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Background: Oilseed plants of the Brassicaceae plant family are cultivated for food, feed and industrial purposes on large-scale in Europe. This review gives an overview of current market-oriented applications of new genomic techniques (NGTs) in relevant Brassicaceae oilseed crops based on a literature survey. In this respect, changes in oil quality, yield, growth and resistance to biotic and abiotic stress are under development in oilseed rape (Brassica napus), camelina (Camelina sativa), and pennycress (Thlaspi arvense). Main findings: Environmental risk scenarios starting with hazard identification are developed for specific NGT applications in Brassicaceae oilseed crops with either a changed oil composition or with fitness-related traits. In case of a changed oil composition, an increase or decrease of polyunsaturated fatty acids (PUFA) may lead to risks for health and survival of pollinators. Regarding fitness-related traits, other risks were identified, i.e. an increased spread and persistence of NGT plants. Furthermore, there are indications for potential disturbance of interactions with the environment, involving signalling pathways and reaction to stress conditions. Conclusion: It is shown that for environmental risk scenarios of the technological specificities of NGTs, the plants' biology and the scale of releases have to be considered in combination. Therefore, the release of NGT plants into the environment for agricultural purposes will, also in future, require risk assessment and monitoring of individual traits as well as of combinatorial and long-term cumulative effects. In addition, risk management should develop concepts and measures to control and potentially limit the scale of releases. This is especially relevant for NGT Brassicaceae in Europe, which is a centre of diversity of this plant family. [ABSTRACT FROM AUTHOR]

Gene drives have great potential for suppression of pest populations and removal of exotic invasive species. CRISPR homing suppression drive is a powerful but unconfined drive, posing risks of uncontrolled spread. Thus, developing methods for confining a gene drive is of great significance. Tethered drive combines a confined system such as Toxin‐Antidote Recessive Embryo drive with a strong drive such as a homing suppression drive. It can prevent the homing drive from spreading beyond the confined drive and can be constructed readily, giving it good prospects for future development. However, we have found that care must be taken when deploying tethered drive systems in some scenarios. Simulations of tethered drive in a panmictic population model reveal that successful deployment requires a proper release ratio between the two components, tailored to prevent the suppression drive from eliminating the confined system before it has the chance to spread. Spatial models where the population moves over a one‐dimensional landscape display a more serious phenomenon of drive wave interference between the two tethered drive components. If the faster suppression drive wave catches up to the confined drive wave, success is still possible, but it is dependent on drive performance and ecological parameters. Two‐dimensional simulations further restrict the parameter range for drive success. Thus, careful consideration must be given to drive performance and ecological conditions, as well as specific release proposals for potential application of tethered drive systems. [ABSTRACT FROM AUTHOR]

Gossypium hirsutum L., commonly known as upland cotton, is cultivated globally for natural fiber, feed, and seed oil. To enhance agricultural productivity and quality, living modified (LM) cotton has been developed and utilized since the late 1990s. Due to environmental concerns, such as biodiversity risks associated with living modified organisms (LMOs), the Korean government, including the Ministry of Environment, has been conducting LMO natural environment monitoring and post-management projects. In this study, we developed a loop-mediated isothermal amplification (LAMP) assay to detect five specific LM cotton events (MON88701, MON531, MON15985, MON88913, and COT102), which were the most abundant volunteers observed from 2019 to 2021 in South Korea. The event-specific LAMP assays for the five LM cotton events were established with a 40-min reaction time using LAMP reaction buffer, Bst DNA polymerase, and event-specific primers. The limit of detection ranged from 0.01 to 1 ng/μL. The assays' specificity and sensitivity were validated through colorimetric changes, fluorescence intensity measurements, and conventional PCR. To demonstrate the practical application of the LAMP assays, we tested 22 LM cotton volunteers collected from the natural environment in 2021. Each LAMP assay event-specifically amplified the respective LM cotton volunteers. These results indicate that the developed LAMP assays are effective tools for the efficient management and detection of LM cotton in field surveys, supporting regulatory compliance and environmental monitoring efforts. [ABSTRACT FROM AUTHOR]

Gene drive could be a powerful tool for addressing problems of conservation, agriculture, and human health caused by insect and animal pests but is likely to be controversial as it involves the release of genetically modified organisms. This study examined the social determinants of opinion of gene drive. We asked a representative sample of the U.S. public to respond to a description of a hypothetical application of a gene-drive mosquito to the problem of malaria and examined the relationship of these responses with demographic and ideological beliefs. We found strong general approval for the use of gene-drive mosquitos to address malaria, coinciding with the concern about a possible environmental impact of modified mosquitos and that gene drives represent "too much power over nature." Among the determinants we measured, respondent acceptance of scientism and trust that scientists are advancing the public's interest were the greatest predictors of views of gene drive. [ABSTRACT FROM AUTHOR]

Species of Saccharomyces genus have played an irreplaceable role in alcoholic beverage and baking industry for centuries. S. cerevisiae has also become an organism of choice for industrial production of alcohol and other valuable chemicals and a model organism shaping the rise of modern genetics and genomics in the past few decades. Today´s brewing industry faces challenges of decreasing consumption of traditional beer styles and increasing consumer demand for new styles, flavors and aromas. The number of currently used brewer's strains and their genetic diversity is yet limited and implementation of more genetic and phenotypic variation is seen as a solution to cope with the market challenges. This requires modification of current production strains or introduction of novel strains from other settings, e.g. industrial or wild habitats into the brewing industry. Due to legal regulation in many countries and negative customer perception of GMO organisms, the production of food and beverages requires non-GMO production organisms, whose development can be difficult and time-consuming. Here, we apply FIND-IT (Fast Identification of Nucleotide variants by DigITal PCR), an ultrafast genome-mining method, for isolation of novel yeast variants with varying flavor profiles. The FIND-IT method uses combination of random mutagenesis, droplet digital PCR with probes that target a specific desired mutation and a sub-isolation of the mutant clone. Such an approach allows the targeted identification and isolation of specific mutant strains with eliminated production of certain flavor and off-flavors and/or changes in the strain metabolism. We demonstrate that the technology is useful for the identification of loss-of function or gain of function mutations in unrelated industrial and wild strains differing in ploidy. Where no other phenotypic selection exists, this technology serves together with standard breeding techniques as a modern tool facilitating a modification of (brewer's) yeast strains leading to diversification of the product portfolio. • Mutagenesis and ddPCR allow for targeted mutant identification in brewer's yeast. • Modification of flavor profiles has been achieved in various industrial yeasts. • Heterothallic S. eubayanus strain facilitates development of novel lager hybrids. • Combination of the method with other non-GM techniques creates phenotypic diversity. • Method enables non-GMO engineering and improvement of brewing-related properties. [ABSTRACT FROM AUTHOR]

