An EU Perspective on Biosafety Considerations for Plants Developed by Genome Editing and Other New Genetic Modification Techniques (nGMs)

The paper examines risks posed by plants produced using new genetic modification techniques (nGMs). For this purpose, a literature survey was conducted from January 2011 to June 2017 and important aspects for a suitable risk assessment were discussed using market-orientated applications in plants. The authors conclude that even small changes in the genome and the high target efficiency of nGMs are not safe per se, especially when new properties are introduced into the plants. nGM plants can have properties that could not be achieved previously by using conventional methods or older genetic engineering techniques. nGM plants with new and previously untested (in terms of the risk assessment) characteristics can arise, for example, through the use of multiplexing approaches and can lead to complex changes in metabolic pathways.

All investigated nGM applications can lead to unintended changes in the genome, such as the occurrence of off-target effects when using SDN techniques, for example. In addition, when assessing the risk of nGMs, all techniques that are involved in the generation of an end product should be considered, since unintended effects can also occur in intermediate experimental steps. Due to the complexity of nGMs, an appropriate risk assessment must consider the type of all genetic engineering methods used and the range of changes that are generated. Therefore, when using new genetic engineering techniques, a case-specific risk assessment should be carried out, which considers the properties of the respective techniques and the new characteristics of the nGM plants.

Eckerstorfer, M. F., Dolezel, M., Heissenberger, A., Miklau, M., Reichenbecher, W., Steinbrecher, R. A., & Wassmann, F. (2019). An EU perspective on biosafety considerations for plants developed by genome editing and other new genetic modification techniques (nGMs). Front Bioeng Biotechnol, 7, 31. doi:10.3389/fbioe.2019.00031