Sunday Evening News 407 - Week 01 - 2025
Weekly report on genetic engineering, genome editing, biotechnology and legal regulation.
January 2025-01-02 - 2025-01-05
Mit den besten Wünschen vom WGG für ein gesundes und erfolgreiches Jahr 2025
Prognose für 2025 – Hoffnung und Zuversicht, aber es wird sicher ein Jahr der Herausforderungen und Umwälzungen.
With best wishes from the WGG for a healthy and successful 2025
Forecast for 2025 - hope and confidence, but it will certainly be a year of challenges and upheaval.
AFBV-WGG-Statement:
Update zu den laufenden Diskussionen über den Regulierungsvorschlag der Europäischen Kommission über Neue Genomische Techniken (NGTs) – Empfehlungen zum Trilog
https://www.wggev.de/ngt-regulierung-kommissionsvorschlag-update-empfehlungen-trilog/
Update on ongoing discussions on the regulatory proposal of the European Commission on New Genomic Techniques („NGTs“): recommendations to reach the Trilogue
https://www.wggev.de/discussion-on-new-genomic-techniques-recommendation-trilogue/
WGG: Neue Genomische Techniken (NGT) in der Pflanzenzüchtung
70 Fragen in sechs Themenblöcken - 70 Antworten kurz und verständlich –
wissenschaftlich korrekt
https://www.wggev.de/fragen-antworten-neue-genomische-techniken-ngt/
Zulassungen von gv-Pflanzen 2024 in der EU
https://www.biotech-gm-food.com/organismen/gentechnisch-veraenderte-pflanzen-gvo
BGF/WGG: Lebensmittelenzyme / Food enzmyes
Enzymes safety assessed in2024
Enzymes 2024 submitted to EFSA for safety assessment.
https://www.biotech-enzymes.com/unionsliste-lebensmittelenzyme-ausstehende-sicherheitsbewertungen
Kommission: Plant Health regulation (EU) 2024/31153
New rules on plant health will enter into force on Sunday 5 January 2025, following the adoption of Regulation (EU) 2024/3115, that amends the Plant Health Regulation (EU) 2016/2031 last year.
https://eur-lex.europa.eu/legal-content/DE/TXT/PDF/?uri=OJ:L_202403115
Meetings-Veranstaltungen
Die Rolle der Pflanzenzüchtung in nachhaltigen Agrarökosystemen (Grüne Gentechnik – Chancen für Nachhaltigkeit?)
Prof. Dr. Dr. Urs Niggli (Präsident des Instituts für Agrarökologie, Aarau, Schweiz) 08.01.2025 20:15, HS 1010
https://www.studiumgenerale.uni-freiburg.de/veranstaltungen-14tage
New Genomic Technologies - A Versatile Toolbox for Crop and Livestock Improvement Mini Symposium
Feb. 10, 2025 @ BOKU Vienna
Press Releases - Media / Presse- und Medienberichte
Marek Strzelecki, Lili Bayer and Anna Wlodarczak-semczuk: Poland takes over EU presidency with focus on security
https://www.reuters.com/world/europe/spats-divisions-mar-start-polands-eu-presidency-2025-01-03/
Fouda M.: Hungary's controversial presidency of the Council of the European Union comes to an end
Rankin J.: Donald Tusk’s Polish revival masks deeper divisions with German neighbours
L. Val Giddings L.V.: 2024 In Review – An Age of Miracles
https://itif.org/publications/2025/01/03/2024-in-review-an-age-of-miracles/
POINT NEWSLETTER NR. 270 – DEZEMBER 2024 - Aktuelle Biotechnologie
https://www.scienceindustries.ch/_file/37174/point-2024-12-270-d.pdf
BDP: "Gentechnik ist kein Selbstzweck, sondern ein wichtiges Werkzeug!"