The unintentional release of living modified organisms (LMOs) into natural environments poses potential ecological risks, particularly in terms of gene flow and biodiversity loss. Since 2009, the Ministry of Environment (MOE) in South Korea has conducted an extensive monitoring project to detect and manage LMOs, with a primary focus on LM canola. This study evaluates the outcomes of the LMO monitoring project over the past 15 years (2009–2023), analyzing the distribution, persistence, and management of LM canola across various environments. Our findings reveal that LM canola predominantly proliferates along roadsides, with occasional occurrences at festival and planting sites. Out of 10,571 monitored sites, 4326 suspicious samples were collected, with a significant increase observed in 2017, underscoring the ongoing risk of accidental releases. This study highlights the critical role of specific environments in the spread of LM canola, and assesses the effectiveness of post-management strategies in controlling these populations. The National Institute of Ecology (NIE) has developed and implemented advanced monitoring protocols and post-management systems tailored to the characteristics of the monitoring sites and the nature of the LMOs. These efforts have been effective in controlling the spread of LM canola, thereby helping to preserve the biodiversity of South Korea's natural environments. In conclusion, the proactive and adaptive strategies employed by the NIE are essential for mitigating the ecological risks associated with LMOs. Our study emphasizes the importance of on-going vigilance and the continuous refinement of monitoring and management practices to safeguard biodiversity and ecosystems. [ABSTRACT FROM AUTHOR]

Simple Summary: The xanthophyll cycle plays an important role in plants' responses to abiotic stress. Zeaxanthin epoxidase (ZEP) contributes to the xanthophyll cycle and the biosynthesis of abscisic acid (ABA) and carotenoids. The biological function of ZEP has been extensively studied in higher plants but has not been reported in Ulva prolifera. In this study, the relative content of xanthophylls was determined in U. prolifera. We also cloned and analyzed a ZEP gene from U. prolifera, namely UpZEP. The expression and biological function of the UpZEP gene were examined. The results of this study provide a theoretical basis for understanding the high-salt resistance of U. prolifera. The xanthophyll cycle is a photoprotective mechanism in plants and algae, which protects the photosynthetic system from excess light damage under abiotic stress. Zeaxanthin is considered to play a pivotal role in this process. In this study, the relative content of xanthophylls was determined using HPLC-MS/MS in Ulva prolifera exposed to different salinities. The results showed that high-salt stress significantly increased the relative content of xanthophylls and led to the accumulation of zeaxanthin. It was speculated that the accumulated zeaxanthin may contribute to the response of U. prolifera to high-salt stress. Zeaxanthin epoxidase (ZEP) is a key enzyme in the xanthophyll cycle and is also involved in the synthesis of abscisic acid and carotenoids. In order to explore the biological function of ZEP, a ZEP gene was cloned and identified from U. prolifera. The CDS of UpZEP is 1122 bp and encodes 373 amino acids. Phylogenetic analysis showed that UpZEP clusters within a clade of green algae. The results of qRT-PCR showed that high-salt stress induced the expression of UpZEP. In addition, heterologous overexpression of the UpZEP gene in yeast and Chlamydomonas reinhardtii improved the salt tolerance of transgenic organisms. In conclusion, the UpZEP gene may be involved in the response of U. prolifera to high-salt stress and can improve the high-salt tolerance of transgenic organisms. [ABSTRACT FROM AUTHOR]

Background PCR-based genetic testing of agricultural products and foods is widely used for detecting various analytical targets such as genetically modified organisms and food allergens. However, it is difficult to obtain accurate genetic testing results from processed foods because DNA is fragmented by heat and pressure during food processing. Thus, we previously developed an analytical method to quantitatively evaluate the degree of DNA fragmentation for the purpose of QC of genetic testing for processed foods. Objective Our previous analytical method requires four PCR primer sets, resulting in high reagent costs and heavy analytical workloads. Therefore, we attempted to develop an easy-to-use test kit for quantifying the degree of DNA fragmentation and to evaluate its analytical performance. Methods To simplify the analysis procedure, we used only two primer sets. In addition, no-fragmentation control templates were prepared to obtain stable measurement results. The precision of the simplified analysis was evaluated through blind tests between laboratories. Results It was confirmed that plant species and extracted DNA concentrations had little effect on analysis with the newly developed test kit. In addition, the analytical values indicating the degree of DNA fragmentation exhibited small variability between laboratories. Conclusion We confirmed the high practicality of the developed test kit. Because DNA fragmentation in cells is a universal phenomenon, we anticipate that the test kit will be used not only for QC of genetic testing but also for food testing, medical diagnostics, and other applications in a range of fields. Highlights The newly developed test kit enables quantitative evaluation of the degree of DNA fragmentation in a simple manner. [ABSTRACT FROM AUTHOR]

