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

Eckerstorfer, Michael; Dolezel, Marion; Engelhard, Margret; Giovannelli, Valeria; Grabowski, Marcin; Heissenberger, Andreas; Lener, Matteo; Reichenbecher, Wolfram; Simon, Samson; Staiano, Giovanni; Saucy, Anne Gabrielle Wüst; Zünd, Jan; Lüthi, Christoph

doi:10.3390/plants12091764

Cited by 6 publications

(5 citation statements)

References 76 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Therefore, requirements regarding a mandatory investigation of intended and unintended genetic alterations, e.g. in the context of the EU GMO regulation, seem to be a scientifically justified necessity as also confirmed by Eckerstorfer et al (2023) .…”

Section: Discussionmentioning

confidence: 86%

A perspective from the EU: unintended genetic changes in plants caused by NGT—their relevance for a comprehensive molecular characterisation and risk assessment

Koller,

Cieslak

2023

Front. Bioeng. Biotechnol.

View full text Add to dashboard Cite

Several regions in the world are currently holding discussions in regard to the regulation of new genomic techniques (NGTs) and their application in agriculture. The European Commission, for instance, is proposing the introduction of specific regulation for NGT plants. Various questions need to be answered including e.g., the extent to which NGT-induced intended and unintended genetic modifications must be subjected to a mandatory risk assessment as part of an approval procedure. This review mostly focuses on findings in regard to unintended genetic changes that can be caused by the application of NGTs. More specifically, the review deals with the application of the nuclease CRISPR/Cas, which is currently the most important tool for developing NGT plants, and its potential to introduce double strand breaks (DSBs) at a targeted DNA sequence. For this purpose, we identified the differences in comparison to non-targeted mutagenesis methods used in conventional breeding. The review concludes that unintended genetic changes caused by NGT processes are relevant to risk assessment. Due to the technical characteristics of NGTs, the sites of the unintended changes, their genomic context and their frequency (in regard to specific sites) mean that the resulting gene combinations (intended or unintended) may be unlikely to occur with conventional methods. This, in turn, implies that the biological effects (phenotypes) can also be different and may cause risks to health and the environment. Therefore, we conclude that the assessment of intended as well as unintended genetic changes should be part of a mandatory comprehensive molecular characterisation and risk assessment of NGT plants that are meant for environmental releases or for market authorisation.

show abstract

Section: Discussionmentioning

confidence: 86%

A perspective from the EU: unintended genetic changes in plants caused by NGT—their relevance for a comprehensive molecular characterisation and risk assessment

Koller,

Cieslak

2023

Front. Bioeng. Biotechnol.

View full text Add to dashboard Cite

show abstract

“…In addition, WGS can identify unintended genetic changes introduced by the GM methods used to develop the particular GM virus application [107]. WGS approaches have been recommended for the assessment of unintended genetic modifications in other GMOs, in particular, for genome-edited GM plants [108,109].…”

Section: Considerations Regarding the Assessment Of Molecular And Phe...mentioning

confidence: 99%

Scanning the Horizon for Environmental Applications of Genetically Modified Viruses Reveals Challenges for Their Environmental Risk Assessment

Eckerstorfer,

Dolezel,

Miklau

et al. 2024

IJMS

Self Cite

View full text Add to dashboard Cite

The release of novel genetically modified (GM) virus applications into the environment for agricultural, veterinary, and nature-conservation purposes poses a number of significant challenges for risk assessors and regulatory authorities. Continuous efforts to scan the horizon for emerging applications are needed to gain an overview of new GM virus applications. In addition, appropriate approaches for risk assessment and management have to be developed. These approaches need to address pertinent challenges, in particular with regard to the environmental release of GM virus applications with a high probability for transmission and spreading, including transboundary movements and a high potential to result in adverse environmental effects. However, the current preparedness at the EU and international level to assess such GM virus application is limited. This study addresses some of the challenges associated with the current situation, firstly, by conducting a horizon scan to identify emerging GM virus applications with relevance for the environment. Secondly, outstanding issues regarding the environmental risk assessment (ERA) of GM virus applications are identified based on an evaluation of case study examples. Specifically, the limited scientific information available for the ERA of some applications and the lack of detailed and appropriate guidance for ERA are discussed. Furthermore, considerations are provided for future work that is needed to establish adequate risk assessment and management approaches.

show abstract

“… 64 And there are other views that propose that for genome editing applications, the level of robustness in the evidence currently required for the Environmental Risk Assessment of GMOs needs to be maintained. 205 …”

Section: Gm Regulation In Major Economies (Based On Gdp Ranking)mentioning

confidence: 99%

Processes for regulating genetically modified and gene edited plants

Caradus

2023

GM Crops & Food

View full text Add to dashboard Cite

Innovation in agriculture has been essential in improving productivity of crops and forages to support a growing population, improving living standards while contributing toward maintaining environment integrity, human health, and wellbeing through provision of more nutritious, varied, and abundant food sources. A crucial part of that innovation has involved a range of techniques for both expanding and exploiting the genetic potential of plants. However, some techniques used for generating new variation for plant breeders to exploit are deemed higher risk than others despite end products of both processes at times being for all intents and purposes identical for the benefits they provide. As a result, public concerns often triggered by poor communication from innovators, resulting in mistrust and suspicion has, in turn, caused the development of a range of regulatory systems. The logic and motivations for modes of regulation used are reviewed and how the benefits from use of these technologies can be delivered more efficiently and effectively is discussed.

show abstract

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

Cited by 6 publications

References 76 publications

A perspective from the EU: unintended genetic changes in plants caused by NGT—their relevance for a comprehensive molecular characterisation and risk assessment

A perspective from the EU: unintended genetic changes in plants caused by NGT—their relevance for a comprehensive molecular characterisation and risk assessment

Scanning the Horizon for Environmental Applications of Genetically Modified Viruses Reveals Challenges for Their Environmental Risk Assessment

Processes for regulating genetically modified and gene edited plants

Contact Info

Product

Resources

About