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The diversity of genetically modified plants used for food and feed is increasing worldwide. For the detection and control of these products, efficient and reliable analytical tools are a prerequisite. This can be done by screening for specific DNA-elements and constructs characteristic of transgenic plants. In the past, numerous methods have already been published. However, several genetically modified plants are not covered by common screening methods. Here, a new qualitative triplex real-time polymerase chain reaction (PCR) method is presented, detecting two transgene flanking sequences and the transition between the Cassava Vein Mosaic Virus Promotor (P-CsVMV) and the phosphinothricin-N-acetyltransferase (pat) gene. These sequences are present in several transgenic plants and therefore, the described triplex method can be used as a screening tool to guide further analysis and increase the efficiency of the analysis strategy for GMO detection. The method is characterized by high specificity, sensitivity and robustness and is provided as a ring-trial validated method in the Official Collection of Methods according to the German Food and Feed Act. [ABSTRACT FROM AUTHOR]

Intensification in agriculture affects many insect species, including butterflies. Insect‐resistant crops, such as Bt (Bacillus thuringiensis) maize, which produces a toxin active against Lepidoptera, are an alternative to insecticide sprays. Genetically modified crops are regulated in most countries and require an environmental risk assessment. In the European Union, such assessments include the use of simulation models to predict the effects on nontarget Lepidoptera (NTL). To support the assessment of protected NTL, we extended an individual‐based, stochastic, spatially explicit mathematical model (LepiX) to include a wider range of exposure scenarios, a species‐sensitivity distribution, and an option for repeated exposure of individuals. We applied the model to transgenic maize DAS‐1507, which expresses a high concentration of Bt toxin in pollen that may be consumed by NTL larvae on their host plants nearby. Even in the most conservative scenario without repeated exposure, mortality estimates for highly sensitive species ranged from 41% to 6% at distances of 10–1000 m from the nearest maize field. Repeated exposure can cause additional mortality and thus is relevant for the overall risk assessment. Uncertainties in both exposure and ecotoxicity estimates strongly influenced the predicted mortalities. Care should be taken to include these uncertainties in the model scenarios used for decision‐making. In accordance with other modeling results, our simulations demonstrated that mean mortality may not be safe for protected species. With its high pollen expression, DAS‐1507 maize may pose risks to sensitive and protected butterfly and moth species that may be difficult to manage. High expression of Bt toxin in pollen is unnecessary for controlling target pests. Consequently, we suggest that Bt maize with high pollen expression not be cultivated in regions where protected butterflies are to be conserved. [ABSTRACT FROM AUTHOR]

Background: For market approval of genetically modified plants (GMPs), the evaluation of agronomic and phenotypic plant traits is a standard requirement and part of the comparative assessment of the GMP and its conventional counterpart. This comparative assessment is a starting point for environmental risk assessment (ERA) and should inform all areas of risk. We scrutinize frequently used approaches to characterize GMPs in EU market applications and discuss their usefulness for drawing conclusions on risks related to the plant's ability to survive, persist or become invasive. Results: Our analysis shows that the agronomic and phenotypic characterization of GMPs, although based on guidelines, is confined to plant traits and test designs that are relevant for the quality control and agronomic performance of genetically modified (GM) crops. We provide evidence of how methodological approaches frequently applied during the agronomic and phenotypic characterization of the GMP could be improved and complemented to better inform on potential phenotypic changes relevant to assessing environmental risks. These approaches refer to (i) the assessment of the survival of GM seeds and plants (e.g., volunteers); (ii) the consideration of environmental exposure and (iii) improved methodological approaches for the assessment of biotic and abiotic stress responses for GMPs. Conclusions: The comparative assessment of agronomic and phenotypic plant traits currently does not provide suitable data to draw conclusions on environmental risks relating to the persistence and invasiveness of the GMP. Ecologically more realistic assessments should be part of the phenotypic characterization of GMPs and need guidance and decision criteria to be implemented in ERA. This is of considerable importance, as new genomic techniques are expected to increase the diversity and complexity of GM plants and traits, particularly stress tolerance, which may affect the survival of GMPs in the environment. [ABSTRACT FROM AUTHOR]

The development and improvement of molecular biology methods have led to the creation of new technologies that make it possible to modify plant genomes by transferring and integrating into the genomes' heterologous genes from various expression systems (genetic engineering), as well as inducing knockouts of one or more target genes of interest (genomic editing). The development of genome-editing methods is a new milestone in the development of modern breeding methods and certainly relies on the knowledge and technologies developed for transgenesis. This review will discuss issues related to the advantages and disadvantages of both technologies for improving the economically valuable traits of important crops. [ABSTRACT FROM AUTHOR]

The history of US biotechnology oversight for genetically modified plants is analyzed in the context of policy process theories to derive insights for contemporary governance of gene-edited plants. The Advocacy Coalition Framework sheds light on how opposing coalitions with different policy beliefs struggled to influence oversight, along with coalition disputes over the scope of issues that should be considered in regulatory policy-making. The Multiple Streams Approach and Punctuated Equilibrium Theory explain how focusing events arising from these struggles opened "windows of opportunity" to put issues on the public policy agenda and force changes to oversight over time. For example, nongovernmental organizations had a prominent role in bringing legal challenges through federal courts or in raising attention to risk issues in the media—efforts that prompted advancements in federal regulations, guidance documents, or risk-mitigation practices for biotechnology oversight. These policy dynamics depended on public information to bring controversies to light and elicit a policy response. However, recent biotech regulations allow for gene-edited crops to enter the marketplace without requirements for public disclosure or tracking. Lack of transparency jeopardizes the public legitimacy of gene-edited crops, venues for public participation in biotechnology oversight, and ultimately responsiveness to adapt oversight to future biotech products and emerging risks. [ABSTRACT FROM AUTHOR]