Only some selected press releases or media reports are listed here. The daily up-date of the press releases and
media reports are ►here: January week 01
Publications – Publikationen
Appels R., Eversole K., Feuillet C., Gallagher D.; Editors (2024): The Wheat Genome
https://doi.org/10.1007/978-3-031-38294-9
Sánchez, M.A. (2024): The Global Advance of Genome-Edited Plants to the Market: The Key Role of Chile in Its Development. Plants 13, 3597 | https://doi.org/10.3390/plants13243597
The global advancement of genome-edited plants toward commercialization has been significantly shaped by the functionality and flexibility of some regulatory frameworks governing plant genome editing. These frameworks vary widely across countries, reflecting diverse approaches to assessing and managing the risks and benefits of genome-editing technologies. While some nations have adopted product-based frameworks that focus on the characteristics of the final plant rather than the technique used, others rely on more restrictive process-based regulations. This variability influences the pace of innovation, the types of products able to enter the market, and their global trade potential. Chile stands out as a leader in this landscape, having implemented a science-driven and flexible regulatory framework. Its system promotes innovation by facilitating genome-edited plant research and development, field testing, and local commercialization. This regulatory adaptability positions Chile as a critical player in supporting the global integration of genome-editing technologies into agriculture, fostering advancements that address food security, sustainability, and climate resilience.
https://www.mdpi.com/2223-7747/13/24/3597
Varacca A., Soregaroli C., Kardung M., Espa I, Colombo I., Cortesi B., Wesseler J. (2024): The effect of the EU's novel food
regulations on firm investment decisions. Journal of Agricultural Economics | https://doi.org/10.1111/1477-9552.12622
In this study, we assess the effect of the European Union's novel food regulations on firms' incentives to invest in such products. We adopt a conceptual framework based on real option value theory, which underpins an empirical analysis of a detailed dataset comprising 326 applications submitted under both the 1997 EU novel food regulation and its 2018 replacement. We investigate the dynamics of novel food applications under these regulations and disentangle the determinants of successful cases. Our results show a relatively stable number of applications over the years, with a spike after the introduction of the 2018 regulation, which sought to simplify and centralise the approval process. This upsurge can be interpreted as a reduction in the real option value of postponing investments, attributable to the introduction of a transitional regime and of 5-year data protection measures. However, the new regulation did not shorten the authorisation process, with the expected benefits of centralisation compromised by operational bottlenecks and a lower chance of approval. Finally, we find that approvals under the 2018 regulation are more likely when applicants are private entities from non-EU countries and have substantial experience with novel foods. Our empirical evidence suggests that the new regulation may be insufficient to speed up and streamline the novel food assessment process, which is inevitably constrained by EU food safety principles. This, in turn, may discourage future investments.
https://onlinelibrary.wiley.com/doi/10.1111/1477-9552.12622
Hulot, J.-F. (2024): Rethinking Food and Farming in Europe. Proceedings 2025, 113, 1.
https://doi.org/10.3390/proceedings2025113001
Food security in Europe remains assured, but at too high an environmental cost. The old agro-chemical model has proven inadequate to meet the multi-faceted challenges of the 21st century. The most promising model must be sustainable and simultaneously improve economic performance, environmental protection, and social impact. Agro-ecology meets those goals, but its implementation would require a complete rethinking of EU policies for agriculture and food. The Common Agricultural Policy must radically change from quantitative to qualitative support and favour a demand-led rather than a supply-led approach to reflect consumer needs, not only in food pricing terms but also in nutritional and health aspects.
https://www.mdpi.com/2504-3900/113/1/1
Groover, E., Njuguna, E., Bansal, K.C. et al. (2024): A technical approach to global plant genome editing regulation.