Societal Impact Statement: The problem of genetically modified maize contamination in Mexico is the result of both planned and unplanned consequences of scientific and political choices. We show how a risk management strategy based on the modernist dichotomy between "modern" and "native" has failed to protect Mexican landraces and has marginalized other forms of knowledge that are urgently needed to understand and support the fluidity of Mexican biocultural landscapes. Farmers' seed systems are a fundamental source of crop resilience and evolution. They can constitute safe pathways for creating new maize varieties able to withstand climate and societal changes. Summary: In 2001, an alert on the contamination of Mexican maize landraces by genetically modified (GM) maize spurred new actions to conserve the world's biggest reservoir of maize genetic diversity. We analyze how the largest maize collection effort in Mexican history, and the definition of the conservation procedures employed in it, either involved or marginalized different approaches to this environmental problem.The article is grounded in the sociohistorical analysis of the controversy of GM maize contamination and brings together new historiographical perspectives on Mexican scientific and political interest in native maize. It also draws on ethnographic approaches, extended fieldwork, and analysis of data from Mexican government agencies.We show how different epistemological traditions have made the risk of GM maize contamination (in)visible and thereby generated normative choices. We illustrate how the GMO controversy brought the theme of native maize back onto the Mexican political and scientific agenda. The normativity that shaped the controversy in the 2000s influenced current knowledge and how the problem of GM maize introgression is still addressed today.The entanglements between biotechnology, native landraces, and farmers' practices are too dense to be "scientized" and kept separate to be made manageable as areas of purely technical "risk." The result is a geography of maize infused with all sorts of temporalities and materiality, which escapes the bounds of technoscientific framings. This intricate environment‐making process calls for new collaborations among epistemic cultures to tackle the possible consequences of GMOs for agrobiodiversity, seed systems, and their resilience. [ABSTRACT FROM AUTHOR]

Mutagenesis is an important tool in crop improvement and free of the regulatory restrictions imposed on genetically modified organisms. Barley (Hordeum vulgare L.) is a diploid species with a genome smaller than those of other members of the Triticeae crops, making it an attractive model for genetic studies in Triticeae crops. In this study, we report an ethyl methane sulfonate (EMS)-mutagenized population in the Chinese barley landrace TX9425, which is tolerant to both abiotic and biotic stress. A TILLING (Targeting Induced Locus Lesion in Genomes) population consisting of 2000 M2 lines was also constructed based on the CEL I enzyme with subsequent polyacrylamide electrophoresis, which decreased the cost and labor investment. The mutant phenotypes of the M2 and M3 generations were scored and revealed the presence of a wide spectrum of morphological diversity. The population was evaluated by screening for induced mutations in five genes of interest. A detailed analysis was performed for the HvGLR3.5 gene and three mutations were identified by screening in 2000 M2 lines. Two of three mutations displayed tuft and yellow striped leaves compared to the wild type. Altogether, our study shows the efficiency of screening and the great potential of the new TILLING population for genetic studies in the barley crop model system. [ABSTRACT FROM AUTHOR]

Since the development of recombinant DNA technologies, the need to establish biosafety and biosecurity measures to control genetically modified organisms has been clear. Auxotrophies, or conditional suicide switches, have been used as firewalls to avoid horizontal or vertical gene transfer, but their efficacy has important limitations. The use of xenobiological systems has been proposed as the ultimate biosafety tool to circumvent biosafety problems in genetically modified organisms. Xenobiology is a subfield of Synthetic Biology that aims to construct orthogonal biological systems based on alternative biochemistries. Establishing true orthogonality in cell-based or cell-free systems promises to improve and assure that we can progress in synthetic biology safely. Although a wide array of strategies for orthogonal genetic systems have been tested, the construction of a host harboring fully orthogonal genetic system, with all parts operating in an orchestrated, integrated, and controlled manner, still poses an extraordinary challenge for researchers. In this study, we have performed a thorough review of the current literature to present the main advances in the use of xenobiology as a strategy for biocontainment, expanding on the opportunities and challenges of this field of research. [ABSTRACT FROM AUTHOR]

The marketing authorization of Advanced Therapy Medicinal Products (ATMPs) in Brazil is recent. The features of these therapies impose specialized regulatory action and are consequently challenging for developers. The goal of this study was to identify the industry's experience in clinical development, marketing authorization and access to ATMPs through the Unified Health System (SUS, acronym in Portuguese), from a regulatory perspective. A survey containing structured questions was conducted among research participants who work at companies that commercialize ATMPs. A descriptive analysis was performed. We invited 15 foreign pharmaceutical companies, of which 10 agreed to participate. Overall, participants assessed that Brazil has a well-established regulatory system, especially the sanitary registration by the National Health Surveillance Agency (Anvisa), which ensures the quality, safety, and efficacy of the products. The Agency's good interaction with the regulated sector, the harmonization of sanitary and ethical assessment systems with other countries, and the analysis time in the biosafety assessment of Genetically Modified Organisms (GMOs) stand out as positive in industry's evaluation. On the other hand, it is important to advance the pricing regulation for these products since Brazilian regulations do not establish specific criteria for ATMP. One of the biggest challenges is the difficulty for the SUS in reimbursing these very high-cost therapies, especially using current Health Technology Assessment (HTA) methods. Considering the increasing number of approvals of cell and gene therapies in Brazil in the coming years, a close dialogue between the industry and the public sector is recommended to advance regulatory improvements (pricing and HTA). Additionally, the construction of policies to promote the national Health Economic-Industrial Complex, based on a mission-oriented vision that encourages innovative models of financing, especially those that consider risk-sharing and co-financing technologies, will help provide the population with universal, equitable and sustainable access to ATMP in the SUS. [ABSTRACT FROM AUTHOR]

A commentary on the 2024 article "Reasons and Reproduction: Gene Editing and Genetic Selection," by J. McMahan and J. Savulescu is presented. Topics covered include the variations of the two-tier view of the authors, how the variations yield different ethical implications when causing a particular disability and a response to the objection that such a subject-dependent value profile would not work at the embryonic stage.

