Recommendations for the Assessment of Potential Environmental Effects of Genome-Editing Applications in Plants in the EU.

Autor: Eckerstorfer MF; Umweltbundesamt-Environment Agency Austria (EAA), Landuse and Biosafety Unit, Spittelauer Lände 5, 1090 Vienna, Austria., Dolezel M; Umweltbundesamt-Environment Agency Austria (EAA), Landuse and Biosafety Unit, Spittelauer Lände 5, 1090 Vienna, Austria., Engelhard M; Federal Agency for Nature Conservation, Division of Assessment of GMOs/Enforcement of Genetic Engineering Act, Konstantinstr. 110, 53179 Bonn, Germany., Giovannelli V; ISPRA (Italian Institute for Environmental Protection and Research), Department for Environmental Monitoring and Protection and for Biodiversity Conservation, Via Vitaliano Brancati, 48, 00144 Rome, Italy., Grabowski M; Ministry of Climate and Environment, Department Nature Conservation, GMO Unit, Wawelska 52/54, 00-922 Warsaw, Poland., Heissenberger A; Umweltbundesamt-Environment Agency Austria (EAA), Landuse and Biosafety Unit, Spittelauer Lände 5, 1090 Vienna, Austria., Lener M; ISPRA (Italian Institute for Environmental Protection and Research), Department for Environmental Monitoring and Protection and for Biodiversity Conservation, Via Vitaliano Brancati, 48, 00144 Rome, Italy., Reichenbecher W; Federal Agency for Nature Conservation, Division of Assessment of GMOs/Enforcement of Genetic Engineering Act, Konstantinstr. 110, 53179 Bonn, Germany., Simon S; Federal Agency for Nature Conservation, Division of Assessment of GMOs/Enforcement of Genetic Engineering Act, Konstantinstr. 110, 53179 Bonn, Germany., Staiano G; ISPRA (Italian Institute for Environmental Protection and Research), Department for Environmental Monitoring and Protection and for Biodiversity Conservation, Via Vitaliano Brancati, 48, 00144 Rome, Italy., Wüst Saucy AG; Federal Office for the Environment (FOEN), Biotechnology Section, Soil and Biotechnology Division, 3003 Bern, Switzerland., Zünd J; Federal Office for the Environment (FOEN), Biotechnology Section, Soil and Biotechnology Division, 3003 Bern, Switzerland., Lüthi C; Federal Office for the Environment (FOEN), Biotechnology Section, Soil and Biotechnology Division, 3003 Bern, Switzerland.
Jazyk: angličtina
Zdroj: Plants (Basel, Switzerland) [Plants (Basel)] 2023 Apr 25; Vol. 12 (9). Date of Electronic Publication: 2023 Apr 25.
DOI: 10.3390/plants12091764
Abstrakt: 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.
Databáze: MEDLINE
Externí odkaz: