Sunday Evening News 437 - Week 33 - 2025
Weekly report on genetic engineering, genome editing, biotechnology and legal regulation.
August 2025-08-11 - August 2025-08-17
Bei den Pressemeldungen sollten Sie sich die vom Informationsdienst Gentechnik und die von IFOAM ansehen. Letztere bezieht sich auf die Publikation von: Fraiture M.-A., D'aes J., Gobbo A, Delvoye M. et al. (2025): Genetic fingerprints derived from genome database mining allow accurate identification of genome-edited rice in the food chain via targeted high-throughput sequencing. Food Research International, 117218 | https://doi.org/10.1016/j.foodres.2025.117218
Unter den Publikationen empfehle ich Kershen D.L. (2025): Agricultural biotechnology in the courts: judicial opinions and commentary. Front. Bioeng. Biotechnol., Sec. Biosafety and Biosecurity Volume 13 - 2025 | https://doi.org/10.3389/fbioe.2025.1592675
Please have you say: On Monday 11 August, the European Commission opened a public consultation on the EU Biotech Act, scheduled to run until 10 November 2025.
For press releases, check out the ones from the Genetic Engineering Information Service and IFOAM. The latter refers to the publication of: Fraiture M.-A., D'aes J., Gobbo A, Delvoye M. et al. (2025): Genetic fingerprints obtained from the analysis of genome databases enable the accurate identification of genome-edited rice in the food chain through targeted high-throughput sequencing. Food Research International, 117218 | https://doi.org/10.1016/j.foodres.2025.117218
Among the publications, I recommend Kershen D.L. (2025): Agricultural biotechnology in court: court rulings and comments. Front. Bioeng. Biotechnol., Sec. Biosafety and Biosecurity Volume 13 – 2025 | https://doi.org/10.3389/fbioe.2025.1592675
Please share your opinion: On Monday, August 11, the European Commission launched a public consultation on EU biotech legislation, which will run until November 10, 2025.
Meetings – Conferences / Treffen - Veranstaltungen
BIOFLAVOUR 2025 - Biotechnology of Flavours, Fragrances and Functional Ingredients
16 - 18 September 2025 DECHEMA House · Frankfurt · Germany
https://dechema.de/en/bioflavour2025
53. Deutsche Lebensmittelchemietage: 22. - 24. September 2025, Halle (Saale)
https://veranstaltungen.gdch.de/microsite/index.cfm?l=11752&sp_id=1&selMicrosite=128453
Press Releases - Media / Presse- und Medienberichte
Bodenmüller K.: Kommunikation- Universität Zürich: KI kombiniert mit CRISPR ermöglicht präzise Genveränderung
https://idw-online.de/en/news856619
Neuer Werkzeugkasten zur Züchtung klimaresilienter Nutzpflanzen
Grimm V.: Europas strategische Bewährungsprobe
VLOG-Newsletter 05/25: August
https://www.ohnegentechnik.org/vlog-newsletter-august-2025
More bio-based innovation can help reduce environmental impacts, boost Europe’s bioeconomy and sustainability
Testbiotech: Why plants obtained from new genetic engineering should not be deregulated
Pelouze G.-A.: The Wang study : A 7 years analysis to end emotional era on GMOs ?
Informationsdienst Gentechnik: Neue Gentechnik: Labore machen Nachweis zum Trilogthema
https://www.keine-gentechnik.de/nachricht/neue-gentechnik-labore-machen-nachweis-zum-trilogthema
IFOAM: DARWIN project develops a genetic fingerprint approach to detect gene-edited organisms
Only some selected press releases or media reports are listed here. The daily up-date of the press releases and
media reports are ►here: August week 33
Publications – Publikationen
Kershen D.L. (2025): Agricultural biotechnology in the courts: judicial opinions and commentary. Front. Bioeng. Biotechnol.,
Sec. Biosafety and Biosecurity Volume 13 - 2025 | https://doi.org/10.3389/fbioe.2025.1592675
Seven jurisdictions from around the world have issued judicial opinions that address fundamental issues about the governance and regulatory systems of agricultural biotechnology. This article summarizes these legal proceedings and describes their impact upon agricultural biotechnology. The article then provides a commentary and critique of the legal proceedings and resulting judicial opinions.
