Sunday Evening News 420 - Week 14 - 2025
Weekly report on genetic engineering, genome editing, biotechnology and legal regulation.
March 2025-03-31 - April 2025-04-06
EU-Rat: Vergleich der NGT-Vorschläge von Kommission, Parlament und Rat (Dokument 7448/25, 263 Seiten).
https://data.consilium.europa.eu/doc/document/ST-7448-2025-INIT/en/pdf
Kommission: Stakeholder Questionnaire – Regulatory framework for biotechnology and biomanufacturing in the EU
https://ec.europa.eu/eusurvey/runner/BiotechActStakeholderSurvey
Im 1. Quartal 2025 hat die EFSA die Sicherheitsbewertung von ► Mais DAS1131 als Neuzulassung in einer Rekordzeit von 26,3 Monaten abgeschlossen.
In Quartal 1-2025 wurden die Sicherheitsbewertungen von 20 Lebensmittelenzymen veröffentlicht. 11 der Enzyme werden mit gentechnisch veränderten Mikroorganismen gewonnen. Bei 6 Enzymen handelt es sich um die Erweiterung des Anwendungsspektrums.
https://www.biotech-enzymes.com/unit-list/lebensmittelenzyme-sicherheitsbewertungen-efsa-2025
Von 8 Lebensmittelenzyme wurden die Stellungnahmen vom Panel angenommen.
EU Council: Comparison of the NGT proposals of the Commission, Parliament and Council (document 7448/25, 263 pages).
https://data.consilium.europa.eu/doc/document/ST-7448-2025-INIT/en/pdf
In the first quarter of 2025, EFSA completed the safety assessment of ► maize DAS 1131 as a new authorization in a record time of 26.3 months.
The safety assessments of 20 food enzymes were published in the first quarter of 2025. For 6 enzymes, the range of applications was extended. 11 of the enzymes are produced using genetically modified microorganisms The opinions of 8 food enzymes were accepted by the panel.
https://www.biotech-enzymes.com/unit-list/lebensmittelenzyme-sicherheitsbewertungen-efsa-2025
Meetings – Conferences / Treffen - Veranstaltungen
BUND Position: Gentechnik in Landwirtschaft und Naturschutz
09.04.2025 17:30-19:00: Online über Zoom
https://aktion.bund.net/webinar-bund-position-gentechnik
Join GeneBEcon’s Four Webinars on Consumer Perceptions, Crop Innovations and the GeneBeWise
Press Releases - Media / Presse- und Medienberichte
Klaus T.: Viele Bundesländer wollen lockerere Regeln für Gentechnik
Goggemos D.: Einigung ist schwierig (in Sachen NGT-Pflanze - Koalition)
POINT NEWSLETTER NR. 273 – MÄRZ 2025 - Aktuelle Biotechnologie
https://www.scienceindustries.ch/_file/37613/point-2025-03-273-d.pdf
UVEK: Bundesrat eröffnet Vernehmlassung zum Gesetz über Pflanzen aus neuen Züchtungstechnologien
Lanz S.: Rösti informiert: So will der Bundesrat neue Gentechnik erlauben
Informationsdienst Gentechnik: Schweizer Regierung legt Gesetzentwurf zu Neuer Gentechnik vor
Switzerland Considers Gene Editing Authorization to Boost Crops
TO THE AMERICAN PEOPLE
The Trump Effect on Cell and Gene: Science versus Shockwaves
Pilet J.: GRAS no more? Kennedy moves to end self-affirmed food additives
RiskMonger: What is Farming?
https://risk-monger.com/2025/04/02/what-is-farming/
Only some selected press releases or media reports are listed here. The daily up-date of the press releases and
media reports are ►here: April week 14
Publications – Publikationen
Gilbertson, L., Puchta, H. & Slotkin, R.K. (2025): The future of genome editing in plants. Nat. Plants. | https://doi.org/10.1038/s41477-025-01956-4
The future of genome editing in plants differs from how it is used today. For both research and product development, we need to think beyond the creation of simple single-nucleotide polymorphisms and short deletions in genes. We believe that the future of genome editing in plants involves mimicking the natural evolutionary processes that have shaped plant genomes and been the target of artificial selection during crop domestication and improvement. This includes programming large structural variations (insertions, duplications, deletions, inversions and translocations) and controlling plant recombination and endogenous transposable elements that naturally reshape plant genomes. The key is that genome editing will be used to reshape plant genomes in a manner that could have happened naturally, but now these changes can be directed rapidly in the laboratory.