The European Union has been very slow to embrace GMOs in comparison with most other countries, requiring extensive authorizations for use and especially crop cultivation, where only one Maize variety is currently approved. However, with more testing recent advances in Genetic Bioengineering and the current concerns regarding the global and European food supply, it is important to question whether the European scepticism surrounding GM crops is justified. Hence, the aim of this paper is to review the studies regarding GMO safety for use in food and feed and discuss the benefits of their large scale use in the European Union. Our results conclude that the extensive use and cultivation of GM crops in the European Union would be both beneficial and safe. [ABSTRACT FROM AUTHOR]

This article discusses women’s reproductive agency and/or suppression in connection with biotechnological innovations in the agricultural industry, especially genetically modified crops (GMOs). To do so, it takes up Ruth Ozeki’s creative response on this interconnection, the 2002 novel All Over Creation, which utilizes a fictional farmer community in Idaho to address broader cultural issues such as sexism, racism, and reproductive justice. The analysis shows how All Over Creation first and foremost succeeds via a multivocal narrative to create a feminist response to both neoliberal biotechnological enhancements and dominant cultural notions of fertility, reproduction, and motherhood. At the same time, this article neglects the utopian potential that critics and reviewers have attributed to the text, and instead reveals how such a reading not only ignores substantial aspects of the novel’s ideological complexity, but also unmasks a reader’s complicity with (hetero-)normative understandings of reproduction. [ABSTRACT FROM AUTHOR]

The development and improvement of molecular biology methods have led to the creation of new technologies that make it possible to modify plant genomes by transferring and integrating into the genomes’ heterologous genes from various expression systems (genetic engineering), as well as inducing knockouts of one or more target genes of interest (genomic editing). The development of genome-editing methods is a new milestone in the development of modern breeding methods and certainly relies on the knowledge and technologies developed for transgenesis. This review will discuss issues related to the advantages and disadvantages of both technologies for improving the economically valuable traits of important crops.

This study presents the possible consequences of maintaining the current regulatory regime of the experimental release of genetically modified higher plants in the EU for the products of new genomic techniques (NGTs). Currently, the experimental release is a crucial stage before the authorization of a product for the market. By analyzing the data on the performance of field trials in the EU (numbers, sizes, dominating countries) and comparing the present regulatory provisions with those of selected third countries (including new provisions adopted in the UK), this study shows that the current framework of GMO (genetically modified organisms) field trials is ill-fitted for breeding activities. Due to strict limitations placed on the operator of a field trial in the EU, easing the regulatory burdens on the authorization of certain NGT products for the market may not provide researchers (especially, plant breeders) the competitive position they need if the present legal conditions for carrying out GMO field trials with certain NGT products (especially, those that are considered GMOs covered by the EU GMO legislation) are not going to change as well. [ABSTRACT FROM AUTHOR]

Since the first successful transgenic plants obtained in 1983, dozens of plants have been tested. On the one hand, genetically modified plants solve the problems of agricultural production. However, due to exogenous genes of transgenic plants, such as its seeds or pollen drift, diffusion between populations will likely lead to superweeds or affect the original traits. The detection technology of transgenic plants and their products have received considerable attention. Electrochemical sensing technology is a fast, low-cost, and portable analysis technology. This review interprets the application of electrochemical technology in the analysis and detection of transgenic products through bibliometrics. A total of 83 research articles were analyzed, spanning 2001 to 2021. We described the different stages in the development history of the subject and the contributions of countries and institutions to the topic. Although there were more annual publications in some years, there was no explosive growth in any period. The lack of breakthroughs in this technology is a significant factor in the lack of experts from other fields cross-examining the subject. Through keyword co-occurrence analysis, different research directions on this topic were discussed. The use of nanomaterials with excellent electrical conductivity allows for more sensitive detection of GM crops by electrochemical sensors. Furthermore, co-citation analysis was used to interpret the most popular reports on the topic. In the end, we predict the future development of this topic according to the analysis results. [ABSTRACT FROM AUTHOR]

Plant diseases represent a major constraint on agricultural production. Finding sustainable novel means for their control is an important challenge. The ever‐increasing knowledge and understanding of plant–microbe interactions has led to several ingenious transgenic approaches to combat disease. The first transgenic disease‐resistant plants expressed single or a few stacked genes encoding antimicrobial proteins. Whereas the first attempts were disappointing in the field, several examples from recent field studies are promising and some of these use ingenious designer approaches. Less progress has been made with antimicrobial metabolites where the challenges lie in obtaining biosynthetic genes and in coordinating their expression. The increased understanding of the processes regulating plant defence (plant immunity) and modes of action of pathogen effector proteins have also led to novel strategies for designing resistant plants. The most promising of these is host‐induced gene silencing that targets specific pathogens, either the effectors or, preferably, essential housekeeping genes. With these approaches, and several maverick examples of "genes pulled out of a hat," the technical effort in designing resistant plants is finally paying off. The prospects are good, biologically speaking, but can industry deliver? There is still an issue of public acceptance of genetic engineering of crop plants, especially in Europe; so whilst considerable strategic and practical progress has been made over the last decade, vanishingly few products have been adopted by agriculture. Some of these have been in use for over two decades. As yet, all are against viral diseases and not against diseases caused by microorganisms. [ABSTRACT FROM AUTHOR]

