Abstract
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.
Highlights
The ruling of the European Court of Justice (ECJ) in the case C-528/16 delivered in July 2018 clarified that plants developed by novel genomic techniques for directed mutagenesis are considered genetically modified organisms (GMOs) in the EU in accordance with Directive 2001/18/EC and Regulation (EC) on the deliberate release and placing on the market of 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
Based on the discussion of the suitability of general denominators for risk/safety, we argue that a case-specific risk assessment within the current regulatory frameworks for GMOs should be conducted
Summary
The ruling of the European Court of Justice (ECJ) in the case C-528/16 delivered in July 2018 clarified that plants developed by novel genomic techniques for directed mutagenesis are considered genetically modified organisms (GMOs) in the EU in accordance with Directive 2001/18/EC on the deliberate release and placing on the market of GMOs. Against the background of the different national systems for the regulation of GMOs, some countries, including a number of Latin American countries, have already introduced supplementary legislation to facilitate the determination of the regulatory status of individual GE applications with regard to the existing biosafety laws [18]. Some countries, such as Australia, have decided to exclude some types of GE applications from their regulatory framework for GMOs [19]. We note that considerations regarding the risk assessment for GE plants will inform the debate on options for further regulation [20]
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