A commentary on the 2024 article "Reasons and Reproduction: Gene Editing and Genetic Selection," by J. McMahan and J. Savulescu is presented. Topics covered include how impersonal reasons speak in favor of genetic selection and genetic editing, how the two methods differ as regards persona-affecting reasons and how both approaches lead to dynamic inconsistencies and to sub-optimal outcomes being chosen.

Many writers in bioethics, science, and medicine contend that embryo selection is a morally better way of avoiding genetic disorders then gene editing, as the latter has risks that the former does not. We argue that one reason to use gene editing is that in many cases it would be better for the person who would develop from the edited embryo, so that not to have done it would have been worse for that person. By contrast, embryo selection is never better for the person who develops from the selected embryo. This reason to use gene editing has, however, been challenged on two grounds: first, that it makes no difference, morally, whether a bad effect is worse for someone, or a good effect better for someone; and, second, that beneficent gene editing would not be unequivocally better for the person who would develop from the edited embryo. We argue that both of these objections can be satisfactorily answered and thus that there is indeed a significant moral reason, at least in some cases, to use gene editing rather than embryo selection. [ABSTRACT FROM AUTHOR]

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technologies have revolutionized genome editing, significantly advancing the improvement of cultivated crop species. This review provides an overview of genome-edited crops that have either reached the market or received the necessary approvals but are not yet available to consumers. We analyze various genome-editing studies to understand the distribution of different genome-editing systems, the types of site-directed nucleases employed, and the geographical spread of these studies, with a specific focus on global and European contexts. Additionally, we examine the target crops involved. The review also outlines the multiple steps required for the legal acceptance of genome-edited crops within European jurisdictions. We conclude with suggestions for the future prospects of genome-editing research in Europe, aiming to streamline the approval process and enhance the development and adoption of genome-edited crops. [ABSTRACT FROM AUTHOR]

In Türkiye, in accordance with European Union harmonization laws, the Biosafety Act No. 5977 entered into force on September 18, 2010. The basic legislation regarding the application process is composed of the Biosafety Act, Regulations on Genetically Modified Organisms and Their Products, and Regulations on Working Procedures and Principles of Biosafety Board and Committees. Biosafety legislation foresees a special application procedure for genetically modified organism (GMO) food, food products, feed, and other products. The application regulated in the Biosafety Law is a special administrative procedure in nature. The primary objective of this study is to explain the legal regime of this application procedure. While explaining this issue, relevant limitations will be discussed in detail, and solutions will be presented for such limitations. This study was divided into two parts. The first part examines the basic concepts related to the application will be examined, including its scope and nature of the application, the prohibitions, and exceptions related to the application, the applicant, and the relevant authorities. The second part focuses on the application process, covering notifications to the applicant and reasons for rejection of the application, evaluation of the application, final decision stage, and simplified procedure. [ABSTRACT FROM AUTHOR]

EFSA was asked by the European Parliament to provide a scientific opinion on the analysis by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) of Annex I of the European Commission proposal for a regulation 'on plants obtained by certain new genomic techniques (NGTs) and their food and feed, and amending regulation (EU) 2017/625'. The Panel on genetically modified organisms (GMO) assessed the opinion published by ANSES, which focuses on (i) the need to clarify the definitions and scope, (ii) the scientific basis for the equivalence criteria and (iii) the need to take potential risks from category 1 NGT plants into account. The EFSA GMO Panel considered the ANSES analysis and comments on various terms used in the criteria in Annex I of the European Commission proposal and discussed definitions based on previous EFSA GMO Panel opinions. The EFSA GMO Panel concluded that the available scientific literature shows that plants containing the types and numbers of genetic modifications used as criteria to identify category 1 NGT plants in the European Commission proposal do exist as the result of spontaneous mutations or random mutagenesis. Therefore, it is scientifically justified to consider category 1 NGT plants as equivalent to conventionally bred plants with respect to the similarity of genetic modifications and the similarity of potential risks. The EFSA GMO Panel did not identify any additional hazards and risks associated with the use of NGTs compared to conventional breeding techniques in its previous Opinions. [ABSTRACT FROM AUTHOR]

Purpose: More than 20 genetically modified (GM) food crops including rice have been approved in many countries. GM rice and derived products have not yet been approved in India so they are considered as unauthorized genetically modified organisms (GMOs) in the country. Therefore it is important to track whether the rice containing food items, available in the marketplace are GMO-free. Methods: A pilot study was conducted to check the GM status of 30 samples of packed rice grains and processed food products with rice as an ingredient, using polymerase chain reaction (PCR) assays targeting Cauliflower Mosaic Virus 35 S promoter (P-35 S), nopaline synthase terminator (T-nos), phosphinothricin-N-acetyltransferase (pat) and cry1Ac gene, which could cover screening for all the globally approved GM rice events. Results: Based on the results, none of the samples tested were found positive for P-35 S, T-nos, pat and cry1Ac. Conclusion: The unauthorized presence of GM rice ingredients was not detected in the samples tested. Such studies may further be conducted for the testing of GM ingredients derived from cereals other than rice in the food products imported from the country where GM events of respective cereal crop are approved, as a part of regulatory requirement. [ABSTRACT FROM AUTHOR]

Information on the state of the environment is important to achieve the objectives of the European Green Deal, including the EU's Biodiversity Strategy for 2030. The existing regulatory provisions for genetically modified organisms (GMOs) foresee an obligatory post-market environmental monitoring (PMEM) of potential adverse effects upon release into the environment. So far, GMO monitoring activities have focused on genetically modified crops. With the advent of new genomic techniques (NGT), novel GMO applications are being developed and may be released into a range of different, non-agricultural environments with potential implications for ecosystems and biodiversity. This challenges the current monitoring concepts and requires adaptation of existing monitoring programs to meet monitoring requirements. While the incorporation of existing biodiversity monitoring programs into GMO monitoring at the national level is important, additional monitoring activities will also be required. Using case examples, we highlight that monitoring requirements for novel GMO applications differ from those of GM crop plants previously authorized for commercial use in the European Union. [ABSTRACT FROM AUTHOR]