Although nearly three decades have passed since genetically modified crops (so-called 'GMOs') were widely commercialized, vociferous debate remains about the use of biotechnology in agriculture, despite a worldwide scientific consensus on their safety and utility. This study analyzes the volume and tenor of the GMO conversation as it played out on social and traditional media between 2018 and 2020, looking at 103,084 online and print articles published in English-language media around the world as well as 1,716,071 social media posts. To our knowledge, our analysis is the first comprehensive survey of the shifting traditional and online media discourse on this issue during this time period. While the volume of traditional media coverage of GMOs increased significantly during the period, this was combined with a dramatic drop in the volume of social media posts of over 80%. Traditional media tended to be somewhat more positive in their coverage than social media in 2018 and 2019, but that gap disappeared in 2020. Both traditional and social media saw trends toward increasing favorability, with the positive trend especially robust in social media. The large decline in volume of social media posts, combined with a strong trend toward greater favorability, may indicate a drop in the salience of the GMO debate among the wider population even while the volume of coverage in traditional media increased. Overall, our results suggest that both social and traditional media may be moving toward a more favorable and less polarized conversation on ag-biotech overall. [ABSTRACT FROM AUTHOR]

Agrobacterium tumefaciens-mediated gene transfer—actually the most used method to engineer plants—may lead to integration of multiple copies of T-DNA in the plant genome, as well as to chimeric tissues composed of modified cells and wild type cells. A molecular characterization of the transformed lines is thus a good practice to select the best ones for further investigation. Nowadays, several quantitative and semi-quantitative techniques are available to estimate the copy number (CN) of the T-DNA in genetically modified plants. In this study, we compared three methods based on (1) real-time polymerase chain reaction (qPCR), (2) droplet digital PCR (ddPCR), and (3) next generation sequencing (NGS), to carry out a molecular characterization of grapevine edited lines. These lines contain a knock-out mutation, obtained via CRISPR/Cas9 technology, in genes involved in plant susceptibility to two important mildew diseases of grapevine. According to our results, qPCR and ddPCR outputs are largely in agreement in terms of accuracy, especially for low CN values, while ddPCR resulted more precise than qPCR. With regard to the NGS analysis, the CNs detected with this method were often not consistent with those calculated by qPCR and ddPCR, and NGS was not able to discriminate the integration points in three out of ten lines. Nevertheless, the NGS method can positively identify T-DNA truncations or the presence of tandem/inverted repeats, providing distinct and relevant information about the transgene integration asset. Moreover, the expression analysis of Cas9 and single guide RNA (sgRNA), and the sequencing of the target site added new information to be related to CN data. This work, by reporting a practical case-study on grapevine edited lines, explores pros and cons of the most advanced diagnostic techniques available for the precocious selection of the proper transgenic material. The results may be of interest both to scientists developing new transgenic lines, and to laboratories in charge of GMO control. [ABSTRACT FROM AUTHOR]

In the globalized agri-food system of the 21st century, plantations of genetically modified crops have increased considerably worldwide, justified by arguments such as food security and feeding the world's population. In Brazil, genetically modified organisms (GMOs) have indisputably consolidated as a hegemonic type of market-centered agriculture, despite continuous resistance. Therefore, the research question guiding this study is what are the discursive articulations that prompted GMO hegemony in Brazil, despite the distinctive counterhegemonic articulations shaping this field of struggle? Grounded on Laclau and Mouffe's political discourse theory (PDT) of hegemony formation, we qualitatively assess a corpus of mainstream newspaper articles and documental sources to develop a longitudinal analysis of the GMO arena. Our analysis of key periods helps elucidate GMO hegemony establishment in Brazil, comprising six articulation processes conducted by pro-GMO actors concerning anti-GMO discourses. Our paper contributes to a better understanding of how hegemonic actors in rural Brazil shaped articulation practices to establish GMO hegemony, diminishing state and media control, and fostering market-oriented arrangements. • GMOs represent a cornerstone of agro-neoliberalism in Brazil, despite resistance. • This hegemony developed through discursive articulations that aim at fixing meanings. • A longitudinal analysis enabled these discursive articulations to be identified. • Key periods over the last decades led to the settlement of GMO hegemony. • Pro-GMO actors followed a modus operandi, comprising six articulation processes. [ABSTRACT FROM AUTHOR]

Copyright of Clivajes - Revista de Ciencias Sociales is the property of Universidad Veracruzana and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

