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

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 addres...

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Detalles Bibliográficos
Autores principales: Eckerstorfer, Michael F., Grabowski, Marcin, Lener, Matteo, Engelhard, Margret, Simon, Samson, Dolezel, Marion, Heissenberger, Andreas, Lüthi, Christoph
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9245463/
https://www.ncbi.nlm.nih.gov/pubmed/35822764
http://dx.doi.org/10.3390/biotech10030010
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author Eckerstorfer, Michael F.
Grabowski, Marcin
Lener, Matteo
Engelhard, Margret
Simon, Samson
Dolezel, Marion
Heissenberger, Andreas
Lüthi, Christoph
author_facet Eckerstorfer, Michael F.
Grabowski, Marcin
Lener, Matteo
Engelhard, Margret
Simon, Samson
Dolezel, Marion
Heissenberger, Andreas
Lüthi, Christoph
author_sort Eckerstorfer, Michael F.
collection PubMed
description 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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spelling pubmed-92454632022-07-06 Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU Eckerstorfer, Michael F. Grabowski, Marcin Lener, Matteo Engelhard, Margret Simon, Samson Dolezel, Marion Heissenberger, Andreas Lüthi, Christoph BioTech (Basel) Review 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. MDPI 2021-06-22 /pmc/articles/PMC9245463/ /pubmed/35822764 http://dx.doi.org/10.3390/biotech10030010 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Eckerstorfer, Michael F.
Grabowski, Marcin
Lener, Matteo
Engelhard, Margret
Simon, Samson
Dolezel, Marion
Heissenberger, Andreas
Lüthi, Christoph
Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU
title Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU
title_full Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU
title_fullStr Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU
title_full_unstemmed Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU
title_short Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU
title_sort biosafety of genome editing applications in plant breeding: considerations for a focused case-specific risk assessment in the eu
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9245463/
https://www.ncbi.nlm.nih.gov/pubmed/35822764
http://dx.doi.org/10.3390/biotech10030010
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