Naert, T., Yamamoto, T., Han, S. et al. (2025): Precise, predictable genome integrations by deep-learning-assisted design
of microhomology-based templates. Nat Biotechnol | https://doi.org/10.1038/s41587-025-02771-0
Precise CRISPR-based DNA integration and editing remain challenging, largely because of insufficient control of the repair process. We find that repair at the genome–cargo interface is predictable by deep learning models and adheres to sequence-context-specific rules. On the basis of in silico predictions, we devised a strategy of base-pair tandem repeat repair arms matching microhomologies at double-strand breaks. These repeat homology arms promote frame-retentive cassette integration and reduce deletions both at the target site and within the transgene. We demonstrate precise integrations at 32 loci in HEK293T cells. Germline-transmissible transgene integration and endogenous protein tagging in Xenopus and adult mouse brains demonstrated precise integration during early embryonic cleavage and in nondividing, differentiated cells. Optimized repair arms also facilitated small edits for scarless single-nucleotide or double-nucleotide changes using oligonucleotide templates in vitro and in vivo. We provide the design tool Pythia to facilitate precise genomic integration and editing for experimental and therapeutic purposes for a wide range of target cell types and applications.
https://www.nature.com/articles/s41587-025-02771-0
Engelhorn, J., Snodgrass, S.J., Kok, A. et al. (2025): Genetic variation at transcription factor binding sites largely explains
phenotypic heritability in maize. Nat Genet | https://doi.org/10.1038/s41588-025-02246-7
Comprehensive maps of functional variation at transcription factor (TF) binding sites (cis-elements) are crucial for elucidating how genotype shapes phenotype. Here, we report the construction of a pan-cistrome of the maize leaf under well-watered and drought conditions. We quantified haplotype-specific TF footprints across a pan-genome of 25 maize hybrids and mapped over 200,000 variants, genetic, epigenetic, or both (termed binding quantitative trait loci (bQTL)), linked to cis-element occupancy. Three lines of evidence support the functional significance of bQTL: (1) coincidence with causative loci that regulate traits, including vgt1, ZmTRE1 and the MITE transposon near ZmNAC111 under drought; (2) bQTL allelic bias is shared between inbred parents and matches chromatin immunoprecipitation sequencing results; and (3) partitioning genetic variation across genomic regions demonstrates that bQTL capture the majority of heritable trait variation across ~72% of 143 phenotypes. Our study provides an auspicious approach to make functional cis-variation accessible at scale for genetic studies and targeted engineering of complex traits.
https://www.nature.com/articles/s41588-025-02246-7
Richardson R.A.K., Hong S.S., Byrne, J.A. +1, and Amaral L.A.N.(2025): The entities enabling scientific fraud at scale are large,
resilient, and growing rapidly. PNAS 122 (32) e2420092122| https://doi.org/10.1073/pnas.2420092122
Science is characterized by collaboration and cooperation, but also by uncertainty, competition, and inequality. While there has always been some concern that these pressures may compel some to defect from the scientific research ethos—i.e., fail to make genuine contributions to the production of knowledge or to the training of an expert workforce—the focus has largely been on the actions of lone individuals. Recently, however, reports of coordinated scientific fraud activities have increased. Some suggest that the ease of communication provided by the internet and open-access publishing have created the conditions for the emergence of entities—paper mills (i.e., sellers of mass-produced low quality and fabricated research), brokers (i.e., conduits between producers and publishers of fraudulent research), predatory journals, who do not conduct any quality controls on submissions—that facilitate systematic scientific fraud. Here, we demonstrate through case studies that i) individuals have cooperated to publish papers that were eventually retracted in a number of journals, ii) brokers have enabled publication in targeted journals at scale, and iii), within a field of science, not all subfields are equally targeted for scientific fraud. Our results reveal some of the strategies that enable the entities promoting scientific fraud to evade interventions. Our final analysis suggests that this ability to evade interventions is enabling the number of fraudulent publications to grow at a rate far outpacing that of legitimate science.
https://www.pnas.org/doi/10.1073/pnas.2420092122
Sakthivel S.K., Vennapusa A.R. and Melmaiee K. (2025): Enhancing quality and climate resilient traits in vegetatively
propagated polyploids: transgenic and genome editing advancements, challenges and future directions. Front. Genet. 16:1599242 | https://doi.org/10.3389/fgene.2025.1599242
Vegetatively propagated polyploid crops such as potato, strawberry, sugarcane, and banana play a crucial role in global agriculture by meeting essential nutritional and food demands. The quality of the economically important traits in these crops is significantly affected by global climate change. However, their complex genomes and clonal propagation nature pose significant challenges for traditional breeding to improve quality and climate-resilient traits. Transgenics and genome editing offer promising solutions in crop improvement to enhance yield, quality, and biotic and abiotic stress tolerance. Despite these advancements, several challenges persist, such as a lack of genotype-independent transformation protocols, random transgene integration, unintended mutations, and somaclonal variation. The complexity of polyploid genomes also necessitates optimizing editing tools to improve precision and efficiency. Regulatory hurdles and public acceptance further influence the commercial success of genetically engineered crops. Employing efficient transgene-free genome-editing platforms can help to overcome the regulatory hurdles and accelerate breeding even in heterozygous backgrounds. This review reports the recent progress, obstacles, and prospects of transgenics and genome editing in vegetatively propagated crops, namely, potato, strawberry, banana, and sugarcane, focusing on quality and climate-resilient traits and methods to address technical challenges and navigate regulatory hurdles. The reported advancements in genetic engineering approaches for addressing challenges in improving the vegetatively propagated polyploid crops have tremendous potential in ensuring food security and agricultural sustainability in the face of climate change.