An intensely debated question is whether or how a mandatory environmental risk assessment (ERA) should be conducted for plants obtained through novel genomic techniques, including genome editing (GE). Some countries have already exempted certain types of GE applications from their regulations addressing genetically modified organisms (GMOs). In the European Union, the European Court of Justice confirmed in 2018 that plants developed by novel genomic techniques for directed mutagenesis are regulated as GMOs. Thus, they have to undergo an ERA prior to deliberate release or being placed on the market. Recently, the European Food Safety Authority (EFSA) published two opinions on the relevance of the current EU ERA framework for GM plants obtained through novel genomic techniques (NGTs). Regarding GE plants, the opinions confirmed that the existing ERA framework is suitable in general and that the current ERA requirements need to be applied in a case specific manner. Since EFSA did not provide further guidance, this review addresses a couple of issues relevant for the case-specific assessment of GE plants. We discuss the suitability of general denominators of risk/safety and address characteristics of GE plants which require particular assessment approaches. We suggest integrating the following two sets of considerations into the ERA: considerations related to the traits developed by GE and considerations addressing the assessment of method-related unintended effects, e.g., due to off-target modifications. In conclusion, we recommend that further specific guidance for the ERA and monitoring should be developed to facilitate a focused assessment approach for GE plants. [ABSTRACT FROM AUTHOR]

Copyright of Revista Colombiana de Ciencias Hortícolas is the property of Revista Colombiana de Ciencias Horticolas and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Molecular characterization of genetically modified plants can provide crucial information for the development of detection and identification methods, to comply with traceability, and labeling requirements prior to commercialization. Detailed description of the genetic modification was previously a challenging step in the safety assessment, since it required the use of laborious and time-consuming techniques. In this study an accurate, simple, and fast method was developed for molecular characterization of genetically modified (GM) plants, following a user-friendly workflow for researchers with limited bioinformatic capabilities. Three GM events from a diverse array of crop species—perennial ryegrass, white clover, and canola—were used to test the approach that exploits long-read sequencing by the MinION device, from Oxford Nanopore Technologies. The method delivered a higher degree of resolution of the transgenic events within the host genome than has previously been possible with the standard Illumina short-range sequencing strategies. The flanking sequences, copy number, and presence of backbone sequences, and overall transgene insertion structure were determined for each of the plant genomes, with the additional identification of moderate-sized secondary insertions that would have previously been missed. The proposed workflow takes only about 1 week from DNA extraction to analyzed result, and the method will complement the existing approaches for molecular characterization of GM plants, since it makes the process faster, simpler, and more cost-effective. [ABSTRACT FROM AUTHOR]

This statement supplements and updates the GMO Panel guidance document on allergenicity of genetically modified (GM) plants published in 2017. In that guidance document, the GMO Panel considered that additional investigations on in vitro protein digestibility were needed before providing any additional recommendations in the form of guidance to applicants. Thus, an interim phase was proposed to assess the utility of an enhanced in vitro digestion test, as compared to the classical pepsin resistance test. Historically, resistance to degradation by pepsin using the classical pepsin resistance test has been considered as additional information, in a weight-of-evidence approach, for the assessment of allergenicity and toxicity of newly expressed proteins in GM plants. However, more recent evidence does not support this test as a good predictor of allergenic potential for hazard. Furthermore, there is a need for more reliable systems to predict the fate of the proteins in the gastrointestinal tract and how they interact with the relevant human cells. Nevertheless, the classical pepsin resistance test can still provide some information on the physicochemical properties of novel proteins relating to their stability under acidic conditions. But other methods can be used to obtain data on protein's structural and/or functional integrity. It is acknowledged that the classical pepsin resistance test is embedded into international guidelines, e.g. Codex Alimentarius and Regulation (EU) No 503/2013. For future development, a deeper understanding of protein digestion in the gastrointestinal tract could enable the framing of more robust strategies for the safety assessment of proteins. Given the high complexity of the digestion and absorption process of dietary proteins, it is needed to clarify and identify the aspects that could be relevant to assess potential risks of allergenicity and toxicity of proteins. To this end, a series of research questions to be addressed are also formulated in this statement. [ABSTRACT FROM AUTHOR]

This paper updates previous assessments of the environmental impacts associated with using crop biotechnology (specifically genetically modified crops) in global agriculture. It focuses on the environmental impacts associated with changes in pesticide use and greenhouse gas emissions arising from the use of GM crops since their first widespread commercial use 22 years ago. The adoption of GM insect resistant and herbicide tolerant technology has reduced pesticide spraying by 775.4 million kg (8.3%) and, as a result, decreased the environmental impact associated with herbicide and insecticide use on these crops (as measured by the indicator, the Environmental Impact Quotient (EIQ)) by 18.5%. The technology has also facilitated important cuts in fuel use and tillage changes, resulting in a significant reduction in the release of greenhouse gas emissions from the GM cropping area. In 2018, this was equivalent to removing 15.27 million cars from the roads. [ABSTRACT FROM AUTHOR]

The probability of contamination of non-transgenic varieties with genetically modified (GM) products increase as a result of global expansion of areas sown with transgenic crops. DNA-based methods as accurate, efficient and reliable methods are preferable for detection of GM material in raw or highly processed foods. Isolation of high quality DNA with a suitable and efficient DNA extraction protocol is crucial for getting precise results in DNA amplification. In this study, we performed modifications of previously known Sodium dodecyl sulfate (SDS)-based DNA extraction method regarding the incubation period, DNA pellet washing and addition of organic solvent extraction, to improve DNA quality and to reduce costs. Raw corn kernels and roasted soybean seed were used as samples. DNA was extracted following three protocols, modifications of Edwards protocol. The type of detergent used in raw corn sample did not cause significant effects on extracted DNA yield and purity, while in roasted soybean samples the 2% (w/v) SDS lysis buffer gave the highest DNA yield. The additional incubation step raised the DNA yield from raw corn for 121%, while the purest DNA from soybean sample was obtained using organic solvent extraction. Electrophoretic determination of DNA integrity showed varying degree of DNA smearing from roasted soybean. Contrary, all extraction protocols used on raw corn kernels produced a high molecular weight DNA. Thus, our in-house DNA extraction protocol is as efficient but more cost effective compared to commercial kits and can be used for raw corn, while the protocol for roasted soybean needs further improvement. [ABSTRACT FROM AUTHOR]

