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Biosafety of Genome Editing Applications
In the European Union plants developed by novel genomic techniques for directed mutagenesis are have to undergo an Environmental Risk Assessment (ERA) prior to release or placing on the market. However, specific guidance for such an ERA is still lacking. In this review we discuss the limited suitability of general denominators of risk/safety to predict the risks associated with individual genome edited (GE) plants and argue that there is no safety by default for whole groups of GE applications encompassing different individual GE organisms. We suggest integrating the following two sets of considerations into the ERA to address particular characteristics of GE plants: 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.
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.
2. Genome Editing
|Box 1: Crucial aspects for a two-pronged assessment strategy to address trait-related effects and method-related modifications, respectively.|
The entry is from 10.3390/biotech10030010
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