Recommendations for the Assessment of Potential Environmental Effects of Genome-Editing Applications in Plants in the EU
The current initiative of the European Commission (EC) concerning plants produced using certain new genomic techniques, in particular, targeted mutagenesis and cisgenesis, underlines that a high level of protection for human and animal health and the environment needs to be maintained when using suc...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-04-01
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| Series: | Plants |
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| Online Access: | https://www.mdpi.com/2223-7747/12/9/1764 |
| _version_ | 1797601934769651712 |
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| author | Michael F. Eckerstorfer Marion Dolezel Margret Engelhard Valeria Giovannelli Marcin Grabowski Andreas Heissenberger Matteo Lener Wolfram Reichenbecher Samson Simon Giovanni Staiano Anne Gabrielle Wüst Saucy Jan Zünd Christoph Lüthi |
| author_facet | Michael F. Eckerstorfer Marion Dolezel Margret Engelhard Valeria Giovannelli Marcin Grabowski Andreas Heissenberger Matteo Lener Wolfram Reichenbecher Samson Simon Giovanni Staiano Anne Gabrielle Wüst Saucy Jan Zünd Christoph Lüthi |
| author_sort | Michael F. Eckerstorfer |
| collection | DOAJ |
| description | The current initiative of the European Commission (EC) concerning plants produced using certain new genomic techniques, in particular, targeted mutagenesis and cisgenesis, underlines that a high level of protection for human and animal health and the environment needs to be maintained when using such applications. The current EU biosafety regulation framework ensures a high level of protection with a mandatory environmental risk assessment (ERA) of genetically modified (GM) products prior to the authorization of individual GMOs for environmental release or marketing. However, the guidance available from the European Food Safety Authority (EFSA) for conducting such an ERA is not specific enough regarding the techniques under discussion and needs to be further developed to support the policy goals towards ERA, i.e., a case-by-case assessment approach proportionate to the respective risks, currently put forward by the EC. This review identifies important elements for the case-by-case approach for the ERA that need to be taken into account in the framework for a risk-oriented regulatory approach. We also discuss that the comparison of genome-edited plants with plants developed using conventional breeding methods should be conducted at the level of a scientific case-by-case assessment of individual applications rather than at a general, technology-based level. Our considerations aim to support the development of further specific guidance for the ERA of genome-edited plants. |
| first_indexed | 2024-03-11T04:10:14Z |
| format | Article |
| id | doaj.art-942c4e8f865a4c2e8bd08557388af158 |
| institution | Directory Open Access Journal |
| issn | 2223-7747 |
| language | English |
| last_indexed | 2024-03-11T04:10:14Z |
| publishDate | 2023-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Plants |
| spelling | doaj.art-942c4e8f865a4c2e8bd08557388af1582023-11-17T23:31:24ZengMDPI AGPlants2223-77472023-04-01129176410.3390/plants12091764Recommendations for the Assessment of Potential Environmental Effects of Genome-Editing Applications in Plants in the EUMichael F. Eckerstorfer0Marion Dolezel1Margret Engelhard2Valeria Giovannelli3Marcin Grabowski4Andreas Heissenberger5Matteo Lener6Wolfram Reichenbecher7Samson Simon8Giovanni Staiano9Anne Gabrielle Wüst Saucy10Jan Zünd11Christoph Lüthi12Umweltbundesamt–Environment Agency Austria (EAA), Landuse and Biosafety Unit, Spittelauer Lände 5, 1090 Vienna, AustriaUmweltbundesamt–Environment Agency Austria (EAA), Landuse and Biosafety Unit, Spittelauer Lände 5, 1090 Vienna, AustriaFederal Agency for Nature Conservation, Division of Assessment of GMOs/Enforcement of Genetic Engineering Act, Konstantinstr. 