Soy and maize are the most cultivated genetically modified (GM) crops in the world, which are commonly used in many food products. Establishing regulations for food products containing transgenic materials are obligatory in many countries in order to provide consumers with information. For this purpose, an accurate qualitative polymerase chain reaction (PCR) method was applied to investigate GM food products from Iran. In present study, a total of 90 non-labeled soy and maize samples were collected from Tehran's market and their DNA were extracted by a kit. All samples were analyzed to screen the 35 S promoter and (nopaline synthase) NOS terminator elements. Having screened the GM positive samples, they were subjected to identification of specific transgenic events RR soy, Bt11 and MON810 maize with PCR. According to our results, 95% of soy and 60% of maize analyzed samples were positive for the 35 S promoter and NOS terminator. Furthermore, event-specific analysis indicated the presence of RR soy, Bt11 and MON810 maize in tested samples, while none of these food-derived samples demonstrated any GM label. The obtained results revealed that the necessity of monitoring system to provide a good reliable control of GM materials in food products and subsequently on their labeling. [ABSTRACT FROM AUTHOR]

CRISPR/Cas genome editing of plants is realized in three basic variants, including knockout mutations as indels, insertion of alien DNA fragments, and base editing via deamination of nitrogenous bases. The most important stages of the CRISPR/Cas-based genome editing are the choice of a target site, design of guide RNAs, creation of genetically engineered constructions, and delivery of CRISPR/Cas components into a plant cell. Rapid developments in the field of plant genome editing with the use of CRISPR/Cas systems requires more detailed consideration of the last stage, so this review is dedicated to the description of the main ways to deliver CRISPR/Cas components into cells of higher plants. In the first studies on the genome editing of different plant species, these components were delivered to the target site mainly by Agrobacterium tumefaciens. This approach supposes integration of T-DNA into a genome and a stable expression of CRISPR/Cas components or their transient expression in the case of agroinfiltration. Another widespread approach included the use of plant viruses as delivery platforms; in this case, viruses were used mainly for production of an increased amount of guide RNAs that significantly improved the efficiency of genome editing. Another approach provides for the use of another bacterium, A. rhizogenes, as a platform for delivery of CRISPR/Cas components. This bacterium induces hairy root formation that may be an indirect confirmation of successful genome editing and assist in the selection of genetically modified forms. Other common ways to obtain genetically edited plants are the biolistic delivery of genetically engineered constructions into explants and various protoplast transformation technologies. The review also considers some issues transgenic and GM status of CRISPR/Cas-edited plants to transgenic and GM plants. There are a number of cases in which new organisms created by a CRISPR/Cas genome editing without any introduction of alien DNA were not considered as transgenic ones; it is quite possible that such plants will not fall under Russian legislation prohibiting GMO cultivation. [ABSTRACT FROM AUTHOR]

Abstract A novel amperometric genosensor based on PNA probes covalently bound on the surface of Single Walled Carbon Nanotubes – Screen Printed Electrodes (SWCNT-SPEs) was developed and validated in samples of non-amplified genomic DNA extracted from genetically modified (GM)-Soy. The sandwich assay is based on a first recognition of a 20-mer portion of the target DNA by a complementary PNA Capture Probe (CP) and a second hybridization with a PNA Signalling Probe (SP), with a complementary sequence to a different portion of the target DNA. The SP was labelled with biotin to measure current signal by means of a final incubation of an Alkaline Phosphatase-streptavidin conjugate (ALP-Strp). The electrochemical detection was carried out using hydroquinone diphosphate (HQDP) as enzymatic substrate. The genoassay provided a linear range from 250 pM to 2.5 nM, LOD of 64 pM and LOQ of 215 pM Excellent selectivity towards one base mismatch (1-MM) or scrambled (SCR) sequences was obtained. A simple protocol for extraction and analysis of non-amplified soybean genomic DNA without sample treatment was developed and validated. Our study provides insight into how the outstanding recognition efficiency of PNAs can be combined with the unique properties of CNTs in terms of signal response enhancement for direct detection of genomic DNA samples at the level of interest without previous amplification. Highlights • First amperometric genosensor based on PNA immobilized on carbon nanotubes. • PNA provided high selectivity while carbon nanotubes exhibited high sensitivity. • Direct determination of genomic DNA from GM Soy, without preamplification. • Validation on soybean flour, matching the EC Regulation (0.9% threshold limit). • Screening tool valuable for food authenticity assessment. [ABSTRACT FROM AUTHOR]

Knowledge of the number of DNA sequences targeted by the taxon-specific reference assays is essential for correct GM quantification and is key to the harmonisation of measurement results. In the present study droplet digital PCR (ddPCR) was used to determine the number of DNA target copies of taxon-specific assays validated for real-time PCR for the four main genetically modified (GM) crops. The transferability of experimental conditions from real-time PCR to ddPCR was also explored, as well as the effect of DNA digestion. The results of this study indicate that for each crop at least one taxon-specific assay can be identified as having a single DNA target. A short list of taxon-specific reference assays is proposed as best candidates for the relative quantification of GM events for soybean, maize, cotton and oilseed rape. The investigated assays could be in most cases transferred to ddPCR without further optimisation. The use of DNA digestion did not improve ddPCR characteristics such as rain and resolution at the conditions tested. [ABSTRACT FROM AUTHOR]