The adoption of genetically modified organisms (GMOs) in Ghana has raised a lot of public concerns and mixed feelings among some Ghanaians. Our present study, therefore, explored the current knowledge of the general public on GMOs, their perceptions, and factors that influence their understanding of GMOs. A total of 200 Ghanaians were interviewed using an online semi-structured questionnaire to solicit information on their knowledge of GMOs. The findings of the study showed that most Ghanaians (183 out of 200) are aware of GMOs. Age and level of education significantly influenced consumers' awareness of GMOs. The results also revealed that most of the participants have a medium to a high level of knowledge of GMOs; however, limited information about GMOs is available to the public. About 61% of the respondents are willing to consume GMOs when made available in Ghana. Also, the findings of the study showed that the respondents would prefer GM-labelled products. The educational level of the respondents significantly influenced their knowledge and understanding of GMOs. The study recommends that scientists and various media platforms provide a platform to address the concerns of the public on GMOs and occasionally engage them in GMO-related issues and their role in addressing food insecurity and malnutrition. [ABSTRACT FROM AUTHOR]

To protect individuals who already have or are at risk of developing immune‐mediated adverse reactions to food, novel foods and genetically modified organisms (GMOs) undergo an allergenicity risk assessment. There are shortcomings in this process that could be improved through use of well‐defined clinically relevant allergen molecules with different allergenic potential. The objective of this project was to develop novel strategies for predicting allergenicity of innovative/novel proteins that address this issue. We undertook a systematic review of allergen molecules in foods listed on Annex II of the Food Information for Consumers Regulation together with additional foods known to cause IgE‐mediated food allergies in at least one European region with a prevalence of 0.5%. Around 750 in‐scope papers were quality assessed to allow clinical relevance of allergen molecules to be ranked. The best characterised clinically relevant allergens were identified in peanut, hazelnut, cow's milk, fish and crustacean shellfish with data lacking for allergens from foods such as pecan, Macadamia, lupin and melon. Furthermore, an assessment of in silico tools allergenicity prediction found that, whilst many were able to correctly predict allergenicity, none were able to provide an output that could be linked to the clinical relevance. Building on these outcomes an approach for allergenicity risk assessment has been developed that brings together elements of exposure assessment, combining in silico, in vitro, and in vivo methods. Tools for assessment of risks of cross‐reactive allergies are more mature and only require refinement to improve the outputs to inform the allergenicity risk assessment process. However, as mechanisms underlying development of food allergy are not fully elucidated, and remain a matter of ongoing research, prediction of de novo sensitisation is uncertain. [ABSTRACT FROM AUTHOR]

Over recent years, dozens of legal challenges have been instituted in response to government action during the COVID-19 pandemic. While public health orders have been challenged on several grounds, few cases have succeeded. Fewer cases still have called into question decisions made by the Therapeutic Goods Administration (TGA) to approve the COVID-19 vaccines. This section provides a brief update on one recent, partially successful COVID-19 health directions case before examining two applications in the Federal Court of Australia seeking judicial review of the TGA's approval of the COVID-19 vaccines. The section argues that, while both TGA applications were dismissed for lack of standing, they illustrate how and why third parties will ordinarily not be entitled to challenge administrative decisions about therapeutic goods. [ABSTRACT FROM AUTHOR]

If genetically modified organisms (GMOs) are approved in the EU for experimental release or marketing authorization (placing on the market), a risk assessment (RA) is carried out beforehand to determine whether this may be associated with negative effects on human health, nature or the environment. Applications are reviewed by the European Food Safety Authority (EFSA) and the national Competent Authorities of the Member States. However, the potential ramifications of the GMOs that are systematically addressed in the current RA context are limited. Broader consideration can include environmental and health aspects beyond the scope of the statutory RA, as well as societal, ethical and cultural impacts. These other levels of impact may be considered during the comitology process of authorisation, but how this is done is typically not made explicit in a systematic way. However, with the dynamic developments of new kinds of GMOs, these considerations as well as transparency regarding the role of broader considerations in political decision-making become more and more relevant. Against this backdrop, we identified the requirements and suggest the main elements for such a broader assessment. We use insights from the field of Technology Assessment (TA) to explore the requirements for operationalising a rapid but still systematic, transparent and broad case-by-case GMO assessment compatible with the existing legislative framework. [ABSTRACT FROM AUTHOR]

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The international working group "Development of methods for identification of foodstuffs produced by means of genetic engineering techniques" was established pursuant to § 64 of the German Food and Feed Code (LFGB). It has developed a guideline for implementing and verifying digital PCR methods previously validated as real-time PCR techniques. While event-specific methods in testing of genetically modified organisms (GMO) have traditionally relied on real-time PCR, new digital PCR technologies offer significant advantages and therefore, leading to an increased use by control laboratories. This guideline provides practical recommendations for transferring the real-time PCR to digital PCR and for verifying the digital PCR method. The guideline is applicable to analysis of GMO in food, feed and seed and is freely available on the website of the Federal Office of Consumer Protection and Food Safety (BVL). [ABSTRACT FROM AUTHOR]