https://www.frontiersin.org/journals/genetics/articles/10.3389/fgene.2025.1599242/full
Lanzoni, A., Bosi, S., Bregola, V. et al. (2025): Dietary effects of transgenic MON810 Bt-maize pollen on fitness of
Hippodamia variegata Goeze. Arthropod-Plant Interactions 19, 54 | https://doi.org/10.1007/s11829-025-10161-1
Plant food such as pollen represents part of the diet of many predaceous coccinellids, exploited as a supplemental food source when prey is scarce. They can therefore suffer adverse effects when foraging on genetically modified plants expressing Cry1Ab toxin derived from Bacillus thuringiensis Berliner. The Variegated Lady Beetle, Hippodamia variegata Goeze, a very common and important aphid predator in the Mediterranean area, feeds preferably on aphids but can use plant pollen as a supplemental food source. Hence, it can be exposed to Cry proteins when foraging on insect-resistant Bt-maize. In the current study, an experimental methodology to provide pollen to the coccinellids and quantify the amount of pollen eaten was developed. Using this methodology, the potential effects of the consumption of Bt-maize pollen on the fitness of H. variegata were evaluated. Both standardized laboratory bioassays and demographic approach by means of an age-structured matrix population model were performed. Both biological and demographic parameters did not differ between coccinellids fed Bt- or non-Bt-maize pollen. However, demographic analyses showed that some effects of Bt pollen exposure on H. variegata occurred. Indeed, the Bt-pollen-fed females had a higher expected lifetime reproduction; however, a reduced life expectancy occurred early in life for their offspring. As a result, the consumption of Bt-maize pollen causes a lower increase in H. variegata population since a reduction of offspring survival seems only partially outweighed by increased female fecundity. Overall, this study shows that the consumption of Bt-maize pollen expressing Cry1Ab by adults of H. variegata does not significantly affect their fitness, but it also shows that this outcome is a result of a trade-off among vital rates such as age-specific fecundity and survival probability that are positively or negatively influenced. Moreover, the methodology proposed in this study provides a sound exposure system to supply pollen to the coccinellids and appears functional to quantify maize pollen consumption by H. variegata adults.
https://link.springer.com/article/10.1007/s11829-025-10161-1
Wang C., Calcaterra J., Anderson B., Timothy Rydel T. et al. (2024): Risk assessment of homologous variants of biotech trait
proteins using a bridging approach. GM Crops & Food, 15:1, 336-351, DOI: 10.1080/21645698.2024.2420412
A transgenic protein is frequently expressed as different homologous variants in genetically modified crops due to differential processing of targeting peptides or optimization of activity and specificity. The aim of this study was to develop a science-based approach for risk assessment of homologous protein variants using dicamba mono-oxygenase (DMO) as a case study. In this study, DMO expressed in the next-generation dicamba-tolerant maize, sugar beet and soybean crops exhibited up to 27 amino acid sequence differences in the N-terminus. Structure modeling using AlphaFold, ESMFold and OpenFold demonstrates that these small N-terminal extensions lack an ordered secondary structure and do not disrupt the DMO functional structure. Three DMO variants were demonstrated to have equivalent immunoreactivity and functional activity ranging from 214 to 331 nmol/min/mg. Repeated toxicity studies using each DMO variant found no test substance-related adverse effects. These results support that homologous protein variants, which have demonstrated physicochemical and functional equivalence, can leverage existing safety data from one variant without requiring additional de novo safety assessments.
