In April 2021, the EU Commission published a study on the judgment of the European Court of Justice (ECJ) regarding the status of Novel Genomic Techniques (NGTs) under Union law. This study contains information on the status and use of biotechnological methods developed since 2001, in plants, animals, and micro-organisms for agri-food, industrial, and pharmaceutical application. Additionally, it covers an overview of the risk assessment of plants developed through NGTs [1]. In 2018, the ECJ’s ruling in case C-528/16 including the status of genome-edited (GE) plants resulted in their strict regulation under the legal framework for genetically modified organisms (GMO Directive 2001/18/EC). Therefore, their release, placing on the market, labeling, and traceability have to follow the same regulations as transgenic plants produced with other biotechnological methods. As a consequence, there are currently no crops released on the European market that were developed using NGTs, such as CRISPR, TALEN, or comparable techniques [1]. In contrast to this process-based approach on NGT regulation, many countries outside of the European Union (e.g. Australia, New Zealand, and Japan) decided on an evidence-based product-oriented regulation.
As early-career researchers in the fields of biotechnology, plant biology, and breeding throughout Europe, this regulation affects not only the application of our basic research results but also hinders the validation of scientific findings under real environmental conditions by complicating field trials. Several scientific societies published statements as well as recommendations regarding the European legal and political frameworks around new breeding technologies and their applications [2, 3]. As scientists from different research institutes within the European Union, we are concerned about growing discrepancies between scientific consensus and political actions. With our knowledge and professional education, we can and wish to contribute to a more sustainable and environmentally-friendly European agriculture as well as a secured food supply for a growing population.
In contrast to previous technologies for the generation of GMOs, new breeding technologies are usually not utilized to insert genetic sequences from the same or different species into the plants genetic material. Instead, genome editing is widely used to introduce targeted point mutations, insertions, and deletions of single nucleotides without introducing (foreign) DNA into the plant’s genome. These changes are indistinguishable from naturally and spontaneously occurring mutations or those induced in the context of conventional breeding by chemical or radioactive mutagenesis [4]. In 2019, a report of the European Network of GMO Laboratories concluded that unambiguous detection and tracing of mutations induced by genome editing without previous knowledge about the given mutation is likely to fail [5]. The main difference between the two breeding approaches is that in genome editing the locations of the mutations are not left to chance. Instead, changes in the DNA are induced at previously defined positions within the target genes. This enables a faster translation of basic research results into application. Therefore, according to the current state of knowledge including an assessment by the EFSA Panel on Genetically Modified Organisms, an evidence-based risk assessment does not see any greater risks in the application of targeted mutagenesis in comparison with conventional breeding methods [6].
Possible results of new breeding technologies span from increased yields [7], and increased yield-stability under adverse climate conditions such as drought [8], and increasing soil salinity [9], to resistances against plant pathogens like viruses [10] and pathogenic fungi [11]. With respect to climate change, two IPCC reports mention the potential of new breeding technologies [12, 13]. The resulting crops could not only be more resilient and sustainable, but they could also contribute to carbon sequestration and reduced soil erosion. Other aims of GE-assisted breeding could include crops with an improved nutritional value which are already marketed in the USA and Japan [14, 15], or the de novo domestication of wild crop relatives [16, 17]. This would increase the available genetic resources for breeding and could benefit (genetic) biodiversity in agriculture.
Breeding and releasing a stable high-quality crop variety takes between 10 and 20 years. Therefore, the development of plants we need by 2040 has to start now. Locally adapted, resilient, and nutrient-efficient plant varieties are essential to provide food, medicine, and fibers. While the demand for such goods will increase with the growth of the global population, the area of arable land will decrease due to the adverse effects of climate change and necessary biodiversity conservation projects. Given the urgency to develop more resilient and diverse crops, plant breeding should have the widest possible range of safe methods at its disposal. Instead of the legislation and admission of crop varieties based on the method used for their production, we strongly favor a product-oriented approach with case-by-case admissions regardless of the production process. This would allow plant breeders to employ new breeding technologies for seed production while still enabling the European Union and its member states to control for sustainable and environmentally safe application. As a final remark, we would like to disclose that NGTs are not a universal remedy for the environmental and climate change-related tasks at hand. But they are a valuable addition to the methods of plant breeding and the current legal framework around them will negatively impact plant research and breeding in the European Union.
Therefore, we urge you to reconsider the current state of the regulations that apply to the cultivation and release of genome-edited plants in Europe.