https://www.nature.com/articles/s41477-025-01956-4
Zanatta, C.B.; Narendja, F.; El Jawhary, H.; Abou-Sleymane, G.;Subburaj, S.; Nodari, R.O.;Agapito-Tenfen, S.Z. (2025): Suitability
of Real-Time PCR Methods for New Genomic Technique Detection in the Context of the European Regulations: A Case Study in Arabidopsis. Int. J.Mol. Sci. 2025, 26, 3308. https://doi.org/ 10.3390/ijms26073308
PCR methods are widely applied for the detection of genetically modified organisms (GMOs) in Europe, facilitating compliance with stringent regulatory requirements and enabling the accurate identification and quantification of genetically modified traits in various crops and foodstuffs. This manuscript investigates the suitability of real-time PCR methods for detecting organisms generated through new genomic techniques (NGTs), specifically focusing on a case study using Arabidopsis thaliana as a model gene-edited plant. Given the complexities of European regulations regarding genetically modified organisms (GMOs) and the classification of gene-edited plants, there is a pressing need for robust detection methods. Our study highlights the development and validation of a novel single-plex real-time PCR method targeting a specific single nucleotide polymorphism (SNP) in the grf1-3 gene modified using CRISPR-Cas9 technology. We emphasize the effectiveness of locked nucleic acid (LNA)-modified primers in improving specificity. The results demonstrate that while the grf1-3 LNA method successfully detected and quantified gene-edited Arabidopsis DNA, achieving absolute specificity remains a challenge. This study also addresses the significance of the cross-laboratory method for validation, demonstrating that the method developed for an SNP-modified allele can be performed in accordance with the precision and trueness criteria established by the European Network of GMO Laboratories (ENGL). Furthermore, we call for continued collaboration among regulatory agencies, academia, and industry stakeholders to refine detection strategies. This proactive approach is essential not only for regulatory compliance but also for maintaining public trust in the safe integration of gene-edited organisms into food products.
https://www.mdpi.com/1422-0067/26/7/3308
Caradus J.R.(2025): Is co-existence and/or containment of genetically modified plants possible, and is it important?,
New Zealand Journal of Agricultural Research | https://doi.org/10.1080/00288233.2025.2479724
Co-existence and containment of genetically modified (GM) plants has been a contentious issue since GM technologies were first commercially released in the mid-1990s. In the first decade of commercial GM plant use, there were a significant number of contamination incidents resulting from GM presence in non-GM crops and seed, some with a significant financial penalty. However, these types of incidents seem to be less frequent in recent times. Co-existence regulations and guidance have been developed in many countries and can occur with appropriate planning and communication within farming communities. This appears to be working effectively since countries with the largest areas devoted to organic agriculture also have amongst the highest land area used for GM crops. Strategies for effective co-existence include both on-farm management decisions and downstream segregation during processing of products, including seed for sowing in the supply chain. Co-existence on-farm is important and is reliant on agronomic strategies such as planting times, crop placement, separation distances and physical containment to limit pollen dispersal and seed movement, which could be assisted by using biological/molecular containment through genetic manipulation to disrupt the pollination and fertilisation process. Co-existence of GM and non-GM crops has been and is possible.
https://www.tandfonline.com/doi/full/10.1080/00288233.2025.2479724#abstract
Nayak N, Mehrotra S, Karamchandani AN,Santelia D and Mehrotra R (2025): Recent advances in designing synthetic plant
regulatory modules. Front. Plant Sci. 16:1567659. | https://doi.org/10.3389/fpls.2025.1567659
Introducing novel functions in plants through synthetic multigene circuits requires strict transcriptional regulation. Currently, the use of natural regulatory modules in synthetic circuits is hindered by our limited knowledge of complex plant regulatory mechanisms, the paucity of characterized promoters, and the possibility of crosstalk with endogenous circuits. Synthetic regulatory modules can overcome these limitations. This article introduces an integrative de novo approach for designing plant synthetic promoters by utilizing the available online tools and databases. The recent achievements in designing and validating synthetic plant promoters, enhancers, transcription factors, and the challenges of establishing synthetic circuits in plants are also discussed.
https://www.frontiersin.org/journals/plant-science/articles/10.3389/fpls.2025.1567659/full
Mitchell K.J., Cheney N. (2025): The Genomic Code: the genome instantiates a generative model of the organism, Trends in
Genetics | DOI: 10.1016/j.tig.2025.01.008
How does the genome encode the form of the organism? What is the nature of this genomic code? Inspired by recent work in machine learning and neuroscience, we propose that the genome encodes a generative model of the organism. In this scheme, by analogy with variational autoencoders (VAEs), the genome comprises a connectionist network, embodying a compressed space of ‘latent variables’, with weights that get encoded by the learning algorithm of evolution and decoded through the processes of development. The generative model analogy accounts for the complex, distributed genetic architecture of most traits and the emergent robustness and evolvability of developmental processes, while also offering a conception that lends itself to formalization.