The present of genetically modified organism (GMO) in food materials such as soybeans regulated by Indonesian Food and Drug Administration. To impose the law, reliable methods to detect transgenic component are needed. Validation of the real-time polymerase chain reaction (real time-PCR) to detect the presence of transgenic in soybeans and tempeh has been accomplished. The method used a specific primer to amplify promoter 35S. The method could correctly distinguish GMO soybeans from non-transgenic one. The precision of the method is high as represented by CV value of Ct, which is 7.1% (acceptance criteria < 25%). The realtime PCR still give precise fluorescent signal up to 5pg of DNA template, as a representation of limit of detection of the methods. By the method, one commercial soybean labeled as non-GMO has been detected as GMO soybean, while most imported soybeans as well as the commercial tempeh are GMO. [ABSTRACT FROM AUTHOR]

Genetically Modified (GM) foods have been a debated topic for decades, and consumer concerns are widespread. Scientific proposals to increase consumer acceptance include the use of cisgenics, where GM technology is used but the inserted gene(s) originates from closely related organisms. Results from a choice experiment display greater willingness to pay (WTP) for cisgenics than transgenics, although traditional methods are preferred, and more accessible information about the technologies increases acceptance. The disutility from cisgenics and transgenics is offset by the utility from product quality improvement related to eating experience, indicating potential demand for cisgenic food, provided it improves the product in aspects of importance to the consumers. [ABSTRACT FROM AUTHOR]

Analysis of non-transgenic seed samples for the presence of genetically modified maize MON863 revealed unexpected amplification signals using an official qPCR method. These amplification signals only occured when using other master mix products as in the original validation process. DNA sequence data from an unspecific amplicon could be mapped to mitochondrial maize DNA reference sequence. Oligo sequence analysis revealed that forward primer and probe both can hybridize to the mitochondrial maize DNA leading to unspecific amplification signals in qPCR. Therefore, we designed and validated a new qPCR method for event MON863 with a LOD of 5 copies per reaction. The method shows high specificity as no unspecific amplification signal was detected after analysis of reference material for different genetically modified crops and conventional maize samples. Robustness tests were performed in two different laboratories and no effects on method performance could be observed when using different master mixes and qPCR devices, as well as with variation in oligonucleotide concentrations. [ABSTRACT FROM AUTHOR]

Soybean MON 87751 was developed through Agrobacterium tumefaciens-mediated transformation to provide protection certain specific lepidopteran pests by the expression of the Cry1A.105 and Cry2Ab2 proteins derived from Bacillus thuringiensis. The molecular characterisation data and bioinformatic analyses did not identify issues requiring assessment for food and feed safety. None of the compositional, agronomic and phenotypic differences identified between soybean MON 87751 and the conventional counterpart required further assessment. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the Cry1A.105 and Cry2Ab2 proteins as expressed in soybean MON 87751, and found no evidence that the genetic modification might significantly change the overall allergenicity of soybean MON 87751. The nutritional impact of soybean MON 87751-derived food and feed is expected to be the same as those derived from the conventional counterpart and non-GM commercial reference varieties. The GMO Panel concludes that soybean MON 87751, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the non-GM soybean reference varieties tested, and no post-market monitoring of food and feed is considered necessary. In the case of accidental release of viable soybean MON 87751 seeds into the environment, soybean MON 87751 would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87751. In conclusion, soybean MON 87751, as described in this application, is as safe as its conventional counterpart and the tested non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment. [ABSTRACT FROM AUTHOR]

The three-event stack cotton GHB614 x T304-40 x GHB119 was produced by conventional crossing to combine three single events, GHB614, T304-40 and GHB119. The genetically modified organisms (GMO) Panel previously assessed the three single cotton events and did not identify safety concerns. No new data on the single cotton events that could lead to modification of the original conclusions on their safety were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single cotton events and of the newly expressed proteins in the three-event stack cotton did not give rise to food and feed safety concern. The GMO Panel considers that the three-event stack cotton GHB614 x T304-40 x GHB119 has the same nutritional impact as its comparator and the non-GM reference varieties tested. The GMO Panel concludes that the three-event stack cotton GHB614 x T304-40 x GHB119, as described in this application, is nutritionally equivalent to and as safe as its comparator and the non-GM reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable GHB614 x T304-40 x GHB119 cottonseeds into the environment, this three-event stack would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton GHB614 x T304-40 x GHB119 seeds. The GMO Panel concludes that cotton GHB614 x T304-40 x GHB119, as described in this application, is as safe as its comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment. [ABSTRACT FROM AUTHOR]