Nat Biotechnol 42, 1773–1780 (2024). https://doi.org/10.1038/s41587-024-02489-5
The Innovate Genomics Institute brought together regulators from 16 countries to discuss global capacity building for the regulation of genome-edited crops. The workshop provided insights into the suitable use of technical analyses to validate edits and raised future considerations regarding regulation reporting, offering suggestions to help countries meet their objectives in the ever-growing landscape of genome editing techniques.
https://www.nature.com/articles/s41587-024-02489-5
Soga, K., Hashimoto, Y., Egi, T., Taguchi, C., Yoshiba, S., Shibata, N., … Takabatake, R. (2024): Distribution status of genetically
modified soybeans from the United States and Canada to Japan in 2021 and 2022. GM Crops & Food, 16(1), 1–10 | https://doi.org/10.1080/21645698.2024.2444048
The number of authorized genetically modified (GM) soybeans has increased worldwide. In Japan, 34 GM soybeans containing single events and their stacked varieties have been approved as food. However, not all approved GM events are commercially cultivated or distributed. In this study, we evaluated domestically distributed samples from the United States (US) and Canada using 17 event-specific detection methods for GM soybeans. Identity-preserved (IP) soybean samples imported from the US and Canada, and non-IP samples from the US in 2021 and 2022 were analyzed. Four GM soybean events consisting of MON89788, A5547–127, MON87708, and DAS-44406 were detected in all lots in the non-IP samples. Furthermore, a single-kernel-based analysis was conducted to determine whether the detected GM soybean events are stacked. The results suggest that DAS-44406 is rapidly increasing, particularly as a single event among GM soybeans.
https://www.tandfonline.com/doi/full/10.1080/21645698.2024.2444048?src=exp-la#abstract
Degache A, Louvel S, Abrial S, Tournay V (2024) How French culture influences the framing of genetic modifications on the
internet: Insights from Google-based corpus analysis. PLoS ONE 19(12): e0311934. | https://doi.org/10.1371/journal.pone.0311934
Since the mid-1990s, genetically modified (GM) crops and foodstuffs have been the subject of much controversy. While research has highlighted a disparity between attitudes toward the consumption of GM products, this study focuses on the circulation of cultural frame-works for GMs online. We use two datasets obtained using Google as a privileged observation site for understanding how debates regarding genetic engineering are framed in global and local contexts. While the English-language corpus brings to the fore the framing of GM products in terms of economic value, the French-language corpus is characterized by the strong association of such products with matters relating to risk. This has consequences for public perceptions of biotechnologies. Stakeholders using communication media to convey GM issues could assist public understanding by taking these cultural differences into account.
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0311934
Liu, Q., Wang, Q., Ning, L. et al. (2024): Efficient identification of genomic insertions and surrounding regions in two
transgenic maize events using third-generation single-molecule nanopore sequencing technology. Sci Rep 14, 31921 | https://doi.org/10.1038/s41598-024-83403-6
The increasing development of new genetically modified organisms underscores the critical need for comprehensive safety assessments, emphasizing the significance of molecular evidence such as gene integration, copy numbers, and adjacent sequences. In this study, the maize nitrate-efficient utilization gene ZmNRT1.1 A was introduced into maize variety y822 using transgenic technology, producing transgenic maize events ND4401 and ND4403 with enhanced tolerance to low nitrogen stress. Southern hybridization confirmed that the exogenous T-DNA was singly inserted in both maize transformation events, ND4401 and ND4403. This study utilized third-generation sequencing technology—nanopore single-molecule sequencing—to perform molecular characterization of the integration events. It successfully determined the exogenous gene insertion sites and flanking sequences in ND4401 and ND4403. Comparative analysis with the control group facilitated the preliminary identification of the integration sites of the exogenous T-DNA fragments in these transgenic maize events. Based on the obtained flanking sequences, specific PCR primers were designed for different transformation events. The insertion site for ND4401 was pinpointed in the non-coding region of chromosome 5, and for ND4403, in the non-coding region of chromosome 3. Utilizing the sequencing results, the study developed specific detection primers for the maize transformation events, establishing a precise method for detecting newly created transgenic maize events, which will contribute to subsequent safety assessments.