https://doi.org/10.1080/21645698.2024.2420412
Carvalho A.S.P., Wigert S.T., Kirsch R. et al. (2025): Symbionts with eroded genomes adjust gene expression according to
host life-stage and environment. EMBO Reports | DOI: 10.1038/s44319-025-00525-2
Symbiotic bacteria in long-term host associations frequently undergo extreme genome reduction. While they retain genes beneficial to the host, their repertoire of transcription factors is severely reduced. Here, we assessed whether genome-eroded symbionts can still regulate gene expression by characterizing the transcriptional responses of obligate symbionts in reed beetles to different temperatures and host life stages. These symbionts feature a small genome (~0.5 Mb), encoding for 9–10 essential amino acid biosynthesis pathways, 0–2 pectinases, and 4–5 transcription factors. We found that the symbionts respond to winter conditions by upregulating a heat-shock sigma factor and downregulating translation machinery. Across life stages, symbionts adjusted gene expression to meet the hosts’ nutritional demands, upregulating amino acid biosynthesis in larvae, while expression and activity of host and symbiont enzymes involved in plant cell wall breakdown increased in the folivorous adults. In addition, the regulation of symbiont cell morphology genes corresponded to cell shape differences across life stages. Thus, reed beetle symbionts may use their few transcription factors to respond to the host’s environment, highlighting the regulatory potential of long-term coevolved symbionts despite severely reduced genomes.
https://www.embopress.org/doi/full/10.1038/s44319-025-00525-2
Quijada, N.M., Cobo-Díaz, J.F., Valentino, V. et al. (2025): The food-associated resistome is shaped by processing and
production environments. Nat Microbiol 10, 1854–1867 | https://doi.org/10.1038/s41564-025-02059-8
Food production systems may act as transmission routes for antimicrobial-resistant (AMR) bacteria and AMR genes (AMRGs) to humans. However, the food resistome remains poorly characterized. Here 1,780 raw-material (milk, brine, fresh meat and so on), end-product (cheese, fish, meat products and vegetables) and surface (processing, cooling, smoking, ripening and packing rooms) samples from 113 food processing facilities were subjected to whole-metagenome sequencing. Assembly-free analyses demonstrated that >70% of all known AMRGs, including many predicted to confer resistance to critically important antibiotics, circulate throughout food production chains, with those conferring resistance to tetracyclines, β-lactams, aminoglycosides and macrolides being the most abundant overall. An assembly-based analysis highlighted that bacteria from the ESKAPEE group, together with Staphylococcus equorum and Acinetobacter johnsonii, were the main AMRG carriers. Further evaluation demonstrated that ~40% of the AMRGs were associated with mobile genetic elements, mainly plasmids. These findings will help guide the appropriate use of biocides and other antimicrobials in food production settings when designing efficient antimicrobial stewardship policies.
https://www.nature.com/articles/s41564-025-02059-8
Musa S., Kukurová K., Ciesarová Z., Eisenhardt K., Scherf K.A. (2025): Asparaginase treatment for acrylamide reduction in
wheat and oat flakes: From laboratory- to pilot-scale. Applied Food Research 5 (2), 101237 | https://doi.org/10.1016/j.afres.2025.101237
Acrylamide is a contaminant in food that is produced during high-temperature processing. There is a growing need for mitigation strategies due to health concerns and regulatory guidelines. This study aims to evaluate the effectiveness of four commercial asparaginases in the reduction of acrylamide in wheat and oat flakes, as well as their impact on product quality. Additionally, scale-up experiments were conducted with one of the asparaginases to evaluate the transferability of laboratory-scale results into pilot-scale production for bran flakes. On a laboratory-scale, asparaginase treatment resulted in a higher reduction of acrylamide in oat flakes by 928 µg/kg using PreventASe XR, compared to the wheat flakes, which reduced acrylamide by 360 µg/kg using PreventASe L. These represent a reduction of up to 77 % and 58 %, for oat and wheat flakes, respectively, compared to the control. This is the first study to compare multiple commercial asparaginases across two whole grain matrices in flakes, providing a direct side-by-side evaluation of their performance. Moreover, we demonstrate the challenges of translating enzymatic mitigation from lab to pilot-scale, where acrylamide dropped by only 76 µg/kg, underlining key practical barriers in industrial applications. Minimal impacts on color and texture were observed. Our results contribute new insights into enzyme-based acrylamide reduction and point to the importance of optimizing processing conditions for the application of asparaginases on an industrial scale, benefiting both producers and consumers.
https://www.sciencedirect.com/science/article/pii/S2772502225005426
Bohl, M., Gregersen, S., Li, Z. et al. (2025): High-amylose barley bread improves postprandial glycemia compared to regular
barley and wheat bread in subjects with or without type 2 diabetes. Eur J Clin Nutr | https://doi.org/10.1038/s41430-025-01646-6
Background: Genetically modified (GMO) high-amylose barley lowers postprandial glucose. Since certain EU countries do not allow GMO barley, we therefore assessed if high-amylose barley made from traditional breeding (Lean Baking Barley, LBB) lowers postprandial glucose compared to bread made from regular barley (RB) or wheat (WF) in individuals with or without type 2 diabetes (T2D).