In this opinion, the GMO Panel assessed the four-event stack maize Bt11 x MIR162 x 1507 x GA21 and three of its subcombinations, independently of their origin. The GMO Panel previously assessed the four single events and seven of their combinations and did not identify safety concerns. No new data on the single events or the seven subcombinations leading to modification of the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single events in the four-event stack maize did not give rise to food/feed safety issues. Based on the nutritional assessment of the compositional characteristics of maize Bt11 x MIR162 x 1507 x GA21, foods and feeds derived from the genetically modified (GM) maize are expected to have the same nutritional impact as those derived from non-GM maize varieties. In the case of accidental release of viable grains of maize Bt11 x MIR162 x 1507 x GA21 into the environment, this would not raise environmental safety concerns. The GMO Panel concludes that maize Bt11 x MIR162 x 1507 x GA21 is nutritionally equivalent to and as safe as its non-GM comparator in the context of the scope of this application. For the three subcombinations included in the scope, for which no experimental data were provided, the GMO Panel assessed the likelihood of interactions among the single events and concluded that their combinations would not raise safety concerns. These maize subcombinations are therefore expected to be as safe as the single events, the previously assessed subcombinations and the four-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize Bt11 x MIR162 x 1507 x GA21 and its subcombinations. A minority opinion expressed by a GMO Panel member is appended to this opinion. [ABSTRACT FROM AUTHOR]

This paper updates previous assessments of the environmental impacts associated with using crop biotechnology in global agriculture. It focuses on the environmental impacts associated with changes in pesticide use and greenhouse gas emissions arising from the use of GM crops since their first widespread commercial use over 20 years ago. The adoption of GM insect resistant and herbicide tolerant technology has reduced pesticide spraying by 671.4 million kg (8.2%) and, as a result, decreased the environmental impact associated with herbicide and insecticide use on these crops (as measured by the indicator, the Environmental Impact Quotient (EIQ)) by 18.4%. The technology has also facilitated important cuts in fuel use and tillage changes, resulting in a significant reduction in the release of greenhouse gas emissions from the GM cropping area. In 2016, this was equivalent to removing 16.7 million cars from the roads. [ABSTRACT FROM AUTHOR]

Bees play an important role in the pollination of a wide range of plants and are likely to encounter genetically engineered crops (often termed "genetically modified" or "GM") during their foraging period, especially insect-resistant crops since these crops have been cultivated worldwide. Thus, it is important to assess potential impacts of these crops on the nontarget organism honey bee (Apis mellifera L.), the most important pollinator species worldwide. In the present study, we gathered all scientific data related to the effects of insect-resistant GM crops (mostly corn and cotton, and also oilseed rape, rice, soybean, and wheat) on honey bees. Assessments included feeding honey bees with purified insecticidal toxins or transgenic pollen collected from GM crops producing such toxins, namely protease inhibitors (PIs), Cry or VIP toxins from Bacillus thuringiensis. RNAi-producing and herbicide-tolerant crops were also included. A total of 64 peer-reviewed studies have been published between 1994 and 2017. We also compiled 18 studies submitted to and examined by the US EPA between 1993 and 2002. Our analyses converge to the conclusion that the studied Cry proteins, RNAi or herbicide-tolerance proteins do not negatively affect the survival of honey bees and have no potential sublethal effect in controlled laboratory conditions or in field/semifield trials. The risk of PI will mainly depend on their concentration in pollen and need to be assessed case by case. [ABSTRACT FROM AUTHOR]

Biotech news coverage in English-language Russian media fits the profile of the Russian information warfare strategy described in recent military reports. This raises the question of whether Russia views the dissemination of anti-GMO information as just one of many divisive issues it can exploit as part of its information war, or if GMOs serve more expansive disruptive purposes. Distinctive patterns in Russian news provide evidence of a coordinated information campaign that could turn public opinion against genetic engineering. The recent branding of Russian agriculture as the ecologically clean alternative to genetically engineered foods is suggestive of an economic motive behind the information campaign against western biotechnologies. [ABSTRACT FROM AUTHOR]

Regulating Genome Edited Crops (GEC) is emerging as an important issue as such crops is expected to be cultivated commercially in many countries within the next few years. GEC are not Genetically Modified Crops because there is no insertion of foreign gene or DNA in them and the process of genome editing does not involve adding foreign genetic elements in them. But the European Court of Justice in its ruling given in July 2018 has declared that GEC should be regulated as GM crops. This has resulted in controversy as it is feared that if GEC are to be treated as GMOs it would create regulatory hurdles and confusion among public. This note discusses the issues in regulating Genome Edited Crops, in light of this decision. [ABSTRACT FROM AUTHOR]

In spite of the lack of scientific justification for skepticism about crops modified with molecular techniques of genetic engineering, they have been the most scrutinized agricultural products in human history. The assumption that “genetically engineered” or “genetically modified” is a meaningful - and dangerous - classification has led to excessive and dilatory regulation. The modern molecular techniques are an extension, or refinement, of older, less precise, less predictable methods of genetic modification, but as long as today's activists and regulators remain convinced that so called “GMOs” represent a distinct and dangerous category of research and products, genetic engineering will fall short of its potential. [ABSTRACT FROM AUTHOR]

This document provides guidance for the risk assessment under Regulation (EC) No 1829/2003 of the unintended, adventitious or technically unavoidable presence in food and feed of low level of genetically modified plant material intended for markets other than in the European Union. In this context, the presence at low level is defined to be maximum 0.9% of genetically modified plant material per ingredient. This guidance is intended to assist applicants by indicating which scientific requirements of Annex II of Regulation (EU) No 503/2013 are considered necessary for the risk assessment of the presence at low levels of genetically modified plant material in food and feed. [ABSTRACT FROM AUTHOR]