The Ser/Leu-swapped genetic code can act as a genetic firewall, mitigating biohazard risks arising from horizontal gene transfer in genetically modified organisms. Our prior work demonstrated the orthogonality of this swapped code to the standard genetic code using a cell-free translation system comprised of 21 in vitro transcribed tRNAs. In this study, to advance this system for protein engineering, we introduce a natural/in vitro transcribed-hybrid tRNA set. This set combines natural tRNAs from Escherichia coli (excluding Ser, Leu, and Tyr) and in vitro transcribed tRNAs, encompassing anticodon-swapped tRNASerGAG and tRNALeuGGA. This approach reduces the number of in vitro transcribed tRNAs required from 21 to only 4. In this optimized system, the production of a model protein, superfolder green fluorescent protein, increases to 3.5-fold. With this hybrid tRNA set, the Ser/Leu-swapped cell-free translation system will stand as a potent tool for protein production with reduced biohazard concerns in future biological endeavors. The use of orthogonal genetic code can help to prevent the escape of hazardous genes through horizontal gene transfer. Here, the authors develop a cell-free translation system with the Ser/Leu-swapped genetic code using a hybrid tRNA set and show its application in enhancing the production of superfolder GFP. [ABSTRACT FROM AUTHOR]

NOD1 and NOD2 as two representative members of nucleotide-binding oligomerization domain (NOD)-like receptor (NLR) family play important roles in antimicrobial immunity. However, transcription mechanism of nod1 and nod2 and their signal circle are less understood in teleost fish. In this study, with the cloning of card9 and ripk2 in Chinese perch, the interaction between NOD1, NOD2, and CARD9 and RIPK2 were revealed through coimmunoprecipitation and immunofluorescence assays. The overexpression of NOD1, NOD2, RIPK2 and CARD9 induced significantly the promoter activity of NF-kB, IFNh and IFNc. Furthermore, it was found that nod1 and nod2 were induced by poly(I:C), type I IFNs, RLR and even NOD1/NOD2 themselves through the ISRE site of their proximal promoters. It is thus indicated that nod1 and nod2 can be classified also as ISGs due to the presence of ISRE in their proximal promoter, and their expression can be mechanistically controlled through PRR pathway as well as through IFN signaling in antiviral immune response. [ABSTRACT FROM AUTHOR]

Transcription initiation, the first step in gene expression, has been studied extensively in dilute buffer, a condition which fails to consider the crowded environment in live cells. Recent reports indicate the kinetics of promoter escape is altered in crowded conditions for a consensus bacterial promoter. Here, we use a real‐time fluorescence enhancement assay to study the kinetics of unwound bubble formation and promoter escape for three separate promoters. We find that the effect of crowding on transcription initiation is complex, with lower rates of unwound bubble formation, higher rates of promoter escape, and large variations depending on promoter identity. Based on our results, we suggest that altered conditions of crowding inside a live cell can trigger global changes. [ABSTRACT FROM AUTHOR]

The emergence of new technologies often brings with it a complex interplay between their acceptance by society, gauging their risks, and whether it is warranted for the state to be involved -- typically via new or amended regulation. However, what drives regulators and decision-makers to even consider the question of whether there is a need for involvement has remained under-studied. In this article, we propose viewing regulation as a process with five distinct phases: laissez-faire, awareness, politicisation, regulation and cool-off. A critical phase is the transition between awareness and politicisation, as the latter commonly leads to regulatory action. We look at the emergence of regulation for artificial intelligence, aviation, genetically modified organisms, disinformation and retail self-checkouts to show that there is a correlation between distrust and politicisation. We further show the probable causal link specifically for regulating artificial intelligence in the EU, and derive possible policy implications from this conclusion. [ABSTRACT FROM AUTHOR]

We devised a novel strategy that relies on a combination of the primer exchange reaction (PER) with transcription isothermal amplification, termed PER-Trap, for a sensitive biomolecular assay. Its design allowed light-up RNA aptamers to be produced as the final product, leading to the generation of an amplified fluorescence signal. The utility of PER-Trap was successfully demonstrated by the detection of exosomes. [ABSTRACT FROM AUTHOR]

Background: Advancement in agricultural biotechnology has resulted in increasing numbers of commercial varieties of genetically modified (GM) crops worldwide. Though several databases on GM crops are available, these databases generally focus on collecting and providing information on transgenic crops rather than on screening strategies. To overcome this, we constructed a novel tool named, Genetically Modified Organisms Identification Tool (GMOIT), designed to integrate basic and genetic information on genetic modification events and detection methods. Results: At present, data for each element from 118 independent genetic modification events in soybean, maize, canola, and rice were included in the database. Particularly, GMOIT allows users to customize assay ranges and thus obtain the corresponding optimized screening strategies using common elements or specific locations as the detection targets with high flexibility. Using the 118 genetic modification events currently included in GMOIT as the range and algorithm selection results, a "6 + 4" protocol (six exogenous elements and four endogenous reference genes as the detection targets) covering 108 events for the four crops was established. Plasmids pGMOIT-1 and pGMOIT-2 were constructed as positive controls or calibrators in qualitative and quantitative transgene detection. Conclusions: Our study provides a simple, practical tool for selecting, detecting, and screening strategies for a sustainable and efficient application of genetic modification. [ABSTRACT FROM AUTHOR]

Xanthomonas oryzae pv. oryzae (Xoo) injects major transcription activator-like effectors (TALEs) into plant cells to activate susceptibility (S) genes for promoting bacterial leaf blight in rice. Numerous resistance (R) genes have been used to construct differential cultivars of rice to identify races of Xoo, but the S genes were rarely considered. Different edited lines of rice cv. Kitaake were constructed using CRISPR/Cas9 gene-editing, including single, double and triple edits in the effector-binding elements (EBEs) located in the promoters of rice S genes OsSWEET11a, OsSWEET13 and OsSWEET14. The near-isogenic lines (NILs) were used as tracers to detect major TALEs (PthXo1, PthXo2, PthXo3 and their variants) in 50 Xoo strains. The pathotypes produced on the tracers determined six major TALE types in the 50 Xoo strains. The presence of the major TALEs in Xoo strains was consistent with the expression of S genes in the tracers, and it was also by known genome sequences. The EBE editing had little effect on agronomic traits, which was conducive to balancing yield and resistance. The rice-tracers generated here provide a valuable tool to track major TALEs of Xoo in Asia which then shows what rice cultivars are needed to combat Xoo in the field. [ABSTRACT FROM AUTHOR]

