Michalopoulos, 2018;Purnhagen et al, 2018a;Science Media Centre, 2018;Marks and Livingstone, 2019), the Judgment does not bring good news to plant breeders and the agricultural sector (Michalopoulos, 2018;Purnhagen et al, 2018a;Science Media Centre, 2018;Urnov et al, 2018). However, it needs to be noted that the approach of the Court toward NBT, aligned with "the Applicants [Confédération paysanne and Others] together with the French Government" (Opinion of Advocate General Bobek, para 87), is coherent with the European understanding of the precautionary principle in this field as well as with recital 17 Directive 2001/18/EC [anticipated by legal scholars like Krämer (2015) and Spranger (2015), and noticed also by Purnhagen et al (2018a) and Eriksson (2018)]. Certainly, the role of recital 17 Directive 2001/18/EC acknowledged by the Court contradicts the approach of the Advocate General to recital 17 Directive 2001/18/EC based on historical interpretation (cf.…”

“…The application before the Conseil d'État (the French court that referred the questions for preliminary ruling) requested to "revoke Article D. 531-2 of the Environmental Code, transposing Directive 2001/18, which excludes mutagenesis from the definition of techniques giving rise to genetic modification within the meaning of Article L. 531-1 of the code, and ban the cultivation and marketing of herbicidetolerant rape varieties obtained by mutagenesis" (Judgment, para 20). Therefore, the request was not focused on NBT but on herbicide tolerant crops (Eriksson, 2018;Leyser, 2018) and on mutagenesis (Purnhagen et al, 2018a;2018b) in a broad sense. Furthermore, as acknowledged by the Conseil d'État, "[t]he only herbicide resistant seeds registered in the common catalogue of varieties of agricultural plant species are the result of in vitro random mutagenesis.…”

“…With respect to the concept of "mutagenesis," it must be noted that the Court recognizes the vagueness of Directive 2001/18/EC (see Judgment, para 43: "by referring generally to mutagenesis, that provision does not, on its own, provide any conclusive guidance as to the types of techniques/methods [ … ]"). Indeed, Directive 2001/ 18/EC does not address the concept of "mutagenesis" (Krämer, 2015;Spranger, 2015;Purnhagen et al 2018b;Eriksson, 2018;Eriksson et al, 2018); but the Court implicitly admits that, at least some applications of these NBT, might eventually fit within the notion of "mutagenesis" from Directive 2001/18/EC (see the references to "new techniques/methods of mutagenesis" (Judgment, paras 48, 51, and 53) as well as the reasoning of the Court in paras 28-38).…”

“…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.…”

GARNet gene editing workshop

“…Stefan Jansson (Umea University, Sweden) provided the opening keynote presentation to the Bristol meeting, outlining how the Swedish Board of Agriculture does not consider GE plants any differently from those generated by conventional mutagenesis techniques (Eriksson, ). Stefan has travelled through different Nordic countries to showcase the first GE meal, and highlighted challenges that will arise if countries differently interpret the GMO directive, now encompassing GE plants.…”