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Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU

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Umweltbundesamt–Environment Agency Austria (EAA), Landuse & Biosafety Unit, Spittelauer Lände 5, 1090 Vienna, Austria
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Ministry of Climate and Environment, Department Nature Conservation, GMO Unit, Wawelska 52/54, 00-922 Warszawa, Poland
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ISPRA (Italian Institute for Environmental Protection and Research), Department for Environmental Monitoring and Protection and for Biodiversity Conservation, Via Vitaliano Brancati, 48, 00144 Roma, Italy
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Federal Agency for Nature Conservation, Division of Assessment of GMOs/Enforcement of Genetic Engineering Act, Konstantinstr. 110, 53179 Bonn, Germany
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Federal Office for the Environment (FOEN), Biotechnology Section, Soil and Biotechnology Division, BAFU, CH-3003 Bern, Switzerland
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Author to whom correspondence should be addressed.
Academic Editor: Vasiliki Mollaki
BioTech 2021, 10(3), 10; https://doi.org/10.3390/biotech10030010
Received: 14 May 2021 / Revised: 10 June 2021 / Accepted: 15 June 2021 / Published: 22 June 2021
(This article belongs to the Special Issue Biotechnology and Bioethics)
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. View Full-Text
Keywords: novel genomic techniques; genome editing; CRISPR/Cas; plant modification; GMO; environmental risk assessment; biosafety regulation novel genomic techniques; genome editing; CRISPR/Cas; plant modification; GMO; environmental risk assessment; biosafety regulation
MDPI and ACS Style

Eckerstorfer, M.F.; Grabowski, M.; Lener, M.; Engelhard, M.; Simon, S.; Dolezel, M.; Heissenberger, A.; Lüthi, C. Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU. BioTech 2021, 10, 10. https://doi.org/10.3390/biotech10030010

AMA Style

Eckerstorfer MF, Grabowski M, Lener M, Engelhard M, Simon S, Dolezel M, Heissenberger A, Lüthi C. Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU. BioTech. 2021; 10(3):10. https://doi.org/10.3390/biotech10030010

Chicago/Turabian Style

Eckerstorfer, Michael F., Marcin Grabowski, Matteo Lener, Margret Engelhard, Samson Simon, Marion Dolezel, Andreas Heissenberger, and Christoph Lüthi. 2021. "Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU" BioTech 10, no. 3: 10. https://doi.org/10.3390/biotech10030010

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