Yao Y., Guo W., Gou J., Baloch F.S. et al. (2025): Wheat2035: Integrating pan-omics and advanced biotechnology for future
wheat design. Molecular Plant, 18 (2) , 272 - 297 |
Wheat (Triticum aestivum) production is vital for global food security, providing energy and protein to millions of people worldwide. Recent advancements in wheat research have led to significant increases in production, fueled by technological and scientific innovation. Here, we summarize the major advancements in wheat research, particularly the integration of biotechnologies and a deeper understanding of wheat biology. The shift from multi-omics to pan-omics approaches in wheat research has greatly enhanced our understanding of the complex genome, genomic variations, and regulatory networks to decode complex traits. We also outline key scientific questions, potential research directions, and technological strategies for improving wheat over the next decade. Since global wheat production is expected to increase by 60% in 2050, continued innovation and collaboration are crucial. Integrating biotechnologies and a deeper understanding of wheat biology will be essential for addressing future challenges in wheat production, ensuring sustainable practices and improved productivity.
Horizontal gene transfer of cold shock protein genes boosted wheat adaptation and expansion. Nat. Plants (2025).
https://doi.org/10.1038/s41477-025-01985-z
CSP-H genes (encoding cold shock proteins) were horizontally transferred from bacteria to Triticeae and improved wheat adaptation by enhancing its tolerance to various abiotic stresses. Because these genes are integrated into the recipient genome and have been positively selected for thousands of years, they provide great potential for modern transgenic engineering and synthetic biology.
https://www.nature.com/articles/s41477-025-01985-z
Sutherland C., Gleim S., Lubieniechi S., Stuart J. Smyth S.J. (2025): Rate of herbicide resistant weed development: A Canadian
Prairie case study, GM Crops & Food, 16:1, 252-262, | https://doi.org/10.1080/21645698.2025.2477231
Genetically modified crop adoption in Canada has been the key driver in removing tillage as the lead form of weed control, due to increased weed control efficiency. Land use has transitioned from the use of summerfallow to continuous cropping, predominantly involving zero or minimum tillage practices. Prairie crop rotations have diversified away from mainly cereals to include three-year rotations of cereals, pulses, and oilseeds. Total herbicide volume applied has increased as crop production acres increased, but the rate of herbicide active ingredient applied per hectare has declined. Diverse crop rotations allow for weed control using herbicides with different modes of action, reducing selection pressure for resistant weed development. Herbicide-resistant weeds are an important concern for farmers, as the loss of key herbicides would make weed control exceedingly more difficult. The objective of this case study is to examine herbicide resistance weed development in the Canadian Prairies and to identify changes in resistance development following GM crop adoption.
https://www.tandfonline.com/doi/full/10.1080/21645698.2025.2477231#abstract
Butterfield G.L., Rohm D., Roberts A., +6 , Gersbach C.A. (2025): Characterization of diverse Cas9 orthologs for genome and
epigenome editing, PNAS 122 (11) e2417674122 | https://doi.org/10.1073/pnas.2417674122
CRISPR-Cas9 systems have revolutionized biotechnology, creating diverse new opportunities for biomedical research and therapeutic genome and epigenome editing. Despite the abundance of bacterial CRISPR-Cas9 systems, relatively few are effective in human cells, limiting the overall potential of CRISPR technology. To expand the CRISPR-Cas toolbox, we characterized a set of type II CRISPR-Cas9 systems from select bacterial genera and species encoding diverse Cas9s. Four systems demonstrated robust and specific gene repression in human cells when used as nuclease-null dCas9s fused with a KRAB domain and were also highly active nucleases in human cells. These systems have distinct protospacer adjacent motifs (PAMs), including AT-rich motifs and sgRNA features orthogonal to the commonly used Staphylococcus aureus and Streptococcus pyogenes Cas9s. Additionally, we assessed gene activation when fused with the p300 catalytic domain. Notably, S. uberis Cas9 performed competitively against benchmarks with promising repression, activation, nuclease, and base editing activity. This study expands the CRISPR-Cas9 repertoire, enabling effective genome and epigenome editing for diverse applications.