Sincerely,
Your next generation of plant scientists in Europe
Sources:
[1] Information of the European Council on the study on new genomic techniques: https://ec.europa.eu/food/plant/gmo/modern_biotech/new-genomic-techniques_en
[2] German National Academy of Sciences Leopoldina, German Research Foundation, Union of the German Academies of Sciences and Humanities: Towards a scientifically justified, differentiated regulation of genome edited plants in the EU (Short version of the statement, 2019) https://www.leopoldina.org/uploads/tx_leopublication/2019_Stellungnahme_Genomeditierte_Pflanzen_short_en_web.pdf,
[3] Statement of John Skehel, Vice-President and Biological Secretary of The Royal Society on the ECJs judgement https://royalsociety.org/news/2018/07/ecj-genome-editing-ruling-john-skehel/
[4]: Risk Assessment and Regulation of Plants Modified by Modern Biotechniques: Current Status and Future Challenges. Joachim Schiemann, Antje Dietz-Pfeilstetter, Frank Hartung, Christian Kohl, Jörg Romeis, Thorben Sprink. Annual Review of Plant Biology (2019) 70:1, 699-726
[5] European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained by new mutagenesis techniques, 26 March 2019 (JRC116289) https://gmo-crl.jrc.ec.europa.eu/doc/JRC116289-GE-report-ENGL.pdf
[6] EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Naegeli H, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Mullins E, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta J, Gennaro A, Paraskevopoulos K, Raffaello T and Rostoks N, 2020. Applicability of the EFSA Opinion on site-directed nucleases type 3 for the safety assessment of plants developed using site-directed nucleases type 1 and 2 and oligonucleotide-directed mutagenesis. EFSA Journal 2020;18(11):6299, 14 pp. https://doi.org/10.2903/j.efsa.2020.6299
[7] Liu, L., Gallagher, J., Arevalo, E.D. et al. Enhancing grain-yield-related traits by CRISPR–Cas9 promoter editing of maize CLE genes. Nat. Plants 7, 287–294 (2021). https://doi.org/10.1038/s41477-021-00858-5
[8]: Santosh Kumar, V.V., Verma, R.K., Yadav, S.K. et al. CRISPR-Cas9 mediated genome editing of drought and salt tolerance (OsDST) gene in indica mega rice cultivar MTU1010. Physiol Mol Biol Plants 26, 1099–1110 (2020). https://doi.org/10.1007/s12298-020-00819-w
[9] Zhang, A., Liu, Y., Wang, F. et al. Enhanced rice salinity tolerance via CRISPR/Cas9-targeted mutagenesis of the OsRR22 gene. Mol Breeding 39, 47 (2019). https://doi.org/10.1007/s11032-019-0954-y
[10] Kis, A., Hamar, É., Tholt, G., Bán, R. and Havelda, Z. (2019), Creating highly efficient resistance against wheat dwarf virus in barley by employing CRISPR/Cas9 system. Plant Biotechnol J, 17: 1004-1006. https://doi.org/10.1111/pbi.13077
Daniel Stirnweis, Samira Désiré Milani, Tina Jordan, Beat Keller, and Susanne Brunner. Molecular Plant-Microbe Interactions®, (2014) 27:3, 265-276
[12] de Coninck, H., A. Revi, M. Babiker, P. Bertoldi, M. Buckeridge, A. Cartwright, W. Dong, J. Ford, S. Fuss, J.-C. Hourcade, D. Ley, R. Mechler, P. Newman, A. Revokatova, S. Schultz, L. Steg, and T. Sugiyama, 2018: Strengthening and Implementing the Global Response. In: Global Warming of 1.5°C. An IPCC Special Report on the impacts of global warming of 1.5°C above pre-industrial levels and related global greenhouse gas emission pathways, in the context of strengthening the global response to the threat of climate change, sustainable development, and efforts to eradicate poverty [MassonDelmotte,V., P. Zhai, H.-O. Pörtner, D. Roberts, J. Skea, P.R. Shukla, A. Pirani, W. Moufouma-Okia, C. Péan, R. Pidcock, S. Connors, J.B.R. Matthews, Y. Chen, X. Zhou, M.I. Gomis, E. Lonnoy, T. Maycock, M. Tignor, and T. Waterfield (eds.)]. In Press. Kapitel 4 S. 316 u. 329
[13] Mbow, C., C. Rosenzweig, L.G. Barioni, T.G. Benton, M. Herrero, M. Krishnapillai, E. Liwenga, P. Pradhan, M.G. Rivera-Ferre, T. Sapkota, F.N. Tubiello, Y. Xu, 2019: Food Security. In: Climate Change and Land: an IPCC special report on climate change, desertification, land degradation, sustainable land management, food security, and greenhouse gas fluxes in terrestrial ecosystems [P.R. Shukla, J. Skea, E. Calvo Buendia, V. Masson-Delmotte, H.-O. Pörtner, D.C. Roberts, P. Zhai, R. Slade, S. Connors, R. van Diemen, M. Ferrat, E. Haughey, S. Luz, S. Neogi, M. Pathak, J. Petzold, J. Portugal Pereira, P. Vyas, E. Huntley, K. Kissick, M. Belkacemi, J. Malley, (eds.)]. In press.Kapitel 5, S. 513
[14] USDA Classifies Gene-Edited Soybean As Non-Regulated. International Service for the Acquisition of Agri-biotech Applications (2020) https://www.isaaa.org/kc/cropbiotechupdate/article/default.asp?ID=18161
[15] Japan Launches World’s First Genome-Edited Tomato. International Service for the Acquisition of Agri-biotech Applications (2021) https://www.isaaa.org/kc/cropbiotechupdate/article/default.asp?ID=18668
[16] Zsögön, A., Čermák, T., Naves, E. et al. De novo domestication of wild tomato using genome editing. Nat Biotechnol 36, 1211–1216 (2018). https://doi.org/10.1038/nbt.4272
[17] Hong Yu, Tao Lin, Xiangbing Meng, Huilong Du, Jingkun Zhang, Guifu Liu, Mingjiang Chen, Yanhui Jing, Liquan Kou, Xiuxiu Li, Qiang Gao, Yan Liang, Xiangdong Liu, Zhilan Fan, Yuntao Liang, Zhukuan Cheng, Mingsheng Chen, Zhixi Tian, Yonghong Wang, Chengcai Chu, Jianru Zuo, Jianmin Wan, Qian Qian, Bin Han, Andrea Zuccolo, Rod A. Wing, Caixia Gao, Chengzhi Liang, Jiayang Li. A route to de novo domestication of wild allotetraploid rice. Cell, Volume 184, Issue 5, (2021) https://doi.org/10.1016/j.cell.2021.01.013.
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