scholarly journals Implications of the EFSA Scientific Opinion on Site Directed Nucleases 1 and 2 for Risk Assessment of Genome-Edited Plants in the EU

Agronomy ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 572
Author(s):  
Nils Rostoks

Genome editing is a set of techniques for introducing targeted changes in genomes. It may be achieved by enzymes collectively called site-directed nucleases (SDN). Site-specificity of SDNs is provided either by the DNA binding domain of the protein molecule itself or by RNA molecule(s) that direct SDN to a specific site in the genome. In contrast to transgenesis resulting in the insertion of exogenous DNA, genome editing only affects specific endogenous sequences. Therefore, multiple jurisdictions around the world have exempted certain types of genome-edited organisms from national biosafety regulations completely, or on a case-by-case basis. In the EU, however, the ruling of the Court of Justice on the scope of mutagenesis exemption case C-528/16 indicated that the genome-edited organisms are subject to the GMO Directive, but the practical implications for stakeholders wishing to develop and authorize genome-edited products in the EU remain unclear. European Food Safety Authority in response to a request by European Commission has produced a scientific opinion on plants developed by SDN-1, SDN-2, and oligonucleotide-directed mutagenesis (ODM) genome editing techniques. In this review, I will (1) provide a conceptual background on GMO risk assessment in the EU; (2) will introduce the main conclusions of the EFSA opinion, and (3) will outline the potential impact on the risk assessment of genome-edited plants.

2014 ◽  
Vol 5 (2) ◽  
pp. 208-212 ◽  
Author(s):  
Maria Weimer ◽  
Gaia Pisani

The EU authorization process of the insect-resistant maize 1507, branded by its developer company Pioneer-DuPont as ‘Herculex’, is perhaps the most interesting and emblematic example of the current regulatory crisis of GMO regulation in Europe. The case is particularly controversial, because it concerns the first risk assessment regarding the cultivation of a GMO issued by the European Food Safety Authority (EFSA) since its establishment in 2005. It involves a long and complicated authorization process marked by persistent contestation of both the EFSA's risk assessment and the Commission's risk management; a total of six EFSA opinions; administrative delay; and ultimately a judicial condemnation of the Commission’s behavior by the EU General Court.This case is of particular relevance, because it registers a slight yet meaningful change in the EFSA's approach to GMO risk assessment including the way the EFSA has dealt with competing scientific opinions, risks and uncertainty involved in GMO regulation. Moreover, in the field of GMO authorizations under the new legislative framework, the European Parliament (EP) has actively intervened in the administrative authorization process. It should be noted that the outcome of this process remains unclear at the moment, given that at the time of writing the Commission has not yet taken its final decision on Maize 1507. The present report aims to offer an overview of this year-long and controversial process including the approaches taken by the relevant institutions involved therein.


Agronomy ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1212
Author(s):  
Alexander Gocht ◽  
Nicola Consmüller ◽  
Ferike Thom ◽  
Harald Grethe

Genome-edited crops are on the verge of being placed on the market and their agricultural and food products will thus be internationally traded soon. National regulations, however, diverge regarding the classification of genome-edited crops. Major countries such as the US and Brazil do not specifically regulate genome-edited crops, while in the European Union, they fall under GMO legislation, according to the European Court of Justice (ECJ). As it is in some cases impossible to analytically distinguish between products from genome-edited plants and those from non-genome-edited plants, EU importers may fear the risk of violating EU legislation. They may choose not to import any agricultural and food products based on crops for which genome-edited varieties are available. Therefore, crop products of which the EU is currently a net importer would become more expensive in the EU, and production would intensify. Furthermore, an intense substitution of products covered and not covered by genome editing would occur in consumption, production, and trade. We analyzed the effects of such a cease of EU imports for cereals and soy in the EU agricultural sector with the comparative static agricultural sector equilibrium model CAPRI. Our results indicate dramatic effects on agricultural and food prices as well as on farm income. The intensification of EU agriculture may result in negative net environmental effects in the EU as well as in an increase in global greenhouse gas (GHG) emissions. This suggests that trade effects should be considered when developing domestic regulation for genome-edited crops.


BioTech ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. 10
Author(s):  
Michael F. Eckerstorfer ◽  
Marcin Grabowski ◽  
Matteo Lener ◽  
Margret Engelhard ◽  
Samson Simon ◽  
...  

An intensely debated question is whether or how a mandatory environmental risk assessment (ERA) should be conducted for plants obtained through novel genomic techniques, including genome editing (GE). Some countries have already exempted certain types of GE applications from their regulations addressing genetically modified organisms (GMOs). In the European Union, the European Court of Justice confirmed in 2018 that plants developed by novel genomic techniques for directed mutagenesis are regulated as GMOs. Thus, they have to undergo an ERA prior to deliberate release or being placed on the market. Recently, the European Food Safety Authority (EFSA) published two opinions on the relevance of the current EU ERA framework for GM plants obtained through novel genomic techniques (NGTs). Regarding GE plants, the opinions confirmed that the existing ERA framework is suitable in general and that the current ERA requirements need to be applied in a case specific manner. Since EFSA did not provide further guidance, this review addresses a couple of issues relevant for the case-specific assessment of GE plants. We discuss the suitability of general denominators of risk/safety and address characteristics of GE plants which require particular assessment approaches. We suggest integrating the following two sets of considerations into the ERA: considerations related to the traits developed by GE and considerations addressing the assessment of method-related unintended effects, e.g., due to off-target modifications. In conclusion, we recommend that further specific guidance for the ERA and monitoring should be developed to facilitate a focused assessment approach for GE plants.


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