https://www.pnas.org/doi/10.1073/pnas.2417674122
Maximiano, M. R., Franco O.L. (20025). CRISPR/Cas genome editing: Innovations and impacts on animal protein
production. CABI Reviews 20:1 0003 | https://doi.org/10.1079/cabireviews.2025.0003
Food security has become an urgent global challenge as global population growth and climate change intensify. Livestock production systems must adapt to meet the growing demand for high-quality animal protein while minimizing environmental impacts. CRISPR/Cas genome editing has emerged as a transformative technology, enabling precise genetic modifications that enhance productivity, improve disease resistance, and promote animal welfare. In this context, this review aims to provide a comprehensive analysis of the current advancements in CRISPR/Cas genome editing tools for animal protein production, while addressing the challenges and future prospects of applying genome editing in livestock farming. Several studies have targeted genes associated with meat production, milk improvement, disease susceptibility, and animal welfare. The results have shown success in developing edited animals that increase meat production and milk quality and make animals more resilient to various infections, thereby reducing the economic losses associated with disease outbreaks. However, this advance still faces challenges, including technical, regulatory and ethical issues, and public acceptance. Even so, some of these edited animals are in the advanced stages of the regulatory approval process in some countries, including cattle with heat tolerance, pigs with resistance against PRRS-virus, and some fish that present an increase in meat production. In this context, this review consolidates current knowledge on CRISPR/Cas applications in animal protein production, highlights significant achievements, and addresses challenges related to the regulatory landscape, public perception, and ethical concerns. Furthermore, it emphasizes the importance of adaptable regulatory frameworks to ensure the responsible and sustainable advancement of genome editing in livestock.
https://www.cabidigitallibrary.org/doi/10.1079/cabireviews.2025.0003
Knoblich M., Gursinsky T., Gago-Zachert S.,Weinholdt C., Grau J., Behrens S.-E. (2025): A new level of RNA-based plant
protection: dsRNAs designed from functionally characterized siRNAs highly effective against Cucumber mosaic virus, Nucleic Acids Research 53,(5), 24, gkaf136 | https://doi.org/10.1093/nar/gkaf136
RNA-mediated crop protection increasingly becomes a viable alternative to agrochemicals that threaten biodiversity and human health. Pathogen-derived double-stranded RNAs (dsRNAs) are processed into small interfering RNAs (siRNAs), which can then induce silencing of target RNAs, e.g. viral genomes. However, with currently used dsRNAs, which largely consist of undefined regions of the target RNAs, silencing is often ineffective: processing in the plant generates siRNA pools that contain only a few functionally effective siRNAs (esiRNAs). Using an in vitro screen that reliably identifies esiRNAs from siRNA pools, we identified esiRNAs against Cucumber mosaic virus (CMV), a devastating plant pathogen. Topical application of esiRNAs to plants resulted in highly effective protection against massive CMV infection. However, optimal protection was achieved with newly designed multivalent ‘effective dsRNAs’ (edsRNAs), which contain the sequences of several esiRNAs and are preferentially processed into these esiRNAs. The esiRNA components can attack one or more target RNAs at different sites, be active in different silencing complexes, and provide cross-protection against different viral variants—important properties for combating rapidly mutating pathogens such as CMV. esiRNAs and edsRNAs have thus been established as a new class of ‘RNA actives’ that significantly increase the efficacy and specificity of RNA-mediated plant protection.
https://academic.oup.com/nar/article/53/5/gkaf136/8074820
Eckerstorfer, M.F.; Dolezel,M.; Miklau, M.; Greiter, A. et al. (2025): Environmental Applications of GM Microorganisms: Tiny
Critters Posing Huge Challenges for Risk Assessment and Governance. Int. J. Mol. Sci. 2025, 26, 3174. | https://doi.org/10.3390/ijms26073174
In recent years, the interest in developing genetically modified microorganisms (GMMs), including GMMs developed by genome editing, for use in the environment has significantly increased. However, the scientific knowledge on the ecology of such GMMs is severely limited. There is also little experience at the hands of regulators on how to evaluate the environmental safety of GMMs and on how to assess whether they provide sustainable alternatives to current (agricultural) production systems. This review analyzes two different GMM applications, GM microalgae for biofuel production and nitrogen-fixing GM soil bacteria for use as biofertilizers. We assess the challenges posed by such GMMs for regulatory environmental risk assessment (ERA) against the background of the GMO legislation existing in the European Union (EU). Based on our analysis, we present recommendations for ERA and the monitoring of GMM applications, and in particular for the improvement of the existing EU guidance. We also explore whether existing approaches for technology assessment can provide a framework for the broader assessment of GMM applications. To this end, we recommend developing and implementing an evidence-based sustainability analysis and other methods of technology assessment to support decision making and to address broader societal concerns linked to the use of GMM applications in the environment.
https://www.mdpi.com/1422-0067/26/7/3174
EFSA
FEZ Panel (2025): Safety evaluation of the food enzyme cellulose 1,4-β-cellobiosidase (non-reducing end) from the non-genetically
modified Trichoderma citrinoviride strain C1-5-2. EFSA Journal, 23(4), e9333. https://doi.org/10.2903/j.efsa.2025.9333
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9333
CEP Panel (2024): Safety evaluation of the food enzyme mucorpepsin from the non-genetically modified Rhizomucor miehei strain
M19-21. EFSA Journal, 22(2), e8633. https://doi.org/10.2903/j.efsa.2024.8633
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8633 (nicht neu – Ergänzungen und Korrekturen)