Written by: Nick Vangheluwe, Euroseeds & 'Plants for the Future' - European Technology Platform
New technologies for the genetic improvement of plants have the potential to contribute substantially to the global challenges of food and agricultural systems. The discovery of CRISPR-based and related genome editing technologies has resulted in the development of a broad repertoire of applications. Policy discussions are ongoing, which will determine to what extent Europe is going to embrace genome-edited plants in agriculture.
Since the discovery of Gregory Mendel’s laws of inheritance in 1865, genetic improvement of plants underwent many technological breakthroughs ranging from deliberate crossing and hybrid breeding, to mutation breeding. Another wave of innovations was introduced in the last decades through technological advancements in molecular biology ranging from genetic modification to high-throughput sequencing. These technologies have generated a wealth of knowledge on plant biology and the function of genes specifying particular plant characteristics (e.g. pest resistance).
The latest innovation in plant breeding is genome editing and worldwide a plethora of genome editing methods have been developed, adapted and employed for the genetic improvement of plants. CRISPR is currently by far the most frequently used method and in 2020, the Nobel Prize in Chemistry was awarded to Dr. Emmanuelle Charpentier and Dr. Jennifer Doudna for the development of the CRISPR genome editing tool. Genome editing heralds a new age of plant breeding because it enables the development of new plant varieties in a much more knowledge-based manner and at unprecedented speed & efficiency.
Genome editing of plants is primarily used to introduce small, targeted genetic changes, which are in regulatory terms being referred to as Site-Directed Nuclease 1 (SDN-1) applications. In this case, the nature of introduced genetic changes does not differ from spontaneous genetic changes, or those resulting from conventional breeding methods. An increasing number of researchers employ genome editing and consider that this new breeding method will contribute to make food systems more sustainable and more resilient to climate change.
However, in July 2018, the Court of Justice of the European Union judged that organisms made with “new mutagenesis techniques” are not exempted from the European regulatory framework for genetically modified organisms (GMOs). In other words, regardless of the genetic change that was introduced with genome editing, these plants are considered GMOs according to EU law. Taking into account the negative perception of genetically modified plants as well as the political unwillingness to authorise the cultivation of these plants, this court ruling was perceived as a huge setback for the future of genome-edited plants in Europe.
Shortly after, the scientific community in European life sciences research centres and institutes have been reaching out to policy makers at the EU level and urging them to take action in order to enable the potential of genome editing for plant improvement in agriculture. Many researchers are of the opinion that the GMO legislation (adopted in 2001) no longer reflects the scientific and technological progress. In particular, another regulatory approach for genome-edited plants with small, targeted genetic changes is proposed because these changes can also occur spontaneously in plants or be the result of conventional plant breeding methods.
In April 2020, the European Commission published its study on “new genomic techniques” and concluded that the current legal framework in Europe governing new genomic techniques including genome editing is not fit for purpose. In addition, the Commission proposed to initiate a targeted policy action on plants obtained from certain new genomic techniques: “targeted mutagenesis” and “cisgenesis”. Targeted mutagenesis constitutes the process of small, targeted genetic changes in plants using genome editing methods (cf. SDN-1 applications).
An accompanying study conducted by the Joint Research Centre, revealed that applications of genome editing at (pre-)market stages are still few, however, the R&D pipeline is very rich. Plants with small, targeted genetic changes are primarily being developed and the characteristics range from disease resistance to nutrient use efficiency. Two genome-edited plants are currently on the market: high-oleic soybean in the US and tomato with increased φ-aminobutyric acid levels which is available in Japan. Nevertheless, many more applications are expected to be developed and eventually to reach the market. Companies such as Inari and Keygene aim to genetically improve crops using genome editing methods and have respectively R&D facilities in Ghent (Belgium) and in Wageningen (The Netherlands).
The policy action proposed by the Commission reflects the policy calls of the scientific community (among others) over the past years and highlights the importance of researchers’ involvement in the policy environment. In a next step, the Commission will carry out an impact assessment to examine potential policy options. The earliest possible legislative proposal for a new regulation is planned in the second quarter of 2023. In the meantime, researchers will continue to have a vital role in informing and communicating about ongoing research activities and the potential of genome-edited crops for more sustainable agriculture in Europe.