GM crops are the most studied crops in history. Approximately 5% of the safety studies on them show adverse effects that are a cause for concern and tend to be featured in media reports. Although these reports are based on just a handful of GM events, they are used to cast doubt on all GM crops. Furthermore, they tend to come from just a few laboratories and are published in less important journals. Importantly, a close examination of these reports invariably shows methodological flaws that invalidate any conclusions of adverse effects. Twenty years after commercial cultivation of GM crops began, a bona fide report of an adverse health effect due to a commercialized modification in a crop has yet to be reported. [ABSTRACT FROM AUTHOR]

The introduction of genes isolated from different Bacillus thuringiensis strains to express Cry-type toxins in transgenic crops is a common strategy to confer insect resistance traits. This work intended to extensively in silico analyse Cry1A(b)16 protein for the identification of peptide markers for the biorecognition of transgenic crops. By combining two different strategies based on several bioinformatic tools for linear epitope prediction, a set of seven peptides was successfully selected as potential Cry1A(b)16 immunogens. For the prediction of conformational epitopes, Cry1A(b)16 models were built on the basis of three independent templates of homologue proteins of Cry1A(a) and Cry1A(c) using an integrated approach. PcH_736-746 and PcH_876-886 peptides were selected as the best candidates, being synthesised and used for the production of polyclonal antibodies. To the best of our knowledge, this is the first attempt of selecting and defining linear peptides as immunogenic markers of Cry1A(b)-type toxins in transgenic maize. [ABSTRACT FROM AUTHOR]

In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO Panel) assessed the three-event stack maize MON 87427 × MON 89034 × NK603 and its three subcombinations, independently of their origin. The GMO Panel has previously assessed the three single events combined to produce this three-event stack maize and did not identify safety concerns. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single maize events and of the newly expressed proteins in the three-event stack maize did not give rise to issues regarding food and feed safety or nutrition. In the case of accidental release of viable grains of maize MON 87427 × MON 89034 × NK603 into the environment, the three-event stack maize would not raise environmental safety concerns. The GMO Panel concludes that the threeevent stack maize is as safe and as nutritious as the non-GM comparator and the tested non-GM reference varieties in the context of its scope. The GMO Panel considered that its previous conclusions on the two-event stack maize MON 89034 × NK603 remain valid. For the two maize subcombinations for which no experimental data were provided the GMO Panel assessed the likelihood of interactions among the single events, and concluded that their combination would not raise safety concerns. These two subcombinations are therefore expected to be as safe as the single events, the previously assessed maize MON 89034 × NK603 and maize MON 87427 × MON 89034 × NK603. Since the post-market environmental monitoring plan for the three-event stack maize does not include any provisions for the two subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly. [ABSTRACT FROM AUTHOR]

The GMO Panel has previously assessed genetically modified (GM) soybean 40-3-2 as a single event and as part of a two-event stack, 305423 × 40-3-2. These soybean events were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential effects on human and animal health and the environment. On 4 April 2017, European Commission requested EFSA to analyse new nucleic acid sequencing and updated bioinformatics data for soybean event 40-3-2 and to indicate whether the conclusions of the GMO Panel on the previously assessed GM soybeans remain valid. The new sequencing data indicated that, the sequence of soybean event 40-3-2 as present in the stacked soybean 305423 × 40-3-2 contains an additional nucleotide in the 50 flanking region of a 72 bp additional insert of CP4 EPSPS present in soybean 40-3-2. Re-examination of the original sequencing data of the single soybean event 40-3-2 by the applicant, indicated that this additional nucleotide was already present in the original plant material used for the risk assessment of soybean event 40-3-2. Thus, with the exception of bioinformatics analyses, the studies performed for the risk assessment of the single event soybean 40-3-2 and the two-event stack soybean 305423 × 40-3-2 remain valid. The updated bioinformatic analyses performed on the corrected sequence did not give rise to safety issues. Therefore, EFSA concludes, based on the information provided, that the original risk assessment of the soybean event 40-3-2 as a single and the stacked soybean 305423 × 40-3-2 remains valid. [ABSTRACT FROM AUTHOR]

In this opinion, the GMO Panel assessed the five-event stack maize MON 87427 ×MON 89034 × 1507 × MON 88017 × 59122 and its 25 subcombinations, independently of their origin. The GMO Panel has previously assessed the five single events combined to produce this five-event stack maize and 11 subcombinations of these events and did not identify safety concerns. No new data on the single events or their previously assessed subcombinations, leading to modification of the original conclusions were identified. The combination of the single events and of the newly expressed proteins in the five-event stack maize did not give rise to issues - based on the molecular, agronomic/ phenotypic or compositional characteristics - regarding food and feed safety and nutrition. Considering the scope of this application, the known biological function of the newly expressed proteins and the data available for the five-event stack maize and its previously assessed maize subcombinations, the GMO Panel considered that different combinations of the single events would not raise environmental concerns. The GMO Panel concludes that the five-event stack maize is as safe and as nutritious as the non-genetically modified (GM) comparator and the tested non-GM reference varieties in the context of its scope. For the 14 maize subcombinations for which no experimental data were provided, the GMO Panel assessed the likelihood of interactions among the single events, and concluded that their combinations would not raise safety concerns. These maize subcombinations are therefore expected to be as safe as the single events, the previously assessed subcombinations and maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122. Since the post-market environmental monitoring plan for the five-event stack maize does not include any provisions for the 14 maize subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly. [ABSTRACT FROM AUTHOR]