110, 53179 Bonn, GermanyISPRA (Italian Institute for Environmental Protection and Research), Department for Environmental Monitoring and Protection and for Biodiversity Conservation, Via Vitaliano Brancati, 48, 00144 Rome, ItalyMinistry of Climate and Environment, Department Nature Conservation, GMO Unit, Wawelska 52/54, 00-922 Warsaw, PolandUmweltbundesamt–Environment Agency Austria (EAA), Landuse and Biosafety Unit, Spittelauer Lände 5, 1090 Vienna, AustriaISPRA (Italian Institute for Environmental Protection and Research), Department for Environmental Monitoring and Protection and for Biodiversity Conservation, Via Vitaliano Brancati, 48, 00144 Rome, ItalyFederal Agency for Nature Conservation, Division of Assessment of GMOs/Enforcement of Genetic Engineering Act, Konstantinstr. 110, 53179 Bonn, GermanyFederal Agency for Nature Conservation, Division of Assessment of GMOs/Enforcement of Genetic Engineering Act, Konstantinstr. 110, 53179 Bonn, GermanyISPRA (Italian Institute for Environmental Protection and Research), Department for Environmental Monitoring and Protection and for Biodiversity Conservation, Via Vitaliano Brancati, 48, 00144 Rome, ItalyFederal Office for the Environment (FOEN), Biotechnology Section, Soil and Biotechnology Division, 3003 Bern, SwitzerlandFederal Office for the Environment (FOEN), Biotechnology Section, Soil and Biotechnology Division, 3003 Bern, SwitzerlandFederal Office for the Environment (FOEN), Biotechnology Section, Soil and Biotechnology Division, 3003 Bern, SwitzerlandThe current initiative of the European Commission (EC) concerning plants produced using certain new genomic techniques, in particular, targeted mutagenesis and cisgenesis, underlines that a high level of protection for human and animal health and the environment needs to be maintained when using such applications. The current EU biosafety regulation framework ensures a high level of protection with a mandatory environmental risk assessment (ERA) of genetically modified (GM) products prior to the authorization of individual GMOs for environmental release or marketing. However, the guidance available from the European Food Safety Authority (EFSA) for conducting such an ERA is not specific enough regarding the techniques under discussion and needs to be further developed to support the policy goals towards ERA, i.e., a case-by-case assessment approach proportionate to the respective risks, currently put forward by the EC. This review identifies important elements for the case-by-case approach for the ERA that need to be taken into account in the framework for a risk-oriented regulatory approach. We also discuss that the comparison of genome-edited plants with plants developed using conventional breeding methods should be conducted at the level of a scientific case-by-case assessment of individual applications rather than at a general, technology-based level. Our considerations aim to support the development of further specific guidance for the ERA of genome-edited plants.https://www.mdpi.com/2223-7747/12/9/1764new genomic techniquesgenome-editingCRISPR/Casplant modificationGMOenvironmental risk assessment |
| spellingShingle | Michael F. Eckerstorfer Marion Dolezel Margret Engelhard Valeria Giovannelli Marcin Grabowski Andreas Heissenberger Matteo Lener Wolfram Reichenbecher Samson Simon Giovanni Staiano Anne Gabrielle Wüst Saucy Jan Zünd Christoph Lüthi Recommendations for the Assessment of Potential Environmental Effects of Genome-Editing Applications in Plants in the EU Plants new genomic techniques genome-editing CRISPR/Cas plant modification GMO environmental risk assessment |
| title | Recommendations for the Assessment of Potential Environmental Effects of Genome-Editing Applications in Plants in the EU |
| title_full | Recommendations for the Assessment of Potential Environmental Effects of Genome-Editing Applications in Plants in the EU |
| title_fullStr | Recommendations for the Assessment of Potential Environmental Effects of Genome-Editing Applications in Plants in the EU |
| title_full_unstemmed | Recommendations for the Assessment of Potential Environmental Effects of Genome-Editing Applications in Plants in the EU |
| title_short | Recommendations for the Assessment of Potential Environmental Effects of Genome-Editing Applications in Plants in the EU |
| title_sort | recommendations for the assessment of potential environmental effects of genome editing applications in plants in the eu |
| topic | new genomic techniques genome-editing CRISPR/Cas plant modification GMO environmental risk assessment |
| url | https://www.mdpi.com/2223-7747/12/9/1764 |
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