Lysine lactylation (Kla) links metabolism and gene regulation and plays a key role in multiple biological processes. However, the regulatory mechanism and functional consequence of Kla remain to be explored. Here, we report that HBO1 functions as a lysine lactyltransferase to regulate transcription. We show that HBO1 catalyzes the addition of Kla in vitro and intracellularly, and E508 is a key site for the lactyltransferase activity of HBO1. Quantitative proteomic analysis further reveals 95 endogenous Kla sites targeted by HBO1, with the majority located on histones. Using site-specific antibodies, we find that HBO1 may preferentially catalyze histone H3K9la and scaffold proteins including JADE1 and BRPF2 can promote the enzymatic activity for histone Kla. Notably, CUT&Tag assays demonstrate that HBO1 is required for histone H3K9la on transcription start sites (TSSs). Besides, the regulated Kla can promote key signaling pathways and tumorigenesis, which is further supported by evaluating the malignant behaviors of HBO1- knockout (KO) tumor cells, as well as the level of histone H3K9la in clinical tissues. Our study reveals HBO1 serves as a lactyltransferase to mediate a histone Kla-dependent gene transcription. The regulatory mechanism and functional consequence of lysine lactylation remain to be explored. Here, the authors identify HBO1 as a lysine lactyltransferase and suggest a potential role of HBO1 in tumorigenesis through H3K9la-mediated transcription regulation. [ABSTRACT FROM AUTHOR]

Cell state transitions are prevalent in biology, playing a fundamental role in development, homeostasis and repair. Dysregulation of cell state transitions can lead to or occur in a wide range of diseases. In this letter, I explore and highlight the role of post-transcriptional regulatory mechanisms in determining the dynamics of cell state transitions. I propose that regulation of protein levels after transcription provides an under-appreciated regulatory route to obtain fast and sharp transitions between distinct cell states. This article is part of a discussion meeting issue 'Causes and consequences of stochastic processes in development and disease'. [ABSTRACT FROM AUTHOR]

Food safety, closely related to economic development of food industry and public health, has become a global concern and gained increasing attention worldwide. Effective detection technology is of great importance to guarantee food safety. Although several classical detection methods have been developed, they have some limitations in portability, selectivity, and sensitivity. The emerging CRISPR-Cas systems, uniquely integrating target recognition specificity, signal transduction, and efficient signal amplification abilities, possess superior specificity and sensitivity, showing huge potential to address aforementioned challenges and develop next-generation techniques for food safety detection. In this review, we focus on recent progress of CRISPR-Cas mediated biosensing and their applications in food safety monitoring. The properties and principles of commonly used CRISPR-Cas systems are highlighted. Notably, the frequently coupled nucleic acid amplification strategies to enhance their selectivity and sensitivity, especially isothermal amplification methods, as well as various signal output modes are also systematically summarized. Meanwhile, the application of CRISPR-Cas systems-based biosensors in food safety detection including foodborne virus, foodborne bacteria, food fraud, genetically modified organisms (GMOs), toxins, heavy metal ions, antibiotic residues, and pesticide residues is comprehensively described. Furthermore, the current challenges and future prospects in this field are tentatively discussed. [ABSTRACT FROM AUTHOR]

Paired Ga sites represented by the Ga–O–Si–O–Ga sequence were firstly formed intentionally in CHA-type zeolite frameworks via the transcription of pre-formed paired Ga species in a Ga-rich amorphous silica–gallia under seed-assisted hydrothermal conditions. Such paired Ga sites behaved as ion-exchange sites for capturing divalent cation, Co2+. [ABSTRACT FROM AUTHOR]

Transcription termination has evolved to proceed through diverse mechanisms. For several classes of terminators, multiple models have been debatably proposed. Recent single-molecule studies on bacterial terminators have resolved several long-standing controversies. First, termination mode or outcome is twofold rather than single. RNA is released alone before DNA or together with DNA from RNA polymerase (RNAP), i.e. with RNA release for termination, RNAP retains on or dissociates off DNA, respectively. The concomitant release, described in textbooks, results in one-step decomposition of transcription complexes, and this ‘decomposing termination’ prevails at ρ factor-dependent terminators. Contrastingly, the sequential release was recently discovered abundantly from RNA hairpin-dependent intrinsic terminations. RNA-only release allows RNAP to diffuse on DNA in both directions and recycle for reinitiation. This ‘recycling termination’ enables one-dimensional reinitiation, which would be more expeditious than three-dimensional reinitiation by RNAP dissociated at decomposing termination. Second, while both recycling and decomposing terminations occur at a hairpin-dependent terminator, four termination mechanisms compatibly operate at a ρ-dependent terminator with ρ in alternative modes and even intrinsically without ρ. RNA-bound catch-up ρ mediates recycling termination first and decomposing termination later, while RNAP-prebound stand-by ρ invokes only decomposing termination slowly. Without ρ, decomposing termination occurs slightly and sluggishly. These four mechanisms operate on distinct timescales, providing orderly fail-safes. The stand-by mechanism is benefited by terminational pause prolongation and modulated by accompanying riboswitches more greatly than the catchup mechanisms. Conclusively, any mechanism alone is insufficient to perfect termination, and multiple mechanisms operate compatibly to achieve maximum possible efficiency under separate controls. [ABSTRACT FROM AUTHOR]