Methods: In a randomised crossover design, 38 participants (18 T2D and 20 non-T2D) consumed 160 g of bread made from 100% LBB, RB, or WF. Postprandial metabolic responses, appetite and bread perception were measured. A mixed model ANOVA was used for analysis.
Results: LBB bread reduced 4 h postprandial glucose measured as incremental area under the curve (iAUC) by 41% and 39% vs. WF and RB bread in T2D and by 28% and 32% in non-T2D (all, P < 0.05). In T2D, LBB reduced postprandial insulin (iAUC) by 52% and 38% vs. WF and RB, and by 60% vs. WF in non-T2D (all, P < 0.05). Postprandial GIP (iAUC) was lower after LBB in both groups vs. RB and WF (P < 0.05). GLP-1 (iAUC) and FFA (tAUC) were lower after LBB vs. WF in non-T2D (P < 0.05), but not in T2D. Appetite scores were similar for all breads. Overall liking was higher for WF but did not differ between barley types.
Conclusion: LBB breads reduce postprandial glucose and insulin compared to RB and WF bread in individuals irrespective of T2D. LBB may have potential as a functional food in prevention and management of T2D.
https://www.nature.com/articles/s41430-025-01646-6
Wakasa, Y., Kawakatsu, T., Hayashi, S. et al. (2025): Evaluation of transgenic rice seeds expressing T cell epitopes of
Japanese cedar pollen allergens. Transgenic Res 34, 37 | https://doi.org/10.1007/s11248-025-00456-7
A new line of cedar pollen allergen–accumulating transgenic rice, which accumulated the 7Crp peptide comprised of 7 concatenated major T cell epitopes of cedar pollen allergens, was developed; it improved on the shortcomings of an original transgenic line. The new line has one copy of inserted T-DNA and a substantial expression of the 7Crp peptide, and was named Os7Crp2. Regulatory approval is needed before commercializing this cedar pollen peptide rice as a genetically modified food product in Japan. Therefore Os7Crp2 was evaluated for the criteria required for food safety assessments, under the guidance of Standards for the Safety Assessment of Genetically Modified Foods (Seed Plants) in Japan. No statistically significant differences were found between Os7Crp2 and the control (parental) Dongtokoi cultivar in physicochemical properties, expressed traits, or concentrations of key components, except for the insertion of the T-DNA and expression of the recombinant protein derived from the transgenes. These results suggest that Os7Crp2 is compositionally equivalent to non-transgenic rice.
https://link.springer.com/article/10.1007/s11248-025-00456-7
Risse, J., Pietrek, L., Cantz, T. et al. (2025): “Snip, snip, cure”? Philosophical, legal and biomedical perspectives on novel
somatic genomic therapies. Med Health Care and Philos | https://doi.org/10.1007/s11019-025-10284-5
The advent of innovative techniques, such as the CRISPR/Cas system, has opened up a new range of possibilities for modifying the genome, with the potential to address previously unmet therapeutic needs of patients with genetic diseases. These new possibilities have not only raised ethical concerns but also challenged existing classifications of genome modification techniques. While the legal status of some of these new therapies remains uncertain, there is an ongoing debate within philosophy of biology about the information-related metaphors adopted by scientists to describe and classify the genome and its therapeutic modification. Given the continuing advance of new genomic therapies, we show, employing an interdisciplinary approach, that a comprehensive framework for the classification of these technologies is needed to resolve legal and philosophical issues. The first section provides an analysis of the current state of novel genome-modifying techniques in medical genetics. In the second section, we assess the regulatory status of these techniques within the European regulatory framework for advanced therapy medicinal products (ATMPs). Drawing on these results, we argue in the third section from a philosophical perspective that metaphors, such as ‘editing’ the genome, which are based on a conception of the genome as linear information, cannot adequately capture the breadth of advanced genomic technologies. To accurately categorise these techniques in a manner that meets their diverse applications, we propose introducing the umbrella term ‘somatic genomic therapies’ (SGTs). Urging an integrative approach to defining and classifying new technologies in medical genetics, we advocate for the development of an integrative concept of SGTs.
https://link.springer.com/article/10.1007/s11019-025-10284-5