The successful progression of meiosis prophase I requires integrating information from the structural and molecular levels. In this study, we show that ZFP541 and KCTD19 work in the same genetic pathway to regulate the progression of male meiosis and thus fertility. The Zfp541 and/or Kctd19 knockout male mice show various structural and recombination defects including detached chromosome ends, aberrant localization of chromosome axis components and recombination proteins, and globally altered histone modifications. Further analyses on RNA‐seq, ChIP‐seq, and ATAC‐seq data provide molecular evidence for the above defects and reveal that ZFP541/KCTD19 activates the expression of many genes by repressing several major transcription repressors. More importantly, we reveal an unexpected role of ZFP541/KCTD19 in directly modulating chromatin organization. These results suggest that ZFP541/KCTD19 simultaneously regulates the transcription cascade and chromatin organization to ensure the coordinated progression of multiple events at chromosome structural and biochemical levels during meiosis prophase I. [ABSTRACT FROM AUTHOR]

Transcription therapy is an emerging approach that centers on identifying the factors associated with the malfunctioning gene transcription machinery that causes diseases and controlling them with designer agents. Until now, the primary research focus in therapeutic gene modulation has been on small‐molecule drugs that target epigenetic enzymes and critical signaling pathways. However, nucleic acid‐based small molecules have gained popularity in recent years for their amenability to be pre‐designed and realize operative control over the dynamic transcription machinery that governs how the immune system responds to diseases. Pyrrole–imidazole polyamides (PIPs) are well‐established DNA‐based small‐molecule gene regulators that overcome the limitations of their conventional counterparts owing to their sequence‐targeted specificity, versatile regulatory efficiency, and biocompatibility. Here, we emphasize the rational design of PIPs, their functional mechanisms, and their potential as targeted transcription therapeutics for disease treatment by regulating the immune response. Furthermore, we also discuss the challenges and foresight of this approach in personalized immunotherapy in precision medicine. [ABSTRACT FROM AUTHOR]

Following the submission of dossier GMFF‐2022‐3670 under Regulation (EC) No 1829/2003 from Corteva Agriscience Belgium BV and Bayer Agriculture BV, the Panel on genetically modified organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant and insect‐resistant genetically modified maize MON 89034 × 1507 × NK603, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and a search for additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in maize MON 89034 × 1507 × NK603 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF‐2022‐3670 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034 × 1507 × NK603. [ABSTRACT FROM AUTHOR]

Following the joint submission of dossier GMFF‐2022‐9170 under Regulation (EC) No 1829/2003 from Bayer Agriculture B.V. and Corteva Agriscience Belgium B.V., the Panel on genetically modified organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide tolerant and insect resistant genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post‐market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF‐2022‐9170 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations. [ABSTRACT FROM AUTHOR]

Genetically modified (GM) maize MON 94804 was developed to achieve a reduction in plant height by introducing the GA20ox_SUP suppression cassette. The molecular characterisation and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the agronomic/phenotypic and compositional differences identified between maize MON 94804 and its conventional counterpart needs further assessment, except for ear height, plant height and levels of carbohydrates in forage, which do not raise safety or nutritional concerns. The Panel on Genetically Modified Organisms (GMO Panel) does not identify safety concerns regarding the toxicity and allergenicity of the GA20ox_SUP precursor‐miRNA and derived mature miRNA as expressed in maize MON 94804 and finds no evidence that the genetic modification would change the overall allergenicity of maize MON 94804. In the context of this application, the consumption of food and feed from maize MON 94804 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MON 94804 is as safe as the conventional counterpart and non‐GM maize varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 94804 grains into the environment, this would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 94804. The GMO Panel concludes that maize MON 94804 is as safe as its conventional counterpart and the tested non‐GM maize varieties with respect to potential effects on human and animal health and the environment. [ABSTRACT FROM AUTHOR]

Highly pathogenic avian influenza viruses (HPAIV) are a major threat to the global poultry industry and public health due to their zoonotic potential. Since 2016, Europe and France have faced major epizootics caused by clade 2.3.4.4b H5 HPAIV. To reduce sample-to-result times, point-of-care testing is urgently needed to help prevent further outbreaks and the propagation of the virus. This study presents the design of a novel real-time colourimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay for the detection of clade 2.3.4.4b H5 HPAIV. A clinical validation of this RT-LAMP assay was performed on 198 pools of clinical swabs sampled in 52 poultry flocks during the H5 HPAI 2020–2022 epizootics in France. This RT-LAMP assay allowed the specific detection of HPAIV H5Nx clade 2.3.4.4b within 30 min with a sensitivity of 86.11%. This rapid, easy-to-perform, inexpensive, molecular detection assay could be included in the HPAIV surveillance toolbox. [ABSTRACT FROM AUTHOR]

Vibrio parahaemolyticus, the leading cause of seafood-associated gastroenteritis, has a strong capacity to form biofilms on surfaces, which is strictly regulated by the CpsS–CpsR–CpsQ regulatory cascade. OpaR, a master regulator of quorum sensing, is a global regulator that controls multiple cellular pathways including biofilm formation and virulence. QsvR is an AraC-type regulator that works coordinately with OpaR to control biofilm formation and virulence gene expression of V. parahaemolyticus. QsvR and OpaR activate cpsQ transcription. OpaR also activates cpsR transcription, but lacks the detailed regulatory mechanisms. Furthermore, it is still unknown whether QsvR regulates cpsR transcription, as well as whether QsvR and OpaR regulate cpsS transcription. In this study, the results of quantitative real-time PCR and LacZ fusion assays demonstrated that deletion of qsvR and/or opaR significantly decreased the expression levels of cpsS and cpsR compared to the wild-type strain. However, the results of two-plasmid lacZ reporter and electrophoretic mobility-shift assays showed that both QsvR and OpaR were unable to bind the regulatory DNA regions of cpsS and cpsR. Therefore, transcription of cpsS and cpsR was coordinately and indirectly activated by QsvR and OpaR. This work enriched our knowledge on the regulatory network of biofilm formation in V. parahaemolyticus. [ABSTRACT FROM AUTHOR]